cyrilzakka/clinical-trials huggingface dataset:
Mandibular Advancement Device and Changes in Nocturia

The main purpose of this study is to test is mandibular advacenment device (MAD) use is associated with reductions in nocturia.

After been informed about the study and informed about risks and benefits, participants will be fitted with a MAD and will be asked to completed questionnaires at baseline, in between follow ups and during follow ups. Nocturia will be assess and appliance will be titrated every 2 weeks until participants report less than 2 voiding per night according to the daily dairies. At that point, second sleep study with MAD in place will be performed to assess treatment effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* English speaker
* \>18 y/o
* Obstructive sleep apnea diagnosis with AHI≥5
* ≥ 2 voiding/night at baseline
* Upon clinical examination ≥ 8 teeth per arch, range of mandibular protrusion ≥5 mm
* Consent to participate in the study.

Exclusion Criteria:

* Patients with concomitant diagnosed sleep disorders (i.e. insomnia, narcolepsy, restless legs syndrome, rapid eye movement sleep behavior disorder).
* Prostate/kidney problems (urological disease: (eg overactive bladder, benign prostate hyperplasia)
* Pregnancy
* Heart failure, use of diuretics, diabetes, Parkinson's disease or dementia.
* Patients using combination therapy for the management of obstructive sleep apnea (OSA) (i.e. positive airway pressure (PAP) therapy or positional therapy).
* Upon clinical examination: periodontal disease (\>4 mm on periodontal probing, with bleeding on probing, visual signs of periodontal inflammation); tooth horizontal mobility \>1 mm, vertical mobility, and unfavorable crown to root ratio; open cavities, loose or fractured restorations, or patient undergoing restorative dental treatments.
* Exaggerated gag reflex.
* Lack of coordination or dexterity.
* Inadequate English comprehension.
A Dose-Finding Study to Evaluate the Efficacy and Safety of GSK3858279 in Adults With Knee Osteoarthritis (OA) Pain

This is dose-finding study of GSK3858279 in participants with moderate to severe knee osteoarthritis pain. The purpose of this study is to investigate and provide the data necessary to select the optimal effective and safe dose(s) of GSK3858279.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be 40 to 80 years of age inclusive
* OA of the index knee as defined by symptomatic for ≥ 6 months with a clinical diagnosis of OA as per American College of Rheumatology (ACR) clinical diagnosis criteria.
* Kellgren and Lawrence (KL) score ≥ 2 on X-ray in the index knee
* An average of the average daily pain score of ≥4 and less than or equal to (≤) 9 by the 11-point NRS (0-10)
* Body mass index (BMI) of \< 40 kilogram per meter square (kg/m\^2) (inclusive).
* Capable of giving signed informed consent.

Exclusion Criteria:

* History or presence of cardiovascular, renal, gastrointestinal, lymphatic disorders which in the opinion of the investigator would interfere with the study procedures and/or assessments.
* History or current evidence of any inflammatory arthritis such as rheumatoid arthritis, infective arthritis, Paget's disease, osteonecrosis, osteoporotic fracture, or any other joint disease that in the Investigator's opinion would interfere with the assessment of pain and other symptoms of osteoarthritis.
* History of significant trauma or surgery to a knee or hip within the last 6 months.
* Current immunodeficiency diseases including but not limited to acquired immunodeficiency disorder or immunoglobulin deficiency.
* Current or previous active Mycobacterium tuberculosis
* History or evidence of clinically significant multiple or severe drug allergies
* History of malignancy within the last 5 years, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
* Alanine transaminase (ALT) \>1.5 times upper limit of normal (ULN).
* Bilirubin \>1.5 times ULN (isolated bilirubin \>1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin \< 35 percent (%)
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
* Evidence of renal insufficiency, indicated by estimated creatinine clearance \< 60 milliliter/ minute (mL/min)/1.73 square meter (m\^2) at screening.
* Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
A Study Evaluating Efruxifermin in Subjects With Non-invasively Diagnosed Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Nonalcoholic Fatty Liver Disease (NAFLD)/Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

The aim of this study is to assess the safety and tolerability of EFX compared to placebo in subjects with non-invasively diagnosed NASH/MASH and NAFLD/MASLD.


Eligibility Criteria:
Inclusion Criteria:

Main Study Only:

* Males and non-pregnant, non-lactating females between 18 - 80 (between 19-80 in the Republic of Korea) years of age inclusive, on the day of signing informed consent
* Previous history or presence of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose) or type 2 diabetes
* Suspected or confirmed diagnosis of NASH/MASH or NAFLD/MASLD or non-invasively diagnosed NASH/MASH or NAFLD/MASLD

Open-Label Rollover

* Prior participation in the placebo arm of a previous Akero Phase 2 study

Exclusion Criteria:

* Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results, including but not limited to: alcoholic liver disease, autoimmune disorders (e.g., primary biliary cholangitis \[PBC\], primary sclerosing cholangitis \[PSC\], autoimmune hepatitis), drug induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency
* Type 1 or unstable Type 2 diabetes

A reduced list of inclusion and exclusion criteria apply to participants in the open-label rollover extension.

Other inclusion and exclusion criteria may apply.
A Product Performance Evaluation of a Novel Contact Lens for Daily Disposable Use

Evaluation of the clinical performance of a novel Bausch \& Lomb daily disposable contact lens when compared to the currently marketed Bausch \& Lomb SofLens® daily disposable contact lenses and the currently marketed Johnson and Johnson 1-Day Acuvue Moist contact lenses when worn by adapted soft contact lens wearers on a daily disposable basis.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with VA correctable to 0.3 logMAR (driving vision) or better in each eye.
* Subjects must have clear central corneas and be free of any anterior segment disorders.
* Subjects must be myopic and require lens correction in both eyes.

Exclusion Criteria:

* Subjects with any systemic disease affecting ocular health.
* Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
* Subjects wearing monovision, multifocal or toric contact lenses.
* Subjects with grade 2 or greater slit lamp findings.
Persistence of the Immune Response to Hepatitis B in 7-9 Years Old Children Previously Vaccinated With DTPa-HBV-IPV/Hib

Persistence of seroprotective antibody concentrations \& immunological memory shown by the ability to mount a response to a challenge dose of HBV vaccine


Eligibility Criteria:
Inclusion Criteria:

* A male or female aged 7 to 9 years at the time of study entry .
* Subjects who have received a total of 4 doses of DTPa-HBV-IPV/Hib vaccine or a total of 4 doses of HBV vaccine in previous vaccination studies.
* Evidence of previous hepatitis B booster vaccination or disease since administration of the fourth dose of DTPa-HBV-IPV/Hib or HBV vaccine.
Study of Real Clinical Practice to Evaluate the Effects of Oral Dydrogesterone for Treatment of Confirmed Endometriosis

A non-interventional, observational program to assess the effects of dydrogesterone (Duphaston®) 6-months-administration in patients with confirmed endometriosis in a post-marketing setting in the Russian Federation

A non-interventional, observational program to assess the effects of oral dydrogesterone therapy in a post-marketing setting whether the effects are related to the regimen of dydrogesterone therapy. In this observational program, assuming that dydrogesterone plays a role in the treatment of endometriosis without suppression of ovulation, the goal is to observe the possible implications of such treatment in terms of treatment regimen and response pattern. In the study will be described effects of Duphaston® 6-months-administration in patients with confirmed endometriosis by assessing pain relief, quality of life, need of self-medication with analgesics, etc.

Eligibility Criteria:
Inclusion Criteria:

* Female, aged ≥ 18 years and ≤ 45 years.
* Complaints on chronic pelvic pain with or without dysmenorrhea assessed by 11-items NRS.
* External genital endometriosis confirmed by laparoscopy.
* Existing pelvic (vaginal) ultrasound data not earlier than 2 months before inclusion in the study.
* Prescribed treatment with Duphaston® according local labelling for treatment of endometriosis 10 mg 2-3 times a day from the 5th to the 25th day of the menstrual period cycle or continuously.
* No hormonal treatment in 2 cycles before enrollment.
* Signed Patient Authorization for Use/Disclosure of Data.

Exclusion Criteria:

* Any co-existing disease(s) needing chronic drug therapy (e.g. Crohn's disease, diabetes etc); Severe concomitant medical illness.
* Severe other genital pathology excluding endometriosis (e.g. Multiple/severe myoma; adenomyosis, inflammatory diseases, etc.).
* Routine consumption of analgesics other than for the pain of endometriosis.
* Patients receiving hormonal contraceptives in last 2 cycles (including intrauterine devices, contraceptive patches, contraceptive rings, oral contraceptives etc.).
* Ongoing pregnancy.
* Menopause or premature ovarian failure.
* Contraindications to dydrogesterone treatment listed in the locally approved label (Instructions for the medical use of Duphaston®).
* Any other condition that precludes use of dydrogesterone in a particular patient, in accordance with the precautions and special warnings listed in the locally approved label (Instructions for the medical use of Duphaston®).
* Abnormal results of pap smear test.
* Other conditions that made the patients participation impossible (based on the investigator decision).
* Fertility treatments using assisted reproductive technology.
To Investigate Efficacy and Safety of Pemetrexed as Second or Third Line Therapy in Patients With Non-small Cell Lung Cancer (NSCLC)

To investigate efficacy and safety of pemetrexed as second or third line therapy in patients with non-small cell lung cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* Clinical stage III or IV
* Previously treated with one or two chemotherapeutic regimens
* Performance status: 0-2

Exclusion Criteria:

- Inability or unwillingness to take folic acid or vitamin B12 supplementation
Experience of Pain During Oocyte Retrieval- a Comparison Between Two Aspiration Needles

The purpose of the study is to compare the pain experience between the patients that have had their transvaginal oocytes retrieval with ultrasound guidance performed with reduced single lumen needle (Vitrolife Sweden AB, Gothenburg) with the patients that have had follicle aspiration needle, 1.4 outer diameter (Vitrolife Sweden AB, Gothenburg), during the procedure.

Although the patient is sedated and local analgesia has been given, transvaginal oocytes retrieval with ultrasound guidance can still cause a lot of pain, both during and after the procedure. To reduce the pain, some clinics prefer to use needles as thin as 0.8 mm (outer diameter, OD). A disadvantage with these needles is the increased aspiration time. Therefore a new needle has been developed that has the possibility to reduce pain without a large increase in aspiration time. The needle has a 50 mm long tip with an outer diameter of 0.9 mm. The remaining part of the needle is 300 mm long with an outer diameter of 1.4 mm.

Eligibility Criteria:
Inclusion Criteria:

* The patient has signed an informed consent form before the oocyte retrieval
* The patient is undergoing oocyte retrieval with local anaesthesia
* The patient can speak and understand Swedish

Exclusion Criteria:

* The patient has previously participated in Vitrolife-needle-01 study
* The patient has a body mass index ≥35
* Other contra indicator for oocyte retrieval
Carbidopa/Levodopa Combined With Behavioral Therapy for the Treatment of Cocaine Dependence

Cocaine dependence is a major public health problem and the development of a treatment for this disorder is a priority. To date, treatment interventions based on positive incentive principles have shown the strongest effects for improving substance use outcomes. One such example is contingency management (CM) interventions in which nondrug rewards are used to compete with cocaine. Recent evidence suggests that certain medications improve response to CM interventions, particularly agents that target dopamine reward systems in the brain. A promising dopamine-enhancing medication is levodopa. The study team has observed the strongest effects of levodopa when the medication is administered in the context of CM therapy, perhaps through mechanisms that enhance reward saliency. The proposed study is designed to further evaluate this promising treatment approach. Cocaine dependent outpatients will participate in a randomized, 2-group (levodopa vs. placebo), double-blind clinical trial. CM will be behavioral therapy platform for both treatment groups. The study will test the primary hypothesis that CM+levodopa will be more effective than CM+placebo in reducing cocaine use. This study is expected to validate the usefulness of a new behavioral-pharmacological treatment approach for cocaine dependence.


Eligibility Criteria:
Inclusion Criteria:

* between 18 and 60 years of age
* meet Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition (DSM-IV) criteria for current cocaine dependence.
* be in acceptable health on the basis of interview, medical history and physical exam.

Exclusion Criteria:

* current DSM-IV diagnosis of any psychoactive substance dependence other than cocaine, marijuana, or nicotine.
* have a DSM-IV axis I psychiatric disorder or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe.
* have significant current suicidal or homicidal ideation.
* have medical conditions contraindicating levodopa/carbidopa pharmacotherapy. Conditions include severe pulmonary disease (bronchial asthma, emphysema), cardiovascular disease (severe or history of myocardial infarction with residual arrhythmias), narrow angle glaucoma, melanoma, history of peptic ulcer, renal function impairment.
* taking medications known to have significant drug interactions with levodopa/carbidopa (e.g., monoamine oxidase (MAO) inhibitors, anticonvulsants, haloperidol, phenothiazines, selegiline, anesthetics).
* currently or recently (last 3 months) treated for substance use or another psychiatric condition.
* having conditions of probation or parole requiring reports of drug use to officers of the court.
* impending incarceration.
* pregnant or nursing for female patients.
* inability to read, write, or speak English.
Face-to-face Versus Online Hypnotherapy for the Treatment of Irritable Bowel Syndrome

Psychological therapies are effective in reducing irritable bowel syndrome (IBS) symptom severity and increasing quality of life and are recommended for the management of IBS by guidelines. Evidence appears strongest for the efficacy of hypnotherapy as psychological treatment. However, therapist-led interventions are time consuming and relatively costly. Approaches based on e-health are cost saving and appear more attractive to patients as no visits to a therapist are necessary. Therefore, the investigators plan to conduct a multicentre randomised controlled trial to examine whether the effectiveness of online hypnotherapy is non-inferior compared to individual face-to-face hypnotherapy delivered by a therapist, according to current FDA guidelines. Online psychoeducation will be used as control condition. In addition, the investigators hypothesize that treatment with online hypnotherapy is a more cost-effective therapy than face-to-face hypnotherapy in IBS patients.


Eligibility Criteria:
Inclusion criteria:

* Age 16-65 years
* A diagnosis of IBS according to the Rome IV criteria
* In the presence of alarm symptoms, such as rectal blood loss, weight loss, anemia, first onset of symptoms above 50 years of age, patients will be first referred for further investigation by their treating physician to exclude organic disorders, conform current Dutch guidelines for IBS.
* Women in fertile age must use contraception or be postmenopausal for at least two years.

Exclusion criteria:

* Insufficient command of the Dutch language
* No access to internet
* Evidence of current anxiety and/or depression disorder as defined by a score ≥10 on the GAD-7 and/or PHQ-9 questionnaire. In this case it is conceivable that the IBS symptoms are strongly related to psychopathology for which different treatment might be more appropriate.
* History of ulcerative colitis, Crohn's disease, coeliac disease or significant liver disease
* Major surgery to the lower gastrointestinal tract, such as partial or total colectomy, small bowel resection or partial or total gastrectomy
* Past or present radiotherapy to the abdomen
* Current pregnancy or lactation
* Using of psychoactive medication in case there's no stable dose for at least 3 months prior to inclusion
* Use of over-the-counter or prescription antidiarrheals, analgesics and laxatives (only be allowed as specific rescue medication)
* Hypnotherapy treatment received in the last 3 months prior to inclusion
* Using more than 20 units of alcohol per week
* Using drugs of abuse
Diagnostic and Prognostic Biomarkers of Sepsis

This study aims to evaluate sepsis biomarkers as soluble triggering receptor expressed on myeloid cells 1 (sTREM-1) and soluble urokinase plasminogen activator receptor (sUPAR) in diagnosis of sepsis in comparison to the traditional blood culture and C-reactive protein (CRP) and to evaluate the prognostic value of these biomarkers in comparison to sequential organ failure assessment score (SOFA score), Acute Physiology and Chronic Health Evaluation II ( APACHI score), 28 day mortality.

Sepsis is usually diagnosed in patients have clinically suspected infections with systemic inflammatory response syndrome (SIRS) manifestations. Patients with SIRS as those with trauma or stroke have the same classic infection signs such as fever and elevated leukocytic count, as long as the microbiological diagnosis is the ultimate diagnostic method, but it has poor sensitivity with delayed results. New biomarkers such as sTREM-1 and sUPAR can be used for rapid diagnosis of sepsis and differentiating it from non infectious inflammatory syndromes. Also these soluble biomarkers can be used for predicting the prognosis of sepsis patients

Eligibility Criteria:
Inclusion Criteria:

* Temperature of \>38oC
* Heart rate of \>90 beats/min
* Respiratory rate of \>20 breaths/min
* Partial pressure of arterial carbon dioxide (PaCO2) of \<32 mmHg
* White blood cell (WBC) count of \>12,000 cells/mm3

Exclusion Criteria:

* HIV patients
* Patients with neutropenia \<1000 cells/mm3
* \<18 years of age.
Thrombosed External Hemorrhoids: Comparison of the Thrombectomy and Local Excision Procedures in Terms of Results and Outcome (TEH)

The primary aim of the current study is to evaluate and compare 6-month complication rates after thrombectomy and local excision treatments.

The investigators aim to compare thrombectomy and local excision treatments in many different aspects:

* The investigators will follow these patients for 6 months by scheduling follow-up visits (or by phone if the patient cannot attend) 4 times during this period (1st week, 1st month, 3rd month, 6th month).
* The investigators will examine bleeding, pain, anal stricture/stenosis, infection, time until return to normal daily activity, relapse and incontinence after treatment
* To assess quality of life outcomes, the investigators use the 36-Item Short Form Health Survey (SF-36). These measures rely upon patient self-reporting and are utilized for routine monitoring and assessment of care outcomes in patients.
* The investigators will use the Wexner incontinence score for assessment of incontinence.

In each hospital, medical students, residents and surgeons can be involved in the study. In the following 6-month period, all collaborators will be collecting the data of the patients who have been operated for external hemorrhoids via the thrombectomy or local excision procedures.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are diagnosis with thrombosed external hemorrhoids.
* Providing a written informed consent form for the surgeries and for participation in the study
* Patients aged 18 years and over should be included

Exclusion Criteria:

* Patients younger than 18 years of age,
* Pregnancy
* Patients who have a history of cancer or inflammatory bowel disease(IBD)
* Patients who have a history of anorectal fistula
* Patients with metabolic disorders
* Patients with alcohol or substance addiction
* Patients who refuse to participate in the study and do not provide informed consent
* Patients who, at any stage of the study, indicate that they want to leave the study.
Cerebral Small Vessel Disease Registry Study

The aim of this study is to determine the clinical spectrum and natural progression of Cerebral Small Vessel Disease (CSVD) and in a prospective multicenter study, to assess the clinical, genetic and epigenetic features of patients with CSVD, , to find independent imaging markers, and to optimize clinical management.


Eligibility Criteria:
Inclusion Criteria:

1. Sign informed consent.
2. Age\>18
3. At least one of the following CSVD MRI characteristics: ①recent small subcortical infarct;②lacune of presumed vascular origin;③white matter hypertensity of presumed vascular origin;④perivascular space;⑤cerebral microbleeds;⑥brain atrophy

Exclusion Criteria:

1. Unable to cooperate with inspectors
2. Non-vascular white matter lesions
3. Other cognitive diseases (such as alzheimer's disease, Parkinson's disease or thyroid disease)
4. Serious systemic illness, such as heart, liver, kidney disease or major mental illness
5. Contraindications for imaging examination
N. Meningitidis Carriage Study

This carriage study aims to evaluate the presence of meningococcus in Asian populations (and potential for disease) and explore the extent and serogroup distribution of meningococci circulating in the population.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes can and will comply with the requirements of the protocol or subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol.
* Written informed consent obtained from the subject/from the parent(s)/LAR of the subject.
* Asymptomatic subjects attending a school or university.
* A male or female between, and including 5 and 24 years of age at the time of enrollment.

Exclusion Criteria:

* Subjects who have received a meningococcal conjugate vaccine.
* Use of any investigational or non-registered product within one week before the enrollment visit.
* Acute respiratory tract infection within 14 days of sample collection.
* Immune deficiencies, haematological disorders and oncological disease.
* Use of steroids or immunosuppressant drugs within 14 days of sample collection.
* Administration of antibiotics within the 2 weeks preceding the collection of sample.
* Cranio-facial malformations prohibiting the collection of posterior pharyngeal swabs.
* Child in care.