cyrilzakka/clinical-trials huggingface dataset:
Obeticholic Acid in Bariatric and Gallstone Disease

By binding to the nuclear receptor FXR, bile acids not only regulate their own turn-over but presumably also pivotal steps in cholesterol, triglyceride and glucose metabolism as shown in laboratory animals. Obeticholic acid (OCA) is a semisynthetic bile acid with very high affinity to FXR. In a pharmacodynamic study the effects of OCA on bile acid, lipid and glucose turn-over are studied in 20 morbidly obese and 20 gallstones patents, respectively, that are administered OCA at 25 mg/day in three weeks before bariatric (BS) or gallstone (GS) surgery where in addition to blood samples also biopsies are taken from the liver and in the case of BS, omental and subcutaneous adipose tissue and in case of GS, gallbladder bile.

In a placebo-controlled double-blind randomized trial, 20 otherwise healthy morbidly obese patients scheduled for bariatric surgery, and 20 otherwise healthy gallstone patients will be administered 25 mg/day INT-747 or placebo for three weeks until the day before surgery. Serum from days 1 and 21 will be analyzed for routine liver tests, bile acids, a complete lipid profile including FA and in addition for 7α-hydroxy-4-cholesten-3-one and FGF-19, markers for bile acid synthesis and its intestinal stimulation. For the evaluation of insulin resistance and possible pre-diabetes, plasma will be taken for the estimation of HOMA index and oral glucose tolerance test (OGTT) will be performed at days 1 and 21. At surgery, a liver biopsy (0.5-1 g) and a white adipose tissue (WAT) specimen (1 cm2) will be taken and immediately frozen in liquid nitrogen for mRNA and protein preparation for quantitative RT-PCR and Western analysis, respectively, histopathological NAFLD grading, and measuring of hepatic and WAT lipase activity. In gallstone patients, gallbladder bile will be sampled for the measurements of biliary lipids (cholesterol, phospholipids, bile acids) and the calculation of the cholesterol saturation index.

Eligibility Criteria:
Inclusion Criteria:

* In the obesity group: BMI ≥35 kg/m2
* In the gallstone group: symptomatic, ultrasound verified gallstone disease

Exclusion Criteria:

* Chronic liver disease other than NAFLD (viral hepatitis, autoimmune liver disease, hemochromatosis, homozygous alpha1-antitrypsin deficiency and Wilson disease)
* Previous gastric or small bowel surgery
* Inflammatory bowel disease
* Uncontrolled diabetes mellitus (fasting blood glucose \>6.7 mmol/L), hypothyroidism or hyperthyroidism, or other significant endocrine disease.
* Pregnancy. A urine pregnancy test will be performed the day before start of medication. Women of childbearing potential can only be included if a safe and reliable contraception is used, e.g., oral contraceptives.
* Elevations of transaminases (ALAT/ASAT) or alkaline phosphatase or bilirubin above 2xULN (upper limit of normal) the day before start of medication.
* Other serious disease, including depressive disorders treated by medication
* Patients who will not comply with the protocol.
* A subject who is euthyroid on a stable replacement dose of thyroid hormone is acceptable provided the TSH is within normal range.
TRACY - Track My Cycle

The primary aim of the pilot study is to collect data for the fine-tuning and evaluation of the Ava algorithm. Secondary outcomes are the estimation of the accuracy in detecting the fertility status of each cycle day.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 40 at the time of admission
* Not pregnant and no pregnancy wish during the pilot study period
* Have a regular sleep pattern (sleep at least four hours per night and not working nightshift)
* Have regular menstrual cycles

Exclusion Criteria:

* Pregnant at study admission
* Currently breastfeeding or have breastfed in the past 6 months before study admission
* Currently using hormonal contraception or hormonal medication
* Health-related conditions that may affect menstrual cycle length and variability (e.g. PCOS, menopause, thyroid dysfunction)
* Unable to understand study instructions and/or not able to understand English or German
* More than one international overseas travel per month
* Unwilling to sign the ICF.
The Safety and Efficiency of Propranolol as an Initial Treatment for Pediatric Hemangioma

The purpose of this study is to determine the safety and efficiency of Propranolol as an initial treatment for pediatric hemangioma.

* Randomized (A group : propranolol, B group : prednisolone)
* A group : 3 days admission and medication for 16 weeks
* B group : medication for 16 weeks without admission
* Hemangioma volume comparison by using MRI
* other measurement and drug adverse reaction monitoring

Eligibility Criteria:
Inclusion Criteria:

* Hemangioma patient ( 0 \~ 9 months old)
* No treatment before
* 10 \~ 20 % volume increase in 2 \~ 4 weeks
* Hemangioma that caused organ function
* Hemangioma that will cause aesthetic problem

Exclusion Criteria:

* Cardiovascular disease (impossible to use propranolol)
* Drug adverse reaction or allergy history (propranolol, steroid)
* Bradycardia, Atrioventricular block, atrial block
* Cardiogenic Shock
* Right heart failure (pulmonary hypertension)
* Congestive heart failure
* Hypotension
* Peripheral nerve disease (moderate)
* Angina
* Hormone deficiency patient
* Pulmonary disease (asthma)
* diabetic ketoacidosis
* laser treatment history
Zalutumumab With or Without Irinotecan Chemotherapy in Cetuximab-Refractory Colorectal Cancer

The purpose of this trial is to determine the safety and efficacy of Zalutumumab alone or in combination with Irinotecan for the treatment of patients with Colorectal Cancer


Eligibility Criteria:
Inclusion Criteria:

1. Males and Females age ≥ 18 years
2. Confirmed diagnosis of CRC
3. Documented disease progression
4. Failure and/or intolerance to standard chemotherapy

Exclusion Criteria:

1. Prior treatment with anti-EGFR antibodies other than cetuximab
2. Expected survival \< 3 months
3. Clinical significant cardiac disease and/or uncontrolled medical conditions
10 Years Cardiovascular Risk Score Among Primary Health Care Centre Attendees, Assiut Governorate.

The study aim to assess cardiovascular risk score among patients of AlHadary primary health care centre in Waldeya, Assiut governorate. And to determine the awareness about cardiovascular risk among these patients as well.

An analytical, cross-sectional study will be conducted in a primary health care center in Assiut governorate. Aiming to assess cardiovascular risk among attendees of the center and determine the awareness about cardiovascular risk among them.

Eligibility Criteria:
Inclusion Criteria:

* Male 30-65 years old, or female 40-70 years old.

Exclusion Criteria:

* History of ischemic heart disease, stroke, transitory ischemic attack (TIA) or peripheral artery disease (PAD) in electronic health record.
* History of diabetes
Evaluate F901318 (Olorofim) Treatment of Invasive Fungal Infections in Participants Lacking Treatment Options

A study to evaluate olorofim (F901318) for the treatment of invasive fungal infections in participants lacking suitable alternative treatment options.

An open label, single arm Phase IIb study of olorofim (F901318) in participants with invasive fungal infections with limited treatment options. Participants received study treatment for up to 12 weeks in the main phase of the study. At the Investigator's request and after discussion with the medical monitor, open-label treatment with F901318 could be continued in patients judged by the Investigator to need therapy beyond 84 days and considered likely to continue to benefit from extended treatment.

Eligibility Criteria:
Inclusion Criteria:

* Male and female aged at least 18 years, or male and female aged 16 years or 17 years and who weigh at least 40 kg whom have given informed consent
* Ability and willingness to comply with the protocol.
* Able to take oral medication
* Females must be non-lactating and at no risk of pregnancy
* Male with female partners of childbearing potential must either abstain from sexual intercourse or use a highly effective means of contraception
* Participants with invasive fungal disease
* Participants who have limited alternative treatment options

Exclusion Criteria:

* Women who are pregnant or breastfeeding.
* Known history of allergy, hypersensitivity, or any serious reaction to any component of the study drug.
* Participants with chronic aspergillosis, aspergilloma or allergic bronchopulmonary aspergillosis.
* Human Immunodeficiency Virus (HIV) infection but not currently receiving antiretroviral therapy.
* Participants with a medical condition that may jeopardize adherence to the protocol or may cause unacceptable additional risk to the participant
* Previously enrolled participants or participants enrolled in any clinical trial within the last 30 days
* Participants receiving treatment limited to supportive care due to predicted short survival time.
* Prohibited concomitant medications.
* Any exclusion criteria required by local regulatory authorities.
Rectal Indomethacin to Prevent Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis

The purpose of this study is to assess whether peri-procedural administration of rectal indomethacin, compared to placebo, can reduce the incidence of post-ERCP pancreatitis.


Eligibility Criteria:
Inclusion Criteria:

1. Scheduled for an ERCP at Dartmouth-Hitchcock
2. Age greater than 18 years old
3. Ability to provide written informed consent

Exclusion Criteria:

1. Inability to provide written informed consent
2. ERCP being performed for diagnosis and/or treatment of acute pancreatitis
3. Current ongoing acute pancreatitis
4. Previously documented allergy to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
5. Contra-indication to NSAID therapy (creatinine level \>1.4 or active peptic ulcer disease), already taking NSAIDs (other than aspirin therapy for cardioprotection)
6. Pregnant or nursing mothers
Incidence of Urinary Tract Infection After Urodynamic Investigation

The purpose of this study is to evaluate the incidence of urinary tract infection after urodynamic investigation and to identify the involved germs.

Patients with neurogenic bladder dysfunction after spinal cord injury need lifelong urologic control examinations with CMG (urodynamic examination). The manipulation may cause urinary tract infections which have to be treated. Patients often noticed an infection after a CMG examination. Aim of this study is the determination of the infection rate and germs. Also should be noticed the pre-interventional infections and differences between the causing germs. Simultaneously the investigators test the reliability of the quicktest for urinary infection. Additionally the investigators will examine the Quality of Life in patients with neurogenic bladder dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Patients with neurogenic lower urinary tract dysfunction with scheduled urodynamic investigation
* No antibiotic treatment
* Written informed consent

Exclusion Criteria:

* Pregnancy and breastfeeding
* Current antibiotic therapy
Comparison of Graft Quality and Patient Morbidity Following Palatal Harvesting.

The purpose of this study is to compare four different connective tissue graft harvesting technique in terms of graft quality and patient post-operative morbidity

The primary aim is to compare 4 different connective tissue graft harvesting techniques in terms of morbidity and in terms of quality of the graft.

The secondary aim is to evaluate the outcome of gingival recessions treated with grafts obtained from different harvesting approaches, in terms of mean root coverage, complete root coverage, keratinized tissue gain, clinical attachment level gain and gingival thickness

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or greater,
* Patients with no reported systemic diseases,
* Healthy periodontium or demonstrating stable periodontal condition following conventional periodontal therapy,
* Full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) of \< 15%,
* Clinical indication for periodontal plastic surgery utilizing CTG to treat either a single or a maximum of two recession defects (Miller class I, II) around natural teeth
* No history of previous palatal harvesting

Exclusion Criteria:

* Pregnancy
* Systemic condition that generally precludes surgical therapy or that could influence the outcome of therapy (e.g. Diabetes with HbA1c \> 7%, INR \> 3 etc.)
* Non-compensated systemic disease
* Poor oral hygiene with full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) \> 20% at baseline
* Inadequate endodontic treatment or tooth mobility at the site of surgery
* Radiographic evidence of bone loss
Screening for Urinary Incontinence by Primary Care Providers

The purpose of this study is to:

* Assess the rate of screening for urinary incontinence (UI) in women by their primary care providers
* Identify the type of screening used by primary care providers
* Identify barriers to screening for UI
* Identify differences in screening rates between specialties
* Assess whether primary care providers view UI as a serious medical problem
* Assess the comfort level of primary care providers in the diagnosis and treatment of UI
* Identify primary care providers' preferred mode of learning more about UI

UI is a very common condition whose prevalence can be expected to increase dramatically in the coming decades. Treatment options are available to improve women's health and quality of life. However, inadequate communication between physicians and patients leads to decreased diagnosis and treatment. Past studies evaluating the use of screening by primary care providers, who act as gatekeepers in our healthcare system, clearly demonstrate that improvements must be made in the screening system. We propose a survey of local primary care providers to quantify screening rates for UI and identify barriers to successful screening. The information collected in this survey will allow us to identify methods such as targeted education opportunities and patient literature or questionnaires that will assist providers and their patients in initiating discussion and evaluation of UI.

Eligibility Criteria:
Inclusion Criteria:

* All primary care providers in the Greater Rochester metropolitan area, including: Primary care Medical Doctors (MD), Doctors of Osteopathy (DO), Primary care Nurse Practitioners (NP), and Physician Assistants (PA)

Exclusion Criteria:

* Physicians in the Greater Rochester metropolitan area who are not primary care providers
Feedback and Outcomes for Clinically Useful Student Services (FOCUSS)

The purpose of the study is to examine the implementation outcomes (i.e., feasibility, appropriateness, acceptability, and fidelity) of MBC in school-based mental health treatment services. The investigators plan to observe the effectiveness of MBC on student engagement and treatment outcomes as a secondary goal. This pilot implementation-effectiveness trial is designed to inform a future, large-scale trial with more participants.

A clustered, multiple-baseline design will be used to examine the impact of implementation support on clinicians' fidelity, use and ratings of MBC appropriateness, acceptability and fidelity. Approximately 50 school-based mental health (SMH) clinicians will be recruited to participate from up to three school districts. All clinicians will receive the same implementation supports; there is no random assignment to condition. Following an initial control period of at least 1 month, school districts will start receiving implementation supports. During the initial control period, baseline MBC use, attitudes, acceptability, feasibility and appropriateness (per clinician self-report) will be collected, as well as needs assessment data from clinician surveys to inform necessary adjustments to the implementation supports. Baseline engagement and student outcomes will be collected after initial clinician training session. MBC implementation outcomes (i.e., MBC use, attitudes, acceptability, appropriateness, and feasibility), engagement and student outcomes will be collected at 3-month and 6-month follow-up during intervention supports, plus a 9-month follow-up interval. This allows clinicians in the two school districts to be compared to each other and to their own baseline. The primary comparison is pre-post ratings of implementation outcomes for all N=50 clinicians. The secondary comparisons are pre-post ratings of engagement and student outcomes, and between-agency differences.

Eligibility Criteria:
Inclusion Criteria:

To be eligible for inclusion in the study, a clinician must meet all of the following criteria:

* Female, male or other gender ≥18 years of age at the time of recruitment.
* Provide school-based individual and/or family mental health treatment in an elementary, middle or high school in a participating school district.
* Hold a professional license or certification in their state to provide mental health treatment OR be supervised by a licensed or certified mental health professional in their state.
* English-speaking.
* Ability to provide informed consent.

Exclusion Criteria:

- Clinicians who do not meet all inclusion criteria are excluded. There are no other exclusion criteria.
Desogestrel (DSG) and Corifolitropin (FSH-CTP) Alfa for Ovarian Stimulation in Donors

Currently, controlled ovarian stimulation (COS) in oocyte donors is performed by daily injections of gonadotropins( recombinant FSH) plus a GnRH Antagonist usually form 5th-6th stimulation day until ovulation induction with a bolus of another injection of a gonadotropin-releasing hormone (GnRH) Agonist. Injections of the GnRH Antagonist avoid untimely luteinizing hormone (LH) surge and spontaneous ovulation prior to follicular aspiration. There is a preparation of long-acting recombinant follicle stimulating hormone (rFSH= (corifollitropin alfa (FSH-CTP), Elonva®, MSD), that allows that a single subcutaneous injection substitutes the first 7 days of daily gonadotropin injections. On the other hand, a contraceptive oral progesterone only( Desogestrel, DSG) is available for contraception, avoiding the LH surge.

In donors, by administering a single injection of FSH-CTP and oral desogestrel since the first menstruation day, the total number of injections administered is reduced and less discomfort is experienced without adverse impact on ovarian response.

Other authors have reported good results using similar synthetic progestins (Medroxyprogesterone, dihydrogesterone, and natural progesterone).

No description of the hormonal and ovarian response under this protocol has been published. Direct comparison between this novel protocol and the classical GnRH- antagonist plus daily gonadotropins has not been reported.


Eligibility Criteria:
Inclusion Criteria:

-Fulfilling inclusión medical and legal criteria (RD - Spanish law adapting european rule-9/2014)

* Who had had undergone previously convencional COS (controlled ovarian stimulation) with FSH-CTP and daily antagonist injections
* Given signed consent form.

Exclusion Criteria:

* Previous low response to COS
* Previous ovarian hyperstimulation syndrome.
* Ovarian cysts.
Evaluation of Desensitization Protocols in Reduction of Dentin Hypersensitivity

The aim of this study is through a double blind randomized clinical trial, evaluate the effectiveness of different clinical protocols in the reduction of dentin hypersensitivity. The desensitization approach (single agent or associated agents) and the long-term effectiveness (baseline, 1 week, 2 weeks, 4 weeks, 12 weeks and 24 weeks) will be evaluated. Data will be collected, tabulated and submitted to statistical analysis.

Dentin hypersensitivity is characterized as an acute and short-term pain with multifactorial etiology. This condition is a clinical challenge due to the different treatment protocols available. Therefore, the aim of this study is through a double blind randomized clinical trial, evaluate the effectiveness of different clinical protocols in the reduction of dentin hypersensitivity. Thirty-two patients with dentin hypersensitivity in at least three teeth will be selected.The teeth will be randomly divided into two different groups according to the desensitization approach (single agent with neural action; single agent with obliterating action; associated technique (neural and obliterator agents). The dentin hypersensitivity level will be evaluated immediately after desensitization and after 1, 2, 4,12 and 24 weeks. Data will be collected, tabulated and submitted to statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals
* Both genres, interested in the treatment of Dentin Hypersensitivity
* Patients with all teeth in their mouth
* Patients who have at least three teeth with Dentin hypersensitivity in different quadrants
* Good oral hygiene

Exclusion Criteria:

* Caries or unsatisfactory restorations
* Presence of periodontal disease and or parafunctional habits
* Cracks or enamel fractures
* Extensive or unsatisfactory restorations
* Recent restorations involving the labial surface
* Pulpitis
* Dentures
* Orthodontics
* Smokers
* Pregnant women
* Gastroesophageal disease presence
* Uncontrolled systemic disease
* Severe bruxism
* Constant use of analgesic
* Allergic response to dental products
Efficacy and Safety Study of MSRD-100 in Subjects With Atopic Dermatitis >=3 Months of Age and Older

This is a double-blind, randomized, vehicle-controlled, multi-center, parallel group Phase 3 study of MSRD-100 in the treatment of atopic dermatitis in subjects aged 3 months and up.

This is a 4-week efficacy, safety and tolerability study of MSRD-100 applied twice daily for 4 weeks compared to its vehicle among subjects ≥3 months of age in the treatment of atopic dermatitis covering ≥5% body surface area.

The study will consist of up to 4 visits which includes Screening - Visit 1 (Screening), Baseline - Visit 2 , Visit 3 (Day 14), and an End of Treatment/Final Study Visit - Visit 4 (Day 28).

Study IDs M169981001 and M169981002 are two identical studies being run in parallel with different study sites.

Eligibility Criteria:
Key Inclusion Criteria:

1. Subjects who are male or female, ≥3 months of age on the date of Baseline Visit.
2. Subjects with a diagnosis of atopic dermatitis, active inflammation and meeting the Hanifin and Rajka Diagnosis Criteria for Atopic Dermatitis.
3. Subjects must have an Investigator Global Assessment (IGA) score of ≥2 at baseline.
4. Subjects who have atopic dermatitis covering ≥5% Body Surface Area (BSA) excluding the eyelids, perioral area, around the nostrils, and in the diaper area (for subjects who wear diapers or plastic pants).
5. Subjects who have atopic dermatitis with a sign and symptom score ≥ 2 on the following three signs and symptoms: erythema, infiltration/papulation, and erosion/oozing/crusting present in at least one body surface area affected.

Key Exclusion Criteria:

1. Unstable course of Atopic Dermatitis (spontaneously improving or rapidly deteriorating) as determined by the investigator over the previous 4 weeks prior to baseline.
2. Concurrent conditions and history of other diseases.
3. Used any of the following treatments within the indicated washout period before the baseline visit or those who would require the following during the study.
4. Subjects who require treatment with any other topical or systemic therapy for the study disease other than bland emollients in untreated areas of disease.