cyrilzakka/clinical-trials huggingface dataset:
The Role of Clinical Parameters in Predicting the Severity of Obstructive Sleep Apnea

Investigate the role of clinical parameters in predicting the severity of obstructive sleep apnea

During the last two decades the obstructive sleep apnea syndrome (OSAS) has been increasingly recognized as a distinct clinical entity. This condition is caused by recurrent upper airway obstruction during sleep, is manifest as loud snoring, arterial oxygen desaturation, sleep fragmentation, and excessive daytime sleepiness1,2. Epidemiological series have shown that about 4% of the population suffers from symptomatic OSAS that requires treatment3-5. OSAS is associated with increased rates of many chronic diseases6,7 and is a serious and potentially life-threatening disorder that is far more common than generally believed. Thus, untreated OSAS may pose a significant public health problem8. Epidemiological data demonstrating the relationship between OSAS and cardiovascular morbidity highlight the potential importance of early recognition and treatment9.

The mechanisms responsible for upper airway obstruction in patients with OSAS are highly complicated and as yet not fully understood. Several causes for OSAS have been suggested. It appears to result from a variable combination of anatomic and pathophysiologic factors, some of which may be under genetic control10. The relaxation of upper airway musculature has been studied in relation to OSAS11-13. Anatomic narrowing of the upper airway as a result of alterations in craniofacial morphology or soft tissue enlargement, the Bernoulli effect, sleep posture, age, male gender, and adipose tissue in the pharynx have been suggested in the etiology of OSAS14-17.

Several studies have suggested that ethnicity may be an important risk factor in OSAS17-20. Recent reports have suggested that Asian subjects with OSAS have a greater severity of illness compared with white subjects21,22. Some studies reported that obesity is the strongest risk factor for OSAS in middle-aged adults3,23,24. However, we have treated many non-obese Taiwanese young adults with severe OSAS. Previous researches have suggested that there may be differences in obesity and craniofacial anatomy as risk factors between Asians and whites25 and that the etiology of OSAS in obese patients may be different from that in non-obese patients16,26,27. It is still unclear whether there are differences in clinical evaluation parameters between non-obese Asian patients with severe OSAS and simple snoring.

We hypothesized that there are predictor factors in routine clinical examinations for diagnosis of OSAS in non-obese young adult patients. Therefore, the objectives of this study are to compare the clinical parameters in non-obese patients with severe OSAS with those of simple snorers and to find the risk factors for OSAS in a non-obese young adult Taiwanese population.

Eligibility Criteria:
Inclusion Criteria:

* Obstructive sleep apnea or snoring patients

Exclusion Criteria:

* Patients with any concurrent medical illnesses except hypertension
Deep Brain Stimulation and Digestive Symptomatology

Patients with Parkinson's disease (PD) frequently experience upper gastrointestinal disorders. During the disease, weight loss is often noticed. Recently, many studies have demonstrated that STN-DBS improved extrapyramidal symptoms. Interestingly, PD patients gain weight after STN-DBS, at least in part due to a decrease in resting energy expenditure.

Purpose: To evaluate benefits of STN-DBS on upper gastrointestinal symptoms and motility.

Patients et method: PD patients waiting for STN-DBS, will be assessed in a preoperative time (2 times at, at least, 3 month intervals, to evaluate the natural history of the disease on upper gastrointestinal symptoms and motility) and in a postoperative time, after 6 months of chronic STN-DBS. Each assessment will include : 1/ questionnaires about frequency and severity of upper gastrointestinal symptoms; 2/ a nutritional assessment (body mass index, dietary assessment); 3/ the gastric emptying measurement with the 13C-octanoic acid breath test; 4/ the colorectal transit time measurement with radio-opaque markers 5/ an indirect calorimetry to estimate resting energy expenditure; 6/ and plasmatic leptin and ghrelin concentrations, hormones involved in the homeostatic regulation of appetite.

Perspectives: This physiopathological study should allow us to understand the mechanisms of the effects of STN-DBS on upper gastrointestinal symptoms and weight regulation in PD patients.


Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease
* Electrode implantation for deep brain stimulation in progress
* Age \<70 yr
* Motor fluctuations and dyskinesias
* Motor symptoms improvement with L-dopa \> 50%
* No dementia
* No depression
* No major psychiatric symptom
* Normal brain MRI

Exclusion Criteria:

* Contra-indication of neurosurgery
* Pregnancy
* Diabetes
* Obesity
* Compulsive eating disorders
* Organic digestive disease
* Gastrointestinal resection
* Prokinetic treatment
* Coagulopathy
Transumbilical Versus Lateral Transabdominal Removal of Benign Adnexal Masses Via Laparoscopy

In cases of benign adnexal mass laparoscopic surgery, women were randomized to two groups: transumbilical vs. transabdominal removal. Need for pain medication, postoperative pain and patients´ satisfaction were assessed between the groups, as well as surgeons´ opinions and costs.

Women assigned to laparoscopic surgery for removal of a benign adnexal mass were randomly divided into two groups as regards surgery: a transumbilical (TU) group (n=21) and a transabdominal (TA) group (n=21). General anesthesia and use of local anesthetics were standardized. Visual analog scale (VAS) scores for pain and side effects (nausea/vomiting) and the amount of postoperative analgesic used were recorded for 24 hours. Investigators also investigated the expenses related to endobags and trocars. Further, peri- and postoperative complications were recorded. Investigators inquired about patient satisfaction as well as the surgeons' opinions of the alternative methods available.

Eligibility Criteria:
Inclusion Criteria:

* The criteria for inclusion were scheduled laparoscopy for oophorectomy, salpingo-oophorectomy or cyst enucleation.

Exclusion Criteria:

* The exclusion criteria were contraindications to any of the forms of medication used in the study (oxycodone, ketoprofen, paracetamol),
* language difficulties (inability to understand and speak Finnish or Swedish)
* and suspicion of malignancy.
AI DErived Plaque Quantification: CCTA and AI-QCPA for Determining Effective CAD Management

The objective of HeartFlow's DECIDE Registry is to collect observational data about the management of patients before and after HeartFlow Artificial Intelligence-Quantitative Coronary Plaque Analysis (AI-QCPA).

The DECIDE Registry is a post-market, multi-center, data collection study assessing the change in management of clinically stable patients who undergo CCTA with plaque detected. Data will be retrospectively collected following the CCTA, and analyses will be completed 90 days, 180 days, and 1 year after CCTA. Data may be retrospectively collected annually up to 5 years.

Eligibility Criteria:
Inclusion Criteria (all must be present) :

1. Groups 1, 2,4,5 and 6: CCTA and plaque detected
2. Group 3: Any patient with a stress test (stress echocardiogram or nuclear imaging including SPECT or PET) and no CCTA within the 90 days prior to site activation
3. Groups 1,2,3 and 4: Clinically stable, symptomatic
4. Group 6: Clinically stable without symptoms suggestive of CAD at the time of the CCTA

Exclusion Criteria (all must be absent) :

1. ED presentation (at the time of the CCTA or stress test)
2. Groups 1,2,3,4, and 6: Previous history of CAD (prior to the CCTA or stress test with history of revascularization)
3. Group 5: Prior history of PCI in multiple vessel territories, PCI in the Left Main, CABG, and/or any other conditions or limitations which would prevent successful CCTA processing by HeartFlow
4. Acute chest pain (in patients who have not been ruled out for ACS)
5. Previously evaluated with and/or in a study which includes AI-QCPA
Relationship: Interstitial Cystitis & Vulvodynia-Part 2

The etiology of pain in women with IC is often difficult to identify resulting in unnecessary medical and surgical treatments (e.g. hysterectomies). The vulva may actually be the site of some of the reported pain in women with IC, not the urethra or bladder. IC and vulvodynia can impact one's sexual functioning and diminish one's quality of life. Unfortunately, vulvodynia is often unrecognized since it is not part of the usual urological assessment with IC patients.

Vulvodynia is characterized by persistent generalized or localized vulvar pain of varying degrees often characterized as "burning," suggestive of a neuropathic pain response.

In a mailed survey (Part 1 of this study), 127 women with a documented diagnosis of IC agreed to be contacted for an in-office examination. The mailed survey was internally developed specifically for this project and included items related to demographics, adolescent and adult history related to genital pain and current health. The last section allowed the subject to include contact information if they would also like to participate in Part 2 (additional questionnaires and examination) of the study.

The study coordinator will review those surveys containing contact information and all women at least 18 years of age will be invited to the WISH program (Beaumont Women's Initiative for Pelvic Pain and Sexual Health) to be examined by a certified Nurse Practitioner (NP) who will be blinded to their survey responses.

Questionnaires will be completed by the subject. These questionnaires relate to one's history, pain symptoms, quality of life, bladder symptoms and sexual function and will be completed prior to the examination. The NP will perform all the clinical evaluations. A vaginal pH and wet mount slide will be done first. Testing for vulvodynia will be done utilizing an algesiometer q-tip followed by Neurometer® surface CPT testing for pain threshold (not tolerance) to quantify pain levels in the distribution of the pudendal nerve on the perineum and vulva will be done. The Neurometer® current perception threshold (CPT) is a device for evaluating and measuring sensation It is a battery-operated stimulator which delivers painless electrical stimulation via surface electrodes at frequencies of 5 Hz, 250 Hz, and 2000 Hz and at a current of 0.01 to 99mAmps.

Eligibility Criteria:
Inclusion Criteria

* Women with interstitial cystitis and vulvar pain who agreed to be contacted in Part 1 (HIC #2007-183) of this study.
* Age 18 or older
* Capable of giving informed consent
* Capable and willing to follow all study procedures

Exclusion Criteria:

* Pregnant women· Vaginitis (may be treated, then tested later)
* Vulvar disease (other than vulvodynia)-lichen planus, lichen sclerosis, neoplasia
* The subject is deemed unsuitable for enrollment by the investigators based on their history or physical examination.
* Neuropathy
Method of Level (MOL) Therapy for Psychosis

The study is a systematic case replication series of a new psychological therapy Method of Levels (MOL) for people who experience psychosis. Between 6 and 8 people with psychosis who receive services from CMHT will be recruited. Participants will complete baseline questionnaires measuring their symptoms and distress and will be offered up to 12 sessions of MOL. Following the completion of therapy they will complete the questionnaires measuring symptoms and distress again.

Psychosis is an enduring and distressing mental illness which can cause high levels of disability. Recommended treatments include antipsychotic medication and Cognitive Behaviour Therapy (CBT). Antipsychotic drugs cause serious negative side effects which are intolerable for some patients. CBT can be difficult to conduct in the presence of comorbid problems and can be too demanding for some patients. Both medication and CBT sometimes fail to sufficiently reduce the symptoms. Method of Levels (MOL) is a flexible, short-term, cognitive therapy informed by a theory that explains the underpinnings of psychological distress and the mechanisms of action in effective therapy. The purpose of the current study is to evaluate the utility of MOL for individuals with non-affective psychosis who are under the care of secondary mental health services. A case series will explore the efficacy of MOL for the levels of symptoms, distress and general functioning. MOL will be offered to 6-8 individuals with psychosis within a flexible appointment scheduling system. Levels of symptoms, distress and general functioning will be measured before and after treatment. Open feedback interviews following the completion of treatment will allow us to evaluate the patients' experience of MOL. The project will provide preliminary data which will inform clinical practice and contribute to large scale research of MOL.

Eligibility Criteria:
Inclusion Criteria:

* Participants have to be registered with a Community Mental Health Services
* Participants need to either meet ICD-10 criteria for schizophrenia, schizoaffective disorder and delusional disorder or meet entry criteria for an Early Intervention for Psychosis service.

Exclusion Criteria:

* Known moderate to severe learning disability
* Known organic basis of symptoms
* Known lack of capacity to consent to participating in research
* Lack of fluency in English (since MOL therapy will be conducted in English and due to use of standardised assessment tools). This will be determined by the researcher.
* Acute inpatient status
* A primary diagnosis of a drug or alcohol dependency
* Concurrent psychological therapy.
Disturbance of the Intestinal Microbiota by Temocillin vs Cefotaxime in Treatment of Febrile Urinary Tract Infections

This study will evaluate the ecological impact on the intestinal microbiota and compare the safety and efficacy of temocillin compared to cefotaxime, in empiric treatment of febrile UTI. Half of participants will receive temocillin and the other half will receive cefotaxime.

Temocillin is a narrow spectrum antibiotic with activity against gram negative bacteria inclusive many ESBL producing bacteria. Temocillin is approved and marketed in a few European countries since the 1980´s but not in Sweden.

The aim of the study is to find an ecological favorable alternative to cephalosporins in the treatment of this common indication.

The hypothesis is that treatment with temocillin causes less disturbances on the intestinal microbiota while at least comparable efficacy.

The study will be performed as an open prospective multicentre study with two parallel groups comparing 2 g temocillin three times daily with 1-2 g cefotaxim three times daily for 7-10 days in male and female adult patients with febrile urinary tract infection.

Eligibility Criteria:
Inclusion Criteria:

* Males and females ≥ 18 years of age with suspected or confirmed febrile UTI, fulfilling at least one of the following signs and symptoms:

  * Flank pain or suprapubic pain, Tenderness over the kidney on physical examination, Urinary symptoms such as dysuria, urinary frequency or urinary urgency
* Fever ≥ 38.0°C (highest temperature recorded at home or at the hospital)
* Positive urinalysis tests (U-Nitrit and/or U-LPK)
* Have a pre-treatment baseline urinary culture obtained
* Require iv antibacterial treatment of the presumed infection
* Fertile women: Agree to practice highly effective anti-contraceptive methods from study-start to TOC
* Signed informed consent

Exclusion Criteria:

* Have a documented history of hypersensitivity or allergic reaction to any beta-lactam
* Pregnant or nursing women
* Receipt of any prior potentially therapeutic antibacterial agent within 1 month before randomisation and sampling for urine and faecal cultures. Exceptions will prior treatment with pivmecillinam or nitrofurantoin.
* Known chronic renal insufficiency (creatinine clearance \< 10 mL/min at screening as estimated by Cockcroft-Gault), or receiving intermittent haemodialysis or peritoneal dialysis
* Known colonization with ESBL
* Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the subject or the quality of study data.
An Exploratory Investigation of a B12 Vitamin to Increase Energy and Focus

This study aims to examine the effects of Sourse's Hype Bites at being able to increase vitamin B12 levels to promote positive health outcomes. Participants will consume Hype Bites daily. Participants will also take surveys and blood samples to examine both the subjective experience of taking Hype Bites as well as changes in biomarkers across the trial.


Eligibility Criteria:
Inclusion Criteria:

* BMI \< 40 On a stable, consistent dietary regimen Must be on a vegan or vegetarian diet May experience the feeling of being tired often/several times a week. May experience brain fog May experience negative mood states

Exclusion Criteria:

* Females who are pregnant or breastfeeding Currently take vitamin B12 during the past four weeks Chronic conditions such has oncological of psychiatric disorders Anyone with IBS or IBD Anyone with a previous severe allergic reaction Anyone unwilling to follow the study protocol
Impact of Vitamin C on Biomarkers of Neurologic Injury in Survivors of Cardiac Arrest

Out-of-hospital cardiac arrest (OHCA) is one of the leading cause of death in the world. In Slovenia approximately 25% of resuscitated patients survives to discharge from hospitals, usually with poorer functional status.

One of key pathophysiological process responsible for poorer functional status is global hypoxic-ischemic injury, which is two-stage. Primary stage occurs immediately after cardiac arrest due to cessation of blood flow. With return of spontaneous circulation a secondary injury occurs, of which the leading process is an imbalance between oxygen delivery and consumption. Reperfusion exposes ischemic tissue to oxygen, resulting in the formation of large amounts of highly reactive oxygen species (ROS) within minutes. ROS lead to oxidative stress, which causes extensive damage to cell structures and leads to cell death. Consequently, necrosis and apoptosis are responsible for organ dysfunction and functional outcome of these patients.

Such injury of neural tissue causes brain damage, which is ultimately responsible for poor neurological and thus functional outcome of OHCA survivors. The extent of brain damage can be determined in several ways: clinically by assessing quantitative and qualitative consciousness and the presence of involuntary movements in an unconscious patient, by assessing activity on electroencephalographic record, by imaging of the brain with computed tomography and magnetic resonance imaging, as well as by assessing levels of biological markers of brain injury. Of the latter, the S-100b protein and neuron-specific enolase have been shown to be suitable for such assessment.

Oxidative stress is counteracted by the body with endogenous antioxidants that balance excess free radicals and stabilize cellular function. Vitamin C (ascorbic acid) is the body's main antioxidant and is primarily consumed during oxidative stress. Large amounts of ROS rapidly depletes the body's vitamin C stores.

Humans cannot synthesise vitamin C and enteral uptake of vitamin C is limited by transporter saturation. On the other hand, parenteral (venous) dosing of vitamin C can achieve concentrations of vitamin C above physiological and thus produce a stronger antioxidant effect. The beneficial effect of parenteral dosing of vitamin C has been establish in several preclinical and clinical studies in patients with ischemic stroke and cardiac arrest.

The investigators hypothesize that there is a similarly beneficial effect of vitamin C in survivors of OHCA.


Eligibility Criteria:
Inclusion Criteria:

- comatose survivors of out-of-hospital arrest

Exclusion Criteria:

* patients with trauma, asphyxia, drowning or electrocution as a cause of cardiac arrest
* history of oxalate nephropathy or nephrolithiasis, glucose-6-phosphate dehydrogenase deficiency, and hemochromatosis
* pregnancy
A Comparison of Clinical Outcomes of Warmed Embryo Vitrified at 2PN Stage and Fresh Embryo Transfers

The aim of this study was to compare the clinical outcomes between fresh embryo and frozen embryo transfer in in vitro fertilization (IVF). All frozen embryo was vitrified at pronuclear stage (2PN) and cultured to cleavage embryos for transfer.

This is a retrospective study. All IVF cycles were included in this study and further divided into fresh and frozen embryo transfer groups. The collection data including: stimulation protocols, medicines, blood test results, pregnancy test and all clinical data. The primary outcome is pregnancy rate and secondary outcome is implantation rate.

Study design

Study progress:

Stage 1: collection of all data from frozen embryo transfer and fresh embryo transfer groups.

Stage 2: selection data and check the delivery outcomes Stage 3: analysis data and presentation. Including criteria: all patients who underwent IVF. Excluding criteria: No. Statistics analysis: chi-test, t-test

Assessment point:

Primary endpoint: pregnancy rate Secondary endpoint: implantation rate Withdraw criteria: not application. Treatments: not application. Collection number: 500 patients. Scheduled trial period: 2017.05.01\~2018.04.30

Expected research results:

The implantation rate in frozen embryo transfer group which vitrified at 2PN stage is higher than fresh embryo transfer.

The pregnancy rate in frozen embryo transfer group which vitrified at 2PN stage is higher than fresh embryo transfer.

This study is only data analysis, no additional collection of samples. This study does not involve vulnerable groups.

Eligibility Criteria:
Inclusion Criteria:

* all patients with in vitro fertilization protocols

Exclusion Criteria:

* none
Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management

PROSPER-FM is a multi-center, randomized, non-significant risk device study to evaluate the safety and efficacy of two digital therapy smartphone applications in participants with fibromyalgia. Eligible participants are randomized (1:1) to either the Digital Acceptance and Commitment Therapy (Digital ACT) group or the Digital Symptom Tracker group and receive assigned therapy for 12 weeks.


Eligibility Criteria:
Key Inclusion Criteria:

1. Participant is 22 to 75 years of age, inclusive
2. Participant has a diagnosis of primary FM as defined by the 2016 American College of Rheumatology Preliminary Diagnostic Criteria for FM
3. Participants with ongoing treatments should be on stable therapy for 30 days prior to screening appointment.
4. Participant is capable of reading and understanding English and has provided written informed consent to participate.

Key Exclusion Criteria:

1. Lifetime history of bipolar or other psychotic disorder
2. Severe depression at screening (measured by BDI-II)
3. The participant is at increased risk of suicide on the basis of the investigator's judgment or the Columbia-Suicide Severity Rating Scale ("C-SSRS")
4. Participant has any other disease or medical condition that, in the opinion of the Investigator or Sponsor, could endanger the participant, interfere with the evaluation of the study device's efficacy or safety, or compromise the participant's ability to comply with/complete the study.