cyrilzakka/clinical-trials huggingface dataset:
Artificial Reproductive Techniques (ART) and Progression of Endometriosis Symptoms

This project will investigate worsening of symptoms in endometriosis patients undergoing artificial reproductive techniques (ART). The study compares patients with peritoneal/ovarian and deep infiltrating endometriosis to relevant reference groups. Symptoms are monitored with a questionnaire with the categories quality of life, pain and bowel habits. The EHP-30® questionnaire is included in the questionnaire.

Endometriosis affects up to 10% of all fertile women, and is associated with symptoms like infertility, dysmenorrhea, deep dyspareunia and chronic pelvic pain. 10-25% of endometriosis patients need artificial reproductive techniques (ART) to become pregnant. Endometriosis is estrogen dependent, and in theory this means, that the increased levels of estrogen during fertility treatment will worsen endometriosis symptoms. Endometriosis is a benign disease, and treatment is guided by the patient's symptoms. Worsening of endometriosis symptoms during fertility treatment may result in cessation of the treatment, operation and risk of complications.

This project will investigate worsening of symptoms in endometriosis patients undergoing artificial reproductive techniques (ART). The study compares endometriosis patients undergoing ART to two relevant reference groups; one group consisting women undergoing ART with infertility because of factors other than endometriosis, and one group consisting women with medically treated endometriosis not undergoing ART. Symptoms of endometriosis during ART will be monitored using a questionnaire that among other questions includes the validated questionnaire Endometriosis Health Profile 30® (EHP-30®). The questionnaire is administered before starting ART and later in the cycle before the patient gets to know if she is pregnant. The questionnaires as well as data collection will be administered electronically in REDCap® which is a secure web application for building and managing online surveys and databases.

Eligibility Criteria:
Inclusion Criteria:

* Female
* \< 40 years
* Either undergoing ART (IVF or ICSI) with or without endometriosis or medically treated endometriosis

Exclusion Criteria:

* \> 40 years
GooDMoMS: A Multimodel Pregnancy and Postpartum Intervention for Gestational Diabetics

This study includes a behavioral educational intervention that focuses on healthy eating and physical activity during pregnancy and the postpartum among women newly diagnosed with gestational diabetes mellitus (GDM).

This is a pilot trial in which 30 women newly diagnosed with gestational diabetes are randomized to either one of two groups: 1) active internet intervention or 2) self-directed educational intervention. The primary pregnancy outcome is change in A1C. The primary postpartum outcome is weight.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with gestational diabetes
* Planning to delivery with the study area

Exclusion Criteria:

* Pre-existing diabetes (type 1 or type 2 diabetes)
* Non-English speaking
* Not planning to delivery in the study area
Effect of Different Bandage Interface Pressures on Breast Cancer Related Lymphedema

The goal of this randomised comparison study is to compare different bandage interface pressures in individuals with breast cancer related lymphedema

The main questions it aims to answer are:

* Is high or low bandage pressure effective in reducing edema and soft tissue thickness?
* do bandages applied with high or low bandage pressure comprimise sleep, comfort or subjective benefit from treatment?

Participants will recieve complex decongestive physiotherapy. Bandage will apply high or low pressure. Effects of high and low bandage interface pressures will compare

The aim of this study was to evaluate the effect of compression bandage applied with different pressures on skin and subcutaneous thickness in individuals with breast cancer-related lymphedema.

individuals with stage 2 unilateral lymphedema participated in the study. Skin and subcutaneous thicknesses, extremity volumes, sleep quality, treatment benefit, comfort during treatment were evaluated respectively by ultrasound from 6 reference points as dorsum of hand, wrist volar, forearm dorsum, forearm volar, arm dorsum, arm volar, volumetric measurement, Pittsburgh Sleep Quality Index, Patient Benefit Index-Lymphedema, and visual analog scale. Complex decongestive physiotherapy was applied to individuals randomly divided into two groups: low (20-30 mmHg) and high bandage pressure (45-55 mmHg). Individuals were evaluated before treatment, at 1st, 10th session, end of treatment, and at 3 months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Stage 2 unilateral BCRL involving whole extremity according to ISL
* To be volunteer.

Exclusion Criteria:

* Acute deep vein thrombosis
* Acute soft tissue infection
* Peripheral artery disease in upper extremity
* Systemic diseases with peripheral edema (kidney, hearth insufficiency etc.),
* Allergy to materials used for treatment
* Mental diseases effect cooperation
* Sensory loss in the effected limb
* Open wound in the effected limb.
Evaluation of a Third and Fourth Dose of StaphVAX® in Adults With End-Stage Renal Disease

This study is a continued evaluation of the immune response to StaphVAX , a Staphylococcus aureus type 5 and 8 capsular polysaccharide conjugate vaccine, in end-stage renal disease patients, by giving a 3rd and 4th dose to a subset of the participants in the previous efficacy trial. Participants continue to receive the vaccine or placebo in a blinded manner, and are also randomly assigned to 1 of 2 different intervals between the doses. The immunogenicity is measured by the antibodies in the blood, and typical vaccine safety information is also collected.


Eligibility Criteria:
Inclusion Criteria:

* Participation in prior study Nabi-1371
* Written informed consent
* Negative serum pregnancy test, where appropriate
* Expect to comply with protocol procedures and schedule

Exclusion Criteria:

* Known HIV
* Immunomodulatory drugs
* Malignancy (other than basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or early stage prostate cancer)
* Active infection in the 2 weeks prior to study injection
* Serious S. aureus infection within the last 2 months prior to injection
* Hypersensitivity to components of StaphVAX
Positive Psychology Interventions in Individuals With Chronic Pain and Spinal Cord Injury

Background:

Chronic pain is one of the most burdensome potential consequences of a physical disability, such as spinal cord injury (SCI). Estimates of the incidence of chronic pain in SCI range between 65 - 80%. A recent pilot-study of a computer-based tailored positive psychology intervention showed a significant reduction in pain intensity, pain interference, pain catastrophizing and depression and an enhancement of subjective well-being and control over pain in persons with chronic pain secondary to a physical disability.

Study Objective:

Objective 1: To determine the efficacy of a tailored positive psychology intervention (T3P) in a community-based, single-blind, randomized, controlled, parallel group trial on subjective well-being and pain in individuals with chronic pain secondary to SCI.

Hypothesis 1: T3P will result in (1) greater immediate and long-lasting increase in subjective well-being, and perceived control over pain and (2) greater immediate and long-lasting decrease in depression, pain intensity, pain interference and catastrophizing, relative to an active control treatment.

Specific aim 1: To increase the understanding of the mechanisms underlying T3P by determining potential mediation effects.

Hypothesis 2: (1) Pain catastrophizing and pain control mediate the effect of T3P on pain intensity, and (2) positive and negative affect mediate the effect of T3P on life satisfaction and depression.

Objective 2: To identify for whom T3P is most effective by exploring potential moderator effects.

Study Design:

The proposed study is a single-blind, randomized, controlled trial with a parallel group design to determine the effects and mechanisms of T3P in a Swiss community sample of persons with chronic pain secondary to SCI.


Eligibility Criteria:
Inclusion Criteria:

* Registered in Swiss Spinal Cord Injury Cohort Study (SwiSCI)
* Individuals who experience an average disability-related pain intensity of ≥ 4 on a 0-10 numeric rating scale in the past week
* Individuals who experience pain at least half the days in the past four weeks, and
* Individuals are able to speak, read and write German

Exclusion Criteria:

* Individuals who report current participation in any psychotherapy (e.g. psychotherapy, hypnosis, biofeedback) once a month or more often
* Individuals who report hospitalization for psychiatric reasons within the past year
* Individuals with a severe cognitive impairment defined as one or more errors on a Six-Item Screening
Anti-Inflammatory and Anti-Platelet Effect of Clopidogrel and Aspirin vs Aspirin Alone in Symptomatic Polyvascular Disease and in Patients With Multiple Recurrent Cardiovascular Events

This is a monocentric, randomized, opened study to assess the anti-inflammatory and anti-platelet effect of Clopidogrel and aspirin versus aspirin or clopidogrel alone in patients with symptomatic polyvascular disease and with multiple recurrent cardiovascular events.


Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic polyvascular disease or recurrent cardiovascular events. In particular patients with established stable coronary artery disease associated with peripheral disease or cerebrovascular disease and patients with more than two acute cardiovascular events.

Exclusion Criteria:

* chronic treatment with anticoagulant drugs and the use of other antiplatelet therapy;
* intolerance/allergy to Aspirin or to Clopidogrel
* platelet counts outside the range of 125-450 10\^9/l
* inflammatory or infectious disease
* malignancies or immunologic or hematological disorders.
Perinatal Mental Health Study (PMHS) India

The purpose of this observational study is to improve understanding of mental disorders among perinatal women in India.

The purpose of this observational study is to assess the mental health of perinatal women living in two low-income settings in India. The first phase will explore women's awareness of mental illness and acceptability of screening for mental disorders. The second phase will be a validation study, during which the psychometric properties of screening tools will be assessed against a gold standard. The third stage will comprise a cohort study, during which the prevalence of and risk factors for mental disorders among perinatal and non-perinatal women will be established.

Eligibility Criteria:
Inclusion Criteria:

For Phase 1 (qualitative study) and Phase 2 (validation study):

Pregnant women:

* Aged 18 to 45 years
* Currently pregnant (any trimester)
* Willing and able to give informed consent

Post-partum women:

* Aged 18 to 45 years
* Currently post-partum (between 1-12 months postpartum)
* Willing and able to give informed consent

Non-perinatal women:

* Aged 18 to 45 years
* Not currently pregnant and not given birth in the past 12 months
* Willing and able to give informed consent

For Phase 3 (prospective cohort study):

Perinatal women:

* Aged 18 to 45 years
* In early pregnancy (estimated gestational age \<20 weeks) at recruitment
* Not planning to relocate for the duration of the study period
* Willing and able to give informed consent
* Expressed a willingness to continue to participate for the four planned visits

Non-perinatal women:

* Aged 18 to 45 years
* Not currently pregnant and not given birth in the last 12 months
* Not planning to relocate for the duration of the study period
* Willing and able to give informed consent
* Expressed a willingness to continue to participate for the four planned visits

Exclusion Criteria:

The participant may not enter the study if:

* They have an acutely severe psychiatric illness which impairs their ability to take part in the study
* They are not willing or able to provide informed consent

Other than for current severe psychiatric illness which affects ability to participate in the study, we will not exclude any participant on the basis of current or prior physical, psychological or psychiatric co-morbidities so long as she is willing to participate, her ability to take part is not compromised and her ability to give informed consent is not impaired by these conditions.
Development of Endothelial Biomarkers

The main objective is to develop and validate new endothelial function markers discriminating and reproducible by assessing the ability to reveal changes in endothelial function in response to positive and negative nutritional stimuli.

The study will be randomized (on the order of taking the products: a single dose of lipids or a single dose of flavonoids), single-blinded, cross-over for each population (healthy and metabolic syndrome).

Eligibility Criteria:
Inclusion Criteria:

* - 40 to 65 years old
* male
* non-smokers

Specific inclusion criteria for healthy subjects :

* Healthy subjects should not take antihypertensive or statin.
* Healthy subjects should not present metabolic syndrome but one criterion of the metabolic syndrome will be tolerated.

Specific inclusion criteria for subjects with metabolic syndrome :

- subjects with metabolic syndrome must have at least 3 of the 5 criteria associated with the metabolic syndrome.

Exclusion Criteria:

* treatment vasodilator nitric oxide liberating,
* diabetes and coronary artery disease,
* chronic alcoholism,
* severe hepatic impairment,
* end stage renal failure or dialysis,
* neurological tremor,
* cancer, mental illness or other severe disease which can impact informed consent and / or results,
* Refusal to be registered in the National File of Volunteers
* Person in exclusion of the National Volunteer File
Efficacy of Radial Keratotomy in the Optical Rehabilitation of Mild to Moderate Keratoconus Cases

Keratoconus is a progressive ectatic disorder that steepens the cornea resulting in a conical shape. Radial Keratotomy can provide an optical rehabilitation by its flattening effect. It can also halt the progression of disease owing to fibrotic activation in perpendicular corneal incisions.


Eligibility Criteria:
Inclusion Criteria:

* keratoconus with a central corneal thickness (CCT) over 400µm,
* poor corrected visual acuity (≤0.4 at Snellen visual acuity charts),
* contact lens intolerance

Exclusion Criteria:

* apical scarring,
* ocular or systemic problem other than keratoconus
Developing Evidence to Inform Regulatory Policy on Nicotine Content in E-Liquids

The goal of this observational study is to learn if electronic cigarette users who currently choose to use lower nicotine eliquids have reduced harm compared those who choose higher nicotine eliquids.

The main questions it aims to answer are:

* Do lower nicotine users actually consume less nicotine compared to higher nicotine users?
* Do lower nicotine users have lower amounts of harmful and potentially harmful constituent exposures compared to higher nicotine users?
* Do lower nicotine users perceive their choice of product to be less harmful than higher nicotine products? Researchers will monitor ecig users of different nicotine concentrations for two weeks in their natural environment to determine how much eliquid and nicotine they consumed, assess their daily mood and craving, and measure exposure and health effect.

Participants will:

* Complete surveys on history of tobacco use, nicotine dependence and perception.
* Use their electronic cigarette with their usual nicotine eliquid ad lib for two weeks in their natural environment.
* Complete daily questionnaires for mood and craving for two weeks in their natural environment.
* Collect three salivary samples at home, morning, afternoon and evening, each day for two weeks, in their natural environment.
* Use a topography monitor to record puffing behavior for every puff taken during week two, in their natural environment.
* Provide saliva, urine and blood samples in the lab at the end of each week.


Eligibility Criteria:
Inclusion Criteria:

* Age 21 yrs or older
* Pod-style or pen-style users, not adjustable for power or airflow, nicotine greater than 0 mg/mL
* Current everyday users
* Use history of at least 30 days
* No current use of combustible tobacco product, or nicotine replacement therapy
* CO less than 6 ppm at intake
* No plans to quit tobacco use in the next 30 days

Exclusion Criteria:

* History of acute or chronic asthma
* Previous diagnosis of cancer
* Other chronic medical conditions
* Use of chronic prescription medications
* Pneumonia in prior six weeks
* Upper respiratory tract infection or other febrile illness in previous 2 weeks
* On antioxidants or anti-inflammatory therapy
* Pregnant women or women who intend to become pregnant
If Different Types of Periampullary Diverticula Affect ERCP Cannulation?

To study the influence of different types of periampullary diverticulum(PAD) on ERCP difficult cannulation and postoperative complications.

Periampullary diverticula (PAD) are extraluminal out-pouching of the duodenum mucosa often occurring within a radius of 2-3 cm from the ampulla of Vater or hepatopancreatic ampulla. More PAD cases have been identified over recent years, and it's generally believed that up to 27% of elderly cases may have PAD. Several classifications of PAD have been proposed, and the most commonly used distinguishes intraluminal and extraluminal diverticula. Recent studies suggest that PAD is a risk factor for the development of bile duct diseases, and it may cause endoscopic retrograde cholangiopancreatography (ERCP) procedures to fail, but some other studies have come to the opposite conclusion.

During ERCP procedures, the investigators found that different types of PAD seem to have some differences in the size of the diverticulum, difficulty in intubation, and complications. The investigators plan to this retrospectively study collecting 4 years of cases to evaluate the clinical features of different types of PAD in terms of difficult cannulation and complications.

Eligibility Criteria:
Inclusion Criteria:

* 18-90 years old ERCP patients
* With native papilla

Exclusion Criteria:

* Unwillingness or inability to consent for the study
* Coagulation dysfunction (INR\> 1.5) and low peripheral blood platelet count (\<50×10\^9 / L) or using anti-coagulation drugs
* Previous ERCP
* Prior surgery of Bismuth Ⅱ, Roux-en-Y and Cholangiojejunostomy
* Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage or perforation, severe liver disease(such as decompensated liver cirrhosis, liver failure and so on), septic shock
* Biliary-duodenal fistula confirmed during ERCP
* Pregnant women or breastfeeding
Effects of Transvenous Vagus Nerve Stimulation on Immune Response: a Pilot Study

The purpose of this study is to assess the effect of transvenous vagus nerve stimulation (tVNS) on the immune response.

In the human endotoxemia model, intravenously administered endotoxin (lipopolysaccharide \[LPS\]) elicits a systemic immune response with release of pro-inflammatory cytokines, such as TNF α. This trial will determine if an anti-inflammatory effect can be produced by acute VNS using a minimally invasive delivery method.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent to participate in this trial
2. Male subjects aged 18 to 35 years inclusive
3. Healthy as determined by medical history, physical examination, vital signs, 12 lead electrocardiogram, and clinical laboratory parameters

Exclusion Criteria:

* Use of any medication(including herbal remedies and vitamin/mineral supplements) or recreational drugs within 7 days prior to profiling day
* Smoking
* Use of caffeine, or alcohol or within 1 day prior to profiling day
* Previous participation in a trial where LPS was administered
* Surgery or trauma with significant blood loss or blood donation within 3 months prior to profiling day
* Participation in another clinical trial within 3 months prior to profiling day.
* History, signs or symptoms of cardiovascular disease
* An implant that in the opinion of the investigator may make invasive procedures risky for the subject due to the increased risks associated with a possible infection.
* Subject has an implanted active cardiac device (ICD, IPG and/or CRT)
* Implanted active neurostimulation device
* Subject has internal jugular vein that cannot be accessed
* History of vaso-vagal collapse or of orthostatic hypotension
* History of atrial or ventricular arrhythmia
* Resting pulse rate ≤45 or ≥100 beats / min
* Hypertension (RR systolic \>160 or RR diastolic \>90)
* Hypotension (RR systolic \<100 or RR diastolic \<50)
* Conduction abnormalities on the ECG consisting of a 1st degree atrioventricular block or a complex bundle branch block
* Subject is diagnosed with epilepsy or history of seizures
* Renal impairment: plasma creatinine \>120 µmol/L
* Liver function abnormality: alkaline phosphatase\>230 U/L and/or ALT\>90 U/L
* Coagulation abnormalities: APTT or PT \> 1.5 times the reference range
* History of asthma
* Immuno-deficiency
* CRP \> 20 mg/L, WBC \> 12x109/L, or clinically significant acute illness, including infections, within 2 weeks before profiling day
* Known or suspected of not being able to comply with the trial protocol
* Inability to personally provide written informed consent (e.g. for linguistic or mental reasons) and/or take part in the study.
Outcomes of Enhanced Recovery After Cesarean (ERAC) Protocol

In recent years, a set of evidence-based recommendations called Enhanced Recovery After Surgery (ERAS) is being applied for care of cesarean sections. The effectiveness of ERAS in reducing the length of hospitalization, postoperative complications, the need for analgesics right away after surgery, and the financial cost in the context of cesarean sections has been shown in several studies. There is strong evidence that following ERAS protocols aids postoperative recovery positively. This will be a randomized trial to determine if there is a difference regarding adverse maternal outcomes between ERAS group and standard of care.

Cesarean section is one of the most common surgeries performed today with over one million performed in the United States annually. Our institiution is a tertiary maternity hospital with approximately 3500 cesarean sections annually. A standardized set of guidelines known as Enhanced Recovery After Surgery (ERAS) has been used in a variety of surgical specialties, including colorectal, urologic, gynecologic, and hepatobiliary surgery. The adoption of ERAS guidelines for the obstetric population now offers evidence-based recommendations for postoperative care following cesarean delivery.

At our institution, due to large volume of cesarean section, we encounter a variety of postoperative complications. Institutional standard of care for preoperative, intraoperative and postoperative care has been applied by all providers. In light of recent positive evidence when ERAS protocol is applied, our team aimed to design a randomized controlled trial for comparison of maternal outcomes in ERAS and standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who had cesarean delivery
* Gestational age \>37/0 weeks

Exclusion Criteria:

* Diabetes
* Placenta accreta spectrum
* Hypertensive disorders of pregnancy
* Placental abruption
* Need for emergent/urgent cesarean
* Pregnancy complicated by an active infection
* History of allergic reaction to diclofenac sodium, paracetamol or metoclopramide