cyrilzakka/clinical-trials huggingface dataset:
Ocrelizumab in Breastmilk

The goal of the current project is to measure the levels of ocrelizumab in the breastmilk of women with multiple sclerosis (MS) and clinically isolated syndrome (CIS) who are postpartum, and to collect information on 12-month infant development outcomes (length, weight, head circumference, infections) in their offspring.

This study will fill a significant unmet need as many women with MS at high risk for postpartum relapses are not effectively treated for their MS in the postpartum period due to lack of information about the presence, concentration and effects of medications in breastmilk.

Levels of ocrelizumab in breastmilk will be serially evaluated across one drug half-life from women with MS and CIS who are postpartum and lactating at the time of the infusion (whether or not they plan to continue to breastfeed their baby after the infusion). The timeline for breastmilk sample is dependent on infusion schedule and dosing if receiving 600mg infusion x1, collection will occur: before infusion and at 8H, 24H, 7D, 20D, 30D, 60D, and 90D post infusion; if receiving 300mg infusion x2 collection will occur: before infusion 1, at 8H, 24H, 7D, and 14D (before infusion 2) after infusion 1 and after infusion 2 at 8H, 24H, 7D, 20D, 30D, 60D, and 90D in 20. Blood samples to determine serum concentration of ocrelizumab will be collected, when possible, at the 24-hour, 14 day (if receiving 300mg infusion x2), and 20D timepoint(s). Both women continuing to breastfeed their infant post-infusion and those that chose to discontinue will be included in the study.

In order to ensure broad collaboration as well as rapid recruitment, samples will be collected from patients fitting eligibility criteria upon referral to our study by other investigators.

Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 18 and 64 that carry a diagnosis of Clinically Isolated Syndrome or Multiple Sclerosis (based on the 2010 McDonald Criteria).
* Participants must be pregnant, contemplating pregnancy or postpartum at the time of enrollment.
* Participants must be receiving treatment with ocrelizumab infusion between 2 and 36 weeks postpartum (300mg x2 or 600mg x1).
* Participants must be willing to provide breastmilk samples before and after their first and, if applicable, second ocrelizumab infusions postpartum.
* A signed informed consent and HIPAA authorization form is required for participation.

Exclusion Criteria:

* Patients unable to provide informed consent.
* Patients unable or unwilling to provide breast milk samples for analysis.
Study of the Large Diameter GORE EXCLUDER® AAA Endoprosthesis in Abdominal Aneurysms

The purpose of this study is to assess the safety and efficacy of the 31 mm GORE EXCLUDER® AAA Endoprosthesis in the treatment of infrarenal abdominal aortic aneurysms

The primary objective of this study was to estimate the safety of the 31 mm GORE EXCLUDER® AAA Endoprosthesis as compared to open surgical repair when used in the treatment of infrarenal abdominal aortic aneurysms. A secondary objective was to compare device performance of the original GORE EXCLUDER® AAA Endoprosthesis to the 31mm EXCLUDER when used in the treatment of infrarenal abdominal aortic aneurysms.

Eligibility Criteria:
Inclusion Criteria:

* Infrarenal AAA \> or equal to 4.5 cm in diameter
* Proximal infrarenal aortic neck length \> or equal 15mm
* Anatomy meets 31mm EXCLUDER specification criteria
* Access vessel able to receive 20 Fr. introducer sheath
* Life expectancy \>2 years
* Surgical candidate
* ASA Class I, II, III, or IV
* NYHA Class I, II, III
* 21 years of age or older
* Male or infertile female
* Ability to comply with protocol requirements including follow-up
* Signed Informed Consent Form

Exclusion Criteria:

* Mycotic or ruptured aneurysm
* Participating in another investigational device or drug study within 1 year
* Documented history of drug abuse within 6 months
* Coexisting thoracic aortic aneurysm (50% larger than proximal aorta)
* Myocardial infarction or cerebral vascular accident within 6 weeks
* Pulmonary insufficiency requiring chronic home oxygen therapy or inability to ambulate due to pulmonary function
* Renal insufficiency (Creatinine \> 2.5 mg/dL) without dialysis
* Iliac anatomy that would require occlusion of both internal iliac arteries
* "Planned" occlusion or reimplantation of significant mesenteric or renal arteries
* "Planned" concomitant surgical procedure or previous major surgery within 30 days
* Previous prosthesis placement in the same position of the aorta or iliac arteries
* Degenerative connective tissue disease, e.g., Marfans and Ehlers Danlos Syndrome
* Proximal neck angulation \> 60 degrees
* Presence of significant thrombus at arterial implantation sites
Valsartan Intensified Primary Care Reduction of Blood Pressure Study

This study will assess the efficacy of an intensive blood pressure management strategy compared to usual care in a primary care (general practice) setting.


Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed or currently treated hypertensive patients who have not attained their blood pressure target and require active pharmacological treatment as recommended by the local guidelines as judged by the general practitioner

Exclusion Criteria:

* significantly elevated blood pressure (severe hypertension)
* requiring 3 or more antihypertensive drugs
* severe kidney disease or dialyses
* clinical diagnosis requiring concomitant therapy with antihypertensive treatment that would be outside the therapies allowed under study protocol

Other protocol-defined inclusion/exclusion criteria may apply
Validation of a Simulated Clinical Evaluation of Ventilators

The purpose of this study is to evaluate the ability of a device reproducing patients' respiratory characteristics to select in-VITRO the most appropriate ventilator for a given pathology.

Context : Mechanical ventilation is an essential element in the management of chronic as well as acute respiratory failure allowing an improvement of both mortality and morbidity. However, considering the wide choice of ventilators available on the market, it has become increasingly difficult to choose the most appropriate ventilator according to the pathology presented by a patient, patients being able to try only a limited number of devices. Patient-ventilator synchronization is a crucial part of ventilation efficacy and its success. It depends on both the physiopathological characteristics of patients and specific properties of the ventilation device.

Objective : To evaluate the ability of a device reproducing patients' respiratory characteristics to select in-VITRO the most appropriate ventilator for a given pathology.

Method : Multi-center transversal study. Selection, after an initial bench-evaluation, of three ventilators. Clinical evaluation of their efficacy and synchronization between patient and ventilator and establishment of a classification.

Second bench evaluation of the studied ventilators while the bench is simulating the ventilation characteristic of previously studied patients in order to compare the results obtained in VITRO to the results obtained in vivo.

Selection criteria : Patients requiring mechanical ventilation for management of either chronic or acute respiratory failure.

Patients, centers : 4 groups of 14 patients presenting chronic respiratory disease followed in the ICU of RAYMOND POINCARE HOSPITAL in GARCHES and in the pulmonary departments of the Armand Trousseau hospital and the PITIE SALPETRIERE IN PARIS; 1 cohort of 12 patients admitted in the ICU of Henri Mondor in CRETEIL IN PARIS for acute respiratory failure.

Study duration : 33 months (bench study : 3 + 6 months, clinical study : 24 months) Perspectives : Developing an evaluation tool allowing the rapid assessment of any new available ventilator according to the specific characteristics (and needs) of a patient and to a given pathology. Selecting the most appropriate ventilator for a given patient.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring mechanical ventilation for management of either chronic or acute respiratory failure.
* Old of at least 6 years
* Having given his consent writes after enlightened information, him even and the parents for least than 18 years, only he for most than 18 years
* Realization of a preliminary medical examination

Exclusion Criteria:

* Patients presenting criteria of pointed exacerbation of the respiratory disease
Experiences of Visitors to a Regional Major Trauma Intensive Care Unit

Since 2011, people who have had a serious accident in England are no longer looked after at the hospital nearest to them. Instead, they are cared for at a specialist hospital called the regional major trauma centre. This is so that they can get the best possible care from specialist professionals.

St George's is the regional major trauma centre for the 2.6 million people living in South West London and Surrey County. This area stretches about 40 miles across.

About one fifth of major trauma patients who come to St George's live more than one hour's journey away. Their visitors often travel a similar distance or even further. Family members and friends play an important part during the patient's stay. It is important to support visitors.

The aim of this study is to describe the experiences of visitors whose family member or friend has been admitted to the major trauma intensive care unit at St George's. In particular, the aim is to describe the experiences of visitors who travel from far.

First, ten visitors will be interviewed to find out more about their experiences. From these data, a survey questionnaire will then be developed and approximately 150 visitors who have been to St George's in recent months will be surveyed. This will give in-depth insights to understanding peoples' experiences of visiting at St George's, and what people thought was going well and things that could be better. The study will end with a service improvement workshop with representatives from the team at St George's and visitors. Study findings will be discussed and decisions on what should be improved will be made.

This study is being funded by St George's Hospital Charity. The study runs from August 2017 to October 2018.


Eligibility Criteria:
Inclusion Criteria:

* Visitors (i.e. designated next of kin and/or other family member or friend with a close relationship and significant involvement in the patient's circumstances and care) of a patient who has been admitted to intensive care at St George's University Hospitals NHS Foundation Trust under the major trauma care pathway
* Ordinary residence further away than one hour's drive from St George's Hospital (estimated driving time in mid-week mid-morning traffic according to Google Maps, equating to a distance of approximately 30 miles)
* Adults (18 years and over)
* Written informed consent (for semi-structured qualitative interviews)

Exclusion Criteria:

* Ordinary residence within one hour's drive from St George's Hospital (estimated driving time in mid-week mid-morning traffic according to Google Maps, equating to a distance of within approximately 30 miles)
* Limited English (for semi-structured qualitative interviews)
Office Based Hand Surgery Using WALANT (Wide Awake Local Anesthesia No Tourniquet): Outcomes and Cost Savings Analysis

This study is aimed at determining if office based surgery is an effective way of cutting health care cost while maintaining patient safety and satisfaction.

The study is a retrospective chart review with prospective patient satisfaction and functional outcome surveys.

Patients that have had office based procedures that otherwise could be performed in the outpatient surgical setting from January 1, 2015 to December 4, 2015 will be contacted for study enrollment. Patient satisfaction and functional outcome surveys will be administered to those patients that consent to the research study.

The data to be collected will include but is not limited to: age gender limb dominance, complications and co-morbidities.

Eligibility Criteria:
Inclusion Criteria:

* Patients seen for office based procedures that otherwise would be performed in the outpatient surgical setting from January 1, 2015 to December 4, 2015

Exclusion Criteria:

* K-wire hardware removal
* Closed reductions
* Patients receiving antibiotics at the time of the procedure
Combination of Probiotic and Calcium in Healthy Adults

The study was conducted to investigate the effect of the probiotic L. paracasei LPC 37 alone or in combination with a calcium supplement of the human microbiota and further physiological parameters.

Animal studies suggest that calcium beneficially influence the microbiota in the gut. This effect of calcium is due to the formation of amorphous calcium phosphate, which has the ability to bind bile acids and other cytotoxic substances in the gut. The precipitation of the cytotoxic substances leads to a less aggressive environment in the gut and might be stimulate the adhesion of the microbiota.

Thirty-two healthy men and women participated in a placebo-controlled, double-blind and cross over human study. The participants were randomly divided into two groups. All probands consumed a probiotic drink for four weeks (10e+10 CFU/d). Additionally, one group consumed a pentacalcium phosphate-enriched bread (1 g Ca/d) and the other group consumed a bread without pentacalcium phosphate. After a two-week wash-out and a two-week placebo period the invention changed for another four weeks (cross over). At the end of each intervention and placebo period, subjects consumed a defined diet for three days. Furthermore, there was a three-day quantitative stool and urine collection and a fasting venous blood sample was taken.

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects
* blood cholesterol concentration \> 5 mmol/l

Exclusion Criteria:

* pregnancy, lactation
* intake of dietary supplements
* intake of prebiotics and probiotics
* chronic diseases
Continuous Endostar Infusion Combined With Radiotherapy in Esophageal Cancer Patients

This study is to explore the clinical efficacy of continuous Endostar infusion combined with radiotherapy in esophageal cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological diagnosis of previously untreated stage I-III esophageal cancer
* Measurable disease according to RECIST criteria
* ECOG Performance Status 0-1
* The length of esophageal carcinoma ≤ 10 cm
* Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 90g/L
* Renal function: Cr ≤ 2.0×UNL
* Hepatic function: BIL ≤ 2.0×UNL, ALT/AST ≤ 5.0×UNL

Exclusion Criteria:

* Pregnant or lactating women
* Evidence of bleeding diathesis, serious infection
* Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)
* Uncontrollable mental and nervous disorders
The Role of Emotional Arousal in Food Preference and Taste

The purpose of this study is to examine the role of stress in food craving and food consumption in obesity. Using experimentally validated guided imagery procedure, the investigators propose to examine the stress response using subjective, physiological and neurobiological measurements.

One hundred and fifty men and women will participate in three laboratory sessions to assess stress responses to personal stress imagery, food cue imagery, and to neutral-relaxing imagery. Subjects will be distributed into 3 groups stratified by BMI category. Subject recruitment, eligibility determination, baseline assessments and script development will be conducted at the Yale Stress Center. Subjects will complete a variety of diagnostic, cognitive and psychological assessments, a comprehensive physical examination and blood work and will be involved in development of imagery scripts from personal stress, food cue and neutral-relaxing situations. Subjects will then be scheduled for three laboratory sessions at the Yale Stress Center. Subjects will also participate in an imagery and relaxation training session followed by three laboratory sessions. The three laboratory sessions will be conducted within a brief interval of days, when subjects will be exposed to a personal stress, a food cue and a neutral-relaxing imagery condition, one condition per day. The order of imagery conditions will be randomly assigned and counterbalanced across subjects in order to balance any influences due to order of imagery conditions.

Eligibility Criteria:
Inclusion Criteria:

* Between ages 18-45 years
* Able to read and write
* Normal/lean BMI group: BMI 18.5-24.9 as calculated based on height and weight.
* Overweight BMI group: BMI 25.0 - 29.9 as calculated based on height and weight Obese BMI group: BMI 30-35 as calculated based on height and weight.
* Do not meet criteria for any current Axis I DSM-IV psychiatric diagnoses and provide negative urine toxicology screens during initial appointments and at admission for laboratory sessions.

Exclusion Criteria:

* Meet current criteria for dependence on any psychoactive substance, including nicotine and caffeine
* Current use of any psychoactive drugs, including anxiolytics, antidepressants, naltrexone or antabuse
* Any psychotic disorder or current psychiatric symptoms requiring specific attention, including need for psychiatric medications for current major depression and anxiety disorders
* Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, liver, thyroid pathology; subjects on medications for any medical condition will be excluded
* Women on oral contraceptives, peri and post menopausal women, and those with hysterectomies
* Pregnant and lactating women will be excluded.
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PB-119 Injection in Chinese Obese Subjects

The trial is conducted in a single-center, randomized, double-blind, placebocontrolled, dose-increasing design. To evaluate the safety, tolerability, pharmacokinetics(PK) characteristics, efficacy and immunogenicity of PB-119 injection in Chinese obese subjects.

The trial is conducted in a single-center, randomized, double-blind, placebocontrolled, dose-increasing design. To evaluate the safety, tolerability, PK characteristics, efficacy and immunogenicity of PB-119 injection in Chinese obese subjects. The study consists of 1-2 cohort . 32 patients are planned to be included in each cohort (24 patients receive study drug，8 patients receive placebo) Subjects will receive treatment for 20 weeks after screening and complete 4 weeks of safety follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Chinese male or female subjects aged 18-60 years (both inclusive).
2. Body weight ≥70 kg(male) or 60 kg(female), and body mass index (BMI)

   ≥30.0 kg/m2 at screening.
3. Weight change \<5% in the past 3 months before screening.

Exclusion Criteria:

1. Fasting Plasma Glucose（FPG） ≥7.0mmol/L or glycosylated hemoglobin (HbA1c) ≥6.5% or diagnosed diabetes
2. FPG \<3.9 mmol/L at screening and/or a history of hypoglycemia.
3. History of Cushing's syndrome, polycystic ovaries, or other hereditary endocrine disorders, or obesity caused by secondary factors such as cortisol hormones.
4. Abnormal Thyroid-Stimulating hormone(TSH), Serum Free Triiodothyronine（FT3）, Serum Free Thyroxine（FT4） or diagnosed thyroid dysfunction
5. History of multiple endocrine neoplasia syndrome type 2 (MEN-2) , medullary thyroid carcinoma (MTC) or Category 4 and above thyroid nodules by Thyroid ultrasound Chinese Ultrasound Thyroid Imaging Reporting and Data System （C-TIRADS）
6. Diagnosed cardiovascular and cerebrovascular diseases with obvious clinical significance within 6 months before screening
7. Systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 100 mmHg at screening or randomization.
8. Time history from the starting point of P-wave to the starting point of QRS wave（PR intervals ）\> 210 msec and/or QRS complex（QRS） \> 120 msec and/or Corrected QT Interval（QTcF） \> 450 msec at screening or randomization.
9. Serum amylase or lipase \> 3× upper limit of normal (ULN) at screening or before randomization, or previously diagnosed acute/chronic pancreatitis.
10. Low density lipoprotein cholesterol(LDL-C) ≥4.40 mmol/L or triglyceride (TG) ≥5.65 mmol/L.
11. Use of any approved or unapproved drugs or products that have an effect on body weight within 3 months prior to screening
12. History of bariatric surgery for weight loss before screening.
A Study to Evaluate the Safety, Tolerability, and Drug Levels of Danicamtiv in Healthy Japanese and Caucasian Participants

The purpose of this study is to assess the safety, tolerability, and single-dose pharmacokinetics of danicamtiv in healthy Japanese and Caucasian participants.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index between 18 and 30 kilograms/meter squared inclusive, at the screening visit.
* Japanese participants must be of Japanese descent (both biological parents are ethnically Japanese).
* Caucasian participants must be of European or Latin American Caucasian descent.
* A female participant is eligible to participate if she is a woman of nonchildbearing potential as defined in the protocol.
* Males who are sexually active with woman of childbearing potential must agree to follow protocol-defined instructions for method(s) of contraception.

Exclusion Criteria:

* Any acute or chronic medical illness.
* Active infection, including with coronavirus disease-19, diagnosed clinically by the investigator.
* History of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or sponsor clinical trial physician, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.

Note: Other protocol-defined inclusion/exclusion criteria apply.
Evaluation of Patients With Suspected Endofibrosis

Define responses to exercise on both arterial bruits and oxymetry in patients referred for suspected endofibrosis.

Recording of oxymetry during exercise and recovery. Recording of vascular bruits at rest ajnd post exercise.

Eligibility Criteria:
Inclusion Criteria:

Referred for exercise test -

Exclusion Criteria:

None

-