cyrilzakka/clinical-trials huggingface dataset:
A Phase 1 Study to Compare the PK and Safety of Naproxcinod in Hepatic Impaired Patients and Matching Healthy Subjects

This is an open-label study that will compare the pharmacokinetic and safety effects of naproxcinod in hepatic impaired patients vs. matching healthy subjects.

This is an open-label, non-randomized, parallel-group study that will be conducted at two study sites. Patients with hepatic impairment and matched healthy subjects will receive naproxcinod 750 mg bid for 6 days and qd for the last day.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female, age 40 to 75 years with stable hepatic insufficiency conforming to Child-Pugh classification B OR
* Male or Female, age 40 to 75 years with similar distribution of age, weight, gender, smoking habits, and race, and in general good health

Exclusion Criteria:

* Current or expected use of anticoagulants or analgesic, anti-inflammatory therapies except lose dose aspirin
* History of renal impairment
* Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding within the last 6 months
* Clinically relevant abnormal ECG
* Alcohol or drug abuse within the last 6 months
* Any significant or chronic disease (except hepatic insufficiency for the patient cohort) which may interfere with study evaluations
Efficacy and Safety of M100907 on Sleep Maintenance Insomnia With a Sub-study in Stable Type II Diabetes Mellitus

The purpose of this study is to assess efficacy and safety of volinanserin in the population of patients complaining of sleep maintenance insomnia. The objective of the substudy is to assess glycemic control in the subgroup of patients with type II diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary insomnia based on Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) criteria
* Disturbances of sleep maintenance criteria based on patient's information related to sleep pattern during the preceding month

Sub-study :

* Patients will be included if they have an established medical diagnosis of type II Diabetes Mellitus, and have been treated either with an oral hypoglycemic agent and/or insulin for at least three months prior to the Screening Visit (with stable regimen for at least one month prior to screening)

Exclusion Criteria:

* Females who are lactating or who are pregnant
* Night shift workers, and individuals who nap 3 or more times per week over the preceding month
* Consumption of xanthine-containing beverages (i.e. tea, coffee, cola) comprising more than 5 cups/day
* Participation in another trial having received study medication within 1 month before the screening visit
* Body Mass Index ≥ 33
* Use of over-the-counter medications such as tryptophan, valerian root, kava, melatonin, St. John's Wort, Alluna or prescription sleep medication
* Use of any substance with psychotropic effects or properties know to affect sleep/wake
* History of primary hypersomnia, narcolepsy, breathing-related sleep disorder, circadian rhythm sleep disorder, parasomnia, dyssomnia
* Clinically significant, severe or unstable, acute or chronically progressive medical or surgical disorder
* Positive qualitative urine drug screen (opiates, cocaine, amphetamine...)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Fixed Low-dose Heparin Versus Standard Adjusted-dose Heparin Infusion in Adults Receiving Venovenous ECMO With a Heparin Bonded Circuit.

Heparin is a blood thinner used to prevent blood clots in patients on a form of life-support called ECMO. Heparin can cause bleeding - the most common complication of ECMO. New materials used in ECMO machines may help prevent clots - this could allow the use of lower doses of heparin which might reduce the risk of bleeding. Our study will compare low dose to high dose heparin in patients on ECMO. We think low dose heparin may be adequate to prevent clotting, but may cause less bleeding and be safer for patients.

Intravenous heparin is considered standard therapy to prevent clotting complications in patients on ECMO, however the optimal method of heparin dosing has not yet been determined. International surveys have shown that most ECMO centers use adjusted dose heparin to achieve an activated clotting time of at least 180 seconds. However, heparin may contribute to the most common complication of ECMO - bleeding. Advances in material technology have potentially reduced the thrombogenicity of modern ECMO circuits. Our observational data suggest that fixed low dose heparin infusion may reduce the rate of bleeding complications from 75% to 50% compared to standard adjusted-dose heparin, without increasing clotting complications. We intend to perform a randomized controlled trial in adults receiving venovenous ECMO comparing these two heparin regimens. The main outcome measures are bleeding complications and oxygenator failure due to clotting. A safety committee will monitor the results of the study. Power calculations indicate a sample size of 110 patients is required, which we estimate will take us five years to achieve.

Eligibility Criteria:
Inclusion Criteria:

* on ECMO for acute respiratory failure, achieving ECMO blood flow rate \>3L/min,
* patient or surrogate able to speak/understand English or Spanish

Exclusion Criteria:

* History of heparin-induced thrombocytopenia, decision by clinicians to run ECMO off heparin due to high bleeding risk,
* pregnancy
Registry Study on Biological Disease Profile and Clinical Outcome in Patients With Newly Diagnosed or Existent Lung Cancer The LuCa Biology and Outcome (BiO)-Project

Registry Study on Biological Disease Profile and Clinical Outcome in Patients with Newly Diagnosed or Existent Lung Cancer

The LuCa Biology and Outcome (BiO)-Project


Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected diagnosis of lung cancer, or previously diagnosed lung cancer
* Age ≥ 18 years. There is no upper age limit.

Exclusion Criteria:

* Severe neurological or psychiatric disorder interfering with ability to give an informed consent
* No consent for registration, storage and processing of the individual disease characteristics and course as well as information of the family physician about study participation
* No consent for biobanking of patient's biological specimens and performance of analyses on stored material.
Study of Apixaban for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery

The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein Thrombosis \[DVT\]) and lung (pulmonary embolism \[PE\]) that sometimes occur after knee replacement surgery and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be studied.


Eligibility Criteria:
Key Inclusion Criteria:

* Men and non-pregnant, non-breastfeeding women
* 18 years or older
* Scheduled for knee replacement surgery

Key Exclusion Criteria:

* hereditary or acquired bleeding disorders
* clotting disorders
* bleeding or high risk for bleeding
* drugs that affect bleeding or coagulation
* need for ongoing parenteral or oral anticoagulation
Comparison of Knee Kinematics for Subjects Implanted With Either a ConforMIS or Traditional Knee Implant

A better understanding of knee joint kinematics is important to explain the premature polyethylene wear failures within total knee arthroplasties (TKAs) and to help design a prosthesis that most closely approximates the normal knee. Previously, most experimental studies of knee kinematics have involved cadaveric, in vitro analyses, or have not tested the knee in a weight-bearing mode. Others have used exoskeletal linkages and skin markers that permit error due to undesired motions between markers and the underlying bone. More recently, fluoroscopy has been used to assess in vivo kinematics for subjects having a TKA.

ConforMIS has attempted to follow a clearly different path than the major orthopaedic companies. They have chosen to offer patients a personalized knee implant based off of each patient's femoral and tibial bone geometry. The hypothesis is that these subjects will experience a more normal-like kinematic pattern, eliminating paradoxical anterior sliding during weight-bearing knee flexion. Therefore, the objective for this study is to analyze the in vivo kinematics for 25 patients implanted with a personalized ConforMIS TKA and 25 patients implanted with a traditional TKA design to determine if there are any kinematic differences between these TKA designs.

Each subject will be asked to perform five activities in one continuous sequence: (1) stand up from a chair, (2) walk up stairs, (3) walk down stairs, (4) level walking, and (5) a deep knee bend. Subjects will be video recorded from the waist down while performing the activities. The speed level of each trial will be based on the comfort level of the patient. The fluoroscopic images will be stored digitally for subsequent analysis on secure servers and workstations at the University of Tennessee.

Eligibility Criteria:
Inclusion Criteria:

* At least 6 months post-op with no other surgical procedures conducted within the past 6 months
* Between 40-70 years of age
* Body weight of less than 250lbs
* BMI of less than 38
* Pregnant females will be excluded
* TKA patients will be judged Clinically successful with an American Knee Society score of greater than 90
* Must have 100 degrees post-op passive flexion with no ligamentous laxity or pain
* Participants must be able to walk on level ground without aid of any kind and ascend/descend stairs without assistance.
* All potential subjects will have either a personalized ConforMIS™ TKA or a traditional TKA manufactured by an orthopaedic company other than ConforMIS.
* Patients from the physician's list who do not meet the study requirements will not be considered.
* Patients must be willing to sign the Informed Consent and HIPAA forms to participate in the study.
* Patients must be between 160cm (5'3) and 193cm (6'4) tall.
Multiple-Ascending Dose Study

The purpose of this study is to determine the safety and tolerability of BMS-820836 after multiple doses


Eligibility Criteria:
Inclusion Criteria:

* Panels 1-6: Healthy Male Subjects
* Panel 7: Females
* Ages 21 to 55, inclusive
* Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive
* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations

Exclusion Criteria:

* Any major surgery within 4 weeks of study drug administration
* History of cholecystectomy
* History of glaucoma or a confirmed intraocular pressure indicative of glaucoma at screening. (Normal IOP \<21 mmHg)
* Confirmed QTc (Fridericia) value ≥ 450 msec
* Confirmed QT ≥ 500 msec
* Confirmed PR ≥ 210 msec
* Confirmed QRS ≥ 120 msec
* Confirmed resting supine systolic blood pressure \> 140 mmHg
* Confirmed resting supine diastolic blood pressure \> 90 mmHg
* Confirmed resting heart rate \< 45 bpm or \> 100 bpm
* Orthostatic vital sign changes (ie., a decrease in systolic blood pressure from supine to standing \> 40 mmHg and an increase in heart rate from supine to standing \> 20 bpm) or symptoms of orthostasis
* History of peppermint allergies
* Exposure to any investigational drug or placebo within 12 weeks of study drug administration
Endoscopic Severity Image Recognition to Advance Research and Training in Inflammatory Bowel Disease (EVEREST - IBD)

To develop and train a convolutional neural network to detect and characterize disease severity of inflammatory bowel disease during endoscopy

To develop and train a Convolutional Neural Network to detect and characterize disease severity in inflammatory bowel disease during endoscopy. This initiative will inevitably establish a high-quality large image database. Our secondary study aims are therefore to use the images we collect to advance the field of deep learning and computer aided diagnosis in inflammatory bowel disease by establishing an image database. This will involve developing a framework combining deep learning and computer vision algorithms. The ultimate aim is to use the image database to produce high impact research outcomes and training resources leading to an improvement in the quality of endoscopy performed, reduce inter-observer variability in disease assessment and a reduction in missed bowel cancer rates and associated mortality.

Eligibility Criteria:
Inclusion Criteria:

* • Any adult patient aged 16 years or older who has consented to undergo endoscopic investigation where images are captured as part of routine clinical care.

Exclusion Criteria:

* • Any patient under the age of 16

  * Patients who are unable to give informed consent to undergo endoscopic investigation or those who do not wish their pseudo-anonymised images to be used
A Study of Effects of Fesoterodine in Men at High Risk for Overactive Bladder/Detrusor Overactivity Post Robotic-Assisted Lap. Prostatectomy

The investigators will assess the incidence of Overactive Bladder/Detrusor Overactivity (OAB/DO) post-operatively in patients post robotic assisted radical prostatectomy (RARP) and to investigate whether fesoterodine will alter the incidence of OAB/DO in these patients. Additionally, the correlation between OAB symptoms and urodynamic DO will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Men aged 30 to 90 years old with prostate adenocarcinoma who have already made their treatment selection of RARP, and only men with an AUA symptom score greater than 7 will be included. All subjects must be able to read and comprehend fully the informed consent.

Exclusion Criteria:

* Men with prostate neoplasms other than adenocarcinoma
* Subjects receiving other treatments for prostate cancer will be excluded.
* Any subject with a preexisting bladder disease will be excluded.
* Subjects with acute urinary retention and/or deceased gastrointestinal motility.
* Subjects with glaucoma.
* Subjects with hepatic or renal impairment.
* Subjects taking CYP3A4 Inhibitors (e.g.ketoconazole, itraconazole, clarithromycin).
* Subjects with myasthenia gravis
* Subjects who are unwilling or unable to complete the subject questionnaires
* Subjects, who in the opinion of the investigator, would be non-compliant with the majority of the visits scheduled or study procedures.
INSUlin Regimens and VASCular Functions

Vago-sympathetic activity, arterial stiffness and endothelial function are integrators of cardiovascular risk. The aim of this pilot study is, in type 2 diabetic patients now requiring insulin, to compare the effects of improving glycemic control on these parameters with 3 different insulin regimens which will act especially at fasting or in post-prandial periods or both. Non invasive explorations will be performed before randomization and after 4 to 5 weeks of insulin therapy, at fasting and each hour after a standardized breakfast.

Vago-sympathetic activity, arterial stiffness and endothelial function are integrators of cardiovascular risk. The effect of controlling fasting or post-prandial blood glucose or both on these parameters has not been studied in type 2 diabetic patients.

The aim of this pilot study is to compare the effects of improving fasting or post-prandial blood glucose glycemic control or both with 3 different insulin regimens for 4 to 5 weeks, on vago-sympathetic activity, arterial stiffness and endothelial function.

Patients will be recruited in the department of Endocrinology-Diabetology-Nutrition of Jean VERDIER hospital, AP-HP, and the department of Endocrinology and Metabolism of AVICENNE hospital, BOBIGNY, AP-HP, France. After an half day of cardiovascular explorations, 42 patients will be randomized in 3 groups determining their treatment for the following 4-5 weeks : insulin therapy with detemir at dinner or bed time, or with aspart at each meal, or with both of them.

Investigations will be performed in the morning 1) at the time of randomisation and 2) 4-5 weeks after the beginning of insulin therapy. We will evaluate at fasting and each hour after a standardized breakfast biological and metabolic parameters, arterial stiffness, endothelial function and nervous autonomic system with non-invasive devices: Sphygmocor®, Finapres®, laser-doppler et Endopat2000®. Body composition will be evaluated with impedance maestri and BodPod®.

Eligibility Criteria:
Inclusion Criteria:

* Consent patient
* Adults from 30 to 72 years old
* type 2 diabetic patients for at least 1 year
* able to self measure capillary blood glucose
* body mass index 20-37 kg/m²,
* HbA1c 7.1-12% under Metformin and SULFUNYREAS therapy for at least 2 months
* anti-hypertensive treatment or dyslipidemic treatment unchanged for 3 months

Exclusion criteria:

* pregnancy
* other antidiabetic medication in the previous 2 months,
* anti-hypertensive or lipid-lowering therapies having been changed in the previous 2 months,
* insulin allergy,
* uncontrolled preproliferative or proliferative diabetic retinopathy
* uncontrolled hypertension
* renal failure(creatinin clearance \<40 ml/min)
* hepatocellular deficiency (prothrombin time \<70%)
* anemia
* peripheral occlusive arterial disease
* cardiac arrhythmia
Assessment of Effect of Rapastinel on Driving Performance

Based on the pharmacological class of rapastinel, this study will be conducted to evaluate the participant's driving performance after single IV doses of rapastinel as compared with single oral doses of alprazolam, a benzodiazepine that demonstrates driving impairment, and placebo in healthy participants.


Eligibility Criteria:
Inclusion Criteria

* Participant possesses a valid driver's license and is an active driver. Drives a minimum of 5,000 miles (about 8,000 km) per year for the previous 3 years.
* Participant has a regular sleep pattern, is not engaged in shift-work, and in general, has at least 7 hours of sleep each night (bedtime occurs between 21:00 and 24:00 hours).

Exclusion Criteria

* A history within 2 years of, or current intervention for, a sleeping disorder (including excessive snoring, obstructive sleep apnea) or a chronic painful condition that interferes with the participant's sleep.
* A history of difficulty in falling asleep or staying asleep in the previous 3 months that is considered clinically significant by the investigator.
* Participant has traveled across 1 or more time zones (transmeridian travel) in the 14 days before study intervention or is expected to travel across 1 or more time zones during the study.
* Expected to work on a rotating shift during their participation in the study.
* Participant works a night shift.
In-office Hysteroscopic Laser Ablation for Symptomatic Submucous Uterine Fibroids

To evaluate feasibility and efficacy of in-office hysteroscopic ablation of submucous uterine fibroid using diode laser

A pilot study was conducted between January 2018 and January 2019 in a tertiary care university hospital. Patients with at least one symptomatic, class 0-2 of FIGO classification, uterine fibroid of ≤ 7cm in size were eligible for inclusion. Evaluation of the changes in fibroid size and vascularity was performed using 3D Doppler ultrasonography. Vaporization of the fibroid core was conducted using a 1470nm wavelength diode laser inserted through the hysteroscope's working channel. Primary outcome was the evaluation of the fibroid volume before and at 2 months after the procedure.

Eligibility Criteria:
Inclusion Criteria:

* symptomatic patients without desire of future fertility (symptoms included heavy menstrual bleeding, abdominal discomfort, bulk symptoms such as urinary frequency, pelvic pressure and constipation),
* grade 0-2 (FIGO classification) ≤ 7cm fibroids with evident vascularity seen by 3D-DS compared to its adjacent myometrial tissue

Exclusion Criteria:

* intramural fibroids (FIGO class 3 or more),
* \>2 submucosal fibroids,
* pelvic inflammatory disease,
* known gynecologic malignancy,
* severe cervical stenosis,
* pregnancy
* desire of future fertility,
* previous cervical surgery
Peritoneal Carcinomatosis Extent Evaluation: Radiologic, Laparoscopic and Pathologic.

pathologically proved ovarian cancer patients that underwent contrast enhanced abdomino-pelvic CT and diagnostic laparoscopy before cytoreductive surgery (CRS) will be included in the study. Calculation of PCI (peritoneal cancer index) using Sugarbaker's method, peritoneal carcinomatosis extent will be categorized into low, moderate and large. Agreement in general and in each category between CT, laparoscopy, surgery and pathology will be assessed using kappa agreement.

we will search medical records of primary ovarian cancer patients underwent CT abdomen, laparoscopy followed by cytoreductive surgery to calculate peritoneal carcinomatosis extent by each modality.

Regional PCI was calculated in each of the 13 anatomical abdominopelvic regions, then total PCI by summation of the lesion size score, it ranged from 0 to 39. Categorization of peritoneal carcinomatosis was classified into 3 categories low if PCI \< 10, moderate if 10-20, and large if \>20.

Eligibility Criteria:
Inclusion Criteria:pathologically proved ovarian cancer patients underwent contrast enhanced abdominopelvic CT and diagnostic laparoscopy before cytoreductive surgery -

Exclusion Criteria:recurrent ovarian cancer

-
Effect of Daily Calorie or Alternate-day Calorie Reductions on Risk for Cardiovascular Disease and Cancer

The purpose of this study is to examine and compare the effects of alternate-day reductions in calorie intake or daily calorie restriction on the risk for cardiovascular disease and cancer.

Overweight individuals are at greater risk for certain chronic diseases such as cardiovascular disease and cancer when compared to those who are normal weight. Dietary restriction has been shown to lower the risk of these chronic diseases in overweight human subjects as well as in normal weight rodents. The majority of studies examining dietary restriction protocols in rodents or humans implement daily calorie restriction (CR), i.e. where the amount of energy consumed is decreased by a certain percentage every day. Another dietary restriction regimen employed, although less commonly, is intermittent caloric restriction, or alternate-day fasting (ADF), i.e. where food is available ad-librium every other day, alternating with a partial or complete caloric restriction day. Recent findings suggest that ADF may modulate certain indices of disease risk to a similar extent as daily CR in animal models. The effect of ADF regimens in comparison with CR regimens on disease risk has yet to be performed in human subjects, however. ADF protocols need not result in weight loss, and would therefore be appropriate for non-obese individuals. Accumulating evidence suggest that adipose tissue may play a role in modulating chronic disease risk by releasing substrates, such as fatty acids, or a variety of hormones, including adiponectin and leptin. The effect of ADF and CR on adipose tissue metabolism and hormone release remains unclear. Accordingly, the aim of the present study is to compare ADF regimes to CR for their effects on risk factors for cardiovascular disease and cancer and their effects on adipose tissue metabolism and hormone secretion, in normal weight to modestly overweight (BMI 22-27 kg/m2) human subjects.

Eligibility Criteria:
Inclusion Criteria:

* Male and female; body mass index (BMI) between 20-30 kg/m2;
* Age between 35-65 years; sedentary (light exercise less than 1h per week) or moderately active (1 to 2h per week);
* Weight stable for \>3 months prior to the beginning of the study;
* Able to give written informed consent;
* Female subjects must be post-menopausal for at least 2 years and can not be on hormone replacement therapy (HRT).

Exclusion Criteria:

* Diabetic;
* History of cardiovascular disease, i.e. myocardial infarction or stroke;
* History of cancer;
* Taking glucose lowering medication;
* Taking weight loss medication