cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Various Degrees of Impaired Renal Function

This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability of oral semaglutide in subjects with various degrees of impaired renal function compared to subjects with normal renal function.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18-85 years (both inclusive) at the time of signing inform consent
* Subject with normal renal function or renal impairment (mild, moderate, severe or end-stage renal disease requiring dialysis)
* For subject with normal renal function: good general health (as judged by the investigator)
* Body mass index (BMI) 18.5-40.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods
* History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease
* Uncontrolled hypertension (defined as systolic blood pressure above or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg)
* Any blood draw or donation of blood or plasma in excess of 400 mL within the 3 months preceding the screening visit (Visit 2)
* History of significant drug abuse, or a positive drug test at the screening visit (Visit 2)
Tolerability of Sifrol® in Ambulatory Patients Suffering From Parkinson's Disease

Study to obtain information about the co-operation of the different physician-colleagues in the treatment of patients with Parkinson's disease, both in private practices and clinics and about the primary treatment strategies in the pharmacotherapy of Parkinson's disease and to collect data on the tolerability of Sifrol® in ambulatory patients suffering from Parkinson's disease under routing conditions


Eligibility Criteria:
Inclusion Criteria:

* Patients with Parkinson's disease who present to the specialist neurologist practice for the first time without or with referral and who are planned to receive or either be switched to Sifrol or continue the previously prescribed therapy with Sifrol® can be included in this observational study

Exclusion Criteria:

* Neurologists are asked to consider the Summary of Product Characteristics (SPC) for Sifrol®
REBECCA Real-world Early BrEast CanCer mAnagement

This is a French observational, national, multicenter prospective cohort study of patients with HER2-negative eBC treated with olaparib at their physician's discretion.

The purpose to this observational study is to evaluate the rate of completion of adjuvant Olaparib treatment for HER2-negative early breast cancer patients in France.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged ≥ 18 years
* Patient diagnosed with HER2-negative eBC
* Patient about to be initiated with adjuvant Olaparib at their physician's discretion
* Patient has been informed and does not object to participation in the study.

Exclusion Criteria:

* Patient not consenting to participate.
* Patients included in the Early Access Program
Study of the Anti-HCV Drug (BMS-790052) Combined With Peginterferon and Ribavirin in Patients Who Failed Prior Treatment

The purpose of this study is to determine whether BMS-790052 added to Peginterferon Alfa-2a and ribavirin can result in higher cure rates in patients who previously failed therapy and may have limited response to retreatment with Peginterferon Alfa-2a and ribavirin alone.


Eligibility Criteria:
Inclusion Criteria:

* Subjects chronically infected with HCV genotype 1
* Non-responder to prior therapy with peginterferon alfa and ribavirin
* HCV RNA viral load of 100,00 IU/mL
* Results of a liver biopsy ≤ 24 months prior to randomization consistent with chronic HCV infection; for compensated cirrhotics can be any time prior to randomization (compensated cirrhotics biopsy enrollment will be capped at 25% of randomized study population)
* Ultrasound, CT scan or MRI results 12 months prior to randomization that do not demonstrate hepatocellular carcinoma
* Body Mass Index (BMI) of 18 to 35 kg/m2

Exclusion Criteria:

* Positive for Hepatitis B infection (HBsAg) or HIV-1/HIV-2 antibody at screening
* Evidence of medical condition associated with chronic liver disease other than HCV
* Evidence of decompensated cirrhosis based on radiologic criteria or biopsy
Dual Energy CT Urography With Reduced Iodinated Contrast

The goal of this study is to validate that Dual Energy CT (DECT) urography when performed with a 50% reduction in iodinated contrast dose results in a CT exam with equal or better image quality and equal or better diagnostic capability compared to traditional Single Energy CT (SECT) performed with a standard contrast dose.

The investigators hypothesize that DECT urography performed with a 50% iodine dose reduction is equivalent to SECT urography performed with a full iodine dose for:

* Enhancement of the aorta, renal arteries, and renal veins
* Enhancement of the renal cortex
* Enhancement of the renal pelvis, ureters, and bladder
* Subjective evaluation of image quality
* Objective evaluation of image quality

In addition, the investigators hypothesize that DECT virtual non-contrast images using material suppression from the same low iodine CT exam results in equivalent diagnostic information compared to SECT true non-contrast images obtained in the same patient during the same exam. If the true non-contrast images could be replaced by the virtual non-contrast images without loss of information, there is potential for DECT to both significantly lower radiation dose as well as significantly decreasing iodine dose.

The investigators designed this research protocol to prospectively test these hypotheses in a population scanned with a 50% reduced iodine DECT urography protocol compared to a control population scanned with a standard iodine dose clinical SECT urography protocol.

Eligibility Criteria:
Inclusion Criteria:

* Age \>50
* Outpatient scheduled to have a CT urography at the site

Exclusion Criteria:

* Severe allergy to iodine containing contrast
* Pregnancy (which is very unlikely for those over 50)
* Body mass index (BMI) over 35 kg/m2
* Inability to provide informed consent
* Inpatient
Acute Intermittent Hypoxia and Breathing in Neuromuscular Disease

This project seeks to investigate the effects of a single acute intermittent hypoxia (AIH) session on respiratory and non-respiratory motor function and EMG (electromyography) activity on patients with ALS (amyotrophic lateral sclerosis) and healthy controls.

Most ALS patients survive less than 5 years after diagnosis, and the main cause of death is respiratory failure. The investigators are interested in the therapeutic potential of acute intermittent hypoxia (AIH) for individuals with neuromuscular diseases, such as ALS. More than two decades of research indicates AIH elicits meaningful respiratory and non-respiratory motor recovery. Acute intermittent hypoxia (AIH) consists of alternating periods of breathing mildly hypoxic (lowered oxygen concentration) and normoxic (normal oxygen concentration) air.

The investigators propose to study mechanisms of respiratory plasticity associated with a single presentation of mild AIH. The fundamental hypothesis guiding this proposal is that even a single AIH trial improves respiratory (and non-respiratory) motor function in ALS patients procedure. Participants will then be asked to breathe air with reduced oxygen for short periods of time, for a duration of 45 minutes. The activity of your muscles and your heart function will be monitored throughout the procedure.

Eligibility Criteria:
Inclusion Criteria:

* a healthy adult
* clinical diagnosis of ALS
* baseline FVC \>60% predicted for age, sex and height.

Exclusion Criteria:

* pregnant
* diagnosed cardiovascular disease
* a BMI \>35 kg/m2
* currently take selective serotonin reuptake inhibitors (SSRI)
* history of seizures
* history of hospitalization for sepsis
* respiratory infection or took antibiotic medications within the past 4 weeks
* use external respiratory support during any waking hours
* participate in a pharmaceutical trial to treat ALS
* have any other medical condition the PI or medical director identify would make it unsuitable to participate.
A Study of the Intestinal Microbiome in Patients with Cirrhosis

This study aims to establish a cohort for analyzing the gut microbiome of patients with liver cirrhosis and to identify factors that influence the prognosis of these patients.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 19 years or older:
2. Patients visiting the hospital with liver cirrhosis.
3. Patients diagnosed with liver cirrhosis who can understand the information provided to them or their representatives and have voluntarily given written consent to participate in this study

Exclusion Criteria:

1. Cases not meeting the inclusion criteria
2. Patients who refuse participation
3. Patients who have taken or been administered antibiotics within the past 2 weeks or are scheduled to take or receive antibiotics during the study period
4. Cases where the diagnosis is unclear
5. Cases with incomplete data or missing investigation items
6. Individuals deemed unsuitable by the principal investigator for other reasons
Carotid Ultrasound Under Pulsed-wave Doppler Mode to Check the Pulse in Cardiopulmonary Arrest Patients.

It's crucial to determine whether a pulse is present or not in patient with cardiac arrest. But more and more studies have shown that manual palpation is unreliable for detecting pulse 1-4. Failure to detect pulselessness may cause delay of chest compression and directly affect the patient's outcome. Likewise, failure to rapidly detect return of spontaneous circulation may cause prolonged chest compression and increase associated injury during resuscitation.

More and more studies have demonstrated that echo guided pulse detection is feasible 5-7. The aim of our study is to check carotid pulse via ultrasound. This is a prospective study and the patient selection is in-hospital or out of hospital cardiac arrest. A curvilinear ultrasonography transducer is used and placed transversely on either right/left carotid artery under pulsed-wave doppler mode to check whether the pulse is present or not. The result of ultrasonography will be compared with manual palpation and to determine the accuracy and effectiveness of clinical usage.


Eligibility Criteria:
Inclusion Criteria:

* any patient presenting at ER with cardiac arrest older than 20 years-old

Exclusion Criteria:

* younger than 20 years-old
* patient who is pregnant
Effects of Addition of Magnesium Sulfate in Spinal Anesthesia on Sensory-Motor Blocks and Postoperative Pain in Lumbar Disk Herniation Surgery

The purpose of this study is to Compare three methods of intrathecal bupivacaine; bupivacaine-fentanyl; bupivacaine-fentanyl-magnesium sulfate on sensory-motor blocks and postoperative pain in patients undergoing lumbar disk herniation surgery.

* Comparison three methods of intrathecal bupivacaine;bupivacaine-fentanyl;bupivacaine-fentanyl-magnesium sulfate on sensory-motor blocks in patients undergoing lumbar disk herniation surgery
* Comparison three methods of intrathecal bupivacaine;bupivacaine-fentanyl;bupivacaine-fentanyl-magnesium sulfate on postoperative pain in patients undergoing lumbar disk herniation surgery
* Comparison three methods of intrathecal bupivacaine;bupivacaine-fentanyl;bupivacaine-fentanyl-magnesium sulfate on postoperative side effects in patients undergoing lumbar disk herniation surgery

Eligibility Criteria:
Inclusion Criteria:

* Candidate for lumbar disk herniation surgery
* No contraindication to the spinal anesthesia
* No history of allergy to opioids and magnesium sulfate
* No peripheral or central neuropathies
* No previous history of surgery on same disk level

Exclusion Criteria:

* Patients with intraoperative tearing of dural suc
* Occuring of inadvertent intraoperative complications such as bleeding
Study of MK0928 in Healthy Adult Volunteers in a Model of Insomnia (0928-006)(COMPLETED)

A study to evaluate the safety and effectiveness of Study of MK0928 in Healthy Adult Volunteers in a Model of Insomnia for insomnia (a sleep disorder).


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults who are between the ages of 18 and 64

Exclusion Criteria:

* Adults who are diagnosed with insomnia
Simvastatin Effect on End Stage Renal Failure Patients Treated by Peritoneal Dialysis

This study will analyse the effect of simvastatin on endothelium dependent venodilation in chronic renal failure patients treated by peritoneal dialysis. The hypothesis is that patients will have a greater endothelium dependent venodilation after four months of simvastatin use.

This study will analyse the effect of simvastatin on endothelium dependent venodilation in chronic renal failure patients treated by peritoneal dialysis. The hypothesis is that patients will have a greater endothelium dependent venodilation after four months of simvastatin use.

Eligibility Criteria:
Inclusion Criteria:

* end stage renal failure
* peritoneal dialysis
* LDL cholesterol \> 100mg/dL
* \> 18 years and \< 80 years

Exclusion Criteria:

* using statin or nitrate
* liver disease
* diabetes mellitus
Open-label, Multi-center Trial of Zonisamide as Adjunctive Therapy in Patients With Uncontrolled Partial Epilepsy

The object of this study is to assess the efficacy and safety of zonisamide as adjunctive therapy in patients with uncontrolled partial epilepsy.

The object of this study is to assess the efficacy and safety of zonisamide as adjunctive therapy in patients with uncontrolled partial epilepsy. Subject takes zonisamide for 16 weeks (4 weeks-titration period, 8 weeks maintenance period). Dose range of zonisamide is 100 \~ 400 mg/day and target dose is 300 mg/day. After 16 weeks, zonisamide efficacy is measured by seizure reduction rate (Each type of seizure: simple partial seizures \[SPS\], complex partial seizures \[CPS\], simple partial seizures evolving into generalized tonic-clonic convulsions \[SGTC\] and total seizure frequency), seizure free rate, responder rate, quality of life in epilepsy (QOLIE-31) and investigator's global evaluation scale. Safety of zonisamide in this study will be estimated by adverse event profile, retention rate and dose of exposure. The duration of this clinical study is 2 years including period of subject enrollment.

Eligibility Criteria:
Inclusion criteria:

1. Epilepsy patient over 15 years old who agrees with Informed Consent Form
2. Patient who has classifiable uncontrolled partial epilepsy according to International Classification of Epileptic Seizures.
3. Patient who has 3 \~ dozens of partial seizure (average more than once seizure per 4 weeks) last 12 weeks despite taking 1 \~ 3 antiepileptic drug(s).
4. Patient who takes 1 \~ 3 marketed antiepileptic drug(s) excluding zonisamide at point of enrollment time.
5. Before study visit, patient who takes stable dose of antiepileptic drug more than 4 weeks.

Exclusion criteria:

1. Patient who has progressive central nervous system (CNS) disorder and/or degenerative disease of the brain.
2. Patient who experiences pseudoseizures and/or who has uncountable clusters.
3. Patient who has serious systemic or drug metabolism affecting disorder .
4. Upward of doubled normal glutamic oxaloacetic transaminase (GOT), glutamic pyruvic transaminase (GPT), bilirubin, blood urea nitrogen (BUN), creatinine levels.
5. Patient who has absolute neutrophil counts \<1800/mm3 or platelets \<100,000/mm3.
6. Patient who has medical history of renal stones.
7. Patient who is allergic to sulfonamide.
8. Medical history of medicinal poisoning and/or alcoholism and/or serious psychological disorder.
9. Pregnant women, lactating women, women of childbearing age who do not use a preventive method of conception.
10. A terminal patient and/or a scheduled surgical patient.
11. Patient who has medication history of zonisamide.
12. Patient who participated other clinical trial within the last 12 weeks at point of enrollment time of this study.
Aerobic Walking Exercise for Non-Ambulatory Stroke Survivors

By doing this study, researchers hope to learn the effects of aerobic exercise on heart, lung, and bone health in people who cannot walk after a stroke.


Eligibility Criteria:
Inclusion Criteria:

* Independent ambulation before stroke
* Be able to understand and follow verbal commands in English
* Have physicians' approval for exercise, and be in stable medical condition
* Participant's first stroke
* Unable to walk independently according to Functional Ambulation Category (FAC) (\<2) after in-patient rehabilitation treatment
* Between 6 weeks to 5 years after stroke onset

Exclusion Criteria:

* Current cardiovascular abnormalities other than stroke such as ischemic cardiovascular event or coronary artery bypass surgery less than 3 months ago
* Musculoskeletal disorder which prevents subjects from participating in the exercise
* Resting blood pressure more than 200/110 mm Hg
* Current or previous pulmonary diseases in the past two years
* Osteoporosis and restricted passive movement in the major joints of the lower limbs
* Subjects will be excluded if they are unable to speak or understand English and/or unable to travel to the University of Kansas Medical Center (KUMC) Neuromuscular Research Laboratory
PICO Breast Reduction Clinical Study Looking at Incision Healing Complications

The purpose of this study is to see if the use of a single-use negative pressure wound therapy system (NPWT) will have an effect on the reduction of post-surgical incision healing complications following breast reduction surgery and to assess the medium-term aesthetic appearance and quality of the resultant scar, compared with standard of care dressings.

The aim of the present study is to assess the efficacy and cost-effectiveness of the Single-Use Negative Pressure Wound Therapy (NPWT) system (PICO) with regard to the reduction of postsurgical incision healing complications during the immediate postoperative treatment phase, and to assess the medium-term aesthetic appearance and quality of the resultant scar, in patients undergoing reduction mammoplasty, compared to standard care.

Eligibility Criteria:
Inclusion Criteria:

* Female patient's ≥ 18 years old
* The patient is able to understand the trial and is willing to consent to the trial
* Patient has undergone an elective surgical procedure for bilateral reduction mammoplasty
* Patients postsurgical incisions are of similar length

Exclusion Criteria:

* Pregnant or lactating females
* Patients on steroids or other immune modulators known to impact healing which may affect scar appearance
* Patients with tattoos in the area of the incisions
* Patients with skin conditions (Cutis laxa etc.) that would result in poor healing or widened scars
* Patients with a known significant history of scar problems i.e. hypertrophic scaring or keloids
* Patients who in the opinion of the investigator may not complete the study for any reason
* Patients with a known history of poor compliance with medical treatment
* Patients who have participated in this trial previously and who were withdrawn
* Patients with known allergies to product components (silicone adhesives and polyurethane films (direct contact with wound), acrylic adhesives (direct contact with skin), polyethylene fabrics and super-absorbent powders (polyacrylates) (within the dressing)
* Incisions that are actively bleeding
* Exposure of blood vessels, organs, bone or tendon at the base of the reference wound
* Incisions \> 12 inches (30cm) max linear dimension
GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia

The purpose of this study is to evaluate the efficacy and safety of belimumab in addition to standard therapy compared to placebo in subjects in Northeast Asia with systemic lupus erythematosus (SLE) over a 52 week period.

The purpose of this study is to demonstrate the efficacy and safety of belimumab 10mg/kg administered intravenously (IV) every 4 weeks compared to placebo, in patients with SLE when added to standard of care therapy, as measured by the SLE Responder Index (SRI) at 52 weeks, defined by a composite endpoint using SELENA SLEDAI score, Physician's Global Assessment (PGA) and BILAG A and B organ domain scores.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older.
* Have a clinical diagnosis of SLE according to the American College of Rheumatology (ACR) classification criteria.
* Have active SLE disease.
* Have positive anti-nuclear antibody (ANA) test results.
* Are on a stable SLE treatment regimen.
* Females of childbearing age are willing to use appropriate contraception

Exclusion Criteria:

* Have received treatment with any B cell targeted therapy at any time.
* Have received a biologic investigational agent in the past year.
* Have received 3 or more courses of systemic corticosteroids in the past year.
* Have received intravenous (IV) cyclophosphamide within 180 days prior to Day 0.
* Have severe lupus kidney disease.
* Have active central nervous system (CNS) lupus.
* Have had a major organ transplant.
* Have significant unstable or uncontrolled acute or chronic diseases or conditions not due to SLE.
* Have a planned surgical procedure.
* Cancer within the last 5 years, except for adequately treated skin cancer, or carcinoma in situ of the uterine cervix.
* Have required management of acute or chronic infections in the past 60 days.
* Have current drug or alcohol abuse or dependence.
* Have a historically positive test, or test positive at screening for HIV, Hepatitis B, or Hepatitis C.
* Have an IgA deficiency.
* Have severe laboratory Abnormalities.
* Have had anaphylactic reaction to X-ray contrast agents or biologic agents.
* Suicidal behavior or ideation.
Impact of ICU on the Quality of Life in Cancer Patients

This is an observational, prospective, monocentric, case-control study. Investigators aim to compare the quality of life and oncological treatment strategy in cancer patients admitted or not in ICU.

Inclusion of cancer patients (cases) at discharge of surgical, cardiovascular and thoracic and medical ICU of the Grenoble Alpes University Hospital.

Cases will be matched with cancer patients identified in oncologist's consultation.

Inclusion of controls from oncologist consultations (2 controls for 1 case) For cases and controls, medical data will be collected at inclusion, 3 and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 ans
* Non-opposition of the patient or relatives
* Lung, head and neck or colorectal cancer
* Non scheduled ICU admission
* At least 24 hours of ICU stay
* Alive at ICU discharge
* Able to answer by phone to quality of life questionary

Exclusion Criteria:

* Unable to answer by phone to quality of life questionary
* Patient participating in another clinical study that could interfere with the results of the study