cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Pharmacokinetics of Velpatasvir in Participants With Normal Renal Function and Severe Renal Impairment

The primary objective of the study is to evaluate the single-dose pharmacokinetics (PK) of velpatasvir (formerly GS-5816) in participants with severe renal impairment using matched healthy participants as a control group.


Eligibility Criteria:
Key Inclusion Criteria:

* General good health with stable chronic kidney disease in Severe Renal Impairment Group
* Screening labs within defined thresholds
* Creatinine clearance must be \< 30 mL/min for Severe Renal Impairment group, and ≥ 90 mL/min for Normal Renal Function group

Key Exclusion Criteria:

* Females who are pregnant or nursing, or males who have a pregnant partner
* Infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or HIV
* History of clinically significant illness (including psychiatric or cardiac) or any other medical disorder that may interfere with participant treatment and/or adherence to the protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole (P07812) (COMPLETED)

This randomized, crossover study is to evaluate the early effectiveness, defined as effect on intragastric pH during the first 4 hours after dosing, of Zegerid, Prilosec over-the-counter (OTC) Tablets, and placebo on the 4th day of treatment to inhibit acid secretion. Additional purposes are to:

1. provide pharmacodynamic evidence comparing 24-hr inhibition of acid secretion on the 1st, 4th, and 11th days of dosing with each of the indicated treatments;
2. compare Zegerid and Prilosec OTC for achieving their steady-state effects for controlling 24-hr gastric acidity at steady-state on the 4th and 11th day of dosing.
3. evaluate early effectiveness, defined as effect on intragastric pH during the first 4 hours after administration, of Zegerid, Prilosec OTC Tablets, and placebo on acid inhibition at steady-state when administered on the 11th day of dosing.

Participants were randomized in a 3-way crossover design and received, in random order, Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate), Prilosec OTC Tablets (20 mg-equivalent omeprazole), and Placebo Capsules. Participants received each treatment for 11 days. There was a minimum of a 2-week washout period between treatment arms.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-lactating, non-pregnant female subjects who are 18-65 years of age.
* Physical examination findings within normal limits for age.

Exclusion Criteria:

* History of hypersensitivity, allergy or intolerance to omeprazole, or other proton pump inhibitors
* History of peptic ulcer disease or other acid related gastrointestinal symptoms or heartburn with a frequency of more than one/month.
* Participation in any study of an investigational treatment in the 30 Days before Screening or participation in another study at any time during the period of this study
* Any significant medical illness that would contraindicate participation in the study
* Gastrointestinal disorder or surgery leading to impaired drug absorption
* Any abnormal Screening laboratory value that is clinically significant in the investigator's opinion
* Current use of any prescription or OTC medications that affect gastrointestinal function.
* Currently using or having a history of frequent use of antacids, OTC or prescription (Rx) histamine-2 (H2) receptor antagonists, or OTC or Rx use of proton pump inhibitors.
Isotopic Imaging for Prodromal Alzheimer's Disease

The primary objective of this study is to characterize cerebral metabolism modifications using 18F-FDG PET technology and perfusion with 99MTC-ECD SPECT in patients with prodromal Alzheimer's Disease drawn from a high risk population. We also compare PET and SPECT imaging within this framework, and search for optimal diagnostic thresholds.


Eligibility Criteria:
Inclusion Criteria for the group with memory problems:

* patient consulting for memory problems
* caucasian
* memory complaint is validated by a clinical evaluation
* cognitive performance is sufficiently well preserved so that a diagnostic of dementia cannot be made (according to the DSM-IV-R and NINCDS-ADRDA criteria) at the time of inclusion
* the patient speaks French
* presence of an informant
* accepts to sign consent

Inclusion Criteria for the group without memory problems (reference population):

* at least four years of formal education
* patient consulting for memory problems
* memory problem reported by the patient is not validated by the consultation, nor by the battery of tests specified during screening
* presence of an informant
* Clinical Dementia Rating (CDR) = 0
* accepts to sign consent

Exclusion Criteria:

* Instrumental Activities of Daily Living (IADL): at least two items \> 1
* Anticholinesterasic treatments and/or memantin before study inclusion
* major depressive syndrome, according to the Global Depressive Scale
* Known neurodegenerative disease or general disease or major physical problems that could interfere with cognitive functioning and testing
* Pathology that might lead to death in the short term (evolving cancer, non stable cardiopathy, hepatic, renal or respiratory insufficiency)
* contra-indications for MRI, PET or SPECT scans
* not affiliated with a social security regimen
The Effects of Caffeine on Heart Rate and Heart Rate Variability

In previous research we have shown that an acute caffeine dose of 5 mg/kg body mass reduces heart rate at rest and during low intensity exercise, with the effect dissipating as exercise intensity increases. If, as suspected, the effect at rest and at low intensities is due to an effect of caffeine on parasympathetic activity, this is likely to be reflected in an increase in heart rate variability (the beat-to-beat fluctuation in heart rate). The aim of this study is therefore to investigate the effect of caffeine on heart rate and heart rate variability at rest and during submaximal exercise.


Eligibility Criteria:
Inclusion Criteria:

* Trained cyclists

Exclusion Criteria:

* Injured or a contraindicative medical condition
Safety and Performance Investigation of a New 1-piece Ostomy Product Compared to Standard of Care 1-piece in Subjects With Ileostomy

The objective of the investigation is to document New Mio 1-piece is non-inferior (no worse) in reducing leakage (4-point scale) compared to Standard of Care.


Eligibility Criteria:
Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Be able to handle the appliance themselves or with help from caregiver (e.g. spouse)
4. Have an ileostomy with a diameter between 15 and 45 mm
5. Have had their ostomy for at least three months
6. Currently use a 1-piece flat product with open bag
7. Use minimum 1 product every second day.
8. Be suitable for participation in the investigation and for using a standard adhesive, flat base plate
9. Must use custom cut product
10. Accept to test two 1-piece products within the study

Exclusion Criteria:

1. Use irrigation during the study (flush the stoma with water)
2. Currently receiving or have within the past 2 months received radio- and/or chemotherapy
3. Currently receiving or have within the past month received systemic steroid or local treatment in the peristomal area
4. Are pregnant or breastfeeding
5. Participating in other interventional clinical investigations or have previously participated in this investigation
6. Has more than three days wear time
Study of CMP-CPS-001 in Healthy Volunteers

The objective of this clinical study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of CMP-CPS-001 administered as a subcutaneous injection in adult healthy volunteers.

This is a randomized, double-blind (Sponsor-open), and placebo-controlled study.

The SAD part will be conducted in approximately 48 healthy volunteers, in 4 cohorts of 12, randomized 3:1 to receive a single subcutaneous dose of CMP-CPS-001 or placebo. Participants will be followed for 42 days after dosing.

The MAD part will be conducted in approximately 48 healthy volunteers, in 4 cohorts of 12, randomized 3:1 to receive 3 monthly doses of CMP-CPS-001 or placebo. Participants will be followed for 56 days after the last dose.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults 18 to 55 years inclusive at time of informed consent
* BMI ≥18.0 and ≤32 kg/m2 at screening, and ≤110 kg
* Willing and able to sign informed consent form

Exclusion Criteria:

* Any significant disease or disorder which, in the opinion of the Investigator, may either put the study participant at risk because of participation in the study, may influence the results of the study, or may affect the study participant's ability to participate in the study
* Clinically relevant illness within 7 days before the first dose of study drug
* History of intolerance to subcutaneous injection or relevant abdominal scarring
* Laboratory results outside normal ranges at screening and judged as clinically relevant by the Investigator for liver function, kidney function, and platelets
* Positive viral serology test results for human immunodeficiency virus type 1 or 2 antibodies, hepatitis B surface antigen or hepatitis C virus antibody
* Any other safety laboratory result considered clinically significant and unacceptable by the Investigator
Study of Branched-chain Amino Acids in Cancer Cachexia

Investigate whether supplementation with branched-chain amino acids (BCAAs) has a positive effect on cancer cachexia, as measured by the maintenance or increase in weight and lean body mass (LBM) based on body weight in kilograms (kg) and bioelectrical impedance assessment (BIA).


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Eastern Cooperative Oncology Group (ECOG) performance status score \< 2 and a life expectancy \>3 months
3. Participants must have evaluable disease by RECIST 1.1 criteria17
4. At least four (4) weeks from prior major surgery
5. Participants must be cachectic as defined by the guidelines below18

   * \>5% weight loss over the past 6 months (in absence of simple starvation); OR
   * BMI \<20 and any degree of weight loss \>2%; OR
   * Appendicular skeletal muscle index consistent with sarcopenia (whole body fat-free mass index without bone determined by bioelectrical impedance (men \<14.6 kg/m²; women \<11.4 kg/m²) and weight loss \>2%
6. Participants must be anorexic as defined by reporting one of the following symptoms below3

   * Early satiety
   * Nausea/vomiting
   * Taste alterations
   * Smell alterations
   * Meat aversion

Exclusion Criteria:

1. Patients taking Levadopa
2. Patients with amyotrophic lateral sclerosis (ALS)
3. Patients utilizing a percutaneous gastrostomy tube for drainage
4. Patients unable to consume food or beverage orally
5. Patients on any form of parenteral nutrition which contains BCAA.
6. Serious non-healing wound, ulcer, or burn
7. Patients who are pregnant or lactating
8. Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements
9. Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements
Body Weight Supported Treadmill Training vs. Overground Walking Training in Persons With Chronic Stroke

The purpose of this study is to compare two different walking training programs for persons with chronic stroke.

Body weight supported treadmill training (BWSTT) and overground walking training (OWT) are two interventions commonly applied for enhancing gait and balance in patients with chronic stroke. BWSTT and OWT are often used by clinicians separately or in tandem. While various aspects of the two interventions have been investigated in the past, limited research has been conducted to compare the effects of the two interventions in patients with chronic stroke.

Longer training durations may not always be feasible due to limited reimbursement options, lack of clinic accessibility, or transportation restrictions for patients with chronic deficits following stroke. A short burst of training consisting of a ''booster''-like protocol may provide a convenient option for some patients with chronic stroke to improve necessary functional skills in a short period of time.

The primary purpose of this pilot study is to compare walking speed immediately and 3-months after a short-burst of body-weight support treadmill training (BWSTT) or overground walking training (OWT) for adults with chronic stroke. Twenty participants with chronic stroke will be recruited and screened to determine eligibility for the study. Participants will be randomly assigned to either BWSTT or OWT for 30 minutes, 5 days per week for 2 weeks. Outcome measures will include assessments of gait speed, endurance, walking pattern, fear of falling, balance confidence, anxiety, and activity and participation in daily life. Outcomes will be tested prior to (pre-test) and immediately after (post-test) the assigned intervention and again 3-months after completing the intervention (retention).

Eligibility Criteria:
Inclusion Criteria:

* Minimum of 6 months post-stroke
* Single episode of stroke
* Between the ages of 21-80
* Able to walk with or without the use of an assistive device or orthoses
* Able to ambulate at a self-selected gait speed \< 0.8 m/s as determined by the 10-meter comfortable walk test
* Medically stable with a physician release stating approval to enter an exercise program
* Able to follow at least two-step verbal instructions
* Available for the entire period of the study
* Able to travel to and from research measurement and intervention sessions

Exclusion Criteria:

* Currently receiving physical therapy services
* Co-morbidities or pre-existing cardiovascular conditions that would prohibit gait training and exercise
* Pre-existing neurological or current musculoskeletal conditions that would limit gait ability separate from the effects of stroke
* Complications from other health conditions that could influence walking
* Currently known to be pregnant
Renal Sympathetic Denervation and Potential Effects on Glucose Metabolism and Cardiovascular Risk-Factors

The Re-Shape CV-Risk Study is a clinical study where renal adrenergic denervation (RDN) is done in high risk patients with treatment-resistant hypertension. RDN is a mini-invasive, percutaneous technique where an ablation catheter is inserted through a femoral artery into the renal arteries, for destruction of the adrenergic nerve bundles in the artery adventitia by means of radio-frequency ablation. RDN leads to sympathetic denervation of the kidneys, which in the "Symplicity trials" led to an impressive reduction of blood pressure (- 33 /-11 mmHg). In a pilot study, where 40 % of the patients had diabetes, RDN seemed to have beneficial effects not only on blood pressure, but also on insulin sensitivity and hyperinsulinaemia.

The investigators aim to introduce RDN as a clinical study where blood pressure reduction and methodical, technical aspects will be evaluated, but more importantly, also additional effects of RDN on sub-clinical organ damage (endothelial function, vascular stiffness, fundus-, heart-, kidney injury), quality of life, arrhythmia, and glucose metabolism. The investigators hypothesis is that RDN will have positive effect on glucose metabolism, QOL and sub-clinical organ damage.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 Years.
* Resistant hypertension, as defined in the 2007 ESH-ESC guidelines and confirmed by ambulatory or home blood pressure measurements. (Here office BP \> 140/90 mmHg on 4 or more antihypertensive drugs in adequate dosages (including one diuretic) or certified drug intolerance).
* No known secondary reason for hypertension
* Negative pregnancy test (preferably blood hCG) for female patients of childbearing potential
* Estimated GFR (glomerular filtration rate) \> 45 mL/min/1.73m².
* Willing and able to comply with follow-up requirements
* Signed informed consent

Exclusion Criteria:

* Type 1 and type 2 diabetes
* Pregnancy
* Allergy to the contrast medium used during RDN and Iohexol clearance.
* Age \> 68 years
* Hemodynamically significant heart valve disease
* Pacemaker or ICD
* Medication that may interfere with the procedure (Anticoagulation, Platelet inhibitors, Steroids), if they cannot be temporarily reduced or stopped.
* Cancer
* Patients with transplanted kidneys
* Reno vascular conditions like diameter \< 4mm, renal artery stenosis or significant atherosclerosis, previous renal artery stenting
Furosemide Versus Ethacrynic Acid in Children With Congenital Heart Disease

This study aims to verify if ethacrynic acid continuous infusion is superior to furosemide continuous infusion in total urine output production during the first 24 post operative hours.

Diuretic therapy in children after open heart surgery is widely administered, though no evidence currently supports if an ideal drug or an ideal dosage can be recommended. Loop diuretics are the most effective drugs in terms of urine output production but may cause some collateral effects such as metabolic alkalosis, hypovolemia, hypokalemia, ototoxicity. Furthermore, some reports showed that loop diuretics usage can be associated with an increased risk of renal dysfunction and mortality. However, their use in children with signs of fluid overload, pulmonary edema or oliguria is mandatory and widely practiced.

Furosemide and ethacrynic acid are often prescribed and administered without any specific indication, basing on clinicians preferences.

No study so far, explored the hypothesis of which of these drugs is the most effective in terms of urine output production and safe in terms of renal function.

This study aims to verify if ethacrynic acid continuous infusion is superior to furosemide continuous infusion in total urine output production during the first 24 post operative hours.

Eligibility Criteria:
Inclusion Criteria:

* Children with congenital heart disease undergoing cardiac surgery
* intraoperative aortic cross clamp over 90 minutes or interventional catheterization procedures with post-operative inotrope score over 20
* sign of fluid retention after surgical procedures

Exclusion Criteria:

* Preoperative renal dysfunction
* Preoperative administration of more than 4mg/kg/die loop diuretics
* Need for renal replacement therapy at ICU admission
* Need for ECMO at ICU admission
Family Mid-Upper Arm Circumference (MUAC) Follow-up After Recovery From Acute Malnutrition (MODAM-fMUAC)

Protocols for the community-based management of acute malnutrition (CMAM) have not changed significantly for more than 20 years, with relatively complex treatment protocols and persistent supply chain challenges that have limited overall program coverage, leaving millions of malnourished children without care annually. The overarching goal of this research project is to simultaneously test two novel simplified approaches in CMAM with potential to improve program coverage. The simplified approach includes two parallel clinical trials for SAM and MAM treatment. For the Family MUAC follow-up study, children who recover from these two parallel clinical trials will be enrolled in trial to test the effectiveness of MUAC screening at home by the child's caregivers as a self-referral strategy, compared to a scheduled health facility-led strategy and the standard of care of community-based follow-up visits.


Eligibility Criteria:
Inclusion Criteria:

* children 6-59 months of old who recovered from SAM or MAM following treatment in either the MODAM-SAM or MODAM-MAM trials

Exclusion Criteria:

* caregiver not planning on remaining in the local area for the subsequent 6 months
Treatment of Hidradenitis Suppurativa With Eth 755nm Alexandrite Laser

Patients with bilateral hidradenitis in the axilla, groin and/or inframammary will be treated on one side with the Alexandrite hair removal laser. The other side will serve as the control.

Patients with bilateral disease will be chosen to participate in the study. Patients will be advised to discontinue any prior systemic HS treatments two weeks before their first laser session as a wash out period. One side of the patient will be chosen as the treatment side, the other as an intrinsic control. Each participant will have a total of 4 treatments with the laser, one treatment per month over the duration of 4 months. Patients will then participate in a follow-up clinic visit two months after completion of their last treatment. In between laser sessions, participants will be allowed to use benzoyl peroxide 10% wash as a skin cleanser and clindamycin 1% solution or lotion as a topical therapy, both twice daily to the treatment and control areas. At each visit, photographs will be taken of the lesions to monitor progression and to serve as a comparison to the control side. The treatment side will be treated with the laser and adjusted according to skin type as follows:

Skin type I-II (Fair Caucasian): Fluence: 30J/cm2 Skin type III (Darker Caucasian, light Asian): Fluence: 25 J/cm2 Skin type IV (Mediterranean, Asian, Latin): Fluence: 18 J/cm2 Skin type V (Light skinned black, Darker mediterranean): Fluence: 16J/cm2 Skin type VI (Dark skinned black): Fluence 14 J/cm2

A spot size of 12 mm and a cryogen spray delay of 50/50 will be used for all treated patients. The treatment area will not exceed 15cm x 15cm. If the patient cannot tolerate treatment with the Alexandrite laser, the patient will be terminated from the study. Following each treatment session, the patient will be given an ice pack to reduce any discomfort the patient may experience as a result of treatment with the laser. Clinical evaluation and photographs will determine improvement.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Patients with Hidradenitis Suppurativa with bilateral and symmetric disease with one or more anatomic sites of involvement.

Exclusion Criteria:

* Pregnant patients or patients planning to get pregnant during the time of the study
* Patients on systemic treatment for Hidradenitis Suppurativa
* Patients with photosensitivity disorders
* Patients unable to tolerate the laser treatments
* Intake of a photosensitive medication