cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate BMS-986278 in Participants With Normal Renal Function, Severe Renal Impairment, or End-Stage Renal Disease on Intermittent Hemodialysis

The purpose of this study is to assess the effect of severe renal impairment (RI) and end-stage renal disease (ESRD) with intermittent hemodialysis (IHD) on the pharmacokinetics and safety of BMS-986278. This study plans to use a staged design based on RI severity.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 18 and 45 kg/m2 inclusive, and body weight ≥ 50 kg at screening. Note: for ESRD participants, this body weight should be the prescription dry weight.
* Severe Renal Impaired Participants:

  1. Participant has a supine SBP ≥ 90 and ≤ 180 mmHg, supine DBP ≥ 60 and ≤ 100 mmHg, and heart rate ≥ 40 and ≤ 110 beats per minute.
  2. Participant has severe RI as defined by an eGFR ˂ 30 mL/min and not requiring dialysis at screening.
  3. Participant must be medically stable for at least 1 month before study intervention administration.
* Participants with ESRD:

  1. Participant has ESRD as defined by an eGFR \< 15 mL/min at screening.
  2. Participant required to be on intermittent hemodialysis, an average of 3 hemodialysis treatments per week prior to screening.
  3. Participant has demonstrated adequate hemodialysis measurements (at least 2 Kt/V measurements ≥ 1.2 or 2 urea reduction ratio measurements ≥ 65%) within the 3 months prior to screening.
* Healthy participant should have a supine SBP ≥ 90 and ≤ 160 mm Hg, supine DBP ≥ 50 and ≤ 100 mm Hg, and heart rate ≥ 40 and ≤ 100 beats per minute.
* Healthy participants should have normal renal function, as defined by having an eGFR ≥ 90 mL/min eGFR at screening (calculated using the CKD-EPI equation).

Exclusion Criteria:

* Participant with any significant medical condition, laboratory abnormality, or psychiatric illness.
* Any surgical or medical condition(s) possibly affecting drug absorption, distribution, metabolism, or excretion (eg, bariatric procedure or cholecystectomy).
* Individuals who are of childbearing potential, breastfeeding, or currently pregnant.
* Other protocol defined inclusion/exclusion criteria apply.
Efficacy of Human Coronavirus-immune Convalescent Plasma for the Treatment of COVID-19 Disease in Hospitalized Children

This is a multicentered, open-label, randomized controlled Phase 2 trial to evaluate the safety and efficacy of providing human coronavirus-immune convalescent plasma as treatment for COVID-19 disease in hospitalized children in the context of the COVID-19 pandemic.

SARS-CoV-2 viral infection resulting in COVID-19 disease has recently been designated by the World Health Organization as a global pandemic. Outbreak forecasting and mathematical models suggest that the number of COVID-19 cases will continue to rise over the coming weeks and months. There is an urgent public health need for rapid development of novel interventions. This protocol aims to use passive antibody therapy via convalescent plasma from SARS-CoV-2-infected patients who have developed antibody immunity, COVID-19 convalescent plasma (C19-CP), as treatment for hospitalized children with COVID-19 disease at pediatric academic hospitals across Canada. The unknown role for convalescent plasma in treating COVID-19 necessitates further study.

Eligibility Criteria:
Inclusion Criteria:

1. Age 0 to \<19 years old
2. Hospitalized with symptoms compatible with COVID-19 illness
3. Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen prior to randomization.
4. ABO compatible convalescent plasma available

Exclusion Criteria:

1. Onset of symptoms began \>12 days before screening
2. History of adverse reactions to blood products or other contraindication to transfusion
3. Refusal of plasma for religious or other reasons
4. Acute heart failure with fluid overload
5. Any condition or diagnosis, that could in the opinion of the Site Principal Investigator interfere with the participant's ability to comply with study instructions, or put the participant at risk
6. Anticipated discharge within 24 hours

Note: The intent of this exclusion criteria is to only include participants with acute COVID-19 infections. This protocol is not intended to include participants with post-infectious complications. In cases where the distinction is not clear, participant eligibility will be discussed with the study steering committee prior to enrollment.
PK Study of Pregabalin GLARS Tablet 150mg and IR Formulation After Multiple Dosing Under Fed Condition in Healthy Male Subjects

The purpose of this clinical trial is to compare the pharmacokinetic characteristics of GLA5PR GLARS tablet 150mg and Lyrica Capsule 75mg.

GLA5PR GLARS tablet 150mg is a New Formulation which is made by GL Pharm Tech.

GLARS(Geometrically Long Absorption Regulated System) is New Solution to Sustained Absorption by Extending the Absorption Site.

To overcome the shortcomings of the currently existing sustained release drug delivery technologies the investigators have recently developed a novel drug delivery system to enable a drug to be dissolved irrespective of the surrounding environment and further absorbed up to colon. The investigators coined this "Geometrically Long Absorption Regulated System(GLARS)".

Basically, this system is a triple-layered tablet, comprised of upper and lower layers that swell and draw a sufficient amount of water, plus a highly water - soluble middle layer that rapidly draw water into the tablet core simultaneously.

The water drawn into the tablet (about 3 to 4 times the weight of the tablet itself) functions as an additional media which enables additional and later drug release out of the dosage form. This serves to overcome the shortage of surrounding media that has been reported to be one of the key reasons for mal-absorption of a drug in colon.

As the middle layer induces a rapid water draw into the tablet core, the penetrated water also diffuses to the upper and lower layers, which makes the tablet to rapidly swell and controls drug release.

At virtually the same time, the swollen upper and lower layers form to surround a lateral side of the middle layer, which can, in turn, further control drug release.

This relatively rigid swollen matrix structure makes drug release not affected by surrounding mechanical flux, which can provide relatively consistent in vivo drug release irrespective of degree of gastrointestinal motility.

Eligibility Criteria:
Inclusion Criteria:

* 20\~45 years old, Healthy Adult Male Subject
* ≥ 50kg(Body Weight) and Ideal Body Weight ≤ ±20%

Exclusion Criteria:

* ALT or AST \> 1.25(Upper Normal Range)
* Total Bilirubin \> 1.5 (Upper Normal Range)
The Diagnostic Methods of Early Postoperative Flare-up of Crohn's Disease

Crohn's disease is a chronic inflammatory transmural bowel disorder characterized by high rate of postoperative anastomotic complications and recurrences. Surgery itself can influence immunologic function and trigger inflammatory response, which may result in the flare of Crohn's disease soon after surgery (within one month), especially near the anastomosis. Early flare-up of Crohn's disease can negatively impact the outcomes of operation. However, due to the the complexity of perioperative period and dangerous of invasive examine, it is difficult to distinguish disease flare from postoperative complications.

In this study, the investigators aim to development a diagnostic method of flare-up within one month after surgery, which can help us to detect and then treat disease flare in time.

HBI score, serum CRP, ESR, WBC, Hb, PLT, IL-6，PCT and fecal Calprotectin will be monitored within one month after resection.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing intestinal resection of all macroscopic disease, with an endoscopically accessible anastomosis,

Exclusion Criteria:

* patients have an anastomosis which is endoscopically inaccessible by standard colonoscopy;
* patients withs persisting macroscopic abnormality after surgical resection;
* patients with an end stoma (ileostomy or colostomy);
* patients are not suitable to undergo endoscopy because of co-morbidities or an unwell clinical state;
* patients who are unable to give informed consent;
* patients who are pregnant
Norfloxacin In The Primary Prophylaxis Of Spontaneous Bacterial Peritonitis

Advanced liver disease and low ascitic fluid protein concentration have been identified as risk factors for spontaneous bacterial peritonitis in cirrhosis. Moreover, renal impairment and hyponatremia increase mortality rate of this infection. Aims: To investigate if oral administration of norfloxacin prevents the first episode of SBP, hepatorenal syndrome and improves survival in cirrhotic patients with ascites and low protein concentration in ascitic fluid (\<15 g/L) and at least one of the following inclusion criteria: functional renal failure (serum creatinine ≥ 1,2 mg/dl or BUN ≥ 25 mg/dl), hyponatremia (serum sodium ≤ 130 mEq/L) or advanced liver disease (Child ≥ 9 points with serum bilirubin ≥ 3 mg/dl). Methods: Prospective, multicenter, randomized, double-blind placebo controlled trial comparing oral norfloxacin (400 mg/d; n=35) with placebo (n=35).


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years, protein concentration in ascitic fluid \< 15 g/L and at least one of the following: serum creatinine ≥ 1.2 mg/dl or BUN ≥ 25 mg/dl, serum sodium ≤ 130 mEq/L or severe liver failure as defined by a Child-Pugh score ≥ 9 points and a serum bilirubin ≥ 3 mg/dl.

Exclusion Criteria:

* Previous history of spontaneous bacterial peritonitis or of norfloxacin prophylaxis, allergy to quinolones, hepatocellular carcinoma, organic renal failure and HIV infection
Evaluation of Ocular Lens Proteins in Cataract From Individuals With Down Syndrome

This study involves the collection ocular lens tissue from individuals with Down syndrome and age-matched controls at the time of cataract surgery.

Individuals with Down syndrome have an increased rate of cataract. The reason for this increase is unclear. Normally, once cataracts become a significant impairment, an ophthalmologist will determine when cataract surgery should be performed. When this surgery is performed, cataractous tissues are cut out and discarded with medical waste. In this study, these tissue will be collected and protein analysis performed to determine what changes in different proteins are found in Down syndrome lenses as compared to normal cataractous lenses.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing cataract surgery for lens extraction.

Exclusion Criteria:

* Known genetic cause other than Down syndrome causing cataract.
Effect of Nivolumab vs Placebo in Patients With Acute Myocardial Infarction: A Randomized Clinical Trial

Myocardial infarction (MI) is a major contributor to morbidity and mortality in China. The goal of this interventional, randomised controlled clinical trial is to evaluate the effectiveness and safety of a single administration of Nivolumab to the patients presenting with an acute anterior ST-segmental elevated myocardial infarction. Researchers will investigate if Nivolumab treatment can effectively and safely reduce infarct size as well as improve cardiac function of the patients with acute myocardial infarction.

The efficacy and safety of nivolumab as compared with placebo in the treatment of acute anterior ST segment elevation myocardial infarction are not known. In this phase 1/2, randomized, placebo-controlled, open-label trial, we randomly assigned adults with acute anterior ST segment elevation myocardial infarction to receive either nivolumab (5mg/kg for single administration) or placebo. The primary end points were difference in infarct size/LV mass% from baseline to 3 months after Nivolumab administration and the incidence of adverse events during 3 months after Nivolumab administration. Secondary end points included difference in LVEF%, LVESV/Body surface area, LVEDV/Body surface area, Trponin T and proBNP from baseline to 3 months after Nivolumab administration.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 80 years;
2. Signed informed consent and expected compliance with protocol;
3. Acute anterior ST segment elevation myocardial infarction;
4. Emergency coronary angiography for revascularization of occlusive vessels within 24 hours of chest pain onset;
5. Left ventricular ejection fraction is less than 45% (LVEF≤45%) as revealed by Echo within 72 hours after revascularization.

Exclusion Criteria:

1. Cardiogenic shock;
2. Cardiac arrest/ventricular fibrillation;
3. History of severe renal failure, glomerular filtration rate (eGFR) \< 30ml/min;
4. History of severe infection, hepatobiliary obstruction or malignant tumor;
5. Receiving immunosuppressive therapy;
6. Women who are pregnant or may become pregnant;
7. There are contraindications to study drugs or magnetic resonance examination;
8. No written informed consent was obtained.
Cognitive Behavioural Therapy Versus Psychoeducation for Perinatal Anxiety

Anxiety during pregnancy and the postpartum (perinatal) period is very common and is associated with adverse consequences for mothers and their infants. Currently, medication is the most commonly prescribed treatment for perinatal anxiety and the lack of nonmedication-based interventions for perinatal anxiety is a barrier to receiving effective treatment for many women. As such, the present single-blind, randomized controlled trial seeks to evaluate whether group-based cognitive behavioural therapy, the gold-standard psychological treatment for anxiety disorders in the general population, effectively treats perinatal anxiety symptoms when compared to a psychoeducation group, which is currently the most commonly prescribed non-medication-based treatment for perinatal distress.


Eligibility Criteria:
Inclusion Criteria:

1. Women 18 and older that are pregnant or between 0-12 months postpartum;
2. Principal diagnosis of an anxiety disorder as per the Mini International Neuropsychiatric Interview for DSM-5 (version 7.0.2) with or without comorbid depression;
3. No concurrent psychological treatment;
4. Not taking psychoactive medication or a) medications are stable in dose and type for at least 8 weeks prior to the study (as per Canadian psychiatric guidelines; and b) medications remain stable throughout the study;
5. Fluent in English, minimal grade 8 reading level.

Exclusion Criteria:

1. Severe depression/suicidality requiring acute intervention;
2. Women with psychotic or current substance use disorders,
3. medication changes in dose or type or less than 5/6 sessions complete (will continue with treatment but be excluded from the study).
Simultaneous Measurement of Electroencephalography (EEG) and Functional Magnetic Resonance Imaging (fMRI) in Patients With Alcoholism

Investigation of inpatients with alcoholism after detoxification with simultaneous Electroencephalography (EEG) and functional Magnetic Resonance Imaging (fMRI).


Eligibility Criteria:
Inclusion Criteria:

* Age of 18 or more
* Inpatient with alcoholism after detoxification.

Exclusion Criteria:

* Neurological disease
A Study of MabThera/Rituxan (Rituximab) in Patients With Relapsed Centroblastic Centrocytic Non-Hodgkin's Lymphoma

This study will evaluate the efficacy and safety of MabThera/Rituxan in patients with relapsed low-grade centroblastic centrocytic non-Hodgkin's lymphoma. Patients will receive once-weekly intravenous MabThera/Rituxan for 4 weeks; responding patients will be treated a second time in case of relapse (defined as progression after complete or partial response). The anticipated time on study treatment is \<3 months.


Eligibility Criteria:
Inclusion Criteria:

* adult patients \>= 18 years of age;
* centrocytic centroblastic non-Hodgkin's lymphoma stage III-IV;
* relapse after chemotherapy (with or without interferon maintenance therapy).

Exclusion Criteria:

* primary refractory lymphomas;
* more than 3 relapses of centroblastic centrocytic non-Hodgkin's lymphoma;
* clinically significant cardiac disease.
TIMP-2 and IGFBP7 for the Prediction of the Cardiac Surgery Associated Acute Kidney Injury

The purpose of this study is to analyze the new biomarkers (TIMP-2 and IGFBP-7) of tubular renal cell damage for the prediction of the Cardiac Surgery Associated acute kidney injury.


Eligibility Criteria:
Inclusion Criteria:

* planned cardiac surgery

Exclusion Criteria:

* renal dialysis
* minors
* emergency
* no cardiopulmonary bypass
Effect of Different Remineralizing Agents on White Spot Lesions Treatment in Children

One hundred children with white spot lesions on their teeth were divivided into 5 groups of different remineralizing agents to assess their effect on color change and remineralization

Children having at least one tooth clinically diagnosed by white spot lesion were randomly allocated to five groups.

Group one: No treatment was applied (negative control). Group two: Fluoride gel was applied for 5 minutes (positive control). Group three: Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) (MI paste) was applied for 5 minutes.

Group four: Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) + fluoride (MI paste plus) were applied for 5 minutes.

Group five: Nano hydroxyapatite paste (Apagard primo toothpaste) was be applied for 5 minutes.

All children involved in this study were instructed to brush their teeth under the supervision of the researcher before the application of the studied agent.

Each agent was applied to the labial surfaces of each tooth affected with white spot lesion for 5 minutes after cleaning and drying with a cotton roll using an applicator tip. After each application, children were instructed not to eat or drink for one hour. This application was be repeated in-office after one then after two weeks then after six weeks.

Participants received a sterilized pouch containing a sterile container with one of the pastes according to the study group for home application. The application of the paste was carried out under parental supervision and was asked to apply each of the pastes at home three times a day till the end of the study

Eligibility Criteria:
Inclusion Criteria:

1. Presence of at least one tooth affected by white spot lesion.
2. Good oral hygiene and regular tooth brushing at least twice daily.

Exclusion Criteria:

1. Unwillingness to be randomly assigned to 1 of the 3 treatment groups.
2. Presence of abnormal oral, medical, or mental condition.
3. Presence of any milk-related allergies.
4. Presence of dentin caries or enamel hypoplasia on maxillary anterior teeth.
5. Presence of periodontal pockets around maxillary anterior teeth.
Laparoscopic Retrovesical Colpopectinopexia

The purpose of this study is to identify whether a new operative technic would be acceptable in female with pelvic organ prolapse.

A new operative technic use to treat pelvic organ prolapse in women. Investigators plan to evaluate the results of procedure in the field of recurrence rate, effectiveness, mortality,morbidity and learning curves.

Eligibility Criteria:
Inclusion Criteria:

* all female with cystocele 1-2-3 grade? hysterocele 1-2 (POP-Q)

Exclusion Criteria:

* rectocele more then 1 grade (POP-Q) hysterocele more then 2
Comparison of the Impact of Three Programs of Inspiratory Muscles.

Ventilator-induced diaphragmatic dysfunction appears to contribute to slow weaning from mechanical ventilation. Several trials of inspiratory muscle training to facilitate weaning in intensive care have been performed, with inconsistent results, utilizing different methods of IMT in different populations.

In this study, the investigators want to compare the incidence of 3 inspiratory muscle training programs on inspiratory strength, on difficult to wean patients in intensive care unit.

This is a multi-center randomized trial not blinded with 3 parallels groups:

* Martin's group: a threshold-based IMT is performed like used by Martin in a randomized trial in 2011, in a view of inspiratory strength increase.
* Cader's group: a threshold-based IMT is performed like used by Cader in a randomized trial in 2010 , in a view of inspiratory endurance increase.
* EDRIC's group: a new treshold-based IMT is performed, in a view of both inspiratory strength and endurance increase.

The investigators think that a new threshold-based IMT performed in a view of both inspiratory strength and endurance increase, is more effective and well tolerated than the 2 others protocols.

The main objective of this study is to determinate which IMT program is the most effective on the inspiratory muscle strength and endurance increase. The investigators will be able to study the impact on the weaning time of IMT performed with the best protocol.

The investigators are going to conduct a randomized trial with intention-to-treat analysis. Following 18h of invasive mechanical ventilation in a controlled mode, the failure of the first single breathe trial of 2 hours and the presence of sevrability criterias defined by the European consensus conference in 2007, 88 participants will be included. Participants will be randomizesd to receive one of the 3 protocols of IMT, 2 times per day, 7 days per week, from the inclusion to the extubation.

The ratio of randomization will be 1:1:2 for a better evaluation of EDRIC's group wich propose a new IMT protocol.

Eligibility Criteria:
Inclusion Criteria:

* Patient ventilated more than 18h in a controlled mode;
* First single breathe trial of 2 hours failure;
* Presence of sevrability criterias definied by the European consensus conference in 2007 an usually used:

  * diminution of the sedfative agents,
  * Patients with spontaneous beath in VAC mode or patient ventilated in a VSAI-PEP mode,
  * PaO2/FiO2 ≥150,
  * Absence d'inotropes ou de vasopresseurs à forte dose ou dose croissante (\<1mg/h),
  * SaO2 \> 90% with FiO2 ≤ 50%,
  * PEP ≤ 8cmH2O,
  * Corporal température between 36°C and 39°C,
  * Glasgow Score ≥ 8.

Exclusion Criteria:

* Age \< 18 years ;
* medically unstable;
* Poor vital pronostic at very short term;
* Cardiac arrest with a poor neurological prognostic;
* Neuromuscular disease ;
* Pneumothorax non drained ;
* Tracheostomy ;
* Current pregnancy ;
* Patients with guardianship or trusteeship.