cyrilzakka/clinical-trials huggingface dataset:
Intradialisis Physical Exercise in Quality of Life and Health

Evaluate the effectiveness of different modalities of physical exercise about clinical health indicators and quality of life of patients with chronic kidney disease undergoing hemodialysis.

Objective of this study will be evaluate the effectiveness of different modalities of physical exercise about clinical health indicators and quality of life of patients with chronic kidney disease undergoing on hemodialysis. This study will include to 100 people over 18 years old who are stage five of chronic kidney disease and go to hemodialysis units of Bogota D.C, Colombia.

The ransomized controlled clinical trial to clusters, with 3 groups of intervetion and 1 control, double masking. All the participants receive information on informed consent. The study was approved by the ethics committee of the Universidad del Rosario

Eligibility Criteria:
Inclusion Criteria:

* Include participants with stage five of chronic kidney disease,
* People over 18 years old.
* Their participation is voluntary and their have signed the informed consent form.
* Persons that are undergoing hemodialysis for at least 3 months.
* Persons have ability to do exercise protocols.
* Persons have the approval by nephrologist doctor and deportologist for to do the study according to the results of initial medical assessment.

Exclusion Criteria:

* Surgical intervention to least 6 months.
* Skeletal limitations that affect exercise performance.
* Psychiatric disorders and psychological such as depression, anxiety that could be affect participation of the study.
* Body Mass Index greater than 30 kg/m2 and not less than 18.5 kg/m2.
* Hemodialysis catheter dysfunction or infection as well as participation in home exercise programs.
Evaluation of the Benefits of Enhanced Recovery After Surgery (ERAS) Protocol in Pelvic Prolapse

ERAS protocols have been shown to improve recovery in terms of reduced pain, shortened time to ambulation and length of hospital stay. This study aims to investigate the impact of ERAS protocol on time to mobilization and length of hospital stay in patients undergoing surgery for urinary incontinence and pelvic prolapse.

ERAS protocols containing several preoperative, intraoperative and postoperative measures have been shown to improve recovery in terms of reduced pain, shortened time to ambulation and length of hospital stay in patients undergoing surgery. However, data concerning the role of ERAS protocols in urogynecological surgery is limited. The present study, therefore, aimed to address the role of ERAS protocols in patients undergoing surgery for urinary incontinence and pelvic prolapse.

Eligibility Criteria:
Inclusion Criteria:

* Must be scheduled for surgery because of urinary incontinence or pelvic organ prolapse

Exclusion Criteria:

* Insulin dependent diabetes
Study of ABBV-383 Assessing Adverse Events and Clinical Activity With Subcutaneous (SC) Injection in Adult Participants With Relapsed or Refractory Multiple Myeloma

Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine the safety and pharmacokinetics of ABBV-383 in adult participants with relapsed/refractory (R/R) MM.

ABBV-383 is an investigational drug being developed for the treatment of R/R MM. This study is broken into 3 Arms: Arm A with 2 parts and Arm B as an expansion. Participants will receive ABBV-383 as a subcutaneous (SC) injection and intravenous (IV) infusion in Arm A and SC injections of ABBV-383 in Arm B. Around 55 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 25 sites across the world

In Arm A participants will receive one of two doses of ABBV-383 as an SC injection and (IV) infusions, during the 151 week study duration. In Arm B, participants will receive the selected dose from Arm A as SC injections, during the 151 week study duration.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance of \<= 2.
* Participants with relapsed or refractory multiple myeloma who have received 3-5 prior lines of therapies and with prior triple class exposure including a proteasome inhibitor, anti-CD38 monoclonal antibody and an immunomodulatory drug.
* Must be naïve to treatment with ABBV-383.

Exclusion Criteria:

- Received B-cell maturation antigen (BCMA)xCD3 bispecific antibody.
A Phase I Trial of Alloreactive Cell Infusion Following Transplantation of Haplotype Cells in Patients With Myeloid Malignancies

The purpose of this study is to determine the maximum tolerated dose of alloreactive NK cells that can be transfused following stem cell transplant.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically documented AML, ALL, MDS, CML,
* Identification of haploidentical donor
* LVEF \> 45% corrected
* DLCO \> 50% predicted
* Serum Creatinine \<= 2 mg/dL
* Bilirubin \< 2 x ULN
* AST, ALT \< 2 x ULN
* Age ≤ 65 years
* Performance Status 0-1

Exclusion Criteria:

* Patients relapsing \<6 months after autologous SCT are not eligible.
* Patients with active infections requiring oral or intravenous antibiotics are not eligible for enrollment until resolution of infection
* No HIV disease
* Non-pregnant and non-nursing
Titrating-Dose of Lonafarnib in Combination With Ritonavir

A phase 2, open-label study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic activity of titrating-dose lonafarnib/ritonavir in patients chronically infected with hepatitis delta virus (HDV)

This is a Phase 2 study of 24 weeks of treatment with a dose-titration regimen of lonafarnib/ritonavir in up to 15 patients chronically infected with HDV: lonafarnib starting at 50 mg twice daily (BID) in combination with ritonavir 100 mg BID and escalating lonafarnib as tolerated.

The duration of the study for each patient is approximately 13 months (up to 4 weeks for screening, 24 weeks of treatment, 4 weeks for the primary follow-up visit, and monthly safety follow-up visits for 5 months thereafter). The 6-month follow-up after the last dose of study drug is designed to allow evaluation of the clinical and virologic course after completion of the 24-week Treatment Period.

Eligibility Criteria:
Key Inclusion Criteria:

1. Male or female, 18 to 65 years of age, inclusive
2. Chronic HDV infection documented by a positive HDV antibody (Ab) test of at least 6 months duration and detectable HDV ribonucleic acid (RNA) by quantitative polymerase chain reaction (qPCR) at study entry
3. Liver biopsy demonstrating evidence of chronic hepatitis
4. Willingness to practice appropriate contraception

Key Exclusion Criteria:

1. Previous use of lonafarnib
2. Co-infected with human immunodeficiency virus (HIV) or hepatitis C virus (HCV)
3. Active jaundice defined by total bilirubin level \>2.0 mg/dL and known not to have Gilbert's disease
4. Decompensated liver disease or cirrhosis, history of bleeding esophageal varices, ascites, or hepatic encephalopathy
5. Serum creatinine concentration ≥1.5 times upper limit of normal (ULN)
6. Evidence of another form of viral hepatitis (not including hepatitis B virus or HCV) or another form of liver disease
7. Evidence of hepatocellular carcinoma
8. Use of alfa interferon, either interferon alfa-2a or interferon alfa-2b, or peginterferon alfa-2a within 2 months before the start of screening
9. Concomitant use of any of the following:

   1. Medications or foods that are known moderate or strong inducers or inhibitors of CYP3A4 or CYP2C19
   2. Drugs known to prolong the PR interval or QT interval of the electrocardiogram
   3. Receipt of systemic immunosuppressive therapy within the 3 months before start of screening
   4. Statins, due to inhibition of mevalonate synthesis, which reduces protein prenylation
   5. Medications contraindicated in the prescribing information for ritonavir
Added Value of Speckle Tracking in the Evaluation of Patients With Sickle Cell Disease

Sickle Cell Disease is a serious disease that is life-threatening for patients being homozygous for the SS form or heterozygous for the SC or βthal forms. The CHU Brugmann hospital currently regularly treats about 70 homozygous adult patients and this number is in constant augmentation.

Sickle cell disease patients may develop a cardiomyopathy due to chronic anemia, the haemosiderosis risk or, less frequently, to coronary vaso-occlusive damages.

The hypervolemia in patients with sickle cell disease causes an overestimation of the ejected left ventricular fraction measured by echocardiography, this parameter being very dependent of the blood volume.It has already been shown that the left ventricular ejection fraction was normal in most patients with sickle cell disease, but that its evaluation by parameters independent from the blood volume showed the existence of a dysfunction.

Myocardial strain, as measured by speckle tracking, is a echographic evaluation method of the cardiac function, independent of the blood volume. This technique hasn't been used much in sickle cell disease patients. A study using 3D speckle tracking on a limited number of sickle cell disease patients failed to show a strain anomaly. Moreover, the study highlighted a higher global longitudinal strain in this patient population. The investigators find these data hard to explain and in contradiction with previous studies using other cardiac function evaluation techniques, independent from the blood volume.

The primary goal of this study is thus

* to study the longitudinal strain by 2D echography
* to determine if anomalies of the longitudinal strain exist in sickle cell disease patients with a normal ejected left ventricular fraction, compared to a control group of healthy patients.

The secondary goal of this study is to correlate, inside the sickle cell disease group, the possible strain anomalies with biological gravity parameters of the disease.


Eligibility Criteria:
Inclusion Criteria:

* All sickle cell disease patients

Exclusion Criteria:

* Insufficient echogenicity
Efficacy of Adding Topiramate to Current Treatment in Refractory Obsessive Compulsive Disorder (OCD)

SRI's are considered first-line treatments for OCD, however many patients continue to have significant symptoms despite an adequate trial of an SRI. Neuroimaging studies have shown that the glutamate neurological system is involved in OCD. This study will test the safety and efficacy of topiramate, a drug, which targets glutamate, in the treatment of OCD, where the OCD has been un-responsive, or partially responsive to regular SRI treatment.


Eligibility Criteria:
Inclusion Criteria:

* Outpatient with primary DSM- IV OCD
* Completion of a 14-week open label trial of one the following SRI's: fluoxetine 80 mg/day, paroxetine 60 mg/day, fluvoxamine 300 mg/day, clomipramine 250 mg/day, sertraline 200 mg/day, citalopram 60 mg/day, escitalopram 30 mg/day and demonstrating a non or partial responses to SRI treatment (CGI-I of 3 or 4, Y-BOCS reduction of \< 35%)
* Stable (8 wks or longer) concurrent medications including benzodiazepines, sedative hypnotics, antipsychotics, and antidepressants.

Exclusion Criteria:

* Any other primary DSM-IV diagnosis; DSM-IV criteria for body dysmorphic disorder, bipolar affective disorder, schizophrenia, psychotic disorder, current alcohol/substance abuse.
* A previous adequate trial of topiramate
* Comorbid major depressive disorder diagnosis which predates OCD diagnosis
* Cognitive behavioural therapy or additional psychotherapy in past four months
* Allergy or hypersensitivity to topiramate
* BMI \< 20
* History of kidney stones
Safety and Efficacy of Long-acting Repeatable Octreotide Acetate for Injectable Suspension vs. Surgery in Treatment-naïve Patients With Acromegaly

Currently, the first line treatment for acromegaly is surgery, in order to remove the adenoma causing overproduction of growth hormone which leads to acromegaly. The objective of this study is to assess the safety and efficacy of long-acting repeatable formulation of octreotide and to compare it to the safety and efficacy of surgery in patients with acromegaly who have not had any previous treatment for acromegaly.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed or previously untreated acromegalic patients
* Lack of suppression of GH nadir to \<1.0 µg/L, after oral administration of 75 g of glucose (OGTT)
* IGF-I levels above the upper limits of normal, i.e. 97th percentile (adjusted for age and gender)

Exclusion Criteria:

* Requires surgery for recent significant deterioration in visual fields or other neurological signs, which are related to the pituitary tumor mass
* No evidence of pituitary adenoma on Magnetic Resonance Imaging (MRI)
* Symptomatic cholelithiasis

Other protocol-defined exclusion criteria may apply.
The Effect of Probiotics on Constipation, and Intestinal Microflora in Children With Functional Constipation

To compare the differences of fecal microflora between constipated and non-constipated healthy children, and evaluate the efficacy of probiotics in reducing symptoms of constipation and the influence of intestinal microflora in children with functional constipation.

The investigators performed a monocentric, prospective, randomized controlled trial including 120 pediatric patients (aged 6 months - 10 years old) with functional constipation and 30 healthy age-matched healthy children as control. The investigators shall evaluate the children according to the Rome III Diagnostic Criteria for functional constipation.

The 120 enrolled patients are randomized in to two groups: Group A receiving magnesium oxide and probiotics (MIYAIRI-BM), Group B receiving only magnesium oxide. Each patient is assigned the evaluation constipation symptoms and detection of microflora (beneficial and harmful bacteria) in fecal samples at the enrollment, 4 weeks, and 12 weeks. Patients who take less than 80% of the appropriate dose of medications are withdrawn from the study. All patients included in the study will be given informed oral consent before entering the study.

The data of the fecal microflora evaluated in 60 healthy children are used as control.

Eligibility Criteria:
Inclusion Criteria:

Rome III Diagnostic Criteria for functional constipation for children aged 6 months - 4 years old is as the following:

1. Two or fewer defecations per week.
2. At least one episode per week of incontinence after acquiring toileting skills.
3. History of excessive stool retention.
4. History of painful or hard bowel movements.
5. Presence of a large fecal mass in the rectum.
6. History of large-diameter stools that may obstruct the toilet. Children aged 6 months - 4 years old is evaluated as functional constipation if two of the situations mentioned above lasted for one month.

Rome III Diagnostic Criteria for functional constipation for children aged 4 years old and above is as the following:

1. Two or fewer defecations in the toilet per week.
2. At least one episode of fecal incontinence per week.
3. History of retentive posturing or excessive volitional stool retention.
4. History of painful or hard bowel movements.
5. Presence of a large fecal mass in the rectum.
6. History of large diameter stools that may obstruct the toilet. Children aged 4 years old and above is evaluated as functional constipation if two of the situations mentioned above happens at least once per week

Exclusion Criteria:

1. gastroesophageal reflux disease
2. inflammatory bowel disease
3. cardiopulmonary diseases
4. liver disease
5. renal disease
6. genetic diseases
7. endocrinal diseases
8. received abdominal surgeries
Clinical Study of Stent Versus Direct Atherectomy to Treat Lower Limb Ischemia

This is a randomized study comparing stent and plaque excision systems in treatment of lower limb (superficial femoral or popliteal artery) ischemia.

This is a randomized study comparing stent and plaque excision systems in treatment of diabetic lower limb (superficial femoral or popliteal artery) ischemia.

Eligibility Criteria:
Inclusion Criteria:

Provides written informed consent Willing to comply with follow-up evaluations at specified times Has claudication or rest pain due to peripheral arterial disease Disease located within the femoropopliteal artery Patient has a de novo or restenotic lesion(s) with \>50% stenosis documented angiographically and no prior stent in the target lesion.

Patient has symptoms of peripheral arterial disease classified as Rutherford Category 2 or greater.

Exclusion Criteria:

Previously implanted stent(s) or stent graft(s) in target leg Life expectancy less than 12 months Has any planned surgical or endovascular intervention of target vessel 30 days before or after index procedure Thrombophlebitis, uremia, or deep venous thrombus, within past 30 days. Receiving dialysis or immunosuppressant therapy. Recent stroke within past 90 days. Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix®) or ticlopidine (Ticlid®), heparin, Nitinol (nickel titanium), contrast agent, that cannot be medically managed.

Tissue loss due to ischemic disease (Rutherford/Becker category 5 or 6) Serum creatinine level \>/= 2.5 mg/dl at time of screening visit Known or suspected active infection at the time of the procedure Bleeding diathesis Patient is unwilling or unable to comply with procedures specified in the protocol or has difficulty or inability to return for follow-up visits as specified by the protocol.

Patient is known to be pregnant, incarcerated, mentally incompetent, and/or alcohol or drug abuser.

Patient is currently participating in any other investigational drug or medical device study that has not completed primary endpoint(s) evaluation or clinically interferes with the endpoints from this study or future participation in such studies prior to the completion of this study.
Low-potassium Content Vegetables in Chronic Kidney Disease

Prior observational studies have shown that higher levels of vegetables and fruits consumption are associated with lower risk of all-cause mortality in patients with chronic kidney disease (CKD). However, compared with the normal population, patients with CKD are more likely to consume less vegetables and fruits. Thus, the investigators aim to evaluate whether proving low-potassium content vegetables to this population are able to reach the recommended target of daily vegetables intake and not increase the risk of hyperkalemia.

Prior observational studies have shown that higher levels of vegetables and fruits consumption are associated with lower risk of all-cause mortality in patients with chronic kidney disease (CKD). However, compared with the normal population, patients with CKD are more likely to consume less vegetables and fruits. According to the suggestions from 2018 Ministry of Health and Welfare in Taiwan, vegetables intake are at least 3 to 5 servings daily based on the daily energy requirement. In our own data, the average daily vegetables intake was only 2.1 servings among patients with CKD stages 3 to 5 not yet on dialysis. Therefore, the investigators aim to evaluate whether proving low-potassium content vegetables to patients with CKD stages 3 to 5 not yet on dialysis are able to reach the recommended target of daily vegetables intake and not increase the risk of hyperkalemia.

Eligibility Criteria:
Inclusion Criteria:

* CKD stage 3b\~5, not yet on dialysis
* Age ≥20 years
* Stable doses of medications for 4 weeks
* Serum potassium level: ≥3.5 and \< 5.5 mmol/L

Exclusion Criteria:

* Anticipated to receive dialysis within 3 month
* Major gastrointestinal diseases (inflammatory bowel disease, celiac disease) or intestinal resection
* Patients with infection, malignancy, heart failure, liver cirrhosis or impaired cognitive or mental disorders
* Patients who are just hospitalized due to an acute cardiovascular events or infection 3 months prior to the start of study
* Patients with kidney transplants
* Patients who receive immunosuppressant
* Pregnant women or patients who are planning to become pregnant
Role of Inflammation in Progressive Multifocal Leukoencephalopathy (PML)

This is a continuation of our previous studies on Progressive Multifocal Leukoencephalopathy (PML). We will focus on the role of inflammation in PML, and define prognostic markers of disease evolution.

To determine precisely what are the host or viral factors that may predict a favorable outcome for PML patients and the role of inflammation in preventing JCV from causing brain disease. One of the goals of this study is to help establish non-invasive markers of PML evolution by studying the brain metabolism in PML lesions using Magnetic Resonance Imaging (MRI), Magnetic Spectroscopy (MRS) and other advanced imaging modalities.

Eligibility Criteria:
Inclusion Criteria:

* PML patients of 18 years of age or older will be included in this study.

Exclusion Criteria:

1. Presence of opportunistic brain lesions other than PML. ( e.g., toxoplasmosis, lymphoma)
2. Presence of confounding neurological disorder such as brain neoplasm etc.

In addition patients with a contraindication to MRI examination will be excluded from study. Contraindications to the MRI examination include:

1. Medically unstable or hematological, renal, or hepatic dysfunction.
2. Cardiac pacemaker
3. Internal clips,
4. Metal implants, or external clips with 10 mm of the head.
5. Metal in the eyes.
6. Pregnant
7. Claustrophobia
HPV Vaccine Immunity in High-risk Women

This is a single arm immunological study based in Vietnam. The study will examine human papillomavirus (HPV) vaccine responses in high-risk women (female-sex-worker; FSW). We aim to recruit 60 women (aged 18-25 years old) and provide them with a standard 3-dose schedule of licensed 4vHPV vaccine (Gardasil®, Merck). Blood and cervical swab samples will be collected for immunology and virology testing, respectively.

Multiple sexual partners (\>4) is a risk factor for human papillomavirus (HPV) infection and cervical cancer. Due to the nature of their work, female sex workers (FSW) are at a particular high risk of HPV infection and developing cervical cancer. These groups are also likely to be reservoirs for HPV transmission since they are less likely to clear the infection and are known to be infected with multiple HPV types simultaneously. Benefits in vaccinating HPV-infected individuals, includes protecting them against HPV vaccine types that the person is not currently infected with as well as re-infection with the same HPV type. Therefore, immunising FSW with HPV vaccine is a novel strategy to reduce their risk of cervical cancer as well as downstream effects on HPV transmission. FSW is common in low-and middle-income countries (LMICs) of Asia (i.e. Vietnam), but the use of HPV vaccine in LMICs is very low often due to high costs and logistical difficulties in vaccine delivery. Furthermore, available data on the immunogenicity of HPV vaccine in FSW are limited. The aim of this study is to determine the immunogenicity of HPV vaccine in FSW and compare their antibody responses among young women (non-FSW) of the same age group by comparison with published data.

Eligibility Criteria:
Inclusion Criteria:

* Each participant must meet all of the following criteria to be enrolled in this trial:

  * Is between the reporting ages of 18-25 years at the time of recruitment
  * Engage in commercial sex in the last month

Exclusion Criteria:

* Participants meeting any of the following criteria will be excluded from the trial:

  * Pregnant or possibly pregnant
  * Has received any HPV vaccine previously
  * Has an axillary temperate greater than 38°C
  * Known allergies to any vaccine component
  * incapacity to provide consent