cyrilzakka/clinical-trials huggingface dataset:
The Nutrition Challenge: A Health Promotion Campaign

The purpose of the challenge is to see if we, as the nutrition experts, can follow the dietary and physical activity guidelines promoted to the public. We have an opportunity to "practice what we preach." Scientific evidence demonstrates, knowledge is not enough to change ones'behaviors. It is through positive approaches and lifestyle changes that behavior can be altered. By experiencing the planning, work, and motivation required to make lifestyle changes we can all be better clinicians.


Eligibility Criteria:
Inclusion Criteria:

* Regular access to the internet
Safety, Efficacy and Pharmacokinetics of ALD403

The purpose of this study is to assess the safety, pharmacokinetics and efficacy of a single dose of ALD403 in the prevention of migraine headache in frequent episodic migraineurs for 24 weeks.


Eligibility Criteria:
Inclusion Criteria

* Diagnosis of migraine at ≤ 50 years of age (ICHD-II, 2004 Section 1)
* History of migraine ≥ 12 months with

  * ≥ 5 and ≤ 14 migraine days in each 28 day period in the 3 months prior to screening
  * use of acute migraine medications ≤ 14 days per 28 day period and, within those days, ≤ 10 days of triptan use per 28 day period in the 3 months prior to screening and the 28 day period of completion of eDiary prior to randomization
* Women of child-bearing potential and males with partners of child-bearing potential must agree to use adequate contraception (oral or injectable \[depot\] estrogen, and/or progestogen, or selective estrogen receptor modulator contraceptive therapeutic, intrauterine contraceptive device, or double barrier method \[e.g., condom and diaphragm or spermicidal gel\]). Non-childbearing potential is defined as post-menopausal for at least 1 year or surgical sterilization or hysterectomy at least 3 months before screening
* Any hormonal therapy (e.g., oral contraceptives, hormone replacement therapy) use is stable and ongoing for at least 3 months prior to screening and during the 28 day period from screening to randomization
* Agree not to post any personal medical data related to the trial or information related to the trial on any website or social media site (e.g., Facebook, Twitter) until the trial has been completed

Exclusion Criteria

* Confounding pain syndromes including fibromyalgia, chronic musculoskeletal (e.g., low back pain), psychiatric conditions, dementia, or major neurological disorders other than migraine that interfere with the participation in the trial
* Diagnosis of complicated migraine, chronic tension-type headache, hypnic headache, hemicrania continua, new daily persistent headache, basilar, hemiplegic, or familial hemiplegic migraine
* Regular use (greater than 7 days) of prophylactic headache medication (any preventive medication or supplement with evidence of efficacy from at least 1 placebo-controlled trial) within 3 months, or onabotulinumtoxin A within 6 months prior to screening or during the 28 day period prior to randomization
* Cardiac surgery or cardiac symptoms within 3 months of screening and during the 28 day period prior to randomization
* Suspected or diagnosis of hypertension with or without antihypertensive treatment
* Any ongoing co-morbidity that in the opinion of the Investigator will interfere with the participation in the trial
* Body Mass Index (BMI) \> 39 at screening
* Pregnant, breast-feeding, or planning to become pregnant during the trial
* Patients who have used opioids \> 5 days for the treatment of pain in more than 2 of the 6 months prior to screening or in the 28 day period prior to randomization
Photobiomodulation Therapy in the Management of Chemotherapy-Induced Peripheral Neuropathy

This study aims to investigate the effectiveness of photobiomodulation therapy (PBM) in the management of chemotherapy-induced peripheral neuropathy (CIPN). Therefore, the hypothesis is that PBM can reduce the severity of CIPN in cancer patients, increasing the patient's quality of life.

Chemotherapy-induced peripheral neuropathy (CIPN) is one of the common complications of cancer treatment and involves paresthesia, numbness and/or burning pain in distal limbs. This condition has a high health impact because it is associated with psychological distress, fall risk, and poor sleep quality. Furthermore, it impairs patients' daily activities and thereby decreases their quality of life. The overall incidence of CIPN is approximately 68% in the first month after chemotherapy. The available evidence for preventive and therapeutic options for CIPN is limited. Therefore, only symptom management based on pharmacological and/or physical therapy is applied with limited success. Our research group showed that photobiomodulation (PBM) has the potential to reduce the development of CIPN in breast cancer patients (unpublished data). PBM uses visible and/or (near)-infrared light at a low power produced by laser diodes or light-emitting diodes (LED) to stimulate tissue repair and reduce inflammation and (neuropathic) pain. The aim of this project is to evaluate the effectiveness of PBM in the management of CIPN in general.

Eligibility Criteria:
Inclusion Criteria:

* Finished one of the following types of chemotherapy: paclitaxel, docetaxel, oxaliplatin, cisplatin, vincristine, thalidomide and/or bortezomib.
* Diagnosed with CIPN
* Age 18 years or above
* Have no documented or observable psychiatric or neurological disorders that might interfere with study participation (e.g., dementia or psychosis)
* Dutch-speaking
* Signed informed consent

Exclusion Criteria:

* Taking stable doses of medication on prescription for peripheral neuropathy. Related medications are: gabapentin, pregabalin (Lyrica), nortriptyline, amitriptyline, duloxetine (Cymbalta), and venlafaxine.
* Severe or unstable cardio- respiratory or musculoskeletal disease
* Interruption of more than two consecutive laser treatments
* Dark brown or black skin pigmentation (described as skin type VI in the Fitzpatrick scale)
PD-1 Inhibitor Tislelizumab Maintenance Therapy in R/R DLBCL Patients After ASCT

This is a multicenter, randomized controlled, prospective clinical trial. The objective is to investigate the efficacy and safety of Tislelizumab maintenance therapy in newly diagnosed diffuse large B-cell lymphoma (DLBCL) patients after autologous hematopoietic stem cell transplantation (ASCT).

This is a multicenter, randomized controlled, prospective clinical trial. The objective is to investigate the efficacy and safety of Tislelizumab maintenance therapy in newly diagnosed diffuse large B-cell lymphoma (DLBCL) patients after autologous hematopoietic stem cell transplantation (ASCT). 94 patients were randomly divided into two groups according to the ratio of 1:1. The whole trial included screening period (day-28 to day-1), treatment period (Tislelizumab, 200mg every 8 weeks, 12 times) and follow-up period (2 years after the enrollment).

Eligibility Criteria:
Inclusion Criteria:

1. Male and female, aged 18-65;
2. relapsed/refractory DLBCL patients after autologous stem cell transplantation;
3. Laboratory tests (blood tests, liver and renal function) meet the following requirements:

   1. Blood tests: white blood cell count ≥ 3.0 × 109 / L, absolute neutrophil count ≥ 1.5 × 109 / L, hemoglobin ≥ 90g / L, platelet ≥ 75 × 109 / L
   2. Liver function: transaminase ≤ 2.5 × upper limit of normal value, bilirubin ≤ 1.5 × upper limit of normal value;
   3. Renal function: serum creatinine 44-133 mmol / L;
4. The score of ECOG was 0-2;
5. The subject or his legal representative must provide written informed consent before the special examination or procedure of the study.

Exclusion Criteria:

1. Pregnant or lactating women;
2. Severe complications or infection;
3. Lymphoma involving central nervous system;
4. Participate in other clinical trials at the same time;
5. According to the judgment of the researcher, the patients who are not suitable for this study were selected.
Positron Emission Tomography (PET) Imaging of Glial Activation in Psychotic Disease States

Many neurological diseases, including AIDS dementia, Alzheimer's disease and schizophrenia, involve an inflammatory component thought to specifically involve glial cell activation. The Investigators has been concerned with the development of tools for noninvasive imaging of inflammatory processes in psychotic disease. Here, the investigators aim to use PET-based neuroimaging with carbon-11 N,N-diethyl-2-(4-methoxyphenyl)-5,7-dimethylpyrazolo\[1,5-a\]pyrimidine-3-acetamide, (\[11C\]DPA)-713 to quantify regional distribution of translocator protein (TSPO), a putative marker of inflammation, in the brains of patients with schizophrenia and bipolar disorder, type I. The investigators will focus on patients in the early stages of disease (within first five years of onset of schizophrenia diagnosis and within first five years of first manis, respectively) to minimize the confounds of age-, chronic illness-, and medication- effects on our results.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers 18-65 years of age
* Patients diagnosed with recent onset schizophrenia (within 5 years of onset), 18-65 years of age
* Patients diagnosed with recent onset bipolar disorder (within 5 years of onset of first mania), 18-65 years of age
* screening laboratory tests will be obtained for subjects within a 10 day period prior to the PET study and the results must be within normal limits for gender and age. These tests will be repeated with a 7-day window following the PET study
* EKG conducted within 10 day period prior to the PET study. The EKG will be repeated within 7 days following the study.
* Subject agrees to return to the Hospital for a follow-up EKG and laboratory testing of blood and urine.
* For females of childbearing potential, negative serum pregnancy test within a 10 day period prior to PET study.

Exclusion Criteria:

* history of recent nosocomial infection,
* history of chronic neurological disorder, such as multiple sclerosis or epilepsy, or structural,central nervous system (CNS) abnormality such as stroke or arteriovenous malformation,
* history of head injury with loss of consciousness \> 1 hour,
* history of active substance abuse as defined by substance abuse including alcohol abuse over the 6 months prior to the study,
* dependence on benzodiazepine medication
* contraindications to MRI scanning to include pacemakers, metallic implants/prosthesis or prohibitive claustrophobia, etc.
* contraindications to PET scanning to include pregnancy, etc. For females of childbearing potential, negative serum pregnancy test less than 10 days prior to PET study
* ECG demonstrating the patient is not in a sinus rhythm or is having acute ischemia.
* any medical condition that in the opinion of the study investigators would constitute a safety risk to the subject.
Evaluating the Early Bactericidal Activity, Safety and Tolerability of Nebulised RESP301 in Adults With Tuberculosis

A Phase 2, Single-Centre, Open-Label, Parallel Control Arm, Randomised Clinical Study to Evaluate the Early Bactericidal Activity (EBA), Safety and Tolerability of Nebulised RESP301 in Adults with Newly Diagnosed, Rifampicin Susceptible Pulmonary Tuberculosis

A total of approximately 15 participants will be recruited per treatment arm (total of approximately 75 participants in the study). Control arm participants will be split across sequential stages stages 1 and 2, with no stratification.

Stage 1: To determine the EBA of

* Treatment Arm 1 (Active; n = 15) - inhaled RESP301 6 ml dosed via nebulisation administered three times daily over 14 days
* Treatment Arm 2 (Control; n= 5) - HRZE taken orally once daily

On completion of Stage 1, recruitment will be paused and an interim analysis performed to determine whether the study should proceed to Stage 2.

Stage 2: To determine the EBA of

* Treatment Arm 2 (Control; n= 10) - HRZE taken orally once daily
* Treatment Arm 3 (Active; n = 15) - inhaled RESP301 6 ml dosed via nebulisation administered once daily over 14 days
* Treatment Arm 4 (Active; n = 15) - inhaled RESP301 6 ml dosed via nebulisation administered twice daily over 14 days
* Treatment Arm 5 (Active; n = 15) - inhaled RESP301 6 ml dosed via nebulisation administered three times daily in combination with HRZE taken orally once daily over 14 days

Eligibility Criteria:
Inclusion Criteria:

* Provide written, informed consent prior to all study-related procedures and agree to undergo all study procedures
* Body weight (in light clothing and with no shoes) between 40 and 90 kg, inclusive
* Newly diagnosed pulmonary TB
* Rifampicin susceptible pulmonary TB as determined by molecular testing
* Ability to produce an adequate volume of sputum as estimated from a pre-treatment overnight sputum collection sample (estimated 10 ml or more)
* Spirometry performed during screening with a FEV1 of ≥ 40%
* Be of non-childbearing potential or willing to use effective methods of contraception

Exclusion Criteria:

* HIV positive AND CD4 \< 350 cells/mm3 OR are receiving antiviral therapy (ART)
* Methaemoglobin saturation (SpMet) \>3%
* Female participant who is pregnant or breast-feeding
* Participants planning to conceive a child within the anticipated period of study participation and for at least 90 days after the last dose of IMP in the study
* Participation in other clinical studies with investigational agents within 8 weeks prior to screening
* Treatment received for this episode of TB with any drug active against M.tb
* Treatment with immunosuppressive medications such as TNF-alpha inhibitors within 2 weeks prior to screening, or systemic corticosteroids for more than 7 days within 2 weeks prior to screening.
* Treatment with nitric oxide and other nitric oxide donor agents, phosphodiesterase inhibitors and lung surfactant drugs, within 30 days prior to screening
Methotrexate (Rheumatrex) High Dose Special Investigation (Regulatory Post Marketing Commitment Plan)

This Investigation is to be performed for the purpose of assessing the following information in the long-term post-marketing daily medical practice in the patients who receive REUMATOLEX 2 mg Capsule for the treatment of Rheumatoid Arthritis (RA) at the dose higher than 8 mg/week.

1. Condition of occurrence of ADRs
2. Factors considered to affect safety
3. Verification of efficacy

Implemented as a Special Investigation by Central Registration System

Eligibility Criteria:
Inclusion Criteria:

* Patients need to be administered Rheumatrex in order to be enrolled in the survey
* Patients who receive the Rheumatrex at the dose higher than 8 mg/week for the treatment of Rheumatoid Arthritis

Exclusion Criteria:

* Patients who have been treated with Rheumatrex at the dose higher than 8 mg/week since the days when the high dose therapy for RA was not approved
* Patients who have been treated MTX other than Rheumatrex administered Rheumatrex
Hypothalamic-pituitary Effects After Endoscopic Third Ventriculostomy

Background: Endoscopic third ventriculostomy (ETV) is a standard procedure for the treatment of obstructive hydrocephalus in children and adults. Perforation of the third ventricle floor which is part of the hypothalamic-pituitary neuronal network is the key of this surgical procedure.

Purpose: There are no prospective data available about the endocrine effects after ETV in children and adults. The principal aim of this prospective study is to evaluate the variability of hypothalamic-pituitary hormones and clinical effects in children and adults after ETV in order to plan a multicentric study.

Introduction Endoscopic third ventriculostomy (ETV) is a standard procedure for the treatment of obstructive hydrocephalus in children and adults. Perforation of the third ventricle floor which is part of the hypothalamic-pituitary neuronal network is the key of this surgical procedure. Single patients with endocrine or electrolyte abnormalities after ETV have been reported in children or adults. So far there are no prospective data available about the endocrine effects after ETV.

Materials and methods 40 patients (10 children, 30 adults) with obstructive hydrocephalus and inclusion criteria will undergo ETV in our neurosurgical department. Complete hypothalamic-pituitary hormonal evaluation will be done, in children and adults, before the procedure and at 3 and 12 month after ETV. At 3 month, a brain MRI, with hypothalamic-pituitary specifics sequences, will be performed and compared to the preoperative one. Follow up will be at 3 and 12 month after ETV.

Interventions: ETV is performed under general anesthesia with a rigid endoscope. Perforation is made just behind the clivus, halfway between the infundibulum and the mammillary bodies in the midline using a monopolar electrode, followed by dilatation with an inflated balloon catheter. In our department, this procedure is performed only by 2 senior surgeons.

Number of subjects: 40 patients: 10 children, 30 adults. Statistical analysis: stratified analysis.

Eligibility Criteria:
Inclusion Criteria:

* all patients over 6 months old with obstructive hydrocephalus who are referred for planned endoscopic third ventriculocisternostomy

Exclusion Criteria:

* MRI contraindication, non obstructive hydrocephalus, life expectancy inferior of 3 months, ETV in emergency, hydrocephalus aetiology interaction with hypothalamic-pituitary hormones, hydrocephalus already treated, basilar artery malformations, to be allergic to tetracosactide (synacthene) and to benserazide (Levodopa).
Agitation in Post Operative Neurosurgical Patients

Agitation is a significant clinical issue in anesthesiology and critical care medicine. Several studies have carried out to survey the epidemics of agitation in post-anesthesia care unit and intensive care unit, and results revealed that agitation had an adverse impact on outcomes. To our clinical experience, agitation can occur in postoperative neurosurgical patients, and is often difficult to manage. However, agitation in this subset of patients is poorly evaluated. In present study, adult patients following craniotomy will be enrolled consecutively, and incidence, risk factor and outcome of emergent agitation will be investigated. The results of the study will provide basic data for prevention and treatment of agitation in postoperative neurosurgical patients.

The study will enroll 120 consecutive adult patients admitted to Neuro-ICU for post-operative care following craniotomy. Sedation-Agitation Scale (SAS) will be evaluated and documented every hour or as needed during stay in ICU by nurse on duty. Emergent agitation is defined as SAS of 5 to 7 at anytime during the first 24 hr of ICU stay.Patients are divided into 2 groups: non-agitation group (SAS 1-4) and agitation group (SAS 5-7).Data collection includes pre-operative records, events during anesthesia and operation, events during ICU stay, and outcomes. The primary outcome is complications such as self-removal of endotracheal tube, central venous or bladder catheters. The secondary and third outcomes are ICU stay and Glasgow Outcome Scale at hospital discharge, respectively. Incidence of agitation will be calculated to present an epidemiological knowledge. Univariate analyses between the two groups will be used for preliminary selection of model variables. Then stepwise block logistic regression will be applied to model the risk of agitation using significant univariate predictors.

Eligibility Criteria:
Inclusion Criteria:

* adult patients admitted to Neuro-ICU for post-operative care following craniotomy

Exclusion Criteria:

* age\<18 yr old
* time interval between operation to ICU admission is longer than 24 hr
* re-operation within 72 hr
* persistently comatose during first 24 hr after operation (GCS≤8)
Effect of L-Citrulline Supplementation on NAFLD in Adolescents With Obesity

One of the comorbidities of obesity is nonalcoholic fatty liver disease (NAFLD). L-citrulline is a non-protein amino acid that has shown positive effects on the degree of fat retention and metabolic profile in NAFLD. The objective is to assess the effect of oral L-citrulline supplementation on liver function and nonalcoholic fatty liver in adolescents with obesity. A clinical study will be carried out in 40 adolescents (15-19 years) with obesity, they will be divided into a control group that will receive a placebo and an experimental group that will receive 6 g of l-citrulline per day for eight weeks.

It is hypothesized that l-citrulline supplementation decreases liver enzymes and the degree of hepatic steatosis in adolescents with obesity. The aim of the study is to assess the effect of oral L-citrulline supplementation on liver function and nonalcoholic fatty liver in adolescents with obesity. A prospective randomized, double-blind clinical study will be carried out in 40 adolescents (15-19 years) with obesity, they will be divided into a control group that will receive a placebo (carboxymethyl cellulose) and an experimental group that will receive 6 g of pure l-citrulline per day per eight weeks. At the beginning and end of the intervention, anthropometric, biochemical and metabolic data will be evaluated, as well as tests of function and degree of hepatic steatosis.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents between 15 and 19 years old, residents of the city of León, Guanajuato, with obesity due to BMI ≥30 kg / m2 equivalent to the categorization of adults. That they are in stage 5 of Tanner scale with diagnosis of mild, moderate or severe NAFLD and / or alterations in liver enzyme levels. Not be under nutritional treatment, not be smokers, not taking multivitamins, if so, a wash time of 30 days will be given. Not be allergic to l-citrulline or watermelon. Alcohol consumption less than 21 standard drink units for men and 14 standard drink units for women per week (Standard drink: any drink with more than 14 g of pure alcohol).

Exclusion Criteria:

* Present intolerance to l-citrulline or allergy to watermelon.
* Have an adherence of less than 80 percent of the treatments.
* Present other causes of liver disease.
Clinical Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Subjects

The primary objective is to assess the effect of macitentan 10 mg as compared to placebo on exercise capacity through cardiopulmonary exercise testing.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent/assent from the subject and/or a legal representative prior to initiation of any study-mandated procedures
* Fontan-palliated subjects with either intra-atrial lateral tunnel total cavopulmonary connection (LT-TCPC), or extra cardiac tunnel TCPC (EC-TCPC) surgery \> 1 year before Screening. Either LT- or EC-TCPC can be primary or secondary to atrio-pulmonary connection
* New York Heart Association (NYHA) functional class (FC) II or III (assessed by the investigator using the Specific Activity Scale
* Women of childbearing potential must have a negative serum pregnancy test use reliable contraception

Exclusion Criteria:

* Pattern of Fontan circulation severity
* Deterioration of the Fontan-palliated condition.
* Limitations to Cardiopulmonary exercise testing (CPET)
* Peak VO2 \< 15 mL/kg/min.
* Any known factor or disease that may interfere with treatment compliance or full participation in the study