cyrilzakka/clinical-trials huggingface dataset:
An Open-Label, Multicenter, Expanded Access Study of Oral AMN 107 in Adult Patients With Imatinib (Glivec®/Gleevec®_ - Resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase

An Open-Label, Multicenter, Expanded Access Study of Oral AMN 107 in Adult Patients with Imatinib (Glivec®/Gleevec®_ - Resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase


Eligibility Criteria:
Inclusion Criteria:

* Patients with Imatinib (Glivec/Gleevec) Resistant or Intolerant CML in Blast Crisis, Accelerated Phase or Chronic Phase
A Pharmacokinetics Study for Pediatric Participants With Pulmonary Arterial Hypertension

The purpose of this study is to see how much study drug is in the blood of children with pulmonary arterial hypertension (PAH) after dosing to establish the correct dose for further clinical research.

During Period I, tadalafil will be administered orally, once daily, at a low dose for approximately 5 weeks followed by a high dose for approximately 5 weeks. Dose levels are calculated based on body weight cohorts. Heavy weight cohort \>=40 kg, middle weight cohort \>=25 kg to \<40 kg. Light weight cohort\<25 kg. Participants who complete Period 1 may continue taking tadalafil in Period 2 for at least 2 years. Starting dose will not exceed the maximum weight range dose established in Period 1 and after the first 3 months of Period 2, the dose may be adjusted based on available safety and efficacy information.

Eligibility Criteria:
Inclusion Criteria:

* Currently have a diagnosis of PAH that is either:

  * idiopathic (including hereditary), related to collagen vascular disease, related to anorexigen use, associated with surgical repair, of at least 6 month duration, of a congenital systemic to pulmonary shunt (for example, atrial septal defect, ventricular septal defect, patent ductus arteriosus).
* Have a history of the diagnosis of PAH established by a resting mean pulmonary artery pressure ≥25 mm Hg, pulmonary artery wedge pressure ≤15 mm Hg, and a pulmonary vascular resistance (PVR) ≥3 Wood units via right heart catheterization. In the event that a pulmonary artery wedge pressure is unable to be obtained during right heart catheterization, participants with a left ventricular end diastolic pressure \<15 mm Hg, with normal left heart function, and absence of mitral stenosis on echocardiography can be eligible for enrollment
* Have a World Health Organization (WHO) functional class value of I, II or III at the time of enrollment

Exclusion Criteria:

* Have pulmonary hypertension related to conditions other than specified above, including but not limited to chronic thromboembolic disease, portal pulmonary hypertension, left-sided heart disease or lung disease and hypoxia
* History of left-sided heart disease, including any of the following:

  * clinically significant (pulmonary artery occlusion pressure \[PAOP\] 15 to 18 mm Hg) aortic or mitral valve disease (that is, aortic stenosis, aortic insufficiency, mitral stenosis, moderate or greater mitral regurgitation)
  * pericardial constriction
  * restrictive or congestive cardiomyopathy
  * left ventricular ejection fraction \<40% by multigated radionucleotide angiogram (MUGA), angiography, or echocardiography
  * left ventricular shortening fraction \<22% by echocardiography
  * life-threatening cardiac arrhythmias
  * symptomatic coronary artery disease within 5 years of study entry as determined by the physician
* History of atrial septostomy or Potts Shunt within 3 months before administration of study drug
* Unrepaired congenital heart disease
Acceptability/Feasibility of HIV Testing by ELISA or Rapid Test to Adult Patients in Paris, France

CDC recommends universal HIV testing in all adults, at least once during life, to reduce the pool of infected patients unaware of their status. Routine universal HIV testing can use "classical" ELISA tests from serum, or rapid tests, ideally from finger-stick whole blood (FSB), which have shown close predictive values from classical tests. The investigators will compare the acceptability and feasibility of the two methods.

The multi-center prospective randomized study will compare the acceptability and feasibility of routine universal HIV testing to adult patients consulting their general practitioner in Paris, France, using either the " classical " ELISA tests from serum or rapid tests from FSB (Insti®).

Eligibility Criteria:
Inclusion Criteria:

* adult patients consulting their general practitioner in Paris, France

Exclusion Criteria:

* patients previously known as HIV-positive,
* patients who declare having been tested HIV-negative less than three months ago,
* patients who can not give informed consent
A Trial Comparing Risperidone Long-Acting Injection With Oral Antipsychotic in the Treatment of Early Psychosis

The purpose of this study is to evaluate the effectiveness, safety and tolerability of risperidone long-acting injection (LAI) versus oral antipsychotics in participants with recent onset psychosis (abnormal thinking and/or hallucinations).

This is an open-label (all people know identity of intervention), randomized (the study drug is assigned by chance), multicenter (conducted in more than 1 center), and exploratory study in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality) or schizoaffective disorder (mixed psychiatric disorder relating to complex psychotic state that has features of both schizophrenia and mood disorder). Duration of this study will be 24 months. Study assessment visits will be conducted at Screening, Baseline, Week 2, every 4 weeks till Week 22, at Week 28, every 12 weeks till Week 88 and at Week 104. All eligible participants will receive either risperidone long acting injection 25 milligram (mg) intramuscularly (into the muscle) along with their current oral medication (atypical antipsychotic - risperidone, quetiapine, olanzapine) or only their current oral medication. Efficacy will be evaluated primarily by Positive and Negative Syndromes Scale (PANSS), time to relapse and Social and Occupational Functioning Assessment Scale (SOFAS). Participants's safety will be evaluated throughout the study mainly by Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), and Simpson Angus Scale (SAS).

Eligibility Criteria:
Inclusion Criteria:

* In-patients or out-patients
* Primary Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) diagnosis of schizophrenia, schizophreniform disorder or schizoaffective disorder for no longer than 3 years after diagnosis and treatment of a psychotic illness
* Positive and Negative Syndrome Scale (PANSS) score of 60-120 at Visit 1 and 2
* Currently on monotherapy atypical antipsychotic treatment below local label guidelines or treatment naive
* Able to complete self-assessments in either English or French

Exclusion Criteria:

* Current primary Axis-1 diagnosis other than schizophrenia, schizophreniform disorder or schizoaffective disorder, according to DSM-IV
* Current drug or alcohol dependence
* Treatment with a depot antipsychotic within 3 months of study start
* Confirmed or suspected history of lack of tolerability, hypersensitivity or allergy to risperidone
* Risperidone non-responders (based on evidence of adequate trial of treatment)
Manual Therapy vs Stretching vs Routine Physical Therapy in Nonspecific Chronic Neck Pain

The aim of this study is to analyze the effect of Mulligan technique vs stretching techniques and vs routine physical therapy on pain ,range of motion(ROM) and functional disability among restaurant chefs with non-specific chronic pain.

Neck pain (NP) is one of the basic musculoskeletal issues. Neck pain can be due to stress about the musculoskeletal framework because of postural problems and may be related with different causes, such as: - Intervertebral disc herniation, -nerve compression -fracture.

Nonspecific neck pain is a pain located in the lateral and posterior neck that does not show pathognomonic signs and symptoms. When the duration of symptoms is greater than 12 weeks of evolution, it acquires the value of chronicity, being denominated non-specific chronic neck pain (NCNP). It is a common disorder, which generates a great impact and socio-economic cost .

In this study we evaluate the comparison of manual physical therapy vs routine physical therapy vs stretching physical therapy effects among restaurants chefs having non-specific chronic pain.

Eligibility Criteria:
Inclusion Criteria:

* Neck pain for atleast 3 months having no :

  * Neurological Problem
  * Rheumatological Problem
  * Patient had taken any analgesic medication for neck pain for last 3 months.
  * Non specific neck pain
  * Age 18-60 years

Exclusion Criteria:

* Neck pain due to,

  * Tumors
  * Ankylosings Spondylitis
  * Fracture
  * Dislocation
  * Presence of cord compression
  * Vertebrobasilar artery insufficiency
  * Osteoprosis OR Osteopenia
  * Long term use of anticoagulant or corticosteroid drugs
  * Pain due to any congenital deformity, inflammation or any infection
  * Carcinoma
Soy, Bone and Health in College Females

This is a 16-week intervention to determine the efficacy of an isoflavone-rich soy based meal supplement to improve bone health and prevent weight and fat gain in 18-19 year old college females. The primary hypothesis is that participants who receive soy will have favorable changes in blood markers of bone and less weight and fat gain. The soy is provided by Physicians Pharmaceuticals, Inc. (Revival Doctor-formulated soy protein).

The proposed study will be a 16-week randomized, double-blind, placebo-controlled trial designed to test whether a daily isoflavone-rich, soy-based meal replacement Revival Soy shake promotes favorables changes in bone biomarkers and attenuates weight gain in female college students. First-year college females were selected because of the potential for significant weight gain during their freshman year. The study will have a parallel design with two groups: the soy treatment group (SOY; n = 60) and a casein-based control (CON; n = 60). Exclusion criteria include significant weight loss or gain in the past 3 months, vegetarians and heavy soy food consumers, National Collegiate Athletic Association Division I athletes, women with eating disorders, present illnesses, chronic disease, and those taking medications or herbal supplements known to affect body weight, body fat or bone. Participants will be stratified based on BMI (18.0-24.9; 25-29.9; ≥30.0) and randomized to either SOY or CON groups.

Female college freshmen enrolled at the University of Georgia will be recruited in the fall of 2005. The soy-based meal replacements will contain 20 g soy protein and 161.2 mg isoflavones, 220-240 kcal, 31-36 g total carbohydrates, 0-2 g dietary fiber, 500 mg calcium, and 2.0-2.5 g total fat per serving. The control shake will have 20 g casein substituted for soy protein, and will be otherwise identical to the soy shakes. The shakes will be available in two flavors: chocolate and vanilla.

Eligibility Criteria:
Inclusion Criteria:

* 18-19 year old University of Georgia college females of all races/ethnicities.

Exclusion Criteria:

* significant weight loss or gain, currently dieting to lose weight, are planning to lose weight, diet or begin an exercise program, under the age of 18, pregnant or intending to become pregnant, vegetarians, heavy soy food consumers, Division I athletes, women with menstrual irregularities, eating disorders, present or chronic illness, and those taking medications known to affect bone, body weight or body fat.
Pulmonary Hypertension and Arrhythmia

Patients with pulmonary hypertension underwent (routine) Holter ECG and were screened for (malignant) arrhyhtmias. Results of Holter ECGs were correlated with clinicial and technical data (echocardiography and right heart catheterization).


Eligibility Criteria:
Inclusion Criteria: Holter ECG -

Exclusion Criteria: None

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Virtual Reality Birth Simulator

The investigators compared an in-house developed virtual reality simulator for normal vaginal deliveries with a legacy mannequin-based simulation in a cluster randomised study involving Year 4 medical students undergoing their Ob/Gyn clerkship with aims to compare pre- and post-simulation knowledge questionnaire score. As part of a cross-over component, the investigators will also compare feedback scores for each modality and the preferred modality. Ethical approval and waiver of consent has been obtained from the National University of Singapore Institutional Review Board, Reference Number 2020-606.

Simulations training is an important aspect of procedural skills training. This is especially so for normal vaginal deliveries given its intimate and time sensitive nature. Medical students have to also compete with limited learning opportunities against other healthcare trainees in the labour ward. Thus, the need for simulation training has been extensively used in this area. Nevertheless, mannequin-based simulations are also limited in availability due to the need for expensive mannequins, skilled trainers, and suitable venues. The investigators developed a virtual reality normal vaginal delivery simulation (ViVaDex) based on the Oculus® Quest 2 retail Head Mounted Display and aim to compare this against legacy mannequin-based methods (PROMPT Flex®) via a a cluster randomised study involving Year 4 medical students undergoing their Obstetrics and Gynecology clerkship. The investigators would compare percentage correct scores pre- and post-simulation through an 11-item knowledge questionnaires and also conduct a six-domain feedback questionnaire. Due to a planned cross-over component, participants will be able to also state their preferred simulation modality.

Ethical approval and waiver of consent has been obtained from the National University of Singapore Institutional Review Board, Reference Number 2020-606.

Our statistical plan is to use two sample t-test to compare the improvement in pre- and post-simulation percentage correct scores between each modality and chi square testing to assess differences in the proportion who got each question correct. The feedback questionnaire scores will be compared between the VR and mannequin modalities using linear mixed modelling with teaching modality, period, and group being designated as main effects and presented as mean total feasibility scores with differences presented as adjusted mean difference with 95th centile confidence intervals (95% CI). Carryover effect will also be calculated as this is a cross-over study.

Eligibility Criteria:
Inclusion Criteria:

* Medical students undergoing their 4th year obstetrics and gynaecology clerkship

Exclusion Criteria:

* Declined to give consent or to have simulation videotaped
Long-term Consequences of Neuroimaging and Perceived Cognitive Dysfunction in oPRES

The purpose of this study is to explore the long-term consequences of neuroimaging and perceived cognitive dysfunction in obstetrics posterior reversible encephalopathy syndrome.

This is a prospective study. The investigators divided the PE or E patients into two groups, namely PRES group and non-PRES group, according to diagnostic criteria . The general information（demographic data，blood pressure.etc.）and blood sample will be collected. Additionally,all patients receive neuroimaging examination（DTI,ASL,3D-TMI.etc.）and neuro-cognitive test（MMSE,MOCA,CFQ, etc.） to assess the cerebral white matter lesions and cognitive changes.

Eligibility Criteria:
Inclusion Criteria:

1. patients were diagnosed of PE or E
2. patients received cranial image examination
3. patients consent to participate

Exclusion Criteria:

1. patients combined other neurological diseases
2. patients combined mental illness
Neurosensory Abnormalities in SymptomAtic Ocular Surface Patients (NASA)

This study is designed to measure how common nerve abnormalities are within a group of patients who feel discomfort within their eyes.


Eligibility Criteria:
Inclusion Criteria:

* Presents with ocular surface discomfort or for dry eye care
* Best corrected visual acuity of 20/40 or better in each eye
* Subject reported duration of symptoms of at least 3 months
* 100 subjects will be required to be habitual contact lens wearers as defined by use of contact lenses at least 5 hours per day at least 5 days per week for the last year.

Exclusion Criteria:

* Use of contact lenses on the day of the visit
* Pregnant or nursing
* Irregular corneas (e.g., ectatic disease, transplantation, or corneal dystrophies)
* Ocular surgery in the past 3 months
* Ocular infection in the past 3 months
* Active ocular allergies
Gut Permeability-related Inflammation and Cardiovascular Disease Risk in Normal-weight and Metabolically Healthy Obesity

The investigators are examining the extent gut permeability explains observed inflammation in normal-weight and metabolically healthy obesity (and potentially cardiovascular disease risk).

Cardiovascular disease (CVD) is responsible for 25% of deaths in the United States, and chronic inflammation contributes to risk. A growing body of evidence suggests that gut-derived bacterial components (e.g., lipopolysaccharide or LPS) entering the bloodstream when the gut barrier fails (i.e., intestinal permeability) are a prominent source of inflammation in cardiometabolic conditions such as metabolic syndrome, coronary artery disease, and type 2 diabetes. Two groups that are at \> 2x the risk for CVD, but largely still free of overt disease, are those with metabolically healthy obesity and normal-weight obesity. Those with metabolically healthy obesity - defined as having an obese body mass index (BMI) but other clinical risk factors in the normal range (e.g., blood lipids) - and normal-weight obesity - defined as having a normal BMI yet high percent body fat - generally display little evidence of clinical risk, but present with elevated inflammatory markers including C-reactive protein (CRP), tumor necrosis factor (TNF)-a, and interleukin (IL)-6). Therefore, it is likely that chronic inflammation is largely driving CVD risk in metabolically healthy and normal-weight obesity, but the source of this inflammation remains unclear. The primary aim of the proposed project is to determine the extent that markers of intestinal permeability are elevated in metabolically healthy obesity and normal-weight obesity compared to healthy controls and individuals with metabolic syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Control group: normal BMI, body fat percentage \< 25% for men and \< 35% for women, \< 1 of the following: blood pressure \>130/85 mmHg, fasting glucose \>100 mg/dL, fasting triglycerides \>150 mg/dL, HDL cholesterol \< 40 mg/dL (men) or \< 50 mg/dL (women).
* Normal-weight obesity group: normal BMI, body fat percentage \> 25% for men and \> 35% for women.
* Metabolically healthy obesity: BMI \> 30, body fat percentage \> 25% for men and \> 35% for women, and \< 1 of the following: blood pressure \>130/85 mmHg, fasting glucose \>100 mg/dL, fasting triglycerides \>150 mg/dL, HDL cholesterol \< 40 mg/dL (men) or \< 50 mg/dL (women).
* Metabolic syndrome group: BMI \> 30, body fat percentage \> 25% for men and \> 35% for women, and 2 or more of the following: blood pressure \>130/85 mmHg, fasting glucose \>100 mg/dL, fasting triglycerides \>150 mg/dL, HDL cholesterol \< 40 mg/dL (men) or \< 50 mg/dL (women).

Exclusion Criteria:

* Presence of pacemaker
* Pregnant
* Cardiometabolic disease (e.g., diabetes, cardiovascular disease)
* Disease that is inflammatory in nature (e.g., inflammatory bowel disease, rheumatoid arthritis)
* Postmenopausal status
* Use of tobacco products
* Using illicit drugs
* Using lipid lowering drugs
Effects of a Telerehabilitation Approach in Children With Cystic Fibrosis

Patients with cystic fibrosis aged 6-13 will be recruited and randomized into two groups: one will receive telerehabilitation sessions including postural, breathing and high-intensity interval training exercises and one will be subject to routine follow up. Exercise program will be applied three days a week for three months. Children will be assessed by pulmonary function tests, cystic fibrosis quality of life questionnaire, six minute walking test and anxiety and depression scale in children, while caregivers will be assessed by Beck depression scale and situational anxiety inventory.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosed cystic fibrosis

Exclusion Criteria:

* Current pulmonary exacerbation
* Musculoskeletal problems hinder exercising
* No internet access
* Patients and parents do not consent to intervention
A Real-world Study to Assess Safety and Effectiveness of Secukinumab in Pediatric Plaque Psoriasis Patients in China

This is a non-interventional, prospective, multi-center real world setting study, aiming to provide safety and effectiveness data in Chinese pediatric patients with moderate to severe plaque psoriasis treated with Cosentyx® for up to 52 weeks.

Patients who are about to initiate Cosentyx® or have started Cosentyx® within the last 4 weeks and meet the eligibility criteria will be enrolled. Patients will be followed via routine visits in real clinical practice up to 52 weeks. Data from medical records, including safety and effectiveness information of Cosentyx® (e.g., AE, SAE, physical examinations, laboratory tests, disease assessments, etc.) will be collected at each visit. No additional study visits, examinations, laboratory tests or procedures will be mandated throughout the study.

Eligibility Criteria:
Inclusion Criteria:

Patients meeting all of the following criteria are eligible for inclusion in this study:

* Written assent and informed consent must be obtained as per local regulations prior to any study procedures.
* Diagnosed with moderate to severe plaque psoriasis.
* Initiating treatment with Cosentyx® or having started Cosentyx® treatment within the last 4 weeks in routine clinical practice, and its prescription is independent of this study.
* Aged 6 to less than 18 years at the time they are prescribed Cosentyx®.
* Have valid PASI and IGA mod 2011 score at the time they are prescribed Cosentyx®.

Exclusion Criteria:

Patients meeting any of the following criteria are not eligible for inclusion in this study:

* Patients previously treated with other biologics.
* Patients participating in other clinical trials or who previously participated in clinical trials within 30 days before Cosentyx® initiation or a period of 5 half-lives of the investigational drug, whichever is longer.
* Patients in conditions which in the judgment of the clinical investigator renders the patient unsuitable for the study.