cyrilzakka/clinical-trials huggingface dataset:
Test and Treat COVID 65plus+

Patients over equal or older than 65 yearswill be treated with a hydroxychloroquine versus placebo reduced loading dose of 600mg on the first day followed with 400mg/day divided in 2x200mg for 6 more days resulting in a total duration of therapy of 7 days. Measurement of Hydroxychloroquine-levels will be performed on day 7, . A follow-up by video or telephone conference will be performed to observe drug intake and collect adverse events during treatment phase on a daily base on working days and once during the weekend (i.e. 6 out of 7 days). After treatment phase follow-up by telephone calls will be done on day 10, 30, 60 (+/- 2 days).


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age ≥ 65 years
* Mild to moderate symptomatic respiratory tract Infection defined as not requiring hospital admission: SpO2 \>94%, respiratory rate \<20, mental state alert, no signs of septic shock
* Proven SARS-Cov2 infection by throat swab (PCR)
* Onset of symptoms within the last 3 days before randomization
* Must be able to adhere to the study visit schedule and other protocol requirements in the investigator's opinion. I.e. must be able to answer to questions concerning symptoms and side effects and must be able to consent to the informed consent.

Exclusion Criteria:

* Hospitalization at study inclusion
* Weight \<50 kg
* Acute myocardial infarction
* Severe heart failure, characterized as NYHA class 3 or 4
* Use of concomitant medications that prolong the QT/QTc interval.
* QTc \>450ms
* Bilirubin ≥ 1,5 x UNL, (except for known M. Meulengracht)
* AST/ALT ≥ 3 x ULN
* Albumine ≤ 2.8 g/dl
* Hemoglobin ≤ 9 g/dl
* Leucocytes ≤ 2000/µl
* Neutrophiles ≤ 1000/µl
* Thrombocytes ≤ 100.000/µl
* Troponin elevation
* BNP \> 500 pg/ml
* Creatine kinase \> 5 x ULN
* Creatinine \>1,5 mg/dl
* Uncorrected hypopotassemia or hypomagnesemia
* History of hypoglycemic events
* History of or present cardial arrhythmia (except atrial fibrillation or paroxysmal supraventricular tachycardia)
* Bradycardia \< 60 beats/min
* History of Retinopathy or Maculopathy
* Psoriasis
* Myasthenia gravis
* Epilepsy
* Immunodeficiency syndromes or need for highly immunosuppressive medication
* Pre-existing medication with hydroxychloroquine
* Known G6PD deficiency.
* Participation in another interventional study
* Known hypersensibility to hydroxychloroquine and its derivates
Athlete's Heart or Arrhythmogenic Right Ventricular Cardiomyopathy: Contribution of Exercise Cardiovascular Magnetic Resonance (CMR)

Prospective, nonrandomized, single-center, comparative study to define if right ventricular (RV) contractile reserve assessed by exercise CMR helps to improve the differential diagnosis between pathological and physiological remodeling of the RV; ie. arrhythmogenic right ventricular cardiomyopathy (ARVC) and athlete's heart.

Comparison of the RV contractile reserve in 4 groups of patients: Arrhythmogenic right ventricular cardiomyopathy (ARVC) patients; endurance athletes with a dilated RV, endurance athletes with normal RV, untrained subject with normal RV.

Patients will come to the hospital for 3 visits (3 half days):

* Visit 1: clinical evaluation, rest ECG, rest echocardiography, cardio-pulmonary exercise test.
* Visit 2: exercise echocardiography, holter ECG monitor (48 yours)
* Visit 3: rest CMR and exercise CMR (ergocycle)

Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 18 years and older,

  * patients with confirmed ARVC, but with no major RV dysfunction (RVEF \>40%)
  * endurance athletes with dilated RV
  * endurance athletes with non-dilated RV
  * untrained healthy subjects with non-dilated RV
* who signed a written free and informed consent:

Exclusion Criteria:

* Patients with other cardiovascular disease;
* Contra-indication to CMR (in particular presence of a non-CMR compatible implantable cardiac defibrillator);
* Patients with permanent supraventricular arrhythmia;
* Patients unable to perform an exercise test on an ergocycle;
* Person subject to legal protection (safeguard justice, trusteeship and guardianship) and persons deprived of liberty
Uninvasive Cardiac Output Monitoring (USCOM) in Critically Ill Children: Validation and Prediction of Hemodynamic Instability

Hemodynamically unstable ventilated PICU \& PCICU patients, which a decision for commencement in inotropic therapy or fluid bolus has been made, will be recruited. Hemodynamic measurements will be carried out before and after therapy have been made, including customary hemodynamic parameters, echocardiography and USCOM studies.

All parameters will be analyzed for fluid responsiveness or inotropic therapy prediction. Trend in USCOM parameters will be compared to echocardiography CO parameters.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric critically ill ventilated patients admitted to PICU \& PCICU
* Hemodynamically unstable which a decision for commencement in inotropic therapy or fluid bolus has been made
* parental concent

Exclusion Criteria:

* Cardiac shunt
* Aortal anomaly \\ Repair
* Tracheostomy
* Parental refusal to participate
Anti-fatigue Effect of Korean Red Ginseng in Patients With Non-alcoholic Hepatitis

Background: Korea red ginseng (KRG) has anti-carcinogenic activity, anti-oxidant activity, and cancer related anti-fatigue.

Methods: Seventy five patients with non-alcoholic hepatitis were prospectively randomized to receive 3 weeks of KRG or placebo. Liver function test, pro-inflammatory cytokines, adiponectin, fatigue severity scale, and antioxidant activity were check and compared.

Fatigue Severity Scale

We used to be KRUPP's fatigue severity scale. The survey has nine questions as following: (1) my motivation is lower, when I am fatigued (2) exercise brings on my fatigue (3) I am easily fatigued (4) fatigue interferes with my physical functioning (5) fatigue causes frequent problems for me (6) my fatigue prevents sustained physical functioning (7) fatigue interferes with carrying out certain duties and responsibilities (8) fatigue is among my 3 most disabling symptoms (9) fatigue interferes with my work, family, or social life. All subjects scored each question on a 7-point scale (1 = strongly disagree to 4 = neither disagree nor agree to 7 = strongly agree). All fatigue severity scale calculated and collected by one research nurse (C.W.K) in the Department of Internal Medicine.

Eligibility Criteria:
Inclusion Criteria:

* aspartate aminotransferase (AST) ≥ 50 U/L or alanine aminotransferase (ALT) ≥ 50 U/L, and Fatty liver or Hepatitis

Exclusion Criteria:

* viral hepatitis, alcoholic hepatitis, autoimmune hepatitis, pancreatitis, hemochromatosis, Wilson's disease, drug induced liver injury, or cancer
Real-world Effectiveness, Safety and Immunogenicity of Chikungunya Vaccination in Populations at Risk of Severe or Complicated Forms: Prospective Study in La Réunion

Against the backdrop of a growing chikungunya epidemic in La Réunion, this prospective study will assess the real-life efficacy, safety and immunogenicity of IXCHIQ® vaccine in vulnerable individuals (seniors, comorbid patients), defined by the French Health Autority (HAS) as at risk of severe or complicated forms and/or chronic disabling forms (chronic arthritis, chronic fatigue phenotypes). This study will also provide input for the preparation of a cluster randomized trial on a population scale.


Eligibility Criteria:
Inclusion Criteria:

* Eligible for anti-chikungunya vaccination according to french Health Authority (HAS)
* Beneficiary of social security coverage
* Signature of informed consent form

Exclusion Criteria:

* Pregnant women
* Vaccine contraindication for patients undergoing medical treatment
* Persons under guardianship, curatorship or safeguard of justice
* Anyone who has received immunoglobulin or a blood or plasma transfusion 3 months prior to vaccine administration
Oral Ketone Monoester Supplementation and Resting-state Brain Connectivity

People who report subjective memory complaints have a greater risk of developing dementia. Memory issues may be an early warning sign of dysfunctional cerebral glucose metabolism and cerebral blood flow. Interventions that can restore cerebral metabolism and enhance cerebral blood flow may protect against conversion to dementia. Exogenous ketone supplements have been shown rapidly improves brain network function in young adults. Further, infusion studies demonstrate that ketone bodies enhance cerebral blood flow in cognitively normal adults. Whether acute ketone monoester supplementation can improve brain function in adults with subjective memory complaints is currently unknown.

This study will investigate the effects of a single ketone monoester dose on resting-state functional connectivity in the default mode network and resting cerebral blood flow in adults with subjective memory complaints.


Eligibility Criteria:
Inclusion Criteria:

* between the ages of 55 and 70
* presence of subjective memory complaints as determined by the Prospective- Retrospective Memory Questionnaire
* cognitively normal, e.g. score ≥26 on the Montreal Cognitive Assessment

Exclusion Criteria:

* Presence of obesity (body mass index \> 30 kg/m\^2)
* Presence of known cardiovascular disease
* Presence of type 2 diabetes
* History of cardiovascular events requiring hospitalization in the past 3 years (e.g., heart attack, stroke)
* History of concussion(s) with persistent symptoms
* Currently following a ketogenic diet and/or taking ketone body supplements
* Diagnosis of any form of Alzheimer's disease or dementia
To Investigate the Cumulative Live Birth Rates Using GnRH Antagonist or Agonist Protocol for COS in ART Treatment

This is a Phase IV, prospective, randomized controlled study to investigate the cumulative live birth rates (CLBRs) of gonadotrophin-releasing hormone (GnRH) antagonist protocol (GnRH-ant group) compared with the standard GnRH agonist long protocol (GnRH-a group) for controlled ovarian stimulation in supposed normal ovarian responders.

This is a Phase IV, prospective, randomized controlled study to investigate the cumulative live birth rates (CLBRs) of gonadotrophin-releasing hormone (GnRH) antagonist protocol (GnRH-ant group) compared with the standard GnRH agonist long protocol (GnRH-a group) for controlled ovarian stimulation in supposed normal ovarian responders.

In this study, patients who are planning to undergo IVF/ICSI cycle aged ≤38 years old with normal ovarian reserve will be considered for enrollment. Approximately 888 patients will be enrolled at approximately 5 centers in China over a period of 10 months.

About 12-20 visits will be performed in this study for each patient. The CLBR with first live birth resulting from one initiated COS cycle will be compared between GnRH-a group and GnRH-ant group.

Eligibility Criteria:
Inclusion Criteria:

* Infertile women planning to undergo IVF/ICSI cycle using conventional GnRH agonist long protocol or GnRH antagonist protocol
* Age ≤ 38 years old
* Basal AFC 8\~20
* Basal FSH≤10 IU/L
* Basal E 2 \<200pmol/L
* Normal uterus and at least one side of the normal ovary
* Informed consent form signed
* Willing to follow the study protocol, and able to complete this study

Exclusion Criteria:

* Previous IVF/ICSI cycles \>2
* Severe hydro-salpinx (Ultrasound shows hydro salpinx﹥2cm)
* Severe endometriosis (Grade III - IV)
* Polycystic ovarian syndrome (PCOS)
* History of recurrent miscarriages (\>2 times of miscarriages)
* Plan to undergo ovarian stimulation for preimplantation genetic diagnosis or preimplantation genetic screening, oocyte donation, and social or medical freezing of oocytes
* Any major systemic disease that as per Investigator's discretion precludes subject for participation in the study
* With pregnancy contraindications
* Alcoholism, drug abuse, drug addiction or patients with uncured sexually transmitted disease
* According to the judgment of the Investigator, any medical condition or any concomitant surgery/medications that would interfere with evaluation of study medications
* Simultaneous participation in another clinical study
* Plan to use urinary gonadotrophin during COS treatment
Zinc Deficiency in Dilated Cardiomyopathy

The aim of this study is to detect effect of oral zinc supplementation in pediatric patients with dilated cardiomyopathy.

Cardiomyopathies are group of heart diseases that influence cardiac muscles directly and are not related to hypertension, congenital, valvular and pericardial diseases. The most common type of cardiomyopathy is dilate cardiomyopathy.

Dilated cardiomyopathy usually manifests as chronic systolic heart failure leading to arrhythmias and sudden death.

Trace elements are known to have a key role in myocardial metabolism. The human heart requires energy from micro and macro nutrients both to regenerate proteins and cells, and to support cyclic contractions. Heart failure is associated with neuro-hormonal activation leading to elevated levels of inflammatory markers and oxidative stress.

Zinc is an essential micronutrient that impacts the cardiovascular system. There are multiple potential pathophysiologic causes for zinc deficiency in heart failure as result of impaired micronutrient consumption, hyper inflammatory state, diminished absorption and hyperzincuria from heart failure medications. Zinc deficiency may play a role as primary and possible reversible cause of dilated cardiomyopathy.

Plasma zinc levels have been reported in multiple observational studies of patients with heart failure particularly in studies of idiopathic dilated cardiomyopathy, serum zinc levels have been found to be low.

A small but growing body of evidence suggesting the role for oral zinc supplementation in the management of dilated cardiomyopathy however further evaluation of the impact on outcome is needed.

Eligibility Criteria:
Inclusion Criteria:

* children (1-18) year's age with impaired left ventricular systolic function due to dilated cardiomyopathy

Exclusion Criteria:

* patients with congenital heart diseases.
* patients less than one year age.
A Study of Health Care Use and Costs in Participants With Early Stage Alzheimer's Disease (AD)

The purpose of this study is to learn about health care use, costs, and clinical outcomes over time for amyloid positive participants with early stages of AD in the United States. This study is for research purposes only, and is not intended to treat any medical condition. No study therapy(ies) for AD will be administered.


Eligibility Criteria:
Inclusion Criteria:

* Presents within normal course of outpatient care for whom the physician deems to meet clinical criteria for MCI due to AD or mild AD dementia.
* Fully informed written consent of the participant (or his/her legal representative).
* Study partner who has frequent contact with the participant is willing to accompany the participant at the study observations.
* Fully informed written consent of the study partner; this person must be willing to serve as study partner for at least 6 months of the year.
* Able to communicate in English and/or US Spanish.
* Able to provide evidence of amyloid testing.
* Has an Mini-Mental State Examination (MMSE) score of 20 or greater.

Exclusion Criteria:

* Are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study at baseline.
* Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
* Lack of evidence of amyloid positivity through pre-study test. Note: After baseline assessment, participants with amyloid negativity identified as part of the study will not continue in post-baseline assessments.
* Are Lilly employees or are employees of any third-party organization (TPO) involved in study who require exclusion of their employees.
Evaluation of Different Orthodontic Tooth Movements Assisted With Injectable Platelet Rich Fibrin

The present prospective clinical study will be undertaken for assessment of the effect of application of i-PRF on the rate of levelling and alignment, molar distalization\& intrusion of anterior teeth in deep bite cases

Assessment of the effect of application of i-PRF on the rate of levelling and alignment, molar distalization\& intrusion of anterior teeth in deep bite cases

Eligibility Criteria:
Inclusion Criteria:An age range from 15-22 years. Severe crowding or protrusion requiring 1st premolars extractions followed by symmetrical canine retraction.

All permanent teeth present, 3rd molars are excluded. Good oral and general health. No systemic disease/medication that could interfere with orthodontic tooth movement. No previous orthodontic treatment.

-

Exclusion Criteria:Patient diagnosed to have an indication for non-extraction approach.

Poor oral hygiene or periodontally compromised patient. Patient with craniofacial anomalies or previous history of trauma, bruxism or parafunctions.

-
Erlotinib in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme

RATIONALE: Erlotinib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.

PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have recurrent or progressive glioblastoma multiforme.

OBJECTIVES:

* Determine the response rate of patients with recurrent or progressive glioblastoma multiforme treated with erlotinib.
* Determine the progression-free and overall survival of patients treated with this drug.

OUTLINE: Patients receive oral erlotinib daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 73 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed glioblastoma multiforme

  * Radiographic evidence of recurrence or progression

    * Biopsies to confirm tumor recurrence allowed if a sufficent percentage of cases are confirmed to be recurrent tumor
* Previously treated with optimal radiotherapy and at least 1 cytotoxic chemotherapy regimen

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic

* Bilirubin no greater than 2 times normal
* Alkaline phosphatase no greater than 2 times normal
* ALT no greater than 3 times normal

Renal

* BUN no greater than 1.5 times normal OR
* Creatinine no greater than 1.5 times normal

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No medical condition that would interfere with oral administration of erlotinib
* No other medical or psychiatric illness that would preclude study therapy
* No active infection
* No other malignancy within the past 3 years except surgically cured carcinoma in situ of the cervix or nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No concurrent immunotherapy for brain cancer
* No concurrent biologic therapy for brain cancer

Chemotherapy

* See Disease Characteristics
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
* No concurrent chemotherapy for brain cancer

Endocrine therapy

* Concurrent glucocorticosteroids allowed
* No concurrent hormonal therapy for brain cancer

Radiotherapy

* See Disease Characteristics

Surgery

* Not specified

Other

* No prior epidermal growth factor receptor (EGFR) inhibitor
* No concurrent EGFR inhibitor
* No other concurrent antineoplastic therapy
* No concurrent anti-epileptic agents other than modest- or non-enzyme-inducing drugs such as the following:

  * Gabapentin
  * Lamotrigine
  * Divalproex
  * Felbamate
  * Levetiracetam
  * Tiagabine
  * Topiramate
  * Zonisamide
Effect of Different Biomimetic Materials on White Spot Lesions in Enamel

This study will be conducted to evaluate: 1- The remineralizing effect of different biomimetic materials (Zinc carbonate hydroxyapatite nanoparticles, Poly-amido amine (PAMAM) and bioactive glass nanoparticles) on white spot lesions in enamel. 2- The clinical efficacy of these agents on disappearance of these white spots.


Eligibility Criteria:
Inclusion Criteria:

* Total of 21 patients enrolled in this study will be selected having at least 4 teeth (one on each quadrant) which will be extracted for orthodontic treatment.
* These patients will be selected according to age groups between 15-25 years old
* good oral hygiene
* free of destroying habits for dental tissues

Exclusion Criteria:

* Bruxism
* soft drinks consumption
* acid regurgitation, etc.).
* Selected teeth having any cracks, malformations, dysplasia or caries.
A Study of Patients Who Received Inotuzumab Ozogamicin for B-cell ALL (Acute Lymphoblastic Leukemia) That Occurred Again After the Last Treatment

The purpose of the study was to understand the effectiveness and safety of the study medicine called Inotuzumab ozogamicin (InO) in patients with B-cell ALL in whom the disease occurred again after the last treatment.

This retrospective Study enroll adult patients who:

* were CD22 positive (a molecule in the body that stops the over activity of the immune system)
* Received only InO for the treatment of B-cell ALL that occurred again after the last treatment
* were Philadelphia chromosome positive (which occurs because of changes in genes)
* failed treatment with at least one Tyrosine Kinase Inhibitor (type of medicine that blocks the action of enzymes called tyrosine kinases which takes care of many cell functions, such as cell growth and division).

The patient data except their personal details are collected from a hospital based electronic medical record in India.

In this study the effectiveness and safety of InO will be studied after it was released to the market.

To do that, the study aims to gather details of B-cell ALL patients from 7 -10 hospitals across India:

* in whom the disease occurred again
* or those who never showed any improvement to earlier treatments
* now being treated with InO alone

Around 55 patients who have taken InO are likely to be enrolled in the study.

Then by using a statistical model and with all the information gathered, the safety and effectiveness of InO will be decided.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥18 years old at the initiation of InO treatment

  * Patients with relapsed/refractory B-cell ALL
  * Patients who initiated InO monotherapy between Feb'2017 and Feb'2022 and are CD22 positive
  * Ph+ patients who have failed treatment with at least 1 TKI

Exclusion Criteria:

* Patient not completing at least 1 cycle of InO therapy • Patient on InO in combination with chemotherapy
Robots Paired With tDCS in Stroke Recovery

The purpose of this study is to evaluate if multiple therapy sessions of Transcranial Direct Current Stimulation (tDCS non-invasive brain stimulation) combined with robotic arm therapy lead to a greater functional recovery in upper limb mobility after stroke than that provided by robotic arm therapy alone.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* First single focal unilateral lesion with diagnosis verified by brain imaging, which occurred at least 6 months prior
* Cognitive function sufficient enough to understand experiments and follow instructions
* Fugl-Meyer assessment of 7 to 58 out of 66 (neither hemiplegic nor fully recovered motor function in the muscles of the shoulder, elbow, and wrist)

Exclusion Criteria:

* Botox treatment within 6 weeks of enrollment
* Fixed contraction of the affected limb
* Complete flaccid paralysis of the affected limb
* History of hemorrhagic stroke
* Ongoing use of CNS active medications
* Ongoing use of psychoactive medications
* Presence of additional potential tDCS/TMS risk factors including damaged skin at site of stimulation, presence of a magnetically/mechanically active implant, metal in the head, family history of epilepsy, and personal history of seizures