cyrilzakka/clinical-trials huggingface dataset:
Effects of Training Using Volume and Flow-oriented Incentive Spirometry in Healthy Subjects - Case-control Study

Experimental Procedure: The subjects underwent an initial interview in which was filled in a form of anamnesis, in addition to being assessed and reassessed by spirometry, dynamic circumference and manometer. Moreover, responded international physical activity questionnaire (IPAQ - short version) in order to characterize the physical activity level of each participant being classified as inactive, irregularly active, active, and very active. The same examiner performed the assessments and reassessments of individuals after a training program.

Spirometry: It was performed by a portable spirometer Easy One® , according to the guidelines of the American Thoracic Society / European Respiratory Society (ATS / ERS). The values obtained were compared with the values predicted by Knudson et al..

Cirtometry Dynamics: provided information on the degree of thoracoabdominal mobility and was performed with the use of a tape measure , which was used to measure the chest circumference during maximal inspiratory and expiratory phase . Measurements were taken horizontally at three different levels: axillary, xiphoid and abdominal, taking as references the axillary fold bottom edge of the xiphoid and umbilicus, respectively. Three measurements on each level were performed.

The maximum values of inspiration and expiration were obtained, being considered for analysis, the highest value of the three measurements and subsequently the Index of Amplitude (IA) proposed by Jamami et al. was calculated in order to mitigate the different dimensions of the chest and abdomen.

Respiratory muscle strength : They were taken with the subject in a sitting position using a digital manometer (MVD300 - Globalmed®) calibrated, nose clip, with the nozzle held firmly between his lips.

The maximal inspiratory pressure (MIP) was obtained by a maximal inspiration preceded by a maximal expiration next to the residual volume (RV) , and to measure maximal expiratory pressure (MEP) a maximal inspiration was next performed to capacity total lung (CPT) followed by a maximal expiration.

The evaluation was considered complete when the individual performed three acceptable measures and, among these, a minimum of two reproducible . The last value found could not be superior to the others. Maneuvers with the support pressure by three seconds, and reproducible measurements with a variation less than or equal to 10% of the highest value were considered acceptable. For analysis was considered the greatest pressure value achieved. MIP and MEP obtained the values predicted by the equations of Neder et al. were compared.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 30 years
* Spirometric values within normal limits
* Body mass index (BMI) between 18 and 29.9 (kg/m2)
* Without previous or current history of smoking
* Did not report the presence of neuromuscular, respiratory or cardiac disease

Exclusion Criteria:

* Inability to understand and / or perform procedures
* Physically active and very active individuals
Investigation of Serotonin Receptor Binding in the Migraine Brain Using Positron Emission Tomography

Migraine affects 16% of the world population and is one of the most disabling of all disorders. It is a complex brain disorder characterized primarily by recurrent headache attacks. The signaling molecule serotonin (5-hydroxytryptamine, 5-HT) has for decades been thought to play a central role in migraine pathophysiology. The most effective class of abortive migraine drugs, the triptans, act on 5-HT receptors. However, the migraine-specific actions of serotonin and the mechanisms of triptans are still unknown. In this project the investigators will use high-resolution positron emission tomography and specific radioligands to investigate the significance of serotonin in migraine. Two newly developed radioligands that are specific for the 5-HT1B and 5-HT4 receptor, respectively, will be applied. To investigate the level and distribution of serotonin in the migraine brain the investigators will compare the binding of these ligands in episodic migraine patients with healthy controls. In addition, the investigators will include chronic migraine patients to evaluate the relation between the level of serotonin in the brain and the frequency of migraine attacks. To investigate the changes in the serotonin level during a migraine attack and the effects of triptans on the central nervous system the investigators will repeat the scans using the 5-HT1B specific ligand during induced migraine attacks and following treatment with sumatriptan. The results from this study will shed light on the role of serotonin in the migraine brain and elucidate the migraine-specific action of triptans. This will improve our understanding of the migraine pathophysiology and, potentially, facilitate the development of more efficient treatment of migraine.


Eligibility Criteria:
Inclusion Criteria, both groups:

• Written informed consent

Inclusion Criteria, episodic migraine patients:

* Migraine without aura according to the International Headache Society (IHS) 0-4 days per month
* The migraine is treatable with sumatriptan

Inclusion Criteria, chronic migraine patients: Fulfill IHS criteria for chronic migraine

Inclusion Criteria, healthy controls:

* Do not suffer from migraine according to IHS
* Do not have any first degree relatives with migraine

Exclusion Criteria:

* Tension type headache more than 5 days per month during the last year.
* Tension type headache on the experimental day.
* Any other primary headache disorder
* Migraine 48 hour before and after the experimental day (only episodic migraine patients)
* Use of antimigraine medication or pain-killer on the experimental day before PET
* Pregnant or breastfeeding women.
* Contraindications against MRI.
* History or clinical sign of cardio- or cerebrovascular disease.
* Untreated severe mental disorder or drug abuse.
* Other diseases or disorders interpreted, by the examining doctor, to interfere with participation in the study.
* Not accepting information about potential accidental findings during the experiment.
Performance Evaluation Study

This study aims to establish OLO's performance accuracy of CBC results for finger prick samples across the OLO reportable range, and particularly around relevant medical decision points

This study aims to establish OLO's performance accuracy of CBC results for finger prick samples across the OLO reportable range, and particularly around relevant medical decision points.

The evaluation will include two studies:

1. A matrix study will compare a capillary sample collected via finger prick with a venous sample collected into a blood tube, both scanned on OLO.
2. A method comparison study will compare Sight OLO to the site reference analyzer using a venous sample collected into a blood tube.

Eligibility Criteria:
Inclusion Criteria:

* Blood samples will be collected from oncologic patients older than 18 years old arriving at the oncologic daily care center of Ichilov hospital, with predefined normal and abnormal blood counts

Exclusion Criteria:

* Patient younger than 18 years old
* Visibly hemolyzed specimens (sample plasma should be checked for hemolysis by technician while selection of specimen from tube racks).
* Visibly clotted specimens (Reasonable to assume that samples processed with clinical reported results are not clotted).
* A sample that is not successfully scanned on OLO within 3 attempts (e.g. rejected due to irregular cell morphology, or microscopically visible hemolysis).
Use of Sirolimus vs. Tacrolimus For African-American Renal Transplant Recipients

The purpose of this study is to evaluate the efficacy of Sirolimus (Rapamune) in improving the function of the transplant kidney, without any increase in the risk of acute rejection or adverse side effects, compared with Tacrolimus (Prograf).

We hypothesize that Sirolimus, as one component of a long-term steroid-free immunosuppressive regimen, will be effective in maintaining a low incidence of acute rejection and a short- and long-term graft survival comparable to Tacrolimus with better graft function in the high-risk African-American renal transplant population with immediate graft function.

It has been repeatedly demonstrated that African-American renal allograft recipients have worse graft outcomes when compared with Caucasians. This has been attributed to various immunologic and non-immunologic factors, including a greater rate of acute rejection, resistance to standard doses of calcineurin inhibitors (CNIs) and corticosteroids, different pharmacokinetic and pharmacodynamic profiles, and noncompliance. It has therefore been suggested that quadruple immunosuppression, including antilymphocyte antibodies for induction, should be used in this high-risk population to improve graft survival. CNIs are currently the mainstay of immunosuppressive regimens. Tacrolimus has been shown to be significantly more effective than Cyclosporine A in preventing acute rejection. As a result, Tacrolimus has become the CNI of choice in preventing acute rejection, and has produced similar graft survival rates at one year, with higher creatinine clearances. However, there is no report examining the efficacy of Sirolimus in improving renal function and its side effect profile when compared with Tacrolimus in renal allograft recipients, particularly in African-Americans with immediate graft function in a steroid-free environment.

Eligibility Criteria:
Inclusion Criteria:

* African-American living- or deceased-donor renal transplant at least 18 years of age with current and historical negative crossmatch who demonstrate urine output \> 60 ml/hr and fall in serum creatinine \> 20%/day during the first 48 hours posttransplant, without need for dialysis.

Exclusion Criteria:

* Unwillingness to participate in the study
* Current PRA \> 20%
* Noncompliance with the protocol and follow-up visits
* Those who need to be on maintenance steroids due to underlying disease
* Known hypersensitivity to study drugs
* Pregnancy
* Pre-transplant leukopenia, thrombocytopenia, hypercholesterolemia, or hypertriglyceridemia despite optimal medical therapy
* HIV positive recipients.
Obesity and Mortality

Previous analyses of the National Health and Nutrition Examination Survey have suggested that the mortality rate associated with obesity has decreased over calendar time in the U.S. population, potentially due to improvements in the medical care of obesity and its associated diseases. The primary aim of this project is to evaluate whether this reduction in the detrimental association of obesity with mortality rate over calendar time is supported by other data from U.S. prospective studies.


Eligibility Criteria:
Inclusion Criteria:

* U.S. based studies with at least 1500 subjects
* At least 5 years of mortality follow-up
* BMI measured or self-reported available at 2 or more separate calendar time
* Subjects varied in age at baseline

Exclusion Criteria:

* Any study that does not meet the inclusion criteria was excluded
Progressive Resistance Training Program in Head and Neck Cancer Patients

The purpose of this study is to evaluate the feasibility of a 12-week progressive resistance training (PRT) during concurrent chemoradiotherapy in head and neck cancer patients compared to usual care.

12 patients with head and neck cancer will be recruited to this trial. Entering a 12-week PRT program which will start one week before radiotherapy. The tested training program is a 12-week, supervised, group based, progressive resistance training program involving the major muscle groups of the body. The program has previously been found to successfully restore the loss of lean body mass (LBM) in head and neck cancer patients post-treatment. A group based approach will be used to facilitate a social and motivating training environment for the patients. This approach has previously been used for exercise interventions for lung cancer patients at our facility, and was highly appreciated by the patients.

In addition to baseline data (height, tumor stage, performance status, etc), the following parameters will be registered on a weekly basis: Weight, patient reported side effects, as well as a questionnaire on amount of physical activity and food intake.

Physical function and strength will be tested at baseline, after the course of chemoradiotherapy and at the end of the 12-week PRT programme, and at 2, 5, 9 and 13 months follow-up. At similar time points dual energy x-ray absorptiometry (DXA) scans for body composition will be performed using a Lunar iDXA (GE Healthcare).

Blood samples will be drawn at baseline, an additional three times during the first 6 weeks and then weekly in relation to training sessions, and at 2, 5, 9 and 13 months follow-up.

Patient reported quality of life (EORTC Quality of Life Questionaire (QLQ)-C30 and QLQ-H\&N35) will be registered at baseline, after 12-weeks PRT and during 5 and 13 months follow-up.

Study duration is expected to be 7 months for the pilot-trial, with a follow-up of additional 13 months after the last patient has completed the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Patients with head and neck squamous cell carcinoma
* Candidates for concomitant chemoradiotherapy according to Danish Head and Neck Cancer Group (DAHANCA) guidelines.
* Performance status 0-1
* Expected to be able to complete the intervention, i.e. no major comorbidities or social issues that could compromise attendance.
* At least 18 years of age.
Congestive Heart Failure Surgical Treatmment With Autologous Stem Cell Therapy

This research study was designed to test the safety and effectiveness of autologous stem cell graft in the myocardium of patients with refractory Congestive Heart Failure (CHF) with ischemic etiology. Cellular implantation will take place during off-pump revascularization surgery or during an ad hoc procedure using a mini-thoracotomy access.

Primary target: determine the safety of introducing CD 34+ autologous progenitor cells (centrally grafted or mobilized in peripheral blood) in the myocardium of ischemic cardiac disease patients. Secondary target: determine clinical effects of grafted cells on remodeling pathology.

Eligibility Criteria:
Inclusion criteria

* Age \>18 y/o
* CHF with EF \> 35%
* Bilirubinemia, serum transaminase\> 2.5 times normal max level
* Creatininemia \> 2.5 times max level
* NYHA Class \> 3
* Negative pregnancy test (for women in fertile age)

Exclusion criteria

* Impossibility to harvest the bone marrow
* Pregnancy or breast-feeding
* History of malignant neoplasia in the 5-year period before the study (save for in-situ carcinoma of the cervix treated successfully and skin tumors - not melanomas)
* Incapability or unwillingness to comply with the envisaged treatment protocol, follow-up, or tests.
Clinical Trial of Vitamin E to Treat Muscular Cramps in Patients With ALS

Muscular cramps are a common and uncomfortable symptom of amyotrophic lateral sclerosis (ALS). This clinical trial will compare the response of high dose vitamin E supplementation to placebo for treatment of muscular cramps in patients with ALS. We hypothesize that vitamin E will be more effective than placebo in treating cramps.

This will be a single centre randomized placebo controlled crossover design trial. Participants will be randomized at study entry to protocol A (vitamin E first) or protocol B (placebo first). The first 2 weeks of the study will be a baseline assessment of the frequency, severity and duration of cramps. Patients will be blinded for the remainder of the duration of the study. For weeks 3-6 of the study, group A will receive vitamin E 800 IU bid and group B will receive placebo. For weeks 7-10 of the study, group A will receive placebo and group B will receive vitamin E. Participants will record cramp frequency and characteristics via a daily journal for the duration of the study, however the data analysis will focus on cramp frequency only during weeks 5-6 and 9-10. Weeks 3-4 and 7-8 will be used as time periods to allow the new drug to come to steady state and allow for washout of the previous drug. Data analysis will focus on the difference in cramp frequency in individual patients in each treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Adults (\> age 18 years)
* Probable or definite ALS by El Escorial Revised criteria
* At least 2 painful muscle cramps in one or more of the limbs per week.
* May have tried other medications for cramping in the past.
* If participants are currently on treatment for cramps and are continuing to have at least 2 cramps per week, they can be included in the trial. In this situation, the individual's previous cramp medication can be continued during the trial.
* Ideally, patients should not have any medication alterations during the duration of the trial.
* Willing to discontinue supplementary vitamin E and multivitamins containing \> 400 IU of vitamin E during the trial.

Exclusion Criteria:

* Patients who are unable to safely consume the trial capsules. Individuals with significant dysphagia can be included into the study if they have a functioning PEG tube or GJ tube, through which the medication can be given.
* Patients who are unable to fill out the daily diary, either personally or via a proxy.
* Patients who have had medication changes within the last 4 weeks prior to the onset of the trial will be excluded.
Efficacy Evaluation of a Commercial Preparation Containing Lactobacillus Casei DG on the Reduction of the Painful Symptoms Related to the Irritable Bowel Syndrome (IBS). A Pilot Clinical Study

The purpose of this study is to evaluate the efficacy of a treatment with Lactobacillus casei DG in the reduction of the painful symptoms in patients affected by irritable bowel syndrome. After that, the secondary object is to evaluate if the reduction of painful symptoms is related to a relevant reduction of trypsin and tryptase in colonic mucosa.


Eligibility Criteria:
Inclusion Criteria:

* out-Patients with diagnosis of Irritable Bowel syndrome (IBS) according to Rome III Diagnostic Criteria for Functional Gastrointestinal Disorders
* Previous colonoscopy (within 24 month prior the enrollment) with negative results
* written informed consent

Exclusion Criteria:

* systemic or topical therapy with steroids and glucocorticoids such as beclomethasone dipropionate or budesonide, ongoing or within a month prior the enrollment
* therapy with antibiotics or probiotics, ongoing or within a month prior the enrollment
* inflammatory bowel diseases
* copro-paraxitological examination with positive results
* bowel disease with infectious, actinic, endocrine or drug-related origin
* immunodeficiency
* diagnosis of malignant cancer within 5 years prior the enrollment
* renal, hepatic, hematologic, cardiovascular, pulmonary, neurological, psychiatric, immunological, gastrointestinal or endocrine disorders, if found to be clinically relevant
* any severe disease that may interfere with the treatment;
* abuse of alcohol, drugs or medication, psychotropic drugs
* diagnosis of dementia or other disorders that can cause a progressive deterioration of capacity of discernment or mental and physical disability which reduces the ability to follow the prescribed therapy;
* previous participation in this study
* pregnant or nursing (lactating) women
Treatment of Palmoplantar Psoriasis With Low Doses Interferential Current

Interferential current has shown promising results for treating psoriasis with a good tolerance. Prospective randomized studies versus placebo are required to confirm the interest of such an approach.

The Main objective is to assess the efficacy of interferential current for treating palmoplantar psoriasis.

Secondary objectives is to assess the subjective efficacy by the patients, the efficacy on the nails, to study the potential side effects.

Interferential current has shown promising results for treating psoriasis with a good tolerance. Prospective randomized studies versus placebo are required to confirm the interest of such an approach.

Main objective To assess the efficacy of interferential current for treating palmoplantar psoriasis.

Secondary objectives To assess the subjective efficacy by the patients, the efficacy on the nails, to study the potential side effects.

Patients Patients from 18 to 90 year-old with psoriasis on the hands and/or feet. Length of the study: 12 months Methods Monocentric randomized comparative study versus placebo.Intervention V0 : Selection: Information of the patient, control of inclusion and non inclusion criteria.

V1 : Control of inclusion and non inclusion criteria (treatment against psoriasis have to be discontinued for at least 3 weeks and 3 months for anti-IL12/23). Clinical scores and photographs. Explanation of the functioning of the device, then the treatment is followed at home, twice a day 5 minutes. 10% salicylic acid ointment will be applied after each session.

V2 : End of the treatment (12 weeks after V1). Clinical scores and photographs. V3 : End of the follow-up (24 weeks after V1). Clinical scores and photographs.

Eligibility Criteria:
Inclusion Criteria:

* Patients from 18 to 90 year-old with psoriasis on the hands and/or feet diagnosed clinically

Exclusion Criteria:

* Pregnant women,
* implantable electronic device (such as pace maker), betabloquer.
* Concomitant use of a treatment potentially active on psoriasis (steroids, vitamin D analogues, immunosuppressive drug, acitretin, cyclosporine, methotrexate, anti-TNF, anti-IL12/IL23).
ART Drug Dosage Adjustment in HIV-infected Population

The purpose of this study is to determine efficacy of the combination of low dose of Tenofovir, Efavirenz and Lamivudine in treating HIV-infection.

The feedback system control (FSC) technique has been developed to rapidly identify optimal combinations for therapeutic purposes. Low dose of TDF+3TC+EFV combination has been test in vitro study by FSC which showed high efficacy and now the investigators apply it to human to further optimize the ART combination.

Eligibility Criteria:
Inclusion Criteria:

* HIV antibody positive
* HIV RNA below 10\*E5 copies/ml
* CD4 T cell count above 200 cells/ml
* Provision of written informed consent

Exclusion Criteria:

* HIV genotyping resistant to investigating drug
* Pregnant, breastfeeding, or lactating
* Any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with treatment, assessment, compliance with the protocol, or subject safety. This would include any active clinically significant renal, cardiac, pulmonary, vascular, or metabolic (thyroid disorders, adrenal disease) illness, or malignancy
* Medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol
* Laboratory blood values:
* Haemoglobin \<7.0 grams/decilitre (g/dL)
* Neutrophil count \<500/mm3
* Platelet count \<50,000/mm3
* Aspartate aminotransferase or Alanine transaminase \>5 times Upper Limit of Normal (ULN)
* Subjects with an estimated creatinine clearance of \<50 mL/minute