cyrilzakka/clinical-trials huggingface dataset:
Evaluation of "Beauty Drink" on Regulation of Blood Pressure Effect by Clinical Trial

This report assesses the effect of supplementation with gamma-aminobutyric acid on blood pressure among people with mild hypertension. Overall, "Beauty Drink" consumption for 8 weeks could successfully reduce mean diastolic and systolic BP through the suppression of ACE linked to downstream suppression of angiotensin II formation, which further decreases the sympathetic outflow leads to hypertension.

This report assesses the effect of supplementation with gamma-aminobutyric acid on blood pressure among people with mild hypertension. Fifty subjects with systolic blood pressure (SBP) between 120 and 159 mm Hg and/or diastolic blood pressure (DBP) between 80 and 99 mm Hg were randomized to ingest 2 bottles of "Beauty Drink" or placebo per day for 8 weeks of a stage. In addition, anthropometric measurements (blood pressure, body weight, body fat) and blood biochemical markers including fasting blood glucose (FBG), albumin, total cholesterol (TC), triglyceride (TG), HDL-C, LDL-C, creatinine (Cr), blood urea nitrogen (BUN), AST, ALT were examined every four weeks.

Eligibility Criteria:
Inclusion Criteria:

* Eligible subjects were untreated hypertensive men or women aged between 20 and 70 years old with SBP between 120 and 159 mmHg and/or DBP between 80 and 99 mmHg as measured in a sitting position

Exclusion Criteria:

* Subjects were excluded if they had a history of major cardiovascular disease or severe liver dysfunction; Diastolic blood pressure ≥ 100 mmHg or Systolic blood pressure ≥ 160 mmHg;
* Alcoholic;
* US-controlled diabetics;
* Stoke in past one year;
* Mental diseases or melancholia;
* Pregnancy or breast-feeding a child;
* Renal dysfunction;
Study Assessing Hybrid SPECT-CT With Labeled Leukocytes for Diagnosis of Vascular Prosthesis Infections

Vascular Prothesis Infection is a rare but an extremely serious complication. Diagnosis is often difficult (germs are found only in 50% of cases). Conventional imagery is often non-specific and difficult to interpret especially in early postoperative phase. Leukocytes isolated from the patient's blood are labeled with a radiopharmaceutical technetium 99mTc-HMPAO.

The aim of this study is to assess the overall diagnostic performance of scintigraphy (hybrid SPEC-CT) with labeled leucocytes in diagnosis of subdiaphragmatic vascular prothesis infection.


Eligibility Criteria:
Inclusion Criteria:

* patient of more than 18 years old
* Patient with a subdiaphragmatic vascular prosthesis
* Vascular prosthesis infection suspected with clinical (flow from the scare and/or local pain and/or erythema and/or persistent fever and/or bacteraemia) and/or biological (inflammatory syndrome : elevated C-reactive protein and/or erythrocyte sedimentation rate (ESR) and/or white blood cells increased) infection signs
* Patient willing to participate with a signed informed consent
* Patient covered by a healthcare insurance

Exclusion Criteria:

* Pregnant women or of childbearing age without effective contraception
* Prosthesis limited to a bare stent.
* Patient who has been committed to an institution by legal or regulatory order
* Contraindications for labeled leukocytes scintigraphy realization :
* Restlessness, inability to keep still lie at least 1 hour
* Claustrophobia
* Poor compliance predictable or impaired general condition making it impossible to carry out the examination
* Refusal to participate in the study
Robotic TruST-Postural Intervention for Children With Cerebral Palsy

The purpose of this study is to test the efficacy of a motor learning-based postural and reaching control intervention delivered with the robotic Trunk-Support-Trainer (TruST) compared to the same motor learning-based intervention delivered with Static Trunk Support Equipment in children with cerebral palsy (CP) classified as III and IV with the Gross Motor Function Classification System (GMFCS).

This study is a prospective Clinical Randomized Control Trial (RCT) in a group of 82 children with cerebral palsy. The experimental and control groups will receive effective postural-reaching training based on motor learning and control principles. In both groups, participants will engage in play and functional activities that elicit arm movement and challenge trunk postural control, and the motor tasks and activities will be progressed. The main difference is that the experimental group will be trained with TruST in order to add postural task-progression via assistive force fields; which will be tailored to the child's sitting control balance status across training sessions. However, in the control group, postural task-progression will be addressed by lowering the level of rigid trunk support segment by segment across training sessions. The trunk subregion where the support is placed will depend on the child's trunk control ability. Participants will be recruited from the United States.

Eligibility Criteria:
Inclusion Criteria:

* Age 6-17 years
* Diagnosis of Bilateral CP: diplegia, triplegia, or quadriplegia
* Gross Motor Function Classification Systems-Expanded \& Review (GMFCS) levels III or IV
* Ability to sit 5s with trunk support between mid-ribs and pelvis (SATCo = 3-7)
* Cognitive capacity to follow basic verbal instructions (i.e., "do not put your hands on your lap" or "follow and reach the toy")

Exclusion Criteria:

* Absent head control (SATCo = 1)
* Current medical illness unrelated to CP at the time of the study
* Severe dyskinesia that prevents the child from maintaining sitting and recovering balance during reaching movements
* History of recurrent seizures (daily) or drug-resistance epilepsy
* Severe Spinal Deformities: scoliosis \>40◦ and/or kyphosis \>45◦
* Spinal osteosynthesis or orthopedic surgery of spine, upper or lower extremities in the last 6 months
* Severe spasticity of biceps/triceps in both upper extremities (Modified Ashworth Scale = 4)
* Local chemodenervation therapy in spastic muscles (e.g., botulinum toxin or phenol injections) in upper or lower extremities in the previous 3 months or planned during the study
* Other major surgeries in the previous 6 months (if medically contraindicated)
Investigatory Study of Metformin's Pharmacokinetics, Pharmacodynamics and Drug Drug Interactions Classifying the Group by MATE1 Genotype in Healthy Volunteers

This is the investigatory study to find out metformin's pharmacokinetics, pharmacodynamics and drug-drug interactions classifying the group by MATE1 genotype in healthy volunteers. The investigators will apply ranitidine and verapamil to the drug interaction study of metformin.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers aged 20 to 50 years at screening
* Subjects whose weights are heavier than or equal to 50 kg and ±20% of ideal body weight : Ideal body weight = (height cm - 100) x 0.9
* Subjects who provided written, voluntary informed consent to participate in this clinical trial and to comply the directions including contraception after being fully informed of and understand this trial

Exclusion Criteria:

* Subjects who have the clinically significant diseases or history in liver, kidney, nervous system, respiratory system, endocrine system, blood tumor and cardiovascular system.
* Subjects who have participated in other clinical trial within 1 month prior to the first day of drug administration
* Subjects who are inappropriate in the judgement of the investigator due to the reasons including clinical laboratory test results
Tai Chi Exercise on Balance and Awereeness

The aim of this study is to determine the effect of Tai chi exercises on balance and body awareness in younger adults. Forty-two healthy subjects between the ages of 18-25 who do not have any restriction to exercise participate in our study. After recording the sociodemographic characteristics of the subjects, static and dynamic balance and body awareness will be evaluated. Kinesthetic Ability Trainer will be used to assess static and dynamic balance and body awareness will be evulated with Body Awareness Questionnaire. All assessments will be done before and 12 weeks after the tai chi exercise. Tai-chi training will be performed as a group exercise. Duration for tai chi exercise will be 60 minutes for 2 days per week totally 12 weeks.

Tai-chi training was performed as a group exercise. Duration for tai chi exercise was 60 minutes for 2 days per week for 12 weeks. Each session includes 10 min warm-up and cool-down and 40 min Tai Chi exercises. During exercises, attention was paid to correct positioning of the upper and lower extremity joints, and mentally concentration was achieved. Slow and controlled movements were carried out by a specialized physiotherapist

Eligibility Criteria:
Inclusion Criteria:

1. Subjects between the ages of 18-25,
2. Subjects who had lack of disease.

Exclusion Criteria:

1. Subjects with neurological symptoms,
2. Subjects with orthopedic problems,
3. Subjects with heart failure,
4. Subjects with respiratory distress.
Evaluation for Benign and Malignant Pulmonary Ground-glass Nodules Based on MRI Dynamic Contrast Enhanced Imaging

Computed tomography (CT) is critical for the diagnosis of lung nodules as well as for therapeutic management. Repeated CT examinations will raise the issue of the cumulative radiation dose and subsequent risk of cancer, thus pushing the need for imaging techniques using low or no radiation dose. Magnetic Resonance Imagery (MRI) with ultrashort echo time (UTE) pulse sequences with high signal-to-noise and spatial resolution is a promising alternative for lung nodules imaging.The purpose of the study is to evaluate the value of dynamic contrast-enhanced MR imaging (DCE-MRI) to discriminate of malignant from benign lesions.

Computed tomography (CT) is critical for the diagnosis of lung nodules as well as for therapeutic management. Repeated CT examinations will raise the issue of the cumulative radiation dose and subsequent risk of cancer, thus pushing the need for imaging techniques using low or no radiation dose. Magnetic Resonance Imagery (MRI) with ultrashort echo time (UTE) pulse sequences with high signal-to-noise and spatial resolution is a promising alternative for lung nodules imaging.The purpose of the study is to evaluate the value of DCE-MRI to discriminate of malignant from benign lesions.In this study, the investigators are going to validate the efficacy of the DCE-MRI for diagnosing early lung cancer by comparing results of the pre-surgery MRI imaging with the post-surgery pathology.

Eligibility Criteria:
Inclusion Criteria:

* Ground-glass pulmonary nodules found by CT scan
* Plan to accept surgery or puncture due to the pulmonary nodules
* Absence of treatment such as chemotherapy or radiotherapy and biopsy
* Adequate renal function to tolerate intravenous gadolinium
* Agree to sign informed consent
* Able to lie still during DCE-MRI

Exclusion Criteria:

* Fail to understand or agree to sign informed consent
* Implanted pacemaker or cardiac defibrillator
* Contraindications to undergoing MRI
* Uncontrolled intercurrent illness
* Pregnant or breastfeeding
Immediate and Long-term Effects of an Adaptation of the "Balloon-blowing Exercise"

Despite the literature evidence that the "balloon-blowing exercise" improves the pulmonary function as a long-term effect, this exercise has not yet been studied or tested experimentally, meaning that there are no specific and measurable results that attest the improvement on thoracoabdominal movement.


Eligibility Criteria:
The target population consisted of healthy physiotherapy students from School of Health - Polytechnic of Porto, who volunteered to participate in study.

Inclusion criteria:

- In the Experimental Group B were admitted individuals that, through the analysis of the training record sheet, had executed 2⁄3 of the programmed sessions.

Exclusion criteria:

* Individuals that had participated in aerobic physical activities of moderate (i.e., at least 30 minutes on five days per week) or vigorous intensity (i.e., at least 20 minutes on three days per week) for more than one year;
* Chronic nonspecific lumbopelvic pain (i.e., recurrent episodes of lumbopelvic pain for a period exceeding three months);
* Flu symptoms or respiratory infection up to one week before data collection;
* History of recent ribs fracture and pain in the last three months;
* Pulmonary or rib cage previous pathologies;
* Length discrepancy of the lower limbs or other postural asymmetries;
* History of spinal, gynaecological, or abdominal surgery in the previous year;
* Recurrent muscle/joint pain and history of musculoskeletal injury in the last three months;
* Smoking and/or drinking habits.
Transthoracic Shear-wave Ultrasound Elastography

This study aims to provide the information of tissue elasticity in different etiologies of pulmonary lesions and to validate the predictive value of shear-wave elastography in differentiating benign pulmonary lesions from malignant lesions.


Eligibility Criteria:
1. Inclusion criteria: (1) Retrospective cohort from Jan 2016 to Dec 2017 (2) Patients with radiographic evidence of pulmonary tumors
2. Exclusion criteria: (1) age \< 20 y/o (2) patients who can't hold their breath for 5 seconds
A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes

The purpose of this study is to determine the long-term safety of the study intervention orforglipron as a monotherapy or in combination with oral antihyperglycemic medication.

This study includes 3 periods as follows:

* screening and lead-in period: up to 4 weeks
* treatment period: 52 weeks, including 20 weeks of dose escalation, and
* safety follow-up period: 2 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Have Type 2 Diabetes (T2D)
* Have HbA1c ≥7.0% (≥53 mmol/mol) to ≤10.5% (≤91 mmol/mol) as determined by the central laboratory at screening.
* Are of stable weight (±5%) for at least 90 days prior to screening and agree to not initiate an intensive diet or exercise program during the study with the intent of reducing body weight other than the lifestyle and/or dietary measures for diabetes treatment.
* Have a BMI ≥23.0 kilogram/square meter (kg/m²) at screening.

Exclusion Criteria:

* Have Type 1 Diabetes (T1D).
* Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening, or between screening and randomization.
* Have New York Heart Association functional classification IV congestive heart failure.
* Have had any of the following cardiovascular (CV) conditions within 60 days prior to screening, or between screening and randomization.

  * acute myocardial infarction
  * cerebrovascular accident (stroke), or
  * hospitalization for congestive heart failure
* Have acute or chronic hepatitis and pancreatitis
The STIM-ADHF Study

The STIM-ADHF Study is a multi-center, observational study to assess the performance and safety of the CPNS System in patients with ADHF.

The CPNS System is a neuromodulation system used to treat ADHF, a sudden or slow deterioration of chronic heart failure. The CPNS system is intended to provide acute (≤ 5 days) endovascular stimulation of the cardiac autonomic nerves in the right pulmonary artery (PA) in hospitalized ADHF patients. The system consists of an acute temporary neuromodulation stimulation catheter placed in the right pulmonary artery via venous access and a custom stimulator, denoiser, and associated cables. The CN2 Catheter is delivered to the right PA and provides an inotropic and/or lusitropic therapeutic effect by electrical stimulation to the terminal sympathetic nerve branches within the cardio-pulmonary plexus. The study will be conducted at up to 20 study sites worldwide. Up to 50 subjects who meet the eligibility criteria, will be enrolled, treated in-hospital with the Cardionomic CPNS System, monitored closely throughout the hospitalization and followed through 30 days post hospital discharge to evaluate the effect of the CPNS treatment.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to the hospital or planned to be admitted with a principal diagnosis of acute decompensated heart failure
* BMI adjusted BNP ≥ 500 pg/mL or NT-proBNP ≥ 2000 pg/mL
* LVEF ≤ 50%
* At least one sign/symptom of fluid overload
* At least one of the following:
* Inadequate diuretic response
* At least one sign or symptom of low perfusion

Exclusion Criteria:

* Received an inotrope during current hospitalization
* Requires mechanical support
* Cardiogenic shock or impending cardiogenic shock
* Multi-organ failure
* Systolic blood pressure \< 80mmHg or \> 140mmHg
* Symptomatic hypotension
* eGFR \< 25 mL/min/1.732
* Severe hepatic disease
Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen OIT

This is a multi-center, randomized, double-blind placebo controlled study of efficacy and safety of characterized peanut oral immunotherapy in peanut allergic individuals.

This is a multicenter, randomized, double-blind placebo controlled study of efficacy and safety of characterized peanut OIT in peanut allergic individuals. All eligible subjects will receive an escalating dose of CPNA or placebo. Approximately 50 subjects will be randomized 1:1 to peanut OIT or placebo.

Eligibility Criteria:
Key Inclusion Criteria:

* Ages 4 through 26 years, inclusive
* Clinical history of allergy to peanuts or peanut-containing foods
* Serum IgE to peanut \>0.35 kU/L (determined by UniCAP within the past 12 months) and/or a SPT to peanut \>3 mm compared to control
* Experience dose-limiting symptoms at or before the 100mg dose of peanut protein (measured as 200 mg of peanut flour) on abbreviated screening OFC conducted via PRACTALL guidelines
* Use of birth control by females of child-bearing potential

Key Exclusion Criteria:

* History of Cardiovascular disease
* History of frequent or repeated, severe or life-threatening episodes of anaphylactic shock
* History of other chronic disease
* History of eosinophilic gastrointestinal disease
* Severe asthma
* Mild or moderate asthma if uncontrolled
* Use of omalizumab within the past 6 months or current use of other non-traditional forms of allergen immunotherapy
* Use of beta-blockers(oral), angiotensin-converting enzyme (ACE)
* Pregnancy, lactation
* Having the same place of residence as another study subject
* Participation in an interventional clinical trial 30 days prior to randomization
DatScan With Prototype Collimator

A collimator is an accessory to a SPECT/CT scanner. It can be compared to a camera lens or filter that enhances or improves photos. The prototype collimators are able to magnify target organs about four times compared to the current collimators. In this study we are validating a new collimator design, which will allow for quantitative measurement of dopamine receptors within the brain, not previously performed using a single photon gamma camera.

Previously PET/CT has been used for this measurement but the L-DOPA is not FDA approved and thus of limited availability. DatScan (I123 ioflupane) is an FDA approved and clinically indicated biomarker, which has a high binding affinity for presynaptic dopamine transporters (DAT) in the brains of mammals, in particular the striatal region of the brain. A feature of Parkinson's disease is a marked reduction in dopaminergic neurons in the striatal region. By introducing an agent that binds to the dopamine transporters a quantitative measure and spatial distribution of the transporters can be obtained. The use of SPECT/CT (with the new validated collimators) and the FDA approved DATScan biomarker would allow for readily available diagnosis of Parkinson's disease

Eligibility Criteria:
Inclusion Criteria:

* all patients referred

Exclusion Criteria:

* anyone who wishes to not participate and cannot lay on the table for an additional 30 minutes.
Effect of Mulligan Mobilization in Chronic Non-Spesific Low Back Pain

Fifty five participants diagnosed with CNSLBP, will randomized into three groups. Group I (18 subjects) will receive 15 sessions of Conventional Physiotherapy program (CPP) 5 times per week, Group II (19 subjects) will receive 9 sessions of SNAGs, and Group III will receive CPP plus SNAGs. Outcome measures are pain, ROM, spinal mobility, fear avoidance behaviour and function. Measurements will record before, after and 6 month after the end of the treatment.

Inclussion criterias are; low back pain for at least 3 months, intensity of pain ranges from 3 to 6 according to VAS. Exclussion criterias are; undergoing surgical operation in the lumbar region or having a surgical indication, having an exercise therapy and / or physical therapy in the last 1 year, a history of trauma involving lumbar region and systemic and inflammatory disease targeting this region, participants using corticosteroids for a long time and being pregnant.Acording to our criterias 55 participants diagnosed with CNSLBP will randomised into three groups. Group 1 will receive Conventional Physiotherapy programme consisting of Hot pack, US and TENS applications. Group II aill receive Lumbar SNAGS consisting of Lumbar Extension SNAGS in prone, SNAGS in lion position and Lumbar flexion SNAGS in sitting, techniques. Group III will receive 9 sessions of SNAGs, and Group III will receive CPP plus SNAGs.Outcome measures are pain, ROM, spinal mobility, fear avoidance behaviour and function. Measurements will record before, after and 6 month after the end of the treatment. All treatment groups were treated with the same researcher. All assessments were made by another blind researcher three times at before, after and 6 month after treatment.

Eligibility Criteria:
Inclusion Criteria:

* low back pain for at least 3 months
* intensity of pain ranges from 3 to 6 according to VAS

Exclusion Criteria:

* undergoing surgical operation in the lumbar region or having a surgical indication having an exercise therapy and / or physical therapy in the last 1 year
* a history of trauma involving lumbar region and systemic and inflammatory disease targeting this region
* corticosteroids consumption for a long time
* being pregnant.