cyrilzakka/clinical-trials huggingface dataset:
The Study of Active Transfer of Plaque Technique for Unprotected Distal Left Main Bifurcation Lesions

A Prospective Multi-center Randomized Trial Assessing the Efficacy and Safety of Active Transfer of Plaque vs. Provisional T Stenting for the Treatment of Unprotected Distal Left Main Bifurcation Lesions

It is a prospective, multi-center, randomized, open-label, non-inferiority trial. A total of 316 subjects from around 20 selected hospitals will be randomized on a 1:1 basis to either Active transfer of Plaque (ATP) stenting technique or Provisional T stenting technique.

In the ATP treatment of bifurcation lesions, by the balloon pre-dilation in the target side branch, the plaque will be actively transferred from side branch to main vessel. Subsequently, the plaque will be fixed by the expansive stent in main vessel.As to the provisional T treatment, provisional T stenting is the typic step-T stenting. In brief, two wires are advanced to distal MV and SB. Pre dilation is left at operator's discretion, however, pre dilating SB is not encouraged. Kissing balloon inflation before stenting MV is left at operator's discretion. A stent with stent/artery ratio of 1.1:1 is inflated in MV. Rewire to SB is also left at operator's discretion. FKBI is recommended if there is at least one of following: residual stenosis\>70%, \>type B dissection and TIMI flow\<3.

All patients will be followed clinically at 1-, 6- 12- and 24-month after stent implantation. Repeat angiography will be performed in all patients at 13 months after the index procedure.

The primary endpoint of the trial is the rate of TLR at 12-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be at least ≥18, ≤80 years of age.
* Patient has Stable/unstable angina or NSTEMI
* Patient has STEMI\>24-hour from the onset of chest pain to admission.
* LMb (Medina 0,1,1；1,1,1；0,1,0 ；1,1,0).
* Patient is eligible for elective percutaneous coronary intervention (PCI) .
* Patient is an acceptable candidate for coronary artery bypass grafting (CABG).
* Patient (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed; patient is willing to comply with all protocol-required follow-up evaluations

Exclusion Criteria:

* Patient with STEMI (within 24-hour from the onset of chest pain to admission).
* Patient has known allergy to the study stent system or protocol-required concomitant medications that cannot be adequately pre-medicated (everolimus, aspirin, contrast media, acrylic acid, Stainless steel).
* Patient has intolerable to dual anti-platelet therapy.
* Patient has any other serious medical illness that may reduce life expectancy to less than 12 months.
* Patient is pregnant or nursing.
* Patient is participating in another clinical trial that has not reached its primary endpoint within 12 months after the index procedure.
* Patient with severe calcified lesions needing rotational atherectomy.
* Left main In Stent Restenosis.
* Investigator consider that patients don't fit to participate in the study.
PATH to Health: An Exploration of Digital Behavioral Weight Loss Approaches

The purpose of this initial pilot and feasibility study is to test different digital, behavioral weight loss approaches, with or without human support, using a sequential, multiple assignment, randomized trial (SMART) design. All participants in this pilot trial will receive a 3-month mobile health (mHealth) program. The dose of human support will vary by first- and second-line randomizations. The feasibility, acceptability, and preliminary outcomes for each of the treatment sequences will be assessed.

Ninety-nine adults, ages 18-65, with overweight or obesity, will be randomized in total. All participants will receive an mHealth program (App) for program duration that includes activity tracking with a Fitbit, weight tracking with a smart scale, and an app for diet tracking. At baseline, participants will be randomized to either a a) Fully Automated Kick-Off, or b) Human-Enhanced Kick-Off. "Early responders" will continue with to use App, alone. After 4 weeks, "early non-responders" in both arms will be re-randomized once to one of two augmented interventions with human support: Counseling or Check-In. Assessments will occur at baseline, 1 week, 4 weeks, and 3 months to explore feasibility, acceptability, and preliminary outcomes (weight, self-monitoring adherence, behavioral goal adherence).

Eligibility Criteria:
Inclusion Criteria:

* Current age: 18-65 years
* Lives in North Carolina
* Body mass index (BMI) of 27.5-45 kg/m\^2
* Ability to read, write, and speak English
* Ownership of iPhone with a data and texting plan
* Ability to commit to the required counseling sessions (0-5 sessions, based on randomization)
* Is not living a participant or staff member on this trial
* Willingness to be randomized to any of the treatment sequences

Exclusion Criteria:

* Weight loss of more than 10 pounds in the last 6 months that was maintained
* A history of weight loss surgery
* Pre-existing medical condition(s) that prevent them from adhering to a supervised exercise routine
* Have Type 1 Diabetes or are currently taking medicine for Type 2 Diabetes
* Have recently been diagnosed or treated for cancer
* Currently pregnant, pregnant within the past 6 months, or plan to become pregnant in the next 6 months
* Report taking prescription or over the counter medication with a known impact on metabolism or weight
* Report a history of an eating disorder
* History of psychotic disorder or bipolar disorder, or have been hospitalized for depression or other psychiatric disorder within the past 12 months
* History of alcohol or substance abuse
* Current participation in another weight loss program that may interfere with participation in this study
Effects of Transcutaneous Electrical Nerve Stimulation on Spasticity in Children With Cerebral Palsy

Cerebral Palsy (CP) is a group of mental disorder that disrupts the person's ability of moving, maintaining their balance and posture. Cerebral palsy is a motor disorganization in Childhood. Cerebral palsy can occur before birth, during birth, within a month after birth, or during 1st year of life when brain is under development. Symptoms vary from person to person in case of severe CP child must needs the equipment used to enhance their mobility and to train muscles. Transcutaneous electrical nerve stimulation (TENS) is method of relieving pain by using mild electric current. Purpose of this study will be to determine effects of TENS on spasticity and gross motor function in children with cerebral palsy. TENS is a small machine operated with battery containing attached sticky pads known as electrodes placed on stiffed and painful area of muscles. Classified by Ashworth Scale and Modified Tardieu Scale. Subjects will be randomly divided into four groups 1) Group A= TENS on spastic muscle/agonist, 2) Group B= TENS on antagonist, 3) GroupC= TENS on both agonist and antagonist muscle, Group D= conventional physiotherapy total treatment period is about 3 to 6 weeks. This study will help to discuss how much extent TENS will effect spasticity in children with cerebral palsy. Data will be analyzed through SPSS 22


Eligibility Criteria:
Inclusion Criteria:

* Age 6-12
* Both Male and Female
* Spastic Cerebral Palsy

Exclusion Criteria:

* Patients with History of uncontrolled seizures
* Patients undergoing previous tendon lengthening surgery
* History of Botox Injection
The Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Hysterectomized Postmenopausal Women

To determine whether treatment with ESTRATEST® Tablets is superior to treatment with esterified estrogens tablets


Eligibility Criteria:
Inclusion Criteria:

Hysterectomized, menopausal women between the ages of 30 and 65 years of age (inclusive) with symptoms of estrogen and/or androgen deficiency not currently controlled by estrogen therapy as determined by patient report and the Investigator's clinical judgement
Diabetes Treatment With Glucobay in Combination With Metformin

In this prospective, non interventional, observational Post Marketing Survelliance study data are obtained on the efficacy, safety and tolerability of Glucobay treatment on top of metformin under daily life treatment conditions.Specifically investigated is the influence of Glucobay on Post Prandial Blood Glucose and HbA1c as well as on pateint's weight when added to an already existing metformin therapy.The study is planned to carried out in 25000 - 30000 patients from 200 trial sites in India.The PMS study will be performed with commercially available medication prescribed within regular practice of the physician. No other examination will be performed than would be done without Post Marketing Survelliance study.


Eligibility Criteria:
Inclusion Criteria:

* All patient with type 2 diabetes with one of the following treatment ongoing : 1) Metformin 2) Metformin + OHA.
* In such patients, if investigator feels that addition of acarbose would be benficial for the patients

Exclusion Criteria:

* According to local product information
Safety and Tolerability of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency (28 Week Extension)

This clinical trial is designed to provide additional information on the safety and tolerability of vildagliptin (50 mg once daily (qd)) when used in patients with type 2 diabetes mellitus (T2DM) and moderate or severe renal insufficiency


Eligibility Criteria:
Inclusion Criteria:

* Complete the core study

Exclusion Criteria:

* Did not comply with core study requirements
Characterization by Clinimetric Indicators of Chronic Low Back Pain Subjects Versus Healed Patients

Pretending with the use of accelerometers and pressure platform, determine indicators that are useful to therapists to assess postural control and balance, to subsequently allow to evaluate the effect of therapeutic interventions through therapeutic exercise of motor control in patients with chronic low back pain .

The records are made simultaneously with the different evaluation equipment, accelerometer and pressure platform. The tests are performed in a control group of healthy subjects, and in an experimental group with DLC receiving a program of therapeutic exercise based and pain education based on neuroscience.

After the collection of the records, the behavior patterns in both groups are evaluated, the possible differences among them are established for the clinimetric indicators analyzed related to the postural control, as well as a characteristic of the sample.

Subsequently, through the evaluation after the intervention of the experimental group we will analyze the effect of a physiotherapy treatment based on the therapeutic exercise of motor control on parameters related to postural control and clinical variables (perceived pain, mechanosensitivity, disability and proprioceptive repositioning of the lumbar spine )

Eligibility Criteria:
Inclusion Criteria:

* low back pain with painful perception on a daily or almost daily basis for more than three months of clinical course, with or without pain radiating to the lower extremities above the knee.
* not having metal implants in the spine
* own ability to read and write
* and access the study voluntarily.

Exclusion Criteria:

* vestibular disorders
* without severe visual impairment
* no medication intake with a potential effect on balance during the 90 days prior to data collection
* physiotherapy treatment 2 weeks before the study
The Effect of Temperature on Anesthesia and Surgical Resident's Ability to Perform Clinical and Cognitive Tasks

The purpose of the current study is to examine whether changes in intraoperative ambient temperature has in impact on the clinical performance of the physicians in training which include Anesthesiology and Surgical residents, fellows and certified nurse anesthetists (CRNA). Reaction times will be measured via a 10-minute psychomotor vigilance test (PVT, Ambulatory Monitoring Inc., NY) device.


Eligibility Criteria:
Inclusion Criteria:

* CRNA or surgery or anesthesiology resident fellow in ongoing surgery case

Exclusion Criteria:

* unwilling to participate
* any clinical circumstance that precludes participation
Copper Histidinate Treatment for Menkes Disease

This study investigates the clinical effects and safety of subcutaneous Copper Histidinate treatment for newly diagnosed Menkes disease patients under 6 years of age.


Eligibility Criteria:
Inclusion Criteria:

1. The subject must be a newly diagnosed Menkes disease patient in the United States.
2. Must sign and date an informed consent form by parent or legal guardian for this study prior to any assessment being done in this study.
3. Male or female, aged 0 to \<6 years of age.
4. Confirmed diagnosis of Menkes disease based on the following clinical and/or biochemical and/or molecular characteristics:

   Clinical: Abnormal hair color and/or texture, and/or seizures, and/or hypotonia, and/or developmental delay; or Biochemical: Low serum copper levels (\< 75 mcg/dL) and/or ceruloplasmin and/or abnormal plasma catecholamine levels; or Molecular: Mutation(s) in the ATP7A gene (deletion/duplication, nonsense, missense, or canonical or non-canonical splice junction mutations).
5. For newly diagnosed Menkes disease patients, whose molecular ATP7A gene mutation confirmation is pending these patients should have serum copper levels \< 75 mcg/dL.
6. Ability to adhere to the prescribed subcutaneous Copper Histidinate injection regimen.
7. Willingness to comply with all study visits and procedures.

Exclusion Criteria:

1. Pre-existing liver (e.g., hepatitis, biliary atresia, cirrhosis) or kidney disease (e.g., serum creatinine \>1.0 mg/dL).
2. History of bleeding diatheses.
3. Diagnosis of Wilson disease.
4. Any disease or condition that, in the opinion of the Investigator, has a high probability of precluding the subject from completing the study or where the subject cannot or will not appropriately comply with study requirements.
5. Participation in any other investigational trial in which receipt of investigational drug or device occurred within 30 days prior to screening for this study.
Expression of TIM-3 and Correlation With Disease Activity in Pediatric Crohn's Disease With Anti TNF-α Therapy

This study investigated the expression of T-cell immunoglobulin- and mucin-domain-containing molecule 3 (TIM-3) in the colonic mucosa and/or the peripheral blood of children with Crohn's disease during anti TNF-α (infliximab) therapy.

The immunoregulatory effects of TIM-3 on patients with Crohn's disease according to the treatment have not yet been investigated.

Eligibility Criteria:
Inclusion Criteria:

* •Pediatric patients who were diagnosed with severe Crohn's disease who require infliximab treatment

  * confirmed diagnostic of Crohn's disease in clinical, endoscopic and histological findings

Exclusion Criteria:

* •patients who has proven to have infliximab antibody
Artificial Intelligence and Cancer Staging in Upper Gastrointestinal Malignancies

Esophageal and stomach cancers, which constitute cancers of the upper region of the digestive system, are cancers that are frequently observed and unfortunately have a low rate of cured patients. In these cases, the stage of cancer at diagnosis is very important for two reasons; First, the stage of the cancer is directly related to the survival time. Secondly, treatment is planned according to the stage. Different treatments are applied to patients at different stages. Currently, the TNM staging (Tumor, Lymph Node and Metastases) system is the accepted one worldwide. Despite many advanced technology tools used in staging (Computed Tomography, Magnetic Resonance Imaging, Endoscopic Ultrasonography), there are still difficulties in correct staging before surgery or before-after neoadjuvant therapy. Artificial intelligence techniques are increasingly used in the field of health, especially in the diagnosis and treatment of cancers. Obtaining cancer details in radiological images, which cannot be noticed by the human eye, by analyzing big data with the help of algorithms gave rise to the application area of "radiomics". It is stated that with Radiomics, there will be improvements in both the diagnosis and staging of cancers and, accordingly, in the treatment. While there are studies on the use of endoscopic methods with artificial intelligence for the early diagnosis of esophageal cancers, a limited number of studies have been conducted on stage estimation from radiological images. In particular, there are not enough studies on the investigation of changes in tumor size after chemotherapy with artificial intelligence and the estimation of staging. In this study, it was aimed to investigate the predictive efficiency of staging and the accuracy of the algorithm developed with artificial intelligence by processing tomography images in a region where esophageal cancers are endemic as a primary outcome and to evaluate the post-treatment mortality, morbidity rates and complication rates of the patients as a secondary outcome.


Eligibility Criteria:
Inclusion Criteria:

1. Being diagnosed with esophageal cancer (adenocarcinoma or squamous cancer)
2. Being over 18 years old
3. Having a tomography image before or after chemotherapy.
4. Giving informed consent to participate in the study.
5. Having final pathological staging after surgery.

Exclusion Criteria:

1. Previous thoracic surgery.
2. Having a recurrent tumor
3. Inability to perform clinical staging due to technical reasons
4. Drawings cannot be made due to poor tomography quality.
Efficacy of HellenCare in Early-Stage Alzheimer's Disease

The goal of this clinical trial is to evaluate whether HellenCare, a multicomponent nutraceutical, improves cognitive and functional outcomes in patients with early-stage Alzheimer's disease (AD). The investigators will compare changes in outcomes between the HellenCare group and the placebo group to determine if the intervention is effective and safe.


Eligibility Criteria:
Inclusion Criteria:

* Participants aged 50 to 85 years
* Clinically diagnosed for the first time with probable Alzheimer's disease dementia (AD dementia) or AD-related mild cognitive impairment (MCI) according to the National Institute on Aging-Alzheimer's Association (NIA-AA) core clinical criteria.
* MMSE (Mini-Mental State Examination): Score between 22 and 30.
* CDR (Clinical Dementia Rating): Total score of 0.5 or 1. Memory domain score on CDR: ≥0.5.
* Able to comply with study procedures and attend scheduled visits.
* Willingness to participate and provide informed consent.

Exclusion Criteria:

* Presence of other dementia-causing conditions (e.g., vascular dementia, Lewy body dementia, etc)
* Severe neurological comorbidities (e.g., history of seizures, cerebral infarction, intracerebral hemorrhage, traumatic brain injury, brain tumors, etc.)
* Presence of severe anxiety, depression, schizophrenia, bipolar disorder, or other psychotic disorders requiring active treatment.
* History of alcohol or drug dependence within the past 1 year.
* Allergies to study dietary supplement.
* Use of anti-dementia medications ( e.g., donepezil, galantamine, memantine, etc).
Distribution of Highly Sensitive Troponin in the Critically Unwell & Associated Mortality

The current diagnostic criteria for a heart attack require evaluation of a patient's symptoms and ECG but importantly a blood test called troponin. With advancing technology this test has become more sensitive and is now called a high sensitivity troponin. This is a very effective way of rapidly excluding a heart attack if the test is negative. However there are a number of causes of a raised high sensitivity other than a heart attack, particularly critical illness states. In the absence of features of a heart attack an abnormal result therefore suggests that the heart is inflamed or unwell causing the release of high sensitivity troponin. The DIGNITY study will examine the consequences of high sensitivity troponin elevation in patients in intensive care and assess whether it has a role as a biomarker for predicting outcome.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (aged 18 years or older) admitted to any of the three intensive care facilities on site (general, cardiac and neurosciences)
* Biochemistry samples already taken as part of routine clinical care during the ICU stay

Exclusion Criteria:

* Patients aged less than 18 years
* No biochemistry samples taken within the ICU stay
Variation of COMT Val158Met Polymorphism Between COM-ON Patients and METHADOSE Patients

The main objective is to compare the genotypes of the COMT Val158Met polymorphism between opiate-users and opiate-dependent subjects. The secondary objective is to constitute a sample of opiate-users without any lifetime opiate dependence.

The COMT enzyme enables the degradation of brain monoamines such as Dopamine and is encoded by a single gene for which several polymorphisms are known, including the Val158Met polymorphism which has been widely studied in various psychiatric disorders, including addictions, as well as in impulsivity. In most studies it is the Val allele which is found to be associated with addictive behaviors. The study METHADOSE, which began in 2009, includes opiate-dependent patients substituted by methadone. The preliminary analysis of this study shows a genotype distribution different from that of general population samples, with a greater prevalence of Val / Val and Val / Met genotypes. Will be included in the COM ON study subjects who have consumed illicit opiates (heroin, methadone, buprenorphine or morphine) more than 10 times in their life, without ever having the DSM-IV criteria for opiate dependence or abuse. The study will compare, by means of saliva samples, Val / Val and Val / Met genotypes between the subjects recruited in COM ON and those recruited in METHADOSE. Will also be included auto-questionnaires to identify psychological factors that may constitute risk or protective factors vis-à-vis the development of dependence.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old
* Caucasian patients
* Clinical diagnosis of lifetime opiate-using disorder (consumption over 10 times of illicit opiates (heroin, buprenorphine, methadone or morphine))
* Not lifetime history of opioid dependence (DSMIV)
* Patients with health insurance coverage
* Patient was treated with opioids analgesics to alleviate 2 or 3 in their lives

Exclusion Criteria:

* Non-Caucasian patients
* Patients who cannot give their consent and/or who refuse the collection of genetic data
* Patients with no health insurance coverage