cyrilzakka/clinical-trials huggingface dataset:
Craving Network Neurofeedback

This project tests whether individuals with overweight or obesity and high craving can learn to change their brain response to food cues using neurofeedback, to impact their craving and eating behavior.

Aim 1 of this study is to test whether neurofeedback from the craving network is associated with reduced craving network strength.

Aim 2 of this study is to test whether neurofeedback from the craving network is associated with reduced food craving and changes in eating behavior.

Aim 3 of this study is to test whether neurofeedback from the craving network is associated with changes in resting state functional connectivity.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 to 60 years
* Body mass index \>25 kg/m2
* \>2.37 Food Craving Inventory score

Exclusion Criteria:

* Use of anti-obesity medications
* Weight-reduced state defined as \>10% weight reduction in the past 6 months.
* Nicotine use
* Current diagnosis of neurological or psychiatric disorder
* Obesity-related diseases such as type-2 diabetes
* Contraindications to MRI
* Baseline scanning with motion \>0.15mm frame to frame displacement.
Intensive Trauma Treatment for Children Exposed to Parental Conflict

The purpose of this study is to track outcomes of the investigator's therapy approach with children of separation/divorce who have been exposed to parental conflict.


Eligibility Criteria:
Inclusion Criteria:

* child between the ages of 6 - 16
* parent concerned re child's distress and behaviors related to custody, visitation, etc.
* parent has the legal authority to obtain treatment for the child
* parent and child fluent in English

Exclusion Criteria:

* as per clinical judgment of the PI during a telephone screening (interview of the referring parent), determination that the child is unlikely to be responsive to the intensive therapy format. This would typically be due to the child having a severe intellectual impairment, major dissociative disorder, etc.
Early Lung Cancer Detection Using Computed Tomography

Early detection of lung cancer may improve treatment outcomes. Risk factors have been identified, suggesting a population which might benefit from regular screening. Lung cancer screening using low-dose computed tomography (LDCT) has experienced a recent renaissance with reported sensitivity for detection of lung cancer of 2.7% in high-risk populations. The purpose of this study is to evaluate the utility of LCDT for the early diagnosis of lung cancer in Ontario.


Eligibility Criteria:
Inclusion Criteria:

55 years or older at least 10 pack-year history of smoking general good health

Exclusion Criteria:

any prior cancers except non-melanotic skin cancer
An Endoscopic Barbed-clips Suturing for Colorectal ESD

Endoscopic submucosal dissection (ESD) was developed to allow en bloc resection of colorectal neoplasm. Although colorectal ESD has been widely accepted as a minimally invasive treatment option for early colorectal neoplasm, post-ESD bleeding is one of the major adverse events. After ESD procedure, endoscopists close the defects with devices to prevent complications. A novel endoscopic barbed-clips suturing has been developed to simplify endoscopic closure. In this study, the endoscopic barbed-clips will be evaluated when closing defects in the colon after ESD.

Endoscopic submucosal dissection (ESD) has emerged as a new endoscopic technique that allows en-bloc resection of GI lesions, irrespective of size. The most common complications of the ESD techniques are bleeding and perforation. Several reports have shown that if prophylactic closure of a mucosal defect with clips would reduce the risk of bleeding following endoscopic intervention by ESD. With the advancements in endoscopic therapy, various techniques for prevention of post-ESD complications have been reported. However, there have some limitations including their inability to close large defects and the complexity of the approaches and the need for expensive equipment to complete the procedure. To address these issues, we have devised a novel endoscopic barbed-clips suturing method for mucosal defect closure after endoscopic submucosal dissection of colon. In this study, we assessed the technical feasibility of this novel technique.

Eligibility Criteria:
Inclusion Criteria:

* aged≥20 years with a single clinically or histologically diagnosed colorectal lesions of 20-50mm eligible for which fulfilled criteria for ESD;

Exclusion Criteria:

* Patients with coagulopathy (platelet count \< 5 × 10\*4, prothrombin time international normalized ratio \> 2,
* medical conditions requiring the continuous use of antithrombotic agents
* prior abdominal surgery or radiation.
Telemonitoring Impact by the ApTelecare Software in Dialysis Patient

The investigators proposed to conduct a retrospective study to evaluate the impact of the implementation of apTeleCare software on the management of dialysis patients at home in terms of the number and duration of hospitalizations. For this purpose, the investigators will compare patients' data over a 2-year interval before the introduction of Telemonitoring (January 2012 and December 2013 inclusive - Group 1) with patients data who have benefited from this application (between August 2016 and July 2018).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥ 18 years) with no age limit;
* Patients receiving peritoneal dialysis on the investigation center between 2012 and 2014 (Group1) and between 2016 and 2018 (Group 2);
* Patient information in this retrospective study;

Exclusion Criteria:

* Patients who have started a peritoneal dialysis program before the periods of investigation;
* Patients who have been equipped with apTeleCare during the dialysis program;
* Subject under guardianship, curators or safeguard of justice;
* Patient not affiliated to a French social protection;
A Phase 2 Study of Vosoritide in Children with Idiopathic Short Stature

The purpose of this study is to evaluate i) the effect of multiple doses of vosoritide and ii) the effect of the therapeutic dose of vosoritide compared to human growth hormone (hGH), in children with idiopathic short stature (ISS).

Following a minimum 6 month observational period in which baseline growth is assessed, participants in the vosoritide and placebo groups will complete a minimum of 6 months of randomized treatment (maximum of 6 months of placebo treatment), followed by open-label treatment with vosoritide until they reach near-final adult height, or at least 16 years of age for females or 18 years of age for males, whichever comes later. Participants randomized to the hGH group will receive open-label hGH for a minimum of 4 years.

Eligibility Criteria:
Key Inclusion Criteria:

1. Height assessment corresponding to a height Z-score of ≤ -2.25 SDs in reference to the general population of the same age and sex, as calculated using the Centers for Disease Control and Prevention (CDC) growth charts
2. Tanner Stage 1, at time of signing the ICF (unless too young to stage).

Key Exclusions:

1. Known chromosomal imbalance or genetic variant causing short stature syndrome, including but not limited to Laron syndrome, Prader-Willi syndrome, Russell-Silver Syndrome, Turner syndrome, disproportionate skeletal dysplasias, abnormal SHOX gene analysis, or Rasopathy (including Noonan syndrome)
2. Previous treatment with a growth promoting agent
Sphenopalatine Block or Epidural Bloodpatch for Post Dural Puncture Headache: Randomized Controlled Trial

Introduction: Recently sphenopalatine block emerged as an alternative to epidural blood patch for post dural puncture headache but the investigators do not know if it has significant efficacy when compared to epidural blood patch. Method: randomized trial where patients will randomly receive either sphenopalatine block or epidural blood patch. Pain relief to no pain or low intensity pain will be the main outcome

Introduction: Recently sphenopalatine block emerged as an alternative to epidural blood patch for post dural puncture headache but the investigators do not know if it has significant efficacy when compared to epidural blood patch. Method: randomized clinical trial where patients with moderate to severe post dural puncture pain will randomly receive either sphenopalatine block or epidural blood patch. Pain relief to no pain or low intensity pain will be the main outcome. Pain recurrence, survival without pain and side effects (tinitus, low back pain, new dural puncture, sore throat) will be secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic criteria for post dural puncture headache
* Moderate to severe post dural puncture headache

Exclusion Criteria:

* Procedure failures: new dural puncture on epidural blood patch trial, unable to find epidural space, intolerance to insertion of nasal swabs.
* Follow up loss
Seroprevalence of Bordetella Pertussis Antibodies and Anti-pertussis Antibody Response After a Single Dose of Tdap in Pregnant Thai Women

This study evaluated the seroprevalence of Bordetella pertussis antibodies and anti-pertussis antibody response after a single dose of reduced-antigen, combined diphtheria, tetanus, and acellular pertussis vaccine (Tdap) in pregnant Thai women.

All seronegative participants received Tdap, while seropositive participants were equally randomized into 2 groups. Half of seropositive participants received Tdap and the other half received tetanus-diphtheria (Td) as standard protocol.

The primary objective of this study was to determine the seroprevalence of anti-pertussis toxin antibodies (anti-PT IgG) among pregnant Thai women. The secondary objectives were to evaluate antibody response after Tdap vaccination between seronegative and seropositive participants and to compare the different antibody titers at delivery among seropositive participants who received Tdap to those who received tetanus-diphtheria vaccine (Td). The sample size calculation was based on the primary objective. Randomized clinical trial was performed for the latter secondary objective.

Eligibility Criteria:
Inclusion Criteria:

* Thai pregnant women age at least 18 years
* No known underlying disease
* Singleton pregnancy without maternal or fetal complications
* Gestational age not more than 20 weeks at the time of recruitment
* Desired for delivery at Siriraj Hospital

Exclusion Criteria:

* Pregnant women who have any contraindication to Tdap vaccine including

  1. History of serious allergic reaction to any components of Tdap vaccine
  2. History of seizure or coma after receiving Tdap vaccine in childhood
  3. Having an underlying disease involving central nervous system (e.g., epilepsy, Guillain-Barré syndrome)
* History of serious reactions after receiving Tdap vaccine (e.g., severe pain, severe swelling at the injection site)
* Recently had Tdap vaccine injection
* Denied for Tdap vaccine injection
S&P of Q-Fix™ All-Suture Anchor System

Post-market clinical follow-up needed to address existing clinical data and gaps on the existing Q-Fix™ device and meet existing MDD/MEDDEV requirements


Eligibility Criteria:
Inclusion Criteria:

* Subject has undergone arthroscopic or open soft tissue repair with Q-Fix™ All-Suture Anchor System
* Subject was ≥ 13 of age at time of surgery

Exclusion Criteria:

* Subject is ≤ 6 months post-operative
* Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 12 months post-operative.
Oral Paracetamol Premedication Effect on Maternal Pain in Amniocentesis

This randomized controlled trial, compares perioperative and postoperative pain score by using visual analog scale in pregnant women undergoing amniocentesis. The experimental group will be given oral paracetamol premedication whereas the controlled group will be given oral placebo premedication.

Perioperative and postoperative amniocentesis are often painful which cause concerns to those who has to undergo amniocentesis. Anxiety is one of the factor that may prolong operative time, resulting in an increase risk of complication from the procedure. Furthermore, pregnant women, in order to relief the pain, might require others drugs, which has both maternal and fetal side effect. So In conclusion, this study aims to compare efficacy of oral paracetamol premedication and oral placebo premedication by using visual analog scale to evaluate pain.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnant women undergo amniocentesis for the first time at Rajavithi Hospital in 2016-2017

Exclusion Criteria:

* Pregnant women with psychiatric disorder
* Contraindicated to paracetamol
* Pregnant women undergoing amniocentesis due to fetal anomaly
* Take oral paracetamol or other analgesics within 24-48 hrs before operation
* Deny to participate the research
Ultrasonography in Diagnosis of Polyneuropathy

The main goal of this trial is to establish recommendations for clinical practice that enhance the reliability, accessibility and convenience of sheer wave elastography as a routine diagnostic test for diverse peripheral neuropathies.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years
* Clinical signs of particular polyneuropathy not explained by other causes

Exclusion Criteria:

* Entrapment or compression neuropathies
* Nerve trauma
* The diagnosis of vasculitic neuropathy, neuralgic amyotrophy, diabetic radiculo-plexo-neuropathy, hereditary neuropathy with liability to pressure palsies and motor neuron disorders including monomelic amyotrophy.
Anesthesia With Endotracheal Laser Tube

The study examines the special endotracheal laser tube during anesthesia of endolaryngeal laser surgery.

The special endotracheal tube is covered by a special aluminum tape.

Eligibility Criteria:
Inclusion Criteria:

* laser surgery

Exclusion Criteria:

* allergy of propofol
Apple Heart & Movement Study

This study will look for factors that affect heart health and potentially cause deterioration in mobility or heart function. Participant's Apple Watch and iPhone can help researchers gain a better understanding of potential early warning signs. This can lead to new interventions and products that will help millions lead longer, healthier, and more active lives.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years old (at least 19 years old in Alabama and Nebraska, at least 21 years old in Puerto Rico);
* Live in the United States of America;
* Have an iPhone;
* Have an Apple Watch (Series 1 or later) at the time of enrollment;
* Have the Apple Research app installed on your iPhone;
* Be comfortable communicating in written and spoken English;
* Not share your iCloud account, iPhone, or Apple Watch with anyone else;
* Be willing and able to provide informed consent to participate in the study.
A Test and Treat Strategy in New HIV Diagnosis.

This is an open-label, single arm, single-centre prospective study to evaluate the feasibility, efficacy and safety of a once daily fixed dose combination regimen, Biktarvy, as a rapid treatment strategy in newly HIV diagnosed patients that come for the first time to the Hospital Clínic HIV Unit Patients with confirmed HIV-1 diagnosis who wish to start ARV treatment immediately will receive bictegravir 50 mg + emtricitabine 200 mg + tenofovir alafenamide 25 mg within the first week since the HIV-1 confirmation during 48 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old.
2. Having confirmed HIV-1 positive test.
3. Patients not previously treated with antiretroviral treatment (post-exposure prophylaxis will be allowed if not done in the previous 6 months).
4. Clinically stable patients, in the opinion of the investigator, at the time of inclusion.
5. Women of child-bearing potential\* must have a negative pregnancy test in urine before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include: hormonal contraceptive methods intrauterine device, bilateral tubal occlusion, vasectomized partner or sexual abstinence.
6. Written informed consent.

Exclusion Criteria:

1. Pregnant or breastfeeding women at the time of the study inclusion or anticipating pregnancy during the follow-up period.
2. Suspicion of an active opportunistic infection that defers initiating antiretroviral treatment \> 7 days since HIV confirmation.
3. Known hypersensitivity or intolerance of any of the components of Biktarvy®.
4. Patients on treatment with any prohibited medication (see section 5.2: Concomitant, nonpermitted and permitted medication).
5. Any condition which, in the opinion of the principal investigator, may interfere with adequate understanding, cooperation or compliance with the study.
Sugammadex Given for the Reversal of Rocuronium Induced Neuromuscular Blockade Under Sevoflurane Anesthesia in Infants

The objective of this study is to evaluate the efficacy and safety of sugammadex in reversing profound neuromuscular block induced by rocuronium in infant patients


Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 1-12 month,
* ASA physical status 1-3 who underwent elective brain cancer surgery during general anesthesia were included in the study

Exclusion Criteria:

* younger than 1month or older than 12 months.
* hepatic or renal failure
* A history of allergy to study medication
Universal CAR-γδT Cell Injection in the AML Patients

To evaluate the safety of general-purpose CAR-γδT cells in patients with refractory post-transplant relapsed AML.

To evaluate the efficacy and in vivo dynamics of general-purpose CAR-γδT cells in the treatment of refractory relapsed AML patients, and to explore the appropriate therapeutic dose and delivery mode.

Eligibility Criteria:
Inclusion Criteria:

* The clinical diagnosis was difficult to treat recurrent acute myeloid leukemia；
* Flow cytometry (FCM) or immunohistochemistry of tumor\~ cells confirmed positive expression of CD123；
* 18 years old ≤ age ≤70 years old;
* The expected survival from the date of informed consent is more than 3 months;
* ECOG≤2;
* The functions of vital organs shall meet the following conditions:

  1) EF\>50%, and no obvious ECG abnormality; 2) SpO2 90% or more; 3) Cr 2.5 ULN or less; 4) ALT And AST≤5ULN, TBil≤3ULN;
* Subjects who plan to become pregnant must agree before study enrollment and after study duration of 6 months Use contraception; Inform the investigator immediately if the subject is pregnant or suspected to be pregnant;
* Subject or guardian understands and signs the informed consent.

Exclusion Criteria:

* Other diseases that have not been effectively controlled, including but not limited to persistent or poorly controlled infections and diseases Congestive heart failure, unstable angina pectoris, arrhythmias, poorly controlled lung disease Or mental illness;
* Other active malignant tumors;
* Complicated with severe infection that cannot be effectively controlled;
* Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive, peripheral blood hepatitis B virus (HBV)DNA higher than the detection limit should be excluded; If hepatitis C virus (HCV) antibody positive, peripheral blood HCV RNA positive need to be eliminated; Cytomegalovirus (CMV)DNA positive; Epstein-barr virus DNA in peripheral blood was positive;
* Human immunodeficiency virus (HIV) infection or syphilis infection;
* Have a history of severe allergy to biological products (including antibiotics);
* Acute graft-versus-host reaction (GVHD) was still present one month after discontinuation of immunosuppressant therapy Allogeneic hematopoietic stem cell transplantation patients;
* Female subjects are in pregnancy and lactation;
* Active autoimmune diseases requiring systemic immunosuppression;
* Conditions that the investigator believes may increase the risk of the subject or interfere with the results of the test;
Neutrophil Gelatinase-Associated Lipcalin (NGAL) Evaluation Along With B-Type Natriuretic Peptide in Acutely Decompensated HF

This is a multi-center prospective pilot clinical study to assess the utility of the Triage NGAL Test - alone and in conjunction with the Triage BNP test - as an aid in the early risk assessment for heart-failure-related adverse clinical outcomes (deaths, readmissions, and additional emergent outpatient visits) through Day 30 and Day 90 in patients presenting with acutely decompensated heart failure (HF). Its utility as an aid in the early risk assessment for renal dysfunction in patients with acutely decompensated heart failure undergoing treatment with IV diuretics will also be assessed.

Approximately 200 adults presenting to the Emergency Department (ED) / hospital with acutely decompensated HF will be enrolled. EDTA anti-coagulated blood samples will be collected for measurement of blood NGAL levels (using the Triage NGAL Test) at the point of care in all subjects at up to 8 different time points from presentation until discharge.

The results of these NGAL assessments will be blinded to the medical team during the study and will not impact the medical management of the subject.

Blood samples for unblinded assessment of both serum creatinine (analyzed at the hospital's laboratory) and whole blood BNP (analyzed with the Triage BNP Test at the point-of-care or laboratory) will also be obtained at some of the same time points.

Dialysis, emergent outpatient visits for HF, hospitalizations and mortality will be recorded through Day 30 and Day 90. If an additional serum creatinine has been obtained as standard care near Day 30, it will also be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Males and females 18 years of age or older;
* Patients presenting to the emergency department / hospital with symptoms of new or decompensated heart failure and who will be treated with at least one dose of IV diuretic;
* Ability to draw blood samples for baseline NGAL, BNP and creatinine levels either prior to the administration of the first dose of IV diuretic or within 1 hour after the first dose of an IV diuretic
* Ability to provide written informed consent from subject or their authorized representative.

Exclusion Criteria:

* Acute myocardial infarction or active ischemia;
* Patients who are intubated or otherwise not able to communicate or comply with study assessments;
* Cardiogenic shock or any other clinical condition that would contraindicate the administration of an IV agent with potent vasodilating properties;
* Known history of marked renal insufficiency (e.g., usual serum creatinine ≥ 3.0 mg/dL), on dialysis (either acute of chronic) or in imminent need of dialysis at enrollment;
* Prisoners or other institutionalized or vulnerable individuals;
* Participation in an interventional clinical study within the previous 30 days;
* Unlikely to be willing or able to comply with study procedures, including the follow-up at 30 and 90 days .