cyrilzakka/clinical-trials huggingface dataset:
Endoscopic Treatment of Non-variceal Upper GI-bleeding With High Risk of Recurrency - OTSC (Over-the-scope-clip) Versus Standard Therapy (STING2)

Prospective-randomized multi-center trial. Patients with high risk of recurrent GI-bleeding (non-variceal) are identified and randomized into either endoscopic treatment with the OTSC \[Over The Scope Clip\] or endoscopic standard therapy. Hypothesis: Endoscopic therapy with OTSC is superior to standard therapy regarding technical success and rebleeding.

Prospective-randomized multi-center trial. Patients with high risk of recurrent GI-bleeding (non-variceal) are identified (Rockall Score \> 6) and randomized into either endoscopic treatment with the OTSC \[Over The Scope Clip\] or endoscopic standard therapy. 100 Patients are planned. Hypothesis: Endoscopic therapy with OTSC is superior to standard therapy regarding technical success and rebleeding.

Eligibility Criteria:
Inclusion Criteria:

* upper GI-bleeding (non-variceal) with high risk of recurrency
* 18 years and older

Exclusion Criteria:

* variceal-bleeding
* under 18 years
* pregnancy or nursing period
* malignancy
* need for surgical treatment (for example perforation with peritonitis)
Prehabilitation for Aortic Repair Patients

This is a 2-group study comparing the effect of a "prehabilitation" program to usual care on quality of life and clinical outcomes in patients undergoing elective repair of their thoracic aorta.

Patients undergoing elective repair of their thoracic aortic aneurysm will be randomized to a "prehabilitation" program prior to their surgery or to usual care. The prehabilitation program is self-directed program designed to improve health and quality of life prior to surgery. The program is currently offered to general surgery patients; this study will examine the feasibility and acceptability of such a program in a different patient population.

Eligibility Criteria:
Inclusion Criteria:

* Age 21 years or older
* Diagnosis of thoracic aortic disease with scheduled repair
* Medical clearance from cardiothoracic surgeon
* Ability to provide informed consent
* Regular use of a smartphone or personal computer

Exclusion Criteria:

* Conditions that limit walking to a severe degree
* Current participation in regular physical activity program
* Acute aortic dissection
* Recent coronary artery disease events
* Inability to speak and read English
Liquid Biopsy in Monitoring the Therapeutic Efficacy of Targeted Therapy in Advanced/Metastatic Gastric Cancer

To evaluate the clinical significance of cell free DNA (cfDNA) and circulating tumor cells (CTCs) in real-time monitoring the therapeutic response during HER2-targeted therapy in histologically confirmed HER2 positive advanced/metastatic gastric cancer.

The study is a single-center, prospective study undertaken in anticipated 124 patients with both histologically HER2 positive and negative advanced/metastatic gastric cancer. Peripheral blood samples of 12.5 mL were collected from the patients for cfDNA and CTCs analysis. The blood samples will be respectively drawn before therapy, at the time that the patients achieve the optimal response and when they suffer progressive disease. The enumeration of CTCs as well as the detection of HER2 expression will be achieved via the integrated subtraction enrichment (SET) and immunostaining-fluorescence in situ hybridization (iFISH) platform. Further, for the geneomic analysis, the enriched single CTC will be isolated for single-cell targeted sequencing. While for cfDNA analysis, extracted DNA from plasma will be directly subjected to targeted sequencing. The correlation of the HER2 status on CTCs and the HER2 amplification in cfDNA to the therapeutic response will be evaluated. Moreover, gene variations associated with resistance in HER2-targeted therapy will be also studied based on the genomic data from sequencing of CTC and cfDNA.

Eligibility Criteria:
Inclusion Criteria:

* Having signed informed consent
* Age≥ 18 years old
* Histologically confirmed HER2 positive gastric adenocarcinoma
* Unresectable recurrent or metastatic disease
* Measurable disease according to the RECIST criteria
* Karnofsky performance status ≥60
* Life expectancy of ≥2 month
* ALT and AST\<2.5 times ULN (≤5 times ULN in patients with liver metastases)
* Serum albumin level ≥3.0g/dL
* Serum AKP \< 2.5 times ULN
* Serum creatinine \<ULN, and CCr \< 60ml/min
* Bilirubin level \< 1.5 ULN
* WBC\>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet\>100,000/mm3, Hb\>9g/dl

Exclusion Criteria:

* Brain metastasis (known or suspected)
* Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry. Contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on.
* Allergic constitution or allergic history to protium biologic product or any investigating agents.
* Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension.
* Pregnancy or lactation period
* Other previous malignancy within 5 year, except non-melanoma skin cancer
* Pre-existing neuropathy\>grade 1
* Legal incapacity
Bioequivalence And Lack Of Food Effects Of 300mg Lamotrigine XR

This study intends to demonstrate bioequivalence and lack of food effect on 300mg lamotrigine XR in healthy male and female volunteers


Eligibility Criteria:
Inclusion Criteria:

* Body weight \>50 kg (males) or \>45 kg (females) and BMI within the range 19 - 29.9 kg/m2 inclusive.
* Healthy as determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests, vital signs and ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator considers that the finding will not introduce additional risk factors and will not interfere with the study procedures.

Exclusion Criteria:

* Female subjects of childbearing potential will not be eligible to participate who are unwilling or unable to use an appropriate method of contraception as outlined in the inclusion criteria from at least the commencement of their last normal period prior to the first dose of study medication; and to continue until the first normal period (defined as normal for the woman, both in terms of duration and quantity of menses) after treatment or 5 half lives of the study medication, whichever is the longest.
* Female subject is pregnant (positive serum human chorionic gonadotrophin (hCG) test at screening) or lactating.
* Female subjects using hormonal contraceptive precautions including progesterone-coated IUD
* Female subjects using hormonal replacement therapy.
* Subjects who received lamotrigine in a previous study (subjects who received placebo will be allowed).
* Current smokers of 10 or more cigarettes per day.
Caudal Block for Inguinal Hernioplasty in Children

This is a prospective, randomized, controlled clinical study designed to determine the effectiveness of caudal block combined with general anesthesia in providing intra- and postoperative analgesia, and its effect on hemodynamic stability and drug consumption.

This prospective, randomized, controlled clinical study will include 70 boys aged 3-5 years scheduled for inguinal herniorrhaphy. Participants will be randomized in 1:1 ratio into two groups. The first group will receive general anesthesia for surgery, while the second group will receive general anesthesia in combination with caudal block. Postoperative pain, hemodynamic parameters and total consumption of all medicaments in the perioperative period will be monitored. Complications and side effects of drugs will be observed as well.

Eligibility Criteria:
Inclusion Criteria:

* boys between 3 to 5 years old
* scheduled for elective inguinal hernioplasty
* without comorbidities and chronic therapy, ASA class I
* body mass and growth normal for the given age
* no allergies
* no congenital anomalies and birth complications

Exclusion Criteria:

* emergency surgeries
* surgeries longer than 60 minutes
* acute infections with leucocytosis/leucopenia
* acute or chronic diseases
* deformities and disorders of spine and nervous system
* allergies
* pilonidal cyst and/or inflammation in sacral region
IMS-treatment and Canalis Carpi Syndrome

Carpal tunnel syndrome is a condition in which the median nerve is compressed at the wrist, leading to paresthesias, numbness and muscle weakness in the hand. Treatment of the condition often involves surgery.

In this study we wish to se if there is an effect of using intramuscular stimulation (IMS) to release the tension of nervus medianus in the lower arm. The study will be performed by randomization to IMS of musculus pronator teres or a control ("Scam IMS treatment" to the acupuncture point Li11). The two insertion points are approximately 1cm apart in the lower arm.

The most important outcome measure is ultra sound measured diameters for nervus medianus in the carpal tunnel

Eligibility Criteria:
Inclusion Criteria:

* Canalis Carpi Syndrome verified by ultrasound and clinically
* Both genders
* Age from 18 to 67

Exclusion Criteria:

* Negative neurophysiology result.
* Epilepsy,
* Heart disease,
* Rheumatism
* Unstable angina pectoris,
* Metal -allergy,
* Needle- phobia,
* Infection
* Hemophilia
* Cognitive problems
Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics After Intravenous DWJ1521 Administration in Healthy Adult Volunteers

The safety/tolerability and pharmacokinetic properties of DWJ1521 are evaluated after single intravenous administration of DWJ1521 in healthy adults.

The safety/tolerability and pharmacokinetic properties of DWJ1521 single intravenous administration and DWP14012 single oral administration in healthy adults are compared.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults aged 19 to 50 years old at the time of screening test
2. Those who weigh 55.0 kg or more and 90.0 kg or less at the time of the screening test and have a body mass index (BMI) of 18.0 or more and 28.0 or less ☞ BMI(kg/m2) = weight(kg) / {height(m)}2

Exclusion Criteria:

1. Clinically significant, liver, kidney, nervous system, immune system, respiratory system, endocrine system, etc., or blood or tumor disease, cardiovascular disease, mental disease (mood disorder, obsessive-compulsive disorder, etc.) or have a history of character
2. Those with a history of gastrointestinal diseases (gastrointestinal ulcers, gastritis, gastric cramps, gastroesophageal reflux disease, Crohn's disease, etc.) that may affect the safety and pharmacokinetics evaluation of investigational drugs, and those with a history of gastrointestinal surgery (However, simple appendic surgery and hernia surgery are excluded)
3. Those who were tested positive for Helicobacter pylori
4. serologic test results (hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test) positive
5. Those whose blood AST and ALT exceeds 1.5 times the upper limit of the normal range in screening tests including additional tests.
VP3: Vancouver Primary Prevention Program (Anxiety Disorders Prevention in School Children)

Objective:

1. To evaluate the efficacy of a school-based cognitive behavior therapy (CBT) program in reducing anxiety disorder symptoms in at-risk public school children.
2. To determine whether parent education and involvement improves outcome in anxious children treated with CBT.
3. To determine the ability of school personnel in a) recognizing classroom behaviors as anxiety disordered after targeting training of observable child behaviors e.g., avoidance, over-worry, etc.), and b) delivering a cognitive behavior intervention and
4. To evaluate a new measure of teacher-rated anxiety disorder symptoms in children.

Hypothesis:

1. A CBT oriented intervention as delivered by school personnel will be superior to an attention control procedure in reducing anxiety symptoms in at-risk children.
2. Children who have parental involvement will post stronger and more enduring treatment gains.


Eligibility Criteria:
Inclusion Criteria:

Children enrolled in school between the ages of 7 and 13 who display anxiety symptoms.

1. Anxiety disorder symptoms (identified by a score of 56 or higher on the MASC; and teacher report, and /or parent recommendation) as the primary presenting problem. An enrolled child must have at least 2 of these criterions.
2. Fluency in English.
3. Parent willingness to sign consent form and to complete required assessments.
4. Student willingness to participate (child assent) in 10-week affective education program and completion of required assessments.

Exclusion Criteria:
Cultural Adaptation of a SSI for Youth Anxiety

The overarching objective of this protocol is to (1) adapt and (2) disseminate an evidence-based, brief (approximately 30 minute) single session intervention (SSI) to better reflect the cultural and linguistic diversity of Latin, Haitian, and Haitian-American individuals via a fully online platform.


Eligibility Criteria:
Inclusion Criteria:

1. Be caregivers (e.g. biological or adoptive parent, or legal guardian) of a child age 4-10.
2. Affirm that they have read the consent language and study overview on REDCap by checking a box.

Exclusion Criteria:

- Not meet all of the inclusion criteria.
Evaluation of Patient Satisfaction in Hepatitis C Patients Treated With PegIntron Pen and Rebetol in Romania (Study P04301)

The objective of this study is to evaluate patient satisfaction in hepatitis C patients receiving PegIntron pen plus Rebetol. The rationale is that the effectiveness of treatment is correlated with adherence to the prescribed regimen which, in turn, is affected by the ease of use and accuracy of treatment administration. Since the PegIntron pen is a novel device, the results of this study will be used to improve the training of patients and healthcare providers in PegIntron pen use.


Eligibility Criteria:
Inclusion Criteria:

* Patients with hepatitis C under treatment with PegIntron Pen and Rebetol in Romania.

Exclusion Criteria:

* Not applicable
Response of FeNO, Small Airway Dysfunction and Lung Heterogeneity to 2-week Montelukast Treatment in Asthmatic Children.

This study aims to identify markers to prove rapid improvement of lung function, airway inflammation and bronchodilator response after 2-week LTRA administration.

This study is a randomized, double-blind, placebo-controlled, cross-over study with a washout period of at least one week between each study period.

After an initial screening visit, subjects entered a screening period of one to two weeks to ensure clinical stability without medication, which means absence of daily asthma symptoms. Eligible subjects were randomized into either the treatment portion of the trial, in which subjects received montelukast (4 mg or 5 mg) or matching placebo monotherapy in a randomized manner. During each treatment period, which lasted 2 weeks, the study medication was administered between 8:00 and 9:00 A.M. Short acting bronchodilator (for severe symptoms) was permitted during the study period but was withheld 24 hours prior to bronchodilator challenge test.

Inclusion criteria will be mild persistent asthma children old enough to cooperate on performing pulmonary function testing, children with no respiratory symptoms 4 weeks prior to the beginning of the study. Exclusion criteria will be the following: respiratory symptoms including cough, wheezing, dyspnea, or shortness of breath, presence of acute or chronic upper respiratory infections, anatomical nasal disorders (ex, nasal polyps, septum deviation, etc.), previous or current specific immunotherapy, use of systemic corticosteroids, or admission or visit of the emergency department during the previous 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* children diagnosed with mild persistent asthma patients based on the GINA guidelines
* children old enough to cooperate in performing pulmonary function testing
* legal guardians who sufficiently listen to the purpose and voluntarily agree with the participation to sign a written consent approved by IRB
* children with no respiratory symptoms 4 weeks prior to the beginning of the study
* children without chronic respiratory symptoms.

Exclusion Criteria:

* presence of acute or chronic upper respiratory infections, anatomical nasal disorders (ex, nasal polyps, septum deviation, etc.), previous or current specific immunotherapy.
* use of systemic corticosteroids in past 4 weeks.
* admission or visit of the emergency department in past 4 weeks.
Spectro-IRM and Evaluation Response to Prostatic Radiotherapy

Context:

Prostate cancer is the most common non-cutaneous cancer and the second most common cause of cancer-related deaths in European and North-American men.

After external radiotherapy or brachytherapy, the Prostate Specific Antigen (PSA) value is often fluctuating and PSA nadir may only be reached after 2 years or more and may remain detectable several years after the completion of radiation. Moreover, PSA bounces and blips render patients and physicians very anxious about any possibility of a relapse. In this context, biomarkers that could predict the response to radiation earlier than PSA for patients with prostate cancer appear long overdue.

Magnetic Resonance Spectroscopy at 3 Tesla without endorectal coil is a non invasive procedure which allows quantification of metabolites such as Choline, Creatine, Polyamines and Citrate within the prostate gland.

Objectives:

The investigators are conducting a French prospective study on the Evaluation of the Response to Irradiation with MR Spectroscopy (ERIS). Their purpose is to monitor the early response of radiation with 3D MR Spectroscopy during the first year after completion of radiation and its impact on biochemical control. Therefore, the ERIS trial aims to investigate whether or not there could be a correlation between the time course of PSA and that of Choline and Citrate.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with a biopsy-proven prostatic adenocarcinoma
2. Gleason score between 4 and 10
3. Maximal baseline PSA \< 50 ng/ml
4. Age over or = to 18 yr
5. Exclusive radiotherapy and/or brachytherapy with or without androgen deprivation therapy
6. Written informed consent from the patient

Exclusion Criteria:

1. lymph-node metastases
2. Bone metastases
3. Maximal baseline PSA ≥ 50 ng/ml
4. Prior radical prostatectomy
5. Contra-indications for MRI (Pace-maker, hip prothesis...)
Impact of Dural Puncture Epidural Versus Traditional Lumbar Epidural on Onset of Labor Analgesia

This study is to examine the onset of pain relief with two different methods of labor epidural. The traditional labor epidural involves the placement of numbing and anti-pain medicine in the epidural space which surrounds the spinal cord. In order to take effect, the medication has to cross a layer of tissue called the dura. In the current study, the same medications are placed in the epidural space after the dura is punctured with a fine needle. This research, will help evaluate whether this technique will result in earlier onset of pain relief.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant patients in active painful labor
* ASA I and II parturients
* Women Ages 18+ to 40
* Patients who have labor epidural as part of their labor plan will be recruited

Exclusion Criteria:

* Patients admitted to the Labor and Delivery Suite who are committed to have a delivery with the current admission but who do not want a labor epidural
* Patients with the following: bleeding disorders, infection at the site of epidural placement, generalized sepsis, stenotic heart valve lesions, increased intracranial pressure, patients with hypovolemia, and patient refusal
* Parturients with chronic pain syndromes
* Patients on MAO inhibitors
* Patients with allergies to bupivacaine and fentanyl (and other amide local anesthetics) patients with substance abuse history will be excluded
* Non English-speaking patients will be excluded
Salpingectomy Versus Aspiration of Hydrosalpingeal Fluid Prior to IVF-ET

The aim of this randomized controlled trial is to compare the efficacy of ultrasound guided aspiration of hydrosalpingeal fluid with salpingectomy in the management patients with ultrasound visible hydrosalpinges undergoing IVF-ET.

The adverse impact of hydrosalpinx on in vitro fertilisation embryo transfer (IVF-ET) outcomes has been confirmed by several retrospective and prospective studies .

Cochrane review of prospective randomised trials of laparoscopic salpingectomy confirmed the beneficial effect of laparoscopic salpingectomy on IVF-ET outcomes in patients with hydrosalpinges.

Surgery is not usually safe especially in patients with extensive adhesions, morbid obesity or previous multiple laparotomies. Furthermore, many infertile couples refuse to undergo bilateral salpingectomy or proximal tubal occlusion because these procedures remove any hope of spontaneous pregnancy. Other less invasive options for patients with hydrosalpinges as ultrasound-guided aspiration of hydrosalpingeal fluid, antibiotics (alone or combined with aspiration) and hysteroscopic occlusion of fallopian tube were studied in order to find an alternative to salpingectomy . Although these methods are simple and getting popular, current data are inadequate to recommend these treatment options instead of salpingectomy because most of the supporting evidences for these methods come from small retrospective studies.

A recent randomized controlled trial revealed that the aspiration of hydrosalpingeal fluid at the time of oocyte retrieval was associated with improved implantation rate and pregnancy rates.

The aim of this randomized controlled trial is to compare the efficacy of ultrasound guided aspiration of hydrosalpingeal fluid with salpingectomy in the management patients with ultrasound visible hydrosalpinges undergoing IVF-ET

Eligibility Criteria:
Inclusion Criteria:

* Patients with unilateral or bilateral hydrosalpinges visible by ultrasound
* Age between 18 - 37 years
* Period of infertility \> 1 year
* Body mass index between 19-29
* Normal basal luteinizing hormone (LH), follicle stimulating hormone (FSH) and prolactin concentrations.
* Normal recent semen analysis (according to World Health Organization criteria).

Exclusion Criteria:

* Uterine fibroid requiring surgical removal.
* Endometriosis.
* Male factor of infertility requiring ICSI, Previous IVF cycles.
* History of recurrent miscarriage.
* Endocrinologic disorders.
* Presence of systemic disease contraindicating pregnancy.