cyrilzakka/clinical-trials huggingface dataset:
Effect of the French Version If the Metagognitive Bibliotherapy Program "MYMCT" on Obsessive-compulsive Symptoms

Obsessive-compulsive disorder (OCD) is a psychiatric illness characterized by the presence of obsessions and/or compulsions. Without effective treatment, symptoms tend to worsen and become chronic. International guidelines recommend medication and/or psychotherapy as the first-line treatment for OCD. However, the majority of sufferers remain undertreated worldwide. This lack of access to care worsened during the Covid-19 pandemic. Much of this suffering could be avoided by facilitating access to evidence-based therapies. As such, many distance therapeutic interventions have recently developed, such as bibliotherapy. These unguided self-help programs are mostly based on approaches derived from cognitive behavioral therapies (CBTs). Specialized metacognition bibliotherapy is more specifically based on the hypothesis of a cognitive meta-level that affects off-line knowledge and on-line self-regulatory behaviors.

Yet, the majority of OCD sufferers are reported to exhibit inadequate metacognitive processing. Although these metacognitive abilities are often neglected in the OCD literature, they appear to play a significant causal role in the onset and maintenance of obsessive-compulsive symptoms. As a result, OCD-specific metacognitive treatments need to be developed to reduce symptomatology and improve quality of life for these patients. To date and to our knowledge, there is only one validated metacognitive bibliotherapeutic program for OCD. This manual is called "MyMCT: My MetaCognitive Training". A recent meta-analysis confirms its effectiveness with 373 participants from Germany, Switzerland and Russia in reducing obsessions and compulsions. Although these results are promising, MyMCT did not exist in a French version until 2021. Our team then translated the manual on a not-for-profit basis, and an independent translator at Nice University Hospital confirmed that it faithfully transcribed the meaning of the English version. This version has been freely available since November 2021 on the website of the Department of Psychiatry and Psychotherapy at Hamburg-Eppendorf University Medical Center (https://clinical-neuropsychology.de/metacognitive-training-for-ocd-mymct/).

The investigator propose to carry out a single-center randomized controlled research protocol concerning the effects of the French version of MyMCT in OCD patients. This clinical trial will be carried out́ in collaboration with Professor Moritz, author of MyMCT and renowned researcher.


Eligibility Criteria:
Inclusion Criteria:

* With OCD diagnosed by a psychiatrist,
* Unchanged psychiatric medication over the past 3 months,
* Have a good command of the French language,

Exclusion Criteria:

* Person with a psychotic or bipolar comorbidity diagnosed by a psychiatric physician
* Person participating simultaneously in another clinical trial interfering with the results of the present study
Automatic Differentiation of Innocent and Pathologic Murmurs in Pediatrics

The purpose of this preliminary clinical study is to assess the quality of a computational algorithm that automatically classifies murmurs of phonocardiograms (PCGs) as either pathologic (AHA class I) or as no- or innocent (AHA class III) in the pediatric population.

Each patient is auscultated and diagnosed independently by a medical specialist by means of a standard mechanical stethoscope. Additionally, for each patient, a PCG is recorded using a Littmann 3200 electronic stethoscope and later analyzed using the computational algorithm. An echocardiogram is performed as the gold-standard for determining heart pathologies. The results of the computer aided auscultation (CAA) are compared to the findings of the medical professionals as well as to the echocardiogram findings.

Hypothesis: The specific CAA algorithms used in this study are able to differentiate pathologic (AHA class I) from no- or innocent murmurs (AHA class III) in a pediatric population.

Background:

Computer aided auscultation in the differentiation of pathologic (AHA class I) from no- or innocent murmurs (AHA class III) would be of great value to the general practitioner and potentially also to the specialist. This would allow objective screening for structural heart disease, standardized documentation of auscultation findings, and may avoid unnecessary referrals to pediatric cardiologists. Our goal was to further develop and assess the quality of a novel computational algorithm that automatically classifies murmurs of phonocardiograms (PCGs) acquired in a pediatric population.

Methods:

Patients with no-, innocent-, and pathologic murmurs were recruited from the general pediatric cardiology clinic. Using an electronic stethoscope, PCGs were acquired by the pediatric cardiologist from each patient. The PCGs were analyzed by the algorithm and diagnoses were compared to findings by the pediatric specialist and echocardiography as the gold standard.

The following registry procedures and quality factors have been implemented in this preliminary clinical study:

* Quality assurance plan, including

  * data validation
  * proper registration procedures
* Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources (medical records and paper case report forms).
* Standard Operating Procedures to address registry operations and analysis activities, including patient recruitment, data collection, data management, data analysis.

Eligibility Criteria:
Inclusion Criteria:

* outpatient
* parental approval for study participation

Exclusion Criteria:

* none
Vitamin D Supplementation in Obesity and Weight Loss (3DD Study)

In this study, we will provide supplemental vitamin D in postmenopausal overweight/obese women, and hypothesize that it will not affect areal BMD, but will alter bone compartments (trabecular and cortical bone). In addition, higher vitamin D intake will increase serum 25OHD and suppress serum PTH and bone turnover during weight reduction. Secondary outcomes include the influence of vitamin D and weight loss on markers of insulin resistance and on cognitive tests of attention, learning, and memory.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index of 25-40 kg/m2
* Postmenopausal
* Age 50-72 years

Exclusion Criteria:

* Women who are taking any medication known to influence Calcium or bone metabolism,
* Evidence of diseases known to influence Calcium metabolism (i.e. metabolic bone disease)
* hyperparathyroidism
* untreated thyroid disease
* significant immune disease
* hepatic disease
* renal disease or a kidney stone in the last 5 years
* significant cardiac disease
* active malignancy or cancer therapy within the past year
Efficacy and Safety of L. Plantarum and P. Acidilactici in Children With Upper Respiratory Tract Infections

Randomized, placebo-controlled trial to evaluate the coadjuvant effect of a combination of L. plantarum and P. acidilactici probiotic strains, taken twice daily, in children 6 months to 5 years-old with upper respiratory tract infections with pharyngitis and/or tonsillitis. Main objective is to evaluate efficacy of this probiotic in reducing fever and pain, as well to evaluate its safety.

Randomized, placebo-controlled trial (RCT) to evaluate the coadjuvant effect of probiotic strains L. plantarum CECT30292, L.plantarum CECT7484 and CECT7485 together with P. acidilactici CECT7483, taken twice daily, in children 6 months to 5 years-old with upper respiratory tract infections with pharyngitis and/or tonsillitis, as diagnosed by a physician.

Main objective is to evaluate efficacy of this probiotic in reducing fever (as per infrared thermometer, same model for all recruited subjects) and pain (as per FLACC scale \[Face, Legs, Activity, Cry and Consolability\]), as well to evaluate its safety. Secondary objectives include effect on cough, rhinorrhea, nasal congestion, use of concomitant medication, emergency visits, hospitalizations, schooling absences and salivary immune markers.

Probiotic intervention will last 15 days, and patients will return for follow-up visits on the last day of probiotic intervention (day 15), and well as day 30 and 60.

The study aims at enrolling and randomizing 80 children fulfilling entry criteria and living in Mexico City area (2,200m over the sea level), after parents or legal guardians sign informed consent.

Eligibility Criteria:
Inclusion Criteria:

* Male and female children, 6 months to 5 years-old
* Diagnosed with upper respiratory tract infection with pharyngitis and/or tonsillitis by a physician
* With fever \>37.5 Celsius degrees and FLACC (Face, Legs, Activity, Cry and Consolability) score \>3
* Symptom onset no more than 48h before study entry
* Body weight at birth \>2500 gr
* Informed consent provided by parents or legal guardians

Exclusion Criteria:

* Failure to thrive
* Asthma or significant allergic disease
* Use of antibiotics, antivirals, probiotics or prebiotics for more than 48h within 2 weeks of study entry
* History of recurrent respiratory infections (\>2 otitis, \>1 severe sinusitis or \>1 pneumonia) within 12 months of study entry
* History of 2 or more invasive infections (meningitis, cellulitis, osteomyelitis, sepsis)
* Chronic diarrhea or short bowel syndrome
* Congenital heart or respiratory deficiency
* Known alpha1-antitrypsin deficiency
* Concurrent participation in other clinical trial(s)
* Other particular conditions which, in the judgment of the Principal Investigator, may interfere with the study
A Phase I Study of TQ-B3234 on Tolerance and Pharmacokinetics

To study the pharmacokinetic characteristics of TQ-B3234 in the human body, recommend a reasonable regimen for subsequent research.


Eligibility Criteria:
Inclusion Criteria:

* Histological documentation of Advanced solid tumors,such as Malignant Melanoma,Colorectal Cancer,Pancreatic Carcinoma,Thyroid Carcinoma
* Lack of the standard treatment or treatment failure
* 18-65 years,ECOG PS:0-1,Life expectancy of more than 3 months
* Main organs function is normal
* Stop other previous chemotherapy drugs more than 4 weeks
* Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped
* Patients should participate in the study voluntarily and sign informed consent

Exclusion Criteria:

* Patients participated in other anticancer drug clinical trials within 4 weeks or Patients participating in other clinical trials now
* Blood pressure unable to be controlled(systolic pressure\>140 mmHg，diastolic pressure\>90 mmHg). Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QTc≥440ms)
* Patients with non-healing wounds or fractures
* Patients with drug abuse history and unable to get rid of or Patients with mental disorders
* History of immunodeficiency
* Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment
Effect of Esomeprazole 40 mg.Daily for 7 Days on Acid Reflux and Related Arousals During Sleep in Patients With GERD

The purpose of this study is to determine if esomeprazole 40 mg. once daily improves not only nighttime symptoms but also significantly reduces conscious awakenings associated with gastroesophageal reflux and consequently improves sleep quality.

Twenty GERD patients with nighttime heartburn and/or regurgitation at least 3 times a week will be invited to participate in the study. All patients will undergo upper endoscopy to determine presence or absence of esophageal inflammation(using Los Angeles criteria). All patients will be evaluated by the Demographic,Berlin,Epworth Sleepiness Scale Questionnaires, and GERD Symptom Checklist. Thereafter,patients will undergo pH testing w/ an actigraph.The morning of pH probe removal,a Sleep Quality Questionaire will be administered.

Subjects will then receive esomeprazole 40 mg. once daily(30 minutes before breakfast) for 1 week. On day 7,subjects will again undergo pH testing w/ actigraphy, and the results will be analyzed again w/ new integrative software. On the morning of pH probe removal, the sleep Quality Questionnaire will be re-administered.

Eligibility Criteria:
Inclusion Criteria:

* Nocturnal symptoms at least twice a week.
* Ages 18-80
* Erosive esophagitis and/or abnormal pH test -
* Able to read, understand, and complete study questionnaires

Exclusion Criteria:

* Subjects with Barrett's esophagus or peptic stricture on endoscopy
* Subjects with normal endoscopy and pH test
* Subjects with previous upper gastrointestinal surgery
Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy

PE-TRACT is an open-label, assessor-blinded, randomized trial, aiming to compare catheter-directed therapy (CDT) and anticoagulation (CDT group) with anticoagulation alone (No-CDT) in 500 patients with submassive PE, proximal pulmonary artery thrombus and right ventricular dilation.


Eligibility Criteria:
Inclusion Criteria:

1. Symptomatic PE diagnosed by contrast-enhanced CT angiography with involvement of a main or lobar pulmonary artery branch; and
2. Right ventricular (RV) dilation as defined by the presence of an RV/Left ventricular ratio \> 1 on CT angiography

Exclusion Criteria:

1. Age \< 18 years
2. Systolic blood pressure \< 90 mmHg for \>15 consecutive minutes or \> 40 mmHg drop from baseline, or vasopressor requirement for blood pressure support (i.e., massive PE), occurring within 1 hour prior to eligibility assessment.
3. Symptom duration \> 14 days for the current PE episode
4. Irreversible INR \> 3
5. Irreversible Thrombocytopenia (Platelets \< 50,000/microliter)
6. Creatinine \> 2.0 mg/dl
7. Hemoglobin \< 7.0 g/dl
8. Pregnancy (positive urine or blood pregnancy test (a pregnancy test must be obtained within 7 days prior to randomization in people of childbearing potential))
9. Allergy or hypersensitivity to Recombinant Tissue Plasminogen Activator (rt-PA), or iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used
10. Life expectancy \< 1 year
11. Chronic inability to independently walk prior to the current PE episode (e.g. wheelchair dependent, walker or cane dependent, paraplegic, and/or bed-bound)
12. Allergy to heparin or history of Heparin-Induced Thrombocytopenia (HIT)
13. Unable or unwilling to provide informed consent
14. Major contraindication or unsuitability for all CDT methods available at the Clinical Center
Supplemental Oxygen in Catheterized Coronary Emergency Reperfusion

The aim of SOCCER is to evaluate the effects of treatment with supplemental O2 before and during acute balloon angioplasty (PCI) for patients with ST-elevation myocardial infarction (STEMI). One hundred STEMI patients are randomized in the ambulance to either standard O2 treatment (10 l/min) or no supplemental O2, to be given until the end of the acute PCI. Cardiac magnetic resonance imaging and echocardiography during the hospital stay is used to assess infarct size and myocardial performance. All patients are followed for 6 months. At 6 months, perceived health and NT-proBNP are recorded for all patients, and an additional echocardiography is performed. The primary endpoint is the fraction of myocardium saved with the acute PCI. The secondary endpoints include the pain difference between inclusion time and start of PCI and myocardial performance on echocardiography.

Almost all patients with ST elevation myocardial infarction (STEMI) in Sweden undergo acute balloon angioplasty (PCI) to open the occluded coronary artery, and thereby to reduce or abolish the myocardial infarction. Standard treatment in these cases is 10-15 l of supplemental oxygen to reduce the myocardial ischemia and the infarct size. It is, however, unknown whether supplemental O2 is beneficial or detrimental to patients with STEMI undergoing PCI.

This study aims to evaluate the effects of treatment with supplemental O2 in acute PCI for STEMI.

The study is a multicenter single blind parallel group randomized trial. One hundred normoxic STEMI ambulance patients accepted for primary PCI are randomized in the ambulance to either standard O2 treatment (10 l/min) or no supplemental O2, to be given until the end of the acute PCI. All patients undergo cardiac MRI at day 4-6 to determine area at risk, infarct size and myocardial salvage index. Fifty patients undergo an extended echocardiography during the hospital stay to assess infarct size and wall motion score index. All patients are followed for 6 months. At 6 months, perceived health (EQ-5D) and NT-proBNP are recorded for all patients, and an additional echocardiography is performed for the subgroup of 50 patients. The primary endpoint is myocardial salvage index. Secondary endpoints include pain difference between inclusion time and start of PCI and wall motion score index on echocardiography.

Eligibility Criteria:
Inclusion Criteria:

* STEMI patient transported with ambulance to SUS Lund or Malmö or Helsingborg hospital, and accepted for acute PCI
* Symptom duration less than 6 hours
* Normal SaO2 (≥ 94 %) measured with pulse oximeter
* Informed consent

Exclusion Criteria:

* Previous AMI
* Inability to make decision to participate; dementia and the like
* For CMR: Significant claustrophobia, prostheses or other magnetic material inside the body
Elderly Back Pain: Comparing Chiropractic to Medical Care

The purpose of this study is to compare the clinical effectiveness of two types of chiropractic spinal manipulation to conservative medical care for patients at least 55 years old with sub-acute or chronic low back pain (LBP).

Despite the high prevalence of LBP and the associated economic costs, disability, and lost productivity, and despite the development of several treatment guidelines, one of which recommends chiropractic spinal manipulation for some subgroups of patients with pack pain, the management of LBP remains controversial and highly variable across professions and geographic regions. Although one recent publication describes the design of chiropractic and exercise for seniors with low back or neck pain, no published studies to our knowledge, have assessed the effectiveness of chiropractic manipulation compared to medical care for older adults with sub-acute or chronic low back pain.

Eligibility Criteria:
Inclusion Criteria:

* Age 55 or older
* Idiopathic low back pain (LBP) of at least four weeks duration
* Meet the diagnostic classification of 1, 2, or 3 according to the Quebec Task Force on Spinal Disorders

Exclusion Criteria:

* Low back pain (LBP) not meeting Quebec Task Force Diagnostic Classifications 1, 2 or 3, especially LBP associated with: frank radiculopathy, altered lower extremity reflex, dermatomal sensory deficit, progressive unilateral muscle weakness or motor loss, symptoms of cauda equina compression, and CT or MRI evidence of anatomical pathology (e.g. abnormal disc, lateral or central stenosis.
* Co-morbid conditions or general poor health that could significantly complicate the prognosis of LBP, including pregnancy, bleeding disorders, extreme obesity, and clear evidence of narcotic or other drug abuse.
* Major clinical depression defined as scores greater that 29 on the Beck Depression Inventory - Second Edition
* Bone or joint pathology that contraindicate spinal manipulative therapy of joint pathology that contraindicate spinal manipulative therapy of the arthropathies and significant osteoporosis
* Pacemaker, because there are safety issues with equipment used to collect data in the biomechanical testing laboratory
* Current or pending litigation related to current episode of LBP.
* Receiving disability for any health-related condition
* Spinal Manipulative care for any reason within the past month
* Unwilling to postpone use of manual therapies for LBP except those provided in the study for the duration of the study period.
* Unable to read or verbally comprehend English.
The Potential for HPV Self-testing to Promote Participation in Cervical Screening

To explore the potential for vaginal self-sampling to increase participation in cervical screening, we offer the option of self-sampling to a group of non-participants in cervical screening (intervention), in addition to the routine screening (smear) test. Women in the control group will only receive the routine screening invitation letter. The total screening uptake rate, 2 months since the recruitment in each group will be compared.

The aim of this research is to assess the feasibility of making vaginal self sampling available to women who have declined smear testing (defaulters), through the NHS to prevent cervical cancer. We plan to identify all defaulters living in Coventry between 30 and 40 years (n≈6000) from the cervical screening call-recall system. They will be randomized 1:1 to intervention and control arms. Women in the control arm will be sent a routine screening letter reminding them to have a smear test. Women in the intervention arm will be given the option of self-sampling for HPV testing, if they do not wish to have a smear test. They could order a self-HPV test by returning a slip in the pre-paid envelope. We then send the woman a vaginal self-collection kit. Self-collected sample will be returned to the laboratory for HPV testing. Whilst HPV positives (10-15%) will be advised to have a smear test, HPV negatives will be advised to accept their next smear test invitation.

Eligibility Criteria:
Inclusion Criteria:

* All cervical screening programme defaulters living in Coventry

Exclusion Criteria:

1. Pregnancy
2. Total hysterectomy (abdominal/laparoscopic/vaginal)
3. Never been sexually active/ intimate
4. Women who cannot give valid, informed, written consent
5. HPV self-sample returned without a signed consent form
6. Women who request the research team to be excluded from the trial
7. Women who have written to the Screening Services to record their refusal to take part in the NHSCSP
8. Women who are identified as becoming pregnant or undergoing hysterectomy following the initial test will be excluded from the analysis of data for secondary outcomes
Nutritional Prognostic Factors in ALS

Background. Several nutritional factors have been evaluated as prognostic factors for survival in ALS patients at earlier stages of the disease \[body mass index (BMI), body composition expressed as fat free mass (FFM), fat mass (FM), phase angle (PhA), low-density lipoprotein/high-density lipoprotein (LDL/HDL) ratio, cholesterol levels\], while only two studies have evaluated some of these parameters after PEG placement.

Aim. BMI and cholesterol levels were evaluated as prognostic factors for survival after percutaneous endoscopic gastrostomy (PEG) placement Moreover, the relationship between body composition and BMI in a subgroup of ALS patients was evaluated.

Methods. Nutritional and neurological parameters were assessed at the time of PEG placement (T0) in 47 consecutive patients. Body composition and PhA were measured in only 22 patients within 2 months from T0. Survival was calculated as the time from the PEG placement to tracheostomy or death.

Eligibility Criteria:
Inclusion Criteria:

* ALS patients who underwent PEG tube placement from 2006 to 2015 and were referred to the artificial nutrition team of the Gastroenterology Unit

Exclusion Criteria:

* ALS patients without PEG