cyrilzakka/clinical-trials huggingface dataset:
Manual Therapy of Spine With Postural Correction Exercise Compared With Conventional Therapy in Patients With Adhesive Capsulitis - A Randomised Clinical Trial

Adhesive capsulitis (AC) is often self-limited but can persist for years and may never fully resolve. The most effective treatment for adhesive capsulitis is uncertain till date. Though neural links are being studied on one side and postural alteration too was postulated to cause shoulder pathology. However, the effectiveness of C5-C6 and thoracic spine mobilization with postural correction remains unexplored in the treatment of AC. This study aimed to investigate whether C5-C6 and thoracic spine mobilization with postural correction are more effective than conventional therapy in pain, range of motion(ROM), and disability in patients with AC. The outcome of the study must provide valid information to enhance the prognostic value of adhesive capsulitis.

Adhesive capsulitis (AC) is often self-limited but can persist for years and may never fully resolve. The most effective treatment for adhesive capsulitis is uncertain till date. Though neurological control of the shoulder girdle muscles is mainly from cervical roots, particularly from C5/C6 roots, there was not sufficient research to associate this link with AC. Evidence confirms that there is an association between posture and shoulder mobility. However, the effectiveness of C5-C6 and thoracic spine mobilization with postural correction remains unexplored in the treatment of AC. We aimed to investigate whether C5-C6 and thoracic spine mobilization with postural correction are more effective than conventional therapy in pain, range of motion(ROM), and disability in patients with AC.

Methods The protocol is written according to the SPIRIT statement to enhance transparency of content and completeness. Two-group, randomized controlled trial with blinded assessors. A total of 66 adults with AC will be randomly assigned to experimental group to receive C5-C6 and thoracic spine mobilization with postural correction sessions (n=33) and the others(n=33) in control group to receive conventional therapy within a period of 3 weeks. Primary outcomes are Shoulder Pain, range of motion (ROM) of the shoulder joint and Disability Index (SPADI) were to be measured at pre, postintervention following 3 weeks and 3 months..

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with AC \& a Positive for Apley's scratch test.
* Adhesive capsulitis (with symptoms for at least three months and less than 12 months\[18\]
* Both Gender
* Age 27-70
* Sleep-disturbing night pain

Exclusion Criteria:

* Patients who are unwilling to participate
* patients with malignancy
* AC Secondary to fracture and uncontrolled hypertension.
* Unstable cardiac conditions
* Patient with neurological conditions
* Patient with reported concurrent cervical issues
Proton Pump Inhibitor Plus Propranolol Versus Proton Pump Inhibitor Alone on Peptic Ulcer Healing in Patients With Liver Cirrhosis

Proton pump inhibitor plus propranolol versus proton pump inhibitor alone on peptic ulcer healing in patients with liver cirrhosis: a randomized trail

Portal hypertension is responsible for the development of portosystemic collaterals. The hemodynamic alternations may result in mucosal and vascular changes along gastrointestinal (GI) tract as well. According to several epidemiological studies, cirrhotic patients are at a higher risk of developing peptic ulcers, delayed healing, and a higher frequency of ulcer recurrence. The death rate from peptic ulcer disease in cirrhotic patients has been reported to be five times higher than that of the general population. The exact mechanism remains incompletely understood, but may be related to impaired mucosal defense mechanisms. Aggressive factors such as Helicobacter pylori and gastric acid may not be the predominant etiology in such circumstances. Sarfeh et al. found gastric mucosa of portal hypertensive rats, compared with that of controls, has distinctive functional and histologic abnormalities that can explain its increased susceptibility to erosive injury. Auroux et al. found gastroduodenal ulcer was independently associated only with the severity of the hypertensive gastropathy in cirrhotics. Chen et al. found portal hypertension with a hepatic venous pressure gradient \> 12 mmHg may be an important factor contributing to the increased prevalence of gastric ulcer observed in patients with liver cirrhosis. Thereby, we presumed that clinically significant portal hypertension may play a role in development of peptic ulcer in cirrhotic patients. Lebrec et al. elucidated non-selective beta-blocker (NSBB) could significantly decrease portal pressure and lower the risk of GI bleeding in patients with cirrhosis. Kitano et al. found portal hypotensive treatment with NSBB, reduces ethanol-induced gastric mucosal damage in portal hypertensive rats and improves endoscopic signs of portal hypertensive gastropathy in cirrhosis patients. We designed a 2-year randomized trial to evaluate the effectiveness of proton pump inhibitor with or without propranolol on ulcer healing and the incidence of ulcer bleeding in patients with cirrhosis and peptic ulcers.

Eligibility Criteria:
Inclusion Criteria:

* Between 20 and 85 years old
* Liver cirrhosis associated with esophageal varices or gastric varices
* Gastric ulcer or duodenal ulcer ,size bigger or egual than 0.5 cm

Exclusion Criteria:

* Acute bleeding
* Steroid or NSAID user
* Pregnancy, or the patients with other terminal illness (such as other terminal cancers, heart failure, renal failure...)
* Propranolol contraindications (such as atrioventricular block, heart failure, chronic obstructive pulmonary disease, asthma, poorly controlled diabetes, severe peripheral arterial disease...)
Study to Evaluate Solesta for Treatment of Fecal Incontinence

The study will evaluate the safety and efficacy of Solesta as an injectable bulking agent in the treatment of fecal incontinence for a total of 24 months after completed treatment.


Eligibility Criteria:
Inclusion Criteria:

* 18-80 years of age, male or female
* Screening fecal incontinence severity score (CCFIS)
* Fecal incontinence episodes over a 28-day period
* Failed conservative treatment for fecal incontinence

Exclusion Criteria:

* Complete external sphincter disruption
* Significant anorectal disease
* Anorectal surgery within the last 12 months prior to the study
* Active Inflammatory Bowel Disease
* Immunodeficiency or receiving immunosuppressive therapy
* Malignancies in remission for less than 1 years prior to the study
* Bleeding disorders or receiving anticoagulant therapy
* Chemotherapy within the last 6 months prior to the study
* Prior Pelvic radiotherapy
* Pregnant or breast-feeding women, or women of childbearing potential not practicing adequate contraception or planning to stop such contraception within the first year of the study
* Women within 6 months post partum
* Participation in any other clinical study within 3 month prior to the study
* Other severe conditions or in other ways unsuitable to participate according to investigator judgement
New Anticoagulation Strategies of VV-ECMO

Effective and normative anticoagulation is one of the most important components of Extracorporeal membrane oxygenation (ECMO) management. Excessive anticoagulation may lead to hemorrhage, which is the most common and serious complication. Currently, the most common factors for monitoring anticoagulation of ECMO are the activated clotting time (ACT) and activated partial thromboplastin time (APTT). However, there is a lack of a unified understanding of the related monitoring measures, monitoring targets, and bleeding risk assessments, which have been chosen mainly because of experiences reported by various ECMO centers or the results of retrospective studies.Therefore, anticoagulation strategies need to be improved. Our research have found ECMO anticoagulation management should be transformed from monitoring only the APTT/activated clotting time (ACT) to considering the entire coagulation process. To maintain thrombosis ability and PLT function within normal ranges may help reduce hemorrhage rates and improve prognoses. This randomized controlled study aim to develop the safety and efficacy new anticoagulation strategies of VV-ECMO.


Eligibility Criteria:
Inclusion Criteria:

* age more than 18 years old, VV-ECMO is estimated more than 3 days

Exclusion Criteria:

* hemorrhage before VV-ECMO established, VV-ECMO more than 48 hours before admitted, VV-ECMO is estimated less than 3 days
BIO-K+ CL1285 for Prevention of Recurrent Clostridium Difficile Infection

The primary objective of this study is to evaluate the efficacy of BIO-K+ CL1285 for prevention of recurrent Clostridium difficile infection.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. Presence of two or more loose or liquid stools in the 24-hour period prior to initiation of antibiotic therapy
3. Hospitalized and starting antibiotic therapy for Clostridium difficile infection (CDI) or recurrent Clostridium difficile infection (RCDI), diagnosed with a positive stool culture
4. Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only)
5. Understand the nature and purpose of the study including potential risks and side effects
6. Willing to comply with the requirements of the study

Exclusion Criteria:

1. History of 2 or more clostridium difficile infections at any time prior to the current episode
2. Presence of severe chronic and/or inflammatory condition
3. Impaired immunity, e.g. undergoing immunotherapy or chemotherapy
4. Major gastrointestinal complication, e.g. Crohn's disease or ulcer
5. Current treatment with nasogastric tube, ostomy, or parenteral nutrition
6. Use of proton pump inhibitors
7. Pregnant female or breastfeeding
8. Eating disorder
9. History of alcohol, drug, or medication abuse
10. Daily consumption of probiotics, fermented milk, and/or yogurt
11. Known allergies to any substance in the study product
12. Participation in another study with any investigational product within 3 months of screening
Assessment of Sense of Identity in Patients Diagnosed With Borderline Personality Disorder. A Pilot Study

One of the key features and long considered a fundamental element of Borderline Personality Disorder is the disruption of identity. Autobiographical memory is closely linked to the development and maintenance of a coherent, stable sense of self. It enables the individual to understand who he or she is. The investigators hypothesize that individuals diagnosed with Borderline Personality Disorder have a less coherent, stable sense of the self than healthy controls. The aim of the study is therefore to compare the sense of identity between a group of patients diagnosed with Borderline Personality Disorder and a group of healthy individuals (without Borderline Personality Disorder ).

This can be measured by evaluating the content of the self-defining memory using the Self-Defining Memory scale.


Eligibility Criteria:
Inclusion Criteria:

* Subject must have given written consent
* Subject affiliated or beneficiary of a health insurance plan.
* Adult subjects between 25 and 55 years of age
* Oral and written mastery of the French language

Inclusion criteria for the borderline group:

* Subject diagnosed as having borderline personality disorder according to the DSM IV classification

Exclusion criteria for the borderline group:

* Patients without diagnosis of borderline personality disorder according to the DSM IV classification after taking the SCID II (Structured Clinical Interview for DSM-III-R Axis II Disorders) test

Exclusion criteria for the control group:

* Subjects considered Borderline after taking the SCID II (Structured Clinical Interview for DSM-III-R Axis II Disorders) test
* Subjects with a score above 8 on the HADS questionnaire corresponding to questionable symptomatology for anxiety and depressive symptoms.

General exclusion Criteria:

* Subjects under court protection, guardianship or curatorship
* Subjects for whom it is impossible to give informed information
* Subjects participating in a Category 1 or 2 RIPH in the 3 months prior to the study
* Subject refusing to give written consent
* Presence of known neurological disease
* Pregnant or breastfeeding women
Multi-center, Survival Data Collection in Subjects Previously Enrolled in Celgene Protocol CC-5013-MDS-003

Multi-center, survival data collection in subjects previously enrolled in study NCT00065156 (Celgene Protocol CC-5013-MDS-003).


Eligibility Criteria:
Inclusion Criteria:

1. Must have been enrolled in the Celgene protocol CC-5013-MDS-003 study.
2. Must understand and be able to give informed consent (if a subject is deceased, proper legal consent (i.e. next of kin, legal representative) will be obtained prior to collection of data).

Exclusion Criteria:

1. Consent refused for any reason at current or long-term follow up completed in 2007 (long-term follow up: survival data collection completed to obtain further safety information on CC-5013-MDS-003 discontinued subjects from May - October 2007).
Clinico-biological Correlation of Severe Asthma in Children

Asthma is the most common chronic respiratory disorder in children. Despite significant advances in understanding of asthma, available therapies fail to alter the natural history and progression of the disease. Airway epithelial cells are continuously exposed to and injured by environmental irritants, such as viruses and pollutants, and as such are ideally situated to orchestrate airway function in response to these stimuli.

Severe or difficult-to-treat asthma in children is a complicated disorder characterized by ongoing symptoms and persistent airway inflammation and oxidant stress despite corticosteroid treatment. Although severe asthma is likely a heterogeneous disorder, affected children similar clinical features, including gas trapping, bronchial hyperresponsiveness, and aeroallergen sensitization. However, the molecular and cellular pattern of inflammation in children with severe asthma are not uniform : some investigators have found increased eosinophils and TH2 derived cytokines, others have noted noneosinophilic patterns with neutrophil activation.

Given the heterogeneity of the inflammatory response in children with severe asthma, additional methods to distinguish severe asthma are needed.


Eligibility Criteria:
Inclusion Criteria:

* Children 0-18 years
* patients followed regularly for at least one year.
* The diagnosis of asthma is increased according to the criteria of the Global Initiative for Asthma (GINA): children with a history of recurrent episodes of bronchial obstruction.
* children with severe asthma defined by the American Thoracic Society (ATS): Severe asthma is defined by the presence of a major criterion: the need for high doses of inhaled corticosteroids (budesonide dose equivalent 400 micro g) and least two of the five minor criteria:
* The daily use of beta 2 long-acting or short-term daily action (\<4 years) or anti-leukotrienes associated with inhaled corticosteroids Daily or almost daily use of beta-2 short-acting Permanent-bronchial obstruction (FEV \<80% predicted FEV)
* At least one emergency department visit for asthma exacerbations in France
* At least 3 courses of oral corticosteroids per year

Exclusion Criteria:

* parents' refusal to participate in the study
* refusal children to participate pathology underlying cardiac, neuromuscular, immunodeficiency
Intermittent ART in Primary HIV Infection

Interventions during primary HIV infection (PHI) can modify the immune control and the clinical evolution during the chronic phase. Although several studies suggest the benefit of antiretroviral treatment (ART) during PHI, indication of ART is still not universally recommended. The investigators randomized patients with PHI, with a favourable immunological profile and well controlled on ART, to undergone structured treatment interruptions alone or with low doses of IL-2, stopping ART thereafter. The endpoints were immune control of HIV replication and time to resume ART. Immunological profile, specific CD4 and CD8 responses and clinical data were analysed for both groups up to 48 weeks, and during a long follow-up, up to nine years since final ART stop.

The study design included two phases. The first phase consisted in four STI of 8 weeks each (off-ART), separated by 16 weeks of treatment -or the time necessary to reach again to PVL \<20 copies/mL- (on-ART). At the end of the 4th off-ART cycle (week 0) an interim evaluation was performed and the second phase initiated. During the second phase, the first 6 patients received ART until they reach PVL\<20 copies/mL, discontinuing thereafter (final stop). The last 6 patients received ART and low doses of IL-2. ARV therapy was stopped after reaching PVL\<20 copies/mL (final stop) and IL-2 after 6 months of treatment. IL-2 was prescribed at a dose of 750.000 UI/m2 daily and was self-administrated in all patients previous trained by a specialized nurse. ART was resumed in patient dropping CD4 cell count less than 350 cell/mm3 in two consecutive determinations or in patients who developed opportunistic infections. A long term follow up analysis was performed at 3, 6 and 9 years since the final stop. It included time to resume ART, clinical events, survival rate, CD4-CD8-CD4/CD8 ratio.

Eligibility Criteria:
Inclusion Criteria:

* PHI defined by detectable plasma viral load (PVL) or p24 antigen detection coupled with a negative or indeterminate LIA assay (according CDC criteria); negative HIV-1 EIA in the preceding 90 days or by a positive EIA and LIA assay with acute retroviral syndrome in the preceding 90 days of starting ART plus documented negative HIV-1 EIA within the previous year.
* ART started within 90 days from the HIV exposure and continuing in the same treatment at least 12 months before the inclusion, and they must have shown good virological and immunological responses, defined as undetectable PVL (\<20 copies/mL in the last two controls) and CD4 more than 500 cells/mm3 with a CD4/CD8 ratio \>1 in the last 8 months previous to enrolment

Exclusion Criteria:

* Infection of more than 90 days.
* Age under 18 years old.
* AIDS defining condition
Clinical Trial Evaluating Outcomes of Self-Fit and Professionally Fit Hearing Aids

Approximately 48 million people in the United States have hearing loss or hearing difficulties in noisy environments. Whisper.ai Inc has previously brought to market a commercial hearing aid system that reduces background noise and amplifies voices and sounds of interest using its proprietary platform based on machine learning and artificial intelligence technologies.

Whisper.ai Inc now seeks to bring to market a new hearing system that will incorporate a "self-fitting" capability. Self-fitting hearing aids have emerged in recent years as a potentially viable option to calibrate hearing aids to the needs of individual users without clinician intervention. The purpose of this project is to evaluate the efficiency and reliability of the fitting procedure and algorithms developed by Whisper.ai Inc. The study will be carried out using a randomized crossover design in two phases: in phase 1, subjects will be tested and a hearing aid will be fitted using conventional audiological standard procedures , and in phase 2, the subject will be tested and a hearing aid will be fitted using the results of the self-fitting algorithm.

Objective, subjective, and behavioral responses will be gathered from a variety of hearing-related surveys and tests, and will be analyzed quantitatively to evaluate the efficiency and reliability of the self-fitting algorithm. The investigators expect the fitting results of the Whisper.ai self-fitting algorithm to be similar to those of standardized fitting procedures conducted by hearing professionals.


Eligibility Criteria:
Inclusion Criteria:

* Adults age 18-80 years old
* Mild-to-moderate hearing loss in both ears from 500 to 4000 Hz
* Reported one year of previous hearing aid experience in at least one ear
* Ability to use a laptop/desktop computer to browse the internet
* Ability to complete online surveys in a web browser
* Communicates verbally and in writing in English

Exclusion Criteria:

* History of neurological deficits (e.g. stroke, Alzheimer's disease, etc.)
* Inability to remain alert throughout initial testing appointment
Machine Learning for Early Diagnosis of Endometriosis(MLEndo)

The project aims to create a large prospective data bank using the Lucy medical mobile application and collect and analyze patient profiles and structured clinical data with artificial intelligence. In addition, authors will investigate the association of removed or restricted dietary components with quality of life, pain, and central sensitization.

Introduction: Endometriosis is a complex and chronic disease that affects ∼176 million women of reproductive age and remains largely unresolved. It is defined by the presence of endometrium-like tissue outside the uterus and is commonly associated with chronic pelvic pain, infertility, and decreased quality of life. Despite numerous proposed screening and triage methods such as biomarkers, genomic analysis, imaging techniques, and questionnaires to replace invasive diagnostic laparoscopy, none have been widely adopted in clinical practice.

. Despite the availability of various screening methods (e.g., biomarkers, genomic analysis, imaging techniques) that are intended to replace the need for invasive diagnostic laparoscopy, the time to diagnosis remains in the range of 4 to 11 years. Aims: The project aims to create a large prospective data bank using the Lucy medical mobile application and collect and analyze patient profiles and structured clinical data with artificial intelligence. In addition, authors will investigate the association of removed or restricted dietary components with quality of life, pain, and central sensitization. Methods: A Baseline and Longitudinal Questionnaire in the Lucy app collects self-reported information on symptoms related to endometriosis, socio-demographics, mental and physical health, nutritional, and other lifestyle factors. 5,000 women with endometriosis and 5,000 women in a control group will be enrolled and followed up for one year. With this information, any connections between symptoms and endometriosis will be analyzed with machine learning. Conclusions: Authors can develop a phenotypic description of women with endometriosis by linking the collected data with existing registry-based information on endometriosis diagnosis, healthcare utilization, and big data approach. This may help to achieve earlier detection of endometriosis with pelvic pain and significantly reduce the current diagnostic delay. Additionally, authors can identify nutritional components that may worsen the quality of life and pain in women with endometriosis; thus, authors can create evidence-based dietary recommendations.

Keywords: Endometriosis, Machine learning, Non-invasive diagnosis, Diet

Eligibility Criteria:
Inclusion Criteria:

* Women in reproductive age
* 5000 patients with endometriosis
* 5000 patients without endometriosis

Exclusion Criteria:

* Ongoing pregnancy
* Malignant condition of ovary/uterus/breast