cyrilzakka/clinical-trials huggingface dataset:
Congenital Sucrase-Isomaltase Deficiency (CSID) Genetic Prevalence Study (GPS)

Congenital sucrose-isomaltase deficiency (CSID) is a rare, genetic disease in which mutations in the sucrose-isomaltase (SI) gene cause digestion problems of sucrose resulting in diarrhea and abdominal pain. Children with chronic, idiopathic diarrhea or abdominal pain will have their sucrose-isomaltase gene assessed for a panel of known CSID mutations to determine the prevalence of these mutations in an enriched population and also determine functional deficiency using a breath test.


Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years of age or younger.
* A primary clinical diagnosis of chronic idiopathic diarrhea or chronic abdominal pain for at least 4 weeks.
* English or Spanish speaking subjects and parent(s)/guardian only.
* Parental consent from one parent/guardian and also subject assent when appropriate based on individual IRB requirements.

Exclusion Criteria:

* Any condition(s) or finding(s) that in the opinion of the principal investigator suggests an alternative diagnosis for his/her gastrointestinal symptoms.
* Abdominal pain primarily related to constipation.
* Suspected gastrointestinal infectious disease.
* No current use of sacrosidase (Sucraid® Oral Solution).
* Known gastrointestinal disease such as celiac disease.
* Prior consumption of an investigational medication within the last 4 weeks.
* Antibiotics in the last 2 weeks, and no history of viral gastroenteritis within that same period of time.
* Known Hepatitis B or C infection (positive HBsAg or HCV within 6 months of enrollment) or Subject-Pugh Class C liver disease of any cause, HIV infection, tuberculosis, Clostridia difficile co-infection, cancer or systemic infections.
* Severe neurologic impairment that would prevent them from reporting a history of abdominal pain.
* Receiving or received biologic therapies (including infliximab, adalimumab, natalizumab) within 3 months prior to or at enrollment.
* Present or past use of immune modulators therapy (e.g., azathioprine, 6MP, methotrexate).
* Planned or previous abdominal surgery (e.g., bowel resection).
* Subjects with severe, uncontrolled systemic diseases.
* Presence of clinical alarm signs, including hypotension, anemia requiring blood transfusions, altered mental status, or inability to tolerate food and/or fluids by mouth.
Pressures During Prone Positions in Healthy Volunteers

Prone positioning (PP) reduces mortality in the most severe cases of acute respiratory distress syndrome (ARDS). Despite the benefits of PP, this technique presents adverse effects such as an increased risk of bedsores, linked to the duration, which must be around 16 consecutive hours.

There are 2 PP techniques:

1. Positioning with arms alongside the body
2. Swimmer's position At present, no study compares or has compared prospectively, the impact of the type of position used during ventral decubitus on mortality and the incidence of pressure sores, nor on secondary effects in intensive care.

Pressure transducers are available for instantaneous measurement of pressures between 2 interfaces. The investigators have acquired a pressure-measuring device, a mattress topper which is attached to the resuscitation mattress and which, connected to a PC, provides a live display of the pressures between the patient and the mattress.

The investigators would like to use their device to measure pressures during these 2 PP in healthy volunteers, which would enable them to obtain the world's first data on the real pressures generated during PP.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Major volunteer

Exclusion Criteria:

* Volunteers with cervical mobility problems preventing them from rotating their head 90°
* Volunteers with scapulohumeral joint mobility problems preventing them from performing 90° elevation/abduction.
* Pregnant volunteer (confirmed by a blood sample test or a positive pregnancy test).
* Volunteer not affiliated to a French social security system
* Volunteer protected by law
Growth Hormone (GH) in in Vitro Fertilization (IVF) Poor-responder Patients

Experimental study to evaluate if rGH addition to a standard controlled ovarian stimulation treatment improves ovarian response in women with previous poor ovarian response.


Eligibility Criteria:
Inclusion Criteria:

* Women who desire pregnancy with regular spontaneous menstrual cycles of 25-30 days length.
* Infertility requiring IVF with or without ICSI.
* Antecedent of a failed previous IVF cycle with a GnRH long agonist protocol in which at least 3000 IU of FSH were used (cancellation due to poor ovarian response - \< 4 mature follicles - or less than 5 oocytes retrieved)and antral follicle count \< 5.
* Partner sperm.
* Presence of both ovaries and normal uterine cavity.
* PAP smear within normality in previous 3 years.
* Negative pregnancy test (serum or urine) before rFSH administration.
* Willingness of adhesion to protocol during the whole study period.
* Signed informed consent given.

Exclusion Criteria:

* HIV, HCV, HBV positive serologies in women or partner.
* Important systemic diseases that could interfere with gonadotrophin treatment (ovarian and hypothalamic tumors...).
* BMI \> 32 kg/m2 or antecedent of diabetes mellitus.
* Gonadotrophin treatment within the previous 30 days.
* Availability of frozen embryos of previous IVF cycles .
* Abnormal uterine bleeding.
* Previous treatment with LH or LH effect drugs.
* Polycystic ovaries, increased size ovaries or presence of ovarian cysts of unknown ethiology.
* Contraindication for pregnancy.
* Allergies to gonadotrophins or somatotropin.
* History of drug or alcohol abuse in the previous 5 years.
* Previous enrollment in this study or simultaneous participation in another study with drugs.
Early Intervention for Minors in Possession of Alcohol/Drugs: A Feasibility Study

The purpose of this study is to evaluate two brief, sustainable interventions for a sample of 280 adolescents charged with an initial drug-related offense: Motivational Enhancement Therapy (MET) intervention for youth and the Parenting Wisely (PW) intervention for parents. Families are assessed for adolescent substance use, HIV-risk, recidivist substance-related offenses, treatment entry, and other areas of individual and family functioning.

It is expected that the combined MET+PW interventions will be more effective than a treatment-as-usual intervention (drug education group) for adolescents with parents not participating in PW.

Illicit substance use and related problems among adolescents has been consistently high over the past decade and remains one of the most pressing public health concerns in the United States. The objective of this study is to conduct a pilot investigation of the feasibility and effectiveness of two brief empirically based treatments for adolescent substance abuse when implemented as early interventions for youth arrested and charged with first- or second-offense possession of alcohol or drugs. The two examined interventions are Motivational Enhancement therapy (MET) and Parenting Wisely (PW).

Over a one-year period, 280 adolescents and their parents will be referred to the study by the Juvenile Justice Centers in two Oregon counties within the Portland metro area. Families will be randomized to one of four intervention conditions; youth will receive either MET or a drug education intervention (EDUC), and the PW intervention for parents is present or absent. Participants will be assessed for adolescent substance use, HIV-risk, recidivist substance-related offenses, treatment entry, and other areas of individual and family functioning at intake and at 3- and 6-month follow-ups.

Eligibility Criteria:
Inclusion Criteria:

1. 13 - 17 years of age
2. Referral for a 1st or 2nd Minor in Possession (Alcohol) or Less Than an Ounce (Marijuana) offense
3. Adolescents living at home with at least one parent willing to participate in the study
4. Adolescents with sufficient English-language ability to permit participation in the interventions
5. Parent(s) with sufficient English- or Spanish-language ability to complete the English- or Spanish-language versions of PW and the assessment

Exclusion Criteria:

1. Evidence of psychotic or organic state of sufficient severity to interfere with understanding study procedures
2. Danger to self and/or services other than outpatient treatment are required
A Novel Virtual Reality Task in Parkinson's Disease

The purpose of this study is to compare experiences and effects of a virtual reality physical program to an in-person Rock Steady Boxing Program. People with Parkinson's disease, age 18 and up, who participate in Rock Steady Boxing weekly may join this study.

If you agree to be in this study, we will ask you to do the following things:

Provide basic information about yourself, complete tests of thinking on the computer and in person, participate in your regular Rock Steady boxing, and for three weeks replace your Rock Steady Boxing with a virtual reality game done with a headset. You will work independently with a study team member.

* Visit 1 or Visit 1 and 2 if split up: Beginning Measures/Demographics, Parkinson's disease symptoms, Cognition (about 45 minutes), VR training (30 minutes) or Regular Rock Steady Boxing (1 hour)
* Visit 2-5: Virtual Reality training (30 minutes or Regular Rock Steady Boxing (1 hour)
* Visit 6: Virtual Reality training (30 minutes) or Regular Rock Steady Boxing (1 hour), Cognitive measures (about 20 minutes)
* Visit 7: Cognitive measures (about 20 minutes), Virtual Reality training (30 minutes) or Regular Rock Steady Boxing (1 hour); Intrinsic Motivation Inventory (5 minutes)
* Visit 8-11: Virtual Reality training (30 minutes) or Regular Rock Steady Boxing (1 hour)
* Visit 12 or Visit 13 if baseline was split up: Virtual Reality training (30 minutes) or Regular Rock Steady Boxing (1 hour), Cognitive Measures (20 minutes), Intrinsic Motivation Inventory (5 minutes), End of Study Survey (5-10 minutes)

Eligibility Criteria:
Inclusion criteria:

* Diagnosed with Parkinson's disease
* Age 18+ years
* Currently involved in rock steady boxing
* Willing to participate 2-3 days/week

Exclusion criteria:

* Known history of movement-induced vertigo
* Other cognitive or movement disorders
Clinical Research and Data Collection During the Investigation: Influence of a Dedicated Staff

The aim of the study was to evaluate the interest of the recourse of a staff dedicated as CRA to data collection in clinical research

Objectives of clinical studies are notably to evaluate new therapies, to improve diagnostic techniques, to make medico-economic decisions and to enrich scientific knowledge. Clinical studies findings can influence medical practice, or even motivate decisions by public health authorities. The rigor in their behavior is therefore an imperative to respect.

Thus, the quality of the data collected is essential. However, even if the reliability of the clinical data is guaranteed by the monitoring, the completeness of the data remains exceptional.

The increase of data required in clinical studies has led to the emergence of a specialized staff to assist investigators: the clinical research assistants. With dedicated time and specialization in data collection, they facilitate the conduct of clinical studies. However, this data collection aid has not been evaluated.

Eligibility Criteria:
Inclusion Criteria:

- clinical research visit performed in Reims university hospital between January 2010 and January 2015
A Comprehensive Third-generation Intervention for People With Psychosis and Post-traumatic Stress Symptoms

Existing data suggest that both trauma and Post-Traumatic Stress Disorder (PTSD) are very common among individuals with psychosis. The presence of PTSD symptoms in psychosis is associated with worse clinical outcomes and poorer social functioning. However, PTSD is a poorly attended and poorly studied condition among this population. Research to date indicates that trauma-focused treatments are safe and effective for PTSD, even when psychotic comorbidity is present. Recent systematic reviews of psychological interventions for trauma in psychosis found that are effective in reducing trauma symptoms, suggesting that they should be implemented in front-line services. Nonetheless, larger confirmative trials are required to form robust conclusions.The aim of this project is to examine the efficacy of comprehensive third-generation protocol for people with comorbid trauma and psychosis.

This study is a randomized clinical trial at psychiatric rehabilitation services of the Public Network of Care for people with serious mental disorders. We hypothesize that participants receiving the intervention, in comparison with controls, will show a reduction in general, PTSD and psychotic symptomatology, an improvement in levels of functioning and well-being, a greater ability to regulate emotions with more help-seeking behaviours.

Given the complexity of both psychosis and PTSD and the reluctance of professionals to treat it, we plan to develop a precise comprehensive protocol. In order to address all issues associated with both psychosis and comorbid PTSD, the protocol will be developed following the three stages of recovery from trauma: first, focusing on establishing the therapeutic alliance and safety; second, focusing on recounting and re-processing the traumatic event; and third, focusing on reconnecting with others and with life despite the trauma experienced. The therapy will be adapted to the characteristics of people with SMD and administered in 11 90-minute individual sessions per week, combining strategically ACT, Mindfulness, EMDR as well as Positive Psychology interventions.

Eligibility Criteria:
Inclusion Criteria:

Those showing a high risk of PTSD (TSQ ≥6) will be further evaluated to determine whether they meet the inclusion criteria. Participants must:

* Be between the ages of 18 and 65 fluent enough in Spanish language;
* Meet the criteria for a diagnosis of a psychotic spectrum disorder or a mood disorder with psychotic symptoms according to MINI (Sheeman et al., 1997);
* Meet PTSD diagnostic criteria according to the Clinician-Administered PTSD Scale (CAPS; Blake et al., 1995)

Exclusion Criteria:

* Those who have a diagnosis of substance or alcohol abuse or dependence in the 30 days prior to participation in the study
* To have a severe neurocognitive problems or brain damage that interfere with the basic processing of information in psychotherapy.
This is a Non-interventional, Study to Assess Demographic Characteristics and Patient Reported Outcomes in China Patients With SEA Treated With Benralizumab

The objective of this study is to collect empirical data that elucidates the clinical profile and therapeutic efficacy of benralizumab among the patients aged 12 years and above, with severe eosinophilic asthma. The study will focus on the early treatment response, treatment outcomes and the change in asthma control of benralizumab therapy in a real-world setting in China. This study will also describe the physician-reported reasons for discontinuation and switching of benralizumab therapy.


Eligibility Criteria:
Inclusion criteria -Patients are eligible to be included in the study only if all of the following criteria apply:

* Patients must to be 12 years old (inclusive) at the time of signing the informed consent.
* Patients with severe eosinophilic asthma prescribed with benralizumab at the discretion of the clinician.
* Blood EOS≥150/ul in the 3 months prior to or EOS≥300/ul in the 1 year prior to the time of signing the informed consent.
* Participating patients and/or their legally authorized representative must provide signed and dated written informed consent form prior to any study specific procedures.

Exclusion criteria

-Patients should not enter the study if any of the following exclusion criteria are fulfilled:

* Patients currently participating in any other clinical trial.
* Known history of allergy or reaction to any component of the study treatment formulation.
* Malignancy of any kind.
* Patients with prior or ongoing treatment with benralizumab.
Does the Application of a Bilateral-dual Transverse Abdominal Plane (TAP)Block Have an Influence on Lung Function?

TAP-block (Transverse Abdominal Plane) block is a method of regional anesthesia used after abdominal surgery. The method is often applied ultra-sound guided.

In our department, the so-called bilateral dual TAP-block (BD-TAP-block) has been developed. This includes injection of local anesthetics at four sites on the abdominal wall, aiming at the best possible spread of the nerve block.

Clinical experience shows satisfying results on pain relieve using the nerve block, i.e the sensory nerves of the abdominal wall are successfully blocked. However, to our knowledge, clinical investigations regarding the effect on the muscles of the abdominal wall has never been executed.

Patients with chronic lung diseases, who are prone to catch pneumonia post surgery, may have to be able to use accessory muscle groups to prevent pulmonary phlegm stagnation. Therefore it would be inappropriate if the motor nerves supplying these muscles were too, affected by the nerve block.

Our clinical experience has so far not given us suspicion or indication that the motor nerves become blocked, although these nerves are situated in the same muscle layer as the sensory branches.

Hence the investigators would like to examine on healthy, male subjects, whether application of a bilateral-dual TAP-block effects their ability to perform peak-flow and inspiratory and expiratory pressure. Our study hypothesis is:

There is no clinically relevant difference in the spread of results of pulmonary tests (peak flow et.c.) before and after application of bilateral dual TAP-block.


Eligibility Criteria:
Inclusion Criteria:

* No history of asthma
* Young male
* Has to be able to conduct lung function examination and the application of abdominal nerve block

Exclusion Criteria:

* History of asthma
Sorafenib Maintenance for Prophylaxis of Leukemia Relapse in Allo-HSCT Recipients With FLT3 Negative Acute Leukemia

The purpose of this study is to evaluate the efficacy and safety of sorafenib maintenance after allo-HSCT in FLT3-negative acute leukemia patients.

Sorafenib is a multikinase inhibitor that blocks multiple pathways involved in the development and progression of acute leukemia, such as FLT3-ITD, the RAS and RAF gene families, KIT, and the VEGF and PDGF receptors. Recently, two back-to-back randomized controlled trials both reveal that sorafenib maintenance after allo-HSCT could prevent relapse in patients with FLT3-ITD AML, resulting in a survival benefit. Sorafenib has also been explored in the treatment of acute leukemia without FLT3 mutations and shown promising results. Currently, relapse remains the major cause of transplant failure, especially for high-risk and refractory acute leukemia patients. Once patients relapse after allo-HSCT, the prognosis is dismal. Therefore, prevention of relapse is of great importance to improve the prognosis. Based on the current research status, we plan to conduct a prospective, multicenter, phase 2 randomized controlled trial to explore the efficacy and safety of sorafenib maintenance after allo-HSCT in FLT3-negative acute leukemia patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with FLT3-negative acute leukemia undergoing first allo-HSCT
* Age 18 to 65 years old with ECOG performance status 0-2
* Hematopoietic recovery within 60 days post-transplantation
* Sign informed consent form, have the ability to comply with study and follow-up procedures

Exclusion Criteria:

* Acute promyelocytic leukemia (AML subtype M3)
* Acute leukemia with FLT3-ITD or FLT3-TKD mutations
* Philadelphia-positive acute lymphoblastic leukemia
* Chronic myelogenous leukemia with blast crisis
* Intolerance to sorafenib pre-transplantation
* Life expectancy less than 30 days post-transplantation
* Active aGVHD or uncontrolled infections within 60 days post-transplantation
* Cardiac dysfunction (particularly congestive heart failure, unstable coronary artery disease and serious cardiac ventricular arrhythmias requiring antiarrhythmic therapy)
* Respiratory failure ( PaO2 ≤60mmHg)
* Hepatic abnormalities (total bilirubin ≥3 mg/dL, aminotransferase \>2 times the upper limit of normal)
* Renal dysfunction (creatinine clearance rate \< 30 mL/min)
* ECOG performance status 3, 4 or 5
* With any conditions not suitable for the trial (investigators' decision)
Unnecessary, Avoidable Lengths of Stay: a Strategy for Clinician Empowerment and Effectiveness Evaluation

1. Background: In recent years an increasing trend in excessive lengths of stay has been recorded at the Parma University Hospital, compared with regional mean values. Excessive lengths of stay have been demonstrated to constitute not just an economic problem, but also a clinical and public health issue. Since the measures taken at our institution so far have not proven effective, the investigators carried out a literature review, which mostly detected observational studies, restricted to the assessment of the impact of a single intervention.
2. Objectives: This project intends to evaluate the effectiveness of a multifaceted strategy aiming to empower clinicians on the issues associated with excessively long and avoidable hospital stays, and enable them to identify corrective measures (according to the principles of clinical governance).
3. Study design: cluster-randomized, parallel group, open-label, community trial
4. Methods: trained personnel will periodically record causes for excessive lengths of stay in all participating wards using an ad hoc data collection sheet. In the wards randomized to the experimental group, interventions aimed to clinician empowerment - provision of reminders and periodical audits - will be implemented.
5. Expected results: A reduction in the experimental vs. the control arm unnecessary lengths of stay is expected, although the introduced measures will also presumably lead to improvement in the wards where they are not implemented.


Eligibility Criteria:
Inclusion Criteria:

* patients present on the participating wards during one of 12 randomly selected index days (one for each month of data collection)

Exclusion Criteria:

* patients admitted or discharged on the index days
* patients with length of stay (interview date - admission date) \> 90 days