cyrilzakka/clinical-trials huggingface dataset:
MOdification of Fluid Distribution in 90 Minutes

Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS) is a cardiovascular risk factor due to intermittent hypoxia phenomena. Several etiological factors are involved in the pathogenesis of OSAS. Among them, the rostro-caudal displacement of fluid during dorsal decubitus has been highlighted. Under the effect of gravity, an accumulation of fluid is possible in the lower limbs, redistributing itself towards the upper parts of the body during the supine position.

This phenomenon of fluid shift is usually evaluated by impedancemetry after a night in the supine position. However, some authors have shown that fluid shift occurs within 90 minutes after supine. Thus, in the perspective of future studies, in order to simplify the implementation of this evaluation and to reduce the time of hospitalization necessary for the subjects participating in the study, we would like to verify the correlation between the impedancemetry measurement at T 90 min and that obtained after one night of supine position. This is a single-center, prospective, open-label study at the Poitiers University Hospital. We will include 30 patients over 18 years of age admitted to the regional sleep pathology center for suspected nocturnal respiratory disorders to receive polysomnography and able to provide written consent.We excluded : patients younger than 18 years of age, A history of vascular surgery of the lower limbs such as varicose vein surgery, vascular bypass surgery, carcinological surgery with lymph node dissection, the presence of metallic implants in the lower limbs or spine or implantable cardiac devices, those not receiving Social Securitý or not receiving it through a third party, persons receiving enhanced protection, namely minors, and persons deprived of libertý by a judicial or administrative decision, persons staying in a health or social institution, and adults under legal protection.we will perform an impedance measurement at T0, T30, T90, and after overnight supine. Impedance measurement is performed using electrodes delivering a low intensity current of known frequency allowing the study of the liquid volume.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older
* Patients requiring polysomnography at the regional sleep pathology center for suspected nocturnal breathing disorders
* Patients able to give their non-opposition

Exclusion Criteria:

* The presence of metallic implants in the lower limbs or spine or implantable pacemakers because of possible interference with the impedance signals
* A history of amputation of both lower limbs
* Persons benefiting from reinforced protection, namely minors, persons deprived of libertý by a judicial or administrative decision, persons staying in a health or social institution and adults under legal protection, persons in emergency situations.
Help-seeking for Health Problems in People With Parkinson's

Non-motor symptoms (NMS) are common in Parkinson's disease (PD) and cause significant distress and decreased quality of life. A high rate of non-declaration of NMS by patients means that many NMS remain unrecognized and untreated, even in specialist clinical services. In phase one of this research qualitative interviews (phase 1) were guided by the Theoretical Domains Framework and used to identify the barriers for help-seeking. A quantitative questionnaire survey (phase 2) examined the significance of these barriers to help seeking. The present study aims to develop (phase 3) and test the feasibility (phase 4) of a targeted behavioural intervention of barriers which were identified in phases 1 and 2 which prevent help-seeking for NMS in patients with PD. As with phases 1 and 2, the feasibility trial will include people with unreported burdensome NMS, who have not reported them to their PD consultant or nurse. The intervention has been co-designed by people affected by Parkinson's and targets the barriers identified in the previous phases of the research. In phase three of the research, 'think-aloud' interviews will be used to further develop the intervention so that it is acceptable and easy to use. In the final phase, a feasibility trial will be conducted to examine efficacy of the intervention for increasing help-seeking for undeclared NMS. The study has implications for using a theoretically driven behavioural intervention to promote help-seeking for NMS and ultimately increase receipt of clinical care for NMS among patients with PD.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic Parkinson's
* Access to a computer and internet connection
* Experiencing at least one unreported non-motor symptom

Exclusion Criteria:

* Presence of sensory loss or communication difficulty (including inadequate command of English) sufficient to interfere with the assessments.
* Severe cognitive impairment that would make participation in the intervention problematic or distressing. This will be assessed using the Telephone Interview for Cognitive Status-Modified (TICS-M, Brandt et al., 1993). People with a score of less than 20 will be excluded.
Identification and Management of Comorbidities and Extra-intestinal Manifestations in Crohn's Disease: the NEMO Nurse-led Program

Crohn's disease (CD) is a chronic inflammatory disease of the gastrointestinal (GI) tract. Although inflammation is predominantly expressed in the GI tract, extra-intestinal manifestations (EIMs) are so frequent that the concept of systemic disease is now widely accepted. Moreover, similar to other chronic diseases, patients with CD can be affected by other unrelated diseases which are called comorbidities.

Although no specific guidelines on comorbidity and EIMs in CD are available, data from other immune-mediated diseases support the use of nurse-led programs to improve the cost-effectiveness for the management of cardiovascular risk factors, increase rates of pneumococcal vaccination in high-risk patients, provide preventive measures against osteoporosis and increased fracture risk in older women.

The investigators believe that such an initiative can be conducted for CD patients by developing a CD-specific nurse-led program. Moreover, it has been shown that CD patients highly appreciate the "communicator role" and "skilled companionship" performed by nurses to fulfill their needs for attention to the "complete picture".

Therefore, the investigators hypothesize that a nurse-led program would increase the number of measures taken to treat or identify EIMs and/or comorbidities in CD patients and thus revolutionize their management.


Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of CD with a minimum disease duration of 3 months
* CD considered by the treating gastroenterologist to have been stable for at least 3 months
* No surgery planned within 6 months after the inclusion visit

Exclusion Criteria:

* Subject unable to attend all the study visits or comply with study procedures.
* Subject unwilling or not able to understand or sign the informed consent.
Responses to E-cigarette Message Source and Presentation

The goal of this clinical trial is to use crowdsourcing to test the effects of a message source (expert and peer) and message presentation types (one-sided and two-sided) to identify the optimal message type for young adults who vape and do not vape.


Eligibility Criteria:
Inclusion Criteria:

* US residents ages 18-24
* Fluent in English
* Reporting either vaping in the past 30 days or not having vaped in the past 30 days but susceptible to vaping

Exclusion Criteria:

* Age less than 18 or above 24
* Not fluent in English
* Not a member of partnering crowdsourcing behavioral research platform conducting the study
The Effectiveness of Adding Cupping Therapy in Patients With Nonspecific Chronic Lumbar Pain

Low back pain is a major public health problem and is associated with a high rate of absenteeism at work, functional disability and frequent use of health services. Suction cup therapy is a common technique of traditional Chinese medicine (TCM), which has been around for about 3,300 years in Asia and the Middle East and has as its main feature the decrease in signs and symptoms of chronic pain. The technique was widely used in the 19th century throughout Asia and Europe, and in recent years demand has been increasing, possibly due to the inefficiency of conventional therapies and medicines. Objective: To verify the effectiveness of the suction cup therapy technique associated with conventional physiotherapy in patients with chronic low back pain. Method: We will include individuals between 18 and 60 years old, both genders, with low back pain for more than 3 months, without having received physical therapy treatment for a period of 6 months. Individuals with severe spinal diseases, root conditions of the spine, carriers of vascular diseases and pregnant women will be excluded. They will be randomly divided into two groups, Conventional Physiotherapy (group 1) and Conventional Physiotherapy associated with suction cup therapy (group 2).


Eligibility Criteria:
Inclusion Criteria:

* nonspecific chronic low back pain without lower limb irradiation
* Aged between 18 and 60 years,
* Both genders
* Low back pain for more than 3 months
* Without having received physiotherapy treatment for a period of 6 months

Exclusion Criteria:

* individuals with severe spinal diseases (fractures, tumors and inflammatory conditions such as ankylosing spondylitis)
* root conditions of the spine (disc herniation and spondylolisthesis with neurological impairment and narrowing of the spinal canal)
* root conditions of the spine
* carriers of vascular diseases
* pregnant women.
Growth and Development of Children With Congenital Heart Disease (CHD)

The Effect of Individualized Nutrition Training Given to the Families of Children with Congenital Heart Disease (CHD) in the Post-Operative Period on their Growth and Development This study was conducted experimentally to determine the effects of individualized nutrition training given to mothers of children who had surgery for CHD on their growth and development.

The Effect of Individualized Nutrition Training Given to the Families of Children with Congenital Heart Disease (CHD) in the Post-Operative Period on their Growth and Development This study was conducted experimentally to determine the effects of individualized nutrition training given to mothers of children who had surgery for CHD on their growth and development.

The data of the study were collected at Çukurova University Medical Faculty Balcalı Hospital Cardiovascular Surgery between 20/01/2021-30/06/2021. The research was conducted by interviewing the families of 42 children with congenital heart disease. Personal information form, growth parameters and Ankara Developmental Screening Inventory were applied to three groups formed as two experimental and control groups by randomization method. Family-centered care and individualized nutrition training were applied to the first experimental group who was fed orally and and the second experimental group orally and nutritionally fed. These trainings were about nutritional contents suitable for the age of the baby, the way of preparing the food and meeting the calorie needs of the baby. No training was given to the control group during the research process. The growth and development parameters of all three groups were evaluated and the effect of education was examined.

Eligibility Criteria:
Inclusion criteria:

* Congenital heart disease,
* Born on time (38-42 weeks)
* Over 2.300 gr.
* fed with additional nutritional support to oral and oral nutrition,
* Decided to have surgery,
* 0-3 years old,
* The children and their families who were followed up in the post-operative service were included.

Exclusion criteria:

* No congenital heart disease
* Not planned to have surgery,
* over 3 years old,
* Children with additional congenital malformation, dysmorphic syndrome, chromosomal disease, severe infection, hypothyroidism and similar disorders that may cause growth and development retardation were excluded from the study.
Drug-drug Interaction Trial of BI 113608 in Combination With Ketoconazole and Voriconazole in Healthy Male Subjects

The primary objective of this trial is to investigate the relative bioavailability of a single oral dose of BI 113608 without and with ketoconazole and voriconazole at steady state. The assessment of safety and tolerability of BI 113608 administered alone and upon co-administration will be an additional objective of this trial.


Eligibility Criteria:
Inclusion criteria:

1. Healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions.
Safety and Efficacy of Cariprazine as an Adjunctive to Antidepressant Therapy in Major Depressive Disorder

An outpatient study to evaluate the safety and efficacy of cariprazine as adjunct to antidepressant therapy (ADT) in participants with major depressive disorder (MDD) who have an inadequate response to ADT alone. This clinical study compared cariprazine + ADT with placebo + ADT in outpatients with a diagnosis of MDD and an inadequate response to ADT. The study consisted of approximately 2 weeks of screening and washout followed by 8 weeks of double-blind treatment followed by a 1 week safety follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients 18 to 65 years of age, inclusive.
* Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for moderate to severe major depressive disorder (MDD).
* Current major depressive episode of at least 8 weeks and not exceeding 24 months in duration.
* Ongoing inadequate response to protocol allowed antidepressant therapy (ADT).

Exclusion Criteria:

* Principal DSM-IV-TR-based diagnosis of an axis I disorder, other than MDD,
* Women who are pregnant, or planning to become pregnant or breastfeed during the study or not practicing reliable contraception that will continue through out the study.
* History of meeting DSM-IV-TR criteria for:

  1. Depressive episode with psychotic or catatonic features.
  2. Manic, hypomanic or mixed episode, including bipolar disorder and substance induced manic, hypomanic or mixed episode.
  3. Schizophrenia, schizoaffective, or other psychotic disorder.
  4. Obsessive-compulsive disorder.
  5. Bulimia or anorexia nervosa.
  6. Dementia, amnesic, or other cognitive disorder.
  7. Mental retardation.
* Participants considered a suicide risk.
Study of Pomalidomide in Anal Cancer Precursors

This is a single centre open label phase II trial to determine the antitumor efficacy of the oral immunomodulatory agent pomalidomide in persistent human papillomavirus (HPV) -associated high grade squamous intra-epithelial lesions (HSIL) in patients with and without human immunodeficiency virus (HIV) infection.


Eligibility Criteria:
Inclusion Criteria:

1. Persistent high grade squamous intra-epithelial lesion (HSIL) which must meet all of the following criteria:

   i. Pathologically confirmed grade 2 or 3 AIN demonstrated by high resolution anoscopy with grade on each occasion re-confirmed at screening by nominated study pathologist from Douglas Hanly Moir (DHM) (pathology case review to be conducted prior to enrolment) ii. Lesion must have been visualised on at least three sequential occasions over at least 12 months, including the pre enrolment screening high resolution anoscopy (HRA).

   iii. Lesion must have persistent geographical characteristics consistent with a single lesion observed over time (as defined in the Manual of Operations).
2. No history of thromboembolic disease
3. No evidence of anal cancer or Superficially Invasive Squamous Cell Carcinoma of the Anus (SISCCA)
4. Willingness to use appropriate contraception (including refraining from sperm donation)
5. Age 18 years or older
6. Provision of written informed consent

   In addition, for subjects with HIV:
7. Adherence to a stable suppressive antiretroviral therapy (ART) regimen, unchanged for at least two months
8. CD4+ count ≥ 200 cells/µl
9. HIV viral load \< 200 copies/mL for at least six months

Exclusion Criteria:

1. Absolute neutrophil count (ANC) \<1000 cells/μL
2. Haemoglobin \<10.0 g/dL
3. Platelet count \<75,000 cells/μL
4. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> three times upper limit of normal
5. Calculated or measured creatinine clearance (CLCr) ≤ 50 mL/min (calculated by Cockcroft-Gault formula)
6. Patients with significant cardiac dysfunction including congestive heart failure, NY Heart Association Class II; Myocardial infarction within 12 months of starting study; unstable of poorly controlled angina
7. Current pregnancy or breastfeeding
8. Any condition not already outlined above which, in the opinion of the clinical investigator, would place the subject at risk if they participated or would jeopardise adherence or follow up
Total Marrow Irradiation & Autologous Stem Cell Transplantation for Relapsed or Refractory Myeloma

The investigators hypothesize that conformal radiation will allow the administration of higher doses of external beam radiation to marrow based malignancies than total body irradiation (TBI)without increasing the toxicity to normal tissues beyond that induced by TBI. Further,the investigators hypothesize that this will result in an improvement in disease response and disease control for patients with multiple myeloma. This is a dose escalation study of TMI with the primary objective of determining the maximum tolerated dose of TMI when followed by aHSCT in patients with relapsed or refractory multiple myeloma.


Eligibility Criteria:
Inclusion Criteria:

* A subject must meet all of the following criteria to be eligible for the study. These will be evaluated within the four weeks prior to enrolment.
* Subject must have primary refractory or relapsed multiple myeloma.
* Subject must have a measurable serum or urine monoclonal gammopathy at the time of their latest relapse.
* Subject must meet institutional guidelines for autologous HSCT with adequate renal, cardiac, pulmonary and hepatic function.
* An autologous hematopoietic stem cell graft containing more than 2.5 x 106 CD34+ cells/kg must be cryopreserved and available for transplantation.
* Subject must be of age more than 18 and less than 60 years.
* Subject must have an ECOG performance score of 0,1, or 2.
* Subject must have the ability to comply with the protocol visit schedule and other protocol requirements.

Exclusion Criteria:

* A subject meeting any of the following criteria is not eligible for participation in the study:
* Subject with non-secretory multiple myeloma or any plasma cell disorders other that MM.
* Subjects that have not received previous therapy with adequate intense corticosteroids for multiple myeloma.
* Subjects with a severely limited life expectancy by concomitant illness, defined as a life-expectancy of less than 6 months.
* Subjects who have previously received radiation treatments or other neoplastic disorders.
* Subjects with a history of non-compliance in other studies.
* Pregnant or lactating female subjects.
Comparison of Circumferential Pulmonary Vein Isolation and Complex Pulmonary Vein Isolation Additional Linear Ablation for Recurred Atrial Fibrillation After Previous Catheter Ablation: Prospective Randomized Trial (RILI Trial)

The purpose of this study is to compare the clinical outcomes depending on catheter ablation strategy for repeat ablation procedure among the patients with recurred atrial fibrillation after de novo catheter ablation. After randomization, we will conduct circumferential pulmonary vein isolation alone in a group, and additional posterior box isolation in the other group. Non-pulmonary vein foci ablation will be done in all patients. We will compare clinical recurrence rate, complication rate, and procedure time, etc.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with AF aged between 20 and 80 years old.
2. Patients possible to anticoagulation and anti arrhythmic drug
3. Patients who had undergone de novo ablation procedures based on circumferential pulmonary vein isolation with no additional linear ablations
4. Patients undergoing a second ablation procedure due to clinical recurrence resistant to antiarrhythmic drugs with findings of PV reconnections

Exclusion Criteria:

1. Structural cardiac disease 2. Contraindication to brain perfusion CT 3. Catheter ablation history for AF, Cardiac surgery for AF 4. active internal bleeding 5. Impossible to anticoagulation or antiarrhythmic drug 6. valvular AF ((MA\> GII, Mechanical valve, Mitral valve raplacement) 7. Patients with severe medical disease 8. Expected survival \< 1year 9. Severe alcoholics, drug addiction 10. Pregnancy 11. LA diameter\>60mm
A Trial to Investigate the Relative Efficacy, Safety, and Tolerability of Octaplas LG Versus Octaplas SD

The primary objective of the study was to compare the efficacy of Octaplas LG with Octaplas SD in terms of recovery of coagulation factors and other haemostatic parameters. The secondary objective of the study was to compare the safety and tolerability of Octaplas LG with Octaplas SD in terms of haematological and clinical chemistry parameters and adverse event monitoring.


Eligibility Criteria:
Inclusion Criteria:

* Capable of understanding and complying with all aspects of the protocol.
* Signed Informed Consent.
* Capable of understanding the plasmapheresis information sheet and sign it.
* Healthy male or female volunteers, age 18 years or older.
* Women must have negative pregnancy test (human chorionic gonadotropin \[HCG\] based assay).
* Women must have sufficient methods of contraception (eg, intrauterine device, oral contraception, etc).
* No clinically relevant abnormalities in medical history and general physical examination.
* Standard health insurance.

Exclusion Criteria:

* Pregnancy or lactation.
* Tattoos within the last 3 months.
* Subject was treated therapeutically with fresh frozen plasma, blood, or plasma-derived products within the last 6 months.
* Hypersensitivity to blood products or plasma proteins.
* History of angioedema.
* History of coagulation or bleeding disorder or any other known abnormality affecting coagulation, fibrinolysis, or platelet function.
* Any clinically significant abnormal laboratory values.
* IgA deficiency.
* Seropositivity for hepatitis B surface antigen, hepatitis C virus, or human immunodeficiency virus type 1 or type 2 antibodies.
* Symptoms of a clinically relevant illness within 3 weeks before the first trial day.
* History of or suspected drug or alcohol abuse.
* Subjects currently participating in another clinical study.
* Any investigational medicinal product administration within the last 4 weeks.
Heart Pressure Assessment Study With Tolvaptan to Treat Congestive Heart Failure

This study will look at how a single dose of study medication (tolvaptan) versus an inactive sugar pill (placebo) effect pressures in the heart in patients with congestive heart failure. Higher than normal pressures can be related to symptoms of heart failure (shortness of breath, fatigue, etc.).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Class III or IV heart failure for at least 3 months
* Left ventricular ejection fraction less than or equal to 40%
* Currently being treated for heart failure with standard therapies for at least one month

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Inability to take oral medications
* Uncontrolled hypertension, bradyarrhythmias or tachyarrhythmias
* Hypertrophic obstructive cardiomyopathy
* Severe obstructive pulmonary disease
* Significant renal impairment
* Significant uncorrected valvular or congenital heart disease
Prognostic Significance of Mutation Type and Chromosome Fragility in Fanconi Anemia

The goal of this observational study is to analyze the data included in the Spanish Registry of Patients with Fanconi anemia to better understand the natural history of the disease, identify genetic risk and prognostic factors, and identify potential therapeutic strategies.


Eligibility Criteria:
Inclusion Criteria:

* All patients in the Spanish Registry of Patients with Fanconi Anemia

Exclusion Criteria:

-