cyrilzakka/clinical-trials huggingface dataset:
Patient Satisfaction During Physiological Water or Land Birth: a Prospective Study in an French Tertiary Maternity Unit.

A study will be carried out to compare the level of satisfaction and psychological state of women who give birth in water with those who give birth out of water.

The aim is to demonstrate the benefits of water birth and justify its place in the healthcare offering.


Eligibility Criteria:
Inclusion Criteria:

* Major patient
* Social security beneficiary
* Presence of a companion
* Delivery greater than or equal to 37 weeks of amenorhoea
* Spontaneous labor
* Cephalic presentation
* Physiological delivery by woman's choice according to 2017 HAS criteria (French recommendations)

Exclusion Criteria:

* Patient under court protection
* Patient under guardianship or curatorship
* Placement of an epidural
* Language barrier
* Unexpected delivery (unwanted by the woman)
* Scarred uterus
* Meconium fluid
* Maternal pathologies: epilepsy, MS (depending on neurological opinion), diabetes (types 1 and 2), herpes infection, HIV, HBV, HCV
* History of delivery hemorrhage \> 1L
* History of shoulder dystocia/clavicle fracture
* Metrorrhagia
* Administration of nalbuphine within 2 hours of birth.
Functional Recovery in Stroke Patients With Task-Specific Robot-Aided Arm Therapy

The goal of this study is to determine whether task-oriented, robot-aided therapy is more effective than conventional physical and occupational therapy at promoting functional recovery of the affected arm in chronic hemiparetic stroke patients.

Robotic therapy will be performed with ARMin, which is a robotic arm exoskeleton that permits 3D movements of both proximal and distal arm joints. Combined with an audiovisual display, this device allows virtual training of Activities of Daily Living (ADL) and therapeutic gaming. A patient-responsive controller enables the assistance of the device only as needed. Chronic stroke patients (\>6 months post stroke) will be randomly assigned to either an experimental or a control group. The experimental group will perform task-related intensive therapy with the support of ARMin. Therapists will treat the patients of the control group with standard motor relearning therapy.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or more
* first-ever stroke (hemorrhagic or ischemic), verified by brain imaging
* stroke more than six months prior to the study
* termination of conventional therapy and stable recovery stage (outpatients)
* moderate to severe motor impairment of the arm (upper limb portion of FMA score between 8 and 38)
* ability to sit in a chair without any additional support and without leaning on the back rest
* written informed consent signed by the subject (or an authorized representative)

Exclusion Criteria:

* Excessive spasticity of the affected arm (mAS ≥ 3)
* any serious medical or psychiatric illness
* participation in any clinical investigation within 4 weeks prior to the start of this study
* anticipated need for any major surgery during the study
* women known to be pregnant or lactating
* Orthopedic, rheumatologic or other disease restricting movements of the paralyzed upper extremity
* shoulder subluxation (palpatory \> 2 fingers)
* diseased or damaged skin at the paralyzed arm
* inability to communicate effectively with the neurological examiner such that the validity of the patient's data could be compromised
* cyber sickness
* pace-maker or other implanted electric devices
* body weight \> 120kg
* serious cognitive deficits and aphasia preventing the performance of the ARMin treatment
* participation in any therapeutic treatment ("outside therapy") performed with the paralyzed arm during the planned study - including baseline and follow up.
A Psychopathological Study of Latent (Early) Schizophrenia: Clinical Pathology/Neuropsychological Dysfunctions

Current diagnostic criteria of schizophrenia are based on marked positive and negative symptoms. This definition may impede the exploration of basic phenomenological psychopathology or pathological mechanism of schizophrenia. Schizophrenia was found to have neuroanatomical, neurophysiological and neuropsychological impairment. However, the existence of these basic pathological states may not manifest as clinical state of schizophrenia, and it is found in normal relatives of schizophrenia proband. The clinical state of this underlying pathology may include so-called latent or early, or pseudo-neurotic schizophrenia or schizotypal disorder. The manifestation of prominent neurotic symptom state may not only present as an psychopathological issue, but also induce misdiagnosis in clinical practice. This may interfere early diagnosis of schizophrenia and may delay the chance of early and appropriate treatment.

Taking the fact of this disadvantaged conditions, this research is for exploration of clinical pathology and neuropsychological functions of latent or pseudo-neurotic schizophrenia. The strategy ia a natural follow-up study on the clinical cases obtained from the registration record of the medical charts of the National Taiwan University Hospital from 1970 to 1995. The natural follow-up results till study time (5 yrs to 30 yrs following period) will be explored. By using neurotic group (50 cases), latent schizophrenia group (50 cases) and schizotypal group (30 cases), the differences in clinical pathology, neuropsychological functions and family history of schizophrenia will be examined. There are 5 hypotheses to be tested: (1) Schizotaxia may exist as the manifestations of latent schizophrenia, schizotypal disorder and frank schizophrenia. The severity of pathology increased step by step; (2) The syndrome may change from the lower order to higher order to higher order, but not all of them changed to the higher order; (3) The clinical pathology of latent schizophrenia has both neurotic symptom as well as basic symptoms of schizophrenia; (4) There is the same kind of neuropsychological impairment of schizophrenia in the group of latent schizophrenia, and (5) The prevalence of schizophrenia in the first degree relatives of latent schizophrenia is higher than that of the general population. Finally, this study results will help the establishment of valid screening and/or diagnostic method (criteria) of latent schizophrenia for clinical and research usage.


Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia
* Latent Schizophrenia

Exclusion Criteria:

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Anakinra in Myositis

To investigate the effect of the interleukin-1 (IL-1) blocking agent, anakinra, in patients with treatment-resistant inflammatory myopathies.

Patients and methods: Fifteen patients with refractory polymyositis (PM), dermatomyositis (DM), or inclusion body myositis (IBM) were treated with 100 mg anakinra subcutaneously per day during 12 months. Outcome measures included myositis disease activity score with improvement defined according to The International Myositis Assessment and Clinical Studies Group (IMACS) and for muscle performance the functional index of myositis (FI). In addition repeat muscle biopsies were performed


Eligibility Criteria:
Inclusion Criteria:

Men and women aged 18 to 80 years with diagnosis of PM, DM or IBM based Peter and Bohan's and Grigg's criteria. All patients had to be capable of giving informed consent. Other inclusion criteria were muscle strength and/or function reduced at least 20 % below predicted values as measured by functional index (FI) \[45-47\] and failure to respond to treatment with high-dose glucocorticoids (0.75 mg/kg/day for at least one month) in combination with azathioprine and/or methotrexate for at least two months.

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Exclusion Criteria:

serious infections such as hepatitis, pneumonia, pyelonephritis in the previous 3 months; history of opportunistic infections such as tuberculosis, drug resistant atypical mycobacterium, active pneumocystis carinii, active cytomegalovirus infection; documented HIV infection; alcoholism, alcoholic liver disease or other chronic liver disease; chest x-ray suggestive of active tuberculosis; and pregnant, nursing mothers or patients with planned pregnancy within one and a half years of enrolment.

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Osteopathy and Obstructive Sleep Apnea Syndrome II

The main objective is to evaluate an osteopathic compression of pterygopalatine node in healthy subjects and patients suffering from obstructive apnea syndrome (OSA).

Osteopathic compression will be compared to a sham manoeuvre in a cross over design on apnea hypopnea index, pharyngeal collapsibility and symptoms in patients suffering from OSA, and on symptoms and pharyngeal collapsibility in healthy subjects.

Eligibility Criteria:
Obstructive sleep apnea syndrome patient:

Inclusion criteria :

* Male or Female aged 18 years or more
* Obstructive sleep apnea syndrome with apnea/hypopnea index \> or = 15/hour
* Body mass Index \<40kg/m2

Exclusion criteria :

* Pregnant or lactating women
* Participating to another trial
* Acute infectious disease of upper respiratory airway tract at inclusion
* Complete nasal obstruction
* Facial neuralgia at inclusion
* Patients not able to stop treatment for OSA within one week before each visit
* Allergy to latex
* Dental extraction within 15 days before inclusion
* Pharyngeal surgery in the past
* Incapable adult
* Patients treated with Selective Serotonin Reuptake Inhibitor

Healthy Volunteers

Inclusion criteria :

* Male or Female aged ≥18 and ≤ 40 years
* No obstructive sleep apnea syndrome
* Body mass Index \<30kg/m2
* No chronicle respiratory, neurological, cardiac or able to deteriorate sleep quality disease
* Low obstructive sleep apnea syndrome probability measured with Berlin Scale

Exclusion criteria :

* Pregnant or lactating women
* Participating to another trial
* Acute infectious disease of upper respiratory airway tract at inclusion
* Complete nasal obstruction
* Facial neuralgia at inclusion
* allergy to latex
* dental extraction within 15 days before inclusion
* pharyngeal surgery in the past
* incapable adult
* patients treated background treatment
An Open-Label Multiple Dose Study of RZ358 in Patients With Congenital Hyperinsulinism

The objective of this trial is to evaluate the safety, tolerability and glucose-raising effects of RZ358 in patients with Congenital Hyperinsulinism (HI).

There is a significant unmet medical need to develop new therapies aimed at preventing chronic recurrent hypoglycemia in congenital HI, the most common cause of persistent hypoglycemia in children. RZ358 is a human mAb that allosterically attenuates excessive insulin action on target cells. Therefore, RZ358 is ideally suited as a potential therapy for hyperinsulinism, and it is being developed to treat the hypoglycemia associated with diseases such as congenital HI. This is a Phase 2, multicenter, open label clinical study designed to assess the safety and efficacy of four progressively higher doses of RZ358 in separate groups of patients with hyperinsulinemic hypoglycemia due to Congenital HI, not adequately controlled with or without current standard of care. A screening period of up to 5 weeks will evaluate eligibility. Once enrolled, RZ358 will be administered bi-weekly over 8 weeks, and then patients will complete a post-treatment follow-up period of 13 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male or female age 2-45 years old (except age 12-45 in US) with an established clinical diagnosis of congenital hyperinsulinism
* Able to provide written informed consent or, as applicable, assent
* Confirmed hypoglycemia as assessed by CGM, SMBG, and clinical evaluation, during Screening
* Willingness to use contraception if of child-bearing potential

Exclusion Criteria:

* Out of range blood work for study entry
* Body Mass index outside of study entry criteria
* History of malignancy
* Clinically significant diseases, seropositivity for HIV, hepatitis B or C antibody
* Use of systemic corticosteroids within 30 days before Screening
* Known or suspected allergy to the study drug
* Recent use of an investigational drug or treatment, or participation in an investigational study
* Pregnant or lactating women
* History of drug abuse or excessive alcohol use
Plyometric Training in Volleyball Players With Chronic Knee Pain

The study is randomized and single-blinded. Ethical approval is taken from ethical committee of Riphah Internatinal University, Lahore. Participants who meet the inclusion criteria will be enrolled and allocated in group A \& B through random number generator by Non-probability Convenient random sampling technique. Subjects in Group A will receive plyometric training. Group B will receive general training.

The objective of the study is to determine the effects of plyometric training on vertical jumps and dynamic stability in volleyball players with chronic knee pain.

The study is randomized and single-blinded. Ethical approval is taken from ethical committee of Riphah Internatinal University, Lahore. Participants who meet the inclusion criteria will be enrolled and allocated in group A \& B through random number generator by Non-probability Convenient random sampling technique. Subjects in Group A will receive plyometric training. Group B will receive general training.

The outcome measures will be assessed by Vertical jump test, Hop test and Y balance test

The data will be analyzed by SPSS, version 25. Statistical significance is P= 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Both genders. Age between 15 to 30 years ACR criteria for knee OA. BMI less than 30

Exclusion Criteria:

* Players with open wounds. Players with diabetes. Grade IV OA on kellergan Lawrence. Any traumatic condition that can hinder polymetric training. Ankle instability sprain/ strain.
Randomized Comparison of Laparoscopic Sleeve Gastrectomy and Gastric Bypass for Morbid Obesity

Bariatric surgery is the most effective treatment for morbid obesity. Roux-en-Y gastric bypass (RYGB) is a bariatric procedure with known safety and effectiveness. Laparoscopic sleeve gastrectomy (LSG) is a newer procedure gaining popularity. The aim of the study is to compare outcomes of these two surgical methods in terms of weight loss, improvement of common comorbidities of obesity and influence on metabolic and hormonal status.

Authors of the study believe that a more detailed head-to-head comparison of RYGB and LSG is necessary. The former method is the established "gold standard" procedure with good outcomes reported in many studies. However it is much more complex and the learning curve is longer. The latter method was introduced as an initial procedure in superobese patients because of its relative simplicity. It produced good outcomes in this population of superobese patients and surgeons in some centers started to use it as a primary bariatric procedure. RYGB is a restrictive and partially malabsorptive procedure and it is believed to have additional benefits in patients with metabolic disorders such as type 2 diabetes and dyslipidemia. Purely restrictive procedures such as LSG are theoretically less beneficial in this group of patients. In the present study authors will look at weight loss as well as improvement in comorbidities and several biochemical parameters and indices to assess also metabolic action of these two procedures.

Eligibility Criteria:
Inclusion Criteria:

* BMI≥40 kg/m2
* BMI≥35 kg/m2 with at least one comorbidity associated with obesity

Exclusion Criteria:

* BMI \> 60 kg/m2
* poorly controlled significant medical or psychiatric disorders
* active alcohol or substance abuse
* active duodenal/gastric ulcer disease
* difficult to treat gastro-esophageal reflux disease with a large hiatal hernia
* previous major gastrointestinal surgery
* diagnosed or suspected malignancy
Identify the Genes Polymorphisms Related to Non-familial Bradyarrhythmia

Bradyarrhythmia, including sinus node dysfunction and atrioventricular block, is a major cause necessitating pacemaker implantation. In contrast to familial bradyarrhythmia known as by mutations at particular ion channels, limited information is available for the mechanistic study in non-familial bradyarrhythmia.

Possible gene polymorphisms related to non-familial bradyarrhythmia were studied. Comparison of multi-locus analysis and single-locus analysis will be analyzed between the cases and controls. Functional studies will perform to clarify the results of association study.


Eligibility Criteria:
Inclusion Criteria:

* The patients with non-familial bradyarrhythmia

Exclusion Criteria:

* Familial bradyarrhythmia Reversible bradyarrhythmia Bradyarrhythmia after open heart surgery and severe organic heart diseases
Cognitive Behavior Therapy for Somatization Disorder

This study will examine the long-term effects of cognitive behavioral therapy on the physical symptoms, functioning, and health care utilization of people with multiple medically unexplained physical symptoms.

Somatization disorder is a chronic psychological condition that causes numerous physical complaints for which no underlying physical problem can be identified. The disorder often lasts for several years and results in substantial functional impairment. The physical complaints most frequently involve chronic pain and problems with the digestive, nervous, and reproductive systems. Neither pharmacological nor psychosocial treatments for this disorder have been successful in suppressing symptoms. Cognitive behavioral therapy (CBT) is a treatment that focuses on maladaptive patterns of thinking and the beliefs that underlie such thinking. This study will examine the long-term effects of CBT on the physical symptoms, functioning, and health care utilization of people with somatization disorder.

Participants in this open label study will be randomly assigned to receive either CBT supplemented with augmented standard medical care (ASMC) as indicated by a psychiatric consultation letter or ASMC alone. Participants assigned to CBT plus ASMC will receive CBT for 10 weeks. Somatic symptomatology, functional impairment, and health care costs will be assessed at study visits at baseline and Months 3, 9, and 15. The visits at Months 9 and 15 will assess specifically the long-term efficacy of the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Meets DSM-IV criteria for somatization disorder
* Available for follow-up over the ensuing 15 months
* English-speaking

Exclusion Criteria:

* Meets DSM-IV criteria for a psychotic disorder, organic brain syndrome, or psychoactive substance dependence
* Active suicidal ideation
* Unstable major medical condition
* Plans to engage in additional psychotherapy during the first 3 months after study entry
* Current use of any medication that has not been stabilized for the 2 months prior to study entry
Pain and Abdominal Breathing Exercises

Postoperative evaluation of patients who did and did not do preoperative abdominal breathing exercises.

The respiratory type and pattern of all patients will be recorded before gallbladder surgery.

In Group P, abdominal breathing training will be given to the patients in this group. They will perform abdominal breathing for at least 5 minutes 6 times a day until surgery.

In Group C,patients who are not given abdominal breathing.

In the intraoperative period, 10 mg / kg paracetamol and 0.05 mg / kg morphine will be used for postoperative analgesia. After surgery, all patients will be given 10 mg/kg paracetamol every 8 hours and will be fitted with a patient-controlled analgesia (PCA) device (Tramadol HCL). PCA device bolus dose will be set to 20 mg, lock time will be set to 10 minutes and the number of buttons per hour will be set as 3.for postoperative analgesia.After surgery, NRS scores of the patients will be evaluated (in the recovery room, 1,2,6,12 and 24 hours.

Preoperative anxiety, postoperative discharge time and analgesic consumption of all patients will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Planned to gall bladder surgery
* An American Society of Anesthesiologists score of 1,2 or 3

Exclusion Criteria:

* Severe cardiovascular disease
* Respiratory disease
* Psychiatric disease
* Those who have chronic pain
Current Surgical Practices and Surgical Site Infection at Ayder Comprehensive Specialized Hospital in Mekelle, Ethiopia

This study evaluates the current surgical practices at Ayder Comprehensive Specialized Hospital in comparison to the World Health Organization's Surgical Unit Based Safety Programme guidelines and aims to determine how deviations from those guidelines are associated with varying rates of surgical site infection incidence in this population. The results of this study will help elucidate risk factors for surgical site infection and prioritize future interventions to decrease the rate of surgical site infection at Ayder Comprehensive Specialized Hospital, as well as other low and middle-income hospitals. The data collected regarding surgical site infection rates will also prove beneficial in measuring outcomes of any interventions that are developed as a result of this study.

Surgical site infection continues to be a major cause of morbidity and mortality around the world with low and middle-income countries disproportionately affected with rates as high as 30-40% compared to an average rate of less than 3% in high income countries. In addition to the grave clinical implications of these infections, the additional costs incurred by both patients and treating institutions can be catastrophic.

The World Health Organization's "Clean Care is Safer Care" initiated quality improvement projects in five African hospitals between 2013 and 2015, demonstrating that low-cost interventions can decrease the rates of surgical site infection in low and middle-income countries. This successful initiative formed the basis of the World Health Organization's Surgical Unit Based Safety Programme guidelines.

This will be a prospective cohort study collecting data about surgical practices, pre- and post-operative care and post-operative infection from time of admission through post-operative day 30. Patients will be identified when they are scheduled for surgery and undergo consent process. If they consent to participate in the study their clinical course will be followed through post-operative day 30. Inpatient observational data will be collected to determine whether current practices are in line with World Health Organization's Surgical Unit Based Safety Programme guidelines. Potential confounding risk factors for infection will be identified, and post-operative information will be collected through inpatient follow up as well as telephone calls on post-operative day ten and 30 to assess for signs or symptoms of surgical site infection.

Eligibility Criteria:
Inclusion Criteria:

* All patients (male and female) 18 years of age or older undergoing any surgery (elective, scheduled, urgent or emergent) including obstetrics and gynecology cases at ACSH in Mekelle Ethiopia.

Exclusion Criteria:

* Patients under the age of 18.
* Patients who undergo surgery involving permanent implants (as these patients would require follow up for 1 year to effectively rule out surgical site infection and this is beyond the data collection time frame of this study)