cyrilzakka/clinical-trials huggingface dataset:
Effectiveness, Safety and Feasibility of Auxiliary Nurse Midwives' (ANM) Use of Oxytocin in Uniject™ to Prevent Postpartum Hemorrhage in India

This cluster randomized community-based trial is designed to test the hypothesis that the intramuscular administration of 10 IU of oxytocin in Uniject™ during the third stage of labor by an Auxiliary Nurse Midwife (ANM) at births occurring in homes, Sub-Centers and Primary Health Centers in Bagalkot, India will reduce the risk of postpartum hemorrhage by 44% (from 9% to 5%) relative to home births attended by the same type of provider who does not provide the intervention drug. The study will also document correct use of oxytocin in Uniject, adverse maternal and fetal events associated with inappropriate use and a number of indicators reflecting the programmatic feasibility of implementing this intervention.


Eligibility Criteria:
Inclusion Criteria:

* gestational age \>=28 wks at enrollment
* anticipate spontaneous vaginal delivery
* hemoglobin \>=8 gm/dl
* delivery at home, sub-center, or primary health center
* delivery attended by Auxilliary Nurse Midwife

Exclusion Criteria:

* previous caesarean-section
* scheduled for caesarean-section
* antepartum bleeding during current pregnancy
* blood pressure \>140mm of Hg systolic and \>90mm of Hg diastolic
* in active labor at time of recruitment
* high risk medical conditions (diabetes, cardiac ailments, seizures, placenta previa, anticipated breech delivery
COVID-19 and Vitamin D: Length of Hospital Stay and Mortality

The lack of a pharmacological treatment in the COVID-19 pandemic has pushed scientists to search for this issue. Maintaining optimal health is parallel to adequate and balanced nutrition. In this context, can the protective properties of vitamin D play an important role in this pandemic? brought with it the thought. In this study, it was aimed to examine the effect of vitamin D on mortality and hospital stay in COVID-19 disease.

This research was conducted to examine the effect of vitamin D on mortality and hospital stay in COVID-19 disease. For this, the approval of the Ministry of Health and then the ethics committee was obtained. For this reason, patients with positive PCR tests and hospitalized patients with vitamin D levels in their biochemistry were included in the study.

The data of the patients were obtained from the medical records. Information such as age, gender, comorbidities, length of hospital stay, vitamin D level were included in the study. According to the statistical analyzes obtained from these data, it has been shown that vitamin D level has no effect on mortality and hospital stay in COVID-19 disease.

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 PCR (Polymerase Chain Reaction) test positive
* Vitamin D level in biochemical parameters
* Adult patients hospitalized for COVID-19

Exclusion Criteria:

-Patients using drugs that may affect vitamin D absorption, such as corticosteroids, cholesterol-lowering agents, phenobarbital and phenytoin-containing agents
Efficacy, Safety and Tolerability of Repeated Dosis of Intravitreous Bevacizumab in Uveitic Macular Oedema

The purpose of this study is to determine whether intravitreous bevacizumab or intravitreous triamcinolone acetonide are effective and safe in the treatment of uveitic macular oedema


Eligibility Criteria:
Inclusion Criteria:

* adult patients with uveitis or retinal vasculitis with unilateral or bilateral macular oedema
* with macular thickness \> 250 micra using OCT
* visual acuity at least 20/200
* with stable treatment with oral prednisone at least during 3 months, either oral ciclosporin or other immunomodulator to treat intraocular inflammatory disease
* patient that can follow study's requirements
* patient who consents to participate

Exclusion Criteria:

* presence of corneal or crystalline opacity preventing observation of fundus of eye
* patients requiring ocular surgery in next 3 months
* one-eyed
* pregnancy and child breastfeeding
* previous history of glaucoma
* on treatment woth an experimental ocular drug
* previous thromboembolism or receiving oral anticoagulant treatment
* vitrectomy
* patients with proved tractional macular pathology associated to macular oedema
A Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13™ in Healthy Infants (V114-031/PNEU-LINK)

This study is designed to evaluate the safety and tolerability of V114 and Prevnar 13™ in healthy infants. This study will include both full-term infants (≥37 weeks gestational age) and premature infants (\<37 weeks gestational age). Premature infants will be included in a Premature Infant Immunogenicity Substudy, which will assess immunogenicity and safety following administration of V114 or Prevnar 13™.


Eligibility Criteria:
Inclusion Criteria:

* Healthy (based on a review of medical history and physical examination) based on the clinical judgment of the investigator
* Male or female approximately 2 months of age, from 42 days to 90 days inclusive, at the time of obtaining the informed consent
* Have a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent.

Exclusion Criteria:

* History of Invasive Pneumococcal Disease (IPD) (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease
* Known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV) or any diphtheria toxoid containing vaccine
* Known or suspected impairment of immunological function
* History of congenital or acquired immunodeficiency
* Has or his/her mother has a documented human immunodeficiency virus (HIV) infection
* Known or history of functional or anatomic asplenia
* Failure to thrive based on the clinical judgment of the investigator
* Known coagulation disorder contraindicating intramuscular vaccination
* History of autoimmune disease (including but not limited to systemic lupus erythematosus, antiphospholipid syndrome, Behcet's disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, type 1 diabetes mellitus, or other autoimmune disorders)
* Known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders
* Received a dose of any pneumococcal vaccine prior to study entry
* Received a blood transfusion or blood products, including immunoglobulins, before receipt of first dose of study vaccine
* Participated in another clinical study of an investigational product before the beginning or anytime during the duration of the current clinical study. Participants enrolled in observational studies may be included.
* Has any other reason that, in the opinion of the investigator, may interfere with the evaluation required by the study
* Has an immediate family member who is investigational site or Sponsor staff directly involved with this study.
Mitral Loop Cerclage(MLC) for Reducing Functional Mitral Regurgitation

To evaluate safety and feasibility of Mitral Loop Cerclage(MLC) Annuloplasty with CSTV for repair of functional mitral regurgitation.

The objective of this prospective, single-center, open label, feasibility test is to assess the safety and efficacy of Mitral Loop Cerclage Annuloplasty with CSTV protective device in treating functional mitral regurgitation (FMR) associated with heart failure.

Eligibility Criteria:
Inclusion Criteria:

* NYHA(New York Heart Association) Class III - IV, and symptomatic severe functional MR by 2014 ACC/AHA guideline in spite of optimal medical treatment.

(For optimal medical treatments, ①ACE inhibitor or angiotensin receptor blocker ②β-blocker ③ aldosterone antagonists should be given for at least 3 months unless the subject has contraindication for each drug)

Exclusion Criteria:

* Primary Mitral Regurgitation
* LV ejection fraction lower than 25%
* Creatinine ≥2.0 mg/dL
* Anomaly of Coronary Sinus
* Pre-existing devices in coronary sinus such as Implantable Cardioverter Defibrillator and Pacemaker
* 2:1 Atriventricular AV block or higher AV block and ventricular tachycardia
* Subjects with functional MR who need CABG or AVR performed
* Subjects who have functional MR caused by aortic valve disease
* Subjects who have uncontrollable hyperthyroidism
* Subjects who have severe TR due to primary valve leaflet disease
* Subjects who cannot be screened by cardiac CT
* Subjects who have possibility of coronary artery pinching even with Mitral Loop Cerclage system judged by cardiac CT
* Subjects who are unable to take anti-platelet agents
* Subjects who are participated in other clinical trials within 1 month of enrollment
* Subjects who have coagulation disorders
* Subjects who have thrombosis and embolism
* Subjects who are pregnant, or lactating, or plan pregnancy during the clinical trials
* Subjects who are deemed not to be eligible in this study by physician's discretion
Exploring Physiological Responses of Virtual Reality Walking Exercise Versus Treadmill Walking in Healthy Individuals

This study aimed to systematically compare the physiological responses generated by walking exercises conducted in a VR environment versus those performed on a treadmill, with a specific focus on their impacts on the autonomic nervous system and fatigue levels

This study was designed as a single-blind, randomized controlled trial. It was conducted in accordance with the Declaration of Helsinki, adhering to ethical principles for medical research involving human participants. Faculty of health sciences students from İstanbul Atlas University were invited to participate in this study. The inclusion criteria were as follows: aged between 18 and 25 years; classified as inactive or minimally active according to the International Physical Activity Questionnaire score; voluntary consent to participate; and a body mass index (BMI) of ≤30 kg/m².

Participants were excluded from the study if they met any of the following conditions: presence of visual, auditory, vestibular, or neurological deficits; a history of inflammatory diseases, surgeries, or cancer; any cardiopulmonary disorders, including asthma, within the last six months; major musculoskeletal injuries sustained within the last six months; other health issues that could compromise safety during exercise; or conditions known to affect autonomic nervous system (ANS) function, such as diabetes mellitus or autonomic neuropathy or current smoking status or failure to adhere to the experimental procedures of our study.

Our study comprehensively examines the effects of virtual reality (VR) walking exercise and traditional treadmill walking on autonomic nervous system (ANS) and fatigue levels during recovery.

Investigations into the physiological responses elicited by VR exercise interventions underscore a critical gap in our understanding of how VR modalities produce distinct responses compared with conventional exercise forms, particularly treadmill walking.

Eligibility Criteria:
Inclusion Criteria:

* classified as inactive or minimally active according to the International Physical Activity Questionnaire score
* voluntary consent to participate
* body mass index (BMI) of ≤30 kg/m²

Exclusion Criteria:

* presence of visual, auditory, vestibular, or neurological deficits
* a history of inflammatory diseases, surgeries, or cancer
* any cardiopulmonary disorders, including asthma, within the last six months
* major musculoskeletal injuries sustained within the last six months
* function, such as diabetes mellitus or autonomic neuropathy
* current smoking status
The Effectiveness of RPSG Intervention for Nurses During the COVID-19

The cases of COVID-19 are continuing to be confirmed around the world. In the clinical settings, the nurses in evacuation acute wards are main responsibility to undertake the care of emergency patient follow-up and suspected or confirmed COVID-19 cases. Those nurses have to face the high psychological pressure, unknown panic, fear and so on. Thus, the study plans to invite nurses who are working in evacuation acute wards to participate the project called "Remote Psychological Support Group (RPSG)". The study supposes "RPSG" could improve nurses' self-efficacy, fear of COVID-19, psychological distress, and quality of life.

The cases of COVID-19 are continuing to be confirmed around the world. In the clinical settings, the nurses in evacuation acute wards are main responsibility to undertake the care of emergency patient follow-up and suspected or confirmed COVID-19 cases. Those nurses have to face the high psychological pressure, unknown panic, fear and so on. Thus, the study plans to invite nurses who are working in evacuation acute wards to participate the project called "Remote Psychological Support Group (RPSG)". The results of this study will establish the effectiveness of RPSG intervention for nurses on self-efficacy, fear of COVID-19, psychological distress, and quality of life and identify the feasibility of the RPSG. The results are also critical to improving the quality of care for nurses during the COVID-19 outbreak and the RPSG model will establish an important basis for support group in the event of other Severe Pneumonia with Novel Pathogens in the future.

Eligibility Criteria:
Inclusion Criteria:

* The nurses have to above 20 years old.
* The nurses who work in evacuation acute wards.

Exclusion Criteria:

* The nurses who have any mental illness.
Evaluation of a Non-invasive Urinary Collection Technique for the Adaptation of Diuretic Treatment in Incontinent Heart Failure Patient Over 75 Years of Age in the Acute Phase

Heart failure is a general disease affecting many organs and regulatory systems with a prevalence of 10% after 75 years of age, leading to significant hospitalization in the elderly. This generates a significant cost for our health system. The management of patients over 75 years of age in acute heart failure requires special monitoring of diuresis and weight. However, it is sometimes difficult to collect urine from incontinent elderly patients (not catheterized, habitually wearing protection) under intravenous diuretics. The evaluation of a non-invasive technique of urine collection for the adaptation of diuretic treatment in the incontinent patient with heart failure over 75 years of age in the acute phase seems to us to be interesting to conduct.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 75 years of age
* Geriatric short-stay inpatient, geriatric/cardio medicine unit geriatrics
* Incontinent patient with urinary protection
* Patient with acute heart failure according to the diagnosis made by the doctors of unity
* Patient treated with intravenous diuretic
* Patient benefiting from a social security scheme or benefiting from it by a third party
* Patient who gave their non-opposition to the study after clear information

Exclusion Criteria:

* Patient hospitalized in another unit of the geriatric division
* Patient allergic to the protections provided
* Patient carrying a bladder probe upon entry into the unit
* Patient with a precarious non-perfusable venous capital
A Prospective Cohort Study of Patients Suffering From Hand Osteoarthritis Symptoms

The late-stage forms of degenerative osteoarthritis (OA) are very debilitating and less affordable to therapy. The main objective is to identify early onset symptoms of hand OA patients through imaging techniques (such as ultrasound and MRI). Our primary endpoint is to specify patients with high risk of radiological profression (X-ray).


Eligibility Criteria:
Inclusion Criteria:

- Early digital osteoarthritis must combine the clinical AND radiological definition.

Clinical definition:

At least one of the following 4 criteria: Pain or stiffness or swelling or deformity of a digital joint (IPP and / or IPD) A breach of at least one PPI and / or IPD Age under 60 at the time of the first symptoms Clinical symptoms have been changing for less than 3 years

Radiographic definition:

The presence of the achievement of at least one PPI and / or IPD. Presence of at least two of the following three criteria: pinching, marginal subchondral condensation, marginal osteophyte Erosion on radiography is not an exclusion criteria

- Consent form signed

Exclusion criteria:

* patients suffering from rheumatoid arthritis, rheumatoid psoriasis or any other inflammatory rheumatism
* patients suffering from metabolic diseasis such as gout, hemochromatosis, Wilson's disease; or from congenital disease such as displasie, osteogenesis,
* Presence of advanced radiographic osteoarthritis based in Kellgreen Lawrence score (=4) in one joint among the 10 previous sites.
* Not able to provide a sample of blood for any reasons
* MRI contraindication
* Being in exclusion period determined by another previous study
* Subject non affiliated to social insurance
* Pregnant or lactating women
* Vulnerable people based in L1121-5 article of CSP
* Elderly subject or protected subjects disabled to give their consent
* Subjects private of freedom by court or administrative order
Motives for Desiring Children in Different Sexual-romantic Orientations

The goal of this cross-sectional study is to compare the motives for the desire to have children in different sexual-romantic orientation. The main question\[s\] it aims to answer are:

* Do all orientations have the same motives for the desire to have children?
* What are the preferred methods for having a child for the different orientations

Participants will answer an online questionaire .

Researchers will compare the different orientations to see if there are differences.


Eligibility Criteria:
Inclusion Criteria:

* All participants regardless of sex, gender or age

Exclusion Criteria:

* Incomplete questionnaire
* Under 18 years
* Caring for a child in a social, economic or educational way (self-report)
Fiber Intake Among Children in Relation to Milk Type, Gastrointestinal Symptoms and Iron Status: a Cross-sectional Study

Fiber as part of the plants can be provided through eating grains, fruits and vegetables. As source of fiber, exclusively breastfed infants do not need additional dietary fiber because breast-milk provides oligosaccharides to maintain the bulk for normal gastrointestinal movements together with gut probiotics. However, after the period of six months of exclusive breastfeeding, then complementary foods are the initial sources of fiber of children aged 6-59 months diet, e.g. cereals, fruits and legumes should then be introduced. However, investigators should consider on the effect of plant foods as a non-haem iron food source that is less bioavailable for iron absorption. There are other dietary factors that inhibit iron bioavailability, i.e. phytates in grains and rice, vegetables protein, calcium and phosphorus in cow's milk and cheese. iron deficiency is remained common globally, especially for children age 6-24 month in which it can developing into a severe condition, i.e. iron deficiency anemia. Iron deficiency as well as anemia is closely related to delay child growth and development, negatively associated with height-for-age, and anemia are at risk for poorer cognitive, motor, social-emotional, and neurophysiologic development in the short- and long-term outcome. The aim of this study is to see the association between fiber intake from different type of milk consumption sources and dietary habits to gastrointestinal health, anemia and growth status among children aged 6-36 months.

This study is an observational cross-sectional study to get fiber intake profile among children aged 6-36 months in relation to cow's and non-cow's milk consumption, gastrointestinal symptoms, hemoglobin value and nutritional status. The participants in this study are children aged 6-36 months who are recruited from selected Puskesmas (Health Care Center) in Jakarta and Bandung after provided with informed consent from children's parents. To get proportion of low fiber intake with a degree of reliability 95% and significance level of 5%, then 400 subjects is needed as a minimal sample size in this study.

The children's parents will be interviewed about socio-demographic characteristics of the subjects, gastrointestinal symptoms during the past two weeks using VAS (Visual Analogue Scale) on frequency of bowel movements in a week, parents's education, family income, and child's food intake. The children's weight and height will be measured and blood sample will be taken.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 6-36 months who are recruited from selected Puskesmas (Health Care Center) in Jakarta and Bandung after provided with informed consent from their parents

Exclusion Criteria:

* Children who are seriously ill and/or need special medication
Steroid Injection Treatment of Carpal Tunnel Syndrome

The aim of this study is to assess the efficacy of injecting steroid into the carpal tunnel in relieving symptoms of carpal tunnel syndrome for at least 1 year with outcomes measured with patient evaluated symptoms score.Out of the patients referred by primary care, those with a clinical diagnosis of CTS who have tried wrist splint and whose symptom severity is judged by the examining surgeon to warrant surgery are offered to be put on the waiting list for carpal tunnel release. This means a waiting time of approximately 3 months. Patients who give informed consent will be asked to attend the outpatient clinic for a physical examination followed by allocation to one of the three trial groups. Immediately following the allocation the patients will receive the assigned treatment.

www.biomedcentral.com/1471-2474/11/76

Eligibility Criteria:
Inclusion Criteria:

* Primary, idiopathic CTS
* Age 18-70 years, either gender
* Symptom duration of at least 3 months and inadequate response to wrist splint
* Symptoms of classic or probable CTS according to the diagnostic criteria in Katz hand diagram
* Nerve conduction studies showing median neuropathy at the wrist and no other abnormalities or, in the absence of abnormal nerve conduction study results, 2 surgeons should independently diagnose the patient with CTS.
* Scheduled for carpal tunnel release (ie, symptom severity indicating need for surgery)exclusion criteria

Exclusion Criteria:

* Previous steroid injection for CTS in the same wrist
* Inflammatory joint disease, diabetes mellitus· Vibration-induced neuropathy, polyneuropathy
* Pregnancy
* Trauma to the affected hand in the previous year
* Previous CTS surgery in the affected hand
* Inability to complete questionnaires due to language problem or cognitive disorder
* Severe medical illness
* Known abuse of drugs and/or alcohol
Investıgatıon Of The Effect Of The Pandemıc Process In Indıvıduals Wıth Chronıc Low Back And Neck Paın

There are a limited number of studies examining the difficulty of reaching treatment related to the pandemic process and the general effects of the process in patients with chronic low back and neck pain. However, no study has been found that compares the effects of individuals actively carrying and not carrying the Covid-19 virus. For this reason, the aim of the study is to examine the effects of the pandemic process on the cognitive level, pain catastrophization, physical activity level and quality of life in individuals with chronic low back and neck pain.


Eligibility Criteria:
Inclusion Criteria:

* Those between the ages of 18-60,
* Having low back or neck pain lasting longer than 3 months,
* Having a history of Covid-19 (At least 6 weeks-post acute),
* Individuals with chronic low back and neck pain without a history of Covid-19 will be included.

Exclusion Criteria:

* Those with an active diagnosis of Covid-19
* Having a rheumatological disease,
* Broken etc. severe deformity that may lead to nerve injury,
* Having a history of spinal surgery,
* Having neurological disease in addition to spinal pathology,
* Having problems such as cancer, diabetes, dementia, organic brain dysfunction,
* Illiterate individuals will not be included.