cyrilzakka/clinical-trials huggingface dataset:
Post Abortion IUD & Recurrent Abortion 2005-2006

The rate of repeat abortions will be lowest in those women who choose immediate insertion of an IUD post-abortion versus those who immediately choose oral contraceptive pills and those who indicate all other contraceptive choices including no contraception The provision by the health system of IUDs for immediate insertion will result in the lowest health system costs.

The investigators intend to demonstrate whether there are statistically significant differences in the rates of repeat abortions between three groups: 1. women choosing to have an intrauterine device (IUD) inserted immediately post-abortion, 2. those choosing to begin oral contraceptives immediately post-abortion, and 3. all other choices for post abortion contraception including those stating an intention to obtain contraceptives at a later time or from an alternate location or to use no contraception. This data will then be used to conduct a cost-effectiveness analysis of health system provision for cost-free IUDs post-abortion. Thus, if providing a free IUD immediately post-abortion significantly reduces the rate of repeat abortions, it may be more cost- effective for health system services to provide free IUDs at abortion clinics than to field the costs associated with a higher rate of repeat abortions.

The researchers will conduct a retrospective observational cohort study by chart review. The researchers propose to review the charts of women undergoing abortions between January 1, 2005 and December 31, 2006 at Kelowna General Hospital's Women's Services Clinic. The researchers will record the following data from each chart: age, parity, gestational age, date of index therapeutic abortion (TA), dates of subsequent TAs, contraception used at the time of the index conception, contraceptive method chosen post-abortion, and outcome of follow-up at two weeks, such as expulsion of IUD. The researchers will also record the recurrent pregnancy rates.

Eligibility Criteria:
Inclusion Criteria:

* Female resident of Interior Health region seeking an abortion between January 1, 2005 and December 31, 2006

Exclusion Criteria:

* Women undergoing abortions for fetal genetic abnormalities
Leucine Supplementation in Sarcopenic Older Individuals

Caring with older people in west societies has becoming a challenge for all health professional and any measure that can increase health or well-being will be ultimately improve quality of life and life expectancy. Frailty is a geriatric syndrome describing physical and functional decline that occurs as a consequence of certain diseases (e.g., cancer, chronic infection, etc.) but also even without disease. Frailty is characterized by an increased risk for poor outcomes such as incident falls, fractures, disability, comorbidity, health care expenditure and premature mortality. The aetiology of frailty is not well understood but it has been associated with changes in several physiologic systems, including inflammation, metabolic and micronutrients deficits.

The investigators wish to test with a confident perspective that any measured that improve the efficiency of muscular system can prevent the progression of frailty syndrome and that can have many others effects since it has been consistently demonstrated that a proper muscular function in aging is associated with other signs and symptoms. Looking at the literature, there are two clinical trials that evaluated the effect of leucine supplementation in older individuals with beneficial effects. The investigators wish to replicate those findings and to extend the analysis of the effect afforded by leucine supplementation in sarcopenia, frailty and cognitive function in individuals living in nursing homes in Valencia and province. This trial will show the eventual effects of leucine supplementation in elderly people may be also useful to afford some beneficial effects (sleep, cognitive function, depressed mood, balance and gait, etc) by modulating the function of muscular and metabolic system and in reduce the progression of sarcopenia and loss of muscular function.


Eligibility Criteria:
Inclusion Criteria:

* Ability to walk alone or with help of a can or a walker
* Age 60 years or older
* Cognitive function equal or higher than 21points in Mini-mental examination score
* Both genders
* Institutionalized in nursing homes for at least 6 months

Exclusion Criteria:

* Clinical diagnosed severe dementia
* Severe psychiatric disease (i.e. schizophrenia)
* Glomerular filtrate \<30 ml/min/1,73m2
Prolonged Daily Temozolomide for Low-Grade Glioma

The purpose of this trial is to determine the effects (good and bad) temozolomide has on patients with low-grade glioma. It will also determine whether temozolomide is effective in preventing or delaying future tumor growth.

* Treatment with temozolomide is based upon an 11-week cycle (7 weeks on the drug and 4 weeks off). Patients will receive temozolomide once daily for 49 days, then have 28 days without taking temozolomide.
* Every two to four weeks a physical and neurological examination and blood work will be performed. A magnetic resonance imaging (MRI) scan of the patient's brain will be done approximately every three months (before each cycle of treatment).
* Treatment may continue for a maximum of a year and a half based on 6 eleven-week cycles. The actual duration of therapy will depend upon the response to treatment and the development of side effects or toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Histological confirmation of a low-grade glioma (astrocytoma, oligodendroglioma, or mixed oligoastrocytoma)
* Measurable disease on MRI
* Patients that have undergone recent resection for newly diagnosed or recurrent or progressive tumor are eligible if they have recovered from the effects of surgery.
* Patients with recurrent disease my have had one prior chemotherapy regimen
* Older than 18 years of age.
* Karnofsky performance status (KPS) performance score of \> 70%
* Adequate hematologic, renal and liver functions,
* Life expectancy of greater than 12 weeks.
* Negative pregnancy test.

Exclusion Criteria:

* Prior treatment with temozolomide
* Patients who are not neurologically stable
* Acute infection treated with intravenous antibiotics
* Non-malignant systemic disease
* Frequent vomiting, inability to swallow or a medical condition that could interfere with oral medication.
* Previous or concurrent malignancies at other sites, with the exception of surgically cured carcinoma in-situ of the cervix, and basal or squamous cell carcinoma of the skin.
* HIV positive or AIDS-related illness
* Pregnant or nursing women
* Patients with allergy to decarbazine.
Interest of a Short Early Psychological Care in Women With Miscarriage

Miscarriage is a very common complication of pregnancy, accounting for 15.3% (95% CI 12.5-18.7%) of diagnosed pregnancies. Miscarriage would affect one in ten women during her lifetime. Worldwide, 23 million miscarriages occur annually.

Because of its frequency, miscarriage isoften considered as trivial event by caregivers. Still, miscarriage can be a traumatic event. Literature is consistent on the psychological morbidity associated with miscarriage. Anxiety, depression, post-traumatic stress have been studied in women after miscarriage. Cohort studies and clinical trials suggest that psychological and supportive interventions performed in women after miscarriage may improve women's psychological well-being and reduce miscarriage complications in subsequent pregnancies. However, to date, the literature is considered insufficient on the psychological care of women after a miscarriage.

The aim of the study will be to evaluate the interest of a short early psychological care in women with miscarriage.

Eligibility Criteria:
Inclusion Criteria:

* women with an early miscarriage (defined by a spontaneous termination of pregnancy before the 14th week of amenorrhea)
* women aged more than 18
* women agreeing to participate in the study (signing the informed consent form).

Exclusion Criteria:

* ectopic pregnancy
* molar pregnancy
* women with recurrent miscarriages
* women less than 18
Effects of Drospirenone-ethinylestradiol and/or Metformin on Cardiovascular Risk in Hyperinsulinemic Women With Polycystic Ovary Syndrome

To evaluate long-term effects of drospirenone (DRSP)/ethinylestradiol (EE) alone, metformin alone and DRSP/EE plus metformin on some cardiovascular risk factors in hyperinsulinemic PCOS patients

Polycystic ovary syndrome (PCOS), one of the most common endocrine disorders affecting women on reproductive age , seems to be associated with an increased incidence of cardiovascular disease. At present, insulin-sensitizing drugs, such as metformin, represent one of the most important line treatment for hyperinsulinemic PCOS women. Metformin is able to produce favourable outcomes on the metabolic derangements in insulin-resistant normal weight and obese PCOS patients. Oral contraceptives represent the traditional medical therapy for the long-term treatment of PCOS women, in order to obtain regular menstrual cycles and to improve the clinical signs of hyperandrogenism.Based on the above mentioned evidences, the aim of the present study was to evaluate the effects of DRPS/EE alone versus metformin alone versus DRPS/EE plus metformin on the CD4+CD28null T cells frequency and on endocrino-metabolic parameters, in hyperinsulinemic PCOS patients

Eligibility Criteria:
Inclusion Criteria:

* age 18-35
* hyperinsulinemic PCOS

Exclusion Criteria:

* chronic or acute inflammatory disease, cancer, autoimmune disease, treatment with clomiphene citrate, oral contraceptives, antiandrogens, drugs to control appetite or insulin-sensitizing drugs (metformin, pioglitazone and rosiglitazone) during the last 6 months prior to our evaluation, DM2, hypertension, major surgery in the last 3 months or other hormonal dysfunctions (hypothalamic, pituitary, thyroidal, or adrenal causes).
Renal Artery Denervation in Chronic Heart Failure Study

The REACH study, is a prospective, double-blinded, randomised, controlled study of the safety and effectiveness of renal denervation in subjects with chronic systolic heart failure. Bilateral denervation will be performed using the Symplicity Catheter - a percutaneous system that delivers radio frequency (RF) energy through the luminal surface of the renal artery.

Interventional study

Allocation: Randomised Endpoint Classification: Safety / Efficacy Study Intervention Model: Parallel Assignment Masking: Double blind (Subject / CHF team). The interventional operator, will have no role in care of the patient following randomisation.

Primary Purpose: Treatment

Chronic Systolic Heart Failure

Device: Renal denervation (Symplicity Catheter System) Symplicity Catheter System

-Intervention: Device: Renal denervation (Symplicity Catheter System)

Patients are randomised in the cath lab to receive either renal denervation or sham procedure.

Experimental arm: Renal Denervation Control arm: No renal denervation (sham procedure)

In both arms, aftercare is provided by clinicians who are blinded to the randomised allocation arm. Subjects will have been recruited on stable heart failure therapy, and the intention is to maintain this therapy steady during followup.

Eligibility Criteria:
Inclusion Criteria:

* Chronic heart failure due to systolic dysfunction
* New York Heart Association class II or higher
* Maximal pharmacological therapy including (where clinically indicated and tolerated), b-blocker, ACE inhibitors /A2 blocker, Aldosterone blockade.
* Ejection fraction less than 40%

Exclusion Criteria:

* Estimated GFR\<35ml/hr
* Unfavourable renal anatomy (renal artery stenosis)
* Unable to walk on a treadmill for cardiopulmonary exercise test
* Significant valvular disease (moderate or more aortic regurgitation/stenosis or mitral stenosis; severe mitral/tricuspid regurgitation)
* Severe lung disease
* Symptomatic orthostatic dizziness
* Unable to consent
* Pregnancy
PWS Outcomes Assessment Study

This is a longitudinal study during which qualitative interviews will be conducted with caregivers of Soleno C601/C602 study subjects. There is an additional option for caregivers to collect video data of PWS patients doing specific activities of daily life.

The purpose of this study is to understand the real-world and nuanced impact of a potential therapeutic on individual PWS patients. The results of this study will complement the outcomes being captured during the Soleno C601/C602 clinical studies.

There is no treatment or intervention associated with this study.


Eligibility Criteria:
Inclusion Criteria:

Key Inclusion Criteria for Interviews:

Eligible caregivers must:

* Be willing and able to provide informed consent in English
* Care for a C601/C602 trial subject or potential trial subject
* Have access to a smartphone or the internet
* Be able to converse in English

Key Inclusion Criteria for Video Capture:

Eligible PWS participants for the optional daily life video capture must:

* Be willing and able to provide informed consent or assent.
* Be enrolled in the C601/C602 trial
* Be able to converse in English
* Have a caregiver who has access to an Apple or Android smartphone or has internet access and is willing to use a wi-fi-only device to record and upload videos
* Have a caregiver who is willing and able to record activity videos

Exclusion Criteria:

* n/a
Clinical Evaluation of an Investigational Soft Contact Lens

The purpose of this 4-week dispensing trial is to evaluate and compare an investigational soft contact lens worn on a daily disposable basis with three other soft contact lenses also worn on a daily disposable basis.


Eligibility Criteria:
Inclusion Criteria:

* Germany: Be of legal age.
* USA: Be of legal age or, if under legal age, have written consent of parent/guardian to participate and sign informed assent.
* Sign Informed Consent.
* Wear soft contact lenses for at least 3 months prior to the study.
* Wear soft contact lenses on a daily disposable basis, daily wear basis, or occasional extended wear basis.
* Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria:

* Eye injury or surgery within twelve weeks prior to enrollment.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Currently enrolled in any clinical trial.
* Regularly wear contact lenses on an extended/overnight basis.
* Germany: pregnant or lactating.
* Other protocol-defined inclusion/exclusion criteria may apply.
Reproducibility of fNIRS Parameters During Walking

Brain activation can be studied using the Functional Near InfraRed Spectroscopy (fNIRS). It was shown that CPF activation during walking and during dual task could be different in stroke patients and in healthy subjects.

To date, fNIRS reliability is not completely established during walking and during dual task. Therefore, this study will examine the reproducibility of fNIRS parameters during simple walking and during dual task in healthy subjects and in stroke patients.

A fNIRS system will be used to measure the CPF activation. The subjects will walk at their preferred speed on 10 m 3 times and while doing a cognitive task (dual task) 3 times also (in a random order). The same test will be repeated five minutes later. The fNIRS system will be retired and the same test will be repeated 10 min later.

Eligibility Criteria:
Inclusion Criteria:

* Acute stroke group, subacute stroke group, and control group:

  * Age 50 to 80 years
  * Affiliated with a social security plan
  * Able to walk 20 meters unassisted
* Acute Stroke and Subacute Stroke Group:

  * Stroke onset less than 14 days (for the acute stroke group) or between 14 days and 6 months (for the subacute stroke group)
  * Stroke located in the left or right middle cerebral artery.

Exclusion Criteria:

* Acute stroke group, subacute stroke group, and control group:

  * Person under guardianship or curatorship
  * Refusal to sign informed consent
  * Known rheumatologic or cardiologic history
  * Medication that alters the vigilance and may affect walking (high dose psychotropic drugs, antispastic drugs).
* Acute stroke group and subacute stroke group:

  * History of symptomatic stroke
  * Previous neurological disease limiting gait, aphasia or impaired cognitive function (mild cognitive dementia, Alzheimer's or Parkinson's disease)
  * Ambulatory functional category \< 3
* Control group: neurological medical history
The Cork and Kerry Diabetes and Heart Disease Study (Phase II) Mitchelstown Cohort

The aim of the Cork and Kerry Study Phase II (Mitchelstown cohort recruited 2010-11) is to provide an updated profile of glucose tolerance status, cardiovascular health and their related factors in an Irish adult general population sample and to compare the findings with those obtained during baseline assessment of Phase I of the Cork and Kerry study (1998) and the rescreen (2008).

Additional objectives include determining the prevalence of proximal risk factors, such as hypertension, dyslipidaemia, body mass index (BMI) and insulin resistance as well as of more distal risk factors of diet, smoking, alcohol consumption and physical activity, and the association between cardiovascular health and its risk factors with general measures of well-being and mental health. The new cohort includes collection of qualitative and quantitative data in an effort not only to describe the current health status of the cohort and assess individual level determinants but also to provide the appropriate context to interpret the role of behavioural factors and social circumstances on health.

Recruitment was completed on a new cohort of 2047 men and women aged 50-69 years from patients attending a single large primary care centre, the Living Health Clinic in Mitchelstown, a town with a population of 43000 in county Cork. The Living Health clinic includes eight GPs, and the practice serves a catchment area of 20 000, with a mix of urban and rural residents. Participants were randomly selected from all registered attending patients in the 50-69-year age group.

Eligibility Criteria:
Inclusion Criteria:

All participants from the Livinghealth Clinic practice list in the 50-69 year age bracket

Exclusion Criteria:

Duplicates, deaths and ineligibles and those who did not complete the general health questionnaire and physical examination
Study Of Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy

The purpose of this study is to compare the safety and effectiveness of different doses of an investigational medication in women with severe diarrhea-predominant Irritable Bowel Syndrome (IBS) who have failed conventional therapy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with severe diarrhea-predominant Irritable Bowel Syndrome (IBS).
* Failed conventional therapy.
* Willing to make daily calls on a touch-tone telephone.

Exclusion criteria:

* History of or current chronic or severe constipation.
* Bloody diarrhea, abdominal pain with rectal bleeding.
* Thrombophlebitis.
* Abnormal thyroid stimulating hormone (TSH) value.
* Alcohol and/or substance abuse within past two years.
* Pregnant or lactating.
* History/treatment of malignancy within past five years.
Fluid Retention in Rosiglitazone Treated Subjects With Autonomic Neuropathy.

Fluid management study in patients with type 2 diabetes and autonomic neuropathy.


Eligibility Criteria:
Inclusion criteria:

* Subjects with Type 2 Diabetes (T2DM) as defined by the 1999 WHO criteria \[World Health Organisation , 1988/NCD/NCS/99.2\] with stable FPG of = 7.0 and = 15.0 mmol/l who have been established on insulin therapy for at least 6 months
* BMI = 40 kg.m2
* Subject who is willing and able to provide a signed and dated written informed consent.

Exclusion Criteria:

* Subjects with an HbA1c level \> 12%
* Subjects taking oral hypoglycaemic agents other than metformin
* Subjects on insulin dosage \> 200 units/day
Attitude Towards the Concept of CS on Demand

Caesarean section (CS) is a surgical procedure performed to facilitate delivery of the baby through an incision made on the mother's abdomen. Ideally, it is recommended in situations where normal vaginal delivery (VD) can pose risks to either the mother baby or both . In the western world women have only one or two children, while in the East or the Middle East, women are culturally coerced into having many children. Thus, they are more prone to multiple Cesarean deliveries in their lifetime \[1.2\]. ThisAccording to the World Health Organization (WHO), since 1985, the acceptable percentage of worldwide C-sections has been 10-15% of all deliveries \[3\]. One of the most critical findings of the American Center for Disease Control and Prevention found that the Cesarean delivery rate has increased from 20.7% in 1995 to 31.6% in 2016 \[4 \]. It is important to mention that Cesarean deliveries are life-saving procedures when there are obstetrical indications.(5.6) Cesarean delivery indications include fetal malpresentation, multiple pregnancies, chorioamnionitis, arrested labour, oligohydramnios, cord prolapse, cephalo-pelvic disorders, and medical diseases such as eclampsia and HELPP (hemolysis, elevated liver enzymes, and low platelets) syndrome .the number of patients undergoing Cesarean delivery for non-obstetric reasons has rapidly increased. This could be due to many factors influencing the patients' decisions, including possible fetal outcomes concerning beliefs in some cultures and the convenience of patients and obstetricians(7) .cesarean section on demand allows a woman to choose a cesarean section without a medical reason, based solely on her personal preference Five themes that reflected the reasons for elective cesarian birth without medical indication were identified: (1) fear of vaginal birth process, (2) concerns about future sexual life, (3) need for humanized birth, (4) personal reasons, and (5) decision-making process.(8) raising the awareness of providers about the appropriate indications for CS and the importance of advocating for vaginal delivery among eligible women - including those with a previous CScan trigger practice changes that may reduce the incidence of non-medically indicated caesarean delivery


Eligibility Criteria:
Inclusion Criteria:

* pregnant women attending the antenatal care clinic of Sohag University hospital

Exclusion Criteria:

* postmenopausal women
* women with previous two or more cs
* women refusing to participate in the questionnaire
The Effect of Caudal Volumes on the Anatomical Spread of Caudals in Children

Radiological study into the anatomical spread of caudal local anaesthetic in children age 1-7


Eligibility Criteria:
Inclusion Criteria:

* Asa 1 and 2 patients

Exclusion Criteria:

-
The Power of Hand Reflexology in Ameliorating Anxiety, Pain, and Fatigue Among Patients Undergoing Coronary Angiography

Reflexology influences pain perception and pain-impulse transmission by releasing endorphins (12). Patients with a variety of medical illnesses can benefit from hand reflexology by lessening their physical and emotional discomfort (13, 14). Therefore, this study was done to investigate the power of hand reflexology in ameliorating anxiety, pain, and fatigue among patients undergoing coronary angiography


Eligibility Criteria:
Criteria:

Inclusion Criteria:

* Patients between the ages of 20 and 60 who were scheduled for non-emergency CA, Absence of any hands' sensory motor disorders, or upper limb vascular injuries.
* No abnormalities such as amputations, burns, skin lesions, and intervertebral disc herniation.
* No history of mental illnesses.

Exclusion Criteria:

Patients with severe mental problems