cyrilzakka/clinical-trials huggingface dataset:
Stress Echocardiography Versus Exercise ECG (ExECG) in Women With Chest Pain

The overall question the investigators would like to help answer is whether SE with or without MCE data can be widely used as a first line investigation in women with no previous history of Coronary Artery Disease (CAD) who present with chest pain of recent onset. In order to answer this question the investigators will look at the following:

i) Is SE superior to ExECG in terms of cost to diagnosis and negative predictive value of CAD?

ii) What is the additive value of myocardial perfusion data to wall motion data for predicting significant CAD on angiography and future cardiac events in women?

iii) What is the additive value of Carotid ultrasonography in a large population of women referred for stress testing?

The investigators plan to perform a prospective study on all women seen in our RACPC with no previous history of CAD and intermediate pre-test probability of CAD as determined by National Institute for Health and Care Excellence (NICE) guidelines, who require a functional test as part of their assessment. All patients that meet the inclusion criteria and do not meet any of the exclusion criteria will be approached for consent to the study.

Patients who can perform greater than 5 metabolic equivalents (METS) on the Duke Activity Status Index (DASI) questionaire will be randomised between undergoing an Exercise ECG (Ex-ECG) or Exercise Stress Echo (ESE). The DASI is a 12-item questionnaire that estimates self-reported physical work capacity and is converted to an estimate of peak metabolic equivalents. Patients who do not meet this criteria, will undergo a pharmacological stress echocardiogram using Dobutamine (DSE), including Myocardial Contrast Echocardiography (MCE). Investigations will continue to be performed as per standard clinical departmental protocols as described below. In addition, all patients will undergo carotid ultrasonography. The techniques used are described for completeness as they are all well-established in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Age 30 years and above
* No previous history of Coronary Artery Disease
* Chest pain of presumed cardiac origin, which has occurred in the last month prior to the clinic appointment.

Exclusion Criteria:

* Electrocardiogram diagnostic of cardiac ischaemia and/or infarction (ST-segment deviations\>0.5mm, or T-wave inversion).
* Previous history of Coronary Artery Disease
* Chest pain in the last 24 hours
* Inability to provide informed consent
* Pregnancy
The Effects of Multi-strain Probiotics in Adults With Diarrhea Predominant Irritable Bowel Syndrome

The investigators will evaluate the efficacy of multi-strain probiotics in adults with diarrhea predominant irritable bowel syndrome.


Eligibility Criteria:
Inclusion Criteria:

* willing to consent/undergo necessary procedures
* between the age of 19 and 75 years
* diarrhea predominant irritable bowel syndrome (satisfied with Rome II criteria)

Exclusion Criteria:

* uncontrolled hypertension (Blood pressure \> 180/110 mmHg)
* uncontrolled diabetes mellitus (FBS \> 200 mg/dL)
* malignancy, cerebrovascular disease, cardiovascular disease
* history of abdominal surgery except appendectomy and hernia repair
* inflammatory bowel disease
* clinically or laboratory-confirmed gastroenteritis
* the use of motility drug or dietary fiber supplement in 2 weeks
* serum Cr \> 2 x Upper normal limit
* AST or ALT \> 2 x Upper normal limit
* Pregnancy, Lactating woman
Different Positions During Childbirth

To encourage the application the recommended positions of the World Health Organization during normal childbirth and its effect on maternal and labor outcomes

To assess the effects of adopting upright positions (walking, sitting, standing) during first stage of labor.

To measure the effect of different individual positions on maternal-fetal outcomes.

To determine which position was more comfortable for women.

Eligibility Criteria:
Inclusion Criteria:

* aged \> 18 years old with normal pregnancy, primiparas and multi-paras labor cases.

Exclusion Criteria:

* All high-risk associated factors (Hypertension- DM, Heart disease- renal disease) will be excluded.
rTMS Effect on Cognitive and Psychiatric Dysfunction in Patients With Fibromyalgia

the aim of this work was to evaluate the effect of low frequency rTMS over the right dorsolateral prefrontal area (DLPFC) on Fibromyalgia patients. Fibromyalgia Impact Questionnaire (FIQ), Hamilton depression and Anxiety scale and different cognitive rating scales were evaluated pre-1 month post sessions and pre -post 3 months later. all eligible patients with fibromyalgia (FM) were randomized to have 20 sessions of active or sham rTMS over right DLPFC. The improvement changes in groups were compared in each rating scale.

The present study was aimed to evaluate the effect of low frequency rTMS over the right dorsolateral prefrontal area (DLPFC) on Fibromyalgia patients. recruitment of the patients were consecutively. Impact Questionnaire (FIQ), psychiatric and cognitive scales were evaluated before rTMS. 42 eligible patients with fibromyalgia (FM) were randomly assigned to one of two groups with equal ratio. each patient received 20 sessions of active or sham rTMS (1 Hz, 120% of resting motor threshold with total 1200 pules /session) over right DLPFC. follow up of each patient was done blindly at , one and 3 months later with the same rating scales (FIQ, Hamilton depression and anxiety Rating Scales (HDRS and HARS), Montreal Cognitive Assessment (MoCA), Rey Auditory Verbal Learning Test (RAVLT), Tower of London test (TOL), the Trail Making and Digit Span Tests). comparison between the changes in different rating scales were done at 1- and 3-months follow-up.

Eligibility Criteria:
Inclusion Criteria:

The diagnosis of fibromyalgia was made according to American College of Rheumatology criteria with age at and older than 18 years

Exclusion Criteria:

Inflammatory rheumatic disease, auto immune disease, or other painful disorders. Any uncontrolled clinical disease (such as thyroid, cardiovascular, pulmonary, hematological, or renal disease) that affects cognition. Pregnancy, lactation. patients have one of Contra-indications for rTMS (a history of seizures, brain trauma, brain surgery or intracranial hypertension, a pacemaker, or other metallic implants), Past history of other neurological disorders (neurodegenerative diseases, dementia), or primary psychiatric disorders (psychosis, or major depression (17-item Hamilton Depression Rating Scale \> 23), or drug treatments that affect cognition. Inability to cooperate with the questionnaire survey or the patient refuses to participate in the study.
Assessment of Poles' Attitudes Towards Living Kidney Donation

The main goal of the project is to examine the public opinion on living kidney donation and to assess the knowledge of Poles in this field.

Researchers also want to estimate how large percentage of the respondents will declare their willingness to donate a kidney to a stranger and what percentage of respondents would support a possible extension of the existing law on the collection, storage and transplantation of cells, tissues and organs of July 1, 2005 to include donation to a stranger.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Polish citizenship

Exclusion Criteria:

* below 18 yers of age
* not Polish citizen
The Effect and Mechanism of MMP-9 in Inducing Atherosclerosis

The study will assess the serum expression of MMP-9 in normal people, type 2 diabetic patients and type 2 diabetic patients with atherosclerosis.


Eligibility Criteria:
Inclusion Criteria:

* volunteer to participate and be able to sign informed consent prior to the trial.
* patients with type 2 diabetes, aged 18-60 years old, meeting WHO1999 diagnostic criteria, have not used any drugs.
* The patients have completed carotid ultrasound during hospitalization.

Exclusion Criteria:

* patients with any antidiabetic drugs.
* impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value; Serum creatinine was 1.3 times higher than the upper limit of normal.
* drug abuse and alcohol dependence in the past 5 years.
* systemic hormone therapy was used in the last three months.
* patients with infection and stress within 4 weeks.
* any other obvious conditions or associated diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors and other diseases, other pancreatic diseases, history of mental diseases.
Predictive Value of Bone Turnover Markers During Discontinuation With Alendronate

The study is a cohort study comprising 136 patients with osteoporosis stopping treatment with alendronate. The study will contribute with new knowledge about biochemical markers of bone turnover as predictors of bone loss after stopping treatment with alendronate.

Background:

Osteoporosis increases the risk of fractures. Alendronate reduces the risk of both vertebral- and hip fractures by approximately 50%. It has, however, become evident that long-term anti-resorptive may lead to serious side effects such as atypical femoral fractures or osteonecrosis of the jaw. The alendronate extension study (FLEX) showed that despite stopping treatment after five years the anti-fracture efficacy regarding non-vertebral and radiological vertebral fractures persists for an additional five years in patients with bone mineral density (BMD) T-score \> -2.5 at the femoral neck, no fractures during treatment, and no previous vertebral fracture. It is therefore now clinical practice, that treatment is discontinued after five years in patients that fulfil these criteria. Based on the alendronate extension study it was assumed, that bone turnover monitored by biochemical markers would stay suppressed for years after stopping treatment, however, other studies have demonstrated that there is a great variability in the change in bone turnover markers seen after stopping treatment with alendronate in a real-life setting.

Aim:

To investigate the predictive value of markers of bone turnover on bone loss 12 months after stopping alendronate therapy.

Methods:

The study is a cohort study comprising 136 patients with osteoporosis stopping treatment with alendronate.

Perspectives:

The study will contribute with new knowledge about biochemical markers of bone turnover as predictors of bone loss after stopping treatment with alendronate. It will thus be possible to identify patients who will experience a decrease in BMD during treatment break, and for this particular group of patients treatment can be re-initiated earlier so further loss of bone will be avoided. On the other hand, the biochemical markers of bone turnover could also shed light on who can tolerate treatment break, thereby avoid long-term treatment with alendronate, which may be associated with serious side effects. Finally, the use of blood samples rather than DXA will reduce the use of X-rays.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women (postmenopausal for at least two years)
* Men above 50 years
* Treatment for at least five years with alendronate
* BMD T-score total hip \> -2.5
* BMD T-score lumbar spine (L1-L4) \> -4

Exclusion Criteria:

* Any low-energy fracture within the previous five years during alendronate treatment (not including fingers, toes, or skull)
* Low-energy vertebral fracture at any time
* Low-energy hip fracture at any time
* Ongoing treatment with glucocorticoids
* Metabolic bone disease
* Hormone replacement therapy
* Cancer
* Other conditions affecting bone metabolism
Safety and Tolerability of HepaStem in Patients With Cirrhotic and Pre-cirrhotic NASH Patients

Multicenter, open-label, safety and tolerability study of ascending doses of HepaStem in patients with cirrhotic and pre-cirrhotic non-alcoholic steato-hepatitis (NASH) to determine the safety and tolerability of ascending single and repeated doses of HepaStem administered to patients with cirrhotic and pre-cirrhotic non-alcoholic steato-hepatitis (NASH)


Eligibility Criteria:
Main Inclusion Criteria:

* Able and willing to provide written informed consent and comply with the requirements of this study protocol
* Age 18 to 70-years old, inclusive
* Proven diagnosis of NASH based on histological evidence from biopsy performed within 6 months for F3 patients and within 2 years for F4 patients prior to Screening If no biopsy is available within these time windows, a biopsy should be performed at Screening NB: For F4 patients for whom the biopsy cannot confirm the diagnosis of NASH, any other causes of underlying liver diseases should be excluded

Main Exclusion Criteria:

* Alcoholic liver disease or alcohol consumption exceeding the daily intake of 140g/w (two doses) for women and of 210g/w (three doses) for men
* Other causes of liver disease including, but not limited to, alcoholic liver disease, active hepatitis B (HbsAg+), hepatitis C (PCR positive), autoimmune disorders, drug-induced hepatotoxicity, Wilson disease, hemochromatosis, and alpha-1-antitryspin deficiency based on medical history and/ or clinical and biological assessment
* Recent recurrent or ongoing thrombotic or bleeding events within 3 months prior the screening
* Patients considered at persistent risk of thrombosis or bleeding at the time of screening
* Patients with high risk of Gastro intestinal bleeding at time of the screening.
* Cerebrovascular, myocardial, or limb arterial thrombotic event within 12 months prior to the screening and/or not considered stabilized by the investigator
* Bariatric surgery within 1 year prior to the screening
* Coagulation disturbances defined as (Drolz et al. 2016, Nadim et al. 2016, Stravitz et al. 2018, Green et al. 2018): fibrinogen at \< 80 mg/dL and/or platelets at \< 40 x 10³/mm3
* Severe hepatic encephalopathy (defined by West Haven grade \> 2)
* Acute Decompensation of cirrhosis with Chronic Liver Failure Consortium Acute Decompensation (CLIF-C AD) score \> 60
* Acute on Chronic liver failure (ACLF) grade 1, 2 ,3
* MELD score \> 20
* Child Pugh score ≥ C
Silver Leaf During Pregnancy in French Guiana : Use and Impact on Health

This is a descriptive, observational, cross-sectional study among women who have given birth in one of French Guiana's maternity hospitals to determine if the use of silver leaf is frequent and could have an impact on pregancy outcomes. This Fey darjan project is an ancillary study of the Nutri Pou Ti'Moun 1 project

French Guiana's ethnomedicines use is still very dynamic, with a significant level of herbal medicine use per inhabitant (17.6 citations of use per inhabitant surveyed) and the continual integration of new species into the local medicinal flora. Over a period of 30 years, studies noted significant changes and mutations in plant-based care methods, favored by a significant intercultural mix (close border areas and migrant population from the Caribbean and South America).

The species Ocotea guianensis Aublet (Lauraceae), known in French Guiana as 'feuille d'argent' (féy darjan in Creole, silvon leaf in english), is used locally to facilitate childbirth. This use (a decoction of leaves administered to parturients as a sitz bath) among the Palikur (an indigenous Amerindian people from northern Amapá in Brazil and eastern French Guiana) and coastal Creoles. This use has been observed more recently by Tareau (2020) among Haitian and Guyanese Creole women According to a preliminary study by a perinatal network in French Guiana, cases of acute foetal distress at the time of delivery and post-partum haemorrhage have been observed in pregnant women who have used silver leaf decoctions, without a statistical or pathophysiological link being formally established.

From an epidemiological point of view, the frequency of use of Silver Leaf Decoctions (SLD) and the medical consequences of this use during childbirth and the immediate post-partum period have not been quantified in French Guiana. Although health-care providers have observed that some women use SLDs when certain pathological events occur during childbirth, no study has demonstrated a definite link between SLDs and complicated childbirth.

The profile of users, the ways in which SLDs are used during pregnancy, and their impact on childbirth, uterine contractions and the immediate post-partum period also need to be clarified. The perception and representations of this practice from the point of view of caregivers are also elements to be taken into consideration.

The research hypothesis is that the use of silver leaf by parturients in French Guiana is frequent and could have an impact on pregnancy outcomes (prolonged labor, ineffective contractions, perinatal pain, cardio-fetal rhythm abnormalities, post-partum hemorrhage...).

Eligibility Criteria:
Inclusion Criteria:

* Women admitted for delivery in one of the French Guiana maternity hospitals and previsouly included in the study Nutri Pou Ti Moun 1 (NCT05653128)

Exclusion Criteria:

* Refusal to participate to study or absence of collection of non-opposition of participant
* Lack of parental consent for minor participants
* Women under gardianship or curatorship
Office-based Methadone Versus Buprenorphine to Address Retention in Medication for Opioid Use Disorder Treatment.

The purpose of this clinical trial is to compare the effectiveness of office-based methadone with pharmacy administration and/or dispensing to office-based buprenorphine for the treatment of opioid use disorder. This study will also examine factors influencing the implementation of office-based methadone.

This study is a randomized, pragmatic hybrid type 1 effectiveness/implementation multisite (approximately 6 sites) trial to determine whether office-based methadone with pharmacy administration and/or dispensing or buprenorphine (BUP) results in greater treatment retention in approximately 600 patients with opioid use disorder (OUD). This trial will also identify implementation barriers, facilitators and acceptability at the patient, provider and health-systems level for office-based methadone with pharmacy administration and/or dispensing.

Eligibility Criteria:
Inclusion Criteria

* 18 years of age or older;
* Meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for OUD;
* Are initiating a new MOUD treatment episode

Exclusion Criteria

* Have been prescribed (and ingested) or been administered more than 72 hours of MOUD in the 7 days prior to randomization as a "bridge" to the new OUD treatment episode. Such MOUD may include prescribed (and ingested) or administered medically managed withdrawal (aka detoxification).
* Known contraindication to methadone or BUP
* Unwilling to pursue or continue pre-natal care or pregnancy counseling if determined pregnant by urine human chorionic gonadotropin (hCG) testing at the screening assessment
* Be actively suicidal or severely cognitively impaired (e.g., dementia, untreated psychosis) precluding informed consent as determined by site clinician
* Current severe comorbid substance use disorder requiring residential or inpatient treatment services as determined by site clinician
* Be unable or unwilling to provide reliable locator information including 2 or more contacts in addition to themselves
* Be unwilling to follow study procedures (e.g., unwilling to receive treatment from site clinician, use the study pharmacy, unwilling to be randomized to BUP or methadone, or will be unavailable for the follow-up assessments) including allowing the researchers to access their record in the EMR and state's prescription drug monitoring program
* Have previously enrolled in CTN-0131
* Currently enrolled in another research study which will conflict with study procedures
* Are currently in jail, prison or other overnight facility as required by a court of law or have pending legal action that could prevent participation in study activities
* Unable to conduct research assessments in English as determined by Site PI or their designee.
Antibody Detection of Vaccine-Induced Secretory Effects

The purpose of this research study is to conduct a prospective longitudinal surveillance research study, enrolling approximately 60 lactating mothers who receive the SARS-CoV-2 vaccine, and then following their clinical and laboratory parameters for up to 12 months. The overall goal is to investigate the characteristics of antibody formation in lactating women receiving SARS-CoV-2 vaccination, documenting the antibody isotypes, titers, duration, and transfer into milk over time.

As the global and pandemic spread of the novel coronavirus (SARS-CoV-2, COVID-19) continues, many knowledge gaps remain regarding the epidemiology and transmission of infection, the immunological responses after viral exposure, and the immunological protection after vaccine administration. Cincinnati had its first confirmed case of COVID-19 on March 14, 2020, and despite extensive shelter-in-place and social distancing efforts, community spread has continued over the past 10 months with several distinct infection surges. As SARS-CoV-2 vaccines are becoming available in early 2021, it is important to understand the immunological effects of these vaccines and to contrast them to the effects of natural infection. Of particular interest are the immunological effects of SARS-CoV-2 vaccines for lactating women, and whether breast milk will include secretory antibodies against the virus that potentially confer protection to the breastfeeding infant. The investigators have a unique but time-limited opportunity to track the humoral immunological responses of SARS-CoV-2 vaccination among lactating women. The investigators designed Antibody Detection of Vaccine-Induced Secretory Effects (ADVISE) to collect and analyze serial breast milk samples for secretory antibody responses, along with periodic blood testing of the mothers and their breastfeeding children. In ADVISE, the investigators will document the prevalence and cumulative incidence of secretory antibody responses to SARS-CoV-2 vaccines, and gain insights into the protective immunological effects of elective vaccine administration.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18.0 years at the time of enrollment
* Currently lactating mothers
* Planning to receive the SARS-CoV-2 vaccine in the next 60 days, or vaccinated with the SARS-CoV-2 vaccine within the past 60 days
* Cell phone that can be used for text messaging or web-based viewing of surveys
* Willing and able to provide informed consent
* Ability to comply with all study related evaluations and follow-up

Exclusion Criteria:

* Any condition or illness that makes study participation ill-advised