cyrilzakka/clinical-trials huggingface dataset:
Atrial Appendage Closure Prospective Observational Study

The purpose of this research is to monitor how well patients do after surgery for treatment of left atrial appendage (LAA).

Patients will be followed in an observational study. We propose to do a single follow-up TEE at 3 to 6 months (this is standard of care) to confirm LAA (left atrial appendage) occlusion. The TEE is not mandatory (this is not a clinical trial), but will be strongly recommended to patients to confirm the efficacy of treatment. This will help confirm whether patients may safely remain off anticoagulation. The risks of TEE are a less than 1 in 1000 risk of death, and a 1% or less risk of a major complication, such as esophageal perforation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Atrial fibrillation
* Are poor candidates to take warfarin
* Have elected to undergo a LARIAT procedure

Exclusion Criteria:

* none
PK Study of Xevinapant (Debio 1143) in Healthy East Asian Participants

The purpose of this study is to evaluate the pharmacokinetics (PK) of Xevinapant (Debio 1143) and its metabolite D-1143-MET1 as well as safety and tolerability of Xevinapant (Debio 1143) in healthy East Asian participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participant of Japanese or other East Asian origin. Group 1: Japanese participants must be first generation (born in Japan) with both biological parents and all 4 biological grandparents being Japanese native born, lived for less than (\<)10 years outside of Japan, and have no significant change in lifestyle since leaving Japan. Group 2: Other non-Japanese East Asian participants must have both biological parents and 4 biological grandparents of East Asian descent, lived for \<10 years outside of their countries, and have no significant change in lifestyle since leaving from there. East Asia includes Korea or Greater China
* Overtly healthy participants as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring (blood pressure, heart rate, and 12-lead resting ECG)
* Have a body weight within 50 and 110 kilograms \[kg\] (inclusive) and Body Mass Index (BMI) within the range 18.0 to 32.0 kilograms per meter square \[Kg/m\^2\] (inclusive)
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* History of clinically relevant disease of any organ system that may interfere with the objectives of the study or provide a risk to the health of the participant
* History of relevant drug hypersensitivity, ascertained or presumptive allergy/ hypersensitivity to the active drug substance and/or formulation ingredients history of serious allergic reactions leading to hospitalization or any other allergy reaction in general, which the Investigator considers may affect the safety of the participant and/or outcome of the study
* Ongoing or active clinically significant viral (including Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)), bacterial or fungal infection, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives less than or equal to (\<=) 4 weeks prior to or during Screening Period, or completion of oral anti-infectives \<= 2 weeks prior to Screening Visit. Vaginal candidiasis, onychomycosis, and genital or oral herpes simplex virus considered to be sufficiently controlled will not be exclusionary
* History of splenectomy
* History of any malignancy (hematologic or solid tumor) before the Screening Visit, except for adequately treated superficial basal cell carcinoma of the skin (no more than 3 lesions requiring treatment in lifetime) or carcinoma in situ/cervical intraepithelial neoplasia of the uterine cervix
* History of or a positive screening test for hepatitis B, hepatitis C, or human immunodeficiency virus type I and II
* Use of any investigational drug in any clinical study within 5 half-lives from last administration
* Other protocol defined exclusion criteria could apply
Pictorial Warning Labels and Memory for Cigarette Health-risk Information Over Time

Pictorial cigarette warning labels (PWLs) are thought to increase risk knowledge, but experimental research has not examined PWLs' longer term effects on memory for health risks. This trial tests memory for health risks immediately or after a six-week delay for US-representative adult smokers, US-representative teen smokers/vulnerable smokers, and Appalachian-representative adult smokers. In addition, the trial tests the effects of different warning label components and the consequences of memory for labels on risk perceptions and quit intentions.


Eligibility Criteria:
Inclusion Criteria:

* 19-65 years old (adult samples)
* have smoked 100+ lifetime cigarettes (adult samples)
* currently smoke "every day" or "some days." (adult samples)
* 14-18 years old (teen sample)
* have ever smoked a cigarette (teen sample)

Exclusion Criteria:

• have not ever smoked a cigarette (all samples)
Rapid Immunoassay Tests for the Detection of Ruptured Membranes

The aim of the study is to demonstrate substantial equivalence of IGFBP-1/AFP tests with the "predicate device" Amnisure® in detecting pre labor rupture of membranes. 4 test kits are compared against a common referent standard (gold standard), which is clinical assessment.

Premature rupture of membranes (PROM) is defined as spontaneous rupture of membranes (ROM) before the onset of uterine contractions. Its diagnosis is often obvious with the woman presenting with leakage of amniotic fluid, but it could also turn out to be a difficult diagnostic dilemma.

The diagnosis of fetal membrane rupture is conventionally made using a clinical assessment. First, by speculum examination, the clinician looks for amniotic fluid leaking from the cervical os. If clear fluid is visualized leaking from the cervical os, the diagnosis is positive for fetal membrane rupture. More commonly, leaking is absent, and a more extensive workup is required, which includes nitrazine/pH testing, visual inspection of pooling of fluid in the posterior fornix, and a microscopic evaluation of the collected specimen (ferning). Although this approach is considered the standard of care, it is fraught with inaccuracies, requires an intrusive examination and may not provide a rapid diagnosis.

Rapid, point of care, qualitative immunochromatographic tests (ie., Amnisure®, ActimProm®, Amnioquick® Complete and ROM Plus®) that detect proteins found in amniotic fluid at high concentrations, have been used to diagnose the rupture of membranes (ROM) for several years. In many hospitals, Amnisure® has replaced the sterile speculum exam as the standard of care for diagnosing ROM. It identifies Placental Alpha Microglobulin-1 (PAMG-1), a 34 kd fetal glycoprotein, in cervicovaginal secretions.

ROM Plus® ActimProm®and Amnioquick® Complete+ are newer additions into the market for testing for PROM. Both these tests use a monoclonal/polyclonal antibody approach to detect two different proteins found in amniotic fluid at high concentrations. They detect Placental Protein-12 (also known as Insulin-like Growth Factor Binding Protein-1 - IGFBP-1) as well as Alpha Fetoprotein (AFP).

The aim of the study is to demonstrate substantial equivalence of IGFBP-1/AFP tests with the "predicate device" Amnisure®. Stated in statistical terms, the aim is to demonstrated that IGFBP-1/AFP tests are non-inferior to Amnisure® in terms of sensitivity and specificity when both are compared in a paired-sample fashion to a common referent standard (gold standard), which is clinical assessment.

Eligibility Criteria:
Inclusion Criteria:

* Any woman who presents with alleged leakage of amniotic fluid is eligible for recruitment

Exclusion Criteria:

* Known placental previa
* Active vaginal bleeding
Effect of Food and Increased Gastric pH Value on Bioavailability of a Single Dose of BI 207127 in Healthy Caucasian and Japanese Subjects

The purpose of this trial is to investigate the effect of food with different fat content and of gastric pH increase (mediated by multiple dosing of omeprazole) on the relative bioavailability of deleobuvir.


Eligibility Criteria:
Inclusion criteria:

* Healthy males or females according to the investigators assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests. Subjects will be either Caucasian or Japanese (first generation Japanese: born in Japan with parents of Japanese descent, and not more than 5 years out of Japan, documented by medical interview and by appropriate materials - e.g. passport, birth certificate, etc)
* Age 20 to 35 years (incl.)
* BMI 18.5 to 25 kg/m2 (incl.)

Exclusion criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged clinically relevant by the investigator
* Repeated measurement of systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease judged clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug(s)
* Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders
Effect of Eplerenone on Endothelial Function in Patients With Stable Coronary Heart Disease

The aim of the present study is to investigate wether endothelial dysfunction associated with stable coronary artery disease is altered by selective aldosterone antagonism with Eplerenone as potential anti-inflammatory drug versus placebo.

Additionally we hypothesize that selective aldosterone antagonism reduces systemic inflammatory response such as C-reactive proteine, oxidative stress and pro-inflammatory cytokines.


Eligibility Criteria:
Inclusion criteria:

* Male patients (\> 30 years of age) with history of coronary artery disease (documented by coronary angiogram, nuclear imaging, positive stress test)
* Stable cardiovascular medication for at least 4 months Evaluation of the patients will take place at the Department of Internal Medicine, Cardiology, University Hospital Zurich.

Exclusion criteria:

* Evidence for myocardial infarction, unstable angina, stroke within 3 months prior to study entry
* coronary intervention/re-vascularisation procedure within 3 months prior to study entry
* long acting nitrates
* uncontrolled arterial hypertension, defined as RR\>160/90 mmHg
* congestive heart failure (\> NYHA I)
* Ejection fraction \<50%
* AV-Block\>I˚
* creatinine clearance \<50 mL/min
* insulin-dependent diabetes mellitus
* type 2 diabetes with microalbuminuria
* age \< 30 years
* anemia (Hb\<10 g/dl)
* malignancy chronic infection
* smoking
* serum potassium \>5.5 meq/L
* drug abuse
* potassium supplements or potassium-sparing diuretics (amiloride, spironolactone, or triamterene)
* concomitant use of strong inhibitors of CYP450 3A4 (e.g., ketoconazole, itraconazole)
* known history of Cushing disease or Morbus Addisons or diseases of the thyroid gland
Amino Acid Profiling of Spent Culture Medium

The purpose of this study is to develop an algorithm for embryo selection based on amino acid profiling (AAP) of spent culture medium. Development of the algorithm will be based on the ongoing implantation rate of the individual embryos transferred. As evaluated by ultrasound scan in gestational week 7.

IVF/ICSI treatment has permitted many thousands of couples to conceive worldwide yet is limited by low success rates (in UK, approx. 25% live birth rate/treatment cycle for women up to 42 years of age; HFEA Annual Report, 2006) and a confounding high multiple birth rate (23%) due to the transfer of more than a single pre-implantation embryo. Multiple births are associated with prematurity, increased neonatal and maternal mortality and child handicap as well as being a major burden for health care systems. These problems have been highlighted in the data published by the HFEA (2009), which has called for "a professionally-led, coordinated national strategy to reduce the number of multiple births". This challenge could be met if single embryos of known developmental competence could be selected for transfer, thereby making the embryo selection process even more crucial. However, current non-invasive embryo selection criteria using light microscope analysis have limited predictive value for ongoing pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Minimum 4 x 2PN´s on Day 1 post insemination
* Subjects undergoing IVF or ICSI treatment with a maximum of 2 embryos transferred
* Both partners should be capable of understanding the study to which they are consenting
* Females \> 18 and ≤ 40 years of age
* Regular menstrual cycle 21-35 days (both inclusive)
* Women treated with a standard drug protocol

Exclusion Criteria:

* The couple has previously participated in the DK005 study
* Use of assisted hatching
* Indication for TESA or PESA
* Any medical conditions or genetic disorders prohibiting IVF/ICSI or interfering with the interpretation of results of the study (including pre- implantation genetic diagnostics).
* Use of any investigational drug within 30 days before oocyte retrieval
* Any severe chronic disease of relevance for reproductive function.
* Oocyte donation patients (donor or recipient).
Structural Orbital Changes in Anophthalmic Socket Syndrome

Understand better the aetiology and physiopathogenesis of anophthalmic socket syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Unilateral anophthalmic socket syndrome (superior sulcus grading 0 till 4)
* Enucleation/evisceration with primary implant more than 5 years ago
* After informed consent

Exclusion Criteria:

* MRI absolute and relative contraindications such as metallic fragments or metallic containing devices,
* history of orbital trauma, previous anophthalmic socket and eyelid surgery, inflammation, infection, buphthalmos, congenital anophthalmos and radiation
Screening for Sleep Hypoxemia in Pulmonary Arterial Hypertension

In the investigators study, and regarding results of small cohorts in the literature, the investigators hypothesize that hypoxemia is frequent in IPAH and CPEPH. The investigators will explore these patients with a one night polysomnography and transcutaneous capnography, searching for hypoxemia and hypercapnia and by determining its physiopathologic mechanisms.

Pulmonary hypertension (PH) is a rare and severe disease of young adults, characterized by a progressive increase in pulmonary vascular resistances leading to cardiac failure and death. Patients with PH are categorized in two major groups: primary PH (PPH) wich is idiopathic, and secondary PH associated with many conditions such as chronic pulmonary embolic diseases (CPED).Increase in vascular resistance in PH is secondary to vasoconstriction and to a proliferative remodeling process of the arterial wall leading to obliteration of the small arterioles. On the other hand, hypoxemia is known to cause similar changes in vascular architecture. Also, some small cohorts study in the literature mentioned an increase of sleep hypoxemia prevalence accounting for almost 70% of cases. The mechanisms of this hypoxemia are completely unknown.Our study is observational, prospective and transversal, searching for hypoxemic respiratory sleep disorders (HRSD) in PPH and in CPEPH. Included patients will have one night polysomnography (CIDELEC) with a continuous measurement of transcutaneous PCO2.The major objectives are to determine the prevalence of HRSD, their physiopathologic mechanisms and their possible causal factors according to PH history, clinical findings and hemodynamic severity.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 to 75 years
* Patient with IPAH ot CPEPH stable for at least 3 months. Stability is defined by the New York Heart Association classes for dyspnea and the six minutes walking test (6MWT). Furthermore, no changes in medical therapy had occured during the last three months.
* Patients who signed informed consent

Exclusion Criteria:

* Patients with secondary PH associated with other pathologies outside CPEPH ( sclerodermia, systemic lupus erythematous, portal hypertension, chronic HIV infection...)
* Patients who had a functional and/or a hemodynamic degradation during the last 3 months or a change in pulmonary hypertension treatment
* Patients with obstructive or restrictive ventilatory disorder with a Ventricular Ejection Fraction \<60% predicted
* Women without effective contraception
* Patients with a Body Mass Index above 35 kg/m2
* Patient not affiliated to a social security scheme
Transplantation of hAMSCs for Woman With DOR

Patients with Diminished ovarian response (DOR）have a poor in vitro fertilization（IVF） outcome, and is considered one of most challenging tasks in artificial reproductive treatment (ART). Stem cell therapies are rapidly progressing fields and have shown promise in treatment of lots of disease, including aging and premature ovarian failure. The purpose of this study is to determine the safety and efficacy of intra vein injection of human Amniotic Mesenchymal Stem Cells(hAMSCs) in women suffered from infertility caused by DOR.

Patients with Diminished ovarian response (DOR）have a poor in vitro fertilization（IVF） outcome, and is considered one of most challenging tasks in artificial reproductive treatment (ART). Stem cell therapies are rapidly progressing fields and have shown immense promise in the treatment of lots of disease, including aging and premature ovarian failure. The purpose of this study is to determine the safety and efficacy of intra vein injection of human amniotic mesenchymal stem cells(hAMSCs) in women suffered from infertility caused by DOR. The hAMSCs were isolated and cultured in vitro and qualified by National Institutes for Food and Drug Control, China. The serum of each patient was kept and sent for laboratory test before the transplantation. The biomarkers of hAMSCs were detected again before transplantation. The hAMSCs were transplanted via venous in the dorsum of hand. The outcomes of patients were examined during and after the injection. The patients are monitored for hormones, follicles stimulated with minimal stimulation, number of oocyte retrieval and embryos In Vitro Fertilization (IVF).

Eligibility Criteria:
Inclusion Criteria:

1. Women between35 and 45 years, who is diagnosed with Diminished Ovarian Reserve by Bologna criteria, (AFC≤7，or serum AMH level \< 1.10ng/ml), and failed pregnancies in at least two cycles of In Vitro Fertilization(IVF) or Intracytoplasmic Sperm Injection(ICSI).
2. Willing to sign the Informed Consent Form.

Exclusion Criteria:

1. Patients diagnosed with hereditary, immunological and iatrogenic premature ovarian failure
2. Patients allergy to blood products
3. Patients diagnosed with abnormal coagulation function
4. Patients diagnosed with uterine malformation
5. Patients undergoing Preimplantation Genetic Testing
6. Patients diagnosed with hydrosalpinx
7. Patients diagnosed with infectious diseases
8. Contraindications for In Vitro Fertilization-Embryo Transfer(IVF-ET) or pregnancy
9. Prior personal history of stem cell clinical trail or other clinical trails
10. Unwilling to comply with study protocol
11. Patients identified with high risk for stem cell injection
The SafeTrip Study - Step Training to Reduce Falls in Older Adults

Falls in older people are devastating, widespread, costly and increasing in the aging Australian population. Although falls occur in approximately one third of older adults, certain population groups such as the sarcopenic/frail present with further elevated risk of falls. Many exercise interventions have been trialled but systematic review evidence indicates such programs reduce fall rates by an average of only 20% and encounter issues such as compliance.

Reactive balance training (also called perturbation-based balance training) utilises a task-specific approach to balance training, applying repeated exposure to unpredictable perturbations that mimic balance disturbances experienced in daily life. Evidence suggests 50% reductions in falls might be achievable in a time efficient manner with reactive balance training but more evidence is required.

In this study, ecologically valid, unpredictable trips and slips will be exposed to older people in a safe environment to train their reactive balance. Three 40 min weekly training sessions will be followed by 3-monthly retraining session over one year (40 min x 6 training sessions = 4 hours of training in total). The neuromuscular, physiological, psychological, behavioural effects of the reactive balance training will be comprehensively examined.


Eligibility Criteria:
Inclusion Criteria:

* Older persons - aged 65 years and older
* Community-dwelling
* Ability to walk 500m without rest or use of mobility aids

Exclusion Criteria:

* Diagnosed neurological disease - eg Parkinson's disease, multiple sclerosis
* Cognitive impairment and dementia
* Bone fractures or joint replacement (in the past year)
* Pre-existing medical conditions from which the medical practitioner has advised not to exercise
The Efficacy of a RAGT & BWSTT on Children With CP

This study compared the effects of Robotic-assisted Gait Training (RAGT) and body weight support treadmill training (BWSTT) on spatio-temporal gait parameters and walking capacity among ambulatory children with bilateral Cerebral Palsy (CP)

Demographic data were collected from patient medical records in the physiotherapy clinic at King Abdullah Specialist Children's Hospital and by completing the screening sheet . There were two intervention groups in this study. The first group received Robotic-assisted Gait Training (RAGT), while the second group received body weight support treadmill training (BWSTT). All participants from both intervention groups performed the home exercise program. All participants received 24 sessions three times per week over 8 weeks. Some participants were absent from some treatment sessions, either because they were suffering from flu, for reasons related to school, or other reasons. These participants were compensated with other sessions. Outcome measurements were assessed by a physiotherapist blinded to the group allocations. A physiotherapist assessed the participants at baseline and after treatment (at the end of 8 weeks)

Eligibility Criteria:
Inclusion Criteria:

* Children aged from 5 to 14 years with bilateral spastic Cerebral palsy (CP) diagnosed by a pediatrician.
* Gross Motor Function Classifications (GMFCS); levels I (walks without limitation), II (walks with limitation), and III (walks using assistive devices).
* Able to follow instructions and accurately signal pain and discomfort.
* Hip and knee passive Range of Motion (ROM) within the minimum range requirement for Robotic-assisted Gait Training (RAGT) (≤ 10⁰ for hip and knee flexion contracture and ≤ 40⁰ for knee valgus).

Exclusion Criteria:

* Botox injection for lower limb within the past 4 to 6 months.
* Surgical intervention for lower limbs within an 8-month period before the examination date, including tendon release and muscle lengthening in a 1-year period prior to bone surgery.
* Children using an active drug for resisting epilepsy.
* Anatomical leg length difference greater than 2 centimeters (due to the limitations of the RAGT system).
* Bone-articular instability (joint dislocation).
* Fixed joint contractures (bone and joint deformity).
* Baclofen therapy with the use of an implanted infusion pump.
* Inhibited cast for a lower limb within 6 months of the study.
* Significant amblyopia and hearing loss.
* Skin inflammation and open skin lesion around the limb or trunk.
* Significant impairments in endurance due to a limitation in the cardiovascular system based on the patient's history.
* Maximum child weight is 135 kilograms and maximum height is 2.0 meters.