cyrilzakka/clinical-trials huggingface dataset:
Prevention of Pre-eclampsia and SGA by Low-Dose Aspirin in Nulliparous Women With Abnormal First-trimester Uterine Artery Dopplers

The objective of this study is to test the efficacy of low-dose aspirin (160 mg/day), given bedtime and started early during pregnancy (≤ 15 +6 weeks of gestation) in nulliparous pregnant women selected as "high-risk" by the presence of a bilateral uterine artery notch and/or bilateral uterine artery PI ≥ 1.7 during the first trimester ultrasound scan (11-13+6 weeks), to prevent the occurrence of pre-eclampsia or small for gestational age at birth.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Nulliparous (no previous pregnancy ≥ 22 SA)
* Singleton pregnancy
* Gestational age ≤ 15 +6 weeks
* Bilateral uterine artery notch (grade ≥ 2) and/or bilateral uterine artery PI ≥ 1.7 during first trimester ultrasound (CRL between 45 and 84 mm)
* Maternal informed consent obtained
* Affiliated to social security system

Exclusion Criteria:

* Women considering voluntary pregnancy termination (≤ 14 weeks)
* Pre-existing (maternal) indication for premature delivery before 37 weeks
* Fetal condition detected during the first trimester scan (fetal malformation or nuchal translucency ≥ 95th percentile)
* Women under anticoagulation
* Allergy or hypersensitivity to Kardegic® or one of its constituents
* Secondary hemostasis disorder responsible for bleeding or risk of bleeding
* Peptic ulcer under evolution
* Lupus or antiphospholipid syndrome
Accelerometer-linked Online Intervention to Promote Physical Activity in Adolescents

The primary objective of this protocol is to test whether an activity monitor with an online motivational rewards component will increase physical activity levels of middle school-aged students. The secondary objective is to learn about the functionality and utilization of the activity meter device among this age group.

The goal of this pilot study is to find out whether an activity meter linked to web-based rewards will increase physical activity levels in middle school aged students who use it over 6 weeks. To test this, students who participate in the study will be assigned to 1 of 3 groups: the meter with web-based rewards group, the Dance Dance Revolution group, or the control group. The physical activity of participants in all 3 groups will be tracked using the an activity meter that participants will be asked to carry daily for the 6 weeks of the study. Participants given the activity meter with web-based rewards or Dance Dance Revolution will be instructed to use them at their own will, as much or as little as they like. Before beginning the study, all participating students will be asked background questions about themselves (such as their gender, age, and ethnic group) and about the kinds of computer and video game consoles they have access to at home. All participants will also complete short questionnaires at enrollment, week 1, week 3 and week 6. These questions will ask participants about their experiences using the assigned devices, their physical activity levels, and their thoughts about their ability to be physically active. At the end of 6 weeks, all participants will finish the study and return their assigned devices to the study coordinator. Height and weight will be measured at baseline and at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Any student 11 to 14 years old with access to a computer that uses either Windows XP or Mac OS X 10.4 operating system with internet access.

Exclusion Criteria:

* Anyone with a medical condition or existing health complications that will interfere with their ability to be physically active.
* Inability to read and write English (though consent forms for parents that speak other languages will be provided).
Status and Develepment Mental Quality of Life COPD/IPF Inpatients Before and After Pulmonary Rehabilitation

As the result of our last study "Long Term effects of an Inpatient Pulmonary Program in Patients with Pulmonary Fibrosis" already demonstrated the positive effects of a Pulmonary Rehabiliation on the mental status. In this current study the aim will be to analyse the personality type regarding anxiety and depression


Eligibility Criteria:
Inclusion Criteria:

* COPD GOLD III-IV
* IPF according Pulmonary Guidelines

Exclusion Criteria:

\< 30% FVC comorbidities with a negativ influence on the prognosis neurological and orthopaedic deficits, which make the participation of the pulmonary rehabilitation impossible non-compliance no written informed consent of the patient
Effect of Bazedoxifene, Raloxifene, and Placebo on Breast Density

It has been shown that women who have dense breasts have an increased risk of breast cancer compared with women whose breasts are less dense. However, while breast density may be a risk factor, the etiology of the relationship between breast cancer and breast density is not understood. Furthermore, it is well recognized that breast cancer can still develop in women whose breasts are not dense.

At menopause, the amount of breast glandular tissue and stroma naturally decreases due to a lack of hormonal stimulation. This is characterized as a decrease in the mammographic density. Although certain medications, including hormone therapy (HT) and dopamine antagonists can increase breast density, these effects are reversible upon discontinuation of the specific agent. Other medications such as the selective estrogen receptor modulators (SERM), raloxifene (RAL) and tamoxifen, have been shown to not affect breast density and allow the normal age-related changes to occur. The effects of bazedoxifene (BZA), a new SERM, on breast density are not known. The purpose of this study is to examine the effect of BZA on breast density changes over 24 months in postmenopausal women. The results may be useful for clinicians to understand the effect of BZA on breast density and its mammographic effects.

This is an observational, multicenter, double-blind, randomized, placebo- and active comparator-controlled study. It is also an ancillary that will use women who are already participants in a phase 3 trial for fracture reduction (protocol 3068A1-301-WW; primary study). In the primary study, subjects received BZA 20 mg, BZA 40 mg, RAL 60 mg, or placebo. This ancillary study will request a subset of participants to use their mammograms taken in this study. Their mammogram will be digitized by a central imaging center. A single radiologist will perform the quantifications of breast density from the digitized mammograms.


Eligibility Criteria:
1. Each subject must have participated or is currently participating in study 3068A1 301, and must satisfy all of the following criteria
2. Has completed 24 months of treatment.
3. Had a mammogram at the baseline visit and at the month 24 visit, and both are original films that are technically acceptable for reading.
4. Was less than or equal to 62 years of age at the time of study randomization in the primary study.
5. Was at least 80% compliant with test article administration.
6. Did not take any medications 6 months prior to screening in the primary study or during the first 24 months of the study that could cause a change in breast density.
7. Was enrolled at a site that has at least 4 subjects meeting all of the above inclusion criteria.
8. Was enrolled at a clinical site that is still participating in the primary study.
Low Dose Continuous Administration of the Progesterone Receptor Modulator VA2914

The purpose of the present study is to evaluate continuous administration of low doses of VA2914 for potential contraceptive activity and effects on the menstrual cycle and steroid hormone parameters.


Eligibility Criteria:
Inclusion Criteria:

* women in good general health with regular, ovulatory menstrual cycles
* age 18-35
* not pregnant
* not sexually active or reliably use barrier methods of contraception
* normal liver and renal functions and normal laboratory exams

Exclusion Criteria:

* pregnant or breastfeeding
* oral contraception, IUD or other hormonal treatment
* use of agents known to induce hepatic P450
* cardiovascular disorder
* hepatic, renal, or gastrointestinal disorder
* metrorrhagia
* abnormal transvaginal ultrasound (at baseline)
* history of abnormal endometrial biopsy,
* cancer
* depression
* mental illness
* epilepsy
* migraines
* abnormal Pap Smear requiring further exploratory examination
* anovulatory cycle before treatment
* extreme overweight or underweight (body mass index \< 16 ou \>28)
* subjects unlikely to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
* use of narcotics
* more than 10 cigarettes per day, more than 2 glasses of wine/beer per day
* surgical procedures planned in the 6 months following screening visit
Pediatric Metabolic Syndrome Study

The Pediatric Metabolic Syndrome Study is an observational study being conducted at the Medical University of South Carolina to investigate cardiometabolic risk parameters in obese subjects ages 4 to 21. A detailed assessment is performed on eligible subjects including fasting labwork, anthropometrics, nutrition analysis, body composition testing, echocardiography, and carotid IMT measurements.


Eligibility Criteria:
Inclusion Criteria:

age 4 to 21 years history of obesity (BMI at or over the 95th% for age/gender)

Exclusion Criteria:

age below 4 or above 21 years no history of obesity current pregnancy current chronic oral steroid use current insulin use
REcanalization of Distal Cerebral Vessels in Acute Stroke Using ApeRio®

The purpose of the REVISAR PMCF is to collect data in clinical practice of the APERIO® and APERIO® Hybrid(17) Thrombectomy Device, which are intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. Recanalization status will be assessed at the end of the procedure using the modified TICI (Thrombolysis in cerebral infarction) score.

Study Type: prospective, multicenter, single-arm, open-label, national

Participants: 11 participating centers in Germany

PI: Dr. Franziska Dorn, University Hospital Bonn, Germany

Estimated Enrolment: A minimum of 130 patients treated with the APERIO® or APERIO® Hybrid(17) Thrombectomy Device due to thrombotic occlusions in a distal vessel of the anterior and posterior circulation (postbifurcal MCA, ACA, PCA)

Follow up: 3 months

Estimated Final Assessment: End of 2022

This is a prospective, multicenter, single-arm, open-label, national Post-Market Clinical Follow-up Study to collect comprehensive information on technical and clinical success and safety of the use of APERIO® and APERIO® Hybrid(17) Thrombectomy Device in a distal vessel of the anterior and posterior circulation (postbifurcal MCA, ACA, PCA). Aperio® and Aperio® Hybrid(17) Thrombectomy Device will be used within its approved indication.

Eligibility Criteria:
Inclusion Criteria:

* Any patient treated with the APERIO® or APERIO® Hybrid(17) Thrombectomy Device due to occlusion in distal vessel of the anterior and posterior circulation (postbifurcal MCA, ACA, PCA) according to IFU
* Age ≥ 18 years

Exclusion Criteria:

* pre stroke mRS ≥ 3
* Any contraindication according to IFU
Microwave Ablation With Splenic Artery Occlusion for Secondary Hypersplenism

This study assesses the effectiveness of microwave ablation of the spleen in conjunction with splenic artery occlusion for treating secondary hypersplenism.

This open-label, single-arm, single-center clinical trial investigates the combined approach of microwave ablation of the spleen and splenic artery occlusion for managing secondary hypersplenism.

Eligibility Criteria:
Inclusion Criteria:

* 1. written informed consent signed prior to enrolment 2. age \> 18 years, both sexes 3.Patients with severe hypersplenism secondary to cirrhosis with clinical diagnosis, White blood cells \<3×109/L, and/or platelet \<50×109/L 4.Patients who have been repeatedly given drugs to raise white blood cells and platelets in clinical practice have poor effect 5.Mental problems such as clinical symptoms or anxiety in patients require interventional treatment for hypersplenism

Exclusion Criteria:

* Patients with any of the following are not eligible for enrollment in this study

  1. Coagulopathy or other blood disorders
  2. Recent use of anticoagulant drugs
  3. Severe hypertension and cardiac insufficiency
  4. Bone marrow aspiration results showed bone marrow suppression
  5. Combined with other spleen malignant diseases
  6. Severe skin infection at the puncture site
  7. Participated in other clinical studies within 2 months prior to the start of the study
  8. Patient or his/her authorized person is unwilling to sign a written informed consent form or unwilling to comply with the study protocol
IBP-9414 for the Prevention of Necrotizing Enterocolitis

Two different dose levels will be evaluated in two different birth weight categories, compared to placebo with regards to safety and tolerability.


Eligibility Criteria:
Inclusion Criteria:

1. Gestational age ≤32 weeks
2. Birth weight: a) ≤ 2,000 g and b) ≤ 1,000 g.
3. \< 48 hours of age.
4. Written informed consent from the patient's legally authorized representative(s).

Exclusion Criteria:

1. Participation in an additional interventional clinical trial in which an investigational drug will be administered.
2. Infants in extremis to whom no further intensive care is offered by attending neonatologist (e.g., infant being provided only hospice/comfort care).
3. Congenital or acquired gastrointestinal pathology.
4. Other conditions of the infant, which in the opinion of the attending neonatologist, preclude participation.
Clinical Evaluation of Localized Scalp Thread Embedding for Male Androgenetic Alopecia

This clinical study aims to evaluate a breakthrough treatment for hair loss (androgenetic alopecia, AGA) using dissolvable threads placed under the scalp skin. The investigators hypothesize that these specially designed threads can improve hair growth, avoiding the need for invasive surgery.

Current AGA treatments taken orally often have limitations, prompting researchers to explore localized approaches. While early studies show promise for localized scalp thread embedding, three key challenges remain: 1) No standardized way to measure effectiveness, 2) Lack of objective biological markers to track progress, and 3) Limited understanding of how exactly these treatments work.

This study addresses these gaps through precise thread placement in balding areas, following international dermatology guidelines. Using advanced measurement tools, the investigators will track changes in hair thickness (primary measure), blood flow patterns under the skin, and oil gland activity (secondary measures). By focusing on one key treatment factor, this research provides the first comprehensive evidence showing how this minimally invasive approach may slow or reverse AGA progression.


Eligibility Criteria:
Inclusion Criteria:

* Male sex
* Age 18-50 years
* No clinically significant comorbidities
* Androgenetic alopecia (Hamilton-Norwood III-V)
* No systemic anti-hair loss therapy use within 3 months
* No topical hair regrowth agent use within 3 months

Exclusion Criteria:

* Active scalp infection
* Scalp psoriasis
* Scalp eczema
* Open scalp wounds
* Allergy to thread materials
* Uncontrolled diabetes mellitus
* Immunodeficiency disorders
* Non-compliance with follow-up visits
* Refusal to provide informed consent
* Investigator-deemed contraindications
Serial Comparisons of Abdominal and Neurological MRI Scans

The purpose of this study is to compare abdominal weight gain and fat distribution to changes in brain morphology in people taking antipsychotic medications.

Abdominal weight gain is a significant side effect of antipsychotic medications. It has even been suggested to be part of the pathology of severe mental illnesses. Studies have shown that in persons with bipolar disorder, increased body mass index (BMI) is associated with irregular changes in the brain. This association has not been tested in persons with psychosis. In this study, we will be measuring abdominal fat distribution as measured by MRI to see if this is associated with abnormal brain morphology.

Eligibility Criteria:
Inclusion Criteria:

* Must be admitted to the BC (British Columbia) Psychosis Program at UBC (University of British Columbia) Hospital
* Must have clinically diagnosed psychosis (e.g. schizophrenia)
* Must be fluent in English
* Must not be contraindicated for MRI (i.e., must not be claustrophobic, have metal in the body, be pregnant, have BMI greater than or equal to 40, etc.)

Exclusion Criteria:

• None, other than those listed above
Effects of Hamstrings Strengthening in Proffesional Athlets

Athelts that meet the inclusion criteria will be randomized into two groups. The experimental group will receive an 8-week (3 days per week) specificl protocol based on hamstring strengthening (isometric, concentric and excentric exercises), and the control group will not receive any additional exercise. The aim of the study is to investigate the changes in hip and knee muscle strength, in the extensibility of cuadriceps, hamstrings and hip abductors, in the physical functions and in the final marks.


Eligibility Criteria:
Inclusion Criteria:

* Professional Athlet
* 3 or more trainign days
* Previous hamstring injury but without symptoms for 3 months or \>30% difference between cuadriceps and hamstrings strength (considered as a risk for hamstring injury)

Exclusion Criteria:

* Sistemic pathologies
* Any other type of musculoskeletal injuries in lower limb or lumbar spine
* To have a previous specific protocol
* To skip more than 3 training days
* General contraindications for physical activity
Dual Task Aerobic Exercise for Older Adults With Cognitive Impairment (HM2)

The investigators proposed research will establish whether combining aerobic exercise with cognitive challenges is feasible and effective in community dwelling older adults with early signs of cognitive impairment.

To determine the effects of dual-task aerobic exercise training on community dwelling older adults with early signs of cognitive impairment. We will compare an exercise intervention (E-I) versus an exercise control (E-C) group. Each week, both groups will accumulate a minimum of 120 minutes of exercise (target 150 minutes) from community-based group classes (50 minutes of aerobic exercise) and also complete 45 minutes of beginner-level Square Stepping Exercise (SSE). The E-I group will also answer cognitively challenging questions while doing SSE (dual-task training). This study will determine whether a combined multiple modality (primary component being aerobic exercise) and dual-task exercise program is both feasible and effective for improving cognitive and mobility status, as well as vascular compliance, in older adults who may be at risk for cognitive and mobility decline.

Eligibility Criteria:
Inclusion Criteria:

* Male/Female 55-90 years old.
* Montreal Cognitive Assessment score ≤27
* Preserved Instrumental Activities of Daily Living (based on Lawton-Brody Instrumental Activities of Daily Living Sale)

Exclusion Criteria:

* Dementia (i.e., Mini-Mental Examination score \<24 or self-reported physician diagnosis)
* Major Depression (\>=16 on the Center for Epidemiologic Studies - Depression Scale combined with clinical judgment by primary study physician)
* Other neurological or psychiatric disorders
* Recent history of severe cardiovascular conditions
* Significant orthopedic conditions
* Have blood pressure \>180/100 mmHg or \<100/60 mmHg
* Unable to comprehend questionnaire material/study procedures
Cardiovascular Risk Categories and Attaining LDL-C Targets in Middle Eastern Adults Aged 30-55 Years of Age

Individuals evaluated for primary and secondary cardiovascular prevention have different levels of cardiovascular risk These levels of risk are the main determinants of the low-density lipoprotein cholesterol (LDL-C) target blood levels that need to be attained.

Individuals evaluated for primary and secondary cardiovascular prevention fall into different levels of cardiovascular risk according to their clinical profile of having atherosclerotic cardiovascular disease (ASCVD), risk factors, and their SCORE. These levels of risk are the main determinants of the low-density lipoprotein cholesterol (LDL-C) target blood levels that need to be attained using LDL-C-lowering agents (LLA).

Contemporary studies that evaluated levels of cardiovascular risk and LDL-C goal attainment in the Middle East are scarce. A prior study (CEPHEUS LEVANT) in the Middle East demonstrated that about 1 in 4 high-risk patients reach LDL-C goals.

The current study aims at studying cardiovascular risk categories according to the 2019 ESC/EAS and 2018 ACC/AHA Guidelines, and the attainment of LDL-C treatment goals in consecutive individuals aged 18-55 years who are evaluated in tertiary care centers as inpatients or in ambulatory care settings. The above age bracket was chosen because these are the individuals most prone to acute cardiovascular events with a high prevalence of diabetes mellitus and cigarette smoking.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-55 y
* Individuals can give a history of the presence or absence of ASCVD and its risk factors

Exclusion Criteria:

* Age below 18 or older than 55
* Refusal of inability to give history on ASCVD and its risk factors
Zostavax® at Minimum Release Specification Approaching Expiry (V211-044)

Primary objective:

To demonstrate whether or not ZOSTAVAX® at minimum release specification approaching expiry potency elicits an acceptable Varicella-Zoster Virus (VZV) antibody fold rise (measured by glycoprotein Enzyme Linked ImmunoSorbent Assay \[gpELISA\]) from pre-vaccination to 4 weeks post-vaccination.

Secondary objectives:

To describe the safety profile of ZOSTAVAX® at minimum release specification approaching expiry potency.


Eligibility Criteria:
Inclusion Criteria:

* Participant of either gender aged ≥50 years
* Positive history of varicella or residence for \>30 years in a country with endemic VZV infection
* All females must be postmenopausal or have a negative serum or urine pregnancy test or acceptable method of birth control for three months after vaccination
* Participant having signed the informed consent form prior to any study procedure

Exclusion Criteria:

* Febrile within 72 hours prior to vaccination
* Prior history of Herpes Zoster clinically diagnosed by a physician
* Previously received a varicella or zoster vaccine
* Exposure to varicella or herpes-zoster within 4 weeks prior to vaccination
* Received any other live virus vaccine within 4 weeks prior to vaccination, or is expected to receive any other live virus vaccine during the study
* Received any inactivated vaccine within 2 weeks prior to vaccination, or is expected to receive any inactivated vaccine during the study
* Was treated with immunoglobulins or any blood products, other than autologous blood transfusion, given during the 5 months prior to vaccination or is expected to be treated during the study
* Taking any non topical antiviral therapy with activity against herpesviruses.
* On immunosuppressive therapy
* Known or suspected immune dysfunction caused by a medical condition, or any other cause
* History of hypersensitivity reaction or anaphylactoid reaction to any vaccine component, including gelatin or neomycin
* Known active tuberculosis
* Significant underlying illness preventing completion of the study