cyrilzakka/clinical-trials huggingface dataset:
The Efficacy of Different Anti-viral Drugs in COVID 19 Infected Patients

The (World Health Organization) WHO NOR- (Coronavirus infectious disease) COVID 19 study is a multi-centre, adaptive, randomized, open clinical trial to evaluate the safety and efficacy of hydroxychloroquine, remdesivir and standard of care in hospitalized adult patients diagnosed with COVID-19. This trial will follow the core WHO protocol but has additional efficacy, safety and explorative endpoints.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients, 18 years and above
2. Confirmed SARS-2-CoV-2 infection by PCR
3. Admitted to the hospital ward or the ICU
4. Subjects (or legally authorized representative) provides written informed consent prior to initiation of the study

Exclusion Criteria:

1. Severe co-morbidity with life expectancy \<3 months according to investigators assessment
2. (Aspartate Transaminase/ Alanine Aminotransferase) ASAT/ALAT \> 5 times the upper limit of normal
3. Acute co-morbidity within 7 days before inclusion such as myocardial infarction
4. Known intolerance to the available study drugs
5. Pregnancy, possible pregnancy or breast feeding
6. Any reason why, in the opinion of the investigators, the patient should not participate
7. Subject participates in a potentially confounding drug or device trial during the course of the study
8. Prolonged QT interval (\>450 ms)
The Effects of Levcromakalim in Patients With Cluster Headache

Cluster headache is a primary headache disorder characterized by attacks of unilateral headache of short duration and severe pain intensity. There is an unmet need to understand the underlying disease mechanisms that will ultimately lead to the development of disease-specific medicines. Until now, it has been suggested that the calcitonin gene-related peptide (CGRP) plays a major role in the initiation of a cluster headache attack, possibly involving the ATP-sensitive potassium channels. The current study aims to determine whether the opening of ATP-sensitive potassium channels triggers cluster headache attacks in patients with cluster headache.


Eligibility Criteria:
Inclusion Criteria:

* Cluster headache patients meeting ICHD-3 criteria for episodic and chronic cluster headache of either sex. Patients were defined as having episodic cluster headache in the active phase when they had usual attacks within the last 30 days, episodic cluster headache in the remission phase when they were attack-free for at least 30 days, or chronic cluster headache when they had not had more than 30 consecutively attack-free days over the last 12 months or longer.
* Weight between 50 and 100 kg.
* All preventive medications, except steroid treatments or greater occipital nerve blockade within 30 days, were allowed with stable dosing.
* Negative urinary HCG at baseline.

Exclusion Criteria:

* Primary headache types except above.
* Secondary headache disorders, according to ICHD-3.
* Headache at baseline.
* Anamnestic information or clinical signs of (at inclusion date) hypertension (systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>100 mmHg) or hypotension (systolic blood pressure \< 90 mmHg and/or diastolic blood pressure \< 50 mmHg)
* Known severe or treatment-requiring cardiovascular disease including cerebrovascular disease.
* Anamnestic or clinical evidence of mental disorder or substance abuse.
* Anamnestic or clinical evidence of any disease considered by the investigating physician to be relevant to participation in the study.
* Pregnant or lactating women.
CBPR Strategies to Increase Colorectal Cancer Screening in Ohio Appalachia

The purpose of this project is to implement and evaluate an intervention to increase and sustain rates of use of colorectal cancer (CRC) screening among men and women aged 50 and older in 6 intervention counties in Appalachia Ohio. Researchers will employ community-based participatory research (CBPR) in combination with two CRC interventions that have been developed and piloted with community partners to improve CRC screening

PRIMARY OBJECTIVES:

I. Utilize CBPR methods to develop specific county-level media campaigns and a clinic-based chart reminder for 12 Ohio Appalachia counties focused on CRC screening or an attention control message.

II. Implement and test, using a group-randomized design, a staggered county-wide intervention program that consists of county-specific media campaigns, clinic-specific chart reminder systems, and a combination of both strategies in 6 randomly selected intervention counties vs. an attention control condition in 6 randomly selected control counties.

III. Utilize process and outcome evaluation strategies to assess the efficacy of each strategy.

IV. Utilize the results to plan the dissemination of the intervention into 36 Appalachian counties in 6 additional states of the Appalachia Community Cancer Network (ACCN) in a subsequent study.

OUTLINE: Participants are randomized to 1 of 2 arms.

Arm I: Participants are exposed to the "Get Behind Your Health!" media campaign intervention comprising 3 phases: the media campaign, the medical chart reminder, and a combination of media campaign and chart reminder. Participants also undergo telephone interviews during years 2-4.

Arm II: Participants are exposed to a media campaign, patient education material in clinics, and a combination related to healthy eating, "PEACHES" (Promoting Education in Appalachia on Cancer and Healthy Eating Styles). Participants also undergo telephone interviews during years 2-4.

Eligibility Criteria:
Inclusion Criteria:

* Have a working phone number
* Resident of one of the 12 study counties
* Lived in that study county since the start of the project
* No prior history of CRC, familial/hereditary cancer syndrome (e.g. hereditary non-polyposis CRC), polyps, or inflammatory bowel disease (Crohn's disease)
* Not currently pregnant
* Be in good health (i.e., no contraindications to CRC screening)

Exclusion Criteria:

* No working phone number
* Not a resident of one of the 12 study counties
* Does not live in the study county since the start of the project
* Has a prior history of CRC, familial/hereditary cancer syndrome (e.g. hereditary non-polyposis CRC), polyps, or inflammatory bowel disease (Crohn's disease)
* Is currently pregnant
* Not in good health(i.e.has contraindications for CRC screening)
MBCT for People With Parkinson's Disease and Caregivers

This study aims to explore the feasibility and effectiveness of mindfulness-based cognitive therapy (MBCT) in reducing anxiety and/or depressive symptoms in people with Parkinson's disease (PD) and caregivers of people with PD.

An adapted MBCT intervention will be offered to people with Parkinson's disease (PD) and mild-to-moderate depression and/or anxiety, as well as caregivers of people with PD. Several 8-week long MBCT groups will be held between September 2020 and May 2021, based on the adapted protocol. The MBCT intervention will consist of 90-minute weekly groups focused on teaching mindfulness techniques and ways to recognize cognitive patterns that can increase anxiety and/or depression. Participants will be recruited from the community, according to the eligibility criteria detailed below. For all participants, the pre- and post-MBCT anxiety and/or depressive symptom severity and mindfulness levels (as measured with standardized, validated scales) will be compared, using a paired t-test. For caregivers, pre- and post-MBCT caregiver burden scores will be compared as well.

Eligibility Criteria:
Inclusion Criteria:

* Having a diagnosis of Parkinson's disease (PD) or parkinsonism, established by a neurologist, or being a caregiver of a person with PD or parkinsonism
* Being able and willing to attend 8 weekly 90-minute online group sessions (5-6:30 pm PST)
* Mild-to-moderate anxiety: GAD-7 score ≤ 16
* Mild-to-moderate depression: PHQ-9 score ≤ 18

Exclusion Criteria:

* Severe anxiety: GAD-7 score \> 16
* Moderately severe-to-severe depression: PHQ-9 score \> 18
* Cognitive impairment: Montreal Cognitive Assessment (MoCA) score \< 24
* Heavy alcohol or drug use
* Severe psychosis
* Active suicidal or homicidal ideation
* For people with PD: severe motor fluctuations (less than 2 hours "on" time per day)
* Pattern of engagement with health care that indicates low likelihood of completing an 8-week intervention.
Effect of LY2062430 on the Progression of Alzheimer's Disease

Alzheimer's disease (AD) is an age-related degenerative disorder of the brain, characterized by progressive decline in cognitive function and ability to perform activities of daily living, and ultimately can lead to death due to complications of the disease. AD is thought to be caused by an excess of A-Beta amyloid, a sticky protein in the brain that forms amyloid plaques. Treatments that slow the synthesis or deposition of A-Beta amyloid, or that increase clearance, might be expected to slow the progression of AD.

LY2062430 (solanezumab) is a humanized anti-A Beta peptide immunoglobulin G-1 (IgG1) monoclonal antibody being developed for the treatment of AD. The primary hypothesis being tested is that LY2062430 will slow cognitive and functional decline in AD as compared with placebo. Each patient's participation will last approximately 19 months. Patients taking approved AD medications may participate in this study and continue taking these medications during the study.


Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for mild to moderate Alzheimer's Disease (AD) with Mini-Mental State Examination score of 16 through 26 at screening
* Modified Hachinski Ischemia Scale score of less than or equal to 4
* Geriatric Depression Scale score of less than or equal to 6
* A magnetic resonance imaging (MRI) or computerized tomography (CT) scan in the last 2 years with no findings inconsistent with a diagnosis of AD
* If receiving concurrent AD treatment, must be on the medication for at least 4 months at a stable dose for at least 2 months prior to randomization

Exclusion Criteria:

* Has serious or unstable illness(es)
* Does not have a reliable caregiver who is in frequent contact with patient (at least 10 hours per week)
* Meets National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN) criteria for vascular dementia
* Does not have good venous access, such that intravenous (IV) drug delivery would be difficult
* Has had multiple episodes of head trauma or history within the last 5 years of a serious infectious disease affecting the brain
* Has allergies to humanized monoclonal antibodies
* Chronic alcohol and/or drug abuse within the past 5 years
* Has any contraindications for MRI studies
* Requires treatment with another monoclonal antibody
Maintaining Oral Health With Bio-products

This study will follow a randomised, double-blind, cross-over design. Participants will use mouth rinses containing plant extracts and/or fluoride, as well as a mouth rinse containing only water (placebo). They will use oral appliances containing sterilized enamel and dentine slabs, which will be later collected for analyses.

The cross-over design will allow participants to use all rinses, allowing for a comparison between the rinses within each individual.

This study will be made in three in situ parts. Participants will wear an oral appliance containing sterilized enamel and dentine slabs. During this experimental phase, they will use the designated mouth rinse. After this period, the investigators will remove the enamel and dentine slabs, and will also collect salivary pellicle and any bacterial biofilm forming on the participant's teeth. Participants will also donate saliva for proteomic analysis (protein profile) to verify if there are any differences in proteins in saliva to proteins in the pellicle. Throughout the whole study, all participants will use standardized oral hygiene products.

The experimental mouth rinses contain plant extracts that could interact with salivary proteins and influence the salivary pellicle and oral biofilm, thus bringing positive results against tooth (enamel and dentine) demineralisation.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be healthy young adults of both sexes, with normal salivary flow, with no cavitated caries lesions, no gingivitis or periodontal disease, no severe erosive tooth wear, and no other serious general or oral conditions.
* Participants will have signed an informed consent form.

Exclusion Criteria:

* Presenting oral diseases or conditions, such as untreated cavitated caries lesions, gingivitis or periodontitis, severe erosive tooth wear, etc.
* Participants who are under orthodontic treatment (wearing braces),
* Contraindications to the mouth rinses under study, e.g. known hypersensitivity or allergy to the investigational product,
* Participants using drugs that cause hyposalivation,
* Women who are pregnant or breast feeding,
* Intention to become pregnant during the course of the study,
* Individuals suffering from clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
* Participation in another study with investigational drug within the 30 days preceding and during the present study,
* Enrolment of the investigator, his/her family members, employees and other dependent persons,
* Specific exclusions for the disease under study,
* Specific concomitant therapy washout requirements prior to and/or during study participation
Effectiveness Of The Fibulock Intramedullary Nail

The objective of this post-market clinical study is to evaluate efficacy outcomes and complication rates in patients who have received the Fibulock™ Intramedullary Nail.

This is a retrospective/prospective, multi-site observational study, designed to evaluate the clinical outcomes and complication rates in subjects who were previously implanted with a Fibulock™ intramedullary nail.

Patients will be screened for eligibility and subgroupings. Informed consent will be obtained from those who meet screening criteria and are interested in participating in the study.

Sites will be asked to enroll subjects according to past treatment, with the Fibulock™ intramedullary nail for unstable fibula fracture. The sites will enroll subjects in the study based on inclusion/exclusion criteria.

Patient pre-operative, intra-operative and post-operative records will be reviewed retrospectively. Once enrolled, subjects will undergo an evaluation of fracture outcome and complete a VAS pain score, SF-12, and Foot Function Index at 26 weeks and again at 52 weeks post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* An unstable fibula fracture.
* Must be less than 31 weeks post-implantation
* Must have received surgical treatment with the Fibulock Intramedullary Nail for their unstable fibula - fracture
* Male or female greater than or equal to 18 years of age and skeletally mature.
* Able to understand the requirements of the study, provide a written informed consent and comply with the study protocol
* Ability to understand and provide written authorization for use and disclosure of personal health information.

Exclusion Criteria:

* Patients who are not implanted with a Sonoma Fibulock IM Nail
The Role of Nitric Oxide Synthase in Circulating Progenitor Cell Function

Our main hypothesis is that EPC function is impaired in some populations with high cardiovascular risk as a result of reduced eNOS-dependent NO production.

To determine if a correlation exists between EPC function and eNOS-dependent NO production in EPCs from populations with high versus low cardiovascular risk:

1. High and low cardiovascular risk subjects will be identified based on age or history of cardiovascular disease. Endothelial function will be measured by ultrasound.
2. EPCs will be isolated from peripheral blood of these subjects. EPC function will be assessed by measuring adhesion to endothelium, migration, proliferation, and differentiation, and compared to their expression and activity of eNOS.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give written informed consent and comply with study requirements
* Adult of 18 years or older
* Subjects willing to provide blood and tissue samples

Exclusion Criteria:

* Failure to give informed consent.
* Those unable to consent for themselves.
* Those who cannot read English.
* Patients on Viagra, Levitra, or Cialis
* Patients with malignant disease
* Patients with hematological abnormalities
* Patients with fevers of unknown origin
* Severe comorbidity or alcohol/drug dependence
* Women who are post-menopausal and on hormone replacement therapy, or premenopausal and on birth control pills (premenopausal women will be screened verbally and then by assay of LH and FSH levels in blood samples to identify women in the follicular phase of their menstrual cycle, to reduce variability)
Correction of Breech Presentation With Laser Acupuncture

Acupuncture-type interventions (such as moxibustion and acupuncture) at Bladder 67 (BL67, Zhiyin point) have been proposed to have positive effects on breech presentation. However, the role of laser acupuncture for Breech presentation remains unknown. The aim of this study is to evaluate the effectiveness and safety of laser acupuncture in correcting breech presentation.


Eligibility Criteria:
Inclusion Criteria:

* breech presentation or non-cephalic presentation
* gestation age 28\~34 weeks
* singleton

Exclusion Criteria:

* uterus anomaly
* uterus tumors
* risk of preterm labor
The Effect of Prenatal Education on Primary Cesarean Rate

This is a prospective case-control study examining the impact of antenatal education on mode of delivery. The study will include all deliveries occurring between January 2024 and December 2024. Participants will be divided into two groups: a case group consisting of women who attended antenatal classes (pregnancy school) and a control group of women who did not. The primary outcome will be mode of delivery (vaginal or cesarean).

The study will collect data on gravida and parity. Participants will be further categorized into four groups based on their delivery history:

Women undergoing a cesarean section for their first delivery. Women experiencing a normal vaginal delivery for their first delivery. Women with a history of vaginal delivery who have another vaginal delivery in this pregnancy.

Women with a history of vaginal delivery who deliver via cesarean section in this pregnancy.

Each of these four groups will have a corresponding case (antenatal class attendees) and control (non-attendees) subgroup.

Data on cesarean section indications, the name of the physician performing the cesarean, and the hospital's annual primary cesarean section rates will be requested from the hospital and compared across groups. For the case group, information regarding the specific antenatal education received, the gestational week at which the education was received, and patient characteristics such as age, infant birth weight, and educational level will also be collected.

Inclusion Criteria:

All women who gave birth between January 2024 and December 2024 and attended antenatal classes (pregnancy school) will be included in the study.

For the control group (women who did not attend antenatal classes), participants will be randomly selected, matching the case group (antenatal class attendees) in terms of age, education level, and parity.

Exclusion Criteria:

Women with a history of previous cesarean sections who are undergoing a repeat cesarean in this pregnancy will be excluded.

Women with high-risk pregnancies, such as preeclampsia, preterm labor, preterm premature rupture of membranes, multiple pregnancies, previous cesarean section, or placental abruption, will not be included in the study.

Eligibility Criteria:
Inclusion Criteria:

All women who gave birth between January 2024 and December 2024 and attended antenatal classes (gebe okulu) will be included in the study.

For the control group (women who did not attend antenatal classes), participants will be randomly selected, matching the case group (antenatal class attendees) in terms of age, education level, and parity.

Exclusion Criteria:

Women with a history of previous cesarean sections who are undergoing a repeat cesarean in this pregnancy will be excluded.

Women with high-risk pregnancies, such as preeclampsia, preterm labor, preterm premature rupture of membranes, multiple pregnancies, previous cesarean section, or placental abruption, will not be included in the study.
Active Health Management for Children

The purpose of this study was to develop a children's active health index based on the three main factors-the environment, lifestyle, and the physiological and behavioral traits of children of various ages. To acquire dynamic data, a prospective cohort research was carried out. Construct a dynamic digital health portrait to detect and warn children's health problems early, intervene in a timely manner, and explore a new paradigm of children's active health management.

Under the guidance of the World Health Organization's (WHO) Global Strategy for Women's, Children's, and Adolescents' Health (2016-2030) and China's Child Development Programme (2021-2030), as well as the comprehension that the primary focus of medical care in the future will gradually shift from disease diagnosis and treatment to disease prevention and health management, this study will develop a children's active health index based on the three main factors-the environment, lifestyle, and the physiological and behavioral traits of children of various ages-and conduct a prospective child cohort study. Gather multi-dimensional children cohort data from many sources (medical facilities, schools, families, and communities) that covers physiological indicators, behavioral habits, dietary record, and so on. The meta-model of children's active health is built using ordinary differential equations in conjunction with digital intelligence technology, which enables real-time and all-around data collection, establishes dynamic digital health portraits for children, and dynamically monitors the health status of children as it varies over time and in response to environmental changes. The ultimate goal of this approach is to identify and warn children's health problems early on, implement timely intervention, and ultimately investigate a new paradigm of children's active health management.

Eligibility Criteria:
Inclusion Criteria:

* Age≤ 18 years old, regardless of gender.
* Subject and/or guardian agrees to participate in this trial and signs the informed consent form.

Exclusion Criteria:

* The investigator judged that the subject had poor compliance and was unable to complete the study as required.
* Inability to understand the investigator's presentation or description of this trial.
* Other conditions judged by the investigator to be unsuitable for participating in the trial, such as: acute trauma, critical condition, restlessness of the subject, etc.