cyrilzakka/clinical-trials huggingface dataset:
The Effect of Midwife-led Education Based on Pender's Health Promotion Model on Perinatal Mental Health of Migrant Women

This randomized controlled experimental study was conducted to evaluate the effects of midwife-led Pender's Health Promotion Model-based education given to immigrant women on perinatal mental health. The study was conducted with 52 intervention and 54 (n=48 in the post-test) control groups. The study consisted of five interviews. The intervention group received 3 modules of training, and the control group received routine clinical care.

This randomized controlled experimental study was conducted to evaluate the effects of midwife-led Pender's Health Promotion Model-based education given to immigrant women on perinatal mental health. The study was conducted with 52 intervention and 54 (48 in the post-test) control groups. The study consisted of five interviews. Data were collected using an introductory information form, perinatal mental health information form, Edinburgh Postnatal Depression Scale and Perinatal Anxiety Screening Scale. Appropriate statistical analyses were performed in the analysis of data showing non-parametric distribution. The intervention group received 3 modules of training, and the control group received routine clinical care. The depression scores of the women in the intervention group did not show any significant difference over time, while the scores of the control group showed a significant difference. Depression scores between the groups showed significant differences in the third and fourth interviews. The anxiety scores of the women in the intervention and control groups showed a significant difference over time. No significant difference was observed between the groups in terms of anxiety scores. It can be said that the education based on Pender's Health Promotion Model has a protective and improving effect on perinatal health.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer to participate in the study,
* Be over 18 years of age,
* Literate,
* Be of Syrian nationality and native Arabic,
* Be primiparous or multiparous,
* Be in the 28th-34th week of pregnancy.

Exclusion Criteria:

* Having a diagnosed risky pregnancy,
* Having a diagnosed mental illness (psychiatric report status, illness diagnosed by a psychiatrist and receiving treatment),
* Being benefited from psychological counseling, psychotherapy etc. services,
* Being excluded or excluded from the research at any stage of the research.
ESPRIT: European/Australasian Stroke Prevention in Reversible Ischaemia Trial

The objective of ESPRIT was to compare the efficacy and safety of mild anticoagulation or a combination treatment of aspirin and dipyridamole with the efficacy and safety of treatment with aspirin alone after cerebral ischemia of arterial origin.

Low-dose aspirin (ASA) (at least 30 mg/day) prevents only 13% of subsequent vascular events after minor cerebral ischemia of arterial origin. Anticoagulation (AC) has been proven highly effective in preventing vascular events after myocardial infarction and after cerebral ischemia in patients with atrial fibrillation. A previous study on the effects of AC after cerebral ischemia of arterial origin (SPIRIT) showed that high intensity AC (INR 3.0 to 4.5) is not safe, but that mild AC (INR 2.0 to 3.0) was. The 2nd European Stroke Prevention Trial (ESPS-2) reported a 22% relative risk reduction of the combination of ASA and dipyridamole (DIP) above that of ASA only; its results, however, are subject to debate.

Study design: ESPRIT was an open randomised controlled trial allocating patients who experienced a transient ischemic attack (TIA) or a non-disabling ischemic stroke to either:

A. oral AC (INR 2.0 to 3.0);

B. the combination of DIP (400 mg daily) plus ASA (30-325 mg/day); or

C. ASA only (same dose).

The mean follow-up was three years. Primary outcome was the composite of vascular death, stroke, myocardial infarction or major bleeding. Outcome assessment is blind.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting in the participating hospitals with a TIA or non-disabling stroke of atherosclerotic origin
* Randomisation within 6 months after the TIA or minor stroke
* Modified Rankin scale of 3 or less

Exclusion Criteria:

* (Contra)indication to, or intolerance to, anticoagulants, dipyridamole, or aspirin
* Disease expected to cause death within weeks or months
* Source of embolism in the heart
* Moderate or severe ischemic damage to the white matter of the brain (leukoaraiosis)
* Anemia, polycythemia, thrombocytosis, or thrombocytopenia
* Planned carotid endarterectomy
* Intracranial bleeding or cerebral tumour
* TIA or stroke caused by vasculitis, migraine, or dissection
* Severe hypertension
* Liver failure
* Pregnancy
* Chronic alcohol abuse
VEAPS: Vitamin E Atherosclerosis Prevention Study

The purpose of this study is to examine whether vitamin E (DL-alpha-tocopherol) supplementation will reduce the progression of early atherosclerosis in healthy individuals over 40 years of age with low-density lipoprotein (LDL) cholesterol levels greater than or equal to 130mg/dL.

The primary hypothesis to be tested is that vitamin E supplementation of 400 IU/day exerts positive arterial wall effects by reducing progression of early atherosclerosis in healthy individuals 40 years old or older without clinical evidence of cardiovascular disease (CVD). Ultrasonography will be used to measure the rate of change of the distal common carotid artery (CCA) far wall intima-media thickness (IMT). The beneficial effects of vitamin E supplementation are expected to occur with or without a change in LDL-C levels.

A total of 353 men and women will be recruited for the three-year trial. Participants will be randomized into a treatment group to receive either vitamin E (DL-alpha-tocopherol) 400 IU/day or a placebo. The ultrasound measurement of CCA IMT will be repeated every six months for two years.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* 40 years or older
* Fasting LDL-C level 130 mg/dL or greater, TG (triglyceride) levels 500mg/dL or lower

Exclusion Criteria:

* Any clinical signs or symptoms of cardiovascular disease (CVD)
* Diabetes mellitus or fasting serum glucose 140mg/dL or greater
* Regular vitamin E supplementation for more than 1 year
* Lipid standardized plasma vitamin E levels greater than 35 micromoles per liter (μmol/L)
* Uncontrolled hypertension (diastolic blood pressure 100 mmHg or greater)
* Thyroid disease (untreated)
* Renal insufficiency (serum creatinine greater than 2.5 mg/dL)
* Life threatening disease with prognosis less than 5 years
* Alcohol intake greater than 5 drinks per day (1 drink = 1 1/2 oz distilled spirits, 4 oz wine, or 12 oz beer) or substance abuse (intravenous drug abuse, cocaine use)
Neurosensory Deficit of Inferior Alveolar Nerve Following Mandibular Orthognathic Surgery.

This clinical study investigates the sensation deficit in the lower lip and chin area after surgical correction of lower jaw deformity.

The primary null hypothesis is: Lower jaw osteotomy cause no sensory deficit in the inferior alveolar nerve.

The secondary null hypothesis is: Concurrent genioplasty with sagittal split does not increase the risk of sensory deficit in the inferior alveolar nerve.


Eligibility Criteria:
Inclusion Criteria:

* Patients with lower jaw deformity requiring bilateral sagittal split osteotomy

Exclusion Criteria:

* Medically compromised patients
* Previous neurosurgical procedure
* Patients on chronic medications
* Patients with a mental or psychiatric disorder
* Pregnant and lactating female
* Previous neurosensory deficit due to trauma, pathology, or surgery
* Patients with facial pain disorders including trigeminal neuralgia, temporomandibular disorder, or atypical facial pain
The Effect of Hyperoxia on Ventilation During Recovery From General Anesthesia

In this randomized-controlled trial the investigators will examine the effect of oxygen supplementation on the recovery of breathing for 90 minutes in the immediate post-anesthesia period starting from extubation of the trachea.

In a pilot randomized-controlled trial (NCT04723433) the investigators found that hyperoxia, compared with standard O2 supplementation, enhanced ventilation, as estimated by the fraction of time at a transcutaneous PCO2 (TcPCO2) \> 45 mmHg.

More specifically, patients treated with hyperoxia (O2 titrated to: SpO2 \> 96%, N=10; Liberal O2) for 90 minutes post-anesthesia, spent 61.2% of the time at TcPCO2 \> 45 mmHg, compared with 80.6% of the time in those receiving standard O2 supplementation (O2 titrated to: SpO2 between 90-94%, N=9; Conservative O2 - between-group difference of 19.4% (95% CI: -18.7% to 57.6%), ANCOVA adjusted P = 0.140\]. Results were consistent across the 90-min monitoring period. With an observed effect size of 0.73, it was estimated that 30 participants per group are required, to demonstrate this difference with a power of 80% at a two-sided alpha of 5%.

In the present confirmative randomized controlled trial, the investigators plan to estimate and compare the cumulative segment of time during which the transcutaneous partial pressure of carbon dioxide will exceed an upper limit of 45 mmHg (i.e., TcPCO2 \> 45 mmHg) for the 90-min-long post-anesthesia period, between the conventional (titrated to an oxygen saturation \> 96%) and the conservative (titrated to O2 saturation 90-94%) O2 supplementation interventions.

Hypothesis: Conservative use of O2 (titrated to an SpO2: 90 - 94%), will be associated with more hypoventilation (i.e., more time spent with an TcPCO2 \> 45 mmHg) during recovery from general anesthesia, compared to liberal O2 supplementation (SpO2 \> 96%).

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I-III
* Body mass index (BMI) less than 40 kg/m2
* Scheduled to undergo robotic-assisted radical laparoscopic nephrectomy or prostatectomy.

Exclusion Criteria:

* Patients with a diagnosis of chronic obstructive pulmonary disorder (COPD), severe neurological, cardiopulmonary, psychiatric, or untreated thyroid disorder
* Chronic pain condition that is being treated with opioids
* Patients with a hematocrit lower than 30% at the end of surgery, or those with an excessive blood loss, requiring transfusion of blood products during surgery.
Open-label Study of the Absorption, Metabolism, and Excretion of [14C]TVB-2640 Following a Single Oral Dose in Healthy Male Subjects

A Phase 1, Open-label Study of the absorption, metabolism, and excretion of a single oral dose of \[14C\]TVB-2640 healthy male subjects.


Eligibility Criteria:
Key Inclusion Criteria:

* Males, of any race, between 19 and 55 years of age, inclusive.
* In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia \[eg, suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable) at Screening and Check-in as assessed by the Investigator (or designee).
* History of a minimum of 1 bowel movement per day

Key Exclusion Criteria:

* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
* History of corneal edema, keratitis, xerophthalmia (dry eye), or other corneal abnormalities.
* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (cholecystectomy will not be allowed; uncomplicated appendectomy and hernia repair will be allowed).
* Presence of any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines.
* Use of any sensitive substrates of cytochrome P450 (CYP)2C9 or CYP3A4/5, or inhibitors of CYP3A4 within 30 days prior to IMP administration (Day 1).
* Donation or loss of ≥ 550 mL blood from 3 months prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
Online Group-based Dual-task Training to Improve Cognitive Function of Community-dwelling Older Adults

Objectives: This study aims to explore the feasibility, acceptance, and efficacy of online group-based dual-task training as an intervention for improving cognitive function among community-dwelling older adults.

Hypothesis to be tested: We hypothesize that after the intervention, there will be an improvement in the participants' cognitive function as compared with pre-intervention status and with the control group. Also, lower-limb muscle strength and psychosocial wellbeing will be improved after the intervention.

Design and subjects: This is a randomised controlled feasibility study. The target population is community-dwelling older adults with access to an online meeting platform. About 75 participants will be recruited and randomised to the intervention and attention control groups in a ratio of 2:1. Intervention group will receive 60 minutes of online group-based dual-task training twice a week for 12 weeks led by a trained facilitator. Cognitive training components include arithmetic operation, verbal fluency, and upper limb/finger movement. Physical training components are chair-based exercises. The training components will be selected using a co-design approach.

Instruments: Memory Inventory in Chinese (MIC), Digit Span Test, Victoria Stroop Test, Montreal Cognitive Assessment 5-Minutes (Hong Kong Version).

Main outcome measures: Subjective memory complaints as measured by MIC.


Eligibility Criteria:
Inclusion Criteria:

* aged 65 years and above,
* no communication problems,
* able to communicate in Chinese, and
* able to use an online meeting platform.

Exclusion Criteria:

* contraindications to chair-based exercises, and
* engagement in any kind of cognitive training three months prior to the study or during the study period.
Executive, Activities of Daily Living, and Cholinergic Functions in Parkinson's Disease

This research study will evaluate functions of memory, thinking, behavior, and daily life activities and how these relate to the measurement of certain chemicals (acetylcholine and dopamine) in the brain using an imaging procedure called positron emission tomography (PET). You may know that in Alzheimer's dementia (dementia is a disease where persons become forgetful and confused), a reduction in the amount of acetylcholine, a "neurotransmitter" substance (a chemical messenger that nerve cells need to communicate with each other), may be responsible for some of the memory and behavioral changes. At the present time, the investigators have no clear information on the levels of acetylcholine in the brain of patients with Parkinson's disease who also have memory or behavioral changes.


Eligibility Criteria:
Inclusion Criteria:

* PDD: Patients who meet the UK Parkinson's Disease Society Brain Bank Research Center (UKPDSBRC) clinical diagnostic criteria for PD with dementia (MMSE 18-25; n=28; age 50-85 years; M/F) are eligible for the study. Hoehn and Yahr stages I-III.
* PD. Patients with who meet the UKPDSBRC criteria for PD with a MMSE of \>25 (n=28; age 50-85 years; M/F). Hoehn and Yahr stages I-III.
* Normal control subjects (n=16) (age 50-85 years; M/F).
* No current or past history of neurologic or psychiatric illness.

Exclusion Criteria:

* Any subjects on cholinergic, anti-cholinergic drugs will be excluded from the study.
* Current or past history of neurologic or psychiatric illness.
Prevalence of Malnutrition and/or Sarcopenia at Hospital Admission

The purpose of this study is to determine the prevalence of malnutrition and/or sarcopenia at admission to the hospital in older adults.

The primary outcome of this study is to determine the prevalence of malnutrition and/or sarcopenia at admission to the hospital in older adults. The secondary outcome is to assess the relationship between malnutrition/sarcopenia status and length of stay, comorbidity load, polypharmacy, and 30-day readmission.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to the UTMB ACE unit
* Aged 65 years or older
* Able to consent to participate in study (alert and oriented x3)

Exclusion Criteria:

* Because this study aims to determine prevalence of malnutrition and/or sarcopenia at admission to the hospital, patients will be excluded if study measures are not able to be taken within 72 hours of admission.
Virtual Reality Glasses in Palliative Care

Developments in medicine and technology have led to an increase in life expectancy and an increase in the need for palliative care. palliative Care aims to reduce or eliminate a life-threatening situation. The palliative care team cares for the patient and provides informal support to the patient. It should provide care that centers on caregivers (patient's relatives). Relatives of patients who provide palliative care are responsible for their care As it increases, problems such as fatigue, hopelessness and anger may occur. Problems experienced by caregivers of patients Eliminating this problem and integrating it into care by providing psychosocial support is essential for the quality of care. caregivers Health technologies can be used to support In our research, we found that virtual reality glasses were used in palliative care clinics. It is aimed to investigate the effect of patient relatives who care for inpatients on the psychological well-being and care burden. A randomized controlled research design was used in the study. The population of the research is a country in Turkey between June and October 2023. The study consisted of patient relatives who provide care to patients in the palliative care clinic of the public hospital in the province. To research Relatives of patients who met the participation criteria and agreed to participate (control group, n=22; experimental group, n=22) constituted the sample. Data were collected from "Caregiver Introduction Form", "Psychological Well-Being Scale", "Caregiving Burden Scale" and "Virtual Reality Glasses". It was collected using the "Satisfaction Form". Before starting the research, a preliminary study was conducted with four patient relatives. of research In the implementation, firstly the preliminary application of the data collection tools was made. Then, the experimental group was given weekly Videos containing 360-degree images were watched using virtual reality glasses for 30 minutes for three days. In the control group No intervention was made. At the end of the research, the final application of the data collection tools was made. From research The data obtained was analyzed with the SPSS 22.0 package program.


Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the research,
* No vision, hearing or perception impairment that prevents communication,
* Not using glasses to wear VR glasses,
* No psychiatric disease,
* Absence of complaints such as migraine, vertigo, active nausea, vomiting, headache,
* Not having someone to help you care for your patient.

Exclusion Criteria:

* Wanting to leave the research.
Caregiving During Crisis

This study will test a prototype pandemic caregiver training and education course designed for caregivers of persons living with dementia (PLWD). Participants will be randomized to take the course immediately or to take the course after completion of an 8-week waiting period.

Family caregivers, the backbone of care for the upwards of 7 million community-dwelling individuals living with Alzheimer's disease in the U.S., provide at least 85% of the care these individuals receive, at some risk to their own well-being, and are instrumental in navigating healthcare systems. Without their care, it is almost certain that persons living with dementia (PLWD) would have much higher rates of acute and emergency care use than their age-matched peers, perilous venues for them in the best of times, potentially deadly during this pandemic. With coronavirus disease 2019 (COVID-19) restrictions, the amount of care they provide and the expertise needed to provide the care will increase. Typically, caregivers are strangers in healthcare and pandemic landscapes, but they are now called on to enact home care and safety measures and navigate an intricate, complex, and opaque system without the benefit of a compass or a translator, and largely without understanding their role in or having the skills for navigating the system. A variety of interventions have demonstrated benefit in enhancing caregivers' caregiving capacities, with resulting positive outcomes for both caregivers and care recipients. Only a few of these useful interventions, Tele-Savvy among them, have employed distance delivery means, thus enabling rural caregivers and others precluded by circumstance from attending in-person programs to take part in the intervention programs.

The study will assess a psychoeducational intervention for dementia caregivers. Participating caregivers will be randomized to immediately enroll in the study intervention or to be in a waitlist group that will begin the intervention 8 weeks later. Participants will complete interviews at baseline and after the 8-week study period.

Eligibility Criteria:
Inclusion Criteria:

* Providing care for a family member or friend with a confirmed diagnosis of dementia
* Lives in the community
* Co-resides with the PLWD
* Is the main caregiver for the PLWD
* Has access to a computer with internet service
* Can read and understand English

Exclusion Criteria:

* None
The Coronary AccEss After Tavi Registry - A Multicenter Prospective Registry for the Coronary Access After TAVI

The CAvEAT study is a not for profit, international, multicenter study aimed to assess the feasibility of selective coronary angiography (CA) after Transcatheter Aortic Valve Implantation (TAVI), to investigate predictors of successful selective cannulation (anatomical, technical, etc.) and to investigate if there is a significant difference among different type of transcatheter valves in selective coronary cannulation.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic aortic valve disease (stenosis or combined stenosis and regurgitation) candidate to TAVI according to local Heart Team evaluation, including valve-in-valve procedure due to degeneration of a previously implanted surgical bioprosthesis, who undergo coronary access in the same session of TAVI, immediately after transcatheter valve deployment (the procedures have to be consecutive);
* Provision of signed informed consent;
* Age ≥18 Years.

Exclusion Criteria:

* Chronic Kidney Disease stage IV-V (without dialytic treatment; otherwise, patients in dialytic treatment could be included);
* Current participation in an interventional clinical study;
* Age \< 18 years.
Arthroscopic Assisted Lateral Soft Tissue Release for Hallux Valgus

Lateral soft tissue release is commonly performed as part of the surgical correction of hallux valgus. This study will look at the results form a series of patients whom have underwent the arthroscopic lateral soft tissue release.


Eligibility Criteria:
Inclusion:

* \>18 and legally fit for consent
* Symptomatic hallux valgus with HVA \>15 degrees

Exclusion:

* Active physical or mental disorders that could affect rehabilitation including

  * Other conditions affecting ambulation: lower limb injury, neuromuscular problems etc.
  * Mental incapacitation
* Previous hallux valgus surgery