cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the H-Coil Transcranial Magnetic Stimulation (TMS) Device - Safety and Feasibility Study for Treatment of Major Depressive Episode in the Elderly

Purpose: To evaluate the safety and anti-depressive response of the H1 Coil TMS Device in elderly patients suffering from major depressive episode.

Twenty-seven (27) treatment resistance depressed-patients, 68 years of age and above, currently in a depressive episode.All subjects will receive prefrontal deep rTMS of H1 Coil (42 trains of 2 seconds, 10 Hz, with 20 seconds inter-train intervals, up to 120% of motor threshold), for 4 weeks, 5 days a week, overall 20 sessions.Safety and efficacy tests will be conducted before starting the trial (screening), once a week for the trial duration and one month following end of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed by a senior psychiatrist as suffering from major depression episode according to DSM-IV (either as a part of a unipolar or a bipolar disorder).
* Rating on HDRS ≥ 20.
* Age: 68 years and above
* Treated for the current depressive episode, at least 6 weeks per antidepressant with one antidepressant in accepted dose, without improvement, and/or intolerance to 2 antidepressants, according to medical chart and ATHF (antidepressant treatment history form) instruction guidelines.
* Gave informed consent for participation in the study.
* Negative answers on safety screening questionnaire for TMS.
* If referred by a treating psychiatrist, he or she approves of the subject's participation in the study.

Exclusion Criteria:

* Axis 2 diagnosis, which is considered prominent to the current depressive episode.
* Substantial suicidal risk as judged by the treating psychiatrist or by an independent psychiatrist.
* Attempted suicide in the past year.
* Cognitive impermanent - if MMSE \< 24, patient will be further assessed , and may be excluded according to the primary investigator's discretion
* History of seizure.
* History of epilepsy or seizure in first degree relatives.
* Any CNS disorder that may increase risk of seizure significantly
* History of a significant head injury.
* History of any metal in the head (outside the mouth).
* Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps.
* History of frequent or severe headaches.
* Use of hearing aids for hearing loss.
* Known history of cochlear implants.
* History of drug abuse or alcoholism.
* Serious and unstable medical condition, which is likely to exacerbate or endanger the patient during the treatment period.
* Inadequate communication with the patient.
* Under custodial care.
* Participation in current clinical study or clinical study within 30 days prior to this study.
* Patients suffering from bipolar disorder, not currently treated by mood stabilizers
* Patients declared as legally incompetent, with an appointed physical guardian and/or cannot sign informed consent due to cognitive incompetence.
Enhancing Recovery in Coronary Heart Disease (ENRICHD) Patients

To evaluate the effect of psychosocial intervention on mortality and reinfarction in coronary heart disease patients at high psychosocial risk.

BACKGROUND:

As medical treatments for coronary heart disease have become more sophisticated, they have also become more costly. Evidence concerning the effects of medical and rehabilitative therapies on post-myocardial infarction patients' quality of life, including return to work and to normal levels of functioning, has been mixed. At the same time. recent data suggest that psychosocial factors, such as social isolation and depression, are important predictors of morbidity and mortality in coronary heart disease patients. These studies suggest that interventions which provide psychological support to myocardial infarction patients may enhance both the psychosocial and physical recovery of these patients. To the extent that supportive interventions can be shown to impact favorably on survival and health-related quality of life in myocardial infarction patients, the human and financial costs associated with coronary heart disease can be reduced. The initiative originated in the Working Group on Psychosocial Interventions which met in June 1992.

The initiative was given concept clearance by the October 1993 National Heart, Lung, and Blood Advisory Council. The Request for Proposals was released in September 1994.

DESIGN NARRATIVE:

The study design compared a psychosocial intervention group, in which patients were provided with social and psychological treatment designed to decrease social isolation and depression, with a standard medical care group. The combined endpoint was death and reinfarction, measured for up to 4.5 years following hospital discharge. Secondary endpoints included assessment of health quality of life (HQL).

The protocol was approved in May 1996. Recruitment began in October 1996 and ended on October 31, 1999 with 2,481 patients enrolled.

Eligibility Criteria:
Men and women coronary heart disease/myocardial infarction patients, hospitalized for enzyme-documented MI and who are depressed and/or have low social support. Patients must be enrolled with 28 days of the index MI.
Impact of a Multidisciplinary Therapeutic Education Program Being Set up for Patients With Type 2 Diabetes Mellitus

Therapeutic education programs allows in diabetic patients to promote self-care and better perception of the disease The multidisciplinary program of therapeutic education regroups in one day: individual interview, nutritional workshop, self-monitoring blood glucose workshop, physical activity and glycemic objectives workshop.

At the end of the program, individual and personalized goals are given to the patient.

This study aims to evaluate this program success rates and the psychological, anamnesis, and sociological factors linked to success.


Eligibility Criteria:
Inclusion Criteria:

* All Type 2 diabetic patients who participate in the multidisciplinary program
* Signature information form and consent by the patient

Exclusion Criteria:

* None
The Effect and Safety of Low Dose Nebulized Epinephrine in Croup

Croup is common illness presenting emergency department with dyspnea. The main treatment for croup is nebulized L-epinephrine and steroid. The study for the dose of nebulized L-epinephrine is restricted that the study of comparision between racemic epinephrine and L-epinephrine.

The investigators conducted this study to compare the effectiveness of low dose L-epinephrine with conventional dose L-epinephrine.


Eligibility Criteria:
Inclusion Criteria:

* croup children between 6 month and 5 years old
* Westley croup score between 3 and 11

Exclusion Criteria:

* underlying lung or heart disase
* contra indication to dexamethasone
* immune deficient state
* preterm birth
* previous intubation or apnea history
Effects of Diet Manipulation on Women in the Curves Program

The purpose of this study is to look at the effects of a carbohydrate restricted, high protein, high fat diet on weight loss and health outcomes in women participating in the Curves Fitness and Weight Loss Program.

The purpose of this study is to determine if a carbohydrate restricted, high protein, high fat diet (20% carbohydrate, 45% protein, 35% fat; CC-II) promotes more favorable changes in weight loss and health outcomes compared to a traditional high carbohydrate, low protein, low fat diet (55% carbohydrate, 15% protein, 30% fat; AHA) and the Curves moderate carbohydrate restricted, high protein, and low fat diet (30% carbohydrate, 45% protein, 25% fat; CC-I).

Eligibility Criteria:
Inclusion Criteria:

* The participant is an apparently healthy female
* The participant is between the ages of 18 and 60

Exclusion Criteria:

* The participant is pregnant or nursing, or plans to become pregnant during the next 12 months or has been pregnant in the past 12 months
* The participant has uncontrolled metabolic disorder including known electrolyte abnormalities; heart disease, arrhythmias, diabetes, thyroid disease, or hypogonadism; a history of hypertension, hepatorenal, musculoskeletal, autoimmune, or neurological disease
* The participant is currently taking thyroid, hyperlipidemic, hypoglycemic, anti-hypertensive, or androgenic medications
* The participant has taken ergogenic levels of nutritional supplements that may affect muscle mass (e.g., creatine, HMB), anabolic/catabolic hormone levels (androstenedione, DHEA, etc.) or weight loss (e.g., ephedra, thermogenics, etc.) within the past three months
* The participant is willing to participate in a regular moderate exercise program
Growth Hormone Treatment in Children Born Small for Gestational Age: Assessment of Satisfaction

This trial is conducted in Europe. The aim of this trial is to assess satisfaction with growth hormone treatment in children of both sexes born small for gestational age and who are receiving growth hormone treatment.


Eligibility Criteria:
Inclusion Criteria:

* Children treated for 3 years with Maxomat® because of small for gestational age
* Postnatal growth failure by the age of 3 years or more
* No associated growth hormone deficiency
* Height growth velocity greater than 2 cm/yr over the 12 month period preceding the inclusion
* Bone age no more than 13 years for girls and no more than 15 years for boys

Exclusion Criteria:

* Known, evolving tumour
* Hypertrophic cardiomyopathy
* Hypertension not controlled on maximum therapy
* Benign intracranial hypertension
* Known glucose intolerance or known diabetes mellitus
* Acute or active chronic hepatitis
* Chronic renal failure
* Chromosomal and/or genetic syndromes (other than Silver-Russell syndrome) or abnormality
Metabolic Responses After 12-week Hypocaloric Diet Supplemented With a Cereal-based Plant Protein Biscuit

Biscuits enjoy high popularity in the human diet and can be excellent snack alternatives and potential carriers of ingredients with appetite regulating properties. In the present study, the effects of a wheat biscuit enriched with plant proteins originated from legumes and seeds on gastrointestinal hormone responses of women with overweight/obesity after a hypocaloric dietary intervention will be examined.

Women with overweight/obesity will follow a 12-week dietary intervention supplemented with a cereal-based biscuit enriched with plant proteins or a common isocaloric wheat biscuit as a daily snack.

At the beginning and at the end of the dietary intervention postprandial metabolic responses, body weight reduction and subjective appetite ratings will be examined.

Eligibility Criteria:
Inclusion Criteria:

* non-diabetic women with overweight/obesity
* constant body weight for the last three months before enrollment
* standard dietary and physical activity habits

Exclusion Criteria:

* pregnancy
* lactation
* chronic medical illness
* use of nutritional supplements
* alcohol consumption \>2 drinks per day
NIR Fluorescence Imaging of Lymphatic Transport Using ICG

In this phase 1 study, the lymphatic transport will be examined using Near InfraRed Indocyanine Green fluorescence imaging (NIR-ICG) of the upper extremities in healthy individuals using a MultiSpectral Imaging System (MSImager).

Lymphedema from various etiologies (i.e. infection, cancer, surgery, and rheumatoid arthritis) remains a major health concern. Efforts to develop effective treatments for this condition have been limited by the absence of quantitative outcome measures for lymphatic function. Published articles have supported the fact that human lymphatic contractions can be readily visualized after intradermal administration of micrograms of Indocyanine Green using laser-induced fluorescence. The use of lasers imposes a risk of eye injury that requires protective eyewear. To address the risk of laser-induced injury, an imaging system was developed by Drs. Ronald Wood and Jay Reeder in a collaborative effort at the University of Rochester. In place of a laser, this system utilizes a tungsten-halogen lamp fitted with a bandpass filter and a multispectral camera for real-time image acquisition and display. This phase 1 study will examine the validity and reliability of this instrument to measure lymphatic transport, contractions, and pressure in the arms of healthy research subjects and establish baseline parameters for subsequent evaluation of rheumatoid arthritis patients in later studies. Indocyanine Green is a dye that has been used clinically for over 50 years to evaluate hepatic clearance, cardiovascular function testing, and retinal angiography. Indocyanine Green has typically been administered intravenously at concentrations of 2.5 mg/ml at total doses of 25 mg in adults. In this study, intradermal administration of micrograms of Indocyanine Green will be used to establish useful dose ranges and concentrations. The dosage regimen for this study is based on prior demonstrations in published articles of successful noninvasive imaging of lymphatic contractions after intradermal administration of microgram amounts of Indocyanine Green.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent
* Subjects can be either gender but must be at least 18 years old.
* Rheumatoid arthritis subjects may fulfill 2010 American College of Rheumatology criteria.
* Active rheumatoid arthritis subjects, with at least 2 tender or swollen joints.
* Subjects participating in the clearance arm of the study must not have ICG injections for at least 10 weeks.

Exclusion Criteria:

* Individuals with active systemic disorders or inflammatory conditions other than rheumatoid arthritis, (such as chronic infections with hepatitis B, hepatitis C or HIV) that would confound the study results.
* Known sensitivity to iodine because of residual iodide in Indocyanine Green
* Pregnant women should not participate.
Assessment of Airway Obstruction in Infants With Lower Respiratory Infections

The purpose of this study is to evaluate how two different aerosol medications may improve airway function in infants with respiratory illness. We are using two different medications and comparing the difference in lung function after each medication. We will also be taking a nasal wash sample for VEGF. We will be using this in comparing how infants respond to the aerosol medications as well. We hope to help standardize medications used for infants with bronchiolitis and RSV.

We hypothesize that VEGF production is higher in children with RSV infection than in children with other viral infections and normal controls. In addition, the degree of VEGF production is related to severity of airway obstruction. We also hypothesize that infants with higher VEGF levels are more likely to improve lung function following racemic epinephrine than albuterol.

Eligibility Criteria:
Inclusion Criteria:

* Group 1 Infants between 2 and 24 months that are healthy
* Group 2 Infants between 2 and 24 months that have RSV or bronchiolitis and defined as the first episode of wheezing

Exclusion Criteria:

* Group 1 and 2 - no cardiac disease, no oxygen requirement, prematurity \< 37 weeks, and cannot be in the ICU.
Lung Herniation After Uniportal VATS

During patient follow up the investigators noticed the occasional occurence of a lung herniation after uniportal Video assisted thoracoscopic surgery (VATS). Most of These patients were asymptomatic and didn't require any kind of treatment. To analyse the incidence of postoperative lung herniation after uniportal and the presence of symptoms the investigators decided to review every postoperative CT scan from January 2016 until March 2019 to radiologically identify postoperative lung herniations. Afterwards the investigators will contact the respective patient to ask for a follow-up physical examination and symptom evaluation (after consent was signed).


Eligibility Criteria:
Inclusion Criteria:

* Anatomical lung resection using uniportal VATS

Exclusion Criteria:

* Non anatomical lung resection
* Open surgery
* Pneumonectomy
* Informed consent not signed
Open-label, Flexible-dose Study of Vortioxetine in Patients With Depression in India

The purpose of this study is to evaluate the safety and tolerability of flexible doses of vortioxetine (5 - 20 mg/day) over a period of 12 weeks in patients with depression in India


Eligibility Criteria:
Inclusion Criteria:

* The patient has a Major Depressive Episode (MDE), is diagnosed with Major Depressive Disorder (MDD) according to DSM-5® and would benefit from pharmacological treatment with vortioxetine. The current MDE should be confirmed using the Mini International Neuropsychiatric Interview (MINI).
* The patient has a CGI-S ≥4 at screening.

Exclusion Criteria:

* The patient has a significant risk of suicide according to investigator's clinical judgment or has made an actual suicide attempt in the period of 6 months prior to screening.
* The patient previously received vortioxetine.

Other in- and exclusion criteria may apply.
Biomechanical and Viscoelastic Properties of Achilles Tendon in Pregnant Women-Pilot Study

There is anatomical fascial continuity and functional connection between the plantar fascia, which has important roles in foot biomechanics, and the fibers of the Achilles tendon, and the change that will occur in any of these tissues is reflected in the other. However, it has not been objectively clarified how the tissue properties of the Achilles tendon, which plays an important role in foot biomechanics, such as the plantar fascia, change with pregnancy. Therefore, the aim of this pilot study is to investigate the trimester-specific biomechanical (stiffness, decrement and tone) and viscoelastic (creep and relaxation time) properties of the Achilles tendon, which adapts to changes in the foot structure during pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* First pregnancy
* They are between the ages of 18-40
* Pre-pregnancy Body-Mass-Index (BMI) \< 30 kg/m2

Exclusion Criteria:

* Presence of any connective tissue disease that would affect the biomechanical or viscoelastic properties of the fascia
* Deterioration of skin integrity in measurement areas
* Presence of orthopedic, neurological, rheumatic problems that may cause musculoskeletal disorders and deviations from normal in biomechanical alignment
* History of surgery or fracture in the lower extremity and foot-ankle region in the last 6 months
* Defining metabolic disorders such as type I, II diabetes, gestational diabetes mellitus (GDM), preeclampsia
A Pilot Study to Evaluate a Telepharmacy Intervention to Improve Inhaler Adherence in Veterans With COPD

Hypothesis: Can a counseling intervention, delivered by a pharmacist, increase inhaler adherence in veterans with COPD who have demonstrated poor inhaler adherence through pharmacy refill records?

Veterans who receive who receive daily maintenance inhalers from the William S Middleton Memorial Veterans Hospital Pharmacy and who have a medication possession ratio less than 80% over the previous six months will be invited to participate in the study. This study will randomize 100 participants to a usual care arm or a pharmacist counseling intervention. Final data collection will be six months after randomization to determine if both self-reported and refill record adherence has changed.


Eligibility Criteria:
Inclusion Criteria:

* Male and female veterans established with the William S. Middleton Memorial Veterans Hospital and associated Community Based Outpatient Clinics
* Fill their inhaled COPD medications with the VHA
* A diagnosis of COPD and an active prescription for a twice daily long-acting beta-agonist and/or long-acting anticholinergic with or without a prescription for inhaled corticosteroids for at least 4 months.
* Non-adherence to at least one COPD medication, a medication possession ratio of less than 80% or over 120% via the pharmacy refill records.

Exclusion Criteria:

* Patients with a diagnosis or electronic medical record note regarding significant hearing impairment.
* Patients with a diagnosis regarding cognitive deficit and activated power of attorney.
* Patients who use daily nebulization instead of inhalers for maintenance medication.
The Comparison of Educational Effectiveness Between FAST and STROKE 112 in Yunlin Community

FAST and Stroke-112 are two campaigns to reduce the emergency room arrival time of stroke patients. No study has evaluated the effectiveness of these campaigns. This study aimed to compare recalling capacity of people in these two campaigns.

Cerebral vascular accidents have been one of the leading causes of death in Taiwan in recent years. In the modern medical system, treatment for hyperacute stroke including intravenous thrombolysis and intra-arterial thrombectomy. The faster patient received treatment, the better outcome he has.

Prehospital delay of acute stroke treatment has been an important issue in modern medical system. Awareness of stroke symptoms and calling for medical help immediately is the most important part of stroke health education. The most used educational campaign is FAST.

In recent years, there is another stroke educational campaign called STROKE 112. Previous study had showed it has greater acceptance, since the number is easier to remember then letter, especially in non-English speaking countries.

The investigators had conducted a hospital-based randomized study in 2019, which revealed that STROKE 112 had similar, but not superior effectiveness with FAST. However, more study is needed for community-based population.

This study will compare and explore the effectiveness of two stroke educational campaigns, FAST and STROKE 112, on community-based population by using the questionnaire, in Yunlin, Taiwan. The result will been compared and analyzed with previous study, help us modify and enhance our current stroke educational program, shorten the prehospital delay, and improve outcomes of patients with acute stroke.

The subjects will be randomized into either group: FAST or STROKE 112. Then the investigator will give a 15min eduacation. The evaluation will be arranged 5 days and 30 days after the first education, and the outcome is the recalling capacity of the stroke symptoms in the educational campaign.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 20
* individuals who could speak either Mandarin or Taiwanese as their mother tongue

Exclusion Criteria:

* individuals who could not understanding the education campaign(ex. dementia, aphasia)
* individuals who were previously aware about either campaign
Evaluation of Topical B12 for the Treatment of Childhood Atopic Dermatitis

This study is being done to see in B12 applied to the skin will improve the symptoms of eczema in children compared to a placebo creme

INTRODUCTION: Atopic dermatitis is a prevalent disease process in children, affecting up to 20% of children in the United States. Various treatment options are available to treat atopic dermatitis to include topical emollients, topical steroids, and topical calcineurin inhibitors. Each treatment option has benefits and potential risks. This study was done to determine if topical B12 could be a tolerable and efficacious alternative treatment option in this population.

METHODS: The study was conducted as a placebo-controlled, double-blind, prospective, randomized clinical trial with intraindividual left ⁄ right comparison. Parents were given 2 containers of creams and instructed to apply the Vitamin B12 cream to one side of the body and the placebo cream to the contralateral side according to the randomization scheme.

Eligibility Criteria:
Inclusion Criteria:

* children presenting to the Center for Family Medicine or Regional Pediatrics between the ages of 6 months and 18 years old with atopic dermatitis

Exclusion Criteria:

* unwillingness of parent to consent to study protocol, pregnancy or lactation, eczema with superinfection present, known history of allergy to Vitamin B12 or components of the base cream, topical treatment with corticosteroids in the 4 weeks prior to enrollment