cyrilzakka/clinical-trials huggingface dataset:
Vitamin D Supplementation on Cardiovascular Risk Factors

The purpose of the present pilot study is to determine the effect of vitamin D supplementation (4000 IU or 6000 IU once daily for 6 months) on reducing heart disease risk and in improving blood glucose control in type 2 Diabetes subjects . The investigators are working with Hispanics and African Americans living in Miami, Florida.

Insufficient vitamin D levels have been found in subjects with type 2 diabetes (T2D). Similarly, a negative association between serum vitamin D levels and insulin resistance has been reported in a large sample representative of the adult US population and in subjects at risk for T2D. In addition, a strong association between hypovitaminosis D and hypertriglyceridemia has been demonstrated in studies done in US adult population.

Literature has indicated that subjects with T2D and insulin resistance (IR) are more likely to develop arteriosclerosis and all of the complications related to this condition, such as myocardial infarction and stroke.

These findings have increased the interest about the effect of vitamin D on metabolic abnormalities grouped under the term "cardiovascular disease (CVD) risk factors", which includes hypertension, dyslipidemia, obesity, glucose intolerance, inflammation and T2D which is in itself a risk factor for CVD.

Therefore, the purpose of the present pilot study will be to determine the effect of supplemental vitamin D intake (4000 IU or 6000 IU of Cholecalciferol daily for 6 months) on CVD risk markers and glycemic control; primarily lipid panel, insulin resistance, and glycosylated hemoglobin (A1C), in a sample of Hispanics and African-Americans with T2D and vitamin D insufficiency. If repletion of vitamin D level improves insulin resistance, glycemic control, inflammation, hypertension, dyslipidaemia or kidney functions, it may prevent the development of CVD events and decrease T2D complications.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* African American or Hispanic
* able to ambulate on their own
* aged between 30 - 70 years

Exclusion Criteria:

* Taking Supplemental Vitamin D
* Pregnant or Lactating women
* Receiving insulin therapy
* Not participating in other drug trials
* HIV/ hepatitis/ cancer/ liver disease/ heart failure/ any recent surgery/ mental illness/ epilepsy/ any GI or malabsorption disorders
* Kidney failure or on dialysis
Non-invasive Ablation of Ventricular Tachycardia

Phase I/II study of 4-D Navigated Non-invasive radiosurgical ablation of ventricular tachycardia (NIRA-VT).

The goal of this project dealing with 4D-navigated substrate ablation is to evaluate the feasibility and safety of elimination of the scar-related monomorphic ventricular tachycardia (VT) or tachycardias by stereotactic radiosurgical ablation that is completely non-invasive. The arrhythmic substrate is defined as the scar after myocardial infarction (MI) described by transthoracic echocardiography (TTE) and specified by PET-CT or MRI. All sustained monomorphic VT induced by programmed ventricular stimulation via implanted ICD (Implantable Cardioverter Defibrillator) will be analyzed using body surface ECG mapping. The target volume for stereotactic radiosurgical ablation (single dose of 25 Gy) will be based on accordance between a post-infarction scar (PET-CT or MRI imaging) and arrhythmic substrate (body surface ECG mapping).

Eligibility Criteria:
Inclusion Criteria:

* history of sustained monomorphic VT or termination of monomorphic VT by ICD (appropriate therapy) during previous 6 months prior to enrollment
* implantation ICD
* inducibility at least one of monomorphic ventricular tachycardia by ICD during EP study with programmed ventricular stimulation
* history of myocardial infarction (MI)
* left ventricular scar and decreased systolic function of the left ventricle (ejection fraction of left ventricle less than 40%) based on transthoracic ultrasound
* stable chronic heart failure (NYHA II-III)
* older than 18 years
* signed an IRB approved written informed consent document.
* failed at least one invasive catheter ablation procedure or have a contraindication to a catheter ablation procedure

Exclusion Criteria:

* acute myocardial infarction
* chronic heart failure NYHA IV
* channelopathy
* reversible cause of VT (e.g. ionic dysbalance, intoxications)
* pregnancy or breastfeeding
* history of chest radiotherapy
* arrhythmic substrate larger than 100 ccm
Assessment of an Automated Telesurveillance System on Serious Falls Prevention in an Elderly Suffering From Dementia Specialized Care Unit: the URCC

2 URCC in the Limousin region will be equipped with the automated telesurveillance system. Patient will be selected by ward's geriatrician and randomized into two groups after informed consent. One group will have cameras installed and the other will not and will act as a comparison group. Patient will be assessed twice during the study, at admission in (inclusion visit) and at outcome from the URCC (end of study visit). Each assessment implies a standard geriatric assessment, a fall questionnaire, a Neuropsychiatric inventory for behavioral disturbances and a quality of life questionnaire (EQ5D). Every fall will be considered as adverse events and will therefore be listed along the study and characterized in types and number.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged more than 65 years old
* Patient admitted in Limoges or Brive's URCC
* Patient informed consent and/or proxy consent
* Patient covered by the French health insurance

Exclusion Criteria:

* Patient without national health insurance coverage
* Patient with a short term prognosis pathology
Epidemiology of H. Pylori Transmission

This observational epidemiologic study with nested cross-sectional and longitudinal aims will evaluate host immune response to mixed chronic infections (Helicobacter pylori, latent tuberculosis, intestinal helminthiasis) in recent US immigrants.

1750 clinically-well, adult (age 18-55 years), recent immigrants (\<2 years U.S. residence), referred through cooperating public health clinics in the Santa Clara Valley area, CA will be screened for H. pylori, helminth, and latent tuberculosis infections \["Screening" population\]. Of these 1750, 426 will be selected for more intensive study (Cohort population), 105 of whom will receive baseline endoscopy. Of those selected for the cohort, 300 are expected to complete a 9-month follow-up assessment, 75 of whom are expected to undergo a second follow-up endoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Between 18-55 years of age
* Either sex
* If female not pregnant or breastfeeding
* Lived in the United States less than 2 years
* Healthy
* Scheduled for Tuberculosis Skin Test (TST)

Exclusion Criteria:

* Under 18 and older than 55 years of age,
* Pregnant or breastfeeding
* Have lived in Unites States more that 2 years
* Chronic illness
* Not planning to get a TST
Physician Self Disclosure of IUC Use

As many as one-third of female healthcare providers use intrauterine contraception (IUC), but only about 8 percent of US women overall do. This begs the question: Might physician self-disclosure of personal IUC use increase IUC use among patients? However, the positive or negative impact of physician self disclosure on IUC uptake or patient satisfaction is generally unknown. The purpose of this study was to evaluate if physician self-disclosure of personal IUC use increases patient use of IUC or impacts patients' satisfaction with their clinical encounter.

We performed a prospective randomized block design pilot trail of usual contraceptive counseling versus usual counseling plus physician self-disclosure of personal intrauterine contraceptive use.

Eligibility Criteria:
Inclusion Criteria:

* reproductive age
* currently sexually active
* scheduled for benign gynecology visit, annual exam, or family planning visit

Exclusion Criteria:

* seeking pregnancy within 1 year
* currently using IUC
* prior sterilization procedure
* currently pregnant
Progressive Advancements in Neurosurgery, Data and Analysis Database

Neurosurgical diseases encompass a highly heterogeneous group of conditions, including oncological, malformative, traumatic, spinal, vascular, infectious diseases, and cerebrospinal fluid dynamics disorders. Several systematic reviews on the level of evidence in neurosurgical diseases have documented the low percentage of high-quality scientific evidence in this field of medicine. Clinical practice is strongly influenced by individual physician preferences, leading to significant heterogeneity among different centers both in Italy and internationally. This overall picture highlights the need for tools that can accurately characterize the numerous diagnostic variables influencing therapeutic outcomes in patients with neurosurgical diseases.

Primary Objective To establish a prospective data collection of adult patients with neurosurgical diseases, providing real-life data on the current management of patients at the Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome and the participating centers.

Secondary Objectives To create a database of adult patients with neurosurgical diseases who may be potential candidates for enrollment in clinical trials.

To conduct observational research on neurosurgical diseases, particularly in cases where no curative treatment options are currently available.

To identify potential predictors of poor outcomes or treatment response. To assess the clinical history and treatment response of patients, including for internal audit purposes (e.g., supporting Morbidity \& Mortality conferences).

To provide support for the development and monitoring of quality indicators related to patient care.


Eligibility Criteria:
Inclusion Criteria:

* Age at first contact equal to or greater than 18 years at the time of informed consent signature.
* Diagnosis of a neurosurgical disease.

Exclusion Criteria:

* Refusal to provide written informed consent.
Therapeutic Effect of Methalazine on 27 Cases of Suppurative Hidradenitis

Background: Hidradenitis suppurativa (HS) is a chronic inflammatory relapsing disease involving the axillae, breast ,groin and anogenital regions. The therapies of the disease are diverse, including medication and surgery. However, responses to treatments are variable and relapse is common, with no single agent being consistently effective.

Objective: To evaluate the efficacy and safety of oral mesalazine treatment for hidradenitis suppurativa .

Methods: Investigators reported a series of cases of patients who received oral mesalazine(1g qid) for hidradenitis suppurativa in our institution between May 2020 and September 2023. A total of 27 patients, 22 in the mild to moderate group and 5 in the severe group, were included in this study.


Eligibility Criteria:
Inclusion Criteria:

* Recurrent painful or suppurative lesions
* Typical clinical manifestations: the distribution of apocrine sweat glands is deep in painful nodules, abscesses, sinuses, scars;

Exclusion Criteria:

* Severe neurological and psychiatric diseases
* Tumor diseases
* Pregnant women in lactation period
Comparing Highly Purified hMG With Recombinant FSH + Recombinant LH in Women Undergoing Intrauterine Insemination.

The present study aims to elucidate if the FSH and LH activity contained in hMG preparations is comparable to the recombinant FSH and LH administration in a 1:1 ratio. The mean outcome is the corresponding ovarian response in terms of oestradiol increase during stimulation and number of mature follicles the day of hCG administration. The patients will be included and randomized into two groups and stimulated either by HMG injections started on day 3 at a dose of 75 IU every day and fixed for the first 5 days, and in the second group, rFSH and rLH injections be started on day 3 at a dose of 75 UI/day of rFSH + 75UI/day of rLH. Serum estradiol levels will be measured on stimulation day 1, day 6 and the day of hCG injection. All follicles greater than 14 mm of diameter will be recorded on hCG day Intrauterine insemination is performed during two consecutive days starting the day after the human chorionic gonadotrophin (Ovitrelle) injection. Secondary outcomes are Days of stimulation, Total doses of gonadotrophins administrated, Clinical pregnancy , Ongoing pregnancy and Miscarriage rate, and Cancellation rate.


Eligibility Criteria:
Inclusion Criteria:

* Esterility \> 1 year duration
* \< 39 years old
* REM \> 3 millions/ml
* 1 or 2º IUI cycle

Exclusion criteria:

* Ovarian policystic syndrome
* Severe Endometriosis
* Uterine disease (polyps, myomas, intracavitarios, malformations...)
Oral Vitamin D Substitution Weekly or Monthly and Adherence

Vitamin D deficiency (defined as 25(OH)-vitamin D serum level \<50 nmol/l) is cured with supplementation by mouth. National guidelines recommend the administration of 800 IU cholecalciferol daily for an effective treatment, especially during the winter (poor sun exposition). Commercially available pharmaceutical forms are liquid in Switzerland (drops) and solid forms in Germany (tablets and capsules). Because therapeutic range of vitamin D3 is wide and toxicity is seldom reached, even after the consumption of 200'000 IU, and because the administration of 8 drops daily is inconvenient, weekly and monthly administrations of the cumulative amount (i.e., 5'600 IU weekly or 24'000 IU monthly) have been investigated. Both administration schedules are therapeutic equivalent. The study aims to investigate which form (liquid or solid) and which schedule (weekly or monthly) procure the highest adherence behavior with outpatients under polypharmacy i.e., with 4 or more medications daily. The investigators will use commercially available Swiss and German products.

Intervention study in patients with serum vitamin D \<50 nmol/l and polypharmacy, defined as ≥4 medicaments/day. Treatment duration: 6 months. Treatment groups are defined as Lm (liquid monthly 24'000 IU); Lw (liquid weekly 5'600 IU); Sm (solid monthly 20'000 IU) and Sw (solid weekly 5'600 IU). Cross-over design with identical form (liquid or solid) and switching frequence, i.e. from weekly to monthly treatment and vice versa, for 3 months each.

Eligibility Criteria:
Inclusion Criteria:

* vitamin D deficiency by serum level \<50 nmol/l
* polypharmacy defined as 4 daily medicines or more
* speaking German or Swiss German

Exclusion Criteria:

* hypercalcaemia
* substitution treatment with cholecalciferol in the past 3 months
* medication intake provided by a third person and not by the patient himself
Comparison of Online Group Therapy Interventions for Procrastination

The aim of this study is to compare the efficacy of two cognitive behavior therapy (CBT) protocols for procrastination with an active control protocol including cognitive-behavioral elements and with a wait-list control group. The interventions will be delivered online in group settings. All three protocols include identical psychoeducation and cognitive modules related to procrastination, but will differ in the behavioral modules. The behavioral module in one protocol is focused on starting on time and realistic planning. The second protocol implements working time restriction. The active comparator protocol implements the pomodoro time management technique. The wait-list control group will receive one of the CBT protocols after the period of waiting. It is assumed that all active conditions will be superior to the wait-list control, and that CBT protocols will be superior to the protocol including the time management technique. Primary (procrastination) and secondary (depression and anxiety) measures will be collected prior and after the interventions (or waiting period in wait-list group) and after 6-months in the three active condition groups.


Eligibility Criteria:
Inclusion Criteria:

* Bachelor's and Master's university students
* Self-reported primary difficulties related to chronic and severe procrastination
* Serious procrastination problem lasting for at least one year as confirmed during clinical interview
* Having a postponed/procrastinated project to complete in the course of therapy
* Willing to participate in the study
* Fluent in Polish language
* Computer access and stable Internet connection

Exclusion Criteria:

* Current participation in other psychotherapy
* Change of psychiatric medication during last 12 weeks
* Severe anxiety or affective disorders and any other severe psychiatric disorders that require other type of specialized care and are primary to procrastination problem (e.g. major depressive episode, social phobia, PTSD, etc.)
* Active suicidality
* Psychosis, bipolar disorder
* Alcohol or substance dependence
* Severe personality disorders (with exclusion of avoidant, dependent and obsessive-compulsive personality disorders)
Refugee Mental Health and Wellness Pilot Study

This pilot study will develop and examine the acceptability of a Community Navigator program of support for 10-24 older adult Arab Americans participants receiving services at a refugee-serving organization based in Southern California. This program will provide participants with social support from a 'Community Navigator,' who will work with clients to help promote attendance and engagement with the community during social activities and community events. This program aims to reduce feelings of loneliness or social isolation. In partnership with the refugee-serving organization, the UCLA investigators will implement this program in addition to services provided as usual at the community partner site. Researchers will then conduct interviews to explore participants' experiences and perceptions for improvement of the program.

The Refugee Mental Health and Wellness Pilot Study aims to increase community connections and reduce loneliness for older adult immigrants and refugees, specifically from MENA countries of origin through the implementation of a Community Navigator program. This program will be implemented within an existing aging program for older adults at a refugee-serving organization that provides social services, English language classes, and computer classes for this population. The pilot program is an extension of case management services at this organization. The program provides up to ten weekly virtual (through video or telephone) home-visiting sessions. During these sessions, an Arabic-speaking program coordinator or an Arabic-speaking nurse will assess client wellbeing, social service needs, as well as referral to social activities and other services needed over three months. The coordinator or nurse will be trained in a trauma-informed approach to working with refugee and immigrant clients. Participants will be recruited at the partner site. This study aims to recruit between 10-24 older adults interested in participating in semi-structured interviews to examine program acceptability and explore suggestions on improving the program. The baseline and completion survey will collect data on social demographics, social support, depressive symptoms, and loneliness score. Interviews will be conducted at least 6-8 weeks upon enrollment in the program. This pilot study will provide preliminary evidence of the acceptability of Community Navigator support and trial evaluation procedures for testing this. The results will inform a future feasibility study and potentially, and potentially, a randomized controlled trial of this intervention.

Eligibility Criteria:
Inclusion Criteria:

* Adults who self-identify as Arab or Middle Eastern/North Africa over the age of 55

Exclusion Criteria:

* For all participants, those who do not have the capacity to consent to participate.
The Role of ITGAM in Systemic Lupus Erythematosus

Study to examine the role of ITGAM molecule in normal control subjects with known genetic variation in the ITGAM gene.


Eligibility Criteria:
Inclusion Criteria:

* males and females, age 18 or older, enrolled in Genotype and Phenotype Registry, in general good health
* Participants who carry the genotype of interest, based on a buccal or blood derived DNA sample

Exclusion Criteria:

* History of Systemic Lupus Erythematosus, rheumatoid arthritis, or other autoimmune disease
* History of cancer or lymphoma
* Current use of aspirin, prednisone, or NSAID or any immunosuppressant
* Self reported HIV
Prognosis in Pregnant With COVID-19

COVID-19 is a disease whose development, prognosis mechanism and immune status are still unknown. The aim of the study is to determine the relationship between clinical and laboratory data and the severity of the disease by evaluating the hematological and radiological features of the patients. The secondary aim is to determine the predictive values of clinical and laboratory data for the severity of COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Being pregnant with a diagnosis of COVID-19 between the ages of 18-45

Exclusion Criteria:

* Suspected COVID-19 diagnosis
The Role of the Duodenum in the Pathogenesis of Insulin Resistance and Type 2 Diabetes Mellitus

In parallel with the increasing prevalence of obesity worldwide, type 2 diabetes mellitus (T2DM) has reached epidemic proportions. Despite a multitude of available therapies, only bariatric surgery (e.g., roux-en-Y gastric bypass (GBP)) has proven to be an effective long term treatment modality for morbid obesity. Moreover, the majority of T2DM patients who undergo GBP experience normalization of their blood glucose and are able to discontinue their anti-diabetes medications soon after the procedure. The insulin resistant state commonly seen in non-diabetic obese subjects also improves after GBP. Evidence from recent animal studies suggests that the rapid return to euglycemia seen in T2DM patients after GBP might in part result from excluding the duodenum from the flow of nutrients. With the use of enteral feeding tubes, we hope to better understand the factors in the human gut that may predispose obese individuals to the development of insulin resistance and T2DM.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for lean, healthy control subjects:

1. Fasting plasma glucose (FPG) \< 100
2. Age 18 to 55
3. BMI 18.5 to 24.9 kg/m2
4. Stable weight for prior 3 months

Inclusion criteria for prediabetic individuals:

1. Based on American Diabetes Association criteria of FPG \> 100 and \<126
2. Age 18 to 55
3. BMI 35 to 60 kg/m2
4. Stable weight for prior 3 months

Inclusion criteria for diabetic individuals:

1. Diagnosis of type 2 diabetes mellitus (T2DM) for \< 5 years
2. Hemoglobin A1c \< 8%
3. Age 18 to 55
4. BMI 35 to 60 kg/m2
5. Stable weight for prior 3 months

Exclusion Criteria:

Exclusion criteria for all study subjects:

1. Use of any of the following medications: Thiazolidinediones, dipeptidyl-peptidase IV (DPP-IV) inhibitors (e.g., sitagliptin), GLP-1 analogs (e.g., exenatide).
2. Subjects with T2DM who are unable to maintain adequate glycemic control (i.e., having a fasting blood glucose that exceeds 250mg/dL on two consecutive tests) while temporarily discontinuing their oral diabetes medications for the study and in whom the study physician determines insulin therapy would not be appropriate.
3. Females with a positive pregnancy test

5. Prior gastric, duodenal, proximal jejunal surgery or pancreas resection 6. Known malabsorptive disorder 7. History of cancer in past 5 years 8. Renal insufficiency defined by serum creatinine \> 1.5 mg/dl 9. Hepatic enzyme elevations of greater than twice the upper limits of normal 10. Current use of warfarin or clopidogrel 11. Intercurrent infections 12. Contraindication to nasogastric or nasojejunal feeding tube (e.g., deviated nasal septum, prior upper gastrointestinal bleed, or history of easy bleeding) 13. Residence outside the greater Nashville, TN area