cyrilzakka/clinical-trials huggingface dataset:
Effect of Preoperative Vitamin D Supplementation in Liver Transplant Recipients With Vitamin D Deficiency on Post Transplant Outcomes

Liver transplantation (LT) remains the ultimate option to cure intractable end stage liver disease. Vitamin D deficiency is very common in these subsets of patients. Vitamin D is involved in calcium metabolism and bone mineralization, regulation of cytokines, immunomodulation, cellular proliferation and differentiation. Its deficiency can lead to immune dysregulation, and is associated with the development of viral and bacterial infections, cardiovascular and autoimmune diseases, and several types of cancer. To the best of our knowledge, there are no randomized studies which analyze the effect of Vitamin D supplementation preoperatively on post Liver Transplant outcomes. This double blinded placebo-controlled randomized study aims to analyze the effect of preoperative supplementation of Vitamin D in patients with Vitamin D deficiency on post liver transplant outcomes. All eligible adult patients with Chronic Liver Disease and Vitamin D deficiency undergoing Liver Transplant during the study period will be included in the study and randomized into two groups. One group will receive Oral Vitamin D3 - 60000 IU - once a week pre Liver Transplant for a minimum of 6 weeks and the other will receive placebo once a week for a minimum of 6 weeks in addition to 3 months Vitamin D supplementation post Liver Transplant in both arms.

All Liver Transplant Recipients with Vitamin D deficiency will be screened in the pre-operative period in the outpatient department. Pre-operative, intra-operative and post-operative data will be collected from medical records, electronic hospital information system (HIS) and radiological images collected from the hospital Picture archiving and communication system(PACS). The enrolled subjects will be followed up till for a period of 3 months after the Liver Transplant and the post transplant bacterial infection rates will be compared between the two groups along with other parameters.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients \>18 yrs with Cirrhosis of Liver and Vitamin D deficiency ( defined as levels \< 30 ng/ml) undergoing Liver Transplant.

Exclusion Criteria:

* Negative consent Pediatric patients Infection at the time of Liver Transplant Acute Liver Failure Deceased Donor Liver Transplant Patients undergoing Re Liver Transplant Patients already receiving Vitamin D supplements. Patients with Hypoparathyroidism/ Hyperparathyroidism H/o other Solid Organ Transplantation Patients needing urgent Liver transplant before 6 weeks of Vitamin D Supplementation.

Patients with Vitamin D levels \< 10 ng/ml Patients with Osteoporosis ( DEXA BMD T Score \<-2.5)
Improving Quality of Osteoporosis Care Through Patient Storytelling

The purpose of this exploratory study is to test novel, mailed, low-cost, direct-to-patient intervention materials (i.e., a personalized letter and osteoporosis information pamphlet) designed to increase rates of dual energy X-ray absorptiometry (DXA) utilization and improve osteoporosis quality of care.

While the occurrence of a fragility fracture (e.g. hip fracture) is indicative of low BMD and a clinical diagnosis of osteoporosis made, osteoporosis can be identified in asymptomatic patients using dual energy x-ray absorptiometry (DXA). United States (U.S.) guidelines recommend screening bone density tests using central DXA in all women 65 years or older. However, fewer than one-third of eligible U.S. women age 65 and older undergo DXA testing. The main barrier to achieving greater rates of osteoporosis screening is identifying a systematic, effective, and generalizable way for healthcare providers and patients to schedule DXA results.

Given that national guidelines recommend DXA screening for all older women, the reasons a majority of women do not receive DXA testing are likely multifactorial. Patients and their health care providers may be unaware of preventative screening recommendations and the reasons for these recommendations. Screening tests that are required relatively infrequently (i.e. less than once a year) may be difficult for patients and physicians to remember if there are few triggers (e.g. seasonality as a trigger to motivate influenza vaccination). Additionally, primary care providers (PCPs) are responsible for managing a large number of comorbidities and acute care needs and may be unable to stay current with all preventative care needs during increasingly short clinic visits.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 65 or older
* At least one visit with a primary care physician in the previous 12 months

Exclusion Criteria:

* DXA scan in the previous 5 years
The Effect of Complementary Medicine (CAM) Treatments on Common Symptoms in Hospitalized Patients

This study evaluates the effects of complementary medicine (CAM) treatments on patient reported outcomes in hospital settings, for hospitalized people. Various CAM modalities such as acupuncture, reflexology, guided imagery and hypnosis are evaluated. The investigators compare outcomes between two groups: Standard of care (treatments that are provided commonly in hospital) versus standard of care AND CAM treatments. Outcomes assessed are both quantitative i.e. scores on Visual Analogue Scale for various symptoms such as pain, nausea, wellbeing, anxiety, and qualitative such as Measure Yourself Concerns And Wellbeing.

Symptomatic patients are referred to CAM treatments by the medical staff of the departments. Patients interested in CAM treatments may receive various CAM treatments such as reflexology, acupuncture, guided imagery and hypnosis, according to patient preference and practitioner availability. Patients are requested to grade the severity of their symptoms on a visual analogue scale (0-100) before treatment and within 3 hours following treatments. Patients who are interested in standard care alone and not interested in CAM treatments grade their symptoms similarly, and serve as a control group. Primary outcomes are symptomatic relief and secondary outcomes are correlations between belief or disbelief in CAM with the primary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* All hospitalized patients who can consent

Exclusion Criteria:

* Patients who cannot consent
A Novel Combination of Peripheral Nerve Blocks for Patients Scheduled for Shoulder Surgery

Interscalene block has been the traditional regional anesthesia for shoulder surgery and postoperative pain. However, the risk of phrenic nerve palsy and irreversible nerve injury have encouraged search for alternative methods.

Analyzing block effects of the lateral sagittal infraclavicular brachial plexus block(posterior and lateral chord), the investigators found it affecting all shoulder relevant nerves , except for the suprascapular and the supraclavicular nerves.

Accordingly, by combining a superficial cervical plexus block, suprascapular nerve block and block of the posterior and lateral chords infraclavicularly, the investigators believe this novel combination would provide anesthesia for patients scheduled for shoulder surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for shoulder surgery.
* American Society of Anesthesiologist grad I-III,
* 18-70 years,
* BMI 20-35,

Exclusion Criteria:

* Pregnancy,
* coagulopathy,
* allergy to local anesthetics,
* atrioventricular block,
* peripheral neuropathy or drug-treated diabetes.
* Patients using anticoagulation other than acetylsalicylic acid or dipyridamol will be excluded.
Follow-up of Early Breast Cancer by Dynamic Evaluation of CEA and CA 15.3 Followed by 18FDG-PET

The main purpose of follow-up in asymptomatic breast cancer patients during and after adjuvant treatment is to detect breast cancer recurrence and metastatic disease.The aim of this trial is to verify if, in asymptomatic patients, the serial measurement of serum CEA and CA 15.3, with diagnostic imaging procedures (18FDG-PET) performed only in case of a critical increase of serum CEA and CA 15.3 level, can anticipate the diagnosis of breast cancer local and distant recurrence compared to the usual follow-up practice.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥18 years.
* Histologically confirmed stage I-III epithelial breast cancer.
* Adequate surgery of breast and axilla:

  1. patients must have undergone either a total mastectomy or breast conserving surgery
  2. surgical margins of the resected specimen must be histologically free of invasive tumor.
* Cohort 1: if chemotherapy and/or radiotherapy are indicated the patients must be randomized between 1 month and 2 months from the end of chemotherapy and/or radiotherapy; if only hormonal adjuvant therapy is indicated the patients must be randomized within 3 months from the completion of surgery
* Cohort 2: patients must be randomized in the trial after 5 years of follow-up without relapse (but within year 6)
* Signed informed consent obtained prior to any study-specific procedures.

Exclusion Criteria:

* Histologically confirmed stage 0 epithelial breast cancer (carcinoma in situ).
* Special histologies with a high or low risk of relapse (i.e. sarcoma and tubular carcinoma)
* T1a and T1b tumors with all the following characteristics: G1-2 and N0 and RE \> 10%, RPg \> 10% and HER2 negative and Ki67≤14%
* Evidence of distant metastases
* Patients participating to other clinical trials requiring follow-up not equal to standard
* Previous history of cancer within 5 years from randomization (except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, stage I uterine cancer, or other non-breast malignancies with an outcome similar to those mentioned above)
Clary Sage Essential Oil & Pregnancy

The purpose of this study is to evaluate the potential for clary sage essential oil to support overall health, wellbeing, and quality of life during the third trimester of pregnancy among otherwise healthy adult women.

Women will be informed of the opportunity to participate through their care providers, childbirth educators, or doulas. If they meet inclusion criteria, they will be given a brochure describing the risks and benefits of the study and the informed consent paperwork.

If they provide consent, they will be randomized to one of two groups: active essential oil and inert placebo. Both groups will receive a 4-ounce bottle of oil to apply daily during the third trimester of pregnancy. Those in the placebo group will be given an inert plant oil. Those in the intervention group will be given the same oil with the addition of clary sage essential oil.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-39
* Lives in the United States
* Pregnant, singleton
* Low risk
* Less than 27 weeks gestation

Exclusion Criteria:

* PCOS diagnosis
* Uncontrolled Hypertension (i.e. systolic/diastolic blood pressure \> 140/90)
* Gestational Diabetes
* History of Preeclampsia
* Preterm labor
* Incompetent cervix
* Allergy to salvia sclarea or related plants
* Known Birth Defects
* Thyroid Disease diagnosis
Dental Office Prevention Strategies for Children

The overall goal of this study is to improve the standard of care in treating young children who often suffer from chronic caries (dental decay). Current standard of care for children under 12 years old includes a dental cleaning and fluoride treatment. Often this dental cleaning includes a 'dental prophylaxis' with a pumice based paste delivered by a small rubber-like cup that rotates on a slow-speed dental handpiece. The procedure of this dental prophylaxis removes the gross levels of plaque around the supragingival tooth surfaces. After this prophylaxis, a fluoride treatment is delivered. The National Maternal and Child Oral Health Resource Center at Georgetown University has published (Bertness J, Holt K) an extensive publication proving that 5% sodium fluoride varnish has become the 'standard of care' for fluoride treatment in children. This study includes this fluoride standard of care.

Prior to the administration of this standard of care fluoride treatment, a separate step of cleansing the tooth after the dental prophylaxis is added. This study uses a cleansing procedure of 10% povidone iodine (PI) cleansing prior to fluoride varnish (FV) application.

The primary aims of this study are:

1. to measure the changes in overall plaque levels after using a 10% povidone iodine (PI) cleansing prior to fluoride varnish (FV) application.
2. to measure the short term changes in the oral microbial ecology of dental plaque after 10% povidone iodine (PI) cleansing prior to fluoride varnish (FV) application.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria: Ages 6-12 years age. Recent history (\< 24 months) of childhood caries, weight ≥ 15 kg, and current dental radiographic films within standard of care practices. At this time, we are looking for longitudinal changes within this cohort and are not using condition-matched controls.

Exclusion Criteria:

* Exclusion criteria: Weight \<15 kg; Iodine or seafood allergy; hypersensitivity to fluoride varnish; antibiotics within the past 3 months; thyroid disease; significant past or current medical problem history, especially conditions that may affect salivary flow, dietary intake patterns, or routine oral hygiene.
Time-Restricted Eating, Exercise and Cardiometabolic Health in Obesity

In Spain, overweight and obesity prevalence is reaching 70% in men and 50% in women. Excess of triglycerides are usually stored in the subcutaneous adipose tissue (SAT), until a point where SAT is unable to expand further. Therefore, lipids are deposited in visceral and other peripheral organs and tissues that are not otherwise designed for adipose storage such as the liver, pancreas or the skeletal muscle, a process known as ectopic fat deposition. "Time-restricted eating" (TRE) is a recently emerged intermittent fasting approach which has the potential to maximize the beneficial metabolic effects extensively reported for energy intake restriction. Furthermore, exercise reduces hepatic steatosis and improves cardiometabolic health in humans. However, whether the effects of TRE combined with exercise on reducing hepatic steatosis are superior to TRE or exercise intervention alone remains unknown. The TEMPUS study will investigate the effects of a 12-week TRE combined with supervised exercise intervention, as compared with TRE or exercise alone, and usual-care control group, on hepatic fat (primary outcome) and cardiometabolic health (secondary outcomes) in adults with obesity; and to unveil the role of gut microbiota.


Eligibility Criteria:
Inclusion Criteria:

* Aged 25-65 years.
* Body mass index ≥28.0 and \<40.0 kg/m2.
* Weight stability (within 5% of screening weight) for \>3 months prior to study entry.
* Habitual eating window ≥11 hours.

Exclusion Criteria:

* History of a major adverse cardiovascular event, clinically significant kidney, endocrine, or neurological disease, bariatric surgery, HIV/AIDS, known inflammatory and/or rheumatologic disease, cancer, or other medical condition in which fasting or exercise is contraindicated.
* Type 1 or Type 2 diabetes.
* Major psychiatric disorders, eating disorders, sleep disorders, or alcohol abuse.
* Regular use of medication or compounds that may affect study outcomes (e.g., antidiabetic, steroids, beta-blockers, antibiotics, prebiotics, probiotics and symbiotics).
* Participating in a weight loss, a weight-management program or a supervised exercise program (more than 30 minutes three times per week, or 45 minutes twice a week, moderate/vigorous intensity).
* Pregnancy and lactation or planned pregnancy (within the study period).
* Caregiver for a dependent requiring frequent nocturnal care/sleep interruptions. Shift workers with variable hours (e.g., nocturnal).
* Frequent travel over time zones during the study period.
* Fear of needles and claustrophobia to magnetic resonance imaging (MRI).
* Being unable to understand and to accept the instructions or the study objectives and protocol.
Chronotype, Chrononutrition and Glucose Tolerance Among Prediabetic Individuals

Chronotype and chrononutrition, both are emerging research fields in nutritional epidemiology. However, its association with glycemic control in the global population is less clear. A better understanding of how activity/ eating time can influence glucose levels in prediabetic individuals may improve strategies for blood glucose control. The present paper aims to determine the associations of chronotype and chrononutrition with glucose tolerance among prediabetic individuals in Malaysia.

This is a prospective longitudinal study named Chrono-DMTM, that targets to recruit 166 newly diagnosed prediabetic individuals from the community clinics in Malacca, Malaysia. Respondents will be followed-up for 6 months: (1) baseline (1st oral glucose tolerance test (OGTT)); (2) second visit (at 3rd month); and (3) third visit (2nd OGTT at 6th month). Data collection includes sociodemographic and anthropometry measurements (weight, height, body fat, visceral fat, waist and hip circumference). Dietary intake and meal timing are collected using the 3-day dietary record while data on sleep pattern, light exposure, chronotype and chrononutrition will be collected using validated questionnaires. Physical activity will be captured using a validated IPAQ questionnaire and pedometer during periods of wearing Continuous glucose monitoring (CGM) sensor. CGM, fasting plasma glucose (FBG), OGTT and HbA1c are performed to assess glycemic outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed prediabetic individuals who have been first seen by clinical dieticians registered under the Ministry of Health Malaysia.
2. Malaysian ≥ 18 years old.
3. Those who plan to continue prediabetes care at the selected community clinic in Melaka.
4. Those who can read, write and understand the Malay Language.

Exclusion Criteria:

1. Night shift workers at least 3 times per week.
2. Known sleep disorder.
3. Pregnant Women.
4. Those on oral glucose-lowering medications, diabetes supplements, anticonvulsant medications or oral steroids currently or in the last month.
5. Those with prior explored to any information regarding time-of-eating/time-of-activity restriction.
6. Those with chronic kidney disease. They are excluded as current research lack of evidence to support the accuracy of using 24-hour continuous glucose monitoring system (CGMS) (Freestyle Libre Pro, Abbott, Germany).
Prevention of Postoperative Nausea and Vomiting (PONV) by Acupressure

The purpose of this study is to determine whether stimulation to the akupressurpoint P6 with a recently developed bracelet are effective preventing postoperative nausea and vomiting


Eligibility Criteria:
Inclusion Criteria:

* Female,
* Non-smoker,
* \>18 years,
* ASA 1 or 2,
* Signed patient information,
* IV-anaestesia.

Exclusion Criteria:

* Male,
* Smoker,
* ASA 3 or 4,
* Pregnancy,
* Nausea and vomiting within the last 24 h before operation,
* Diabetes,
* Carpaltunnel syndrome,
* Lymphedema of arms,
* Eczema of forearm,
* Patients who earlier has undergone removal of lymph nodes in the armpits,
* Inhalation anaestesia.
Placental Insufficiency Microcirculation Quantification by Ultrafast Doppler (MICRODOPPLER PLACENTA)

To identify fetuses small for their gestational-age who have reached their appropriate growth potential from growth-restricted fetuses due to placental insufficiency is uneasy. Intra Uterine Growth Restriction (IUGR) increases the risk for indicated preterm delivery, neonatal mortality and morbidity. Therefore, improving the knowledge of the placental perfusion is essential to better identify and manage fetal chronic oxygen deprivation associated with placental insufficiency. Thus, the investigators propose to study placental microcirculation with a more efficient Doppler than conventional Doppler use in clinical practice. The Ultrafast Doppler is being able to map placental blood flow and could have potential impact in placental insufficiency diagnosis and prevention. Moreover, this Doppler could discriminate maternal and fetal vascularization.

The hypothesis is that Ultrafast Doppler could help clinician to diagnose and manage preeclampsia and IUGR during pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Patient who accepted to participate in the study
* Woman over 18 years old
* Affiliated to a social security scheme
* Mono-fetal pregnancy
* Patients with normal pregnancy between 11 and 42 weeks of amenorrhea
* Patients hospitalized for preeclampsia and / or intrauterine growth retardation, beyond 20 weeks of amenorrhea

Exclusion Criteria:

* Minors, adults under guardianship, protected persons
* Not affiliated to a social security scheme
* Multiple pregnancy
Whole Blood Bactericidal Activity (WBA) Against Mycobacterium Tuberculosis of Rifampicin in Healthy Volunteers

The purpose of this study is to evaluate the bactericidal activity against Mycobacterium tuberculosis of standard and high doses of rifampicin. Pharmacokinetics (PK) and Whole blood Bactericidal Activity (WBA) will be measured in healthy volunteers following a single dose of rifampicin at standard dose (10mg/kg) or at high dose (20mg/kg or 30mg/kg).

WBA is an ex vivo model for measuring the combined effects of administered drugs, host factors and strain factors on mycobacterial killing. If performed in parallel with PK measurements, the method can be used to evaluate the effect of drugs throughout the dosing cycle. This study aims to compare different doses of rifampicin in the WBA model, compare activity of rifampicin on WBA by different mycobacterium tuberculosis strain types and assess the host immune response following drug administration.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 21 and above
2. Male or female willing to comply with the study visits and procedures
3. Willing and able to provide written informed consent

Exclusion Criteria:

1. Women who are currently pregnant or breastfeeding
2. Signs of active TB
3. On immunosuppressant, antibiotic or any medication known to have interaction with rifampicin
4. Previous allergy to Rifampicin
5. Evidence of renal or hepatic dysfunction or any clinically significant deviation from normal during screening including laboratory determinations
6. Known hepatic disease or alcohol abuse
7. Current use of any other drugs, over the counter medications and herbal preparations that are known or potential inhibitors or inducers of cytochrome P450 enzymes
8. Any other significant condition that would, in the opinion of the investigator, compromise the volunteer's safety or outcome in the trial
9. Current participation in other clinical intervention trial or research protocol
Prospective Study on the Feasibility of Plasma FLT3-Ligand Assay to Achieve a First Estimate of Its Prognostic Value on the Outcome of Patients Treated Intensively for Acute Leukemia

Despite advances in their classification and treatment, acute leukemia remain incurable disease for the majority of patients. It is necessary to identify new prognostic markers of survival and new therapeutic targets to improve prognosis. Some studies have shown that Fms-like tyrosine kinase 3-ligand (FLT3-L) could be interesting from this. A more recent study from our group testing a novel therapy in acute lymphoblastic leukemia, showed an increase of this marker in the blood of patients responding to treatment. The aim of our prospective, non-interventional study is to measure the plasma levels of FLT3-L at different times of the management of patients with acute lymphoblastic leukemia but also myeloid. For this, analyzes of the samples collected in the usual care will be conducted to study the relationship between the plasma concentration of FLT3-L and outcomes. If there is any link, the FLT3-L could serve as a predictor of treatment response.


Eligibility Criteria:
Inclusion Criteria:

* Acute myelogenous leukemia diagnosis or lymphoblastic
* Patient intensively treated
* Patients who agreed to participate in the study and having signed the consent biocollection

Non-Inclusion Criteria:

* Patient aged under 18