cyrilzakka/clinical-trials huggingface dataset:
Vitamin D and Adipose Tissue: a Complex Relationship

The goal of this observational study is to verify the role of adipose tissue in determining the vitamin D serum level after monthly oral administration in subjects with vitamin D deficiency.

The main questions it aims to answer are:

* Adipose tissue represents a storage environment for vitamin D or it's an environment where vitamin D is sequestered and no longer released
* On the other hands, it's possible to verify whether the adipose tissue carries out a bi-modal activity towards vitamin D
* If adipose tissue exerts a bi-modal effect, it is possible to identify a specific threshold between the two effects Participants will undergo anthropometric measurements (height, weight, waist/hip ratio waist circumference) at baseline and after 6 months of intake of cholecalciferol 50,000 IU/month

Vitamin D deficiency and insufficiency are prevalent worldwide, and various factors contribute to their occurrence, including low sun exposure, poor dietary intake, obesity, and abdominal obesity. Abdominal obesity, assessed by waist circumference (WC), is associated with metabolic syndrome and has been linked to low vitamin D levels. This study aimed to investigate the relationship between visceral adipose tissue (VAT) and vitamin D levels, particularly examining the potential threshold for vitamin D storage and sequestration by adipose tissue.

The study is conducted on patients with hypovitaminosis D in an internal medicine outpatient department. Blood samples for the evaluation of calcium and vitamin D levels are collected at baseline and after six months of monthly cholecalciferol supplementation. Ultrasonography are used to evaluate adipose tissue measurements, including subcutaneous adipose tissue thickness, VAT, preperitoneal adipose tissue (PPAT), and prerenal adipose tissue (PRAT). Anthropometric measures such as waist-to-hip ratio and waist-to-height ratio are also assessed.

Eligibility Criteria:
Inclusion Criteria:

* Vitamin D level \< 20 ng/ml
* BMI \> 24

Exclusion Criteria:

* Administration of vitamin D metabolites in the last year
* Previous diagnosis of metabolic bone diseases
* Previous diagnosis of endocrine diseases
* Previous diagnosis of cancer
Survival in Patients Older Than 60 Years With Newly Diagnosed AML in Spain

Prospective, multicenter, observational, national study (EPA-SP) that aims to describe the survival and the quality of life, the clinical management strategies and the prognostic factors for survival related to the patient, in a prospective cohort of patients over 60 with AML diagnosis in Spain and treated outside of clinical trials; that is, under conditions of standard clinical practice.

The study will last 24 months in total from the inclusion of the first patient until the end of the last patient's follow-up

Following the baseline enrolment visit, the following data corresponding to the patient's visits scheduled according to routine clinical practice will be collected in accordance with the following model:

1. Recruitment period: One year of recruitment period, data collection at the baseline visit, every 3 months in one year (month 3, 6, 9 and 12).
2. Follow-up period: data collection at the baseline visit, every 3 months in one year (month 3, 6, 9 and 12).

The patient clinical history and the study´s questionnaires will be the source documents. The study will be carried out in the facilities of the Hematology and Hemotherapy Services of the participating centers, collecting the conditions of medical action according to the standard clinical practice.

Being an observational study, no intervention out of standard clinical practice will be performed. No additional diagnostic or treatment procedures will be applied for the patients.

Eligibility Criteria:
Inclusion Criteria:

* Patient of both sexes, aged 65 years and older.
* Any race, nationality or socioeconomic status.
* AML (defined according to WHO 2016 criteria de novo, with previous hematological history or secondary.
* Diagnosis date later than 1st November 2017 and later than each center activation date.
* Patients on first line treatment with any therapeutic strategy (intensive, attenuated or palliative).
* Having given informed consent prior to start the data collection.

Exclusion Criteria:

* Inability to understand the informed consent form.
* AML previously treated (with or without HSCT).
* Acute promyelocytic leukemia.
* Participation in a clinical trial that includes first-line treatment for AML.
* Do not grant consent.
Experimental Word Learning in Children With and Without Language Impairment

The purpose of this study is to compare the performances of normally developing children and children with Language Impairment (LI) in three different experimental settings designed to promote vocabulary acquisition. This comparison will also provide evidence to support different intervention approaches designed to increase vocabulary abilities, which has been proved to be one of the major deficits of young children with LI.


Eligibility Criteria:
Inclusion Criteria:

* For GP subjects: - diagnosis of Language Impairment
* enrolled in language therapy
* age between 3:0 (years:months) and 3:11
* For GC subjects: - normal performance in a language screening procedure
* normal performance in an expressive vocabulary test

Exclusion Criteria:

* For GP subjects: - hearing impairments
* diagnosed neurological or behavioral conditions
* major cognitive impairment
* For GC subjects: - communication complaints from caregivers
* history of previous enrollment in language therapy
The Influence of Tramadol on Platelet Function

The aim of this ex-vivo study is to quantify the effect of tramadol on platelet aggregation.

The aim of this study is to quantify the effect of tramadol on platelet aggregation. To this end, the effect of tramadol on platelet function will be demonstrated in an ex-vivo study using optical aggregometry (LTA) on whole blood of 15 patients.

The main objective variable is to use platelet function assays (LTA) as well as thrombelastography (TEG) to determine this effect on platelet function.

The null hypothesis of this study is that tramadol does not affect platelet aggregation in healthy patients.

In addition, two further questions will be addressed:

* using a titration series, to attempt to plot a dose/response curve of the effect of tramadol on platelet function.
* tramadol is often administered together with other drugs such as NSAIDs (ibuprofen), novalgin, SSRIs or other opioids such as morphine or in the surgical setting fentanyl and remifentanil. A series of studies will be conducted to determine whether these combinations alter the effect of tramadol on platelet function.

Eligibility Criteria:
Inclusion Criteria:

* 18y and older, healthy volunteers

Exclusion Criteria:

* Age \< 18 years
* Pregnant women
* History of addiction (especially opiate abuse)
* Pre-existing general addictive disease
* Ongoing pain therapy with opiates
* Taking antidepressants (SNRI, SSRI)
* History of thrombocytopathy or coagulation disorders
* Therapy with drugs that influence thrombocyte function (ASS, clopidogrel, prasugrel, ticagrelor or similar)
* Known intolerance to opiates
Evaluating the Impact of Social Music

Mental health vulnerability due to stress is increased in People of African Descent (PADs) in America due to disproportionate effects of racism, poverty, education, and criminal justice sentencing. Various meditation and mindfulness approaches have provided evidence of measured reductions in multiple negative dimensions of stress. However, the majority of these studies do not have an adequate representation of PADs or other marginalized groups and are not designed to be culturally relevant or community based. Music has been shown to alleviate multiple symptoms of stress and has been shown to be a preferred and effective support for meditation and mindfulness. However, its role in stress management in PADs engaged in meditation or mindfulness is seldom studied. This study aims to evaluate the effects of a virtual, community-based music mindfulness program on stress management in PAD community members with anxiety and depression during COVID19.

2b. Social Music Study: Investigators will assess the neural mechanisms of feelings of subjective connectedness during communal music listening and creating between dyads of subjects who are both familiar and unfamiliar with each other.

The investigators also propose a study to investigate the effects of communal drumming in reducing anxiety and increasing connectedness within drum circle community. Investigators hypothesize that these intervention will lead to reductions in scores on stress scales and will provide preliminary data for studies evaluating these types of community programs as an adjunct to the standard of care.

Participants will be screened, consented, and enrolled in dyads in a paradigm in which they will be positioned across from each other while listening to various types of music (i.e. music that is harmonically-intact and music in which the harmonic content has been randomly scrambled).

Survey data will also be collected to assess variables such as musical experience, partner familiarity, perceived stress, etc.

Eligibility Criteria:
Inclusion Criteria:

* ages 16 and older

Exclusion Criteria:

* contraindications to functional Near Infrared Spectroscopy or Electroencephalography
* ages 15 and younger
Prospective Observational Clinical Study to Evaluate Patient Outcomes Following Pharmacogenetic Testing of Patients Undergoing Elective Surgical Procedures

The purpose of this study is to evaluate the effect of pharmacogenetics (PGx) guided treatment when implemented into the pre-operative process for patients undergoing bowel surgery, major urologic procedure, or major ventral hernia repair and requiring post-operative acute pain management in an inpatient basis, as compared to a group of subjects with the same attributes without the guidance of PGx testing (historical control group). This study will also evaluate the frequency with which the standard analgesic care plan is adjusted by test results.

The incidence of opioid-related adverse drug events can reach as high as 50% in surgical patients and poor pain management is a significant risk factor for early readmission. In addition, the rate of non- response to certain analgesics is double in patients who are poor metabolizers as demonstrated by mutations in both CPY26D alleles. There is a growing body of literature that indicate that ineffective acute pain management contributes significantly to the risk of chronic pain syndromes. Genetics and drug interactions can alter both the pharmacokinetics and pharmacodynamics of a multitude of drug compounds and in turn influence both the safety and efficacy of selected therapeutic regimens.

Pharmacogenetic-guided therapy selection can enhance patient response by facilitating the selection of the most appropriate medication at the most effective dose in the shortest possible time.

In this prospective, observational, single-blind study, the investigators will evaluate the clinical impact of pharmacogenetics-guided treatment on patient well-being as determined by post-op pain assessments and the frequency of changes in analgesics predicted by testing results. Additionally, the impact of PGx-guided treatment on narcotic consumption, time to mobilization, number of adverse events, length of stay, and re-admission rates compared to historical data will be evaluated during the duration of the study.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects over the age of 18
* Presenting to the site for a prep-op visit prior to undergoing a major bowel surgery, major urologic procedure or major ventral hernia repair. The pre-op visit must occur at least 3 days prior to the surgical procedure.
* Willing and able to comply with study procedures
* Able to provide written informed consent

Exclusion Criteria:

* Unwilling or unable to provide written informed consent and to comply with study procedures;
* Unwilling or unable to provide buccal swab sample
* History of chronic renal dysfunction, Chronic Kidney Disease (Stage 4 or 5);
* New York Heart Classification \>3
* Abnormal hepatic function within the last 2 years (INR \>1.2 not attributable to anticoagulant medications, AST/aspartate aminotransferase or ALT/alanine aminotransferase \>1.5x normal, or suspected cirrhosis);
* History of malabsorption (short gut syndrome);
* Gastric or small bowel surgery less than 3 months prior to study enrollment;
Efficacy and Safety of COMP360 Psilocybin Therapy in Anorexia Nervosa: a Proof-of-concept Study

Efficacy and Safety of COMP360 Psilocybin therapy in Anorexia Nervosa: a Proof-of-concept Study

This study aims to explore the efficacy and safety of COMP360 25 mg as compared to COMP360 1 mg (control condition) administered with psychological support in participants with Anorexia Nervosa

Eligibility Criteria:
Inclusion Criteria:

1. Any sex and aged 18 years or above at screening.
2. Meeting criteria for AN either restrictive or binge-purging type, according to the DSM-5, based on medical records, clinical assessment, BMI, and documented completion of MINI 7.0.2 and EDE at screening.
3. Have successfully discontinued all prohibited medications for a period of at least two weeks prior to baseline. For fluoxetine (Prozac), immediate cessation at screening period visit 1a followed by at least four weeks of washout will be required prior to baseline.
4. Has a history of disordered eating with duration of at least 3 years prior to screening, that is consistent with AN.
5. BMI ≥15 kg/m2 and ≤20 kg/m2. For participants with a BMI \<16 kg/m2 and \>18.5 kg/m2 at screening, approval from the Medical Monitor will be required. Any participant with a BMI \>18.5 kg/m2 must meet all of the criteria for AN except that, despite significant weight loss, the individual's weight is within or above the normal range.
6. Being otherwise medically stable at screening determined by clinical interview, clinical laboratory values, vital signs, ECG, and medical history.
7. Have at least one documented prior attempt at treatment in the past 3 years.

Exclusion Criteria:

1. Prior or ongoing bipolar disorder, any psychotic disorder, including schizophrenia, schizophreniform disorder, schizoaffective disorder, brief psychotic disorder (unless substance induced or due to a medical condition), antisocial personality disorder, or any serious psychiatric comorbidity as assessed by medical history and a structured clinical interview (MINI 7.0.2).
2. Prior or ongoing paranoid, schizoid, schizotypal, histrionic, narcissistic personality disorder based on medical history and clinical judgment.
3. Borderline personality disorder as demonstrated by medical history, the MINI Plus - BPD and clinical judgment.
4. Significant suicide risk as defined by (1) suicidal ideation as endorsed on items 4 or 5 on the C-SSRS within the past year, at screening or at baseline, or; (2) suicidal behaviours within the past year or; (3) clinical assessment of significant suicidal risk during participant interview.
5. Current (within last year) alcohol or substance use disorder as informed by the DSM-5 assessed via the MINI 7.0.2, and urine toxicology at screening.
6. Other personal circumstances and behaviour judged to be incompatible with establishment of rapport or safe exposure to psilocybin.
7. Exposure to psilocybin, or any other psychedelics, such as ayahuasca, mescaline, LSD, or peyote within the past year.
Low Doses of Cholestyramine in the Treatment of Hyperthyroidism

The enterohepatic circulation of thyroid hormones is increased in thyrotoxicosis.Bile-salt sequestrants (ionic exchange resins) bind thyroid hormones in the intestine and thereby increase their fecal excretion. Based on these observations, the use of cholestyramine has been tried. The present study evaluates the effect of low doses of cholestyramine as an adjunctive therapy in the management of hyperthyroidism

The gastrointestinal tract has a role in thyroid physiology. Thyroid hormone is metabolized mainly in the liver, where it is conjugated to glucurunides and sulfates. These conjugation products are then excreted in the bile. Free hormones are released in the intestine and finally reabsorbed, completing the enterohepatic circulation of thyroid hormone. A very small portion of the daily production of thyroxin (T4) and triiodothyronine (T3), less than 10 percent, is excreted in the stool (1-3). In people with normal thyroid function, this pathway of T4 and T3 recirculation contributes so little to hormone availability that patients who have gastrointestinal disease or are receiving drugs that decrease T4 absorption do not have abnormal thyroid function (4). However, the thyrotoxic states are characterized by an increased enterohepatic circulation of thyroid hormones, as well as an increased urinary and fecal excretion of both conjugated and free T4 (5,6).

Cholestyramine, an ionic exchange resin sequesters T4 in the intestine and increases its fecal excretion. These phenomena were proven in hamsters in mid 1960s (7). Experimentally, it has been shown that 50 mg of cholestyramine can bind approximately 3000 μg of T4 (8) and therefore can enhance the clearance of thyroid hormones. Because of the increased enterohepatic circulation of thyroid hormones during hyperthyroidism, attempts have been made to sequester these hormones in the intestine using ionic exchange resins (9-13). Cholestyramine therapy has been studied in the treatment of thyrotoxicosis as an adjunctive therapy to thionamides, and has been found to decrease thyroid hormone levels rapidly. In several trials, cholestyramine in combination with methimazole (MMI) or propylthiouracil, caused a more rapid decline in thyroid hormone levels than standard therapy with thionamides alone (9-11,13). In all of these trials, cholestyramine was dosed at 4 grams orally two to four times a day.

This study was conducted to examine the efficacy of combination therapy of lower doses of cholestyramine with MMI and propranolol for treating patients with Graves' hyperthyroidism.

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed hyperthyroid Graves' disease

Exclusion Criteria:

* If the patient had been treated previously
* diabetes, kidney, or liver disease
A Phase II Randomized Open Label Study of KLH-2109 in Patients With Endometriosis

The purpose of this study is to evaluate the efficacy and safety of KLH-2109 in patients with endometriosis.


Eligibility Criteria:
Inclusion Criteria:

* Female patients with endometriosis

Exclusion Criteria:

* Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
Beetroot Juice Ingestion and Vertical Jump Performance

Beetroot juice is a dietary supplement with good evidence for improving sports performance in different sport contexts, however, the evidence about the effects of beetroot juice in jump capacity is unclear. Thus, the aim of this study was to conduct a comprehensive examination of beetroot juice effects on vertical jump performance

Beetroot juice is a dietary supplement with good evidence for improving sports performance in different sport contexts, however, the evidence about the effects of beetroot juice in jump capacity is unclear. Therefore a deeper knowledge about the effects of beetroot juice on several components of vertical jump performance remain largely unexplored between we can mention phase duration peak power, average power, peak velocity, initial force, and peak force. Thus, the aim of this study was to conduct a comprehensive examination of beetroot juice effects on several countermovement jump components.

Eligibility Criteria:
Inclusion Criteria:

Experience in resistance training (at least 18 months of three weekly sessions).

A one-repetition maximum weight (1 RM) higher than bodyweight in the bench press and of 1.5 of body weight in squat exercise No sports supplement was taken in the previous three months No smoking. No cardiovascular, pulmonary or neurological disease. To not be considered an elite athlete.

Exclusion Criteria:

Age \<18 year or \> 35 years.
Successful Microsurgical Breast Reconstruction in Minimally Invasive Mastectomy

A retrospective chart review will be conducted to identify patients who received breast reconstruction surgery with DIEP flaps by a single plastic surgeon in one medical center between November 2018 and July 2022. Patients will be grouped based on how the mastectomy was performed, via minimally invasive or conventional approach. Demographic data, flap profile, vessel anastomosis and post-operative complication will be retrospectively reviewed. Data collection includes patient demographics, previous breast surgical history, breast cancer history and adjuvant therapy, surgical details and postoperative events.


Eligibility Criteria:
Inclusion Criteria:

* patients who received nipple sparing mastectomy and breast reconstruction from November 2018 to July 2022 from a single breast reconstruction surgeon.

Exclusion Criteria:

* patients failed to be examined for outcome evaluation will be excluded from the study.
Cooperation of Insulin and GLP-1 on Myocardial Glucose Uptake

27 Type 2 diabetic subjects (HbA1c 7.5 - 9.5%) currently treated with diet and exercise alone or with oral antidiabetic agents will be randomly assigned to one of three treatment groups: insulin detemir, liraglutide, or liraglutide plus detemir (9 subjects per group), on a background of metformin 2000 mg per day. After 3 months' treatment, PET measurements of myocardial fuel selection will take place, under fasting conditions in the morning following that day's treatment injection(s).

The investigators will test the hypothesis that effects of liraglutide plus insulin detemir on myocardial fuel selection will be greater than the effects of either agent alone. 27 Type 2 diabetic subjects (HbA1c 7.5 - 9.5%) currently treated with diet and exercise alone or with oral antidiabetic agents will be randomly assigned to one of three treatment groups: insulin detemir, liraglutide, or liraglutide plus detemir (9 subjects per group). All subjects will undergo an initial standardization of background treatment to metformin 2000 mg per day, followed by randomized assignment to 3 months' treatment with liraglutide 1.8 mg/day (once daily each morning, tapering up according to label instructions) and/or detemir (administered twice daily, initially at 10 units per day then titrated to achieve fasting morning glucose readings below 130 mg/dL). PET measurements of myocardial fuel selection will take place at the end of this treatment period, under fasting conditions in the morning following that day's treatment injection(s).

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic
* 18-50 years
* BMI \> 25kg/m2
* HbA1c 7.0-10.0%
* Treated with up to 2 oral agents

Exclusion Criteria:

* Chronic illness or infection (other than diabetes mellitus)
* Known coronary artery disease, structural heart disease or abnormal ECG on screen.
* Treatment with \>2 antihypertensive agents or blood pressure \>140/95 on two occasions during screening
* History of claustrophobia, musculoskeletal or other factors which would result in an inability to comfortably remain within the PET scanner gantry for the duration of the imaging protocol.
* Occupational, investigational or other known radiation exposure which together with the planned radiologic studies, will result in greater than 500 mrem total exposure in a 12 month period.
* Current pregnancy
* Treatment with GLP-1 agonist or DPP4 inhibitor within the past 6 months
* Known intolerance to GLP-1 agonist
* Personal history of pancreatitis, personal or family history of medullary thyroid carcinoma, or other contraindications to liraglutide treatment.
* Recognized microvascular complications (neuropathy, nephropathy, retinopathy).