cyrilzakka/clinical-trials huggingface dataset:
Vitamin B Complex and Diabetic Nephropathy in Type 1 Diabetes

Homocysteine levels have been found elevated in T1DM patients with Diabetic nephropathy (DN) due to several causes, including dietary deficiencies. Hyperhomocysteinemia induces renal injury and is associated with increasing urinary albumin excretion(UAE). Therefore, the investigators performed a randomized-controlled trial of oral supplementation with vitamin B complex as an adjuvant therapy for nephropathy in pediatric patients with T1DM and assessed its relation to homocysteine levels, glycemic control, microalbuminuria and cystatin C as a marker of nephropathy.

This trial included 80 vitamin B12-deficient T1DM patients with nephropathy, despite oral angiotensin-converting enzyme inhibitors . Enrolled patients aged 12-18 years with at least 5 years disease duration and HbA1c ≤8.5%. Patients were randomly assigned into two groups; intervention group who received vitamin B complex once daily orally . The other group did not receive any supplementation and served as a control group. Both groups were followed-up for 12 weeks with assessment of plasma homocysteine, HbA1c, cystatin C and UAE.

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 1 diabetes.
* Patients aged 12-18 years with at least 5 years disease duration.
* Active diabetic nephropathy in the form of microalbuminuria (urinary albumin excretion \[UAE\] 30-299 mg/g creatinine in two of three samples over a 3- to 6- months period despite angiotensin converting enzyme inhibitors)
* Hemoglobin A1c (HbA1c) ≤8.5%
* Patients on regular visit to clinic.
* Patients on regular insulin therapy.

Exclusion Criteria:

Patients were excluded if they have any of the following:

* Patients with history of liver disease or any disorder likely to impair liver functions or elevated liver enzymes.
* Patients with any evidence of renal impairment due to cause other than diabetes.
* Patients with hypertension.
* Hepatitis virus infection (B or C) or any evidence of infection.
* Taking any vitamins or food supplements one month before study.
* Participation in a previous investigational drug study within 3 months preceding screening.
Investigating the Regulation of Reproductive Hormones in Adult Men

The purpose of the research study is to learn more about the regulation of reproductive hormones in adult men. We would like to understand what role testosterone and estradiol play in controlling the release of LH (lutenizing hormone) and FSH (follicle stimulating hormone). Testosterone and estradiol come from the testes, and LH and FSH are released from a gland in the head called the pituitary.

Men involved in the study will have detailed evaluations that involve overnight stays in the hospital and frequent blood sampling. The men in the study will also be receiving medications that affect the levels of various hormones in the body. This will allow the researchers to learn how various hormones influence each other. Men that participate in the study will receive medical evaluations and monetary compensation. Information gathered from this study will help in the development of new treatments for infertility and potentially new hormonal forms of contraception.

In the United States 10-15% couples seek evaluation for infertility, of whom a male factor is identified in approximately 50% of cases. To date, however, most infertility research has focused on the female partner and in the majority of instances the etiology of male infertility remains poorly understood with inconsistent elevation in FSH levels. Given that spermatogenesis is highly dependent on FSH secretion, this project will focus on delineating the feedback control of FSH in the human male. Such studies, although difficult to perform in the human, are critical to understanding not only the pathophysiology of male infertility, but also to determining the feasibility of hormonal approaches to male contraception. In this protocol, studies of normal, GnRH-deficient and agonadal men employing reversible sex steroid ablation, physiologic sex steroid replacement and manipulation of the GnRH input to the pituitary will permit the non-steroidal, sex steroid, and GnRH-dependent components of FSH regulation to be selectively elucidated.

Eligibility Criteria:
Inclusion Criteria:

* Men aged 18 to 50 years
* In good health
* On no medications

Exclusion Criteria:

Subjects will not be enrolled in this study if there is a history of:

* Liver disease or if screening blood tests demonstrate abnormal liver function tests
* Excessive alcohol consumption
* Illicit drug use
* Severe drug allergy
* Use of any concomitant medications
* Peptic ulcer disease or gastritis
Safety, False-Positive Reactions and Sensitizing Properties of Leishmania Tropica Skin Test Antigen

The efficacy of LtSTA as a skin test antigen depends upon the sensitivity and specificity of the product. This study has been designed to measure the skin test responses to 15, 30, or 50µg doses of LtSTA. The measurements of non-specific reactivity due to components of the antigen solution and the product's ability to sensitize lymphocytes of Leishmania naïve persons when administered intradermally. The presence or absence of a local inflammatory response to the first skin test with each of three doses of LtSTA will provide insight on the specificity of the antigen in a naïve population. The local inflammatory response to LtSTA following the first and second repeat skin tests will indicate if the antigen is sensitizing after intradermal administration.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female in good health;
* Age 18 - 60 years;
* No past history of leishmaniasis or prior participation in a Leishmania study;
* No prior skin test with a Leishmania antigen;
* No occupational, residential, or travel exposure to Leishmania;
* Positive Candin® or Trichophyton skin test (\>= 5 mm induration).

Exclusion Criteria:

* History of adult atopic dermatitis, contact dermatitis to multiple agents, unexplained urticaria, or asthma;
* Active allergic rhinitis or conjunctivitis;
* History of allergy or reactions to phenol, polysorbate 80, or glycerol;
* Medications: currently taking (within the last month) antihistamines or recent history of taking (within the last 1 year) corticosteroids, immunosuppressants;
* Splenectomy;
* Active medical disease\*;

  \*Active Medical Disease: Any active physical or psychiatric condition that may increase the risks associated with participation in the study or interferes with the interpretation of study results. Included chronic medical illnesses are cardiovascular disease, renal insufficiency, chronic respiratory illness, cirrhosis, chronic hepatitis, chronic pancreatitis, chronic diarrhea, malnutrition, malignancy, autoimmune disease, and asthma.
* Pregnancy or lactating;
* Immunization within 4 weeks;
* History of leishmaniasis;
* Occupational exposure to Leishmania;
* Prior participation in a Leishmania study;
* Prior skin test with Leishmania antigen;
* Travel history to Leishmania endemic areas;
* Abnormal screening lab results;
* Keloid scar formation
Surgical Extrusion for the Clinical Crown Lengthening: a 12-months Clinical Study

This is a prospective study in which surgical extrusion of single-rooted teeth is carried out by the same operator in 15 consecutive patients.

Main objective: to evaluate the soft tissue rebound of the teeth 1 year after the surgery.

Null hypothesis (H0): surgical extrusion is not a predictable treatment for the restoration of single rooted teeth.


Eligibility Criteria:
Inclusion Criteria:

* Systemically and periodontally healthy, non-smoking patients.
* Single-rooted, straight teeth with insufficient ferrule, which require restorative treatment.
* Teeth with a favorable crown-root ratio.

Exclusion Criteria:

* Severe systemic disease patients (American Society of Anesthesiologists classification 1 or 2).
* Multi-rooted, curved and/or short teeth.
* Teeth with an uncontrolled periodontal pathology.
* Pregnant women.
* Teeth with types ll or lll mobility.
Performance and Safety of the Lipo-transfer Cannulas in Patients Underlying Lipofilling Treatment

The purpose of this post-market clinical follow up study is to assess the safety and performance of Aesthetic Group cannulas. The study will evaluate the outcome of the Aesthetic Group cannulas range over a period of 1 month after intervention.


Eligibility Criteria:
Inclusion Criteria:

* Patient age ≥ 18 years at intervention
* Patient who will undergo a lipofilling treatment with at least one cannula of Aesthetic Group
* Patient informed of his/her participation and willing to participate in the study.
* Patient able to read, write and understand French.

Exclusion Criteria:

* Patient deprived of freedom, under guardianship/curatorship or placed under judicial protection
* Patient unable to follow study procedures
* Patient with hematologic abnormalities, prior radiotherapy or chemotherapy
* Chronic use of medicines or drugs
* Patient with diabetes mellitus
* Patient with connective tissue diseases, any type of fat tissue disorder (lipodystrophy)
* Patient with bleeding disorders; immune deficits; heart, liver, and kidney insufficiency
* Patient with allergies to local anaesthetics
* Patient with pacemaker and serious heart rhythm disorders
* Pregnant and breastfeeding women
Postmenopausal Women and Their Endothelium

The purpose of this study is to test the effects of a one time dose and 7-days of inorganic nitrate (supplied in the form of beetroot juice) on blood vessel function and resting blood pressure in healthy, postmenopausal women. Participants will drink beetroot juice and a placebo juice on separate visits where blood pressure and blood vessel function will be measured.

Cardiovascular disease is the leading cause of death in the United States. Due to the loss of estrogen, women experience a unique accelerated rise in cardiovascular disease risk factors following menopause. Postmenopausal women represent a population at heightened risk for cardiovascular disease development. Function of the endothelium has been shown to decline across the menopause transition, resulting in less production of nitric oxide. As such the investigators are investigating a potential therapeutic strategy in women have recently undergone menopause to boost nitric oxide availability.

Eligibility Criteria:
Inclusion Criteria:

* Early post-menopausal women who are within 1-6 years following their final menstrual cycle
* Late post-menopausal women who are beyond 6 years following their final menstrual cycle

Exclusion Criteria:

* Individuals with any overt cardiovascular, metabolic, hematologic, pulmonary, renal, musculoskeletal, and/or neurological disease(s).
* Users of any tobacco and/or nicotine products (smokers, chewing tobacco, nicotine-containing patches/gum, smokeless cigarettes)
* Individuals with a BMI \> 35
* Individuals with resting blood pressure \> or = 130/80 mm Hg
* Individuals with high blood lipids (total cholesterol \> or = 240 mg/dl, LDL \> or = 160 mg/dl, triglycerides \> or = 200 mg/dl).
* Postmenopausal women with hyperglycemia (fasting glucose \> or = 110 mg/dl and HbA1c \>6.0%).
* Individuals taking any of the following medications:

  1. blood pressure lowering medication (e.g., beta blockers, ACE inhibitors, angiotensin antagonists, calcium channel blockers, diuretics)
  2. lipid- lowering medication (e.g., statins)
  3. nitrates (e.g. nitroglycerin) for angina
  4. phosphodiesterase inhibitors (e.g., Viagra)
  5. anti-Inflammatory drugs
* Individuals taking hormone therapy
Effects of Cholecalciferol Supplementation in Patients With Chronic Heart Failure and LOw vITamind D Levels

The purpose of this study is to determine whether cholecalciferol supplementation in patients with chronic heart failure and low vitamin D levels improves:

1. performance at six minutes walking test
2. echocardiographic parameters
3. neurohormonal imbalance


Eligibility Criteria:
Inclusion Criteria:

* Heart failure diagnosis according to European Society of Cardiology Guideline criteria
* Age \> 60 years old
* 25(OH) Vitamin D level \< 30 ng/ml
* Clinical and therapeutic stability for one month (NYHA class II or III)

Exclusion Criteria:

* Chronic use of anticonvulsants or barbiturates, steroids, thiazides, aluminium or magnesium, colestipol or cholestyramine
* Glomerular filtration rate lower than 30 ml/min/1.73 m2 according to MDRD equation
* Nephrolitiasis, Sarcoidosis or hypercalcemia
* Recent (three months) acute coronary syndrome or stroke or major vascular surgery
* Reduced life expectancy due to other diseases (active neoplasms, liver cirrhosis...)
Effect of Post-discharge Phone Calls on Patient Outcomes

The purpose of this study is to determine whether a post-discharge telephone call to general medical patients discharged home will improve quality of care and adherence, and reduce hospital readmission.

Currently, discharge from hospital in many institutions is a confusing process for patients filled with uncertainty and potential for harm. For instance, 1 in 5 discharges results in a post discharge adverse event, many of which are related to medication errors. These may lead to serious harm and possibly require readmission to hospital. Telephone follow-up calls after discharge has been studied in small single-center trials and as a part of a coordinated, multi-layered discharge process but its direct effectiveness is not known. Understanding the impact of this simple intervention on patient outcomes is an important step towards improving patients' discharge from hospital.

Eligibility Criteria:
Inclusion Criteria:

* Admission to internal medicine ward
* Discharged to home
* Must have telephone access

Exclusion Criteria:

* Discharged to care facility
* Lack of telephone access
The Effect of Dry Needling With Electrical Stimulation on Individuals With Restless Legs Syndrome

The purpose of this study is to examine the effects of dry needling with electrical stimulation (DNES) on sleep quality, symptom severity, and function in individuals with restless legs syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years
* Clinical diagnosis of restless legs syndrome

Exclusion Criteria:

* Active cancer diagnoses
* Neuropathic pain (e.g., lumbosacral radiculopathy and/or diabetic neuropathy),
* Pregnancy
* Immunocompromised disease (e.g., HIV, AIDS, lupus)
* Insufficient English-language skills to complete all questionnaires
* Inability to maintain treatment positions
* Contraindications to dry needling:35,36

  * Presence of needle phobia
  * History of abnormal reaction to needling or injection
  * History of bleeding disorder
Trial to Evaluate the Effects of Naltrexone in Nonsuicidal Self-injury

The goal of this clinical trial is to learn if naltrexone works to treat nonsuicidal self-injurious behavior in adolescents and adults.

Recruiting participants with nonsuicidal self-injurious behavior and randomizing them to the experiment group and the control group at a 1:1 ratio, the test group administers the experiment drug naltrexone along with the general treatment, and the control group provides a placebo. Clinical evaluation including the frequency of self-injurious behavior is conducted every two weeks. The investigator and participants will double-blinded. Analyze the relationship between changes in clinical symptoms and socio-demographic characteristics, diagnosis, clinical characteristics, and anticipated to discover predictors of treatment effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* Age: 16 years of age or older
* Clinical interviews meet DSM-5\&#39;s nonsuicidal self-injury diagnostic criteria
* Nonsuicidal self-injurious behavior has been observed more than once in the past two months
* Obsessive Compulsive Drinking Scale general craving item 2 or more points (strong desire)
* Self-injurious behavior continues even with 4 weeks of general psychiatric treatment for underlying disease
* Anyone who can independently read and fill out the questionnaire and speak Korean
* Who understand the written consent and voluntarily agree to participate in the study
* Female participants of childbearing age must be negative on urine pregnancy test at screening

Exclusion Criteria:

* currently in psychotic or manic conditions
* currently experiencing serious suicidal thoughts
* history of substance-related disorders including opioid
* do not agree to use very effective contraception from the time of signing the test subject\&#39;s consent form to the end of study period (non-fertility women and postmenopausal women excluded from the contraception requirements)
* Severe medical conditions (angina pectoris, myocardial infarction, arrhythmia, any cancer that is not in remission, hypothyroidism, hyperthyroidism, diabetes, hepatitis B, hepatitis C, epilepsy, dementia, HIV infection)
* intellectual disability or organic brain damage
* difficulty reading and writing Korean
* taking opioid antagonists (methadone, buprenorphine, etc.)
* on an opiate painkiller
* currently opiate dependence
* acute opiate withdrawal symptoms
* naloxone-induced test is positive or the urine test is positive for opiates
* have been sensitized to this drug
* acute hepatitis, liver failure, severe liver failure
* renal disease
* hypersensitivity reaction to the main ingredient or other ingredients of this drug
* a pregnant woman, a woman who may be pregnant, or a lactating woman
* Since this drug contains lactose, genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc
* active liver disease
Study Evaluating AMG 424 in Subjects With Multiple Myeloma

A multi-center Phase 1, First-in-Human study conducted in 2 Parts, testing AMG 424 in subjects with relapsed/ refractory multiple myeloma.

Part 1 of the study is dose evaluating and aimed at assessing the safety and tolerability of AMG 424 while determining the maximum tolerated dose (MTD) and/or biologically active dose in subjects with relapsed/ refractory multiple myeloma.

Part 2 of the study will further evaluate safety and tolerability of the AMG 424 MTD dose determined in Part 1, in groups of subjects with relapsed/ refractory multiple myeloma that include those with high or low cytogenetic risk.

Eligibility Criteria:
Inclusion Criteria:

* Multiple myeloma meeting the following criteria:
* Pathologically-documented diagnosis of multiple myeloma that has relapsed after at least two prior lines of therapy that must include a proteasome inhibitor (PI), immunomodulatory drug (IMiD), and, where approved and available, anti-CD38 therapy in any order OR that is refractory to PI, IMiD, and anti-CD38 therapy.

  ◾Subjects who could not tolerate a PI, IMiDs, or a CD38-directed therapeutic antibody due to unacceptable toxicities are eligible to enroll in the study.
* Measurable disease as per IMWG response criteria
* Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2

Exclusion Criteria:

* Known central nervous system involvement by multiple myeloma
* Previously received allogeneic stem cell transplant and one or more of the following:

  * received the transplant \< 6 months prior to study Day 1
  * received immunosuppressive therapy \< 3 months prior to study Day 1
  * any active acute graft versus host disease (GvHD), grade 2- 4, according to the Glucksberg criteria or active chronic GvHD requiring systemic treatment
  * any systemic therapy against GvHD \< 2 weeks prior to study Day 1
* Autologous stem cell transplantation less than 90 days prior to study day 1
* Multiple myeloma with IgM subtype
* POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
* Evidence of primary or secondary plasma cell leukemia at the time of screening
* Waldenstrom's macroglobulinemia
* Amyloidosis
* Dexamethasone at cumulative doses of greater than 160 mg or equivalent \<3 weeks prior to study Day 1 is not allowed. Use of topical or inhaled steroids is acceptable
* Anticancer treatment (chemotherapy, IMiD, PI, molecular targeted therapy) \< 2 weeks prior to study Day 1
* Treatment with a therapeutic antibody targeting CD38 \< 12 weeks prior to study Day 1
* Systemic radiation therapy or major surgery \< 28 days prior to study Day 1 as well as focal radiotherapy \< 14 days prior to study Day 1.
* Major surgery within 28 days prior to study Day 1
Safety and Tolerability of Egalet-002 in Patients With Moderate-to-Severe Chronic Noncancer Pain

The purpose of this study is to evaluate the safety and tolerability of Egalet-002 in opioid-experienced patients with moderate-to-severe chronic noncancer pain.


Eligibility Criteria:
Inclusion Criteria:

* Is a man or woman between 18 and 75 years of age.
* Has a clinical history of moderate-to-severe chronic noncancer pain ≥6 months.
* Has required opioid therapy for at least 14 days prior to Screening at a dose between 20 mg and 160 mg (inclusive) oxycodone/day (or opioid equivalent), and will, in the opinion of the investigator, continue to require opioid therapy (between 20 mg and 240 mg oxycodone/day, inclusive) for management of moderate-to-severe pain for the duration of the study.
* Has pain either not adequately controlled on current opioid regimen, requires a change of opioid due to tolerability of current opioid regimen or in the opinion of the investigator, would benefit from changing opioid for another reason.
* Has stable health, as determined by the investigator.
* If female, the patient is currently not pregnant, not breast-feeding, nor attempting to become pregnant (for 30 days before screening through the duration of the study), or is of non-childbearing potential.
* Other Criteria Apply

Exclusion Criteria:

* Has cancer-related pain.
* Is receiving \>240 mg oxycodone daily (or opioid equivalent) within 30 days before Screening.
* Has a history of attempted suicide.
* Has used a spinal infusion pump within 6 months before Screening.
* Has clinically unstable cardiac disease (including atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia) and/or respiratory disease (including chronic obstructive pulmonary disease or sleep apnea).
* Has positive urine toxicity screen for drugs of abuse (with the exception of prescribed medications).
* Has positive result for tetrahydrocannabinol (even if legally prescribed).
* Has current (or history of within the last 12 months) drug dependence or substance abuse disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, Text Revision criteria (excluding nicotine).
* Other Criteria Apply
Comprehensive Strategy to Decolonize Methicillin-resistant Staphylococcus Aureus (MRSA) in the Outpatient Setting

The purpose of this study is to determine the effectiveness of topical and oral antibiotics in eliminating carriage of methicillin-resistant Staphylococcus aureus (MRSA) among those living in the community. We hypothesize that a greater proportion of those who receive intervention will eliminate MRSA carriage compared to those who do not receive any intervention.


Eligibility Criteria:
Inclusion Criteria:

* Prior MRSA infection (i.e index case)
* Identified as being colonized with MRSA on initial screen

Exclusion Criteria:

* Are pregnant or breastfeeding.
* Have indwelling catheters.
* Received prior decolonization treatment within last 6 months of enrollment.
* Have allergy to study medication.
* Are colonized with MRSA strain resistant to study medication.
* Have active infection requiring systemic antimicrobials.
* Are household contacts to index case.