cyrilzakka/clinical-trials huggingface dataset:
Comparison of Changes in Serum 25(OH)D Concentrations Following Vitamin D Supplementation With Chewable Tablets Versus Pills

This is a 6-month cross-over trial of vitamin D supplementation in 38 healthy men and women aged 18 years and older. The primary aim is to compare the change in serum 25(OH)D concentration following vitamin D supplementation with chewable tablets versus pills. Secondary aims are to evaluate satisfaction and adherence to the vitamin D chewable tablet supplement. Questionnaires on physical activity, sunlight exposure and dairy product consumption will be administered to adjust for confounding factors. A questionnaire will be administered to assess satisfaction and pill count to evaluate adherence to treatment. This research intends to test the hypothesis that the vitamin D chewable tablet supplement is as effective as a traditional vitamin D pill supplement to increase serum 25(OH)D concentrations.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian men and women;
* Aged 18 years and older;
* Having a serum 25(OH)D concentration of 75 nmol/L or less.

Exclusion Criteria:

* Regular consumption of a supplement containing \> 400 IU/d of vitamin D over the last 2 months;
* Intestinal malabsorption;
* Cirrhosis;
* Renal insufficiency (creatinine clearance \<60 ml/min);
* Hypercalcemia;
* Pregnancy;
* Breastfeeding;
* Inability to provide informed consent.
Effects of Behavioral Interventions on Mechanisms of Pain Regulation and Hedonic Regulation

The overarching aim of this project is to conduct a randomized controlled study to determine whether Mindfulness-Oriented Recovery Enhancement (MORE) vs. a Support Group (SG) can improve pain regulation and hedonic functions (i.e., natural reward responsiveness) thought to be governed by the endogenous opioid system among opioid-treated, chronic, non-neuropathic back pain patients (CNBP) and thereby improve clinical pain, affect, and opioid use.


Eligibility Criteria:
Inclusion Criteria:

1. age 21-60 years of age
2. English fluency
3. 20/20 vision with corrective lenses
4. current chronic, non-neuropathic back pain diagnosis determined by physician assessment
5. reporting pain ≥3 on 0-10 scale with opioid medication
6. current use of prescription opioids for ≥3 consecutive months
7. ability to understand study procedures and to comply with them for the entire length of the study

Exclusion Criteria:

1. Mindfulness experience (e.g., MBSR or shamatha/vipassana meditation)
2. psychosis
3. untreated, active suicidality in the past month
4. and severe non-opioid substance use disorder in the past year as assessed with the MINI
5. clinically unstable illness judged to interfere with treatment, and presence of facial/jaw pain
6. pregnancy
7. inability or unwillingness of individual to give written informed consent
8. physical characteristics that preclude neuroimaging or study procedures (e.g., metal implants, etc.
Study of Trametinib and Nab-paclitaxel in Patients With Melanoma

This study will investigate the combination of two drugs, trametinib and nab-paclitaxel, in patients with advanced unresectable or metastatic melanoma. Each drug has shown activity in trials of patients with melanoma. However, the combination of these two drugs has not been studied. In this trial the investigators will determine the maximum dose of the drug combination to be administered to patients with advanced unresectable or metastatic melanoma and examine the safety profile of the drug combination.

While treatment for melanoma has evolved in the last few years, advanced/metastatic melanoma remains an aggressive disease with poor prognosis. Trametinib and nab-paclitaxel have demonstrated single-agent activity in Phase III trials of patients with melanoma. The investigators propose to investigate this drug combination in patients with advanced unresectable or metastatic melanoma. This open-label Phase I study is designed to determine the maximum tolerated dose (MTD), recommended Phase II dose (RP2D), and safety profile of trametinib and nab-paclitaxel given in combination. Patients with melanoma and known BRAF mutation status will receive escalating doses of trametinib and nab-paclitaxel to determine the MTD. Once the MTD is determined an additional 6 patients will be treated at the MTD to establish the dose for future studies.

Eligibility Criteria:
Inclusion Criteria:

* Adults (≥18 years) with histologically or cytologically-confirmed advanced unresectable or metastatic melanoma. BRAF mutation-positive and wild-type tumors are allowed.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate hematologic, renal, and hepatic function
* Life expectancy ≥12 weeks
* Any pre-existing neuropathy must be \<grade 2 per Common Technology Criteria for Adverse Events (CTCAE) version 4.0

Exclusion Criteria:

* More than 1 prior cytotoxic chemotherapy regimen in the metastatic setting
* Prior MEK inhibitor therapy (prior BRAF inhibitor allowed)
* Prior nab-paclitaxel (prior taxane allowed)
* Use of an investigational anti-cancer drug within 21 days or 5 half-lives (whichever is shorter) prior to first dose. A minimum of 10 days after termination of investigational drug is required. Any drug-related toxicity should have resolved to Grade 1 or baseline.
* Symptomatic or untreated brain metastases
* History of retinal vein occlusion (RVO)
Gray Matters Alzheimer's Disease Prevention Intervention

This is a randomized controlled trial to develop and test the efficacy of a multi-domain lifestyle behavioral intervention designed to promote healthier lifestyle behaviors linked to lower Alzheimer's disease risk among persons aged 40 to 64 years.

This is a randomized controlled trial to develop and test the efficacy of a multi-domain lifestyle behavioral intervention designed to promote healthier lifestyle behaviors linked to lower Alzheimer's disease risk among persons aged 40 to 64 years. Participants are randomized to treatment or control condition. The intervention, spanning a six month period, is an evidence-based health education program.

Eligibility Criteria:
Inclusion Criteria:

* Age
* Residing or working in Cache County Utah
* Possessing smart phone or tablet

Exclusion Criteria:

* Dementia
* Pregnancy
* Untreated chronic major depression or other psychiatric condition
* Body mass index \> 41
* Heart or stroke in prior 6 weeks
* Active cancer treatment
* Unwillingness to seek medical help when serious condition identified at intake
Effectivness and Safety of Acupuncture Combined With Moxibustion for Allergic Rhinitis

A multi-centre clinical trial done by us（ISRCEN90807007）showed that active acupuncture had significantly greater effect on symptoms of allergic rhinitis than either sham acupuncture or no active treatment. The object of that study was to evaluate the effectiveness and safety of acupuncture for allergic rhinitis. As an explanatory research, acupuncture was defined as the only intervention for treatment group and sham acupuncture, no active treatment as its control groups. Besides, acupuncture combined moxibustion showed better and longer effect than acupuncture on allergic rhinitis patients in our previous pilot study. According to this result, we are taking a pragmatic randomized controlled trial to further evaluate whether acupuncture combined moxibustion is more effective than conventional treatment.


Eligibility Criteria:
Inclusion Criteria:

Each participant must have a diagnosis of AR by an otolaryngology doctor, according to the criteria listed in "Allergic Rhinitis and its Impact on Asthma" (ARIA 2008) Symptoms that had persisted for more than 4 days per week for more than four consecutive weeks.

At least one of the following rhinitis-associated conditions: nasal obstruction, rhinorrhea, sneezing and nasal itching.

At least one positive result on an allergy skin prick reaction test at screening.

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Exclusion Criteria:

Active tuberculosis Autoimmune disorders Severe chronic inflammatory diseases History of anaphylactic reactions Specific immunotherapy \>3 years Simultaneous participation in other clinical trials Serious acute or chronic organic disease or mental disorder Congenital nasal abnormalities Pregnancy or breast feeding Blood coagulation disorder and/or current use of anticoagulants Allergy desensitisation therapy (current, during the past two years, or planned in the next two years) Previous systemically administered corticosteroids, antihistamines, or decongestants in the last 1 months prior to enrollment

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Nalmefene Gambling Study: Study of Nalmefene HCl in the Treatment of Pathological Gambling

The purpose of this study is to determine if nalmefene is safe and effective in the treatment of pathological gambling.

Randomized, double-blind, placebo-controlled, parallel-group, multi-centered, outpatient study to assess the efficacy, safety and tolerability of two doses of nalmefene in patients with current diagnosis of pathological gambling.

Eligibility Criteria:
Inclusion Criteria:

* Current diagnosis of pathological gambling as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
Clinical Study to Evaluate the Efficacy and Safety of Neuronox and Botox With Essential Blepharospasm

This clinical study evaluates the efficacy and safety of Neuronox compared with Botox in adults with essential blepharospasm.

Subjects are randomly assigned into the two groups at the ratio of 1:1. The purpose of study is to confirm the non-inferiority of Neuronox to Botox in terms of the efficacy and safety in subjects with essential blepharospasm.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 to 75
* Subjects had to have a confirmed clinical diagnosis of essential blepharospasm requiring treatment by injection

Exclusion Criteria:

* Subjects who underwent surgical operation
* Subjects with Neuroleptic induced blepharospasm
Efficacy and Tolerance of Nova22007 Versus Vehicle in Patients With Vernal Keratoconjunctivitis (VKC)

The primary objective of this study is:

* To assess the efficacy of Nova22007, a cyclosporine A (CsA), 0.05% and 0.1% versus vehicle in patients with vernal keratoconjunctivitis (VKC) after a 4-week treatment period.

The secondary objectives of this study are:

* To compare the safety and ocular tolerance of Nova22007 0.05% and 0.1%;
* To assess the long term safety and ocular tolerance of Nova22007 0.05% and 0.1%; and
* To assess the decrease in frequency of concomitant artificial tears use.


Eligibility Criteria:
Inclusion Criteria:

* At least the two following signs, in at least one eye\* (the same eye should fulfill both criteria):

  * Presence of giant papillae with a diameter ≥ 1 mm on the upper tarsal conjunctiva AND
  * Superficial keratitis
* At least two of the following ocular symptoms with a score \> 2 in at least one eye\*: burning/stinging, tearing, itching, pain, sticky eyelids, foreign body sensation, mucus discharge, and photophobia.
* Hyperemia score equal to or greater than 2.

Exclusion Criteria:

* Concomitant corneal ulcer of infectious origin.
* Active ocular herpes
* Disease that could possibly interfere with the interpretation of the study results: active uveitis (defined by Tyndall score \> 0), previous history of ocular hypertension or glaucoma, or condition incompatible with the frequent assessments needed by the study.
* Active herpes.
* History of malignancy or a recurrence in the last 5 years.
* Abnormality of nasolacrimal drainage apparatus.
* Concomitant disease not stabilized within 1 month before Screening Visit (e.g. diabetes with glycemia out of range, trouble with thyroid secretions, etc.) or judged by the investigator to be incompatible with the study (e.g. current systemic infections), or condition incompatible with the frequent assessments needed by the study.
* Known hypersensitivity to one of the components of the investigational medicinal products (IMP) or test products.
* Severe systemic allergy requiring systemic treatment at study entry.
* Female of childbearing potential.
* History of drug or alcohol addiction (\> 50g/day, 5 glasses alcohol/day).
Long-term Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-36)

The purpose of this extension study is to evaluate the long-term safety, tolerability, and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe chronic obstructive pulmonary disease (COPD). This study will be 54 weeks in duration; a 52-week double-blind treatment period and 2 week follow-up phone call, following a 12 week lead-in study. All patients will be randomized from the lead-in study at one of two doses of aclidinium.


Eligibility Criteria:
Inclusion Criteria:

* Completion of a lead-in study (NCT00891462)

Exclusion Criteria:

* Use or anticipated use of any medication prohibited in this study
* Evidence of abnormal clinical laboratory values, vital signs, or electrocardiographic (ECG) results or the presence of abnormities in physical examination findings
* The presence of anti-cholinergic effects (eg, dry mouth, urinary retention, narrow angle glaucoma)
* QTcB of \>500 msec on both the pre-dose and post-dose ECG
* Women who are pregnant, intend to become pregnant, or are breast-feeding
* A life expectancy of less than 1 year
* Noncompliance with IP dosing and/or attending clinic visits during the lead-in study
* Significant interruption of double-blind therapy during the transition from the lead-in study into the extension study.
Characterization of Bovine Adrenal Medulla as a New Surrogate Model of Non-histaminergic Itch

With this experiment, the experimenter wish evaluate the role of TRPA1 on non-histaminergic itch induced by BAM8-22

With this experiment, the experimenter wish evaluate the role of TRPA1 on non-histaminergic itch induced by BAM8-22 2 (Bovine Adrenal Medulla), which is found naturally in the human body and which has proved to evoke itch. To evaluate the role of TRPA1 it will be used a TRPA1 antagonist (A-967079)

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* 18-60 years
* Speak and understand English

Exclusion Criteria:

* Pregnancy or lactation
* Drug addiction defined as any use of cannabis, opioids or other drugs
* Previous or current history of neurological, dermatological, immunological musculoskeletal, cardiac disorder or mental illnesses that may affect the results (e.g. neuropathy, muscular pain in the upper extremities, etc.)
* Moles, wounds, scars or tattoos in the area to be treated or tested
* Lack of ability to cooperate •
* Current use of medications that may affect the trial such as antihistamines and pain killers.
* Skin diseases
* Consumption of alcohol or painkillers 24 hours before the study days and between these - Acute or chronic pain •
* Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)
A Three-Part Study Of GSK580416 In Healthy Subjects

Studies for GSK580416 have been completed in rats and dogs. The main toxic effects seen in animals affected the digestive system and blood cells. Study OPS106400 will be the first administration of GSK580416 in humans. Parts A and B of this study will examine the safety, tolerability, and pharmacokinetics of increasing single doses of GSK580416 with reference to placebo. Part C of the study will assess the effect of food on the safety, tolerability, and pharmacokinetics of a single dose of GSK580416 in healthy subjects.


Eligibility Criteria:
Inclusion criteria:

* Healthy as determined by a physician
* Healthy male or female of non-child bearing potential between 18 and 55 years of age (inclusive)
* Body weight \> = 50 kg and BMI between 19 and 30 kg/m2 (inclusive)

Exclusion criteria:

* Positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody with 3 months of screening
* Male and female subjects not willing to follow study specified contraceptive methods
* Subjects taking any recreational drugs
* Regular use of tobacco- or nicotine-containing products within 6 months prior to screening
* Has participated in a clinical trial and have not received a drug within 30 days before the dose of study drug
* Has exposed to more than 4 new chemical entities within 12 months before the first dosing day
* Use of prescription or over-the-counter medications within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study drug
* Use of St. John's Wort within 28 days before the first dose of study drug
* Subjects not willing to follow study specified life style restrictions
* Blood donation in excess of 500 mL within a 56 days period
Dietary Magnesium in Preventing Low Blood Magnesium Levels in Patients With Ovarian Cancer Receiving Carboplatin Chemotherapy

This trial studies how well a diet high in magnesium works in preventing low blood magnesium levels (hypomagnesemia) in patients with ovarian cancer receiving carboplatin chemotherapy. Hypomagnesemia is a common side effect of carboplatin-containing chemotherapy. A magnesium rich diet may increase the levels of magnesium in the blood and help prevent hypomagnesemia resulting from carboplatin chemotherapy.

PRIMARY OBJECTIVE:

I. Evaluate intervention feasibility.

SECONDARY OBJECTIVE:

I. Evaluate occurrence of hypomagnesemia and the need for a pharmacy regimen including oral and intravenous magnesium dosage.

EXPLORATORY OBJECTIVE:

I. Explore changes in other electrolytes, weight, and occurrence of chemotherapy delay or discontinuation and hospitalization which can be related to dietary intervention and program completion.

OUTLINE:

Patients receive a dietary magnesium intervention consisting of a food reference list and phone calls or video interviews from a registered dietitian, integrative medicine physician, or a mid-level provider over 10-20 minutes once a week for up to the 6th cycle of chemotherapy (average 15 weeks).

Eligibility Criteria:
Inclusion Criteria:

* Patients with previously untreated ovarian cancer.
* Receiving carboplatin-containing chemotherapy of at least 6 consecutive cycles.
* Able to tolerate an oral diet.

Exclusion Criteria:

* Prior platinum-based chemotherapy.
* Serum creatinine level \> 1.4 mg/dL prior to treatment.
* Artificial nutrition (e.g. Ensure or Boost) accounts for \> 50% of total calorie intake.
Computerized Based Analysis for Detection and Severity Assessment of Stuttering

In the light of previous attempts to design and develop automated and objective measures for automatic speech recognition system that detects disfluent speech and assess its severity, yet fully automated measurement of stuttered speech is not available. This study was triggered by the need to design and develop a simple and reliable computerized tool for identification of stuttering and measurement for its severity. Therefore, the aim of this study is to develop a user interface that can work on windows system for the adopted stuttering recognition model which can be used in clinical practice by physicians and therapists.

Stuttering is a speech disorder in which the normal flow of speech is disrupted by occurrences of dysfluencies, such as repetition, prolongations and blocks (1). Features that have been found to differ between stutterers and nonstutterers are rate of speech and frequency of dysfluent utterances (2).

An Arabic version of stuttering severity instrument (A-SSI) is used to assess the stuttering severity In it, the overall severity score of stuttering is measured by combining the scores of percentages of Stuttered Syllables (%SS), Mean Duration of the Three Longest Stuttering Events (MDTLSE), and Physical Concomitants (PC) (3).

The subjective assessment methods of stuttering are; time-consuming, prone to error, subjective (4), so it is better to automate the measurement of disfluencies using speech recognition technologies and computational intelligence (5).

Speech recognition executes a task similar to what the human brain undertakes (6). Stuttering detection system has three main steps which are acoustic processing, feature extraction and classification/recognition (7). the speech signals are pre-processed (8), and certain features are extracted from them by signal processing techniques, e.g. Mell frequency cepstral coefficients (MFCC) (9). (MFCC) is considered the most popular used feature extraction technique (10).

The classification process contains two steps; training and testing (11). In training process, data is labeled based on the classes and a model is learned. In testing phase: the model is tested and computed the accuracy, sensitivity, and specificity of the classification models (11). Finally, stuttering from non-stuttering speech will be recognized and separated (5) also to assess the severity of stuttered speech.

Eligibility Criteria:
Inclusion Criteria:

1. Age: from 10 to 30 years old.
2. Gender: both sexes will be included in the study.
3. The participants in the study group suffering from developmental stuttering (stuttering symptoms was of early childhood onset, intermittent course and dated since early childhood) seeking speech therapy
4. Have language aptitudes coping with his or her chronological age.

Exclusion Criteria:

* 1. Presence of any other speech or language disorders. 2. Mental Retardation. 3. Poor scholastic performances. 4. Presence of any psychiatric or neurologic disorders.
Herbal Tea in the Treatment of Type 2 Diabetes Mellitus

Diabetes mellitus is a chronic disease caused by inherited and/or acquired deficiency in production of insulin by the pancreas, or by the ineffectiveness of the insulin produced. It has become a major healthcare problem in India. High-quality, low-cost solutions adapted to the local context are critical to addressing the current crisis in the management of diabetes. Herbal tea consists of tulsi, guava and stevia, which has glucose lowering properties.The aim of this trial is to study the effect of a herbal tea in the glycemic response in the early type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

Adults aged over 18 years and having a diagnosis of diabetes and meeting one of the following criteria

1. Fasting Plasma Glucose ≥126 mg/dL, fasting defined as no caloric intake for at least 8 hours, AND
2. 2-h Post load Glucose ≥140 mg/dL during an OGTT. AND
3. Glycosylated haemoglobin (A1C) ≥ 6.5 %.

Exclusion Criteria:

Any one of the following

1. Patients on Insulin therapy.
2. Patients on oral hypoglycemic agents other than metformin
3. Any history suggestive of micro vascular or macro vascular disease - coronary artery disease, stroke, peripheral artery disease or diabetes related retinal changes.
4. Women in child bearing age unable to practice any form of contraception
5. Patients with diagnosis of Anaemia (Hemoglobin \<11 g/dl in Female and \<13 g/dl in Male)
6. Impaired renal function; estimated glomerular function \<60mls/min/1.73m2.
7. Known history of any chronic illness taking regular pharmacological agents.
8. Blood pressure fluctuations exceeding 20 mmHg on 2 subsequent clinic visits or known history of hypotension or bradycardia in last 6 months or taking 3 or more antihypertensive medications regularly in the last 6 weeks
9. Known history of autonomic dysfunction like diabetic autonomic neural imbalance or neuropathy
10. Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days.