cyrilzakka/clinical-trials huggingface dataset:
Absolute Bioavailability and Metabolism Study of CORT118335 in Healthy Male Participants

This study will evaluate the absolute bioavailability of CORT118335 and determine the mass balance recovery, absorption, metabolism and elimination, and metabolite profile and identification of metabolite structures following a single oral dose of CORT118335 in healthy male participants.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65 years of age for Part 1 and 30 to 65 years of age for Part 2
* Body mass index of 18.0 to 30.0 kg/m\^2
* Provide written informed consent
* Have regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day) for Part 2
* Adhere to the contraception requirements.

Exclusion Criteria:

* Have received any investigational medicine in a clinical research study within the previous 3 months or CORT118335 at any time
* Employees or immediate family members of employees of the study site or Sponsor
* Have a pregnant partner
* History of abuse of any drug or alcohol, or regularly consume more than 21 units alcohol/week
* Smokers or users of e-cigarettes and nicotine replacement products within the last 6 months
* Occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017; greater than background radiation exposure from other sources exceeding 5 milliSieverts (mSv) in the last 12 months or 10 mSv in the last 5 years
* Clinically significant abnormal results of clinical laboratory safety tests, electrocardiogram, or measurement of heart rate and blood pressure
* History of clinically significant cardiovascular, renal, hepatic, endocrine, metabolic, respiratory, neurological, or gastrointestinal disease
* History and/or symptoms of adrenal insufficiency or any condition that could be aggravated by glucocorticoid blockade (e.g., an autoimmune disease; allergy requiring treatment)
* Donation or loss of greater than 400 mL of blood within the past 3 months
* Has consumed liquorice or other glycyrrhetic acid derivatives regularly in the past 6 months
* Are taking, or have taken, any prescribed, over-the-counter drug or vitamins/herbal remedies within 14 days (longer restrictions apply for some medicines).

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Comparative Safety and Efficacy Study of New Bifonazol Spray vs Terbinafine Solution vs Placebo

The study shall prove whether 6 consecutive doses of Bifonazole spray show comparable efficacy to a Terbinafine solution applied once.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged between 18 and 70 years
* Positive clinical findings of athlete's foot, limited to interdigital spaces, with a total athlete's foot severity score (AFSS) of at least 5 and not exceeding 10 points for the signs and symptoms of athlete's foot, and no sign or symptom scoring 'severe'

Exclusion Criteria:

* Clinical history suggestive of intolerance or allergies to one of the products or the ingredients of the products
* Plantar tinea pedis ("Mocassin-type")
* Onychomycosis of any toe
* Previous treatment with a systemic antifungal within 6 months prior to screening
* Previous treatment of feet with a topical antifungal within 4 weeks prior to screening
* Previous treatment with a topical antifungal applied to other areas of the body than feet within 2 weeks prior to screening
* Previous treatment of any topical medication applied to the feet within 2 weeks prior to screening
A Novel Role of Alpha Lipoic Acid in Comparison With Selenium in Mitochondrial Resuscitation and miRNA-126 Expression in Hemodialysis Patients

An Open labeled, Paralled, Randomized, Prospective, study was conducted on 60 patients who were randomized into 3 groups, 22, 20 and 18 patients in Control, Selenium and, Thiotacid groups respectively. Serum levels of ROS, CoQ10, and miRNA-126 were assessed at base line and after three months for all patients.


Eligibility Criteria:
Inclusion Criteria:

* prevalent hemodialysis patients

Exclusion Criteria:

* Patients with Inflammatory diseases, hepatic or respiratory diseases, smokers and alcoholics, were excluded from the study.
Assessment of TRACP-5b in Primary and Secondary Osteoporosis

Assessment of the TRACP-5b level in 1ry OP and 2ry OP such as RA and seronegative spondylitis, that may help in surrogating the use of BMD.

Osteoporosis is a disease characterized by low bone density and a deterioration of bone microarchitecture that reduces bone strength and increases the risk of fracture. The hallmark of osteoporosis is the loss of both bone mineral and bone matrix. Although Bone mass density (BMD) is still the gold standard for the diagnosis of osteoporosis, but bone turnover markers (BTMs) can provide helpful information regarding the bone remodelling process. One of these relatively recent markers is the Tartrate-resistant acid phosphatase (TRACP). TRACP, which was first identified in human leukocytes, has 2 isoforms TRAP-5a derived from macrophages and dendritic cells and TRACP-5b secreted by osteoclasts. it is believed that TRACP-5b is a useful marker of osteoclast activity, even a marker for osteoclast number, as it is associated with osteoclast differentiation, activation and proliferation. Furthermore, it has the advantage of not being affected by renal dysfunction, nor food intake and has a weak diurnal variability. And this is why it has been used as one of the bone turnover markers in evaluating the efficacy of different anti-resorptive treatments in postmenopausal osteoporosis and in 2ry OP due to rheumatoid arthritis as well as in evaluating its specificity in identification of postmenopausal OP when compared to measurement of more expensive, relatively unavailable bone mineral density (BMD).So far, limited researches are available regarding the TRACP-5b level difference among 1ry OP (postmenopausal women) and 2ry OP (ex. RA, SpA).

Eligibility Criteria:
Inclusion Criteria:

* Patients with 1ry OP diagnosed by DXA scan .
* Any RA and SpA patients (older than 18 years old), who fulfill the for mentioned diseases criteria with secondary osteoporosis as diagnosed by DXA scan.

Exclusion Criteria:

* Patients unwilling to participate in the study.
* Patients with other autoimmune diseases.
* Patients depending on Glucocorticoids with in the last 6 month.
* Patients with other causes of 2ry OP (ex. Endocrinal abnormalities, Gastrointestinal diseases, Renal diseases.....etc.)
Incidence and Severity of Neuropsychiatric Adverse Events of Efavirenz Given as a Stepped Dosage vs. the Usual Dosage

Background: Neuropsychiatric side effects (NPSEs) occur in a significant proportion of subjects after initiation of efavirenz (EFV) and may limit its use in certain patients.

Objectives: To evaluate the incidence and severity of NPSEs and antiviral efficacy of EFV given as a stepped dosage over 2 weeks versus the usual dosage.

Methods: Randomized, double blind, multicentric clinical trial in which a progressive dosage (arm A: 200 mg qd for 6 days, 400 mg qd for 7 days and 600 mg qd from day 14 forward) was compared with conventional administration (arm B: 600 mg qd from the first day). All patients received additional treatment with 2 NRTIs.

The incidence and intensity of NPSEs and sleep disorders were assessed using a Likert-type scale specifically designed. Efficacy was assessed by percent of virological failures.


Eligibility Criteria:
Inclusion Criteria:

* Age older than 18 years
* HIV-1 infection
* Women of child-bearing age: negative pregnancy test
* Ability to understand and sign a written consent form

Exclusion Criteria:

* Pregnancy..
* Illegal drug or methadone use.
* Major psychiatric disease antecedents or starting new psychotropic agents in the last 4 weeks
* Concomitant treatment with rifamycins, protease inhibitors or drugs which interfere the pharmacokinetic of efavirenz.
* Hepatic insufficiency
Swallowing Training in Parkinson's Disease

Dysphagia in Parkinson's disease(PD) is common and its presence is related to motor and sensory abnormalities, and incoordination between swallowing and breathing. Despite harming as respiratory infections and increased risk of death, treatment of this condition remains uncertain. This study aims to evaluate the effect of oral motor exercises on the swallowing dynamics and quality of life of dysphagic Parkinson's disease patients. This study is an open trial, self-paired and blinded to the examiner. The participants will perform oropharyngeal exercises for five weeks and will be evaluated before and after intervention by swallowing videofluoroscopy and questionnaires about quality of life in dysphagia (SWAL-QOL).


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Parkinson disease
* Complaint of dysphagia

Exclusion Criteria:

* Hoehn and Yahr stage 5
* Other neurological conditions
* Therapy for swallowing in the last 3 months
* Cognitive disorders
* Psychiatric disorders
Sacrocolpopexy Versus Vaginal Mesh Procedure for Pelvic Prolapse

Pelvic prolapse is one of the most frequent pathology in Gynecology. Recurrency of the prolapse after primary surgery is relatively high, 15-30%. Sacrocolpopexy has showed to be effective but it requires a long learning curves and is more aggressive. New meshes techniques seem to be effective, as well, with less learning curve but they are expensive and there are no randomize studies published.

The investigators aim is to compare both techniques in terms of: anatomical and functional efficacy, cost, operating time and complications.


Eligibility Criteria:
Inclusion Criteria:

* Subject has been diagnosed with one or more clinically significant anterior, apical, or posterior genital prolapse disorder(s)(symptomatic POP-Q stage II or higher) requiring surgical repair.

Exclusion Criteria:

* Investigator determines subject is not a candidate for surgical repair of her genital prolapse.
* Subject has had a prior prolapse procedure involving graft placement (synthetic or biologic)
* Subject has active or latent systemic infection or signs of tissue necrosis.
* Subject has restricted leg motion (inability to abduct or adduct leg positioning in the lithotomy position) with or without a hip replacement / prosthesis.
* Subject is currently pregnant or intends to become pregnant during the study period.
* Subject has had radiation therapy to the pelvic area.
* Subject has pelvic cancer, has had pelvic cancer within the past 12 months or has been on cytostatic medication within the past 12 months.
* Subject has uncontrolled diabetes.
* Subject is on any medication with could result in compromised immune response, such as immune modulators.
* Subject has undergone previous pelvic surgery \< 6 months prior to enrollment in this study.
* Subject is unwilling or unable to give valid informed consent.
* Subject is unwilling or unable to comply with the requirements of the protocol, complete all quality of Life questionnaires and return for all follow-up visits.
* Subject with contraindications for laparoscopy
Study to Evaluate Nilotinib in Adult Patients With Imatinib-resistant or Imatinib-intolerant Chronic Myelogenous Leukemia (CML), or Relapse/Refractory Ph+ Acute Lymphoblastic Leukemia (ALL) (Extension Study)

This study will investigate if nilotinib provides an improved safety and efficacy profile over that seen in patients receiving Imatinib.


Eligibility Criteria:
Inclusion Criteria:

* Patients who complete CAMN107A1101 and obtained Informed concent by document

Exclusion Criteria:

* None
TEWL Biomarker Study for Diabetic Foot Ulcer Recurrence

This is a multicenter study of patients with diabetic foot ulcers (DFU) to develop and validate potential tissue-based biomarkers that predict DFU wound recurrence. Trans-epidermal water loss (TEWL) will be measured on the closed wound site and a location similar to the wound site (reference site). Participants will be enrolled within two weeks after closure of their DFU. Complete wound healing will be verified at a second visit two weeks later and this visit will start the 16 week timeline where participants will be followed weekly by phone until the earliest of DFU wound recurrence or 16 weeks. Participants who experience a DFU wound recurrence and a subset of participants who do not experience a DFU wound recurrence by week 16 will be asked to attend one final visit.


Eligibility Criteria:
Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria at Visit 1:

1. Age \> 18 years.
2. Willing and able to comply with protocol instructions.
3. Clinically diagnosed DFU is closed.
4. Clinically diagnosed with diabetes or meeting the American Diabetes Association (ADA) criteria.
5. Provides written informed consent.

   At Visit 2, confirmation of complete wound healing, the following additional inclusion criterion must be met:
6. Confirmation that the target DFU that was assessed as healed at Visit 1 remains healed two weeks later (at Visit 2).

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. DFU wounds closed more than 2 weeks before Visit 1, or to be closed by flap or graft coverage
2. Closed DFU site whose size or location would not allow five separate TEWL measurements
3. Prisoners
Oral Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis in Adult Japanese Participants (ELEVATE UC 40 JAPAN)

The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment in adult Japanese participants with moderately to severely active ulcerative colitis (UC). This study is an extension of study APD334-302 (NCT03996369). Participants will continue with the same blinded treatment assigned in Study APD334-302 for a total treatment duration of 52 weeks (12 weeks in Study APD334-302 plus 40 weeks in Study APD334-308).


Eligibility Criteria:
Inclusion Criteria:

Participants with moderately to severely active ulcerative colitis (UC) are eligible to enroll into this study if they fulfill all of the following:

* Must have completed the Week 12 visit of Study APD334-302
* Ability to provide written informed consent or assent (parent or legal guardian must provide consent for a participant \< 20 years of age or as required per local regulations who has assented to participate in the study) and to be compliant with the schedule of protocol assessments. Enrollment of participants \< 20 years should be conducted only if acceptable according to local laws and regulations.
* Both men and women subjects agree to use a highly effective method of birth control if the possibility of conception exists

Exclusion Criteria:

Participants who meet any of the following exclusion criteria will not be eligible for enrollment into the study:

* If the Investigator considers the participant to be unsuitable for any reason to participate in the study
* Participants requiring partial or total colectomy during the APD334-302 study
* Participants requiring treatment with prohibited concomitant medications
Craniocervical Dysfunction Index in Patients With Temporomandibular Joint Dysfunction

The aims of this study were to perform cultural adaptation of the Craniocervical Dysfunction Index in patients with Temporomandibular Joint Dysfunction, reliability and validity of the index Turkish speaking adults.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 20-60 years
* Clinical diagnosis of non-specific neck pain
* Being able to communicate in Turkish
* Volunteering to participate in the study

Exclusion Criteria:

* Over 60 years of age
* Those with impairments in cervical mobility that affected the postural assessment
Impact of Aripiprazole on Postoperative Analgesia in Laparoscopic Hysterectomy

The analgesic effect of perioperative use of aripiprazole has not been fully investigated.

So, this study aims to test the effects of aripiprazole versus placebo in reducing postoperative pain following laparoscopic hysterectomy and to explore the potential side effects.


Eligibility Criteria:
Inclusion Criteria:

* Physical status American Society of Anesthesiologist (ASA) I or II
* Electively scheduled for laparoscopic hysterectomy,

Exclusion Criteria:

* Patients who refuse to participate
* Body mass index (BMI) \> 30
* ASA physical status \> II
* Diabetes
* Major illnesses (e.g., cardiac, respiratory, renal, hepatic or neurological)
* Coagulation abnormalities
* Pregnancy
* Known hypersensitivity to aripiprazole or contraindications to its use (a psychiatric illness, patients on antidepressants, dementia-related psychosis)
* History of drug addiction or alcohol abuse
* Mental retardation interfering with the evaluation of pain scores or PCA programs .
A Phase 1 Study Assessing Local Cutaneous Effects of SB204

In this study, color (erythema) and pH will be measured on 3 consecutive days after application of 2 doses of SB204 to the cheeks of healthy volunteers.

This study is to evaluate local cutaneous effects, including intensity and duration of erythema and changes in pH following 5 applications (twice daily for two days and once daily on the third day) of SB204 2% and SB204 4% twice daily to the face for 3 days.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Women who are pregnant or nursing
* Subject with known sensitivity to a component of the test materials
The Acute Effect of a Theacrine-based Supplement on Mobilization of Various Stem Cell Populations.

The goal of the study is to determine the acute and short-term supplementation effect of a commercially available theacrine-containing supplement (NAD3) on numbers of various circulating stem cell populations in older adults.

This is a double-blind, placebo-controlled crossover study with 12 participants randomized to receive either NAD3® or a placebo for seven days. Blood samples are collected after an overnight fast, before and after the seven-day supplementation period, as well as one and two hours after the final supplement/placebo dose. Using flow cytometry, circulating stem cells, including lymphocytoid CD34+ stem cells (CD45dimCD34+), stem cells associated with vascular maintenance and repair (CD45dimCD34+CD309+), CD34+ stem cells linked to a progenitor phenotype (CD45dimCD34+CD309neg), circulating endothelial stem cells (CD45negCD31+CD309+), and mesenchymal stem cells (CD45negCD90+) are quantified.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* Age 40-70
* BMI between 21-34.99 kg/m2
* Vital signs with in normal range (heart rate 60-100 beats/minute, blood pressure (40-44 years - 125/83, 45-49 years- 127/84, 50-54 years -129/85, 55-59 years - 131/86, \>60 - 134/87), 36.4-37.4 degrees Celsius
* Sedentary to lightly active (2 or fewer days per week of exercise)

Exclusion Criteria:

* Female participants who are lactating, pregnant or planning to become pregnant during the study
* History of use of illicit drugs or other substances of abuse within 12 months of the screening visit (to be determined at screening)
* Tobacco during the 90 days prior to screening
* Current use of medication/dietary supplements that claim to or have an effect on age-related processes, e.g. "anti-aging" supplements. Participants must undergo a ≥7-day washout period of no supplementation to be eligible.
* Known allergy, intolerance or hypersensitivity to NAD3
* Self-reported active infection or illness of any kind
* Cognitively impaired and/or unable to give informed consent
Use of Track Health Function of the MyHealthevet Personal Health Record

This study was a pilot 3-month clinical trial that investigated the feasibility, effectiveness, and acceptability of using the Track Health function of the Veterans Health Administration's patient health record for effecting a more positive physical activity (PA) and dietary intake lifestyle in a sample of 38 overweight and obese Veterans with prediabetes. Baseline and three-month post-intervention outcomes were measured in two main domains: objective (e.g., weight) and subjective (e.g., self-efficacy).

This was a pilot clinical trial that used a single-group design to test the feasibility, effectiveness, and acceptability of using the Track Health (TH) function of My HealtheVet, the VA's patient health record (PHR), as a tool for effecting a more positive physical activity (PA) and dietary intake lifestyle in overweight and obese Veterans with prediabetes. Baseline and three-month post-intervention outcomes were measured in two main domains: objective (PA as measured by an accelerometer, diet, weight, abdominal circumference, BMI, and blood pressure) and subjective (self-efficacy, intent to adhere to lifestyle change, and patient activation). Assessments, including screening on inclusion and exclusion criteria, physiological measurements, administration of questionnaires, and training on use of two critical features of the TH function--the use of Journals to enter dietary and PA data and the use of Vitals + Readings to enter weight and track physiological measures--took place place across four visits to the study site, which was the Veterans Administration Medical Center in Miami. The investigators hypothesized that this PHR-based intervention would demonstrate improvements and increases, respectively in the objective and subjective domain measures. The investigators also hypothesized that engagement by study participants with MHV would be demonstrated through meeting target criteria regarding making entries into this PHR's TH function, and that participants would be satisfied with the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Veterans with diagnosis of prediabetes (HbA1c 5.7-6.4%, fasting plasma glucose 100-125 mg/dL or oral glucose tolerance test 140-199 mg/dL)
* English speaking
* Access to the Internet
* Body mass index (BMI) of 25-42 kg/m and a sedentary lifestyle (not being physically active three days per week for 20 minutes each time for the previous six months and not performing regular resistance exercise)
* Able to engage in a regular program of mild-to-moderate intensity physical activity but were not currently following a weight loss diet or participating in an intervention trial

Exclusion Criteria:

* Cognitively impaired (Mini-Cog greater than or equal to 3)
* Depressed (PHQ-2 less than or equal to 3)
* Vision or hearing disorders
* Have been diagnosed with diabetes mellitus, uncontrolled hypertension, or cardiovascular disease
* Currently pregnant or nursing.
Impact of Fluid Milk on Post-meal Glycemia and Insulinemia in Overwt/Obese Adults

Blood sugar and insulin levels after a meal may be altered by the food and beverages a person consumes. Keeping a healthy blood sugar level may help prevent and manage type 2 diabetes and related diseases. This study will look at how drinking different common beverages (milk, low-fat milk, nonfat milk, orange juice, coffee, and water) with a meal changes blood sugar and insulin levels.

The broad aim of the proposed research is to evaluate the effects of consuming milk and non-milk beverages with a breakfast meal on postprandial glucose and insulin responses in overweight and obese adults with varying levels of glucose tolerance (normal, pre-diabetic, type 2 diabetes). The investigators expect the consumption of fluid milk with breakfast to decrease the postprandial glucose response relative to other non-milk beverages (orange juice and sweetened coffee). Furthermore, the investigators expect that there will be no difference in the postprandial glucose or insulin response between varieties of fluid milk (skim, low-fat, and whole).

Eligibility Criteria:
Inclusion Criteria:

* 35-65 years old,
* BMI between 27-40 kg/m2,
* HbA1C less than 7.5%,
* weight stable (± 4.5 kg) for the previous 3 months
* willing to consume study foods and beverages.

Exclusion Criteria:

* using exogenous insulin,
* currently (or within the past 6 months) following a vigorous exercise regimen, or weight loss program,
* acute illness,
* smoking,
* pregnant or planning pregnancy in the next 3 months,
* lactose intolerant,
* weight changes of greater than ± 3 kg during the study period