cyrilzakka/clinical-trials huggingface dataset:
Mental Activity During (TMS) Therapy for Depression

The purpose of the study is to assess the effects of different types of mental activity performed while receiving transcranial magnetic stimulation (TMS) for the treatment of major depressive disorder. Our primary aim for this study is to assess the feasibility of combining TMS and computer based cognitive exercise in patients with major depressive disorder who may also have some degree of cognitive dysfunction, and to formally measure changes in mood and cognition over the course of the study.

Patients will receive TMS treatment daily for 6 weeks as part of their standard care. They will complete clinical assessments and participate in cognitive retraining through completion of 15 hours of Lumosity gaming cognitive exercises while simultaneously receiving active TMS stimulation. Those participants in the control group will complete 15 hours of computer gaming activity during the administration of active stimulation. Computer games in the control group exercises are elected by the patient from a library of intellectually and motivationally engaging games drawn from several gaming software compilations that includes Play 101 Games and Hoyle Puzzle and Board Games.

Eligibility Criteria:
Inclusion Criteria:

* • Subject has a diagnosis of depression

  * Subject has been approved and scheduled to receive TMS at Augusta University
  * Subject does not have a major neurocognitive impairment or an alcohol or substance abuse disorder, and can see images on a computer monitor.

Exclusion Criteria:

-
Comparison Study on Topical Anesthetic Agents (LMX4 and BLT) Prior to Fractional Skin Resurfacing

The purpose of this research study is to test which topical anesthesia: LMX4 (Lidocaine 4%) or BLT (Benzocaine 20%, Lidocaine 6%, and Tetracaine 4%) is more effective in reducing discomfort during treatment with the Fraxel DUAL 1550/1927 (Solta Medical, Hayward, CA). No studies have been done on the effectiveness of LMX4 versus BLT using the Fraxel DUAL, although individually LMX4, BLT, and the Fraxel DUAL have been studied extensively.

The hypothesis is that there will be no clinical difference between the two topical anesthetics.

Lasers can be effectively utilized for facial rejuvenation, reduction of photoinduced rhytides, and dyschromia. Topical anesthetics are used to minimize the discomfort associated with laser induced thermal pain. There are currently several formulations of topical anesthesia. However, studies comparing the products are limited especially for the new formulations that claim increased efficacy and faster onset.

LMX4 (Ferndale Laboratories, Ferndale, Michigan) is over the counter topical anesthesia. It is 4% lidocaine that has been formulated into multilamellar vesicles containing several lipid bilayers. This unique liposomal-based delivery system has been reported to deliver a greater concentration of drug. This results in a longer duration of activity and faster onset of action without requiring occlusion.4 Liposomes assist with drug penetration because the skin is lipid bilayer that can encapsulate the drug.

BLT is a compounded topical anesthetic containing 20% benzocaine, 6% lidocaine, and 4% tetracaine. It is commonly prescribed as topical anesthesia. All BLT products will be compounded at the University Physicians Center Pharmacy to ensure safety and uniformity. Anecdotally, some physicians claim it is the topical anesthesia of choice prior to laser surgery.

The objective of the study is to evaluate the clinical efficacy of topical anesthetic compounds prior to fractional skin resurfacing.

Eligibility Criteria:
Inclusion Criteria:

* At least 28 subjects will be included in this study.
* Subjects capable of giving informed consent.
* Patients 18 years of age and older will be included in this study.
* Any patient seeking Fraxel DUAL1550/1927 (Solta Medical) treatment on the face for rhytids, photoaging, hyperpigmentation, and acne scarring at the Hershey Medical Center dermatology clinics will be asked to participate.

Exclusion Criteria:

* Age \<18
* Allergy to lidocaine or tetracaine
* Women who are pregnant or breast-feeding
* Patients with cardiac or respiratory disease, seizure disorders, or neuropathy
* Patients currently taking anxiolytics and opiates
Posturography-Neuropathy

If the classification between hereditary and acquired neuropathy is often easy, there is no completely specific marker allowing the distinction between the two etiologies. Clinical experience suggests that hereditary neuropathies have less impact on balance and gait than the acquired neuropathies at equivalent level of impairment, but this has never been clearly demonstrated.


Eligibility Criteria:
Inclusion Criteria:

* CMT1A for molecular-proven Group 1 (PMP22 duplication)
* IPDC likely or defined for Group 2
* Able to walk 10 m unassisted

Exclusion Criteria:

* Neurological history other than neuropathy: epilepsy, stroke, dementia
* Pregnant women
* Person under guardianship or trusteeship
* Musculoskeletal conditions other than neuropathy impairing walking abilities
* Major comorbidity considered a contraindication by the investigator (cancer, unstable angor, etc.)
Performance and Safety Assessment of T4020 in Managing Corneal Epithelial Defect Following Epi-off Accelerated Crosslinking

The purpose of this study is to assess the performance and safety of T4020 versus saline solution.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients diagnosed with progressive keratoconus
* Patients who signed and dated informed consent

Exclusion Criteria:

* Patient under 18 years
* History within 1 month or any active ocular infection, ocular injury, and associated corneal ulceration and abscess
* Corneal thickness\< 400µm
Designing and Pilot Testing a Just-in-time Adaptive Intervention (JITAI) for Adolescent Depression Treatment in Primary Care

The goal of this clinical trial is to learn if a tailored smartphone intervention called Sidekick can help improve sleep and physical activity for teenagers in depression treatment. The main question it aims to answer is:

Does Sidekick help teens improve sleep or physical activity?

Teen participants will be asked to complete surveys about how they are feeling and doing at the beginning of the study and throughout their participation. All teen participants will be able to use the Sidekick app during the study.


Eligibility Criteria:
Inclusion Criteria:

1. English-speaking
2. 13 to 17 years old
3. PHQ-8 score ≥5
4. PHQ-8 rating of ≥1 on anhedonia, sleep, or fatigue items
5. Own a personal smartphone

Exclusion Criteria:

1. Active safety concerns (e.g., acute suicidal ideation)
2. Diagnosed developmental disability (e.g., autism spectrum)
3. Primary mental health diagnosis other than MDD according to baseline Mini-international Neuropsychiatric Interview (MINI) (comorbidity allowed when MDD primary)
4. Sleep disorder from another medical cause
5. Inability to engage in moderate exercise because of medical concerns;
LIFT-plug vs LIFT, a RCT Trial

To validate the effect of Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug procedure for Anal Fistula Repair in 7 medical centers

The management of trans-sphincteric anal fistulae of cryptoglandular origin is challenging. The ideal management is to effectively heal the fistula without compromising continence, avoid fistula recurrence, and quick recovery. Ligation of the intersphincteric fistula tract (LIFT) and LIFT reinforced with a bioprosthetic graft (BioLIFT) are two recently reported procedures that showed improved healing results. In the LIFT, Rojanasakul et al proposed to identify the fistula tract in the intersphincteric space and subsequent division and ligation of the tract, and the primary healing rate was 94.4%. The following studies reported slightly lower results, but the recurrence rate was as high as 18% to 28%. Ellis et al subsequently described a modified LIFT procedure (BioLIFT procedure) in which a bioprosthetic was placed in the intersphincteric plane to reinforce the closure of the fistula tract (BioLIFT procedure), and yielded a healing rate of 94% in 31 patients who had a minimum of 1 year of follow-up after their last treatment. The investigators modified the LIFT procedure by combining LIFT with the technique of anal fistula plug. The bioprosthetic plug was placed into the fistula tract through the opening in the external sphincter to the external opening in the skin after LIFT procedure. The present study was designed to assess the preliminary results of LIFT-Plug technique prospectively. The purpose of this study is to validate the effect of Ligation of Intersphincteric Fistula Tract (LIFT) Versus LIFT-plug procedure for Anal Fistula Repair in 7 medical centers.

Eligibility Criteria:
Inclusion Criteria:

* High transsphincteric fistula (involving \> 30% of the external anal sphincter)
* Age between 18 and 70 years
* Chronic anal fistula with fistula tracts no more than 2
* No active sepsis or abscess

Exclusion Criteria:

* Fistulas with active inflammation or purulence
* Fistulas related to tumor, Crohn's disease, tuberculosis or acquired immune deficiency syndrome
* Poorly controlled diabetes with fasting blood-glucose \> 8mmol/L
* Preexisting incontinence
* Multiple fistula tracts \> 2
* Fasting blood-glucose ≥ 8mmol/L
* Allergic or contraindication for the use of animal protein
* Pregnant women
* Expected life less than 6 months
* With anorectal abscess
* Serious liver (Child-Pugh C) and chronic kidney disease (CKD) stage 3
Evaluation of Use of Diagnostic AI for Lung Cancer in Practice

This study investigates ways of improving radiologists performance of the classification of CT-scans as cancerous or non-cancerous. Participants interact with an AI to classify CT-scans under three different conditions.

The three conditions are as follows: "probabilistic classification", where the radiologist diagnoses scans using an AI cancer likelihood score; "classification plus detection", where the radiologist see detecting lung nodules in addition to the AI's probabilistic classification score before making her own examination of the CT-scan; and "classification with delayed detection", where the radiologist identifies regions of interest independently of the AI and then sees the AI's detected ROIs.

Eligibility Criteria:
Inclusion Criteria:

* The participant performs radiology screenings professionally

Exclusion Criteria:

-
Effects of CPAP Therapy on PTSD Symptoms

The purpose of this study is to evaluate the effects of treating Obstructive Sleep Apnea (OSA) with continuous positive airway pressure (CPAP) therapy on symptoms of post traumatic stress disorder (PTSD). The study hypotheses are that CPAP use will improve PTSD symptoms overall and that CPAP use will improve sleep quality and duration, nocturnal symptoms related to PTSD, mood, daytime sleepiness, sleep-related quality of life, and general health perception.

Post traumatic stress disorder (PTSD) is associated with increased healthcare utilization, decreased functional status, and overall poor health. Sleep disturbances in PTSD are common, including nightmares, dream enactment, and poor sleep quality. Obstructive sleep apnea (OSA) is also highly prevalent in the veteran population and may exacerbate PTSD symptoms by triggering arousals from sleep that promote recollection of dreams, enactment of dreams, and disrupt sleep continuity. Improvements in sleep quality and PTSD symptoms have been reported when OSA is treated with continuous positive airway pressure (CPAP) therapy. However, formal assessment using validated questionnaires and documentation of CPAP compliance to correlate with these tools has not yet been performed. This study will recruit veterans with PTSD who have been newly diagnosed with OSA and who are willing to try CPAP therapy. Baseline assessments of PTSD symptoms, daytime sleepiness, sleep-related quality of life, sleep quality, general health perception, and mood will be performed before initiation of treatment and after 3 and 6 months of therapy.

This study will have the following specific aims:

Aim 1: To evaluate the effect of CPAP use on PTSD symptoms.

Hypothesis: After 6 months of treatment, CPAP use will improve PTSD symptoms as assessed by the PTSD checklist (PCL-S).

Aim 2: To evaluate the effect of CPAP use on 1)sleep quality and duration, 2)nocturnal symptoms of nightmares, movement disorders, dream enactment, and insomnia, 3)mood, 4)daytime sleepiness, 5)sleep-related quality of life, and 6) general health perception.

Hypothesis: After 6 months of treatment, CPAP use will improve sleep quality, sleep duration, mood, daytime sleepiness, sleep-related quality of life, general health perception, and nocturnal symptoms of nightmares, movement disorders, dream enactment, and insomnia.

Eligibility Criteria:
Inclusion Criteria:The intent is to recruit a study population that is as representative as possible of the veteran PTSD population. Thus, entry criteria are as inclusive as possible:

* age \>18 year
* confirmed diagnosis of PTSD (PCL checklist minimum score of 45)
* confirmed diagnosis of sleep apnea (apnea hypopnea index \>5/h)
* newly starting CPAP (not previously treated)

Exclusion Criteria:

* fatal co-morbidity with life expectancy of less than 6 months,
* residing in a geographically remote area that would make follow up at 3 and 6 months difficult.
Study Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Diabetes Mellitus.

This study is Single arm, Single Centre trial to check the Safety and Efficacy of Bone Marrow Derived Autologous mono nuclear cells (100 Million per dose).trial to be conducted for 36 months in patients with diabetes Mellitus in India,Primary outcome measure are abolition or reduction of insulin by\>50 percentage by the end of 6 months of ABMSCT-Any reduction in requirement of Insulin dosage and Improvement in HbA1C Level.

his study is Single arm, Single Centre trial to check the Safety and Efficacy of Bone Marrow Derived Autologous mono nuclear cells (100 Million per dose).trial to be conducted for 36 months in patients with diabetes Mellitus in India,Primary outcome measure are abolition or reduction of insulin by\>50 percentage by the end of 6 months of ABMSCT-Any reduction in requirement of Insulin dosage and Improvement in HbA1C Level.

Eligibility Criteria:
Inclusion Criteria:

* Patient should suffer from Diabetes Mellitus.
* Willingness to undergo Bone Marrow derived Autologous cell Therapy.
* Ability to comprehend the explained protocol and thereafter give an informed consent as well as sign the required Informed Consent form(ICF) for the study.
* Ability and willingness to regular visit to hospital for protocol procedures and follow up

Exclusion Criteria:

* Patient with History of Immunodeficiency HIV+,Hepatitis B ,HBV and History of Life threatening allergic or immune -Mediated Reaction. the site of bone marrow aspiration potentially limiting Procedure. Alcohol and drug abuse / dependence. Patients with History of Hypertension and Hypersensitive.
A Study to Evaluate the Efficacy and Safety of DA-6034 and to Demonstrate the Non-inferiority of DA-6034

This is a multicenter, double-blinded, double-dummy, active-controlled, randomized, Phase III clinical trial to evaluate the efficacy and safety of DA-6034 and to demonstrate the non-inferiority of DA-6034 compared with Rebamipide in patients with acute or chronic gastritis. Subjects will receive 45mg, 90mg of DA-6034 and 300mg of Rebamipide, two tablets, three times a day for two weeks.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with acute gastritis or chronic gastritis
* 1 or more erosions found in the gastroscope examination
* Age should be: 20≤age≤75

Exclusion Criteria:

* A patient with peptic ulcer and a gastroesophageal reflux disease.
* Received a medication including non-steroid anti-inflammatory drug 2 weeks before the initiation
* Had a surgery regarding gastroesophageal
* A patient with Zollinger-Ellison syndrome
* Had a medical history of a malignant tumor
* A patient who is currently taking anti-thrombotic drugs
Usability and Pilot Testing - Intervention for Smoking Cessation

The purpose of the usability and pilot testing for the project "Developing a Bi-national Buddy Intervention for Smoking Cessation and Cultural Education" is to better understand how users interact with the smoking cessation app, and to improve the product based on the results. In pilot testing the smoking cessation app the investigators will examine the feasibility of our approach. The usability testing portion of the study is intended primarily to improve on the design of the smoking cessation app, and will: gather quantitative data on participant's performance, identify usability problems, and determine user satisfaction with the app. The pilot testing portion of the study will evaluate the feasibility, time, cost and statistical variability in an attempt to predict an appropriate sample size and improve upon the study design prior to performance of a full-scale research study.

Objective 1:To collect quantitative data on participant's performance while using the app for smoking cessation.

Objective 2:To identify problems with usability of the smoking cessation buddy app.

Objective 3:To assess user satisfaction with the smoking cessation buddy app. Objective 4:To improve upon the design of the smoking cessation buddy app Objective 5:To assess the feasibility, time, cost, and statistical variability for a full-scale implementation of this study with the intervention group.

Tobacco use cessation among youth is not adequately addressed in the US and Russia. The proposed intervention utilizes an innovative evidence-based approach while addressing the shortcomings of prior individual intervention components. In this project, investigators seek to refine a smoking cessation app by conducting two rounds of usability testing followed by a pilot test of the final app, to access usability problems, user satisfaction, and user-friendliness. This data will be collected in a de-identified and confidential manner, and will then be analyzed and used to refine the final app that will later be used.

Eligibility Criteria:
Inclusion Criteria:

* Current student
* Current cigarette smoker (smoked in past 30 days)
* speak English
* Own a smartphone
* Has some interest in quitting smoking.

Exclusion Criteria:

* Not meeting inclusion criteria.
Oxidative Stress, Carbohydrate Metabolism Disorders and G6PD Deficiency

The purpose of this study is to investigate the effects of alpha-lipoic acid supplementation on redox status, physiological and biochemical parameters in diabetic individuals with G6PD deficiency, after acute exercise.

In a randomized double-blind, crossover design, a total of forty people will participate in the research voluntarily: (a) ten people with G6PD (Mediterranean type) enzyme deficiency), (b) ten people with G6PD (Mediterranean type) enzyme deficiency and a disorder of carbohydrate metabolism (diabetes, prediabetes), (c) ten people with a disorder of carbohydrate metabolism (diabetes mellitus and prediabetes) and, (d) ten people without any health problem (control group). They will be supplemented with either 600 mg of alpha-lipoic acid (experimental condition) or placebo (control condition) every day for 4 weeks, separated by a 4-week washout period. All participants will be randomly assigned to both conditions.

Before intervention, all participants will be informed about the study protocol, fill a medical history questionnaire and sign an informed consent form. Moreover, measurements of anthropometric characteristics and physiological parameters, as well as a VO2peak test will be performed.

Participants will perform a trial of exercise (70% VO2peak for 45min and 90% till exhaustion) before and after each condition (i.e. a total of 4 trials). Blood samples will be collected before, immediately after and 1 hour after each exercise trial. Moreover, measurements of anthropometric characteristics, physiological and psychological parameters will be performed before and after each condition.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with normal G6PD activity
* Individuals with G6PD deficiency
* Individuals with CHO metabolism disorders (diabetes, prediabetes)
* Individuals with G6PD deficiency and CHO metabolism disorders (diabetes, prediabetes)

Exclusion Criteria:

* Health problems that contraindicate participation to exercise
* Should not take any medication that affects the body's antioxidant mechanisms as well as dietary supplements containing antioxidants
* Women during lactation or gestation
A Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Paclitaxel in Patients With Advanced or Metastatic Solid Tumors

This is an open-label Phase 1b/2 multicenter study of rebastinib (DCC-2036) in combination with paclitaxel designed to evaluate the safety, tolerability, and pharmacokinetics (PK) in patients with advanced or metastatic solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients ≥18 years of age at the time of informed consent
2. Part 1 Histologically confirmed diagnosis of a locally advanced or metastatic solid tumor for which paclitaxel is considered appropriate treatment
3. Part 2

   * Triple-negative and Stage IV inflammatory breast cancer
   * Recurrent ovarian cancer
   * Recurrent, metastatic or high-risk endometrial cancer
   * Advanced (stage III or IV), or recurrent gynecological carcinosarcoma

     * Homologous or heterologous type carcinosarcoma (malignant mixed Mullerian tumor \[MMMT\] allowed
4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of ≤2
5. Able to provide an archival tumor tissue sample
6. Adequate organ function and bone marrow reserve
7. If a female of childbearing potential, must have a negative pregnancy test prior to enrollment
8. Patient must provide signed consent to participate in the study and is willing to comply with study-specific procedures

Exclusion Criteria:

1. Received prior anticancer or other investigational therapy within 28 days or 5× the half-life prior to the first dose
2. Not recovered from prior-treatment toxicities to Grade ≤1
3. Peripheral neuropathy of any etiology \>Grade 1
4. Concurrent malignancy
5. Known active central nervous system (CNS) metastases
6. Use of systemic corticosteroids
7. Known retinal neovascularization, macular edema or macular degeneration
8. History or presence of clinically relevant cardiovascular abnormalities
9. QT interval corrected by Fridericia's formula (QTcF) \>450 ms in males or \>470 ms in females
10. Left ventricular ejection fraction (LVEF) \<50% at screening
11. Arterial thrombotic or embolic events
12. Venous thrombotic event
13. Active infection ≥Grade 3
14. Human immunodeficiency virus (HIV) or hepatitis C (HCV) infection only if taking medications excluded per protocol, active hepatitis B (HBV), or active HCV infection
15. Use of proton pump inhibitors
16. If female, the patient is pregnant or lactating
17. Major surgery 4 weeks prior to the first dose of study drug
18. Malabsorption syndrome or other illness which could affect oral absorption
19. Known allergy or hypersensitivity to any component of rebastinib or any of its excipients.
20. Any other clinically significant comorbidities