cyrilzakka/clinical-trials huggingface dataset:
Technology Enhanced Behavioral Activation Treatment for Substance Use

The purpose of this study is to:

1. test the effect of a smartphone enhanced LETS ACT (LETS ACT-SE) on frequency of substance use
2. use functional magnetic resonance imaging (fMRI) to test the relationship between neuromarkers of reward sensitivity on frequency of substance use.

Comorbid substance use disorder (SUD) and depression is highly prevalent and associated with elevated rates of post treatment relapse to substance use, HIV risk behavior, and associated poor mental and physical health outcomes. Further, rates of substance use and depression disproportionately affect minority groups and those living in poverty. Although efficacious, the often complex, specialized nature of CBT poses problems in its integration into substance use treatment programs. Budget cuts for mental health and substance use treatment both nationally and in the state of North Carolina, reduce availability of publically funded treatment programs and staff to patient ratios. To address this limitation, a behavioral activation (BA) treatment, the Life Enhancement Treatment for Substance Use (LETS ACT), was developed to treat depressive symptoms among a predominantly African American sample of low income illicit drug users currently receiving residential substance use treatment. Collectively, two Stage I studies and 1 year follow-up data from the investigators Stage II R01DA026424 indicate that compared to a control condition, LETS ACT is associated with significantly better outcomes for treatment retention, post treatment abstinence, HIV sexual risk behavior, depressive symptoms, and environmental reward.

Although these strong outcomes suggest that LETS ACT may be ready for a Stage III dissemination trial, it is of note that there was a significant indirect effect of LETS ACT homework compliance on post treatment substance use and HIV sexual risk behavior via the theoretically proposed BA mechanism of action, environmental reward. In the context of limited access to care, these findings point to the need to identify cost-effective delivery-vehicles to increase treatment engagement outside of clinician sessions. Further, identifying neuroscience based biomarkers (neuromarkers) underlying key theoretical aspects of BA (i.e., reward sensitivity), and their relation to heterogeneity in BA treatment response among substance users with depression, are critical for the identification of accurately targeted interventions.

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 55
* Meet criteria for DSM-V substance use disorder
* Elevated depressive symptoms (BDI ≥ 14)

Exclusion Criteria:

* Limited mental competency (MMSE \< 23)
* Psychosis
* The use of psychotropic medication for \< 3 months
* The inability to give informed, voluntary, written consent to participate
Harnessing the Healthy Gut Microbiota to Cure Patients With Recurrent C. Difficile Infection

CDI (Clostridium difficile infection) causes diarrheal illness and can cause colitis which may be fatal. A patient being treated for CDI has a 10-25% chance of developing relapse. Recurrent CDI is on the rise. There are few options available to treat recurrent CDI. "Stool transplant" (infusing donor stool into the intestine of the recipient), is not very palatable to either patient or medical personnel. The investigators will isolate intestinal bacteria from donor stool and use this purified mixture of donor bacteria instead of stool transplant. The investigators hypothesize that this cleaner mixture of purely isolated intestinal bacteria from a healthy donor would be equally effective as conventional fecal bacteriotherapy, which uses donor stool. The use of this prepared mixture of aerobic and anaerobic organisms, or probiotic approach, is based on the same principle of fecal flora reconstitution. However our approach would provide a more controlled, reproducible, cleaner and more aesthetically acceptable method of administration, and from a patient safety perspective, would also be a safer strategy than using freshly defecated donor fecal matter.


Eligibility Criteria:
Inclusion Criteria:

* patients with recurrent CDI that have failed standard therapy

Exclusion Criteria:

* critically ill patients
Effect of Real Time Continuous Glucose Monitoring System on the Management of Type 2 Diabetes

The purpose of this study is to determine whether the Guardian Continuous Glucose Monitoring System in the home setting is more useful than frequent self blood glucose monitoring with a view to modifying patient's diet and exercise habits or improvement self disease control efforts and at last glycemic control in patients with type 2 diabetes

In diabetes management, compliance, disease awareness and empowerment of the patient play an important role and the immediate feedback on the effects of diet and exercise that the self monitoring blood glucose (SMBG) may provide, could enhance patient empowerment. Increased use of SMBG has been shown to be associated with improved medication compliance and better metabolic control by several studies. However, because of many factors, including pain and inconvenience, many diabetic patients do not accept frequent fingersticks for self blood glucose monitoring (SBGM) levels. In addition, the SBGM result gives the data for only a few seconds, without any information on glucose trends.

So we need new glucose monitoring method that could reflect glucose trends and glycemic excursion continuously because glucose monitoring still remains the cornerstone of evaluating the efficacy of therapy and motivating self disease control in subjects with diabetes.

Few studies have examined the effects of real time continuous glucose monitoring system targeting type 2 diabetes. So our goal is to determine whether the Guardian Continuous Glucose Monitoring System in the home setting is more useful than frequent self blood glucose monitoring with a view to modifying patient's diet and exercise habits or improvement self disease control efforts and at last glycemic control in patients with type 2 diabetes

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Group 1: HbA1c \< 8% with a stable insulin or oral hypoglycemic agents (OHA) regimen for the prior 2 months with no plans to switch modality of insulin or OHA administration during the next 3months.
* Group 2: HbA1c \>= 8% and the fasting blood glucose must be \< 130 at the same time with a stable insulin or oral hypoglycemic agents (OHA) regimen for the prior 2 months with no plans to switch modality of insulin or OHA administration during the next 3months

Exclusion Criteria:

* Use of corticosteroids or hormone therapy within the last 6 months
* Presence of another chronic illness
A Phase 3 Clinical Study Patients With Androgenetic Alopecia (AGA)

A Multicenter, Randomized, Double-Blind, and Placebo-Controlled Phase 3 Clinical Study ,the mean change from baseline in vertex target area hair count (TAHC) after treatment for 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Having voluntarily signed the ICF approved by the Ethics Committee and consented to participate in this study before starting any study procedure;
2. Being able to understand and comply with the requirements of the protocol and agreeing to participate in all study visits;
3. Males aged 18 to 41 years (inclusive);
4. Being diagnosed with Type III vertex, Type IV or Type V androgenetic alopecia (AGA) according to the Hamilton-Norwood classification (see Appendix 1 for details);
5. Appropriate medical contraceptive methods being used to prevent the sexual partner from becoming pregnant from the time of signing ICF to 28 days after the last dose; -

Exclusion Criteria:

1. A history of scalp skin abnormalities or scalp skin diseases at the time of screening
2. Patients with secondary alopecia such as those associated with malnutrition, drugs, endocrine , iron deficiency anemia, or systemic lupus erythematosus;
3. Patients with alopecia areata, alopecia cicatrisata, or trichotillomania;
4. Having undergone hair transplantation or extension before screening, or persistent requirement to wear a wig sheath during study treatments;
5. Known allergy to the active ingredient of the investigational drug or any component of the excipients, or to any component of the tattoo liquid;
6. A history of depression, anxiety, personality disorder or other mental disorders;
7. A history of varicocele or infertility ;
8. A history of malignant tumor;
Web-Based Intervention Designed to Educate and Improve Adherence Through Learning to Use Continuous Glucose Monitoring

The goal of this pilot study is to produce a high-quality, theory-driven, therapeutic, web-based intervention that provides extended training and peer support to adolescents and young adults with type 1 diabetes who are newly implementing CGM. Overall, this web-based intervention represents an efficient way to bring together professionally-supported CGM educational materials and social support to overcome known barriers and address factors associated with inconsistent CGM use.


Eligibility Criteria:
Inclusion Criteria:

1. Ability to read and speak English
2. Diagnosed with type 1 diabetes (T1D) for \> 3 months before consent is obtained
3. Aged \>15 years and \<24 years at time of enrollment
4. Must have access to a smartphone, tablet or laptop/desktop computer with high speed internet access and speaker
5. Must be using/initiating a Dexcom CGM

Exclusion Criteria:

1. Cognitive or learning disability (e.g., inability to read) that would preclude their ability to comply with the study protocol
2. Significant medical comorbidity in the adolescent or young adult that could, in the opinion of the PI, affect subject's capacity to follow study protocol
3. Previous use of a CGM within the last 3 months
4. Unwilling or unlikely to return to clinic for a follow-up HbA1c test
5. Unwillingness to accept randomization
Modified Polyurethane Film Dressing For Skin Graft Donor Sites

The purpose of this study is to determine whether the combination of modified polyurethane film and secondary absorbent dressing for skin graft donor sites avoids the regular uncontrolled leakage, but holds up the advantages of film dressings for this kind of wound.


Eligibility Criteria:
Inclusion Criteria:

* Adults over age 18 who require skin grafting

Exclusion Criteria:

* Individuals under the age of 18.
Study Evaluating Workload, Clinical and Therapeutic Management of Psoriatic Arthritis

In Spain, there is little data available concerning the evolution and treatment of Psoriatic Arthritis by rheumatologists and dermatologists. This study is designed to obtain more data about the clinical and therapeutic management of Psoriatic Arthritis in Dermatology and Rheumatology Medical centers.


Eligibility Criteria:
Inclusion Criteria:

1. patients older than 18 years with a psoriatic arthritis diagnosis that go to dermatologic and/or rheumatologic centers or primary care centers.
2. patients that receive pharmacologic treatment for their condition
3. patients that give their written consent to participate
CKD-391 Pharmacokinetic Study Phase I

A randomized, open-label, 2-way crossover study to compare the pharmacokinetics and safety CKD-391 to coadministration Atorvastatin and Ezetimibe in health volunteers.

To compare the CKD-391 (Experimental product) to the dose Atorvastatin calcium and Ezetimibe combination in health male subjects is the purpose of this trial.

Following are evaluated in this trial; Characteristics and safety/Tolerability Of CKD-391.

Eligibility Criteria:
Inclusion Criteria:

* Bwt \>=50kg, BMI 18.5\~25
* signed the informed consent form prior to the study participation

Exclusion Criteria:

* - Clinically significant disease
* Subject has signs of symptoms of acute disease within 28 days of starting administration of investigational drug
* Clinically significant allergic disease
* Impossible to taking the institutional standard meal
* Previously donate whole blood within 60 days or component blood within 20 days
* Previously participated in other trial within 90 days
* Continued to be taking caffeine (caffeine \> 5 cup/day), drinking(alcohol \> 30 g/day) or cannot stop drinking or severe heavy smoker(cigarette \> 10 cigarettes per day)during clinical trials
* An impossible one who participates in clinical trial by investigator's decision including laboratory test result
Validation of Emergency Surgery Score (ESS) in Egyptian Patients Undergoing Emergency Laparotomy

To assess the accuracy of Emergency Surgery Score in predicting postoperative morbidity and mortality in emergency laparotomy.

Emergency laparotomy is the most common emergency surgery which considered a life saving exploratory procedure for which the clinical presentation, underlying pathology, anatomical site of surgery, and preoperative management vary considerably. There are more than 400 OPCS codes describing surgery that could come under the umbrella term of 'emergency laparotomy' which reflect the diverse nature of this surgical cohort. In spite the lack of data on the outcomes of emergency laparotomies it is generally considered very poor mortality rates following emergency laparotomy Internationally reported range from 13% to 18% at 30 days Even after innumerable advances in surgical skills, antimicrobial agents and supportive care. There is a need for early prognostic evaluation of these individuals to identify patients in high risk for more agressive treatment Using an ideal scoring system will help in ;.making appropriate decision on those patients. accurately predicting the risk of developing serious complications or die . Categorizing patients into different risk groups which would help to prognosticate the outcome, select patients for intensive care and determine operative risk, thereby helping to choose the nature of the operative procedure .

The Emergency Surgery Score (ESS) was developed as a novel preoperative risk assessment tool for patients undergoing EGS in 2016 ESS accurately predicts outcomes in all types of emergent laparotomy patients and may prove valuable as a bedside decision-making tool for patient and family counseling, as well as for adequate risk-adjustment in emergent laparotomy quality benchmarking efforts.10

Eligibility Criteria:
Inclusion Criteria:

* Patients more who are 18 years old or older.
* Patients who are in need of an emergency laparotomy within 24 hours of admission.

Exclusion Criteria:

* Patients less than 18 years old.
* Patients who are not accessible for follow up to the 30th postoperative day.
Expanded Access to Ziftomenib

Requests for single patient expanded access to ziftomenib monotherapy may be considered for eligible adult patients with Acute Lymphoblastic Leukemia (ALL), with appropriate mutations, or Acute Myeloid Leukemia (AML), with NPM1 mutations.

To request access, use Responsible Party contact information provided in this record.

Expanded access for ziftomenib is only available in the United States


Eligibility Criteria:
Inclusion/Exclusion Criteria:

Diagnosed with Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL)

Adult, ages 18+

Has exhausted appropriate standard treatments without success and no comparable or satisfactory alternative treatment is available or exists to treat the disease or condition.

Is ineligible for participation in any ongoing clinical study of the investigational drug, which includes lack of access due to geographic limitations.

Meets any other pertinent medical criteria for access to the investigational drug, as established by Kura Oncology

For AML patients: Does not have KMT2A rearrangement
Dietary Oils to Sustain Energy Study

The research study is an intervention and feasibility crossover design pilot study designed to assess if consuming 3 study foods made with either soybean oil or palm oil per day for 4 weeks can alter whole blood, plasma and erythrocyte fatty acids and body weight in overweight/obese adults. Additionally, the study will assess the adherence to consuming 3 study foods per day for 4 weeks and to assess if participant remain unaware of (or masked to) which study food group (soybean oil vs palm oil) they are consuming.

The objectives of the study include

* To determine changes in whole blood, plasma and erythrocyte linoleic acid after 4 weeks of consuming 3 foods products made soybean oil and determine changes in plasma and erythrocyte oleic acid and palmitic acid after 4 weeks of consuming 3 food products per day made with palm oil in overweight/obese adults
* To determine changes in body weight in overweight/obese adults during four weeks of consuming 3 food products per day made with soybean oil and during four weeks of consuming 3 food products per day made with palm oil
* To determine if there is evidence of unmasking of the two food product groups (soybean oil or palm oil) during the study in participants and in study coordinators
* To determine adherence of consuming 3 food products per day made with either soybean or palm oil for 4 weeks in overweight/obese adults

Eligibility Criteria:
Inclusion Criteria:

* Age 25-80 years old
* Nonsmokers
* BMI 25-55 kg/m2

Exclusion Criteria:

* Current or previous diagnosis of heart, kidney, and some liver diseases
* Current or previous diagnosis some circulatory diseases and some autoimmune diseases
* Treatment of current cancer diagnosis or current cancer diagnosis
* Current or previous diagnosis of diabetes
* Gastrointestinal diseases or disorders (including pancreatic) that influence nutrient digestion and absorption or gastric bypass surgery
* Alcohol or drug abuse
* Inability to access veins for venipuncture
* Hypothyroidism or Hyperthyroidism diagnosis
* Food Allergy or intolerances
* Any dietary restriction where consumption of the study foods or any ingredient would be contraindicated
* Use of medications where consuming the study foods would be contraindicated
* Use of supplements or medications for weight loss or following a weight loss program
* Use of supplements high in linoleic acid in the past 4 weeks prior to enrolling
* Pregnancy and lactation
Peer Supported Collaborative Care Mental Health and Substance Use Disorder Care

This is a research study to assess the effectiveness of a peer-led collaborative care model for integrating treatment for substance use and or mental health disorders into HIV care settings.

Depending on whether or not participants enroll in this study, participants will be assigned randomly (by chance, like drawing a number from a hat) to one of two groups. In group 1, participants would receive usual clinical care. In group 2, participants would work with a peer-case manager who would help support participants to engage in substance use or mental health disorder care. Regardless of the group participants are in, participants will fill out a survey when first enrolled in the study, and then again 12 months later.


Eligibility Criteria:
Inclusion Criteria:

* Individuals 18-99 years old
* accessing HIV care at the Bartlett HIV clinic
* Screened positive for a Mental health disorder or substance use disorder based on a computerized self-administered screen with Patient Health Questionnaire (PHQ-9)(score\>10), General Anxiety Disorder (GAD-7) (score\>10), National Institute on Drug Abuse Drug Use Screening Tool: 3 Question Quick Screen (Response of "Yes" to one or more heavy drinking days or "Yes" to use of illegal drugs or prescription drugs for non-medical reasons.
* Does not currently have a Mental Health or Substance Use Disorder treatment provider and or not receiving any current treatment (psychotherapy or pharmacotherapy) for Mental Health or Substance Use Disorder.
* English speaking

Exclusion Criteria:

• Individuals lacking the capacity to consent
The Clinical Validity and Safety of IOP Injection MRI Contrast Agent in Hepatocellular Carcinoma

This study is an exploratory study aiming to collect data on sensitivity and positive predictive value of IOP-enhanced (MPB-1523) MRI compared to dynamic multiphase MDCT for the detection of HCC.

The planned duration of the clinical study for individual subjects is up to 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects ≥18 years of age
2. Patients with suspected HCC scheduled for partial hepatic resection.
3. Presenting with 1 to a maximum of 5 hepatic nodule(s) of equal or more than 1 cm (long axis) previously identified and characterized through multi-phase contrast enhanced CT.
4. Subjects or their partners must use a highly effective method of contraception starting from at least one menstrual cycle prior to starting study drug and till 30 days after the last dose of study drug.

Exclusion Criteria:

1. Subjects who received any previous treatment for HCC.
2. Subjects with a serious allergic history or known allergy of other contrast agent.
3. Subjects with a positive HIV test.
4. Subjects with severe renal insufficiency
5. Subjects with severe liver disease\[HCV\].
6. Subjects with active systemic infections, active and clinically significant cardiac diseases, active gastrointestinal ulcers, or medical conditions that may significantly affect action, adequate absorption, and elimination of investigational contrast agent.
7. Subject with mechanically, electrically or magnetically-activated implanted device or any metal in their body which cannot be removed.
8. Subjects who have participated in other investigational trials within 30 days prior to study enrollment.
9. Female subjects who are pregnant or breastfeeding.
10. Subjects who are clinically unstable and whose clinical course during the screening period is unpredictable.
Anterior Minimal Invasive Surgery Versus Antero-lateral Approach in Hip Joint Hemiarthroplasty

Comparison between two minimally invasive approaches to the hip joint.

Following parameters were compared: modified Barthel-Index, pain, complications, developing of heterotopic ossification.

Eligibility Criteria:
Exclusion Criteria:

Exclusion criteria represented acute local or systemic infection, open or pathological fractures, concomitant injuries of the ipsi- or contralateral leg and rheumatoid arthritis.
Relation Between Bone Density and the Regulation of Mineral Metabolism in Renal Stone Formers

Accumulating evidence indicated that renal calcium stone formers often exhibit a low bone density. Therefore we want to test the hypothesis, that the mineral (calcium) metabolism is differently regulated in calcium stone formers with low as opposed to high bone density.

There is epidemiological evidence associating renal calcium stones and decreased bone mineral density (BMD). The decreased BMD in calcium stone formers is linked to hypercalciuria and both subtypes, fasting as well as absorptive hypercalciuria are associated with a diminished BMD. Higher 1,25-vitamin D plasma concentrations and lower PTH levels are encountered under free-choice diet conditions in patients diagnosed with absorptive and fasting hypercalciuria when compared to normocalciuric stone formers. Reports studying the BMD of stone formers and its link with mineral metabolism variables and urinary calcium excretion under different calcium intakes are rare.

We hypothesize now that PTH and 1,25-vitamin D change differently when calcium stone formers with high, intermediate and low BMD are challenged by a low calcium diet.

Eligibility Criteria:
Inclusion Criteria:

* passage of at least one calcium containing kidney stone

Exclusion Criteria:

* established cause of calcium stone formation (sarcoidosis, primary hyperparathyroidism etc.)
* creatinine clearance \< 60 ml/min
* urinary tract infection