cyrilzakka/clinical-trials huggingface dataset:
Effects of Stress and Drug-cue Exposure (SCM)

The purpose of the proposed study to examine the links among stress, craving for marijuana, and marijuana reminders, or "cues".

In this study, an agent called yohimbine will be used to produce stress-like responses. Yohimbine is known to cause stress response in studies of alcohol and other substance use disorders. This study intends to show it can be used to cause stress in marijuana users as well.

Part of this study will be conducted on a residential unit where participants will live for 7 nights over a 2-week period (4 consecutive nights the 1st week and 3 consecutive nights the 2nd week).

During that time, participants can't leave the unit unescorted or have visitors.

During the inpatient stay participants will participant in experimental sessions where they will be asked to smoke cigarettes containing either marijuana or placebo (a blank).

Participants will be asked to take capsules that could contain yohimbine or placebo (blank).

Participants will be asked to complete questionnaires and will have their vital signs (blood pressure, heart rate) monitored throughout each session.

Participants will be asked to participate in overnight sleep recordings, a polysomnogram (PSG).

Eligibility Criteria:
Inclusion Criteria:

* Participants (18-55 yr) will be current marijuana users, based on self-report and THC-positive urine samples.
* Candidates must meet DSM-5 criteria for Mild-to-Moderate Cannabis Use Disorder (CUD) and be willing to participate in research but not seeking treatment.
* Candidates must be in good health, as assessed using data from psychiatric evaluation, extensive substance use history interview, and medical evaluations including medical history, physical exam, standard lab tests and 12-lead ECG.

Exclusion Criteria:

Candidates with the following conditions will be excluded:

* Serious psychiatric illness (e.g. psychotic or bipolar disorder, recent suicide attempts, major depression).
* Substance Use Disorders other than Cannabis or Nicotine Use Disorders and Mild Alcohol Use Disorder.
* Neurological diseases
* Cardiovascular problems (e.g. including systolic BP \>140 or \<95 mmHg, diastolic BP \>90 mmHg, abnormal ECG).
* Pulmonary diseases
* Systemic diseases
* Cognitive impairment (\<80 IQ)
* Past-month medications that increase study risk.
* Women who are pregnant, lactating, or if heterosexually active and not using medically approved birth control.
* Candidates seeking Substance Use Disorder treatment.
* Individuals unable to give voluntary informed consent will be excluded.
Anterior Maxilla Augmentation Using Chin Bone Ring With Implant Placement

The study aims toward using autogenous bone grafts to solve decreased bone quantity in anterior maxilla while allowing the patient to recieve implants simultaneously (same time of grafting).

* Chin bone ring will be harvested from patient's(10 in number) chin to augment the recent extraction socket with buccal bone defect, followed by implant placement.
* The process of harvesting and placement of ring will be computer guided which adds lots of accuracy to the bone ring required size from the donor site and the proper placement of both the ring and the implant at the recipient site

Eligibility Criteria:
Inclusion Criteria:

* Patients with non-restorable teeth in the maxillary anterior region with insufficient buccal bone height or buccal bone defect.
* Patients who have given their consent for this trial.
* Both genders males and females will be included.

Exclusion Criteria:

* • Untreated periodontitis.

  * Poor oral hygiene and motivation.
  * Uncontrolled diabetes.
  * Pregnant or nursing.
BABE(Body Appreciation and Better Eating), Add Some Self-compassion

Body dissatisfaction is most common among girls in their teenage years and young adulthood, this is also around the time where the risk of developing binge eating disorder is the highest. Black/African American girls are more likely to engage in binge eating behaviors compared to their White American counterparts; however, they receive less help for eating issues. Further, increase rates of obesity in the Black/African American population may indicate that binge eating may be a bigger problem for this population than discussed. Therefore, the primary purpose of this randomized controlled pilot is to assess the feasibility of this pilot study to be used in a large scale fully-powered study. The secondary purpose of this study is to assess if two different nutrition and body image programs elicit positive outcomes among Black/African American teenage girls who indicate a desire to improve body image.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Black (Afro-Latina)/African American teenage girls
* Age 13 to 18 years old
* Attend high school in the United States
* Interest in nutrition

Exclusion Criteria:

* Eating disorder diagnosis
* Pregnancy
Clinical Study on PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells

This study is a randomized controlled, open and multi-center clinical study. Patients who meet the selection criteria and do not meet the exclusion criteria are randomly given PEG-rhG-CSF with a fixed dose of 12mg when white blood cells reach the lowest point, or given rhG-CSF with a daily mobilization of 5-10μ g/kg until the collection is completed, so as to evaluate the effectiveness and safety of PEG-rhG-CSF in mobilizing autologous stem cells for lymphoma and multiple myeloma.


Eligibility Criteria:
Inclusion Criteria:

1. 18-65 years old, regardless of sex;
2. Patients with lymphoma and multiple myeloma who need autologous hematopoietic stem cell transplantation;
3. KPS score ≥70;
4. creatinine clearance rate ≥ 50mL/min, total bilirubin level \< 1.5mg/dL, ALT and AST \< 2 times the upper limit of normal value;
5. Absolute neutrophil count (ANC)≥1.5×109/L, platelet count ≥80×109/L, Hb≥ 75g/L, WBC ≥ 3.0× 109/L;
6. Patients can tolerate chemotherapy;
7. No active infection before chemotherapy;
8. The patient voluntarily participated in this trial and signed the informed consent form;
9. The researcher thinks that the subjects can benefit.

Exclusion Criteria:

1. Those who have previously received allogeneic or autologous hematopoietic stem cell transplantation;
2. Serious or uncontrolled virus infection: HIV, syphilis positive;
3. Severe dysfunction of internal organs;
4. severe mental or nervous system diseases;
5. allergic to PEG-rhG-CSF, rhG-CSF and other preparations or proteins expressed in Escherichia coli;
6. pregnant or lactating female patients; Women of childbearing age refuse to accept contraceptive measures; Those who plan to become pregnant during the study period;
7. The researcher judges other subjects who are not suitable to participate.
Microbiome and Bariatric Surgery

This is a prospective, 24-month, longitudinal study of patients planning to undergo bariatric surgery (Roux-en-Y Gastric Bypass or Sleeve Gastrectomy) in which we aim to identify correlates and predictors of observed weight loss trajectories following bariatric surgery. This approach will expand current knowledge by examining the combined impact of empirically supported behavioral and biological data in a large sample over time. Intensive measurement of problematic eating behaviors, mood, and compliance with diet and exercise regimens post-surgery will be analyzed in the context of lterations in parallel with, or in response to, changes observed in the gut microbiota. Identifying these post-surgical predictors of weight loss and comorbidity resolution will allow for the development of individualized interventions to optimize surgery-related outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. In evaluation for Roux-en-Y Gastric Bypass or Sleeve Gastrectomy.
2. Age 18-65, inclusive

Exclusion Criteria:

1. Alcohol or substance use disorder in past year
2. Severe psychiatric disorder that may affect ability to complete the protocol
3. Regular tobacco use during the last year
4. Current medication taken routinely and known to impact factors that may affect the gut microbiome
5. Use of any oral or injectable antibiotic in the past month
6. Use of commercially available pre/pro biotic in the past month
7. History of significant disease/disorder that would be expected to impact the microbiome of the gut
8. Inability to engage in physical activity or dietary monitoring
9. Nonprescribed/illicit drug use
10. Pregnant or breastfeeding
Bent-arm Throw and Tennis Performance

The objective of this study is to explore the relaitonship betwenn bent-arm throw and tennis serve performance.

Young players (9-12 years) will be assessed at the beginning of the season and at mid-season to measure the accuracy, the speed and the gesture of tennis serve. During a mid-season, they will have to perform a bent-arm throw warm-up program 5 minutes before each training session to increase their ability to throw.


Eligibility Criteria:
Inclusion Criteria:

* age between 9 and 12
* playing tennis at least 2 times a week

Exclusion Criteria:

* history of shoulder injury or shoulder pain
BOLD MRI as a Surrogate of Improved Muscle Oxygenation Following Endovascular Therapy for the Treatment of CLI

The purpose of this study is to determine if an MRI technique called Blood Oxygen Level Dependent, or BOLD, can be used to evaluate blood flow in the leg before and after treatment with standard endovascular therapy in patients with chronic lower limb ischemia.

This study is a prospective single arm, open label registry to evaluate the feasibility of blood oxygen level dependent (BOLD) magnetic resonance imaging for the assessment of a potentially new functional surrogate of altered lower limb skeletal muscle oxygenation after a successful percutaneous endovascular intervention. Baseline MRI assessment using the BOLD technique will be performed on qualified subjects prior to undergoing a standard of care endovascular therapy. Post-procedure BOLD-MRI assessment will also be performed at 30 days and either 90 or 180 days post-procedure. Post-MR image acquisition processing and analysis will be performed, using pre-determined algorithms, by a core laboratory.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 and \< 90 years
* Subject has been informed of the nature of the study and agreed to participate and has signed an IRB approved consent form
* Subject understands the duration of the study and its follow-up visit requirements and agrees to comply
* Subject has documented chronic limb ischemia in the target limb with Rutherford Category 2-5 and pulse plethysmography (PPG), pulse volume recording (PVRs), TcPO2, ABIs or toe pressures and symptoms that conform to the diagnosis of life-style limiting claudication or critical limb ischemia

Exclusion Criteria:

* Adult subjects who lack the capacity to consent for themselves
* Women who are pregnant or wish to become pregnant during the course of the study. (Women of child-bearing potential must undergo pregnancy testing at the time of enrollment, and be counseled in appropriate measures to avoid becoming pregnant for the duration of the study)
* Subjects with contraindications to MR imaging procedures (including the administration of gadolinium based contrast agents)
* Subjects suspected to be unable to withstand the reactive hyperemia protocol
Evaluation of the Performance of MAF-1217 on Cataract Surgery

MAF-1217 is meant as the medical device which is to be effective in most forms of DED; therefore, it is expected that study patients benefit from study participation, and can reduce the signs and symptoms of surgery induced DED in patients undergoing cataract surgery, in a TID application pre-surgery.

This is a multicentre, pre-market, open label, randomized, prospective study exploring the performance of MAF-1217 when administered pre-surgery, in reducing the sign and symptoms of post-surgery DED in patients undergoing cataract surgery. Patients will be enrolled 2 weeks before Surgery (screening visit), will undergo cataract surgery (Day 0 - Baseline/Surgery), and then will be seen at week 1 and 2 after surgery.

Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years old patients, male and female
2. Patients without diagnosed DED (including subclinical DED) or with mild DED, with BUT \>7
3. Normal to mild DED according to OSDI chart
4. Diagnosis of Cataract requiring surgery
5. Wishing to participate in the study and able to sign the ICF
6. Shirmer test \> 15 mm /5'
7. No topic ophthalmic medication, including lubricating eyedrops administration for at least 4 days before screening visit.

Exclusion Criteria:

1. Neuropathic causes of dry eye (diabetes, long-standing contact lens wearing, previous ocular herpes infections)
2. Patients with diagnosis of Glaucoma
3. Functional and anatomic eyelid abnormalities,
4. Complicated cataract,
5. Suture affixing during surgery,
6. Use of artificial tears in the month preceding the study visit
7. Coexisting corneal diseases
8. Autoimmune diseases
9. Past or active cicatricial conjunctivitis
10. Past ocular surface burns
11. Keratinization of the eyelid margin
12. Sjogren syndrome
13. History of corneal trauma
14. Pregnant and lactating women
15. Younger than 18 years old patients
16. Inability to self-administer study medications
17. Known allergic sensitivity to any of the devices ingredients, or any other type of allergy
18. Participation in a clinical trial during the 3 months prior to the beginning of the study
ENLaCE Pilot Study

This is a feasibility study to determine whether the Expanding Networks for Latinos through Community Engagement (ENLaCE) can be used to recruit Latino children into a randomized, controlled trial (RCT) to improve their asthma medication device technique. Children will be recruited from two pediatric ENLaCE clinics in Greensboro and randomly assigned to watch device technique videos (experimental group; n=50) or a nutrition video (control group, n=50) in Spanish or English after a regularly-scheduled medical visit. Children's device technique will be assessed before and after the visit. Process evaluation data will also be collected. The investigators hypothesize that children in the intervention group will have better device technique post-intervention than the control group.

Asthma affects almost 10% of children and is the most common health condition reported by North Carolina public schools. Latino children have higher rates of uncontrolled asthma and more asthma-related emergency department visits than their White counterparts. No studies have evaluated Latino children's asthma device technique; poor technique can compromise medication delivery to the lungs.

The TraCS engagement core has spent the last 18 months developing the Expanding Networks for Latinos through Community Engagement (ENLaCE) network, which is comprised of over 15 organizations in the Greensboro area. The core would now like to conduct a feasibility study to determine whether ENLaCE can be used to recruit Latino children into a randomized, controlled trial (RCT) to improve their asthma medication device technique. This would be the first assessment of whether ENLaCE can be used to recruit patients.

MEDUCATION, an NIH-funded project developed by Polyglot Systems, Inc., has developed asthma device technique videos in Spanish and English. The member groups of ENLaCE believe the MEDUCATION videos are highly relevant for the Greensboro Latino community. Children will be recruited from two pediatric ENLaCE clinics in Greensboro and randomly assigned to watch device technique videos (experimental group; n=50) or a nutrition video (control group, n=50) in Spanish or English after a regularly-scheduled medical visit. Children's device technique will be assessed before and after the visit. Process evaluation data will also be collected.

Eligibility Criteria:
Inclusion Criteria:

Children will be eligible if they:

* are ages 8 through 16 years,
* are able to speak English or Spanish,
* can read the assent form,
* are present at the visit with an adult caregiver (parent or legal guardian) who can speak English or Spanish and who is at least 18 years of age,
* have mild, moderate, or severe persistent asthma, and
* are present for an asthma-related visit (either acute or scheduled).
Study of Netarsudil Ophthalmic Solution in Japanese/Japanese-American Subjects With Open-angle Glaucoma or Ocular Hypertension

To test the safety and effectiveness of AR-13324 0.02% and 0.04% ophthalmic solution relative to placebo in Japanese/Japanese-American subjects with open-angle glaucoma or ocular hypertension in US.


Eligibility Criteria:
Inclusion Criteria:

1. Must be 18 years or older
2. Be of Japanese ethnicity within the 2nd generation defined as (a) 1st generation born in Japan, immigrated to US and (b) 2nd generation - parents are 1st generation and patient was born in US as an American citizen
3. Diagnosis of open-angle glaucoma or ocular hypertension in both eyes
4. Medicated intraocular pressure \>/= 15 mmHg and \< 30 mmHg in both eyes at screening
5. OAG eyes - unmedicated IOP \>/= 15 mmHg and \< 35 mmHg at 2 qualification visits at 08:00, 10:00 and 16:00
6. OHT eyes - unmedicated IOP \>/= 22 mmHg and \< 35mmHg at 08:00, 10:00 and 16:00
7. Best corrected visual acuity + 1.0 logMAR or better by ETDRS in each eye
8. Able to give signed informed consent and follow instructions

Exclusion Criteria:

1. Clinically significant ocular disease
2. Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma or narrow angles
3. Intraocular pressure \>/=35 mmHg in either eye
4. Ocular hyperemia score of moderate (+2) at qualification visit #2
5. Previous glaucoma intraocular surgery
6. Refractive surgery in either eye
7. Ocular injury within 6 months prior to screening or ocular surgery or non-refractive laser treatment within 3 months prior to screening
8. Recent or current ocular infection or inflammation in either eye
9. Use of ocular medication in either eye of any kind within 30 days of screening and throughout the study
10. Mean central corneal thickness \> 620 µm in either eye
11. Any abnormality preventing reliable applanation tonometry of either eye
12. Known hypersensitivity to benzalkonium chloride or excipients of netarsudil ophthalmic solution
13. Clinically significant abnormalities in screening lab tests
14. Clinically significant systemic disease that might interfere with the study
15. Participated in any investigational study within 30 days prior to screening
16. Systemic medication that could have a substantial effect on IOP within 30 days prior to screening or anticipated during the study
17. Women of child-bearing potential who are pregnant, nursing, planning a pregnancy or not using a medically acceptable form of birth control
Curcumin Supplementation and Patients With Type 2 Diabetes

Diabetes mellitus is the most common endocrine disorder, causes many complications such as micro- and macro-vascular diseases. Various kinds of antidiabetic drugs have been developed, but most of them have side effects. Recently, the use of natural plant products has gained more attention among scientists in order to prevent diabetic vascular complications. Curcumin is a natural yellow product derived from the turmeric rhizome which has shown to be non-toxic and exhibits various bio¬logical activities such as anti-oxidant, anti-inflammatory, anti-carcinogenic, and anti-diabetic effects. Curcumin is effective in reducing glycemic index and hyperlipidemia in rodent models and is relatively inexpensive and safe. Most of the studies conducted on animal model, and just a few of them are on human model. The present study was planned to evaluate the effects of curcumin supplementation The effect of curcumin supplementation on anthropometric indices, insulin resistance and oxidative stress in patients with type 2 diabetes


Eligibility Criteria:
insulin Inclusion Criteria:

* a) Tendency to participate b) Age range of 40-65 c) Suffering from diabetes type 2 ( between 1 to 10 yeares) d) BMI 18/5-30 e) Patients with diabetes who administer oral hypoglycemic agents and do not use

Exclusion Criteria:

* a) patients with liver diseases b) patients with kidney diseases c) patients with inflammatory diseases d) patients with liver diseases e) Administering herbal agents f) Administering multivitamins and minerals in past 3 months
A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE)

This randomized, 3-arm, multicenter, phase III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) with pertuzumab or trastuzumab emtansine (T-DM1) with pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab (Herceptin) plus taxane (docetaxel or paclitaxel) in participants with HER2-positive progressive or recurrent locally advanced or previously untreated metastatic breast cancer. Participants will be randomized to 1 of 3 treatment arms (Arms A, B or C). Arm A will be open-label, whereas Arms B and C will be blinded.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants \>/=18 years of age
* HER2-positive breast cancer
* Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease, and be a candidate for chemotherapy. Participants with locally advanced disease must have recurrent or progressive disease, which must not be amenable to resection with curative intent.
* Participants must have measurable and/or non-measurable disease which must be evaluable per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
* Adequate organ function as determined by laboratory results

Exclusion Criteria:

* History of prior (or any) chemotherapy for metastatic breast cancer or recurrent locally advanced disease
* An interval of \<6 months from the last dose of vinca-alkaloid or taxane cytotoxic chemotherapy until the time of metastatic diagnosis
* Hormone therapy \<7 days prior to randomization
* Trastuzumab therapy and/or lapatinib (neo- or adjuvant setting) \<21 days prior to randomization
* Prior trastuzumab emtansine or pertuzumab therapy