cyrilzakka/clinical-trials huggingface dataset:
Effects of an Alternative Treatment for Military Sexual Trauma on PTSD Symptoms, Neurosteroids and Brain Function

Our specific aims are:

1. To examine the efficacy of GIFT in improving MST-related clinical outcomes in women veterans
2. To examine the effects of GIFT on fronto-limbic brain function and
3. To examine the effects of GIFT on levels of neuroactive steroid associated with PTSD.

Guided imagery is a complementary and alternative treatment (CAM) modality. This directed meditation technique uses healing imagery to promote recovery in a variety of illnesses, including cancer, heart disease and, more recently, posttraumatic stress disorder (PTSD). PTSD is a severe and disabling anxiety disorder. It is among the most common mental disorders, affecting 10% of women in the United States during their lifetime. Sexual assault is the most common cause of PTSD. Similarly, military sexual trauma (MST) is disturbingly common among women in the armed forces. At least 20% of women veterans using VA services report a history of sexual assault. Unfortunately, high rates of MST-related PTSD are anticipated among women currently deployed to Iraq and Afghanistan.

To address this issue, we will evaluate a guided imagery intervention for women veterans who have MST-related PTSD. We will evaluate the efficacy of Guided Imagery for Trauma (GIFT) in decreasing PTSD symptoms. Using brain-imaging techniques, this research will examine the effects of GIFT on brain function in the areas associated with PTSD. We will also examine the effects of GIFT on neurosteroids, which are candidate modulators of PTSD symptoms, and may also represent novel targets for therapeutic intervention.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-65
* Status as a woman veteran
* Receives care at the Durham VAMC
* History of MST
* DSM-IV diagnosis of PTSD, confirmed by CAPS interview
* Able to participate in a research interview in English
* Regular telephone access

Exclusion Criteria:

* Current diagnosis of organic or psychotic mental disorder
* Suicidality or parasuicidality
* Ongoing family violence
* Alcohol or drug dependence within previous 3 months
* Enrolled in cognitive-behavioral/exposure-based therapy during study period.
* Supportive therapy and psychiatric medications (if stabilized at least 3 months prior to enrollment) are acceptable.
* An uncontrolled medical condition

Exclusion Criteria for the fMRI only:

* Foreign metallic objects or implanted devices in the body incompatible with MRI
* Positive pregnancy test as determined by serum ß-HCG level
* Claustrophobia
* CNS neoplasms or neurological conditions such as Parkinson's Disease, Huntington's Chorea, demyelinating diseases, seizures, hydrocephalus, etc.
Fluconazole in Preventing Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer

RATIONALE: Giving fluconazole may be effective in preventing or controlling mucositis caused by radiation therapy to the head and neck.

PURPOSE: Randomized phase II/III trial to study the effectiveness of fluconazole in preventing mucositis in patients undergoing radiation therapy for head and neck cancer.

OBJECTIVES:

* Determine the effect of prophylactic antifungal therapy with fluconazole on the incidence and severity of radiation-associated mucositis/thrush in patients with head and neck cancer undergoing definitive radiotherapy.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients undergo standard hyperfractionated radiotherapy 5 days a week for 5-5.6 weeks. Patients receive oral fluconazole on days 1-4 and 28-31 of radiotherapy.
* Arm II: Patients undergo radiotherapy as in arm I. Patients who develop a microbiologically proven fungal infection or clinically evident oral cavity and/or oropharyngeal thrush may receive fluconazole as in arm I.

PROJECTED ACCRUAL: At least 42 patients (26 per arm) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven head and neck cancer undergoing definitive radiotherapy

PATIENT CHARACTERISTICS:

Age:

* Over 21

Performance status:

* Karnofsky 70-100%

Hematopoietic:

* Not specified

Hepatic:

* SGOT and SGPT less than 2 times normal
* Alkaline phosphatase less than 2 times normal

Renal:

* Not specified

Other:

* No history of hypersensitivity to fluconazole
* HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* At least 2 months since prior antifungal agents
* Not currently receiving phenytoin, hydrochlorothiazide, or warfarin

  * If these medications are initiated during study therapy, medication serum levels and electrolytes are monitored for possibility of drug interaction
French Colorectal ESD Cohort in Experts Centers

Initially developed in Japan for the treatment of endemic superficial gastric cancers, endoscopic submucosal dissection (ESD) allows resection of pre-neoplastic and neoplastic lesions of the digestive tract into a single fragment. It allows a perfect pathological analysis, and decreases the rate of recurrence of the adenoma to less than 2%. However, this procedure, which is technically more challenging, is also more risky (perforation rate at 4% vs. 1% for WF-EMR) and longer. Submucosal dissection is also more expensive in terms of equipment, but this difference can be offset by the cost of the high number of iterative colonoscopies required in patients who have had endoscopic resection by WF-EMR.

Scientific debate is agitating the Western world1,2 and Japanese experts do not perform WF-EMR anymore, whereas no comparative prospective study has compared these two procedures.

A lot of centers in France performed colorectal ESD even for benign lesions and nationwide data about safety and efficiency is required to confirm the place of ESD for treatment of large superficial colorectal lesions.

Initially developed in Japan for the treatment of endemic superficial gastric cancers, endoscopic submucosal dissection (ESD) allows resection of pre-neoplastic and neoplastic lesions of the digestive tract into a single fragment. It allows a perfect pathological analysis, and decreases the rate of recurrence of the adenoma to less than 2%. However, this procedure, which is technically more challenging, is also more risky (perforation rate at 4% vs. 1% for WF-EMR) and longer. Submucosal dissection is also more expensive in terms of equipment, but this difference can be offset by the cost of the high number of iterative colonoscopies required in patients who have had endoscopic resection by WF-EMR.

Scientific debate is agitating the Western world1,2 and Japanese experts do not perform WF-EMR anymore, whereas no comparative prospective study has compared these two procedures.

A lot of centers in France performed colorectal ESD even for benign lesions and nationwide data about safety and efficiency is required to confirm the place of ESD for treatment of large superficial colorectal lesions.

Eligibility Criteria:
Inclusion Criteria:

All patients addressed for a colorectal ESD

Exclusion Criteria:

Opposition notified in the context of a non-opposition form after reading the information notice
Use of Wearable Tech to Increase Physical Activity in Inpatient Rehabilitation for Overweight and Obese Patients

The aim of this project is to evaluate whether use of wearable tech increases physical activity in patients participating in inpatient rehabilitation for overweight and obesity.

Obesity is a global epidemic with profound consequences for individuals and societies. Physical exercise is important for weight reduction and weight loss maintenance. Use of wearable tech might facilitate physical activity. Here it will be evaluated whether use of wearable tech that gives feedback about the user's activity level, increases physical activity in people participating in inpatient rehabilitation for overweight and obesity. The control group will be wearing the same wearable tech as the intervention group, but they will not receive any feedback about their activity level.

The feedback application will give participants in the intervention group information about the number of PAI they earn each week. PAI is short for Personal Activity Intelligence. One earns PAI points every time heart rate increases: The higher heart rate, the faster one earns PAI. Previous research have shown that those who achieve 100 PAI or more every week over time, live for an average of more than eight years longer than others.

During the study all participants will take part in a traditional inpatient rehabilitation program (lifestyle modification program). The program consist of three periods at the rehabilitation center with time at home in-between. The study will take place during two periods at the center and one period at home. Time spent on physical activity and number of earned PAI's will be counted during the period at home.

Eligibility Criteria:
Inclusion Criteria:

* taking part in inpatient rehabilitation at Unicare Helefort Rehabilitation center for overweight or obesity.
* having been referred from a hospital outpatient obesity clinic.

Exclusion Criteria:

* not having a smartphone (will not be able to access the mobile application).
* using a wheelchair (the technology will be not able to measure activity correctly)
Stellate Block Versus Nimodipine Infusion for Traumatic Brain Injury

the study is designed to perform an intervention for enhancement of cerebral blood flow in patients with traumatic brain injury showing vasospasm through transcranial doppler


Eligibility Criteria:
Inclusion Criteria:

* patients more than 18 ys old with isolated head trauma and traumatic brain injury

Exclusion Criteria:

* • Hemodynamic instability (mean ABP less than 70 mmHg)

  * History of severe systemic disease including cardiopulmonary failure or hepatorenal failure
  * Allergy to local anesthetics
  * Coagulation disorders
  * Abnormal neck structures disturbing normal anatomy as neck tumors
Evaluation of a 'Hand-Held' Fluorescence Digital Imaging Device for Real-Time Advanced Wound Care Monitoring (SMH/UHN)

Currently, standard wound care practice is suboptimal at assessing wound remodeling and bacterial infection in real-time. An alternative and complimentary means of providing real-time imaging of connective tissue re-modeling and bacterial infection may greatly increase the early detection of infection thus leading to rapid therapeutic intervention. Our new device, PRODIGI(TM), images tissue and bacterial autofluorescence (without agents) and may provide this clinically-important capability.

In preliminary preclinical testing, the investigators have discovered that when wounds are illuminated by violet/blue light, endogenous collagen in the connective tissue matrix emit a characteristic green fluorescent signal, while most pathogenic bacterial species emit a unique red fluorescence signal due to the production of endogenous porphyrins. Therefore, with autofluorescence imaging, no exogenous contrast agents are needed during imaging, making this approach particularly appealing as a diagnostic imaging method for clinical use.

The investigators hypothesize that real-time imaging of tissue autofluorescence signals emanating from endogenous connective tissue (e.g. collagen) and pathogenic bacteria within complex wounds can be used to determine healing status (i.e., collagen re-modeling and wound closure), detect wound bacterial contamination and/or infection that is occult under standard clinical white light evaluation, and guide intervention and wound care.


Eligibility Criteria:
Inclusion Criteria:

1. \> 18 years of age
2. males and females
3. receiving care as in-patient at St. Michael's Hospital
4. presenting with abdominal wounds resulting from general surgery with known or unknown infection status.

Exclusion Criteria:

1. treatment with an investigational drug within 1 month before study enrolment
2. any contra-indication to routine wound care and/or monitoring
3. inability to consent
TEMIS: a Pilot Study to Evaluate a Device to Characterize Ambulatory Physical Activity

Physical inactivity is a major public health issue. Prescription of physical activity appears necessary in some situation with cardiovascular risk. It is important to both qualify and quantify daily physical activity.

The aim of this project is to evaluate the TEMIS system (based on a smart T-shirt) performance in 12 healthy subjects, wearing this system over the daytime during one week.

Healthy subjects have to make different physical activities, wearing the TEMIS system like slow and fast walking, biking, running.

Eligibility Criteria:
Inclusion Criteria:

* Men or women 18 - 50 yo
* BMI between 18 and 30
* Without chronic disease or chronic treatment (oral contraception is allowed)
* Normal electrocardiogram
* Able to do all the specified physical activity requested by the protocol
* Able to use smart phone and computers
* With access to WIFI, bicycle, and car
* Living in the close area
* Affiliated to public health insurance

Exclusion Criteria:

* Severe allergia
* Severe skin lesions at the thorax level
* Not able to use correctly the TEMIS system
* Will take plane during the week of evaluation
* Under protection
L-carnitine to Treat Fatigue Associated With Crohn's Disease

This is a randomized, double-blind, placebo-controlled study, comparing the effect of L-carnitine vs placebo on fatigue among Crohn's disease patients.

The specific aim of this study is to determine if treatment with L-carnitine is more effective than placebo at decreasing fatigue severity scores, while accounting for disease activity and concomitant anemia, depression/anxiety and poor sleep quality.

A total of 100 patients will be recruited, in order to be able ensure to detect a significant difference in fatigue between the treatment and control groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients will have had previously macro- and microscopically verified Crohn's disease, as defined by traditional clinical and endoscopic standards.
* To be included, patients need to have disease which is either in remission or is mild to moderate in severity, as defined by the Harvey-Bradshaw Index Score (HBI\<16).
* In addition, patients will need to answer "yes" to the screening study entry question ("Is fatigue a signficant problem for you currently?").

Exclusion Criteria:

* Exclusion criteria will include:

  * age \<18 or \>70 years
  * pregnancy or delivery within 6 months
  * malignancy diagnosed within 1 year
  * oral/intravenous steroid treatment within 6 months
  * any surgery within 6 months
  * presence of a stoma or ileo-anal J-pouch anastomosis
  * concurrent hepatitis B or C infection
  * cirrhosis
  * renal insufficiency (CrCl\<60) and history of seizure disorder or hypothyrodism.
  * prior to study enrollment
  * women of child-bearing age will need to undergo pregnancy testing.
Study of Allogeneic Bone Marrow Transplantation Following Cyclophosphamide and Radiotherapy in Patients With Fanconi's Anemia

OBJECTIVES:

I. Determine the effectiveness of moderate dose cyclophosphamide and total lymphoid radiotherapy in terms of improving the survival and reducing the morbidity following allogeneic bone marrow transplantation in patients with Fanconi's aplastic anemia.

PROTOCOL OUTLINE: Patients receive cyclophosphamide IV over 2 hours on day -6 through -3 and total lymphoid radiotherapy on day -1. Patients undergo allogeneic bone marrow transplantation on day 0.

Patients are followed for at least 100 days.

Eligibility Criteria:
* Diagnosis of severe aplastic anemia with the typical phenotype of Fanconi's anemia: Short stature Hypoplastic radii Skin pigmentation Renal anomalies Chromosomal fragility
* Family history of Fanconi's anemia
* Histocompatible related donor No evidence of excessive in vitro chromosome fragility typical of Fanconi's anemia Normal CBC and bone marrow
The Integrated Population (I-POP) Health Trial

The primary aim of this study is to determine whether community health worker (CHW) navigation improves outcomes of chronic disease and chronic disease risk factors in a low-income, primarily ethnic minority population when combined with an evidence-based population health model as compared to usual care after 10 months.

The I-POP+CHW participants will be paired with a CHW at baseline to assist with navigation for 10-months between health and wellness services in the selected zip codes: 75210, 75215, 75216, 75217, 75223, or 75227. Participants will receive a multi-level intervention utilizing the current I-POP Health model that includes: 1) Access to health services (including oral health), 2) Access to clinical prevention services, 3) Access to education and facilities to increase physical activity and improved nutrition choices, and 4) Scheduled visits with CHWs for education and navigation. Individuals will complete study measures at baseline, 6-months, and 10-months.

The control group participants will receive access to the same I-POP Health resources without CHW navigation until the end of 10-months (delayed CHW navigation). The current usual care model is outlined below (section 2.3) Participants will complete study measures at baseline, 6-months, and 10-months timepoints. Upon completion of 10-months measures, these individuals will be assigned a CHW and receive delayed navigation.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Ability to alter diet and/or physical activity
* Willing to participate in a 10-month study
* Resident of selected zip codes: 75210, 75215, 75216, 75217, 75223, or 75227
* Not having utilized BSW HWC membership services within the past 12 months
* Not planning to move outside of the selected zip code area within the next 6 months

Exclusion Criteria:

* Below the age of 18 years
* Unable or unwilling to alter diet and/or physical activity
* Not willing to participate in a 10-month study
* Not resident of local selected zip codes: 75210, 75215, 75216, 75217, 75223, or 75227
* Currently using or have used BSW HWC membership services within the past 12 months
* Planning to move outside of the selected zip code area within the next 6 months
Clinical AML Registry and Biomaterial Database of the Study Alliance Leukemia (SAL)

This is a registry study in adult patients with newly diagnosed or refractory/relapsed acute myeloid leukemia.

Investigator's sites: 51 sites in Germany.

Primary objectives:

* Identification of epidemiological data on AML: age, prognostic factors and subgroup distributions. Incidence and age distribution are compared with the data of population-related tumor registry.
* Evaluation of the most important patient-relevant clinical endpoints (outcomes): relapse-free survival (RFS) / time to relapse (TTR), calculation of cumulative incidence of relapse (CIR) and overall survival (OS)
* Documentation of treatment strategy

see brief summary

Eligibility Criteria:
Inclusion Criteria:

* AML according to the WHO (World Health Organization) diagnostic criteria, including acute promyelocytic leukemia
* Age ≥ 18 years. There is no upper age limit.
* Signed written informed consent

Exclusion Criteria:

* there are no exclusion criteria
Study Evaluating the Safety and Efficacy of AR-15512

This will be a Phase 3, multicenter, vehicle-controlled, double-masked, randomized study conducted at approximately 20 sites in the United States. All subjects enrolled will have dry eye disease (DED). The study will consist of Screening (Day -14) and Baseline (Day 1) visits as well as visits at Day 7, Day 14, Day 28, and Day 90 (Study Exit).


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 30 years of age or older at the Screening visit
* Signs of DED at the Screening and Baseline visits assessed by corneal staining and Schirmer test
* Symptoms of DED at both Screening and Baseline visits assessed by SANDE questionnaire and ODS-VAS
* Corrected visual acuity (+0.70 LogMAR) or better in both eyes at both the Screening and Baseline visits

Exclusion Criteria:

* History or presence of any ocular disorder or condition (other than DED) in either eye that would, in the opinion of the investigator, likely interfere with the interpretation of the study results or subject safety
* Regular use of lid hygiene within 14 days prior to the Screening visit or any planned use during the study
* Use of artificial tears within 2 hours prior to the Screening visit or anticipated use during the study
* Use of any topical ocular anti-inflammatory medication within 30 days prior to the Screening visit or anticipated use during the study (e.g., ocular cyclosporine \[Restasis®, Cequa™\], lifitegrast \[Xiidra®\], or any other prescription ophthalmic solution for DED, topical ocular corticosteroid- or non-steroidal-anti-inflammatory agents
* Use of Tyrvaya™ (varenicline solution, nasal spray 0.03mg) within 30 days prior to the Screening visit or anticipated use during the study
* Use of medications for the treatment of severe DED and/or Meibomian gland disease such as oral tetracyclines, oral tetracycline derivatives and oral retinoids within 30 days prior to the Screening visit or anticipated use during the study
* Initiation, discontinuation, or change in dose of a systemic medication known to cause ocular drying (e.g. antihistamines or tricyclic antidepressants) less than 14 days prior to the Screening visit or a change in dosage is anticipated during the study.
* Initiation, discontinuation, or change in dose of a systemic corticosteroid less than 60 days prior to the Screening visit or a change in dosage is anticipated during the study.
* Initiation, discontinuation, or change in dose of a systemic immunomodulator (e.g., hydroxychloroquine, methotrexate, cyclosporine) less than 60 days prior to the Screening visit or a change in dosage is anticipated during the study
* History or presence of significant systemic disease (i.e.: cardiovascular, pulmonary, hepatic, renal, hematologic, immunologic)