cyrilzakka/clinical-trials huggingface dataset:
Bacterial Overgrowth Associated With Chronic Multisymptom Illness Complex

The adverse impact of Gulf War Syndrome (GWS) on the health of veterans and on the resources of the VA Healthcare System underscores the need to resolve its underlying cause. In response, the investigators propose to investigate the central hypothesis that gut bacteria may be responsible for symptoms associated with GWS. The investigators will enroll a total of 120 patients with GWS and 90 healthy controls.

The investigator will assess the prevalence and role of abnormal gut microbial fermentation among Veterans with GWS and investigate the efficacy of diagnostic and treatment strategies directed at indigenous gut microbes in the management of GWS.

Eligibility Criteria:
Inclusion Criteria:

* Gulf War Veterans meeting the 1994 Centers for Disease Control and Prevention (CDC) criteria for the diagnosis of Chronic Fatigue Syndrome(CFS), i.e \> six months of one or more symptoms from at least two of the following three clusters: general fatigue, mood and cognitive abnormalities, and musculoskeletal pain
* Must be under the care of a primary physician and have had a previous diagnosis of Gulf War-related illness or GWS and have medical records documenting investigations to rule out other causes of fatigue
* Minimum of the following laboratory screening tests: complete blood count with leukocyte differential, erythrocyte sedimentation rate, serum electrolytes, calcium, glucose, blood urea nitrogen, creatinine,urinalysis, and thyroid function tests
* Subjects must also have a GI consult first as part of routine care to confirm eligibility and availability
* Patients with Irritable Bowel Syndrome (IBS), fibromyalgia (FM), anxiety or depression will not be excluded, but will be identified for subgroup analysis
* Healthy controls will be screened with complete blood count (CBC) and comprehensive metabolic panel to confirm eligibility

Exclusion Criteria:

* History of peptic ulcer, inflammatory bowel disease, diabetes, cirrhosis, rheumatoid arthritis, lupus, narcotic dependence,celiac disease, tropical sprue, bowel resection(including gastric, small bowel or colon; but gallbladder surgery or appendectomy are NOT exclusion criteria)
* Patients with chronic illness (HIV, tuberculosis)
* Pregnant or breast-feeding, psychotic depression, bipolar disorder, schizophrenia, eating disorders
* Healthy subjects will be excluded if their questionnaire indicated abnormal symptom profile
Evaluating an mHealth Intervention for Reducing Alcohol Use Among Adolescent and Young Adult Cancer Survivors

The objective of this study is to adapt and test the feasibility of a 4-week motivational interviewing mHealth intervention, Tracking and Reducing Alcohol Consumption (TRAC), to reduce alcohol use among adolescent and young adult (AYA) cancer survivors during post-treatment survivorship.

At the end of this study, the feasibility data gathered will inform a definitive randomized controlled trial of TRAC-AYA to test the efficacy of the adapted intervention.

For this study, the investigators will adapt and pilot an existing mHealth intervention (TRAC) to reduce alcohol use among AYAs as part of a randomized controlled trial. TRAC includes weekly phone sessions with an interventionist and incorporates smartphones for daily self-monitoring of alcohol use. Upon enrollment, participants will be randomized into either the intervention (TRAC) arm or control (education and daily self-monitoring) arm.

Researchers will conduct the study in Kentucky, which leads the nation in cancer incidence and mortality, has a higher incidence of AYA cancers compared to other states, is 40% rural, and encompasses over 100 medically underserved areas. Participants will be recruited from the University of Kentucky Markey Cancer Center and its affiliate institutions.

Preliminary data used for this study were collected from a study (PI: Lauckner, K01AA02530) testing the TRAC intervention with people living with HIV/AIDS, which has shown promising preliminary results, with high feasibility, acceptability, and encouraging preliminary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with cancer between age 15-39
* Currently age 18-39
* 3 months-15 years post-treatment
* Meets criteria for risky alcohol use
* Reside in United States

Exclusion Criteria:

* Severe psychopathology
A Prospective Study to Evaluate Clinical Outcomes in Anti-LGI1 Encephalitis

Anti-leucine-rich glioma-inactivated 1 (LGI1) encephalitis has been increasingly identified as the second most common type of autoimmune encephalitis after anti-N-methyl-D-aspartate receptor (NMDAR) encephalitis. It presents with acute or subacute onset of epileptic seizures, anterograde amnesia, behavior disturbances, sleep disorders and hyponatremia. In most patients with anti-LGI1 encephalitis, immunotherapy is successful in treating the encephalitis. However, relapses, chronic epilepsy, cognitive declines and psychiatric problems have been reported in some cases.

So far, prospective studies to evaluate its clinical outcomes still remain limited. In this project, the investigators will use clinical features and advanced paraclinical examinations to prospectively investigate the clinical outcomes and the associated factors in patients with anti-LGI1 encephalitis.

In this prospective study, the investigators are aiming to recruit newly diagnosed patients with anti-LGI1 encephalitis. At the acute stage and during the follow-up, some routine and advanced paraclinical examinations will be conducted, including dynamic blood and/or cerebrospinal fluid (CSF) test, multimodal brain magnetic resonance imaging (MRI) including functional MRI, diffusion tensor imaging, arterial spin labeling, et al), Electroencephalography (EEG) or continuous video-EEG (VEEG), positron emission tomography (PET), neuropsychological tests and some other paraclinical examinations. Through the comprehensive analysis, the clinical outcomes and associated factors are further explored in anti-LGI1 encephalitis.

Eligibility Criteria:
Inclusion Criteria:

1. Meet the 2016 consensus diagnostic criteria for anti-LGI1 encephalitis.
2. Newly diagnosed, and during the acute stage before study enrollment.
3. Sign the informed consent form.

Exclusion Criteria:

1. with the diagnosis of epilepsy, stroke, cerebral trauma, and/or other nervous system disease prior to the onset of encephalitis.
2. with coexisting antibodies, such as anti-contactin-associated protein 2 (CASPR2) antibody.
3. Lost to follow-up.
Tilting of Radioactive Plaques After Initial Accurate Placement for Treatment of Uveal Melanoma

Plaque radiotherapy is a common treatment for uveal melanoma. However, local failure has been reported in up to 20% of patients. We use intraoperative ultrasonography at plaque insertion and removal to evaluate plaque movement as a potential factor in local failure.

Episcleral plaque radiotherapy is a common treatment for uveal melanoma and results in local tumor control in most cases. However, local failure has been reported in a substantial proportion of patients. Since local failure greatly increases the risk of metastatic death, identifying and correcting the causes of local treatment failure are of paramount importance. Poor plaque localization is an important contributing factor to local failure. With the aid of intraoperative ultrasonography, most malpositioned plaques can be identified and readjusted at the time of plaque insertion. However, little is known about plaque movement during the 4-5 days of brachytherapy, which could also contribute to local failure. To address this question, we perform intraoperative B-scan ultrasonography at the time of iodine-125 radioactive plaque insertion and removal in uveal melanoma patients.

Eligibility Criteria:
Inclusion Criteria:

* All patients with uveal melanoma treated with brachytherapy

Exclusion Criteria:

* Ciliary melanoma
Comparative Study of Gene-activated Bone Substitute and Autobone in Treatment of Long Bone Nonunions

The study is aimed to compare the effectiveness of "Histograft" bone substitute (gene-activated bone substitute based on octacalcium phosphate and plasmid DNA encoding VEGFA gene) mixed with shredded autobone and pure shredded auto bone harvested from iliac crest in treatment of patients with long bone nonunions

An open-label randomized controlled clinical trial, two cohorts. Patients who met the inclusion criteria are planned to be enrolled into the trial. Upon enrollment, all patients will undergo screening, a set of clinical examination, instrumental investigations and laboratory tests, including CT of the affected bone with the assessment of nonunion.

All patients enrolled in the study will be subjected to bone reconstructive surgery with nonunion excision and bone grafting with either investigational bone substitute mixed with shredded autobone (in a ratio of 50/50) harvested during the surgery or pure shredded autobone from iliac crest.

The clinical study results will be evaluated at the time points of 1, 15, 45, 90, 180 days with clinical examination, instrumental investigations and laboratory tests. Control CT will be carried out for the primary outcome measure at 90, 180, 360 days after surgery.

Eligibility Criteria:
Inclusion Criteria:

* traumatic isolated closed or open Gustilo I and II, IIIA and IIIB humerus, tibial or femur diaphyseal or metaphysodiaphyseal fracture with a status of atrophic, oligotrophic or normotrophic non-union;
* signed voluntary informed consent

Exclusion Criteria:

* hypertrophic non-union;
* disability or unwillingness to give a voluntary informed consent or follow requirements of the clinical trial;
* segmental bone loss requiring specific therapy (bone transport, vascularized graft, large structural allograft, megaprosthesis, etc);
* other fractures causing interference with weight bearing;
* visceral injuries or diseases interfering with callus formation (severe cranioencephalic trauma, etc.);
* unrecovered vascular or neural injury;
* infection of any location and aetiology;
* pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control;
* malignant tumour (past history or concurrent disease);
* history of bone harvesting on iliac crest contraindicating new iliac crest bone graft harvesting or bone marrow collection;
* conditions limiting study compliance (e.g., dementia, psycho-neurological diseases, drug addiction, and alcoholism);
* medication affecting bone turnover (oral bisphosphonates, PTH, sodium fluoride, strontium ranelate, calcitonin, testosterone, systemic cortico- or anabolic steroids)
Comparing Two Regimens for Medical Abortion: Mifepristone + Misoprostol Versus Misoprostol Alone

This double blinded, placebo-controlled randomized trial will compare the safety, efficacy and acceptability of two medical abortion regimens up to 63 days since last Menstrual Period (LMP) in Tunisia and Vietnam. The first regimen will include a 200 mg oral dose of mifepristone followed by 800 mcg buccal misoprostol. The second regimen will include two 800 mcg doses of buccal misoprostol three hours apart. All drugs are administered AT home by the participant.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age \< 63 days since LMP, confirmed by ultrasound or clinical assessment.
* General good health including absence of conditions which contraindicate the use of mifepristone and misoprostol for pregnancy termination.
* Agrees to return for follow-up visit and willing to provide an address and/or telephone number for purposes of follow-up.
* Able to consent to study participation.

Exclusion Criteria:

* Gestational age \> 63 days LMP
* Confirmed or suspected ectopic or molar pregnancy
* Contraindications to medical abortion including intra-uterine device (IUD) in place (must be removed before procedure), chronic adrenal failure, concurrent long-term corticosteroid therapy, history of allergy to mifepristone, misoprostol or prostaglandin, hemorrhagic disorders or concurrent anticoagulant therapy, inherited porphyries.
Safety and Efficacy of G-Pen Compared to Lilly Glucagon for Hypoglycemia Rescue in Adult Type 1 Diabetics

This is a blinded, randomized crossover study to compare the safety and efficacy of G-Pen (glucagon injection) to Lilly Glucagon (glucagon for injection \[rDNA origin\]) for hypoglycemia rescue of adult patients with type 1 diabetes.

This is a blinded, randomized, Phase 3 comparative efficacy and safety study in adults with type 1 diabetes. Patients will complete screening procedures up to 60 days before randomization to determine eligibility before enrollment to the treatment phase.

The procedure for evaluating the efficacy of the G-Pen (glucagon injection) consists of inducing hypoglycemia by intravenous administration of regular insulin diluted in normal saline. Each participant will undergo two episodes of insulin-induced hypoglycemia, and in random order will receive 1 mg G-Pen (glucagon injection) during one episode and 1 mg Lilly Glucagon during the other episode. There will be wash out period of 7-28 days between treatment visits.

Blood glucose levels will be monitored post-dosing, with a return of plasma glucose to a concentration \> 70 mg/dL within 30 minutes signifying successful hypoglycemia rescue. As a confirmation of efficacy, subjects will complete a questionnaire concerning changes in symptoms of hypoglycemia following treatment with glucagon.

Subjects will return for a follow-up safety visit 3-14 days following administration of the final dose of glucagon.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with type 1 diabetes mellitus for at least 24 months
* usage of daily insulin treatment
* random serum C-peptide concentration \< 0.5 ng/mL

Exclusion Criteria:

* pregnant or nursing
* HbA1c \>9.0%
* renal insufficiency
* hepatic synthetic insufficiency
* aspartate or alanine aminotransferase \> 3 times the upper limit of normal
* hematocrit less than or equal to 30%
* use of \> 2.0 U/kg total insulin dose per day
* inadequate bilateral venous access in both arms
* congestive heart failure, New York Heart Association class II, III or IV
* active malignancy within 5 years, except basal cell or squamous cell skin cancers
* history of breast cancer or malignant melanoma
* major surgical operation within 30 days
* current seizure disorder.
* current bleeding disorder, treatment with warfarin, or platelet count below 50,000
* history of pheochromocytoma or disorder with increased risk of pheochromocytoma
* history of insulinoma
* history of glycogen storage disease.
* positive for HIV, hepatitis C virus or active hepatitis B virus infection
* whole blood donation of 1 pint (500 mL) within 8 weeks
* active substance or alcohol abuse
* administration of glucagon within 28 days
* participation in other studies involving an investigational drug or device within 30 days
Overweighed Children´s Health - Studies of the Effect of Lifestyle and Food Habits

The aim is to investigate the development of overweight and obesity from infancy to school age, and to evaluate an intervention to prevent further development of overweight and obesity among children.

A follow-up study will be conducted on 267 children and will allow comparison between children that developed overweight with the ones who did not. Subjects will be requited at 10 years of age from a previous project. These children have been studied when they were 6-18 months old and a follow-up was conducted at 4 years of age. Sixteen percent of the children were overweight at 4 years of age and retrospective data of e.g. food intake, blood lipids and anthropometric measurements exists. In the present follow-up data regarding food and physical activity habits, anthropometric measurements and blood samples of e.g. blood lipids, IGF1 will be collected.

An intervention study will be conducted on 80-120 overweight children that will be randomized into one intervention and one control group. An intervention during two years will encourage long term healthy habits regarding diet and physical activity through group meetings and supervision. Information about food habits will be collected through questionnaires, interviews and diaries. Measurement of physical activity and energy expenditure will be made with Sense Wear and double labeled water, and will be used to validate reported food intake. Further, anthropometric measurements and blood samples will be collected.


Eligibility Criteria:
Inclusion Criteria for SELFH intervention study:

* age and gender adjusted body mass index (BMI) \> 25
* born in 1995-1998
* living in or nearby the northern city of Umea, Sweden

Exclusion Criteria for SELFH intervention study:

* no chronic disease that could influence metabolic parameters
* no attention deficit disorders
* no access to internet
Intraoperative Folate Targeted Fluorescence in Renal Cell Carcinoma

Primary

• To explore the use of OTL38 and fluorescence imaging to detect RCC in partial nephrectomy at the margins of resection, and in lymph node(s) or other metastases during radical nephrectomy.

Administration of the study drug, OTL38, will begin prior to skin incision in the preoperative area where safety monitoring will occur. The tumor resection occurs approximately 2 hours after being brought back to the operating room and so there is no wait time between infusion and being taken back to operating room. Intraoperative fluorescent imaging will be utilized in parallel with the standard operating procedure to capture images during surgery. Images also will be taken of the excised specimen on the back table. The excised specimen will be sent to the pathology department for fluorescent imaging and immunohistochemistry for FR. Subjects will have a 2-5 day hospital stay (normal nephrectomy recovery period) where safety measurements will be taken. Final safety measurements will be taken at the 10-day and 1-month follow-up visits.

Eligibility Criteria:
Inclusion criteria for localized RCC treated with partial nephrectomy

To be considered eligible to participate in this study, a patient must meet all the inclusion criteria listed below:

* ≥ 18 years of age.
* Have primary or suspected diagnosis of RCC, with presence of cT1-2 renal mass by diagnostic CT assessment.
* Scheduled for partial nephrectomy of renal mass.
* Expected survival of at least 3 months.
* Written informed consent available.
* ECOG ≤ 1 (Appendix G).
* Negative serum or urine pregnancy test within 24 hours for females of child bearing age
* Recovered from toxicity of any prior therapy to ≥ grade 1.

Inclusion criteria for advanced RCC treated with radical nephrectomy

To be considered eligible to participate in this study, a patient must meet all the inclusion criteria listed below:

* ≥ 18 years of age.
* Have pathologic or suspected diagnosis of RCC with presence of cT1-4 renal mass and evidence of nodal or metastatic involvement by diagnostic CT assessment
* Scheduled for radical nephrectomy and lymph node dissection.
* Expected survival of at least 3 months.
* ECOG ≤ 2.
* Negative serum or urine pregnancy test within 24 hours for females of child bearing age.
* Recovered from toxicity of any prior therapy to ≥ grade 1
* Written informed consent available.

Exclusion criteria for both localized and advanced RCC

* History of any anaphylactic reaction, any severe allergy, or any allergy to folate.
* Brain metastases
* Baseline GFR \< 50 mL/min/1.73m2)
* Hepatic toxicity ≥ Grade 2 (using CTCAE version 4 standard definitions).
* Participation in another investigational drug trial either concurrently or 30 days prior to surgery
* Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the patient, limit the patient's ability to complete the study, and/or compromise the objectives of the study.
* Known sensitivity to fluorescent light
Allied Health in Rheumatology Triage Project

There is accumulating evidence that early treatment leads to better outcomes for patients with inflammatory arthritis (IA). Triage, which is the process of identifying the urgency of a patient's disease state efficiently and correctly, may facilitate early referral to a rheumatologist. Several studies have suggested that placing allied health professionals (occupational therapists, physical therapists, nurses, etc.) in a triage roll may reduce wait time for patients with suspected IA. The goal of this investigation will be to demonstrate the system-level impact of an Arthritis Society extended role occupational therapist (OT) or physical therapist (PT) working in a triage role in improving access to rheumatologists for people with IA. In this study two groups will be observed: intervention and "usual care" as determined by historical chart review. Wait times will be compared between both groups.


Eligibility Criteria:
Inclusion Criteria:

* New referrals from a GP
* Adults with possible IA (determined by rheumatologist through paper triage)

Exclusion Criteria:

* Currently on a disease-modifying antirheumatic drug (DMARD)
* Previously seen by a rheumatologist.
* FM, non-IA OA; soft tissue rheumatism; mechanical LBP
Brentuximab for Newly Diagnosed Hodgkin Disease

The addition of Brentuximab vedotin (Bv) to combination chemotherapy will be safe, well tolerated and effective in children, adolescents and young adults with all stages of newly diagnosed Hodgkin lymphoma (HL).


Eligibility Criteria:
Inclusion Criteria:

* Normal Serum creatinine based on age or creatinine clearance \>60 ml/min/1.73 m2 or an equivalent radioisotope glomerular filtration rate (GFR) as determined by the institutional normal range.
* Direct bilirubin \< 1.5 upper limit of normal (ULN) for age, and SGOT (AST) or SGPT (ALT) \<3 x ULN
* Shortening fraction \>27% by echocardiogram, or
* Ejection fraction of \>50% by radionuclide angiogram or echocardiogram.
* For patients age 1-16 years, Lansky score of ≥60.
* For patients \> 16 years, Karnofsky score of ≥60.
* No prior Hodgkin lymphoma directed therapy is allowed except for emergent mediastinal irradiation (\<1000cGy) for superior vena cava (SVC) syndrome.

Exclusion Criteria:

* Females who are pregnant (positive HCG) or lactating.
* Karnofsky \<60% or Lansky \<60% if less than 16 years of age.
* Age ≤1 year or \>29.99 years of age.