cyrilzakka/clinical-trials huggingface dataset:
REVEAL III: Risk Evaluation and Education for Alzheimer's Disease

The purpose of this study is to provide healthy adults with genetic testing and information about their chances of developing Alzheimer's disease.

Alzheimer's disease is a common condition affecting memory and thinking. Genes can sometimes be used to provide risk estimates for the eventual development of certain common diseases. Apolipoprotein E (APOE) is one gene that has been identified which can provide information about a person's chances of developing Alzheimer's diseases. Previous research explored the behavioral and psychological impact of receiving genetic risk information for Alzheimer's disease (AD). The REVEAL I Study, funded in 1999, showed that an Alzheimer's disease genetic risk assessment can be given to relatives of people with AD in a safe way. REVEAL II, which was funded in 2003, demonstrated that this same information can be given in a condensed education and counseling protocol without causing severe psychological harm. REVEAL III will further study different ways of providing genetic risk information for Alzheimer's disease.

Participation in this study will entail an initial screening phone call to determine eligibility, followed by a phone interview which will ask about demographic information and thoughts and feelings about AD. Participants will complete a mailed survey. Following completion of the survey, a genetic counselor will meet with the participant at the clinic to review family and medical history, administer additional questionnaires asking about AD and genetic testing, and draw blood for genetic testing. Results will be disclosed either in person or over the phone about 3 to 4 weeks later. The genetic counselor will make a brief follow-up phone call 1 week after that. The participant will visit the clinic twice to provide additional information, at 6 weeks and 6 months after disclosure. Finally, the participant will complete a mailed 12 month survey, and the genetic counselor will make a brief follow-up phone call.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years to 85 years old

Exclusion Criteria:

* Unable to visit a study site
* Current untreated depression or anxiety
* Family history of AD diagnosed under age 60
* More than one first-degree relative diagnosed with AD (e.g. Mother and brother)
Impact of Acute Exercise Intensity and Pattern on Cytokine Function

The immune system helps prevent illness, fights off infections, and repairs damaged tissues following an injury. However, when immune cells remain active for prolonged periods of time - a state known as "chronic inflammation" - they can contribute to the development and progression of chronic diseases like heart disease and diabetes. Exercise can reduce the risk of developing many of these diseases and at least part of the health benefits of exercise are due to the ability of exercise to reduce "chronic inflammation". The inflammation-lowering effects of exercise are typically captured by measuring hormone-like molecules released from immune cells called "cytokines" in the blood. In addition to changes in circulating cytokine levels, exercise may also alter how immune cells respond to these cytokines. How exercise intensity (i.e., how hard you are working during exercise) and pattern (i.e., exercising as a long continuous bout or in short intervals) impact the ability of immune cells to respond to cytokines is not well understood. A better understanding of how exercise intensity and pattern of exercise for reducing chronic inflammation may help determine the best types of exercises for improving health and preventing chronic diseases.


Eligibility Criteria:
Inclusion Criteria:

* 18-35 years of age
* Body mass index between 18.5-30 kg/m\^2
* Free of cardiometabolic and autoimmune/inflammatory disease

Exclusion Criteria:

* Competitive endurance athlete
* Cigarette smoker
* Currently taking immunomodulatory/anti-inflammatory medications
* Currently pregnant
Feasibility Study of the JewelPump Version 3

The study will be conducted, in cross-over with a time interval of at least 2 days between 2 treatment periods. Patients will be randomized into 2 groups According to the order of the randomization, patients will bear the JewelPump for 5 days, followed by a period of 5 days of treatment with their usual pumps.

The JewelPump (Debiotech) will be compared to the conventional pumps. Patients will treated with the JewelPump during 5 days, and with their usual pump during 5 other days.

The study will be conduct with 15 patients at the following investigation centers : Corbeil Hospital, CHU of Strasbourg, and CHRU of Marseille.

Eligibility Criteria:
Inclusion Criteria:

* Patients type 1 diabetics treated by external insulin pump;
* Patients with HbA1c \< 8.5%
* Patients who signed consent

Exclusion Criteria:

* Patients type 2 diabetics
* Patients who have all serious diseases that could interfere with the study
Evaluation of a Digital Childhood Obesity Treatment

This study aims to evaluate if a web-based digital support system aiming to replacing or complement standardized pediatric behavioural obesity treatment. The hypothesis is that a digital system of communication between the family and the clinic can generate improved treatment results (change in BMI SDS) and reduce the number of missed visits.

Childhood obesity treatment is time consuming for both the health care system, and for the involved families. There is an association between the intensity and the outcome of treatment.

In this study all children who start treatment for childhood obesity will use a digital support system as a complement to behavioral treatment. The digital support system includes daily weighing on scales that do not show any digits, linked to a mobile app where weight development is shown as a moving average in the form of BMI standard deviation score (SDS). The app also provides an individual target curve visualizing the expected weight journey. Weight in growing children is complex to interpret why BMI SDS is used. Objective data from scale are automatically transferred to the database and the clinic and the family have direct contact with the clinic via the app.

The evaluation will be carried out when approximately 120 children have had the opportunity to be treated with the support system for one year. The results will be compared with a matched control group from the BORIS childhood obesity treatment register.

Eligibility Criteria:
Inclusion Criteria:

* Obesity according to International Obesity Task Force (IOTF)

Exclusion Criteria:

* No
A Clinical Trial Evaluating the Efficacy and Safety of Dasatinib in Refractory Metastatic GIST

The purpose of this study is to determine whether dasatinib is effective and safe in the treatment of refractory metastatic gastrointestinal stromal tumor


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed recurrent/metastatic gastrointestinal stromal tumor (GIST). Immunohistochemically, the detection KIT and/or DOG-1 are/is positive
* Patients must have measurable disease meeting the requirement of RECIST 1.1
* Received the gene mutation detection of c - kit/PDGFRA
* Subjects with mutation in exon 11, in exon 9 and wild type c-kit/PDGFRA have failed to imatinib and sunitinib
* Subjects with primary mutation in exon 17 or 18 have failed to imatinib
* Subjects with primary mutation in exon 11 and secondary mutation in exon 17 or 18 have failed to imatinib
* Subjects with mutation in exon 18 of PDGFRA,have received TKI or not
* Eastern Cooperative Oncology Group (ECOG) performance status = 0-2
* Expected OS ≥3 months
* Ability to understand and the willingness to sign a written informed consent document
* Subject will comply with the study procedures and therapy

Exclusion Criteria:

* Local or metastatic GIST is resectable
* Unable to receive the gene mutation detection of c-kit (c-kitproto-oncogeneprotein)/PDGFRA
* AST and/or ALT \> 2.5 times ULN, or Bilirubin \>1.5 times upper limit of normal (ULN)
* Neutrophil count \< 1.5 x 10\^9/L, or Platelet count \<75 x 10\^9/L, or Hemoglobin\<90g/L
* Cr \>1.5×ULN
* Other malignancy within the past 5 years except for adequately treated carcinoma in situ of the cervix or cutaneous basal cell carcinoma
* Known brain metastasis, spinal cord compression, carcinomatous meningitis, or cerebral or soft meningeal disease through CT or MRI during screening stage
* Within the past 5 years, subjects have one of the following disease: myocardial infarction, serious/instable angina pectoris, symptomatic congestive heart failure or cerebrovascular accident from coronary/peripheral artery bypass grafting
* Known human immunodeficiency virus positivity
* Joining in other trail
* Women who are pregnant or lactating; No contraception for subject during childbearing period
* Subject with other serious acute and chronic physical or mental problems, or laboratory abnormality, will increase the risks associated with trail or drug. It will also interference the judgment of the results. In the judgment of the investigator, subject is inadequate to participant the study
Food Oral Immunotherapy for Peanut Allergy

This is an open label observational single center study of clinical food oral immunotherapy outcomes with biomarker samples and participant and/or caregiver-completed questionnaires in participants between 6 months and 65 years of age with IgE-mediated peanut allergy undergoing food oral immunotherapy.

In this research study the investigators want to learn more about the experience of participants with peanut allergy and their caregivers undergoing food oral immunotherapy (OIT) for peanut allergy. Food oral immunotherapy (OIT) is a treatment for individuals with a food allergy to reduce the body's allergic response to the food allergen, resulting in fewer symptoms. The treatment is also called desensitization. An individual becomes desensitized to the food allergen by ingesting small amounts of the food that are slowly increased. Over time, this helps the body's immune system become used to the food so that it no longer causes an allergic reaction. By desensitizing to peanut, it may lower the risk of life-threatening allergic reactions and cause a decreased sensitivity to peanut. The investigators specifically want to learn more about the effects of food OIT on quality of life and other outcomes important to participants with peanut allergy and their caregivers and to ultimately develop tests to predict who may respond favorably to food OIT.

Eligibility Criteria:
Inclusion Criteria:

* Individuals between 6 months and 65 years of age with a diagnosis of immunoglobulin E (IgE)-mediated peanut allergy and their caregivers; a diagnosis of IgE-mediated peanut allergy is defined by: (1) documented history of peanut allergy or determined to be allergic by oral food challenge; (2) evidence of peanut-specific IgE by either: positive skin prick test to peanut allergen (reaction wheal at least 3 mm larger than saline control) or serum peanut-specific IgE \> 0.34 kilo-unit/liter (kU/L) or international unit/milliliter (IU/mL) at screening visit
* Referral by Massachusetts General Hospital (MGH) allergist for food oral immunotherapy
* Willing to sign informed consent or whose caregiver is willing to sign the informed consent (age appropriate)
* Willing to sign the assent form, if age appropriate

Exclusion Criteria:

* History of severe or life-threatening episode of anaphylaxis or anaphylactic shock within 60 days of screening
* Severe or poorly controlled asthma
* Diagnosis of other severe or complicating medical problems, including autoimmune or chronic immune inflammatory conditions or gastrointestinal inflammatory conditions, such as inflammatory bowel diseases and eosinophilic gastrointestinal disorders
* Current use of beta blocker medication(s)
* Inability to cooperate with and/or perform oral food challenge procedures
* Females who are pregnant, planning to become pregnant, or breastfeeding
* Investigator determination of safety concern for any reason
Individualized Study of Refeeding to Optimize iNpatient Gains

The primary purpose of the trial is to compare the efficacy and safety of Individualized Caloric Refeeding (ICR) to the new standard of care, Higher Calorie Refeeding (HCR), in hospitalized patients with atypical anorexia nervosa (AAN), and clinical remission over one year of follow-up.

Atypical Anorexia Nervosa (AAN) is a new diagnosis describing patients with malnutrition and significant weight loss yet "normal" weight. These patients responded poorly to HCR, the superior refeeding treatment in the parent trial, which was designed for low-weight patients with typical AN. The proposed trial will examine the safety and efficacy of a new treatment for AAN with the potential to improve treatment outcomes for this diverse and growing patient population. The major finding motivating the proposed trial is that participants with AAN gained weight 40 percent slower and required 3.0 additional days in hospital to restore medical stability on HCR, as compared to AN. The research team has developed Individualized Caloric Refeeding (ICR), which doses calories to weight consistent with other pediatric treatments (e.g. medication).

The primary purpose of the proposed trial is to compare the efficacy and safety of ICR to the new standard of care (HCR) in hospitalized patients with AAN. The investigators hypothesize that ICR will restore medical stability faster than HCR with no increase in electrolyte abnormalities. After hospitalization, the major barrier to care in AAN is lack of consensus on clinical remission and whether these formerly overweight patients should gain weight to recover. The research team will examine metabolic, hormonal and psychological markers during long-term follow-up, toward the goal of developing a definition of clinical remission in AAN.

Design Summary: Randomized controlled trial in N=74 participants age 12-24 with AAN, consented upon hospital admission, randomly assigned to ICR or HCR, followed daily in hospital and at 3, 6, 9 and 12 mo.

Eligibility Criteria:
Inclusion Criteria:

* Age 12-24 yrs
* Meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for AAN
* Hospitalized with medical instability, as defined by:

  1. night time heart rate (HR) \<45 bpm,
  2. systolic blood pressure (SBP) \<90 mmHg,
  3. temperature \<35.6° C,
  4. orthostatic Δ HR \>35 bpm, or
  5. orthostatic Δ SBP \>20 mmHg

Exclusion Criteria:

* Bulimia nervosa
* Current pregnancy
* Chronic disease (e.g. immune, renal disease)
* Acute/active suicidality or psychosis
* Hospital admissions for refeeding in the prior 6 mo.
Role of 3 Tesla Diffusion Weighted Magnetic Resonance Imaging (DW-MRI) for Diagnosis Bladder Cancer Grade and Stage

assess diagnostic performance of 3-Tesla DW-MRI in detecting and staging bladder cancer and potential role of the ADC value as a biomarker reflecting histological grade and stage.


Eligibility Criteria:
Inclusion Criteria:

* Men and women 18 years or older
* Suspected by the out-patient flexible cystoscopy as Non-muscle invasive bladder cancer.
* Patient who will undergo radical cystectomy.
* Patient with history of allergy to iodinated contrast media

Exclusion Criteria:

* Refuse to complete study requirements
* Patient with any of the following:

  1. Any metallic fragment or foreign body
  2. Coronary and peripheral artery stents
  3. Aortic stent graft
  4. Prosthetic heart valves and annuloplasty rings
  5. Cardiac pacemaker
  6. Implanted cardioverter-defibrillator (ICD)
  7. Retained trans venous pacemaker and defibrillator leads
  8. Cochlear, otologic, or other ear implant
ChonDux for Filling Full Thickness Cartilage Defects in the Femoral Condyle of the Knee

The use of ChonDux Cartilage Repair system for the treatment of single cartilage lesions in the femoral condyle of the knee. The primary outcome measure is degree of lesion fill at 6 months. Filling of the femoral chondral defect of the knee using ChonDux™ Cartilage System may give symptomatic relief of pain and help to restore knee function. Included in this study is pain relief using Visual Analog Scale (VAS), knee function using the International Knee Documentation Committee (IKDC) questionnaire and quality of life using the Short Form-36 (SF-36) survey.

Current treatment approaches for articular cartilage defects have been disappointing and clinical results have been variable. However, when using crosslinked hydrogel technologies, in vitro findings have shown chondrocyte growth and extra-cellular matrix (ECM) production supportive of cartilage production.

Eligibility Criteria:
Inclusion Criteria:

* A standing radiograph of the knee showing a Kellgren score of 0-2
* Body mass index ≤33
* An Outerbridge score of III or IV without need for bone graft
* A meniscus with no more than partial resection in the affected knee

Exclusion Criteria:

* Passive motion deficit of the knee (\>5º of extension, \>15º of flexion)
* Moderate or severe osteoarthritis
* Diabetes mellitus (IDDM Type 1)
* Patellofemoral instability
* Malalignment with \> 5° valgus or varus compared to contralateral knee
* Active osteomyelitis
Impact of Total Intravenous Anesthesia Following Cancer Surgery, TIVACS Study

This phase II trials studies the impact of total intravenous anesthesia (TIVA) following cancer surgery. Surgery and the anesthesia delivered causes physiologic stress and trauma resulting in immune suppression. TIVA is an alternative method of general anesthesia that has several benefits over volatile inhalation agents such as reducing nausea, vomiting, and opioid consumption, and promotes earlier return of bowel function following surgery. In addition, TIVA is less immunosuppressive than inhalational agents and has been shown to decrease cancer cell proliferation, migration, and metastasis formation. Giving TIVA during cancer-directed abdominal surgery may decrease the immunosuppressive state in the peri-surgical period.

PRIMARY OBJECTIVE:

I. To evaluate the impact of anesthetic agent on inflammation and immunosuppression among patients undergoing abdominal cancer surgery.

SECONDARY OBJECTIVE:

I. To determine the impact of anesthetic choice on short-term anesthetic and surgical outcomes.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo surgical resection with TIVA.

ARM II: Patients undergo surgical resection with inhaled volatile anesthetics.

After completion of study treatment, patients are followed up for up to 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Adults: ≥18 years old on the day of consent
* Non-metastatic pancreatic adenocarcinoma
* Able to provide consent
* ECOG performance status of 0 or 1
* Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test for the patient at the time of surgery.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Previous identified allergy or hypersensitivity to any component of the study treatment
* Allergies to eggs, egg products, soybeans, or soy products
* Personal or first degree relative with a history of malignant hyperthermia
* Has a known additional malignancy that is expected to require active treatment within two years, or is likely to be life-limiting in the opinion of the treating investigator. Superficial bladder cancer, non-melanoma skin cancers, or low-grade prostate cancer not requiring therapy would not exclude participation in this trial.
* Uncontrolled intercurrent illness including, but not limited to: Symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant or lactating females
* Major surgery within 2 months before enrollment. Complete healing from major surgery must have occurred 1 month before enrollment. Complete healing from minor surgery (eg, simple excision, tooth extraction) must have occurred at least 7 days before enrollment. Subjects with clinically relevant complications from prior surgery are not eligible.

  * Patients who undergo reoperation during their initial hospitalization will be censored at the time of reoperation.
* Prisoner status
The Relationship Between Morphology and Virulent Genes of Candida Albicans and Clinical Aspects, Surveillance of Fungemia

Candida albicans is the most common and important clinical fungal pathogen. Our previous surveillance disclosed that fluconazole could induce different morphological changes in clinical strains. Our current study on C. albicans causing candiuria disclosed that renal insufficiency , diabetes mellitus, respiratory failure and uremia were risk factors of treatment failure. However, we also found results of E-test drug susceptible test could not predict outcome. Hence, retrospective analysis of 31 months period, cases that had C. albicans inducing candidemia were reviewed and 60 cases were enrolled for morphological study and potential virulent gene analysis.

This study is designed to clarity the clinical meaning of morphological form and virulent genes on candidemia. To do this study is probably helpful for treatment of candidiasis.


Eligibility Criteria:
Inclusion Criteria:

* 2007 to 2010 medical records
* Cases with candidemmia of Candida albicans with available clinical information in medical records for analysis.
* Cases with candidemmia of Candida albicans which clinical isolates were preserved.

Exclusion Criteria:

* Cases were not hospitalized for treatment and data were not available for analysis.
Combining Antidepressant Medication and Psychotherapy for Insomnia to Improve Depression Outcome

This study will examine the effectiveness of a combination of antidepressant medication and sleep-focused psychotherapy to simultaneously treat sleep difficulties and depression.

Difficulties falling and/or staying asleep are common in people who suffer from depression. Persistent insomnia can hinder response to treatment. In addition, individuals whose insomnia does not resolve with standard antidepressant therapy are at increased risk for recurrence of their depression. Between 60% and 84% of people who have major depressive disorder report symptoms of insomnia. This study will assess the efficacy of combining antidepressant medication and sleep-focused psychotherapy to simultaneously treat sleep difficulties and depression.

Participants in this double-blind study will be randomly assigned to receive either desensitization therapy or cognitive behavioral therapy to target insomnia. All participants will also receive escitalopram oxalate, an antidepressant medication. The study will last 12 weeks. The severity of participants' depression and insomnia will be assessed. Study visits will occur weekly for the first 6 weeks, bi-weekly for the last 6 weeks, and once 6 months post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of major depressive disorder
* HRSD(17) score of at least 14
* Presence and complaint of insomnia for at least 1 month
* Fluent in English
* Use of an effective form of contraception throughout the study

Exclusion Criteria:

* Other psychiatric disorders (e.g., bipolar disorder, post traumatic stress disorder, obsessive compulsive disorder, eating disorder)
* Psychotic symptoms
* Serious, unstable, or terminal medical condition
* Axis II diagnosis of antisocial, schizotypal, or severe borderline personality disorder
* Substance abuse
* Not willing to end other psychiatric treatment
* Previous electroconvulsive therapy or vagus nerve stimulation treatment during the last year
* Sleep apnea, restless leg, or periodic limb movement disorder (to be ruled out after first sleep study)
* Other sleep disorders
* Currently pregnant or breastfeeding
* History of seizure disorder
* Disease or condition that produces altered metabolism or hemodynamic responses
* Liver or kidney dysfunction
* Current use of any over the counter medications or herbs for mood or sleep benefits (e.g., melatonin, valerian, kava, hop extract, St. John's Wort, SAMe)