cyrilzakka/clinical-trials huggingface dataset:
Double-blind Randomized Controlled Trial Comparing Suvorexant 20 mg to Placebo for Treatment of Insomnia in Cancer Survivors

Investigators propose a double-blind, placebo-controlled trial evaluating the use of the use of Suvorexant in breast cancer survivors on selective estrogen receptor modulators or aromatase inhibitors with sleep disturbance to assess the impact on insomnia symptoms and quality of life. Breast cancer survivors have an increased risk of insomnia for which Suvorexant has the has the potential ability to impact to improve sleep related outcomes and cancer survivorship outcomes. Breast cancer survivors with sleep disturbance based on an Insomnia Severity Index Score (ISI) \>15 will be randomized to either Suvorexant or placebo, with both arms receiving education on sleep hygiene.

Cancer survivors have an incidence of sleep disturbance and insomnia higher than the general population, with significant potential implications on health outcomes including in survivorship domains and mortality outcomes. Available pharmacologic options for management of sleep disturbance are limited in efficacy and in their side effects. Investigators propose a double-blind placebo-controlled trial evaluating the use of the use of Suvorexant in breast cancer survivors on selective estrogen receptor modulators or aromatase inhibitors with sleep disturbance to assess the impact on insomnia symptoms and quality of life. Evaluation of breast cancer survivors on endocrine therapy uses a study population with high 5-year survival rate while retaining the capacity for recruitment and creating an opportunity to explore potential effects on vasomotor symptoms. Suvorexant has the potential to have a significant impact in cancer survivors not only on sleep related outcomes but also on cancer survivorship outcomes.

The purpose of the research study is to evaluate the ability of Suvorexant, a medication approved by the Food and Drug Administration (FDA) for insomnia, to treat sleep disturbance in breast cancer survivors on endocrine therapy.

Eligibility Criteria:
Inclusion Criteria:

* Adult post menopausal breast cancer survivors (female, \> 18 years old)
* current selective estrogen modulator or aromatase inhibitor use
* at least 6 weeks beyond completion of definitive treatment for breast cancer
* less than 5 years from time of diagnosis.

Exclusion Criteria:

* less than 6-month life expectancy
* current steroid use
* severe depression or anxiety
* severe hepatic impairment
* concurrent use of moderate or strong CYP3A inhibitors
* current receipt of hospice care
* severe mental illness
* current use of greater than 40 morphine milligram equivalents daily
* diagnosis of obstructive sleep apnea, narcolepsy or other sleep related illness other than insomnia
* pregnancy
* treatment with alternate pharmacotherapy for insomnia at the time of trial initiation
* menstrual cycle within the past year
Promoting Engagement in the Drug Resistant TB/HIV Care Continuum in South Africa

The goals of this research are to understand adherence and retention in care for multi-and extensively drug-resistant tuberculosis (M/XDR-TB) patients using a mixed methods approach.

Tuberculosis (TB) remains the leading cause of morbidity and mortality worldwide among people living with HIV. Globally, incidence of multidrug-resistant tuberculosis (MDR-TB) and extensively drug resistant tuberculosis (XDR-TB), the most drug-resistant forms of TB, has approximately doubled over the past fifteen years. Nowhere has this increased incidence generated more concern than in South Africa where interactions between TB and generalized HIV epidemics are causing 'explosive' TB incidence and case-fatality threatening to undermine the progress reached with antiretroviral therapy (ART).

Medication adherence, a key predictor of outcomes in multi-and extensively drug-resistant tuberculosis (M/XDR-TB) and HIV treatment, is understudied in high burden TB/HIV settings. Patient losses during transitions in the care continuum are frequent, increase mortality and limit control of the linked epidemics. Demands of M/XDR-TB HIV treatment are severe including extraordinary pill burden, severe adverse effects, lengthy treatment, isolation and stigma with few parallels in modern medicine.

This is a prospective observational cohort study for patients newly diagnosed with M/XDR-TB initiating treatment. A mixed method approach will be employed to address the complex research questions of distilling determinants of barriers and facilitators to both TB medications and ART; this study will employ complementary qualitative and quantitative methodologies for assessing differential adherence to TB medications and ART.

A sub-set of patients and health care workers will be approached for participation in focus group discussions.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Mycobacterium Tuberculosis (MTB) culture positive with at least isoniazid and rifampicin resistance OR

   Molecular drug susceptibility test confirming resistance to at least isoniazid and rifampicin OR

   Polymerase chain reaction test (GeneXpert MTB/RIF) result showing MTB positive and RIF resistance. Patients enrolled with only a GeneXpert MTB/RIF result will be withdrawn if their subsequent susceptibility test or molecular drug susceptibility test reveals rifampicin monoresistance.
3. Initiating treatment for M/XDR-TB which includes at least 2 new medications
4. Have capacity for informed consent
5. HIV Positive Patients: on antiretroviral therapy (ART) or initiating ART within the following 4 weeks as per clinician recommendation

Exclusion Criteria:

1. Pregnancy
2. Prisoners
3. Discretion of the Investigator of Record or clinician
Fatigue and Molecular Mechanisms in Cancer Patients Receiving CCRT

Cancer-related fatigue (CRF) is a significant problem for cancer patients. This prospective, basic science, observational study will evaluate for changes in CRF associated with molecular characteristics prior to, during, and at the completion of non-investigational, standard-of-care, combined chemotherapy and radiation therapy (CCRT) and to develop and assess predictive models for CRF severity.

Primary Objective For mean, morning and evening CRF:

Aim 1. Evaluate for associations between phenotypic characteristics and initial levels and the trajectories of CRF.

Aim 2. Evaluate for associations between changes in CRF severity and changes in gene expression levels prior to the initiation and at the end of CCRT.

Aim 3. Evaluate for associations between changes in CRF severity and changes in circulating free cytokine levels prior to the initiation and at the end of CCRT.

Aim 4. Develop and assess predictive models for CRF severity midway, at the end of, and at least six months post-CCRT using demographic, clinical, and molecular characteristics collected prior the initiation of CCRT.

Secondary Objectives For the commonly co-occurring symptom of chemotherapy-induced peripheral neuropathy (CIPN):

Secondary Aim 5. Evaluate for associations between phenotypic characteristics and initial levels and the trajectories of CIPN.

Secondary Aim 6. Evaluate for associations between changes in CIPN severity and changes in gene expression levels prior to the initiation and at the end of CCRT.

Secondary Aim 7. Evaluate for associations between changes in CIPN severity and changes in circulating free cytokine levels prior to the initiation and at the end of CCRT.

Secondary Aim 8. Develop and assess predictive models for CIPN severity midway, at the end of, and at least six months post-CCRT using demographic, clinical, and molecular characteristics collected prior the initiation of CCRT.

Exploratory Aim 1 - Evaluate the feasibility of the protocol for the collection of stool samples.

Exploratory Aim 2 - Evaluate the feasibility of processing and storing stool samples.

Exploratory Aim 3 - Evaluate the feasibility of processing and storing performing blood samples and performing Cytometry by time of flight (CyTOF) assays.

Eligibility Criteria:
Inclusion Criteria:

* Participants have not received any prior treatment (i.e., cancer systemic therapies or radiation therapy) in the past year except surgery.
* Participants receiving \>= 15 fractions.
* Participants is male or female and is \>18 years of age on the day of signing the informed consent.
* Ability to understand a written informed consent document.
* Able and willing to complete all of the study questionnaires and provide blood and stool samples prior to, midway, and following the completion of treatment.
* Willing to have medical records reviewed for clinical information.
* Able to read, write and understand English or Spanish.

Exclusion Criteria:

* Contraindication to phlebotomy for removal of approximately 50 mL of peripheral blood within 6 week period (Institutional Review Board (IRB) limit).
Screening and Prospective Cohort Study of Risk Factors for Enhanced Recovery After Spinal Fusion Surgery in Advanced Age Patient

To determine the high risk factors affecting accelerated recovery after spinal fusion surgery in advanced age patient.

To determine the high risk factors affecting accelerated recovery after spinal fusion surgery in elderly patients: a prospective cohort study

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent signed and dated by subject or guardian
2. Commit to follow the research procedures and cooperate with the whole process of the study
3. The subjects are 60 years old or older, regardless of gender
4. Patients with degenerative spinal diseases requiring spinal fusion surgery
5. Generally in good physical condition
6. Able to adhere to and cooperate with research interventions, such as oral medication
7. In fertile women, contraception should be used for at least one month prior to screening, and they should commit to use contraception throughout the study period and continue until the specified time after the study

Exclusion Criteria:

1. Acute infection
2. Congenital malformation
3. Abnormal anatomy or skeletal variation
4. Malignant tumor
5. The surgical area was locally infected with symptoms of local inflammation
6. Fever or leukocytosis
7. Morbid obesity
8. Pregnant and nursing women
9. Mental illness
10. Acute joint disease, bone resorption, osteopenia and/or osteoporosis. Osteoporosis is a relative contraindication, as this condition may limit the degree of correction that can be produced, the amount of mechanical fixation, and/or the quality of the bone graft
11. Patients who are unwilling to cooperate with post-operative treatment
12. Any time an implant is performed it interferes with the anatomy or intended physiological function of the patient
Qingdao Diabetes Prevention Project

Qingdao Diabetes Prevention Project aims to translate the trial experience to communities with specific objectives to:

* raise the public awareness of diabetes and diabetes risk factors
* promote healthy lifestyle of the entire targeting population
* reduce the number of people with obesity
* reduce the number of high-risk people developing diabetes through lifestyle intervention
* prevent the diabetic complications
* evaluate the effect and the cost of the community-based prevention project. The project is community-based targeting at the entire population of 1.94 million living in four administration districts of the city of Qingdao in China. In the first phase of the project (2005-2008) the work emphasis is on health promotion, training over 2000 primary care professionals and 300 school health nurses and establishing a network consisting of 600 community clinics. In the second phase (2008-2012) lifestyle counseling sessions will be provided to about 242112 high-risk individuals identified, and the efficacy and the cost of the project will be evaluated at the end of the project in 2012.

The Qingdao Diabetes Prevention Project targets at two urban districts of Shinan and Shibei and two rural counties of Huangdao and Jiaonan, covering 1.94 million of people living in 512 urban communities and 1128 rural natural villages. There are 637000 households in the targeting districts.

In the first 3-years (2005-2008) we have focused on preparing educational materials, health promotion, distributing the project materials, training health professionals, establishing the project networks, identifying high-risk individuals etc., while from 2008-2011 we will transfer our working emphasis on lifestyle intervention to those with high-risk for diabetes.

According to the data collected in 2006, about 456288 individuals aged 35 years or older are estimated to have a risk score \>=14. We estimate that at least 65% of the non-diabetic high-risk individuals (n=242112) will be identified and referred to one of the 600 community clinics for lifestyle counseling and intervention.

Lifestyle intervention includes individual and group counseling sessions organised by the community doctors in a real life setting. The intervals of the counseling sessions depend on the glucose levels of the high-risk individuals, every three months for those having impaired fasting glucose or/and impaired glucose tolerance and every six months for those with normal glucose levels but with high risk score. At the end of the project, the cost-effectiveness of the community-based intervention will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* individuals Aged 35 years or older
* individuals at high risk for diabetes identified by a risk score assessment
* individuals with baseline measurement of glucose

Exclusion Criteria:

* individuals with a prior history of diabetes or taking antidiabetic drugs
Study to Compare U0267 Against Vehicle in Subjects With Plaque-type Psoriasis Two of Two Phase 3 Studies

The purpose of the study is to demonstrate the safety and efficacy of U0267 in subjects with plaque-type psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects at least 12 years old and in good general health.
* Mild to moderate plaque-type psoriasis

Exclusion Criteria:

* Known allergy or other adverse reaction to calcipotriene or other vitamin D analogs; or to any component of the investigational formulations
* History of hypercalcemia or of vitamin D toxicity.
* Diagnosis of generalized pustular or erythrodermic exfoliative psoriasis.
* Other serious skin disorder or any chronic medical condition that is not well controlled.
* Use of non-biologic systemic anti-psoriatic therapy or biologic therapy within four weeks of enrollment.
* Use of topical therapies that have a known beneficial effect on psoriasis, within 2 weeks of enrollment.
* Systemic medications for other medical conditions that are known to affect psoriasis within the past four weeks of enrollment.
* Use of any investigational therapy within 4 weeks of enrollment.
* Pregnant women, women who are breast feeding, or sexually active women of child bearing potential who are not practicing an acceptable method of birth control.
European and North Indian Cohort of KaWasaki dIsease

Kawasaki disease (KD) is currently the leading cause of acquired heart diseases in children in developed countries. Cardiac involvement is the main determinant of the long-term prognosis of these patients, as coronary aneurisms (CAAs) may lead to ischemic heart disease and even sudden death. The current standard of care for KD has consistently reduced CAAs frequency from 25-30% to about 5%. Unfortunately, 10-20% of KD patients results resistant to standard treatment leading to a major risk of cardiac complications. Thus, scoring systems have been constructed in order to identify patients likely to be resistant to IVIG and who may benefit from more aggressive initial therapy. Different scoring scales developed by Kobayashi, Egami et Sano had shown a good sensitivity (77-86%) and specificity (67-86%) in predicting IVIG unresponsiveness in Japanese populations. However, their predictive value was not confirmed by subsequent studies in different ethnic populations. Recently, the French Kawanet group have proposed a IVIG unresponsiveness score that provided good sensitivity and acceptable specificity in a non-Asian KD population even if it was not subsequent validated by an external study. In our study population, the achievement of specificity and sensitivity values for both scores consistent with those reported by the original studies (sensitivity 70% and specificity 80% for Kobayashi and sensitivity 77% and specificity 60% for Kawanet), will be considered a success.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged less than 18 years at diagnosis
* Diagnosis of KD according to the AHA criteria

Exclusion Criteria:

* Patients who do not meet the criteria for KD
* Patients for which an alternative infectious diagnosis was not investigated and/or excluded.
Safety Evaluation of Dasatinib in Subjects With Scleroderma Pulmonary Fibrosis

The purpose of this study was to evaluate the safety of Dasatininb in the treatment of scleroderma pulmonary interstitial fibrosis.


Eligibility Criteria:
Inclusion Criteria:

Target Population

* meet American College of Rheumatology (ACR) criteria for scleroderma
* have clinical evidence of active skin disease with a skin score of ≥15
* have had the onset of their first non-Raynaud phenomenon feature of SSc no more than 3 years prior to screening
* have evidence of fibrosing alveolitis (active pulmonary fibrosis) manifested by a forced vital capacity (FVC) between 45% and 80% of predicted normal and/or diffusing capacity (DLCO) between 30% and 70% of predicted normal values
* have an abnormal high resolution Computed tomography (CT) scan of the chest/lungs demonstrating typical ground glass changes of alveolitis with background fibrosis
* have adequate renal function- no evidence of renal crisis in the 2 months prior to enrollment and serum creatinine \< 3 mg/dL
* for both sexes, must use an acceptable form of birth control
* age ≥ 18

Exclusion Criteria:

* Clinically significant pleural or pericardial effusion in the previous 12 months: Grade 3 or 4. Patients with recent Grade I or II effusions or peripheral edema will be permitted to enter the study
* Clinically significant cardiac disease (New York Heart Association Class III or IV) including preexisting arrhythmia, (such as ventricular tachycardia, ventricular fibrillation, or "Torsade de Pointes"), myocardial infarction, uncontrolled angina within 6 months, congestive heart failure, cardiomyopathy, or pericardial disease
* Clinically-significant coagulation or platelet function disorder (eg, known von Willebrand's disease)
* Abnormal QTcF interval prolonged (\> 450 msec) after electrolytes have been corrected on baseline electrocardiogram

Laboratory Test Findings

* Hgb \< 10 g/dL; platelet count \< 100,000/dL; WBC \< 3,000/dL; PMN \< 1,000/dL; OR lymphocytes \< 350/dL
* The presence of any of the following laboratory findings at screening: positive for antibodies to hepatitis C virus; positive for antibodies to hepatitis B surface antigen (HBsAg); serum bilirubin 2 times normal, Alanine Aminotransferase (ALT), or Aspartate Aminotransferase (AST)\> 2.5 times upper limit of normal

Prohibited Treatments and/or Therapies

* use of other immunosuppressive therapies must be discontinued at enrollment, eg methotrexate, azathioprine, cyclophosphamide, mycophenolic acid, mycophenolate mofetil, cyclosporine
* treatment with any other experimental or investigational drug(s) concurrently or less than 12 weeks prior to study enrollment
* use of anti-fibrotic agents must be discontinued at enrollment, eg colchicine, D-penicillamine, minocycline or Type 1 oral collagen
Score Predicting Lesion Development on CT Following Mild TBI

Mild traumatic brain injury (mTBI) is one of the most common reasons behind emergency department (ED) visits. A small portion of mTBI patients will develop an intracranial lesion that might require neurosurgical intervention. Several guidelines have been developed to help direct these patients for head Computerized Tomography (CT) scanning, but they lack specificity, mainly focus on ruling out lesions, and do not estimate the risk of lesion development. The aim of this retrospective observational study is to create a risk stratification score that predicts the likelihood of intracranial lesion development, lesion progression, and need for neurosurgical management in patients with mTBI presenting to the ED. Eligible patients are adults (≥ 15 years) with mTBI (defined as admission Glasgow Coma Scale (GCS) 13-15) who presented to the ED within 24 hours of injury to any ED in Stockholm, Sweden between 2010-2020. Reasons for ED visit and Internal Classification of Disease (ICD) codes will be used to screen for patients. Machine-learning models will be applied. The primary outcome will be a traumatic lesion on head CT, defined as a cerebral contusion, subdural haematoma, epidural haematoma, subarachnoid haemorrhage, intraventricular haemorrhage, diffuse axonal injury, skull fracture, traumatic infarction or sinus thrombosis. The secondary outcomes will be any clinically significant lesion, defined as an intracranial finding that led to neurosurgical intervention, discontinuation or reversal of anticoagulant or antiplatelet medication, hospital admission \> 48 hours due to the TBI, or death.


Eligibility Criteria:
Inclusion Criteria:

* Adult (≥ 15 years)
* Presented to emergency department within 24 hours of TBI
* GCS 13-15 at presentation to the emergency department

Exclusion Criteria:

* No CT scan performed
* Patient from another Region in Sweden/another country
* Penetrating TBI
* Secondary transfer from other emergency department
* Medical record missing
A Study of Tocilizumab and Methotrexate in Combination or as Monotherapy in Treatment-Naïve Patients With Early Rheumatoid Arthritis

This randomized, double-blind, placebo-controlled study will compare the efficacy with regard to sustained remission and safety of tocilizumab and methotrexate, in combination or as monotherapy, in treatment-naïve patients with early rheumatoid arthritis. Patients will be randomized to receive either tocilizumab (8mg/kg iv every 4 weeks) plus weekly methotrexate (po in ascending doses), or tocilizumab (8mg/kg iv every 4 weeks) plus placebo, or methotrexate plus placebo. Anticipated time on study treatment is 2 years, and target sample size is 300.

Multi-center, randomized, double-blind, placebo-controlled (double placebo) three-arm parallel group, comparative study. Patients were randomized in a 1:1:1 ratio to one of the following treatments:

* TCZ 8 milligram (mg)/kilogram (kg) + MTX (Group I: TCZ+MTX)
* TCZ 8 mg/kg + placeboMTX (Group II: TCZ+placebo)
* MTX + placeboTCZ (Group III: MTX+placebo)

Randomization was stratified by participating center and baseline Disease Activity Score, scoring 28 joints (DAS28) level (\<5.1 vs. ≥5.1). Patients were evaluated every 4 weeks and at each visit a decision on dosage changes was made based on efficacy parameters (DAS28) and occurrence of adverse events (AEs). Patients received MTX/placeboMTX in climbing dosages. Hydroxychloroquine (HCQ) was added when remission was not reached with the maximum tolerable dosage (MTD) of MTX/placeboMTX. If after 12 additional weeks remission was not reached, HCQ was stopped and replaced by standard of care therapy (in Group I) or placebo therapy was replaced by the corresponding verum resulting in TCZ+MTX combination therapy (in Groups II and III). In case remission was reached, MTX/placeboMTX and TCZ/placeboTCZ had to be decreased. Patients were followed for a maximum of 24 months

Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>/=18 years of age
* early rheumatoid arthritis (disease symptoms \<1 year) according to ACR criteria
* disease activity DAS28 \>2.6
* body weight \</=110kg, BMI \</=36

Exclusion Criteria:

* rheumatic autoimmune disease other than RA
* current inflammatory joint disease other than RA
* previous treatment with any DMARD or biologic drug used in the treatment of RA
* intra-articular, parenteral or oral glucocorticoids used for the arthritis