cyrilzakka/clinical-trials huggingface dataset:
Reducing Hospital Readmissions in Patients With Depressive Symptoms

Project Re-Engineered Discharge (Project RED) has previously demonstrated that patients who received the RED were 30% less likely than patients receiving usual care to access inpatient or emergency services within 30 days of discharge. In this project, the investigators add a new dimension to RED by integrating screening, referral and treatment for depression into the original RED intervention and determining if this enhanced intervention increases the effectiveness of RED in preventing readmissions and controlling costs in the 180 days after discharge for patients with signs of depression.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Admitted to any Boston Medical Center inpatient service or for observation
* Screen positive for depressive symptoms (Patient Health Questionnaire - 2 \>/= 3)
* Speaks English with health care providers
* Has access to a telephone
* Live in the Boston area and don't plan on leaving the Boston area for more than 2 weeks in the next 6 months
* Screen positive for depressive symptoms (PHQ -9 \>/= 10)

Exclusion Criteria:

* Has plans for inpatient rehabilitation, nursing home, or other institutional settings after discharge.
* Suicidal precautions
* Sickle Cell Crisis (SCC)
* Alcohol and/or drug dependence
* Diagnosis of Bipolar Disorder, Schizophrenia or other Psychotic Disorder
* In police custody
Study of Safety and Efficacy of Pembrolizumab and Chemotherapy in Participants With Newly Diagnosed Classical Hodgkin Lymphoma (cHL) (MK-3475-C11/KEYNOTE-C11)

The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) monotherapy, followed by chemotherapy, followed by pembrolizumab consolidation. The primary hypothesis of the study is that the complete response (CR) rate at the end of study intervention according to Lugano 2014 response criteria is higher than conventional chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

The main inclusion criteria include, but are not limited to the following:

* Has a histologically confirmed diagnosis of Ann Arbor Stage III or IV classical Hodgkin Lymphoma (cHL). Stage I and II participants may be enrolled, but must have at least one National Comprehensive Cancer Network (NCCN) unfavorable risk factor per protocol
* Has measurable 2-fluorodeoxyglucose (FDG)-avid disease based on investigator assessment according to Lugano 2014 response criteria
* Has not received prior radiation therapy, chemotherapy, immunotherapy, or other systemic therapy for the treatment of cHL before the first dose of study intervention
* Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 assessed within 7 days before the start of study intervention

Exclusion Criteria:

The main exclusion criteria include, but are not limited to the following:

* Has confirmed nodular lymphocyte-predominant Hodgkin Lymphoma (HL)
* Has an uncontrolled intercurrent cardiovascular illness
* Has received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death ligand 1 protein (PD-L1), or anti- programmed cell death ligand 2 protein (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
* Has received or is expected to receive a live or live-attenuated vaccine within 30 days before the first dose of study intervention
* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
* Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
* Has radiographically detectable central nervous system metastases and/or carcinomatous meningitis
* Has an active autoimmune disease that has required systemic treatment in past 2 years
* Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Has a history or current evidence of pulmonary fibrosis
* Has had an allogenic tissue/solid organ transplant
Study to Evaluate the Safety and Efficacy of PEP005(Ingenol Mebutate) Gel, 0.05%, in Patients With Seborrhoeic Keratosis

This study is primarily designed to investigate whether treatment, once daily for up to three consecutive days, with PEP005 (ingenol mebutate) Gel, 0.05% will be safe and tolerable in patients with Seborrhoeic Keratosis on non-head locations. The secondary endpoint is to investigate the efficacy of PEP005 Gel, 0.05% when administered for up to three consecutive days to Seborrhoeic Keratosis on non-head locations.


Eligibility Criteria:
Inclusion Criteria

1. Patient is male or female and at least 18 years of age.
2. Female patients must be of either:

   * Non-childbearing potential, provided there is a laboratory confirmed serum follicle stimulating hormone (FSH) level ≥ 40mIU/ml or there is a confirmed clinical history of sterility (e.g., the patient is without a uterus); or
   * Childbearing potential, provided there are negative urine pregnancy test results prior to study treatment, to rule out pregnancy.
3. Patient has provided informed consent documented by signing the Informed Consent Form (ICF) prior to any study-related procedures, including any alteration of medications in preparation for study entry.
4. Patient has agreed to allow photographs of the selected treatment lesions to be taken and used as part of the study data package.

Exclusion Criteria

1. Known sensitivity or allergy to any of the ingredients in PEP005 (ingenol mebutate)Gel.
2. Current enrolment or participation in a clinical research study within 30 days of entry into this study.
OPUS School Meal Study - Cross Sectional Analyses From Baseline Investigations

The present study is based on cross-sectional data from the baseline investigations carried out in OPUS School Meal Study - a randomized crossover study carried out in 9 primary schools in Denmark 2011-2012. Approximately 800 Danish school children from 3rd and 4th grades (8-12 year olds) took part in these baseline investigations of socioeconomic status, pubertal status, growth status, learning abilities, well-being, sleep, physical activity and risk markers of Cardiovascular Disease (CVD), type II diabetes and osteoporosis.


Eligibility Criteria:
Inclusion Criteria:

* Pupils in 3rd and 4th grades
* Primary Schools in the Zealand Region and Capital Region of Denmark Schools with an available school kitchen, that can be approved by the food authorities
* Schools where at least 60 % of the pupils in three or more classes signs up to participate in the Study

Exclusion Criteria:

* The children should not participate in a scientific study or have participated in a scientific study within the last 4 weeks. This, however depends on the character of the other study.
* The children must not suffer from serious food allergies or food intolerance.
* The children must not suffer from diseases or conditions that makes them ill-suited for participation in the study, eg. malabsorptive conditions or serious mental disorders
* The schools must not offer an well-established common meal plan, that provides most of the pupils with healthy food on a daily basis
Dehydrated Human Amnion Chorion Membrane (dHACM) vs. Control in the Treatment of Partial Thickness Burns.

Multicenter, prospective, randomized, controlled feasibility trial to determine the safety and effectiveness of Dehydrated Human Amnion Chorion Membrane (dHACM) plus Control as compared to Control alone for the treatment of second degree burns (partial thickness burns) as assessed by time to healing and scarring

Multicenter, prospective, randomized, controlled feasibility trial to determine the safety and effectiveness of Dehydrated Human Amnion Chorion Membrane (dHACM) plus Control as compared to Control alone for the treatment of second degree burns as assessed by time to healing and scarring

Eligibility Criteria:
Inclusion Criteria:

ll patients enrolled must meet all the following criteria:

1. Patient with burn injury that meets all of the following requirements:

   1. Occurred within the last 48 hours
   2. Wound is thermal in nature
   3. Partial-thickness burn (burn extends through the epidermis and may penetrate into the dermis)
   4. Total body surface area (TBSA) of burn(s) is 2-20% for all subjects
   5. Burn area(s) located on smooth, flat surface
   6. 2 burn areas, each with a minimum size of 16cm2 (burn areas may be two separate burns or within one large burn, see Section 9.4.2)
2. Age ≥ 12 months and ≤ 70 years

Exclusion Criteria:

Subjects meeting any of the following criteria will be excluded:

1. Burns meeting any of the following criteria:

   1. Mechanism of injury was electrical, radiation, chemical or frostbite
   2. Wound is larger than 200 cm2
   3. Clinically infected burn (as judged by the investigator)
   4. Previous or planned treatment of the Burn Area(s) with any of the following:

      * Biological Skin Substitutes (including Apligraf®, Dermagraft®, etc.)
2. Patient criteria that will make patient ineligible for enrollment:

   1. Ventilator dependence
   2. Active malignant disease or patient is less than 1 year disease-free
   3. Use of immunosuppressive agents, radiation or chemotherapy within the past 30 days
   4. Auto-immune disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV)
   5. Presence of any condition (including current drug or alcohol abuse, medical or psychiatric condition) that is likely to impair understanding of or compliance with the study protocol in the judgment of the Investigator
   6. Presence of any condition that is likely to compromise healing in the judgment of the Investigator
   7. Pregnancy at enrollment or within last 6 months, women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study OR are unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence)
   8. Patient has been on any investigational drug(s) or therapeutic device(s) in the last 30 days or any previous enrollment in this study
3. Allergy or known sensitivity to any of the following:

   1. Aminoglycosides such as gentamicin sulfate and/or streptomycin sulfate
   2. Silver

      -
The Impact of Creative Interventions on Symptoms of Postnatal Depression

Post-natal depression (PND) is anticipated to affect 12.9% of new mothers with at least 75,000 cases per year in the UK alone. However, despite this, there is currently a worrying lack of support for new mothers, with data suggesting that 64% of healthcare trusts in the UK do not have a strategy for treating postnatal depression, and flaws in the current pharmacological and psychological treatment models. Consequently, research into promising psychosocial interventions such as music is critical to developing new paradigms for treating postnatal depression.

This project is an ambitious programme of research that investigates the effects of music on postnatal depression through two phases: a questionnaire study and an intervention study. This record is for the intervention study. The questionnaire study has a separate record. We are accepting host hospital sites for both.

The study tests the effectiveness of singing interventions led by the Royal College of Music at Chelsea and Westminster Hospital as a psychosocial tool to reduce the occurrence and effects of postnatal depression. It triangulates psychological, physiological, and biological data in a randomised control design to provide a comprehensive insight into the intervention's effects in comparison to a more common psychosocial intervention for new mothers (play groups) and a control group of no psychosocial interventions. The study aims to recruit 50-80 women into each of the three interventions (150-240 total).

The study will used a mixed-method methodology comprising validated psychological scales, in-depth qualitative interviews and observations and biomarker analysis. If results are promising, there are plans in place to scale the singing intervention to more hospitals and community settings.

Phase B will be open to NHS sites within the region of Chelsea and Westminster Hospital London from which women could travel to the sessions to take part.

Eligibility Criteria:
Inclusion Criteria:

* Women who have a child up to 9 months old
* Symptoms suggestive of PND at a minimum score of 10 on the EPDS

Exclusion Criteria:

* Outside the limits of the number of weeks pregnant/post birth
* Living outside England
* Refusal to participants
Study Evaluating HKI-272 Administered to Healthy Subjects

Safety and tolerability of HKI-272 in healthy subjects; the influence of food intake on the same.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
High-intensity Laser Therapy for Sacroiliac Joint Pain

Effect of high intensity laser on sacroiliac joint pain

Effect of high laser in reduction of pain and improve functional disability in adult women

Eligibility Criteria:
Inclusion Criteria:

* The presence of Pain over the sacroiliac joint with no surgical history.
* Unmarried.
* Tender SIJ on palpation.
* Workers with an average age of 18-30 years.
* Body mass index did not exceed 30 kg/m2.

Exclusion Criteria:

* If they have Infections. .Fracture in and around the SIJ Complex.
* Arthritis of joint.
* Pregnancy. .Smoking girls. .Patient not willing to participate in the study. .Any history of surgery. Lumbar spine disc herniation or back injury. Tumor around the joint.
Observational Non-interventional Study (Anwendungsbeobachtung) With Aptivus® (Tipranavir) in HIV-infected Patients.

This observational study is supposed to assess (under conditions of clinical practice in daily routine) whether treatment with Aptivus (tipranavir) in combination with low-dose Norvir (ritonavir) will durably suppress viral load and may achieve suppression of viral load below the limit of detection.


Eligibility Criteria:
Inclusion Criteria:

Highly pre-treated male and female adult patients with virus resistant to multiple protease inhibitors. Aptivus (tipranavir), co-administered with low dose Norvir (ritonavir), is indicated for combination antiretroviral treatment of HIV-1 infection in highly pre-treated adult patients with virus resistant to multiple protease inhibitors.

Exclusion Criteria:

* Age \< 18 years
* pregnant female patients
* Hypersensitivity to the active substance or to any of the excipients.
* Patients with moderate or severe (Child-Pugh B or C) hepatic impairment.
* Rifampicin should not be used with Aptivus (tipranavir) because co-administration may cause large decreases in tipranavir concentrations which may in turn significantly decrease the tipranavir therapeutic effect.
* Herbal preparations containing St John's wort must not be used while taking Aptivus (tipranavir) due to the risk of decreased plasma concentrations and reduced clinical effects of tipranavir.
* Co-administration of Aptivus (tipranavir) with low dose Norvir (ritonavir), with active substances that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated. These active substances include antiarrhythmics (amiodarone, bepridil, quinidine), antihistamines (astemizole, terfenadine), ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine), gastrointestinal motility agents (cisapride), neuroleptics (pimozide, sertindole), sedatives/hypnotics (triazolam) and HMG-CoA reductase inhibitors (simvastatin and lovastatin). In addition, co-administration of Aptivus (tipranavir) with low dose Norvir (ritonavir), with drugs that are highly dependent on CYP2D6 for clearance, such as the antiarrhythmics flecainide and propafenone, is contraindicated.
Effect of IFN-γ on Innate Immune Cells

The investigators hypothesize that neutrophils and monocytes developed under the influence of Interferon- gamma-1b (IFN-γ-1b, Actimmune\*) in vivo will display enhanced function across a broad range of activities related in large part to the transcriptional activation effects of this cytokine. The investigators will evaluate the effects of IFN-γ in healthy human subjects in vivo on gene expression, biologic activity markers, and functional activity of myeloid cells in single dose studies and in steady state studies.

Named for their potent ability to interfere and protect against viral infections, interferons (IFNs) have many regulatory effects on the immune system.1 Of the members of the two classes of these compounds, IFN-γ has the most diverse and powerful immune effects. Studies have mostly evaluated IFN-γ interactions with cells of adaptive immunity, including macrophages and lymphocytes. Effects on innate immunity, particularly polymorphonuclear leukocytes or neutrophils and monocytes are less well studied. However, investigations have suggested that IFN-γ may be involved in signal transduction, gene expression, the respiratory burst and neutrophil NADPH oxidase (Nox2) activity, phagocytosis, motility, microbicidal activity, and apoptosis. Not all of these functions are enhanced by IFN-γ; but the clinical use of this cytokine has been driven, in part by these results. For example, the primary motivation for initiating investigation of its beneficial clinical effects in Chronic Granulomatous Disease (CGD) was its effects on Nox2 activity.2 Most data in this area was based on studies using differentiated neutrophils from peripheral blood.1 However, the phenotype of neutrophils developed under the influence of this cytokine, not just changes expressed by exposure of differentiated cells to IFN-γ, is critical to understanding the physiologic effects of IFN-γ and the broad applications for its use in treatment of a range of human diseases. To expand their understanding of the role of IFN-γ in the development and functional integrity of the neutrophil, the investigators have completed a series of studies with PLB-985 cells in an in vitro culture system of myeloid cells. In this proposal, the investigators will evaluate innate immune activation and phagocyte function in healthy adult volunteers who are receiving IFN-γ.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults over the age of 18 years up to 60 years.
2. At time of screening subject is well and healthy;
3. Acute infections resolved;
4. Subject off treatment medications;
5. No diagnosis of chronic conditions or active health care issues for which the subject is actively followed by a health care provider or is on chronic medications.
6. Non-prescription medications for mild inter-current illnesses will be allowed at the discretion of the principal investigator.

Exclusion Criteria:

1. Pregnancy.
2. History of current infection;
3. Two weeks from most recent intercurrent infection;
4. History of recurrent infections or immunodeficiency.
4-Aminopyridine, Atenolol, or Placebo in Patients With Vestibular Migraine

This phase 2 randomized study will be used to test the efficacy of 4-aminopyridine (4AP) or atenolol to reduce severity and frequency of vestibular and headache symptoms of vestibular migriane sufferers. Blinded study drug will be taken by mouth twice a day for 14 weeks on study.


Eligibility Criteria:
Inclusion Criteria:

* Severe vestibular migraine (VM)

Exclusion Criteria:

* Neurologic or otologic disease other than VM
* Psychiatric illness requiring medication
* Medical illness including cancer, coronary artery or cerebrovascular disease
* Known allergy to one of the test medications
* Contraindication to use of one of the test medications - asthma, symptomatic hypotension, history of seizures
* Taking migraine prophylactic medication or vestibular suppressants.
* Pregnant or breast feeding women
Two WeChat Mini Program-based Interventions Reducing Sexual Risk Behaviors Among Heterosexual Male Factory Workers

A non-blinded parallel group randomized controlled trial is conducted. Adult male full-time employees of factories in Shenzhen who have access to smartphone and WeChat are recruited by staff of the Longhua Center for Disease Control and Prevention (CDC).

After completing an online baseline questionnaire, participants will be randomized evenly to either the intervention group or the control group. Participants in the control group will have access to a WeChat Mini Program providing HIV and sexually transmitted prevention information during the project period. In addition to those received by the control group, the Mini Program will proactively ask participants in the intervention group some simple questions to assess presence of sexual risk behaviors at Month 0 and Month 1, and invite them to watch online health promotion video(s) tailored to their current sexual risk behaviors.

All participants will complete two online follow-up surveys six and twelve months after completion of the interventions.


Eligibility Criteria:
Inclusion Criteria:

* Male at birth
* Aged 18 years or above
* Full-time employee of a factory in Shenzhen
* Having a smartphone with internet access
* Having installed or willing to install WeChat on the smartphone
* Willing to complete follow-up surveys at Month 6 and 12

Exclusion Criteria:

* Oral or anal sex with a man
* Blindness ot deafness
* Not able to communicate effectively with project staff
* Self-reported as HIV positive