cyrilzakka/clinical-trials huggingface dataset:
Bronchodilator Responsiveness in Obliterative Bronchiolitis

This study has been designed to provide a substantial evidence of acute bronchodilator responsiveness to two sequentially inhaled drugs, a beta2-agonist (i.e., albuterol) and an anticholinergic (i.e., tiotropium bromide), in a group of patients who developed obliterative bronchiolitis after hematopoietic stem cell transplantation.

Obliterative bronchiolitis is a life-threatening non-infectious pulmonary complication of allogeneic hematopoietic stem cell transplantation (HSCT). It is characterized by the development of an obstructive abnormality which has been considered to be insensitive to bronchodilator treatments. However, this knowledge stems from measurements of forced expiratory volume in 1 s (FEV1) which is relatively insensitive to changes in small airway caliber. Moreover, it is known from studies in chronic obstructive pulmonary disease that symptoms improve after bronchodilator treatment even when FEV1 is minimally increased and correlate with the reduction of lung hyperinflation, which is the major consequence of severe expiratory airflow limitation. Therefore, measurements of airway caliber by parameters not affected by volume history and absolute lung volumes are preferable for assessing the effect of bronchodilator interventions.

In the current study, the bronchodilators responsiveness will be assessed by using not only spirometry but also measurements of absolute lung volumes and the forced expiratory flow of a partial maneuver (V'part) started from submaximal lung inflation, thus free of volume history effects.

Eligibility Criteria:
Inclusion Criteria:

* Obliterative bronchiolitis (OB) following allogeneic HSCT
* FEV1 to slow inspiratory vital capacity (VC) ratio (FEV1/VC)\<5th percentile
* FEV1 \<75% predicted or absolute FEV1 fall \>10% of pre-HSCT value
* evidence of OB by computed tomography scanning
* negative microbiological yields in bronchoalveolar lavage fluid
* chronic graft-versus-host disease score \>0
* negative history for bronchial asthma, chronic obstructive pulmonary disease or other significant respiratory disease.

Exclusion Criteria:

* inability to perform lung function maneuvers
* pre-existent chronic lung disease other than OB
Safety and Efficacy of Quadriderme® in the Treatment of Impetiginous Eczema (Study P05134AM4)

This is a parallel-group, randomized, active-controlled, double-blind, Phase 4 trial comparing three creams in the treatment of impetiginous eczema:

* Arm A: QUADRIDERME® cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate)
* Arm B: Combination of betamethasone diproprionate cream and gentamicin sulfate cream
* Arm C: Betamethasone diproprionate cream

At 7 sites, in Portugal, a total of 207 subjects will be randomized using a 1:1:1 randomization ratio to receive one of the three possible treatments for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days. Assessments will be made of level of improvement of the target area in each treatment group, number of days for total remission, and safety profile.

Note: This study was terminated early due to lack of recruitment (only 3 of the 207 planned participants were enrolled). Statistical analyses were not performed.

Further, 7 sites were planned, but only 4 sites were approved out of which 3 sites were initiated.


Eligibility Criteria:
Inclusion Criteria:

* Minimum age: 12 years
* Good general health confirmed by clinical history and a physical and skin examination (excluding area of skin with impetiginous eczema).
* Diagnosis of impetiginous eczema.
* Ability to understand the procedures of the protocol and follow the requirements during the course of the study.
* Results of routine laboratory tests - hemogram with leukogram and platelet count, creatinine, glucose, sed. rate, IgE level and transaminases; along with plasma cortisol and adrenocorticotropic hormone (ACTH) levels prior to the start of the treatment. These results must all be within normal limits or not clinically relevant in order to be included in the trial.

Exclusion Criteria:

* Pregnant participants or women of childbearing age who are not using birth control methods considered reliable by the attending physician.
* Participants with a history of hypersensitivity to any of the components of the medication being studied.
* Participants in whom the extent or severity of the lesions requires treatment of a different type than what is planned for this trial.
* Participants who need any other type of topical or systemic medication during the trial that might affect the course of the disease.
* Participants who have been treated with other topical medications during the 14-day period prior to the start of the trial.
* Participants who have received systemic corticosteroids or any other immunosuppressant medication during the 28-day period prior to the start of the study.
Study of Systemic Impact of Trace Elements Release by Implantable Medical Devices. Identification of Biomarkers of Systemic Inflammation

The main objective of this study is to evaluate the systemic impact of salting out of trace elements (TE) by metallic and nonmetallic implantable medical devices (IMD) and in particular the immune response of the organism to these trace elements and of their target organs, and to identify circulating protein biomarkers which might indicate an evolution of inflammation caused by an IMD.

As secondary objectives, the study aims:

* to establish the norms of concentrations of free TE and nanoparticles for some forty of elements (in particular Chrome, Cobalt, Nickel, Titanium, Tantalum, Zirconium, Tungsten, Gold, Silver, Mercury, Molybdenum, Strontium ...) in different materials (blood, urine, hair and the viscera), with non-IMD holder subjects, before and after mineralization of these materials (dead patients and autopsied non-IMD holder subjects and subjects before placement of IMD.
* to evaluate the distribution of concentrations of metals in the same materials and in peri-prothetic environment with IMD holder subjects (dead autopsied patients), more often with no inflammatory sign, with possibility of some probably inflammatory IMD.
* to evaluate the parameters of distributions of concentrations of metals in same materials (with the exception of the viscera) with living IMD holder patients, with inflammatory reaction (during revision surgery).
* to define the most suitable material (accessibility, concentrations, absence of contamination) for follow-up and evolution of inflammation in order to determinate norms of studied metals concentration.
* to determinate proportion between different forms of circulation: particulate form (analysis after full mineralization) or free form (analysis without mineralization, permitting measurement of free forms), trace elements in organism.

Eligibility Criteria:
Inclusion Criteria:

* Inpatient subjects for re-intervention of: hip prosthesis made by ceramic-on-ceramic or metal-on-metal, hip prosthesis made by stainless steel ball and knee prosthesis made by polyethylene-on-metal;
* Autopsied patients with and without IMD;
* Covered by a health insurance.

Exclusion Criteria:

* Infection caused by prosthesis resumption;
* Professional exposure to metals;
* Patient under guardianship.
Use of Real-Time Functional Magnetic Resonance Imaging Neurofeedback to Improve Motor Function in Cerebellar Ataxia

This project will study the feasibility of motor rehabilitation in people with cerebellar ataxia using real-time functional magnetic resonance imaging neurofeedback (rt-fMRI NF) in conjunction with motor imagery. To do so, data will be collected from healthy adults in this protocol, to be compared with data from cerebellar ataxia participants.


Eligibility Criteria:
Inclusion Criteria:

* 18-100 years of age
* At least 8th-grade education
* Right-handedness

Exclusion Criteria:

* History of Axis I psychiatric disorders (including alcohol and drug dependence)
* Severe or unstable medical disorder, neurological disorders, such as stroke or epilepsy
* History of head injury that resulted in a loss of consciousness greater than 5 minutes and/or neurological sequelae
* Any condition that is contraindicated for the MRI environment (e.g., metal in the body, pacemaker, claustrophobia)
* Currently pregnant
* Eligible subjects may be asked to refrain from medications that affect the central nervous system that would also make data difficult to interpret (e.g., sedatives) for an appropriate period of time prior to scanning
* Participants will be excluded if they do not have a home computer with internet available to complete the 3-week at-home component of the study protocol
Supplementation in Adolescent Girls With Endometriosis

The purpose of this study is to determine whether dietary supplementation with Vitamin D or Fish Oil can help to reduce physical and emotional symptoms in adolescent girls with endometriosis.

This is a randomized controlled trial designed to evaluate the effect of dietary supplementation on endometriosis symptom remediation. Adolescent and young adults females aged 12 to 25 years with a surgically-confirmed diagnosis of endometriosis will be eligible for study participation. Subjects will be excluded if they have concurrent chronic illnesses that affect gastrointestinal absorption of nutrients (e.g., celiac disease, IBD, cystic fibrosis), a history of renal stones, are pregnant, or non-English speaking. Once consented, subjects will be randomized to one of 3 treatment assignments: 1) vitamin D3 2000 IU daily (n=30), 2) fish oil 1000 mg daily (n=30), 3) placebo (n=30) and will take these daily for 6 months. Baseline nutrient intake from food and supplements will be assessed using the Food Frequency Questionnaire (FFQ). The 142 item survey assesses usual dietary intake during the past year. Validated rating scales including the visual analog scale (VAS), SF-36, and the World Endometriosis EPHect questionnaires will be used to measure pain and overall quality of life. The SF-36 measures 8 health concepts relevant across disease groups, including limitations to physical or social activities because of health problems, vitality, and general health perception. Patients will complete a full review of medication usage, past medical history, family history, and other lifestyle factors. Anthropometrics will be measured, and vital signs obtained. Measures will be repeated at 3-month intervals for a total of 6 months. Blood will be drawn at baseline, and at 6 months to measure levels of fatty acids, vitamin D, parathyroid hormone (PTH), and calcium.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 12 years -25 years
* Previously surgically diagnosed at Boston Children's Hospital with endometriosis
* At least 6 weeks following laparoscopy
* Minimum pain score within the 4 weeks preceding study baseline
* Must be able to swallow an empty 00 gelatin capsule at baseline
* Must be willing to stop all vitamins and nutritional supplements during trial

Exclusion Criteria:

* Concurrent chronic illnesses that affect gastrointestinal absorption of nutrients (e.g., celiac disease, IBD, cystic fibrosis)
* Vitamin D level of greater than or equal to 100 ng/ml at study baseline
* History of renal stones
* No access to text messages or email
* Pregnancy
* Non-English speaking
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Participants With Chronic Genotype 1 HCV Infection

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in treatment-naive and treatment-experienced participants with chronic genotype 1 hepatitis C virus (HCV) infection.


Eligibility Criteria:
Key Inclusion Criteria:

* Willing and able to provide written informed consent
* HCV RNA ≥ 10\^4 IU/mL at screening
* HCV treatment-naive, as defined as no prior exposure to any interferon (IFN) or other approved or experimental HCV-specific direct-acting antiviral agent; OR HCV treatment-experienced with medical records that include sufficient detail of prior IFN-based treatment to allow for categorization of prior response as either intolerant, non-responder, or experienced viral breakthrough or relapse.
* Genotype 1 HCV at screening
* HCV infection documented by anti-HCV antibody test, genotyping test, or liver biopsy

Key Exclusion Criteria:

* Pregnant or nursing female
* Chronic liver disease of a non-HCV etiology
* Current or prior history of any clinically-significant illness (other than HCV)
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Relapsed/Refractory Marginal Zone Lymphoma

Phase 2, open-label, non-randomized, monotherapy study to evaluate the safety and efficacy of ibrutinib in subject with relapsed/refractory Marginal Zone Lymphoma (MZL).

Ibrutinib is a first-in-class, potent, orally administered covalent inhibitor of Bruton's tyrosine kinase (BTK). Inhibition of BTK blocks downstream B-cell receptor (BCR) signaling pathways and thus prevents B-cell proliferation. In vitro, ibrutinib inhibits purified BTK and selected members of the kinase family with 10-fold specificity compared with non-BTK kinases. Phase 1 and 2 studies of ibrutinib in B-cell malignancies demonstrate modest toxicity and significant single agent activity in a variety of B-cell malignancies, including NHL.

Eligibility Criteria:
Key Inclusion criteria:

* Histologically documented marginal zone lymphoma including splenic, nodal, and extranodal sub-types; subjects with splenic MZL must have an additional measurable lesion, nodal or extranodal, as described in inclusion criteria 5
* Previously received one or more lines of therapy including at least one CD20-directed regimen (either as monotherapy or as chemoimmunotherapy) with documented failure to achieve at least PR or documented PD after, the most recent systemic treatment regimen
* Men and women ≥18 years of age
* ECOG performance status of ≤2
* ≥1 measurable lesion site on CT scan (\>1.5 cm in longest dimension). Lesions in anatomical locations (such as extremities or soft tissue lesions) that are not well visualized by CT may be measured by MRI instead. (Subjects with spleen-only disease are considered as not having measurable disease.)
* Life expectancy of \>3 months, in the opinion of the investigator

Key Exclusion criteria:

* Medically apparent CNS lymphoma or leptomeningeal disease
* History of other malignancies except adequately treated non melanoma skin cancer, curatively treated in-situ cancer, or other solid tumors curatively treated with no evidence of disease for ≥2 years
* History of allogeneic stem-cell (or other organ) transplantation
* Any chemotherapy, anticancer antibodies, or other systemic anticancer therapy within 21 days of the first dose of study drug
* Any external beam radiation therapy within 6 weeks prior to the first dose of the study drug
* Concurrent use of warfarin or other vitamin K antagonists
* Concurrent use of a strong CYP3A inhibitor. Subjects who have received a strong CYP3A inhibitor prior to entering the study must have discontinued therapy for at least 5 half lives of the prohibited medication.
* Recent infection requiring IV anti-infective treatment that was completed ≤14 days before the first dose of study drug
* Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to CTCAE Grade 0 or 1, or to the levels dictated in the eligibility criteria with the exception of alopecia
* Inadequate organ function as defined on laboratory tests
A Study of YM155 Plus Docetaxel in Subjects With Stage III (Unresectable) or Stage IV Melanoma

The purpose of the study is to evaluate survival, response rate, safety and tolerability of YM155 given in combination with docetaxel in subjects with Stage III (unresectable) and Stage IV melanoma.

All subjects will receive YM155 and docetaxel given in a 21-day cycle. The docetaxel dose will be established based on the findings of the lead-in portion of the study (Part 1). Once the docetaxel dose is established, Part 2 enrollment will begin.

Part 1:

Part 1 is a lead-in stage that will confirm if YM155 can be safely administered in combination with docetaxel at a specified dose.

Part 2:

Subjects enrolled in Part 2 will receive YM155 and docetaxel at the dose established during Part 1.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed Stage III (unresectable) or Stage IV melanoma
* No prior systemic treatment or Cytotoxic chemotherapy for advanced melanoma (Stage III or Stage IV)
* If the subject is female, she must be non-pregnant and non-lactating at the Baseline Visit. All sexually active males and females of childbearing potential must agree to use an adequate method of contraception throughout the study period
* Eastern Cooperative Oncology Group (ECOG) performance status \</= 1
* Life expectancy \> 12 weeks
* At least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors ({RECIST} version 1.1)
* Subjects with a previous history of non-melanoma malignancy must have undergone curative therapy for all prior malignancies and be considered disease free for at least 5 years

Exclusion Criteria:

* Major surgery within 21 days of the Baseline Visit
* Presence or history of brain metastases
* Primary ocular, choroidal or mucosal melanoma
* Known history of positive test for Hepatitis B surface Antigen (HsbAg) or Hepatitis C antibody or history of positive test for Human Immunodeficiency Virus (HIV)
* Hypersensitivity to docetaxel or polysorbate 80
* Neuropathy greater than or equal to Grade 2 at Baseline Visit
* The subject has been previously treated with YM155
* Inadequate marrow, hepatic, and/or renal functions
Stress Management to Support Women's Health

The purpose of this study is to evaluate a mindfulness-based cognitive therapy intervention delivered over the phone (MBCT-T) for women with prehypertension. MBCT-T is an evidence-based program that teaches meditation practices and cognitive strategies to reduce stress and negative emotions. It targets psychosocial risk factors that disproportionately affect women, including rumination (i.e., negative thinking) and low social support. Investigators plan to translate the established MBCT-T program into Spanish, conduct focus groups to inform cultural adaptations that may be needed for Latina women, and run a pilot randomized controlled trial to test the feasibility, acceptability and effects of MBCT-T on blood pressure and perceived stress in diverse women with prehypertension.

Chronic stress is associated with the development of hypertension and cardiovascular disease. Reducing stress may be a useful prevention strategy for people at elevated risk of hypertension, including those with prehypertension. Women report different types of stress than men and may need tailored stress management programs.

Eligibility Criteria:
Inclusion Criteria:

* Female
* English- or Spanish-speaking
* A current patient of NYU/Bellevue Hospital Center (BHC) for the NYU study site or San Ysidro Health Center (SYHC) for the UCSD study site
* BP measurement in prehypertensive range (SBP 120-139 mmHg or DBP 80-89 mmHg) recorded in EHR within past 6 months AND BP in prehypertensive range at screening
* Willing to provide informed consent and comply with all aspects of the protocol
* Willing to be audio-taped

Exclusion Criteria:

* Current use of antihypertensive medication
* Clinically significant depressive symptoms (PHQ-8 ≥10)
* Significant cognitive impairment, in the EHR or apparent during screening
* History of current diagnosis of schizophrenia or other psychotic disorders
* Current participation in another clinical trial
A Culinary-Based Intensive Lifestyle Program for Patients With Obesity

The study team proposes in this pilot to test, in a single-arm mixed-methods study, the feasibility, acceptability, and preliminary effectiveness of the 16 modular classes taught by a chef, dietitian, and health coach. While the pilot may not have the power to detect significant change, it will provide preliminary data for a NIH application to further test this curriculum in a pragmatic, community-based, randomized multi-site Teaching Kitchen Collaborative Curriculum (TKCC) study planned for Jan 2022 or thereafter. If effective, the TKCC has potential to impact population health through translation into teaching kitchens nationally and adaptation to clinic /community settings.


Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling
* English speaking patients
* Aged 30-65 (in order to capture adults living independently)
* Diagnosis of class I or II obesity (BMI 30-39.9 kg/m2)
* Participants must be available for and willing to commit to the sixteen classes either in person or virtually.
* Must have a device with a camera (smartphone, tablet, computer)
* Use email and text
* Home Wi-Fi with high-speed internet
* Must have minimal cooktop and oven capacity at home
* Participants will be referred AND have medical clearance from a primary care provider at Dartmouth-Hitchcock

Exclusion Criteria:

* Patients taking obesity or diabetes medications as assessed by study medical director
* severe obesity (BMI≥40kg/m2)
* Diagnosis of Type 2 diabetes (HA1C ≥ 6.5) in the past (excluding gestational diabetes)
* implanted electronic medical device
* History of bariatric surgery
* Current participation in a longitudinal culinary or weight management program, including the D-H Weight and Wellness Center
* Severe mental health or life-threatening illnesses
* Unstable cardiovascular disease
* Hospitalization for depression in past 6 month
* Self-report of alcohol or substance abuse within the past 12 months
* Diet / exercise contraindications
* Other medical, psychiatric, or behavioral limitations that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention protocols determined by PI
* Prisoners
* Pregnant women will not be eligible to participate nor will those unable or unwilling to give informed consent or communicate with local study staff.
Once-a-day Tacrolimus Conversion Study: The OneTAC Trial

This study investigates the use of tacrolimus extended release in stable patients who have undergone a heart transplant. All patients will receive the study medication free of charge for the 1 year duration of the study.

Tacrolimus has been extensively studied in solid organ transplantation. It is FDA approved for heart transplant recipients as a twice a day formulation (Prograf brand name, as well as generic formulations). A modified release formulation is available and FDA approved for kidney transplant recipients (Astagraf, Astellas Pharmaceutical), but is not approved for heart transplant patients.

In this study the investigators will study 100 patients who are stable on twice a day Tacrolimus and convert these subjects to once a day modified release Tacrolimus. The investigators will observe these patients for 1 year following the switch and assess safety and efficacy in a heart transplant population.

Eligibility Criteria:
Inclusion Criteria:

* Adult, age 18 or higher
* Heart transplant recipient at least 365 days post-transplant at time of study screening
* Informed consent available
* Willingness to return for study visits, clinically indicated bloodwork
* On tacrolimus-based chronic immunosuppression.
* Self-identified ethnic group is provided

Exclusion Criteria:

* Prior heart or solid organ transplant
* Less than 365 days post-transplant at study screening
* Receiving cyclosporine based immunosuppression or calcineurin inhibitor free regimen
* Concurrent kidney or other solid organ
* Inability to provide informed consent
* More than 15 years post-transplant