cyrilzakka/clinical-trials huggingface dataset:
Adaptive Intervention to Facilitate PrEP Uptake/Adherence Among Transgender Women

"PrEP N' Shine" is a two-stage randomized controlled pilot trial which utilizes a behavioral intervention to optimize the uptake and adherence of Pre-exposure Prophylaxis (PrEP) in Transgender women (TGW).

The "PrEP N' Shine" package includes two behavioral intervention components:

1. Peer-led, strengths-based case management (SBCM) for PrEP linkage and uptake, and
2. A resource-efficient, adaptive "stepped-care" technology and counseling intervention that addresses individualized barriers to optimal use.

Stage 1: TGW will be equally randomized to receive either the strengths-based case management or standard of care referral to PrEP clinic.

Stage 2: Those from stage 1 who initiate PrEP , regardless of stage 1 randomization condition, will then be equally randomized to either the "PrEP N' Shine" adherence intervention or standard of care comparison condition.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 years or older
* Male sex at birth
* Self-identify as a woman, a transgender woman, or another identity along the male-to-female gender spectrum
* PrEP naïve
* PrEP indicated per CDC guidelines (incl. HIV negative)
* Owns a cell phone or willing to use one in the study
* Able to understand and speak English or Spanish

Exclusion Criteria:

* Unable to provide informed consent due to severe mental or physical illness, cognitive impairment, or substance intoxication at time of visit
* Has lived in RI for less than three months (as a means to enhance participant retention)
* Discovery of active suicidal ideation or major mental illness (e.g. untreated psychosis or mania) at the time of interview (these patients will be referred immediately for treatment, but may join the study when this is resolved)
* Laboratory or clinical findings that would preclude PrEP initiation (e.g. Hepatitis B infection, decreased creatinine clearance)
Research for the Molecular Imaging of the HER2 Targeting Tracer

To use the molecular PET radionuclide (Ga-68 or F-18) labelled HER2 Affibody to detect the expression of HER2 in the primary and metastatic lesions in patients with HER2 positive or suspicious positive tumors; to detect the expression heterogeneity of HER2 in the lesions and inter-lesions; to observe the change of HER2 expression in the course of treatment. To provide an approach for screening patients high expression of HER2, efficacy monitoring, drug resistance and early warning of recurrence and metastasis to achieve the individualized antitumor treatment of targeted drugs.

HER2 is an important biomarker and directly inﬂuences the treatment effect. The guidelines indicate that only HER2-positive patients are eligible for trastuzumab therapy.HER2 positivity is defined as a HER2 score of 3+ by IHC or FISH. However, gastroscopic biopsies are spatiotemporally limited because of the highly heterogeneous expression of HER2. And this procedure is invasive and may substantially increase the incidence of side effects. Additionally, patients with false-negative HER2 results miss the chance for targeted therapy. Moreover, HER2 status can change during the disease process.Thus, a noninvasive, whole-body, HER2-targeted imaging method may be valuable for choosing patients suitable for anti-HER2 therapy and monitoring the therapeutic efficacy. Direct labeling of HER2 antibodies with radionuclides allows clinicians to monitor HER2-targeted therapy and assists in patient staging. With the feasibility of a long half-life and decay time, positron emission tomography (PET) nuclides, such as 64Cu (T1/2= 12.7 h) and 89Zr (T1/2= 78.4 h), can label trastuzumab for the clinical PET imaging of HER2 in GC and breast cancer. Because of the long half-life of 89Zr, 89Zr-trastuzumab is estimated to produce a dosimetry exposure of 0.5 mSv/MBq (compared with the 0.019 mSv/MBq of 18FDG) in patients. Additionally, imaging needs to be performed several days after injection due to the slow blood clearance of antibodies.

In this study, 68Ga-HER2 Affibody or 18F-HER2 Affibody PET/CT imaging will be performed in patients with HER2-positive tumors to access the potential of 68Ga-HER2 Affibody or 18F-HER2 Affibody PET/CT to screen patients who can benefit from HER2 target treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Aged \> 18 years old; ECOG 0 or 1;
2. Patients with HER2 positive or suspicious positive tumors;
3. Has at least one measurable target lesion according to CT or MRI;
4. Life expectancy ≥ 12 weeks.

Exclusion Criteria:

1. Significant hepatic or renal dysfunction;
2. Is pregnant or ready to pregnant;
3. Cannot keep their states for half an hour;
4. Refused to join the clinical research;
5. Suffering from claustrophobia or other mental disorders;
6. Any other situation that researchers considered it unsuitable to participate in the trial.
Effects of Core Stabilization Training With and Without Pressure Biofeedback in Patients With Low Back Pain

Mechanical low back pain is an impairment of musculoskeletal system. Lifetime prevalence of low back pain is 60-85%. Frequent micro-trauma to the structures of the spine, poor control and stabilization leads to LBP and eventually causes functional limitation. The objective of the study to find whether Core Stabilization Training with Pressure Biofeedback could reduce pain and improves functional activity in patients with mechanical low back pain. To study the effectiveness of Core Stabilization Training with Pressure Biofeedback in reducing pain and improving functional activity in subjects with mechanical low backpain between the age group of 25-40 years. To find out the effect of core stabilization training with pressure biofeedback in reducing pain and improving functional activity in subjects with mechanical low back pain between the age group of 25-40 years. The study will be conducted on 30 subjects between the age group of 25-40 years with mechanical low back pain and according to the inclusion criteria were recruited in the study. NPRS at rest and activity, Modified ODI will assess PRE and POST treatment. P value: less than 0.05 using SPSS (Statistical package for social sciences) for NPRS(pain at rest and activity) and modified ODI i.e. core stabilization training with pressure biofeedback had statistical improvement in NPRS (Pain at rest and activity) and modified ODI score. Core stabilization training with pressure biofeedback is effective inreducing pain (at rest and activity) and functional disability in subjects between the age group of 25-40 years with mechanical low back pain


Eligibility Criteria:
Inclusion Criteria:\\

* Male and female patients between the age group 25-40 years having mechanical low back pain persisting for at least 6 months upto1 year.
* Patients complaining Pain when sitting or standing for a long period or Pain when driving long distance, getting in and out of the car or lifting activities.
* Patients with minimum and moderate disability based on Modified Oswestry Disability Index (ODI).
* Patients with greater than and equal to 7 score on NPRS.

Exclusion Criteria:

* Structural deformity (scoliosis, lordosis).
* Systematic inflammatory disease (vasculitis, connective tissue disease and granulomatous disease).
* Nerve root compression (Disc bulge and Lumbar radiculopathy).
* History of spinal surgery or fractures (laminectomy).
A Pilot Study of Tumor-Derived Exosomes as Diagnostic and Prognostic Markers in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy

This is a pilot study evaluating the use of tumor derived exosomes as a marker for response to therapy in women receiving neoadjuvant chemotherapy for newly diagnosed breast cancer. Tumor derived exosome analysis may be a novel diagnostic and prognostic biosignature in breast cancer, which could prove to be a tool for earlier diagnosis, more effective treatments, and improved markers of response in order to increase survival rates.


Eligibility Criteria:
Inclusion Criteria:

* Women with biopsy proven invasive carcinoma of the breast
* Women with locally advanced breast cancer and breast tumors measuring \>/= 2cm who are deemed candidates for preoperative chemotherapy
* Age \>/= 18 years old
* Expected survival \>/= 6 months
* Eastern Cooperative Oncology Group performance status of 0, 1, or 2 at initiation of study
* Initial required laboratory values:

Absolute neutrophil count \>/= 1.5 x 10(9)/L Platelet count \>/= 100,000 x 10(9)/L Creatinine clearance \>/= 50mL/min (calculated by Cockcroft-Gault method) Liver function tests (AST, ALT, total bilirubin) \</= 2.5 x ULN Urine or serum HCG negative (if female of childbearing potential)

* Women may be enrolled on ongoing therapeutic preoperative chemotherapy trials

Exclusion Criteria:

* No prior chemotherapy for breast cancer
* No limitations for prior radiation therapy
* No active, serious infection or medical or psychiatric illness likely to interfere with participation in this trial
* Non-pregnant and non-nursing patients only. Patients of reproductive potential must agree to use an effective means of birth control
* No prior liver transplant or bone marrow transplant
Characteristics of Persons With an Eating Disorder and Type 1 Diabetes

The purpose of this study is to analyze a chart audit of patients seen at Park Nicollet Eating Disorder Institute (EDI) to identify and compare general characteristics of eating disorders with type 1 diabetes patients to a matched eating disordered population without type 1 diabetes, also seen at EDI.

The goal of this study is to conduct a chart audit on all patients with type 1 diabetes who have been seen collaboratively by International Diabetes Center (IDC) and Park Nicollet Eating Disorder Institute (EDI) staff from 2005 - 2008 and their matched eating disordered controls.

Research Questions

1. What are the general characteristics of the ED DM T1 population?
2. How are ED DM T1 patients different from the matched eating disordered patients with respect to race, marital status, age of onset, eating behaviors, self-reported highest and lowest weight, exercise frequency and duration, number of hospital admissions, number of emergency room visits, medication needs, and other medical and psychological/psychiatric comorbidities?
3. How are ED DM T1 patients different from the matched eating disordered patients with respect to the affective and cognitive aspects of eating disorders such as self-reported depression symptoms, body image distortion, thoughts and feelings about eating, psychological concerns, readiness to change, self-esteem and anxiety?
4. For ED DM T1 patients, what is the time relationship of the diagnosis of diabetes and an eating disorder?
5. For ED DM T1 patients, what is the relationship of BMI and A1c?

Eligibility Criteria:
Inclusion Criteria:

* patient seen in both Park Nicollet Eating Disorder Institute and International Diabetes Center for type 1 diabetes from 2005 - 2008
* patient seen only in Park Nicollet Eating Disorder Institute from 2005 - 2008

Exclusion Criteria:

* none
Stem Cell Transplant for Immunologic or Histiocytic Disorders

This study tests the clinical outcomes of a preparative regimen of fludarabine (FLU), anti-thymocyte globulin (ATG)/or Campath, and melphalan; followed by hematopoietic stem cell transplant, and a post transplant regimen of Cyclosporin A (CsA) in patients with immunologic or histiocytic disorders. The researchers hypothesize that this regimen will have a positive effect on post transplant engraftment and the incidence of graft-versus-host-disease (GVHD).

Patients will be randomized biologically into one of 3 arms based upon donor availability: (a) human leukocyte antigen (HLA) genotypic matched sibling donor, (b) HLA phenotypic matched unrelated peripheral blood stem cell (PBSC) donor, (c) two HLA 0-2 antigen mismatched unrelated cord blood donors (double cord).

Prior to transplantation, subjects will receive Melphalan, Fludarabine and Anti-Thymocyte Globulin (ATG) or Campath. These three drugs are being given to subjects to help the new stem cells take and grow. On the day of transplantation, subjects will receive stem cells transfused via intravenous (IV) catheter.

After stem cell transplantation, subjects will be given Cyclosporin A (CsA) and mycophenolate mofetil (MMF) to reduce the risk of graft-versus-host disease, the complication that occurs when the donor's stem cells react against the patient.

Eligibility Criteria:
Inclusion Criteria:

Patients with immunodeficiencies or histiocytic disorders 0-35 years of age with an acceptable stem cell donor and disease characteristic defined by the following:

* Patients with histocytic disorders (hemophagocytic lymphohistiocytosis of any etiology and refractory Langerhans cell histiocytosis) who do not meet eligibility criteria for a myeloablative transplant procedure
* Patients with immunodeficiency disorders in whom residual immune function may not require a fully myeloablative preparative regimen or patient is ineligible for standard myeloablative preparative regimen (any form of severe combined immunodeficiency \[SCID\], or other immunodeficiency with T cell defect)
* Patients with immunodeficiency disorders that have had poor outcome with myeloablative stem cell transplants (including, but not limited to, common variable immunodeficiency \[CVID\], Wiskott Aldrich Syndrome \[WAS\] if \> 5 years of age, ataxia telangiectasia)
* Patients with immunodeficiencies or histocytic disorders that require a second stem cell transplant (SCT) for any reason

Exclusion Criteria:

* Karnofsky or Lansky performance score \<70
* Glomerular filtration rate (GFR)\<30% predicted
* Cardiac function \<50% normal by echocardiogram
* Serum creatinine \> 2x normal for age/weight
* Pregnant or lactating females
* Active serious infection that has not had an adequate course of therapy pre-SCT. Any patient with acquired immune deficiency syndrome (AIDS) or AIDS-related complex (ARC) or human immunodeficiency virus (HIV) seropositivity
Cognitive Therapy to Improve Word Finding

Adults who sustain brain damage due to stroke, traumatic injury or surgery may develop difficulty finding words. This study compares the effectiveness of two behavior-based programs to improve picture naming ability in these individuals.

Difficulty finding words is common in patients with aphasia subsequent to left hemisphere stroke. This study will compare two cognitive therapies for the treatment of acquired word finding difficulties. The therapies use different types of cues. All participants will receive both therapies. Participants in this study will undergo a comprehensive and detailed assessment of language and other cognitive skills. The two treatments will be compared for their efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Word finding difficulty subsequent to stroke, traumatic brain injury, brain surgery or other brain damage occuring at least 6 month prior to participation
* Ability to attend 2 sessions per week for several months at Georgetown University in Washington, DC

Exclusion Criteria:

* History of learning disabilities
* Best corrected vision less than 20/40
* Corrected hearing within functional limits
* Less than 10 years formal education
* Significant memory or comprehension problems
The Oscillation for ARDS Treated Early (OSCILLATE) Trial Pilot Study

Acute respiratory distress syndrome (ARDS) is a common and catastrophic complication of critical illness related to burns, motor vehicle accidents, or overwhelming infection. ARDS kills 40-70% of affected patients. Patients with ARDS require life support in the form of a ventilator to breathe for them while their lungs heal. Ironically, ventilators can cause further damage to the lungs. We are conducting a study comparing 2 methods to protect the lungs from further damage. One method uses standard mechanical ventilators and the other uses a new type of ventilator, called a high frequency oscillator. We propose to test whether this high frequency oscillation will reduce the relative risk of dying from ARDS. 72 patients from 12 intensive care units in Canada and Saudi Arabia will participate in this preliminary study to test the feasibility of our study methods. If feasible, we plan to move on and conduct a large multinational study to definitively answer this question.


Eligibility Criteria:
Inclusion Criteria:

* Patients of either sex, 16 years and above;
* Acute onset of respiratory failure, with fewer than 2 weeks of new pulmonary symptoms;
* Endotracheal intubation or tracheostomy;
* Hypoxaemia - defined as a PaO2/FiO2 ≤ 200 mm Hg;
* Bilateral alveolar consolidation (airspace disease) seen on frontal chest radiograph

Exclusion Criteria:

* Remaining duration of mechanical ventilation \< 48 hours, as judged by the attending physician;
* Primary cause of acute respiratory failure judged by attending physician to be cardiac in origin;
* Lack of commitment to ongoing life support;
* Weight \< 35 kg;
* Severe chronic respiratory disease
* Morbid obesity - defined as \> 1 kg / cm body height;
* Neurological conditions with risk of intracranial hypertension (hypercapnia should be avoided);
* Neuromuscular disease that will result in prolonged need for mechanical ventilation;
* Previous enrolment in this trial;
* All inclusion criteria present for \> 72 hours;
* On HFO at the time of screening.
Phosphodiesterase Type 5 Inhibition With Tadalafil Changes Outcomes in Heart Failure: Extent of Renal Damage

PITCH-ER is an ancillary study of PITCH-HF (NCT01910389). The goal of the PITCH-ER ancillary study is to evaluate the rate of decline in renal function and frequency of development of acute kidney injury (AKI) in patients enrolled in PITCH-HF (who have heart failure and pulmonary hypertension) treated with chronic tadalafil treatment compared to placebo.

The National Heart, Lung, and Blood Institute (NHLBI)-funded parent study (PITCH-HF) is the first well-controlled, randomized, large-scale trial studying the effect of tadalafil, an FDA-approved selective phosphodiesterase type 5 inhibitor (PDE5i), on cardiovascular and heart failure-related deaths and hospitalizations in patients with heart failure and secondary pulmonary hypertension.

Both chronic kidney disease (CKD), as reflected by albuminuria and reduced estimated glomerular filtration rate (eGFR) and acute kidney injury (AKI) significantly contribute to morbidity and mortality in the population of patients who will be enrolled in PITCH-HF. Therapies that alter the course of renal disease in patients with heart failure are lacking. The biology of treatment with PDE5i strongly suggests a potential protective effect of these agents on renal function.

This ancillary PITCH-ER study leverages the PITCH-HF infrastructure and randomization, adding only longitudinal collection of subjects' urine samples to 5 timepoints throughout the study. With these urine samples collected, PITCH-ER will address 2 major patient-oriented questions:

1. Does chronic tadalafil treatment slow the rate of GFR decline and/or modify the development/progression of albuminuria vs placebo? To answer this question, longitudinal measures of eGFR utilizing state-of-the-art equations that incorporate serum creatinine and cystatin C and spot urine albumin-to-creatinine ratios (UACR) will be measured.
2. Does PDE5i treatment reduce AKI frequency and/or the magnitude of urinary biomarker changes reflecting subclinical renal injury vs placebo? An AKI adjudication committee will monitor the incidence of AKI events and their severity using the Kidney Disease Improving Global Outcomes (KDIGO) consensus criteria. Subclinical renal injury will be detected using validated urinary biomarkers: neutrophil gelatinase-associated lipocalin (NGAL) and kidney injury marker 1 (KIM-1).

Since 30% of the overall PITCH-HF population will likely have diabetes (which amplifies the risk for renal injury in HF patients), PITCH-ER will repeat analyses in the population stratified by baseline diabetes status as secondary endpoints.

Eligibility Criteria:
Inclusion Criteria:

* All subjects eligible for enrollment into the PITCH-HF parent trial are eligible to enroll in this ancillary study (Refer to PITCH-HF NCT01910389 for specific eligibility criteria)

Exclusion Criteria:

* Subjects who are not eligible for enrollment into the PITCH-HF parent trial may not enroll in this ancillary study (Refer to PITCH-HF NCT01910389 for specific eligibility criteria)
Study Evaluating Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: The HEADWAY-DLB Study

This study seeks to evaluate the efficacy and safety of intepirdine (RVT-101) in patients with dementia with Lewy bodies.

The efficacy and safety of RVT-101 at doses of 70 mg and 35 mg daily will be evaluated over a 24-week double-blind treatment period in patients with dementia with Lewy bodies.

The randomization ratio will be 1:1:1 (70 mg RVT-101: 35 mg RVT-101: placebo).

Subjects completing this study will be eligible to enroll in an extension study of RVT-101 (Study RVT-101-2002).

Eligibility Criteria:
Inclusion Criteria:

* Male or female subject with probable DLB
* Mini Mental State Examination (MMSE) score of 14-26 inclusive at Screening and Baseline
* Patient has the ability to comply with procedures for cognitive and other testing in the opinion of the investigator
* Patient has a reliable caregiver who is willing to report on the subject's status throughout the study
* Patients currently receiving therapy for DLB are eligible for enrollment

Exclusion Criteria:

* Atypical clinical features or clinical course that would lead the investigator to conclude primary symptoms are more likely explained by an alternate dementia diagnosis.
* Any clinically relevant concomitant disease that, in the opinion of the investigator, makes the patient unsuitable for inclusion in the study.
Computerized Intervention for Distress Intolerance

This study evaluates the impact of a computerized distress intolerance intervention relative to a control intervention on cannabis use-related behavior and neurophysiology.

Distress intolerant cannabis users were randomized to a computerized distress intolerance intervention or a control intervention. Primary and secondary outcomes consist of the treatment target, cannabis use-related behavior, and theoretically-relevant neurophysiological processes (i.e., cannabis cue reactivity, response inhibition).

Eligibility Criteria:
Inclusion Criteria:

* Distress Intolerance Index score \>= 20
* Average cannabis use frequency in the past year \>= 2-3/week

Exclusion Criteria:

* Current suicidal ideation
* History of psychotic symptoms
* Bipolar-spectrum disorder without stabilization on medication for \>= 3 months
* Change in psychotropic medication in the past month
* Current CBT for internalizing or substance use disorders