cyrilzakka/clinical-trials huggingface dataset:
Faith Moves Mountains: A Community Based Participatory Research (CBPR) Appalachian Wellness & Cancer Prevention Program

The study purpose is to evaluate the effectiveness of a set of culturally appropriate, faith-placed lay health advisor interventions aimed at facilitating smoking cessation and increasing cancer screening among Appalachian participants.

The developmental phase of this project incorporated community based participatory research (CBPR) principles to identify the needs and preferences of community members with regard to cancer prevention. In the intervention phase, this group-randomized trial administers and evaluates a set of culturally appropriate interventions aimed at facilitating smoking cessation and increasing cancer screening among participants in 6 distressed Appalachian counties. Faith institutions are recruited and randomized to treatment or wait-list control conditions, and participants are recruited and enrolled within those institutions. Participants select one or more targeted health behaviors from a menu including smoking cessation, colorectal cancer screening, cervical cancer screening, and breast cancer screening, and subsequently receive the intervention(s) aimed at their selected health behaviors.

Eligibility Criteria:
Inclusion Criteria:

* For smoking cessation: age 18 or older; current cigarette smoker; able to provide informed consent
* For cervical cancer screening: female; age 18 or older AND outside of screening guidelines; able to provide informed consent
* For breast cancer screening: female; age 40 or older AND outside of screening guidelines; able to provide informed consent
* For colorectal cancer screening: age 40 or older AND outside of screening guidelines; able to provide informed consent

Exclusion Criteria:

* For smoking cessation: None
* For cervical cancer screening: History of cervical cancer; history of hysterectomy
* For breast cancer screening: History of breast cancer
* For colorectal cancer screening: History of colorectal cancer
Early Postoperative Day 0 Chest Tube Removal After Thoracoscopic Minor Surgeries

The safe conditions for early chest tube removal have been progressively questioned and redefined around reliable digital air flow criteria and extension of liquid threshold accepted. Nevertheless, in current practice, the chest tube remains in restricting early mobilization and optimal compliance with ERAS programme, during the first crucial 24 h after surgery. Thus, to go further, the investigators decide to assess in this study the safety of POD 0 chest tube removal after minor thoracic operations in patients in health condition tolerating operation and anesthesia.

Chest tube management is a key element of postoperative care after thoracic surgeries for different indications. During the last decade, minimally invasive surgery and enhanced recovery after surgery (ERAS) programmes have radically changed the equation of recovery, contributing to reduce postoperative morbidity and enhance quality of life, but the chest tube remains its Achilles heel, still providing postoperative pain and impairing pulmonary function. In this view, early chest tube removal has been widely promoted not only for its economic benefits on length of stay but also for improving quality of life and potentially reducing postoperative complications. In parallel, the change from traditional chest drainage devices to electronic devices has also enabled a more accurate air leak measurement with reduction of interobserver variability, decreased chest drainage duration and shortened LOS. The safe conditions for early chest tube removal have been progressively questioned and redefined around reliable digital air flow criteria and extension of liquid threshold accepted. Nevertheless, in current practice, the chest tube remains in restricting early mobilization and optimal compliance with ERAS programme, during the first crucial 24 h after surgery. Thus, to go further, the investigators decide to assess in this study the safety of POD 0 chest tube removal after minor thoracic operations in patients in health condition tolerating operation and anesthesia.

Eligibility Criteria:
Inclusion Criteria:

1. Thoracoscopic extra-anatomical lung resection (surgical lung biopsy)
2. Thoracoscopic pleural biopsy
3. Signed consent
4. Age of majority

Exclusion Criteria:

1. Anatomical resection
2. Empyema
3. Pleural effusion
4. Pleurodesis
5. Vulnerable persons (Pregnant women, Children and adolescents)
PREMIER: Lifestyle Interventions for Blood Pressure Control

To compare the effectiveness of advice versus two multicomponent lifestyle interventions to control blood pressure in participants with Stage 1 hypertension or higher than optimal blood pressure.

BACKGROUND:

A large body of data has been collected over the years documenting that on the one hand, reduced sodium intake, increased physical activity, weight loss, and moderate alcohol ingestion (Comprehensive Intervention) have been associated with a modest reduction of both systolic and diastolic blood pressure in with high normal and Stage 1 hypertension. On the other hand, the Dietary Approaches to Stop Hypertension (DASH) study has shown that a diet rich in fruits, vegetables, low-fat dairy products, and decreased saturated fat, total fat, and cholesterol (DASH intervention) reduced both diastolic and systolic blood pressure in similar baseline blood pressure groups.

DESIGN NARRATIVE:

A multicenter study to determine the BP-lowering effects of two multi-component lifestyle intervention programs compared with advice only. Eight hundred and ten men and women were randomly assigned to one of three treatment arms: (A) advice only; (B) comprehensive lifestyle intervention, in which participants received an intensive behavioral intervention program to facilitate achieving current lifestyle recommendations for BP control (reduced salt intake, increased physical activity, reduced alcohol intake, and weight control or weight loss if needed); and (C) comprehensive lifestyle intervention plus the DASH diet, in which participants received a behavioral intervention program to promote the DASH dietary pattern in addition to the same lifestyle recommendations for BP control. Participants were followed for 18 months. The primary outcome variable was systolic blood pressure measured at six and 18 months after randomization. Other variables included diastolic blood pressure, dietary adherence, physical activity, and onset of hypertension over the 18 months of follow-up.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
Men and women, age 25 and older who were generally healthy except for higher than optimal or mildly elevated blood pressure.
Determinants of Rehabilitation Outcomes in Survivors of Primary Subarachnoid Haemorrhage

A retrospective, observational single centre study of electronic medical records of discharged patients who were admitted to from 1 January 2015 to 31 December 2018.

Period of data collection was from 5 August 2019 to 15 September 2019.

The objectives of this study were to describe a local cohort of acute SAH survivors during inpatient rehabilitation at a single tertiary rehabilitation centre in Singapore and identify early predictors impacting discharge rehabilitation outcomes.

Eligibility Criteria:
Inclusion Criteria:

* 1. Spontaneous, first-ever SAH diagnosed by admitting neurosurgeons and confirmed on neuroimaging (CT or magnetic resonance imaging) 2. Transferred from acute care facilities or admitted from clinics to TTSH RC 3. Ages between 21 - 85 years 4. Duration of SAH to rehabilitation admission ≤6 months

Exclusion Criteria:

* 1. No radiological evidence of SAH 2. Traumatic SAH 3. Previous diagnosis of SAH 4. Main reason for admission into TTSH RC was not for inpatient rehabilitation (e.g. wound care, medical or social admission)
Brief Anxiety Sensitivity Treatment for Obsessive Compulsive Symptoms

Obsessive-compulsive disorder (OCD), characterized by recurrent obsessions and/or compulsions, is a disabling psychiatric condition affecting approximately 2-3% of the population. Whereas several first-line treatments have been established (e.g., pharmacological and psychological), a substantial proportion of patients (40-60%) fail to experience symptom remission, underscoring the need for research in this area. One approach to increasing treatment efficacy is to target underlying risk factors or dysfunctions that may in turn improve outcomes. One such risk factor is anxiety sensitivity (AS) cognitive concerns. AS cognitive concerns reflects fears of mental incapacitation (e.g., "It scares me when I am unable to keep my mind on a task"). There is recent evidence that AS cognitive concerns is uniquely associated with various obsessive-compulsive (OC) symptom domains. However, questions remain as to whether reductions in AS cognitive concerns will lead to subsequent reductions in OC symptoms. The purpose of the proposed study is to investigate the efficacy of a brief AS cognitive concerns intervention on reductions in OC symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be 18 years of age or older
* Elevated levels of obsessive-compulsive symptoms as indicated by scoring one standard deviation above the non-clinical mean on any Dimensional Obsessive-Compulsive Scale dimension
* Elevated anxiety sensitivity cognitive concerns as indicated by scoring one standard deviation above the non-clinical mean

Exclusion Criteria:

* Evidence of a significant medical illness that would prevent the completion of interoceptive exposure (IE) exercises
* Non-English speakers
* Individuals currently receiving cognitive-behavioral therapy for anxiety and/or mood disorders or who are not stable on psychotropic medications (i.e., new medication or changes in dosage within the last three months)
Caretaker vs. Routine Blood Pressure Sphygmomanometer

Caretaker vs. routine blood pressure sphygmomanometer

The aim of this study is to: Compare blood pressure obtained using routine blood pressure sphygmomanometer to a non-invasive device that continuously monitors central blood pressure (CareTaker).

Eligibility Criteria:
Inclusion Criteria:

* Adults ages \> 18 who are having their blood pressure monitored using routine blood pressure sphygmomanometer.

Exclusion Criteria:

* Patients not scheduled to be monitored using blood pressure sphygmomanometer.
Dance in Parkinson's Disease. A Greek Pilot Study

Dance for Parkinson's Disease® (DfPD®) is a structured dance program that has never been evaluated in Greek PD population. This study assesses for the first time the efficacy, safety and feasibility of DfPD® program in Greek PD patients.

A total of 16 early-to-mid-stage PD patients underwent a total of 16 60-min classes of adjusted to Greek music and dance culture DfPD®, twice weekly, over 8 weeks. Assessments were performed at baseline and at the end of the study period and included quality of life, depressive symptoms, fatigue, cognitive functions, balance and body mass index. Safety and feasibility were also assessed.

Parkinson's Disease (PD) is an idiopathic, neurodegenerative, and progressive movement disorder caused mainly by dysfunction of dopaminergic cells of the substantia nigra. Numerous studies demonstrate the benefits of regular physical exercise in PD, with aerobic exercise having a greater neuroprotective effect by stimulating brain neuroplasticity. People with PD are more easily motivated to attend dance classes systematically than other forms of exercise, they have a high compliance rate with low dropouts, and often continue to practice dance outside the dance intervention.

DfPD® (Dance for Parkinson's Disease®, or Dance for PD®) was developed by the Brooklyn Parkinson Group (BPG) in collaboration with the Mark Morris Dance Group (MMDG) in 2001.This intervention has previously been shown to exert beneficial effect on QoL, motor functions, cognition, self-efficacy, anxiety and depression in people with PD. To the investigators' knowledge, there is no study investigating the effect of any structured dance program in Greek PD patients. Furthermore, no study to date has investigated the effect of DfPD® on PD patients' fatigue. The present pilot study aimed at evaluating for the first time the efficacy, safety and feasibility of a culturally adjusted DfPD® program in Greek patients with early-to-mid-stage PD.

This is a prospective, non-randomized, uncontrolled, open-label, pilot study. A total of 16 early-to-mid-stage PD patients underwent a total of 16 60-min classes of adjusted to Greek music and dance culture DfPD®, twice weekly, over 8 weeks. Assessments were performed at baseline and at the end of the study period and included quality of life, depressive symptoms, fatigue, cognitive functions, balance and body mass index. Safety and feasibility were also assessed.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* An established diagnosis of idiopathic PD of an early-to-moderate severity; that is from 0 to 2,5 according to Hoehn and Yahr (H\&Y) stages
* Ability to understand, write and speak in Greek
* Written consent for participating into the study

Exclusion Criteria:

* A diagnosis of a non-PD tremor disorder
* Moderate-to-severe PD (≥3 H\&Y stages) due to a high falls risk
* Serious health or disability issues (either physical or mental) due of which exercise is not permitted and/or basic instructions during the program cannot be followed
* Mental disorder not related to PD
* Any disease other than PD which could affect mobility levels
JAK Inhibitors for Solid Malignant Tumor Patients with Immune Checkpoint Inhibitors-related Dermatitis: a Open-lable, Single Arm, Phase IIa Trial

Currently, the principal strategy for immune checkpoint inhibitors (ICI)-related dermatitis include systemic use of corticosteroids, which can impair the efficacy of preceding ICIs treatment. Janus kinase inhibitors (JAKi) could be the optimal option for ICI-related dermatitis, which can not only provide rapid relief for ICI-related dermatitis but also potentially enhance the anti-tumor efficacy of ICIs. This is an open-lable, single arm, phase II trial, aims to evaluate efficacy and safety of JAK inhibitors for solid malignant tumor patients with ICI-related dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving treatment with any of the Food and Drug Administration (FDA) approved monoclonal antibodies that block CTLA-4, PD-1, PD-L1, or any combination.

Patients recommended to undergo skin biopsy due to a clinical diagnosis of ICI-induced dermatitis as part of routine and standard clinical care are eligible.

May have been treated with additional steroids or immunomodulators (one or more) prior to study entry (e.g. infliximab, mycophenolate mofetil, intravenous immunoglobulin), provided such immunomodulators are discontinued prior to first dose of study therapy.

Patients must be age 18 or older. Patients diagnosed with solid malignant tumor. Eastern Cooperative Oncology Group (ECOG) performance status \< 2. Measurable disease as per RECIST 1.1 Patients must be able to personally sign and date informed consent indicating that the patient has been informed of all pertinent aspects of the study are eligible.

Adequate organ and marrow function as defined below:

White blood cell (WBC) ≥ 2.0 ×109/L. Neutrophil (ANC) ≥ 1.5 ×109/L. Platelet (PLT) ≥ 75 ×109/L. Hemoglobin (Hgb) ≥ 8.0 g/dL. AST and ALT ≤ 3 x ULN in subjects without hepatic metastases; AST and ALT ≤ 5 x ULN in subjects with hepatic metastases, if AST/ALT elevation is NOT due to ICI-induced hepatitis.

Total bilirubin ≤ 2 x ULN not due to ICI-hepatitis (except subjects with Gilbert syndrome, where total bilirubin must be \< 3.0 mg/dL).

Exclusion Criteria:

* Patients taking antibiotics or who plan to begin taking antibiotics Known medical condition (e.g. a disease associated with chronic skin inflammation such as atopic dermatitis or psoriasis) that, in the investigator's opinion, would increase the risk associated with study participation or interfere with the interpretation of results Not recovered to non-dermatologic =\< grade 1 toxicities related to any prior therapy Pregnant woman Patients with human immunodeficiency virus (HIV), hepatitis B, or C will be excluded from this study Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures (including compliance issues related to feasibility/logistics)
Cord Blood for Neonatal Hypoxic-ischemic Encephalopathy

This is a pilot study to test feasibility of collection, preparation and infusion of a baby's own (autologous)umbilical cord blood in the first 14 days after birth if the baby is born with signs of brain injury.

The purpose of this pilot study is to evaluate the safety and feasibility of infusions of autologous (the patient's own)umbilical cord blood cells in term gestation newborn infants with hypoxic-ischemic encephalopathy. For this study, infants who have signs of moderate to severe encephalopathy at birth whose mothers have previously consented to providing cord blood cells for the Carolinas Cord Blood Bank or other public or private bank that uses accepted standards for collection and handling of cells, or provided verbal consent for cord blood collection for the possibility of their baby's participation in this trial, can receive their own cord blood cells if an adequate number of cells that meet Carolinas Cord Blood Bank Quality standards are available in the first 14 postnatal days. Study activities also include serial blood draws concurrent with clinically indicated blood draws with a total volume of no more than 5 milliliters (1 teaspoon) from all study related tests. Babies will be followed for neurodevelopmental outcome at 4 - 6 and 9 - 12 months at Duke's Special Infant Care Clinic. MRI's will be obtained per clinical routine and results will be analyzed and described in study reports.

Eligibility Criteria:
Inclusion Criteria:

* Mothers must have consented for cord blood collection at delivery
* cord blood must be available for extraction of stem cells.
* \>34 weeks gestation
* cord or neonatal pH\<7.0 or base deficit\>16 milliequivalents per liter (mEq/L) or history of acute perinatal event
* either a 10 minute Apgar \< 5 or continued need for ventilation.
* All infants must have signs of encephalopathy within 6 hours of age.

Exclusion Criteria:

* Inability to enroll by 14 days of age.
* Presence of known chromosomal anomaly.
* Presence of major congenital anomalies.
* Severe intrauterine growth restriction (weight \<1800g)
* Infants in extremis for whom no additional intensive therapy will be offered by attending neonatologist.
* Parents refuse consent.
* Attending neonatologist refuses consent.
* Failure to collect the infant's cord blood and/or laboratory unable to process cord blood.
Effect Kinesio Taping on Acute-onset Muscle Soreness and Calf Muscle Extensibility Among Endurance Athletes

In recent years, athletes have frequently utilized Kinesio tape (KT) to enhance their performance. Despite widespread use, data regarding its efficacy and mechanism of action is lacking among healthy endurance athletes. This study aims to determine the effect of KT application on acute-onset muscle soreness and the extensibility of the calf muscles in endurance athletes.

The study followed a single-blinded one-arm crossover repeated-measures randomized controlled design and included fifty-five endurance athletes (mean age, 16.40±2.69) from different stadia in Delhi, India. Outcome measures, including the ankle dorsiflexion range of motion (ADFROM), were measured using a universal goniometer before, immediately after application of either KT or Sham tape, and after treadmill running. However, the pain due to acute-onset muscle soreness was measured using a numeric pain rating scale (NPRS) immediately, 10 min, and 30 min after treadmill running.

Eligibility Criteria:
Inclusion Criteria:

* Endurance athletes, including Cyclists, Badminton players, Long-distance runners
* Both males and females aged between 10-20 years
* Having BMI within the normal range (19-25)
* Cooperation in the study

Exclusion Criteria:

* Other than endurance athletes
* Aged less than Ten and more than 20 years
* BMI fall beyond the normal range, either underweight or overweight
* Musculoskeletal injuries, skin problems
* Non-cooperation in the study
Biomarker Correlates of Radiologic Imaging

The purpose of this study is to assemble a collection of urine and blood samples for the development and validation of biomarkers potentially useful in correlating or improving the diagnostic utility of abdominal imaging.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Undergoing abdominal CT imaging (standard of care)
* Signed, informed consent

Exclusion Criteria:

* Patients on dialysis
A Phase II Trial of Genexol-PM and Gemcitabine in Patients With Advanced Non-small-cell Lung Cancer

To evaluate the efficacy and safety Genexol-PM(CrEL-free polymeric micelle formulated paclitaxel)and gemcitabine in untreated metastatic NSCLC patients


Eligibility Criteria:
Inclusion Criteria:

* age over 18
* histologically or cytologically confirmted non-small cell lung cancer
* stage IIIb with pleural effusion or stage IV
* ECOG PS 0-2
* at least one measurable lesion
* expected life span more than 3 months
* normal bone marrow, liver, renal function
* no prior chemotherapy or radiotherapy except for whole brain radiotherapy for symptomatic brain metastases
* more than 6 months from the last adjuvant chemotherapy

Exclusion Criteria:

* active infection
* severe comorbitidies
* pregnant or lactating women
* other invasive malignancies
* poorly controlled symptomatic brain metastases
Validation of a Molecular Prognostic Test for Eye Melanoma

Up to half of patients with ocular melanoma (also called iris, choroidal or uveal melanoma) develop metastasis. We have found that certain molecular features of the eye tumor can be detected by gene expression profiling and accurately predict which patients will develop metastasis. This molecular test could eventually allow high risk patients to receive preventative therapy to delay or prevent the development of metastasis. The goal of this study is to prospectively validate the predictive accuracy of the gene expression-based molecular test and compare it to monosomy 3, the most common but potentially less accurate molecular marker for metastasis in ocular melanoma.

We have discovered a gene expression profile derived from primary uveal melanomas that accurately predicts which patients will develop metastasis. Tumors with a class 1 gene expression signature have a very low risk, and those with a class 2 signature have a high risk of metastasis. The molecular test was initially performed on tissue obtained from enucleated eyes using commercial microarray platforms. We are now able to perform the molecular test on fine needle biopsy specimens, and we have developed a customized test that has greater dynamic range and sensitivity than commercial microarray platforms. The goal of this study is to validate the prognostic accuracy of the customized platform by performing the molecular test on primary uveal melanomas obtained from enucleation, local tumor resection or fine needle biopsy. Each sample will be diagnosed as either class 1, class 2 or indeterminate. Outcomes will be collected and the ability of the molecular diagnosis to predict metastasis will be evaluated at regular intervals.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of melanoma of the iris, ciliary body and/or choroid
* treatment to include enucleation, radiotherapy or local tumor resection

Exclusion Criteria:

* evidence of marked tumor necrosis