cyrilzakka/clinical-trials huggingface dataset:
A Study in Participants With Moderate to Severe Psoriasis (UNCOVER-3)

This study will assess the safety and efficacy of ixekizumab (LY2439821), compared to etanercept and placebo in participants with moderate to severe chronic plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Presents with chronic plaque psoriasis based on a confirmed diagnosis of chronic psoriasis for at least 6 months prior to randomization
* At least 10% Body Surface Area (BSA) of Psoriasis at screening and at randomization
* Static Physician Global Assessment (sPGA) score of at least 3 and Psoriasis Area and Severity Index (PASI) score of at least 12 at screening and at randomization
* Candidate for phototherapy and/or systemic therapy
* Men must agree to use a reliable method of birth control or remain abstinent during the study
* Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment

Exclusion Criteria:

* Pustular, erythrodermic, and/or guttate forms of psoriasis
* History of drug-induced psoriasis
* Prior use of etanercept
* Clinically significant flare of psoriasis during the 12 weeks prior to randomization
* Concurrent or recent use of any biologic agent
* Received non-biologic systemic psoriasis therapy or phototherapy (including psoralens and ultraviolet A \[PUVA\], ultraviolet B \[UVB\]) within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization
* Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to randomization and during the study
* Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab
* Serious disorder or illness other than plaque psoriasis
* Serious infection within the last 3 months
* Breastfeeding or nursing (lactating) women
Once Daily Antiretroviral Therapy in HIV Infected Adults Treated With HAART

The combination of two nucleoside analogues and one protease inhibitor is a highly active antiretroviral therapy (HAART) in HIV infected adults. In those with an undetectable viral load, a once daily combination of FTC, ddI, efavirenz would be easier to take, with less side effects and the same efficacy. The aim of the study was to evaluate if the once daily combination presents the same efficacy than the HAART therapy with less side effects and a better adherence.

The combination of two nucleoside analogues and one protease inhibitor is a highly active antiretroviral therapy (HAART) in HIV infected adults, but side effects an the great number of pills induces less adherence to the therapy. Once daily combination with a lower number of pills could be more easy to take, with a greater adherence, less side effects, and the same efficacy. 355 patients are recruited in the study, randomized in two treatment groups: maintenance of the HAART therapy versus changing for a once daily combination of FTC, ddI, efavirenz, during 48 weeks. The primary end-point is the viral success maintained until 48 weeks. Secondary end-point is the safety and adherence.

The trial is prolonged for a total of 48 weeks.

Eligibility Criteria:
Inclusion Criteria:

* HIV infected adults
* Antiretroviral treatment since 6 months, with two nucleoside analogues and one or two protease inhibitors
* CD4 cell count over 100/mm3
* HIV RNA below 400 copies/ml since 6 months
* Signed written informed consent

Exclusion Criteria:

* Previous treatment with non nucleoside analogue, ddI alone
* Pregnancy
* Alcool abuse
* Acute infection, past neurological or pancreatic disease, biological abnormalities
* Chemotherapy or immunotherapy
Efficacy of Osteopathic Manipulation in Chronic Obstructive Pulmonary Disease

The purpose of this study is to determine if osteopathic manipulative treatment (OMT) is effective for persons with emphysema as a component of their chronic obstructive pulmonary disease.

OMT sessions are designed to improve chest wall compliance and diaphragmatic function which produce an immediate positive change in pulmonary function parameters and chest wall mobility. This research project will be a significant step in expanding the understanding of the role of OMT in the treatment of chronic lung disease. It is expected to yield evidence that OMT is an important adjunctive modality that improves pulmonary function, increases exercise tolerance, relieves dyspnea, and improves quality of life in those with COPD, and that would have widespread clinical application plus significant economic benefits.

Participants in this study will be randomly assigned to receive either OMT or sham treatments once a week for 13 weeks. Outcome measures will be obtained at baseline; immediately following the first treatment; at 4, 8, and 12 weeks after initiation of treatment; and 4 weeks after termination of the treatment. Outcome variables include pulmonary function tests; quality-of-life questionnaires (including emotional functioning, fatigue, and dyspnea); and measurements of exercise tolerance and chest wall mobility.

Eligibility Criteria:
Validation of Automated Cardiac Output Measurement

Automated software analysis now allows for quick estimation of cardiac output from the echocardiographic 5-chamber view. This study will validate the automated software method against pulmonary artery thermodilution and against conventional cardiac output measurement with echocardiography.


Eligibility Criteria:
Inclusion Criteria:

* Postoperative cardiac surgery patient
* Pulmonary artery catheter in situ
* Extubated

Exclusion Criteria:

* No echocardiographic image available
* No consent
* Moderat-severe aortic insufficiency
* Moderat-severe tricuspid insufficiency
* Moderat-severe mitral valve insuffficiency
* Arythmia Intracardiac shunt Moderat-severe hemodynamic instability
Phenotypic Measurements and Their Relation to Disease Exacerbation in COPD Patients

This is an observational pilot study focused on collecting data on clinical variables that can improve the understanding of potential predictors of disease exacerbation and readmissions in COPD patients. The study aim is to understand how the variability of clinical parameters (respiratory rate, forced expiratory volume in one second, and oxygen saturation), physical activity and quality of life is associated with the risk of exacerbation in COPD patients.

The investigational product to be used in this trial is the ResMed Biomotion Sensor (ResMed Sensor Technologies, Dublin, Ireland). This device uses very low power radio waves (\~1/100th of the strength of a mobile phone signal) to detect respiratory movements of a person while asleep- without physical contact with the individual. The device is designed to measure up to 5 feet, so that only the person on the side of the bed nearest the device is monitored. Algorithms have been developed to analyze the respiratory movement signals and extract information about respiration rate, bodily movements, sleep/wake patterns and sleep disordered respiration.

Eligibility Criteria:
Inclusion Criteria:

1. Medically stable and ambulatory COPD (primary diagnosis) patients who have had an emergency room visit or hospitalization for an acute exacerbation of COPD within the past 30 days.
2. Sufficient understanding of the English language to be able to read and understand study procedures.

Exclusion Criteria:

1. Currently on admission in the hospital, on non-invasive positive airway pressure ventilation
2. Visual, hearing or cognitive impairments at the discretion of their physician.
3. Currently participating in a COPD telemonitoring program.
4. No AT\&T cellular coverage at their primary residence
5. Any other medical or psychological condition that, in the opinion of the investigator may present an unreasonable risk to the study participant as a result of his/her participation in this study, may make participant's participation unreliable, or may interfere with study assessments.
The Role of the Vitamin D Receptor Gene Polymorphisms in Hepatocarcinogenesis

Previous data have suggested that vitamin D levels may influence cancer development. In particular, several single nucleotide polymorphisms have been described in the Vitamin D receptor( VDR gene), and some polymorphisms are associated with tumor occurrence. For instance, VDR polymorphisms have been related to cancers of the breast, prostate, skin, colon-rectum, bladder and kidney, although with conflicting observations . VDR polymorphisms have also been investigated in the context of some chronic liver diseases, such as chronic hepatitis B, primary biliary cirrhosis and autoimmune hepatitis . In a recent published study, VDR polymorphism may be used as a molecular marker to predict the risk and to evaluate the disease severity of HCC in patients with chronic hepatitis B.

A significant association of VDR (ApaI) polymorphism with the development of HCC in chronic HCV infection may help to identify those who are at high risk of developing HCC.

Hepatitis C virus (HCV) infection is one of the major public health problems worldwide . Chronic HCV infection is characterized by a high rate of progression to fibrosis, chronic hepatitis, leading to cirrhosis and ultimately to hepatocellular carcinoma (HCC). Early detection is critically important because the most effective treatment for HCC is surgical resection or ablation therapy when the tumour is small. On the other hand, genetic factors can also contribute, particularly gene polymorphisms of inflammatory cytokines and growth factor ligands and receptors . Vitamin D is involved in the metabolism of skeleton as a systemic hormone but also has important roles in the regulation of host immune responses, fibrogenesis and development of cancer through vitamin D receptor (VDR). Previous data have suggested that vitamin D levels may influence cancer development. In particular, several single nucleotide polymorphisms have been described in the VDR gene, and some polymorphisms are associated with tumor occurrence. For instance, VDR polymorphisms have been related to cancers of the breast, prostate, skin, colon-rectum, bladder and kidney, although with conflicting observations. VDR polymorphisms have also been investigated in the context of some chronic liver diseases, such as chronic hepatitis B, primary biliary cirrhosis and autoimmune hepatitis . In a recent published study, VDR polymorphism may be used as a molecular marker to predict the risk and to evaluate the disease severity of HCC in patients with chronic hepatitis B.

A significant association of VDR ApaI polymorphism with the development of HCC in chronic HCV infection may help to identify those who are at high risk of developing HCC.

Eligibility Criteria:
Inclusion Criteria:

* Hcv cirrhotic patient with and without Hcc

Exclusion Criteria:

* Malignancy other than HCC
* Co-infection with Hepatitis B virus (HBV) and Human immunodeficiency virus (HIV)
* Cirrhosis is due to causes other than chronic hepatitis C
The Effect of Blood Flow Restriction Method in Patellar Instability

The blood flow restriction method, the effects of which have been frequently investigated in the literature in recent years, can produce muscle hypertrophy with low-intensity load and can be easily tolerated through to low mechanical stress, seems to be an exercise approach that can be used in the recovery of strength in cases with minor patellar instability and can contribute to the recovery of functional capacity without delay.

Patellar instability is defined as disruption of normal movement of the patella in the trochlear groove, symptomatic, medial-lateral displacement. Patients with patellar instability may not be able to tolerate high-intensity quadriceps exercises in the early period of strengthening programs due to pain symptoms, and therefore strength recovery may be delayed. However, it is important to restore muscle strength, especially vastus medialis obliquus strength, as early as possible in patellar instability. The blood flow restriction method, the effects of which have been frequently investigated in the literature in recent years, can produce muscle hypertrophy with low-intensity load and can be easily tolerated through to low mechanical stress, seems to be an exercise approach that can be used in the recovery of strength in cases with minor patellar instability and can contribute to the recovery of functional capacity without delay.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-40 years,
* Volunteering to participate in the study,
* Having a complaint of anterior knee pain for at least 3 months,
* Having been diagnosed with unilateral minor patellar instability,
* Absence of any other ongoing clinical problems that interfere with exercise (will be questioned by the Physical Activity Readiness Questionnaire for All).

Exclusion Criteria:

* History of one or more traumatic-atraumatic patella dislocations,
* Evidence of osteoarthritis on radiological imaging (≥ Kellgren-Lawrence Stage 2)
* Having at least one of the contraindications preventing the application of blood flow restrictive exercises (Smoking, previous venous thromboembolism, risk of peripheral vascular disease (ankle-brachial index \<0.9), coronary heart disease, hypertension, hemophilia, etc.),
* Previously diagnosed cardiovascular disease limiting effort capacity (Myocardial infarction, angina, exercise intolerance, etc.),
* Previously diagnosed neurological disorder or cognitive dysfunction (stroke, dementia, schizophrenia, etc.),
* Orthopedic lower extremity surgery in the last 1 year,
* Body mass index ≥ 30 kg/m2.
Electrical Acupoint Stimulation Reduces Intrathecal Anesthesia Induced Hypotension

The parturients may suffer from hypotension after spinal anesthesia and the incidence could be as high as 70-80% when pharmacological prophylaxis is not used. Acupuncture was reported to treat hypotension both in human and animal studies. Possible mechanisms include modulating cardiovascular and sympathetic system. In this prospective, double-blinded, randomized clinical trial, we tend to investigate the effect of transcutaneous electric acupoint stimulation (TEAS) on hypotension in parturients undergoing cesarean section.


Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years
* American Society of Anesthesiologists physical status Ⅰ-Ⅱ
* singleton pregnancy
* full-term gestation (≥38 weeks)

Exclusion Criteria:

* Parturients suffering from preeclampsia
* Parturients with hypertension, diabetes, or cardiac dysfunction
The Angiography Characteristic of Free Wall Ruptrue in STEMI

To analyze whether the location of myocardial infarction and infarct related artery are related to FWR.

To know the characteristic of FWR that different location of STEMI and coronary distribution

Eligibility Criteria:
Inclusion Criteria:

1. Patients had to be ≥18 years of age, be admitted for STEMI
2. Accord with STEMI diagnostic criteria
3. STEMI patients anticipated to undergo angiography

Exclusion Criteria:

1. Pregnant
2. Acute stroke
3. Aortic dissection
Virtual Health Insurance Navigation Pilot Program for Childhood Survivors (HINTII)

The investigators are conducting a Type I hybrid effectiveness-implementation trial to assess the effectiveness of HINT-S (synchronous) compared to enhanced usual care (EUC) in promoting health insurance literacy, thus reducing worry, unmet health care needs, and financial consequences due to medical costs to improve care and long-term outcomes of childhood cancer survivors. The investigators will also compare HINT-S to HINT-A (asynchronous), a prerecorded, asynchronous version of the 5 HINT-S navigator sessions.

The present study seeks to evaluate a health insurance navigation program with childhood cancer survivors recruited from the Long-Term Follow-Up (LTFU) Cohort. Childhood cancer survivors face health challenges throughout their lives that require monitoring and ongoing care. This is compounded by the tendency among childhood survivors to have higher rates of underinsurance, unmet healthcare needs, and burdensome costs related to care. These burdensome costs also contribute to underutilization of care among survivors. Dr. Park and her colleagues published findings that suggested LTFU survivors had difficulty in understanding how to use their insurance, and often experienced financial-related distress. Understanding and navigating insurance benefits in the current landscape is crucial for cancer survivors to obtain and utilize the health care that they need. With this in mind, the study investigators propose to evaluate the effectiveness of an insurance navigation intervention with LTFU participants, delivered in a synchronous and asynchronous modality.

The navigation intervention will be delivered by a health insurance navigator via HIPAA-compliant videoconferencing for the synchronous group (HINT-S) and will be delivered via pre-recorded video session for the asynchronous group HINT-A). Participants will be randomized into either the two navigation intervention arms (HINT-S and HINT-A; approximately 234 per intervention arm), or the enhanced usual care arm (approximately 52 for control arm). The sample size per arm was chosen to enable evaluation of feasibility and acceptability goals, as well as to explore meaningful differences in the outcomes. To assess the proposed primary and secondary outcomes, all trial participants will complete a baseline and 6-month and 12-month post-program follow-up survey.

Eligibility Criteria:
Inclusion Criteria:

* are 18 years or older at time of enrollment
* are able to give informed consent
* have access to a smartphone, computer, or tablet with internet access
* have US based health insurance
* current LTFU cohort participants
* having access to the CCSS patient portal.

Exclusion Criteria:

* Participants from the pilot trial will not be eligible
Neoadjuvant Radiotherapy for Breast Cancer

The goal of this clinical trial is to compare the effects of neoadjuvant radiotherapy and adjuvant radiotherapy in patients with breast cancer.

The main questions it aims to answer are:

* The clinical effect of neoadjuvant radiotherapy for breast cancer was determined according to the postoperative specimens.
* Evaluate the acute and late toxicity of preoperative radiotherapy Participants will be randomly divided into two groups: the neoadjuvant radiotherapy group and the adjuvant radiotherapy group.


Eligibility Criteria:
Inclusion Criteria:

* Female;
* Age range from 18 to 70 years old;
* The pathological diagnosis is invasive cancer, and immunohistochemical examination has been performed to confirm the status of ER, PR, HER2, Ki67, etc;
* Clarify the BRCA gene mutation status;
* Patients who have a baseline stage of T1-3N0-3M0 and meet one of the following conditions and require neoadjuvant therapy: ① mass\>5cm; ② Axillary lymph node metastasis; ③ HER-2 positive; ④ Three Yin type; ⑤ Those who have a desire to preserve breast, but have a large ratio of tumor size to breast volume, making it difficult to preserve breast;
* Baseline estimation requires adjuvant radiotherapy, which meets one of the following conditions: ① performing breast conserving surgery; ② T3 or N positive patients after mastectomy and axillary dissection; ③ After mastectomy, sentinel lymph nodes were positive and axillary dissection was not performed;
* KPS score ≥ 80;
* The tumor must be visible in CT scan;
* Patients must undergo magnetic resonance imaging to help determine the contour of the tumor and exclude other lesions. If other lesions are found, biopsy must be performed on these lesions and the result is negative before continuing treatment;
* No history of serious internal medicine diseases or other serious comorbidities, such as a history of mental illness, allergies, etc;
* Sign an informed consent form.

Exclusion Criteria:

* Clinical or pathological stage T4 or M1 breast cancer;
* Received preoperative neoadjuvant therapy;
* Pathological confirmation shows that there is no invasive cancer component in DCIS;
* Double breast cancer or previous contralateral breast cancer;
* Imaging examination suggests suspicious malignant lesions in the ipsilateral or contralateral breast, which have not been pathologically confirmed to be benign;
* KPS score ≤ 70;
* There is active infection currently;
* Concomitant with severe heart, liver, kidney, hematopoietic and neurological diseases, psychiatric patients, or estimated survival time\<6 months;
* History of malignant tumors in other areas, excluding curable non melanoma skin cancer and cervical cancer in situ;
* History of radiation therapy at the site of previous radiation therapy;
* Pregnancy and lactation period;
* Those with poor compliance or life-threatening conditions who cannot complete treatment.
Urdu Version Of Nottingham Extended Activities Of Daily Living Scale: Reliability And Validity Study

The aim of the study is to know the validity and reliability as well as to translate and culturally adapt the Nottingham Extended Activities Of Daily Living Scale into Urdu language in Pakistani population of Stroke. This study also aims to correlate the scale with the Modified Barthel Index and Frenchay Activities Index.

As per previous recommendation the English version of Nottingham Extended Activities Of Daily Living Scale will be translated into Urdu and it will be culturally adapted. Nottingham Extended Activities Of Daily Living Scale will be given to eighty individuals of stroke population which were selected on the basis of convenience sampling and the criteria of inclusion and exclusion. Study will investigate both inter-observer and intra-observer reliability of Nottingham Extended Activities Of Daily Living Scale, Modified Barthel Index and Frenchay Activities Index; the 2 set of questionnaire designed will be given to the participants on the same day to be filled, by two observers. And with a gap of half an hour between distributions of first two forms questionnaires will be given for inter-observer assessment. And after a time period of one week a third assessment will be collected by the first observer (intra-observer assessment). Statistical Package of Social Sciences Version 24 will be used for data entry and analysis. Cronbach alpha value will be used for checking internal consistency and intra-class correlation coefficient will be used to analyze test retest reliability.

Eligibility Criteria:
Inclusion Criteria:

1. Having age of 67 years or more
2. Having stroke
3. Both males and females

Exclusion Criteria:

1. Neurological condition other than stroke
2. Any fracture of lower extremity
3. Any amputation of lower extremity
Quality of Life in Ventilator-dependant Neuromuscular Patients

This study aims at evaluating the quality of life of patients with slowly progressive neuromuscular disorders who are dependant on mechanical ventilation (daily usage ≥ 16h).


Eligibility Criteria:
Inclusion Criteria:

* Patients with slowly progressive neuromuscular disorder (NMD), non walking
* Patients dependant on mechanical ventilation (daily usage ≥ 16h) for at least 1 year before inclusion
* Aged ≥ 18 yo
* Consent for participation
* Affiliated to a social security regime

Exclusion Criteria:

* Patients with medically non-stable NMD: fever, acute respiratory infection, organ decompensation
* Patients with significant cognitive impairment (inability to read and/or incomprehension of questions)
* Patients with fast-evolving neuromuscular disease
* Patients declining to participate in the study
* Patients under guardianship and/or trusteeship
* Pregnant women