cyrilzakka/clinical-trials huggingface dataset:
A Study of Aspirin and Clopidogrel in Patients With Idiopathic Pulmonary Arterial Hypertension

Rationale: Idiopathic pulmonary arterial hypertension (IPAH) is characterized by in situ thrombosis and increased thromboxane A2 (Tx-M) synthesis. While both may be attributable to abnormal platelet function, there are no studies of anti-platelet therapy in IPAH.

Objectives: The purpose of this study is to assess the effects of aspirin (ASA) and clopidogrel on platelet function and eicosanoid metabolism in patients with IPAH.

This is a randomized, double-blind, placebo-controlled crossover study of aspirin 81 mg once daily and clopidogrel 75 mg once daily. Platelet function is assessed with plasma P-selectin levels and aggregometry after exposure to adenosine diphosphate, arachidonic acid, and collagen. We will assess serum levels of thromboxane B2 and urinary metabolites of thromboxane A2 and prostaglandin I2 (Tx-M and PGI-M, respectively).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of IPAH
* ≥ 18 years of age
* NYHA functional class I, II, or III
* Clinical stability (i.e., without change in pulmonary arterial hypertension medical regimen within one month prior to enrollment).

Exclusion Criteria:

* Other forms of PAH
* A contraindication to ASA or clopidogrel
* Thrombocytopenia (defined as platelet count ≤ 75,000)
* History of intracranial hemorrhage or chronic thromboembolic disease
* Renal failure
* Inability or unwillingness to avoid non-steroidal anti-inflammatory agents, ASA, or warfarin use for the duration of the trial
Topical Multiple Ascending Dose Study for PF-06423264

The current study is the first clinical trial proposed with PF-06423264. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of multiple ascending doses of PF-06423264 to healthy adult subjects with or without oily skin.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and female of non-childbearing potential;
* Body Mass Index 17.5-35.5 kg/m2;
* Body weight \>50 kg;

Exclusion Criteria:

* Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergises, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
Elaboration of a Pronostic Score of Changes on Wheelchair's Seating System

Development and validation study of a prognostic score - study of prognostic performance by a prospective longitudinal multicenter cohort spread over 8 centers: 4 for the development cohort and 4 for the validation cohort).

Progressive muscle weakness in neuromuscular diseases leads to motor disabilities leading to permanentfull-time wheelchair use. This is the case for infantile spinal muscular atrophy type II (SMA II), where people are dependent on a permanent sitting position from early childhood, at 2 years of age, or for Duchenne muscular dystrophy, when they lose their ability to walk around 10 years without corticosteroid therapy or around 13 years with treatment. These wheelchair users, weakened by the disease, are subject to musculotendinous retractions, osteo-articular stiffness, spinal deformities and pain. In addition, they use the wheelchair on a daily basis, on average 12 hours a day, whose permanent sitting position also conditions the performance of achieving life habits.

The analysis of the static and dynamic seated postural installation in the wheelchair makes it possible to avoid harmful consequences on the health and quality of life of users on a daily basis. When performed early enough, regularly and optimally, it also contributes to the prevention of complications.

In France, these assessments are carried out by occupational therapists, accompanied by doctors of Physical Medicine and Rehabilitation.

The weakness of the literature in this area and the absence of recommendations do not allow the user or any health professional to identify the need and the level of urgency to benefit from a dedicated consultation.

Faced with this observation, the development of a prognostic score for a change in positioning in the wheelchair, based on a prospective multicenter cohort and its validation on an external prospective cohort, will allow any healthcare professional to guide the user to a necessary positioning consultation. The hypothesis is that this score has discriminating qualities and that it is calibrated to predict a change in the seat of the RF and therefore the need to reassess the seated postural installation.

Eligibility Criteria:
Inclusion Criteria:

* Male or female over the age of 18
* Daily wheelchair user (more than 4 hours per day)
* Having a neuromuscular disease such as Duchenne Muscular Dystrophy or Infantile Spinal Muscular Atrophy type II
* Accompanied by an identified medical equipment provider, able to respond to the recommendations of the clinical team
* Patient informed and having signed consent.

Exclusion Criteria:

* Person who already has a seat change or FR prescription at the time of inclusion
* Having undergone surgery less than 1 year ago or a fracture
* Pregnant or breastfeeding women
* Patient under guardianship or curatorship.
Adapting an Intervention for Vaping in Young Veterans

The objective of this proposal is to adapt an evidence-based combustible tobacco counseling intervention following an evidence-based process to include e-cigarette use and update its components for emerging adults (EA).

1. Examine factors related to e-cigarette use, barriers to cessation, and facilitators of use of cessation services among an EA population.
2. Beta-test an initial version of the intervention, delivered via video telehealth and telephone, to examine usability and acceptability.

Use of electronic nicotine products (ENDS) has increased dramatically especially among young adults (EA- aged 18-30) and has been found to lead to immediate harmful health effects and increased addiction to combustible cigarette use. To date no research-tested interventions have been developed for helping people stop use of electronic nicotine products. Emerging adulthood is a developmental period that can lead to adoption of health risk behaviors.

This proposal aims to address nicotine addiction by adapting an evidence-based counseling cessation intervention developed by the American Cancer Society (ACS) for a general population of combustible tobacco smokers, but found to be effective in EA. We will test two methods of providing counseling to participants: video telehealth or telephone. Primary outcome: Compared to self-help guide only, at 3 month follow-up, we hypothesize that participants in either counseling arm will have higher rates as compared to self-help only control of 7-day abstinence from using any nicotine product.

This study fills a critical gap in ENDS research and will provide a model for further research into all-nicotine cessation in this vulnerable population.

Eligibility Criteria:
Inclusion Criteria:

* daily e-cigarette user for at least the past 6 months
* 18-30 years old
* willing to enroll in a program to quit nicotine use within 30 days
* owns smartphone or computer/tablet with camera and internet connectivity
* English speaker

Exclusion Criteria:

* ICD-10 diagnosis of dementia
* current use of combustible tobacco products at least weekly
Fascial Versus Standard Neck Dissection in Patients With N1b Papillary Thyroid Carcinoma

Optimal surgical technique for neck dissection (LND) in thyroid carcinoma remains a subject of debate. Fascial ND (FND) implies the removal of the superficial and middle layers of the deep cervical fascia en bloc with lymph-nodes containing fibro-fatty tissue (levels IIa-Vb and VI-VII for cN1b patients). This retrospective cohort study was designed to compare FND with standard, non-fascial, selective ND (SND).

In thyroid cancer patients, lymph node dissection includes a comprehensive removal of all the target nodal basins: anterior cervical compartment (level VI) and the superior mediastinal nodes that can be reached via cervical incision (level VII) in CND, and levels IIa-Vb in LND. Clearance of those levels without including the enveloping fasciae in the specimen is referred to hereafter as Standard Neck Dissection (SND), as it is the most common technique applied for thyroid tumors. In Fascial Neck Dissection, the comprehensive clearance of the target basins is achieved by following the planes of coalescence of the cervical fascial layers. Those are avascular and enable the removal of the target nodes en bloc with their investing fascial layers.

The aim of this retrospective study was to compare the outcomes between fascial and standard approach in N1b PTC patients that underwent surgery for N1b papillary thyroid cancer. The primary objective was to achieve a significantly higher nodal yield by applying the fascial neck dissection technique and reduce rates of early loco-regional recurrence. Secondary objectives were the evaluation of short and long-term post-operative complications and the cosmetic result.

Eligibility Criteria:
Inclusion Criteria:

Patients who met all the following criteria were eligible for inclusion in this retrospective evaluation:

* Male or female patients, living or deceased, aged 18 years or older at the time of operation
* Unilateral (left/right) or bilateral lateral neck dissection along with central neck dissection
* Patients with papillary cancer, pN1b. This excludes patients with other types of thyroid cancer (e.g., medullary, follicular, and anaplastic);
* Patients that underwent central and/or lateral neck dissection as a primary intervention. This excludes patients with any previous operation for thyroid disease involving any type of lymph node dissection.

Exclusion criteria: patient's age \< 18 years, patients that underwent previous neck dissection of any type and patients who refused or were unable to provide adequate follow up data.
Cetaphil® Daily Facial Moisturizer With Sunscreen SPF 50+ - Human Repeat Insult Patch Test

This study examined the possible sensitization and irritation effects of a moisturizer with sunscreen SPF 50+.

The design for this study is standard for human repeat insult patch tests. To test the moisturizer with sunscreen SPF 50+ for the potential to induce contact sensitization by repetitive applications, healthy subjects received 9 applications at 48 to 72 hour intervals of the moisturizer to the upper back. Patches were remained on the skin for approximately 48 to 72 hours. Twelve to 24 days after the previous applications, subjects were patched with the moisturizer at the original site and an alternative site for 48 hours.

Eligibility Criteria:
Inclusion Criteria:

* Men or women 18 to 70 years of age in general good health
* Can read, understand, and sign informed consent

Exclusion Criteria:

* History of acute or chronic disease
* Diagnosed with chronic skin allergies
* Pregnant or lactating
No Opioids PrescrIptions On Discharge After Surgery

Opioid analgesics are routinely prescribed for these patients for post-operative pain control. Even a short exposure to opioids in opioid-naïve patients following minor or major surgery has been associated with de novo habitual or persistent use of opioids in 5-30% of patients. The goal of the study to eliminate the use of outpatient opioids prescriptions after major urologic surgery.

Nearly 200 million opioid prescriptions are dispensed per year in the United States. Opioid prescriptions given by medical providers are a major contributor to the opioid abuse epidemic. Nearly 40% of opioid overdose-related deaths occur due to prescribed opioids. Among patients diagnosed with opiate dependence, 80% had received an opioid prescription prior to their abuse diagnosis and 51% had a family member who had an opioid prescription, Thus, opioids prescriptions, which are often in excess of the need by the patient, are a major contributor to this public health crisis.

The investigators devised a prospective intervention study to eliminate or significantly reduced the use of opioids prescribed at hospital discharge after major urologic surgery.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing major urologic cancer surgery, either open or laparoscopic, will be included in the study.
* This will include all open or laparoscopic or robotic surgery including radical prostatectomy, radical cystectomy, radical nephrectomy, partial nephrectomy, nephron-ureterectomy, and similar procedures.

Exclusion Criteria:

* Those with allergy or intolerance to NSAIDS may be excluded.
Exercise Training for Rectal Cancer Patients

Cancer treatments often cause acute toxicity during treatment, and late toxicity after treatments have ended. Bowel dysfunctions, incontinence (anal and urinary) and dysfunction are late side effects associated with cancer treatment in general, and patients treated for pelvic malignancies are at a higher risk. In Norway, the incidence of rectal cancer was 1329 in 2010. Advances in the treatment during the past few decades have led to fewer local recurrences and increased long-term survival, and today the relative survival is 66% for women and 64% for men. More patients are having sphincter-preserving surgery with low colorectal or ultralow coloanal anastomoses, and low anterior resection (LAR) is done in 70% of the patients with curative surgery. Unfortunately, many patients experience altered bowel function after LAR. Frequent bowel movements, urgency, evacuatory difficulties and fecal incontinence are common and distressing complications. These functional disturbances are seen in up to 50-60% of the patients, and most frequent when surgery is combined with neoadjuvant therapy. Urinary incontinence and decreased sexual function is also common in both men and women following rectal cancer treatment.

In many surgical settings, patients with higher preoperative physical fitness rehabilitate more quickly and have fewer operative complications compared with patients who are less physically fit. Additionally, specific strength training of the pelvic floor muscles builds up muscle volume, elevates the location of the pelvic floor muscles and pelvic organs, and closes the levator hiatus thus providing improved structural support for the pelvic floor as well as more optimal automatic function. The aim of the present trial is to investigate whether exercise training including pelvic floor muscle training during preoperative radiotherapy can reduce symptoms of bowel, urinary and sexual dysfunction and affect the physiology of the anal sphincter muscle after LAR. In addition quality of life, cardiopulmonary parameters and postoperative complications will be studied.


Eligibility Criteria:
Inclusion Criteria:

* Cancer recti
* Planned curative LAR with preoperative radiotherapy
* Cancer stadium I-III
* Able to speak and understand Norwegian

Exclusion Criteria:

* Previous radiotherapy
* Previous pelvic surgery
* Diseases affecting the anal sphincter
Photodynamic Therapy of Actinic Keratoses With Alacare®

This study aims to collect data on the frequency of SCCs in the Alacare®-treated area during an interval of two years after Alacare®-PDT.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Patients with 3 to 6 mild AK lesions on the hairless areas of the head and face which were treated with Alacare®-PDT according to the SPC
A Study of AEB1102 (Pegzilarginase) in Patients With Arginase I Deficiency

The purpose of this study is to investigate the long-term safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of intravenous AEB1102 in patients who complete Study CAEB1102-101A.

Purpose of this study is to investigate the long-term safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of intravenous AEB1102 in patients who complete Study CAEB1102-101A.

Eligibility Criteria:
Inclusion Criteria:

1. Complete treatment in Study CAEB1102-101A without experiencing any clinically significant adverse event or other unmanageable drug toxicity that would preclude continued dosing
2. Confirmation by the Investigator and the Sponsor determine that it is acceptable for the patient to continue dosing with AEB1102
3. If female and of child-bearing potential, has a negative serum pregnancy test within 7 days before enrollment
4. If sexually active (male or female), must be surgically sterile, post-menopausal (female), or must agree to use a physician-approved method of birth control during the study and for a minimum of 30 days after the last study drug administration
5. Patient or legal guardian is able and willing to provide written informed consent and where required assent, and to comply with all requirements of study participation (including all study procedures and continuation of prescribed diet without modification), prior to any screening procedures

Exclusion Criteria:

1. Clinically significant concurrent disease, serious intercurrent illness, or other extenuating circumstances
Development of Core Outcomes for Age-related Macular Degeneration (AMD) Interventions- Caregivers' Perspective

This study will explore experience of AMD caregivers in order to develop a core outcome set (COS) for age related macular degeneration (AMD) randomised controlled trials (RCTs) trying to capture what research outcomes are important from their perspective.

People 18 years of age and older who have been AMD caregivers for at least 6 months may be eligible for this study.

The aim is to conduct three focus groups lasting approximately one hour. The plan is to enrol 18-24 participants (6-8 participants per each of 3 focus groups).Two researchers will be involved in conducting the focus groups. A moderator will ensure fluid discussion, while the second investigator will be taking notes and audio-recording the discussion.

Randomised controlled trials (RCTs) are widely employed interventional studies in medicine, yet many times their outcomes are presented inconsistently. The COMET Initiative (Core Outcome Measures for Effectiveness Trials) suggests that a solution for that issue would be preparation of a core outcome set (COS)a minimal group of outcome measures relevant to different group of stakeholders (e.g. clinicians, patients, carers) that would be implemented in each RCT in a particular area. The overall aim is to prepare a COS for age related-macular degeneration (AMD) RCTs. As first step to develop a COS for AMD, the investigators conducted a systematic review that confirmed variability in AMD trials' outcome selection. The current step encompasses involvement of different stakeholders' groups in focus groups: patients and caregivers (current project) such as family members and friends helping AMD patients with their everyday living. Knowledge of caregivers' perspective on living with, treatment and outcomes for AMD is a key consideration when building up a COS, because they may not only evaluate existing outcomes, but also their experience may be translate into new outcomes. In the current focus group study, caregivers will be invited for a one hour discussion. The investigators plan to arrange three focus groups with approximately 8 participants each. Two researchers will be present to help facilitate discussion. Participants will be asked about their experience related to their help brought to AMD patients, observations of living with and treatment of AMD as well as about AMD study outcomes and their importance.

Eligibility Criteria:
Inclusion Criteria:

* English speaking participants
* AMD patients' caregivers defined as people actively taking part in providing support for AMD patients
* Being a caregiver for at least 6 months
* Having daily contact with AMD patients (not necessarily living with patients)

Exclusion Criteria:

* Non-English speaking participants
* Being a caregiver for less than 6 months
* Not having daily contact with AMD patients
Safety and Efficacy Active Drug vs. Placebo in Subjects With Asthma

This study is a double-blind, parallel-group, randomized study of active drug vs placebo in asthma.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with Asthma

Exclusion Criteria:

-
Prospective Exploratory Study of FAPi PET/CT in Prostate Cancer With Histopathology Validation

This exploratory study investigates how a new imaging technique called FAPI PET/CT can determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues in patients with prostate cancer. Because some cancers take up 68Ga-FAPi-46 it can be seen with PET. FAP stands for Fibroblast Activation Protein. FAP is produced by cells that surround tumors. The function of FAP is not well understood but imaging studies have shown that FAP can be detected with FAPI PET/CT. Imaging FAP with FAPI PET/CT may in the future provide additional information about various cancers including prostate cancer.

PRIMARY OBJECTIVE:

I. To define the biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues of patients with prostate cancer.

SECONDARY OBJECTIVES:

I. To evaluate whether 68Ga-FAPi-46 and gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) accumulation observed by positron emission tomography (PET) correlates with the amount of fibroblast activation protein (FAP) and prostate specific membrane antigen (PSMA) in excised cancer tissue, respectively.

II. To assess the 68Ga-FAPI-46 biodistribution correlation with 68Ga-PSMA-11.

OUTLINE:

Patients receive 68Ga-FAPi-46 intravenously (IV) and undergo PET/computed tomography (CT) imaging over 20-50 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent a 68Ga-PSMA-11 PET/CT scan within 3 months of enrollment
* Patients who are scheduled to undergo surgical excision or biopsy of a prostate cancer primary, recurrent or metastatic lesion
* Patients can provide written informed consent
* Patients are able to remain still for duration of imaging procedure (up to one hour)

Exclusion Criteria:

* Patients with any new prostate therapy between the PSMA PET/CT and the FAP inhibitor (FAPI) PET/CT
"Living Together With Dementia"_Creation and Validation of a Training Program for Family Caregivers of People With Dementia to Live at Home

This study aims to experimentally evaluate the training program for family caregivers of people with dementia_"Living together with Dementia."

This study will begin in March 2016, with the initial assessment of family caregivers of people with dementia.

These were recruited through hospital neurology clinic and must comply with a set of pre-established criteria.

It is expected a total of 20 participants in the study (10 in the experimental group and 10 in control group).

Interventions will take place over the months of March and April. The final evaluation is scheduled for late April and the follow up to July 2016.

an evaluation document itself for this study was built.

Eligibility Criteria:
Inclusion Criteria:

* Be primary caregiver of the person with dementia
* Be able to read and write
* Carers of peolpe with dementia in initial or moderate stage

Exclusion Criteria:

* The person with dementia have severe mental pathologies associated