cyrilzakka/clinical-trials huggingface dataset:
CHIlled Platelet Study "CHIPS"

A phase 3 randomized partial blind storage duration ranging study in patients undergoing complex cardiac surgery that will compare the transfusion of cold stored platelets to standard room temperature stored platelets. The primary objective is to establish that cold stored platelets have a non-inferiority (or superiority) to room temperature platelets.


Eligibility Criteria:
Inclusion Criteria:

* Viable neonates ≥ 3 kg at time of enrollment (as defined in Section 4.1) OR age greater than 28 days and less than 85 years of age at time of consent; AND
* Planned complex cardiac surgery with planned use of cardiopulmonary bypass, with an expectation of bleeding requiring platelet transfusion.

Exclusion Criteria:

* Expected order for washed or volume reduced platelets
* Patient with known anti-platelet antibodies
* Platelet transfusion refractoriness due to anti-HLA antibodies
* Known or suspected pregnancy
* Previously randomized in this study
* Conscious objection or unwillingness to receive blood products
* Known IgA deficiency
* Known congenital platelet disorder
* Known congenital bleeding disorder
* Planned post-operative extracorporeal membrane oxygenation (ECMO), ventricular assist device (VAD), and/or continuous renal replacement therapy (CRRT)/ hemodialysis
* Patients intended to receive whole blood either intra-operative or post-operative for bleeding
* Platelet transfusion (of any type) within 24 hours prior to the date of surgery
* Pre-operative thrombocytopenia, defined as platelet count \<75x10(9)/L, based on the most recent labs completed within 72 hours prior to the date of surgery.
Prospective Investigation of Multiple Sclerosis in the Three Rivers Region

In this longitudinal prospective natural history study of multiple sclerosis (MS), the overarching goal is to understand the factors that influence individual variation in disease trajectory and treatment response and pave the way for realizing precision medicine in MS. Because MS is a chronic neurological disorder, this observational cohort study will span a 30-year time frame.

Research Activities: Initial Questionnaire, Questionnaire for Self-Reported Outcomes, Biological Sample Collection (Blood, Stool, Urine, Cerebrospinal fluid), Genetic Analysis, Standard Quantitative Assessment of Function, Cognitive Assessment, Neuroimaging, Biometric Sensors, Social Network Questionnaire, Connor-Davidson Resilience Scale, NEO Five-Factor Inventory, and the COVID19 Response Surveys.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for MS patients include:

  1. willing and able to give consent
  2. age 7 years or older
  3. diagnosis of multiple sclerosis or related disorders, including a first central nervous system demyelinating episode with a positive MRI scan or abnormal MRI scans characteristic of MS but no clinical symptoms of the disease
* For healthy controls:

  1. Age 7 years or older
  2. Willing and able to provide consent (for \>=18 years) or assent with permission from at least one of the child's parents (for \<18 years)
  3. No known personal history of multiple sclerosis or related disorders
  4. No other chronic diseases
  5. Family members, unrelated household controls, or controls from the general population could be eligible

There is no exclusion criteria.
Mucormycosis in COVID-19

The purpose is to allow phsyician reporters to contribute to MUNCO registry. Mucormycosis in COVID-19 is a rapidly escalating medical emergency reported in high numbers in India during the ongoing coronavirus surge. There is very little known about the risk factors, patterns and complications of mucormycosis as it occurs either during the infection or treatment phase of the novel coronavirus (COVID-19). In light of this emerging epidemic within a pandemic, it is of time sensitive importance to obtain a better understanding of the risk factors and outcomes of this fatal complication


Eligibility Criteria:
Inclusion Criteria:

Diagnosed case of Mycotic Infection in COVID-19

Exclusion Criteria:

* None
Observational Study of Outcomes in Cystic Fibrosis Patients With Selected Gating Mutations on a CFTR Allele (The VOCAL Study)

To describe the effectiveness of Kalydeco® treatment in patients with cystic fibrosis (CF) who have 1 of 8 non G551D gating CFTR mutations (G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P, or G1349D).


Eligibility Criteria:
Inclusion Criteria:

* Male or female with confirmed diagnosis of CF16
* At least 1 allele with 1 of the following CFTR mutations: G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P, G1349D
* Six years of age or older on the date of signed (Informed Consent Form) ICF, and where appropriate, date of assent
* Signed ICFs and, where appropriate, signed Assent Form
* Able to understand the study requirements and comply with study data collection procedures

Exclusion Criteria:

* Previously exposed to Kalydeco, except currently treated patients who started Kalydeco treatment within 6 months of enrollment
* Currently enrolled in a Kalydeco interventional study or other interventional therapeutic clinical study directed at CFTR modulation
* History of organ transplantation
Prolonged Smoking Cessation Using Prescription Step Care

Smoking is the number one preventable cause of morbidity and mortality in this nation. Unfortunately, more than 50% of those who quit following a smoking cessation intervention typically relapse within two weeks, with approximately 80% relapsing within six months. Therefore, tobacco use can be conceptualized as a chronic condition. As with many chronic medical problems, tobacco use interventions may benefit from a step care approach to treatment.

A total of 400 adult smokers will be enrolled in the study. Participants will be randomly assigned to one of two treatment conditions consisting of: 1) A State of the Art Smoking Cessation Intervention + Recycling or: 2) A State of the Art Smoking Cessation Intervention + Step Care. Long term smoking cessation will be assessed by self-report, exhaled carbon monoxide levels, and salivary cotinine. The primary endpoint of the study will be smoking abstinence rates at two-year follow-up. It is predicted that long-term cessation rates will be significantly higher in the step care condition than for those assigned to the recycling group.

A common approach to increasing long-term adherence and control of chronic medical problems such as hypertension in both general and preventive medicine is the concept of step care. Despite a high degree of interest in applying the step care model to smoking cessation (Abrams et al., 1996; Hughes, 1994), little empirical work has been conducted utilizing this treatment approach. The purpose of this study is to evaluate the long-term efficacy of a step care model for smoking cessation that is disseminable in primary care settings. With that introduction, we propose the following specific aims:

Aim 1: To enroll approximately 400 adult cigarette smokers recruited mainly from primary care settings;

Aim 2: To randomize these participants to: 1) State of the Art Smoking Cessation + Recycling or 2) State of the Art Smoking Cessation + Step Care; and

Aim 3: To evaluate the long-term (24 months post-randomization) relative success of the interventions. It is predicted that long-term cessation rates will be significantly higher in the step care condition.

Eligibility Criteria:
Cigarette smokers who are 18 years of age or older, who self-report smoking at least 10 cigarettes each day, and who are willing to accept random assignment are eligible to participate. Potential participants must agree to commit to the study for at least 24 months, be screened and agree to potentially participate in more intensive interventions to help them stop smoking, and agree to not seek other treatment for smoking cessation during the treatment phase of the study.
Surveillance for Low and Low-Intermediate Risk Non-muscle Invasive Bladder Cancer: A Pilot Study

This is a two-arm, randomized-controlled pilot study with 2 year duration. The "intervention" refers to surveillance based on the European Association of Urology (EAU) guidelines and the "control" refers to surveillance based on the American Urological Association (AUA) guidelines.

This is a two-arm, randomized-controlled pilot study with 2 year duration. The "intervention" refers to surveillance based on the EAU guidelines and the "control" refers to surveillance based on the AUA guidelines.

Research methods: Participants who presents with non-muscle invasive bladder cancer and meets the inclusion/exclusion criteria will be given an option to participate in the study. Participants will be enrolled at the Urology Clinics at the University of Texas Health Science Center San Antonio (UTHSCSA) Medical Arts and Research Center (MARC) and South Texas Veterans Health Care System (STVHCS). Non-local site include the University of Texas Southwestern Medical Center (UTSW). The research procedures consist of urine collection, cystoscopy, and patient satisfaction and cost questionnaires. The evaluation will be done by the tumor recurrence and progression of the disease. At various time points throughout the study, urine may be obtained from the patient and banked in the Genitourinary (GU) Tissue Bank. Subjects asked to provide a urine sample(s) will be asked to sign a separate informed consent. The urine is de-identified in the lab per the Health Insurance Portability and Accountability Act (HIPAA) protocol GU Tissue Bank Institutional Review Board (IRB) # 20050234H). Patients will undergo cystoscopy in clinic (standard of care). In the intervention arm, patient surveillance cystoscopy will be performed at 3, 12 months and again at 24 months following the diagnosis of bladder cancer. Patients randomized to the control arm, will undergo surveillance cystoscopy every 3 months for 2 years following the diagnosis of bladder cancer. Because use of cytology is variable among the participating urologist, the utilization of cytology will be at the treating urologist's discretion as per usual standard care. Study duration will be 2 years from most recent biopsy. Patients will be placed on the surveillance schedule based on the length of time from their last tumor.

Eligibility Criteria:
Inclusion Criteria:

* Must have non-muscle invasive low-grade, papillary (Ta) bladder cancer.
* Must have a negative cystoscopy following most recent biopsy.
* Must be able to give informed consent.
* Must be age 18 or older.
* Must be at low- or low-intermediate risk for disease recurrence and progression according to the EAU guidelines.

Exclusion Criteria:

* Have a history of invasive (\>=T1) bladder cancer.
* Have a history of carcinoma-in-situ (CIS).
* Unable to give informed consent.
* \< 18 or younger.
* Variant histology (micropapillary, nested variant, non-urothelial cell carcinoma elements).
* Had a surveillance cystoscopy following most recent biopsy.
The Usefulness of Patients Receiving Their Own Letter After an Outpatient Attendance

As part of the NHS plan it has been proposed to extend some consultants' usual practices and to send all patients copies of the letters sent to their general practitioners (GPs) following outpatient consultations. The current Secretary of State for Health has further extended this proposal and suggested that patients should have a specific letter to themselves after a hospital consultation.

The aim of this study is to send patients both a copy of the letter sent to their GPs and a specific letter to themselves and to assess the usefulness and comprehensibility of each.

As part of the NHS plan it has been proposed to extend some consultants' usual practices and to send all patients copies of the letters sent to their general practitioners following outpatient consultations. The current Secretary of State for Health has further extended this proposal and suggested that patients should have a specific letter to themselves after a hospital consultation.

The aim of this study is to send patients both a copy of the letter sent to their GPs and a specific letter to themselves and to assess the usefulness and comprehensibility of each. This study will assess the two styles of letter in Cardiology and Respiratory Outpatient Clinics staffed by 7 consultants and will involve a group of 15-20 patients from each of the clinics, total number approximately 150 patients.

All patients attending the clinics will be given a sheet outlining the study before their consultations. If they are interested in the study, patients will be given a Patient Information Sheet and asked consent to take part. The length of each of the two dictated letters will be recorded. To avoid costs to the NHS, the direct to patient letters will be typed at the study investigators' cost. Two copies of each letter, a short explanatory letter and a questionnaire will be sent to the patient and the patient will be asked to circle points in each of the letters which are unclear and return them to the department. At the end of the study the general practitioners will be contacted and asked their views about the two letters.

Eligibility Criteria:
Inclusion Criteria:

* All patients attending respiratory/cardiology outpatient clinics

Exclusion Criteria:

* Patients with reading/language difficulties
Complications in Body Contouring Surgery

The objective of this study is to describe the wound related complication rate in post-bariatric body contouring surgery patients who are treated according to the new Dutch guideline and to asses the factors associated with a higher complication rate.

In the recently published guideline of the Dutch Association of Plastic Surgeons it is advised that assessment and improvement of the nutritional status should be part of pre-operative work-up of all post-bariatric patients who undergo body contouring surgery (BCS). The assessment should consist of consultation of a dietician and measurement of the nutritional parameters associated with wound healing. It is advised to assess the following parameters:

* albumin
* hemoglobin
* vitamin D (25-hydroxy vitamin D)
* ferritin
* folic acid
* vitamin B12

Standard treatment in this study will consist of the pre-operative work-up as advised by the guideline. Participants will have a consultation with the dietician to assess (protein) intake. In addition the first blood sample, which is part of standard treatment according to the new protocol, will be obtained to assess foregoing parameters. If there are nutritional deficiencies they will be treated according to the protocol of the department of Bariatric Surgery of the treating hospital.

To evaluate the effect of the treatment of deficiencies and to be sure that there are no deficiencies present during the BCS a second blood sample will be drawn during the body contouring procedure. For study purposes this second sample will be collected in all patients, even if a deficiency was not present at the first blood sample.

The dietician will assess current intake of the patients, with special attention the protein intake. Based on guidelines on protein-intake in post-bariatric patients and after consultation of experts (Dieticians of Maastricht University) investigators decided that the aim of the minimum protein intake is 1.5 gram per kilogram bodyweight (calculated with BMI 27kg/m2) per day. The first consultation at the dietician will be eight weeks prior to surgery. Patients will be advised to start with the extra protein-intake four weeks prior to surgery and continue this until the wounds are completely healed.

Six weeks after surgery a questionnaire will be handed-out to the patients, to assess the compliance to the treatment regime.

Eligibility Criteria:
Inclusion Criteria:

* post-bariatric patient
* undergoing BCS because of skin surplus
* contouring in one of the following regions: abdomen, mammae, legs, arms, upper body or lower body.

Exclusion Criteria:

* BMI higher than 34.9 kg/m2
* weight unstable in last 12 months
* diabetes mellitus defined by currently using either oral medication or insulin
* active smoker
* using immunosuppressive drugs, e.g. corticosteroids, methotrexate
* using anti-coagulants other than acetylsalicylic acid
* coagulopathy, vasculitis, connective tissue disorder
* kidney failure (GFR\<30) or liver failure
WES of NF2-associated in Comparison to Sporadic Vestibular Schwannomas - Correlation With Clinical Data

Whole exome sequencing (WES) of 50 sporadic and 50 Neurofibromatosis Type2 (NF2)-associated vestibularis schwannomas (VS) in children and young adults. The aim is to gain insight into the complete genome of the NF2 associated VS compared to sporadic VS (control group). These data are to be correlated with the clinic, ie the auditory function (audiogram, acoustically evoked potentials) and the clinical picture as well as the tumor growth rate and general data such as sex, age, side, etc.

Whole exome sequencing (WES) of 50 sporadic and 50 Neurofibromatosis Type2 (NF2)-associated vestibularis schwannomas (VS) in children and young adults. The aim is to gain insight into the complete genome of the NF2 associated VS compared to sporadic VS (control group). These data are to be correlated with the clinic, ie the auditory function (audiogram, acoustically evoked potentials) and the clinical picture as well as the tumor growth rate and general data such as sex, age, side, etc.

The analysis of genetic changes should provide a better insight into the oncogenesis of these tumors. The distinct genetic characteristics between NF2-associated and sporadic VS suggest a different oncogenesis of these tumors.

The correlation of the genetic characteristics with the partly very different clinical appearance and a very different dynamics of the disease, in particular the tumor volume in the course, identifies the underlying modifiers of the disease course.

Based on these genetic modifiers, patients can be stratified and individual clinical therapy decisions can be made.

By demonstrating these genetic profiles in the peripheral blood, prospective conclusions can be drawn about expected disease progression before intervention as well as for therapy monitoring

Eligibility Criteria:
Inclusion Criteria:

* Study population: Operated NF2-associated VS
* Control group: Operated sporadic VS
* Consent to participation in the study by the patient / legal guardian in prospective inclusion or consent to the use of stored specimens in retrospective inclusion
* Age: 0 -99 years

Exclusion Criteria:

* Lack of informed consent
* Patient's request (withdrawal of the consent statement for the evaluation of the data and further storage of the blood / tissue samples)
Coreg and HSRs-Updated Analysis

A cluster of reports of hypersensitivity reactions among patients who switched from carvedilol (immediate release formulation, referred to hereafter as carvedilol) to carvedilol extended release was received during the initial post-launch period of carvedilol extended release. In follow up to this observation, product labeling for both agents was updated and a nested case control study was subsequently conducted to examine the risk of serious hypersensitivity reactions i.e. anaphylactic reaction and/or angioedema among patients who used carvedilol extended release compared to carvedilol and separately compared to other long acting beta(β)-blockers. This proposed analysis is an update to the previously conducted analysis using the same database, LabRx, now containing 2 additional years of data, which should provide a larger number of carvedilol extended release exposed subjects.


Eligibility Criteria:
Inclusion Criteria:

* At least one prescription claim for a β-blocker during follow-up time available in the database.
* At least one month of enrollment in the healthcare plan

Exclusion Criteria:

* None
Timing of Mobilization on Delirium in Patients After Cardiac Surgery

Early mobilization is recommended because it is effective in improving symptoms for patients after cardiac surgery. However, the optimal timing of mobilization for postoperative patients is not unclear. How early is early? As early mobilization in the ICU is safe and may reduce healthcare costs, the goal was to assess the effect of early mobilization in the ICU on the incidence and duration of delirium.

The prevalence of cardiac diseases is high, as the standard treatment for many heart diseases, a bunch of strategies are performed to improve the outcome of cardiac surgery.

Early mobilization is recommended because it is effective in improving symptoms for patients after cardiac surgery. However, the optimal timing of mobilization for postoperative patients is not unclear. How early is early? As early mobilization in the ICU is safe and may reduce healthcare costs, the goal was to assess the effect of early mobilization in the ICU on the incidence and duration of delirium.

Eligibility Criteria:
Inclusion Criteria:

* 1. \> 18-year-old postoperative cardiac patient admitted to ICU, the time \< 24h
* 2. Patients agree to participate in clinical research and sign informed consent before the start of the study

Exclusion Criteria:

Patients who meet any of the following criteria are not eligible for inclusion in this study:

* 1. Pregnant and lactating women
* 2. There are contraindications to getting out of bed：
* 2.1 Low cardiac output syndrome
* (1) Application of IABP or PCPS (percutaneous cardiopulmonary support)
* (2) High doses of vasoactive drugs (norepinephrine\> 0.5ug/kg.min)
* (3) SBP\<=80mmHg
* (4) Acrocyanosis, wet and cold
* (5) Metabolic acidosis
* (6) Urine output less than 0.5ml/kg.h for more than 2 hours
* 2.2 Heart rate greater than or equal to 120 beats per minute at rest
* 2.3 Orthostatic hypotension (systolic blood pressure less than 80 mmHg after postural change)
* 2.4 Presence of arrhythmias leading to a drop in blood pressure (e.g., decreased blood pressure due to new-onset atrial fibrillation)
* 2.5 Difficulty breathing at rest or respiratory rate greater than 30 breaths per minute
* 2.6 Postoperative bleeding (200ml in 2-3 hours)
Mechanical Properties of Peripheral and Accessory Respiratory Muscles in Chronic Obstructive Pulmonary Disease Patients

The biomechanical properties of accessory respiratory muscles and peripheral muscles of COPD and healthy subjects will be measured and compared with the MyotonPro device.


Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with group C and D COPD according to GOLD staging
* Having been using the same medications for the last 4 weeks
* No additional comorbid diseases of the orthopedic, neurological or cardiac system

Exclusion Criteria:

* Presence of another respiratory system disease other than COPD
* Patients who have had an acute COPD exacerbation in the last 4 weeks
* Patients experiencing COPD exacerbations during the study protocol
* Presence of fatty tissue at the measurement points, which may impair the measurement quality.
* Have already participated in another clinical trial within the last 30 days that may affect the results of the study.

Inclusion Criteria for Healthy Cases

* Being over 18 years of age
* Not having any diagnosed chronic disease
* Not being a smoker