cyrilzakka/clinical-trials huggingface dataset:
Theophylline for Low Adenosine Syncope

The study aims at assessing that theophylline is effective in patients with no prodromes, normal heart and with low values of plasmatic adenosine compared with a propensity-score matched untreated control population who have received an implantable cardiac monitor (ICM) for diagnosis of unexplained or atypical reflex syncope.

Theophylline has been used for 3 decades in ordinary medical practice to tentatively prevent syncopal recurrences in patients affected by neurally-mediated syncope. Observational studies report a recurrence rate with this drug ranging between 12% and 22%. Theophylline was much more effective in selected patients with syncope without prodromes and normal heart who had ECG documentation of long pauses at the time of syncopal attack and low values of baseline plasmatic adenosine. Since theophylline is a non-selective antagonist of purinergic receptors, it has been hypothesized that purinergic receptors are involved in the mechanism of syncope in such patients. Conversely, theophylline was suspected to be ineffective (or less effective) in patients affected by other forms of neurally-mediated syncope.

The present study aims at assessing that theophylline is effective in patients with no prodromes, normal heart and with low values of plasmatic adenosine compared with a propensity-score matched untreated control population.

This will be a multicenter, non interventional study, verified by ICM, with 2 predefined subgroups:

Subgroup #1

* Low adenosine group: Patients with Low Adenosine values (\<0.40 μmol/L)
* Normal/high adenosine (≥0.40 μmol/L) group: any other patient Subgroup #2
* Patients with no prodromes or very short prodromes (≤5 sec), normal heart and normal ECG (No prodrome group)
* Any other form of atypical neurally-mediated syncope with prodromes \>5 sec. Remote or in-hospital periodic follow-up will be done according to centre's clinical practice for ICM monitoring.

Patients will be followed up until the first primary endpoint event with a maximum follow-up of 24 months since start of theophylline treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female gender with age \>18 years
2. Unexplained syncope without prodrome or neurally-mediated syncope with atypical prodrome, with normal heart and normal ECG
3. Two syncopes /last year or 3 syncopes /last 2 years before start of theophylline treatment
4. Having received an ICM according to conventional guideline-based indications
5. Being treated with oral theophylline therapy, while been waiting for ICM diagnosis
6. Having signed a written informed consent to the study participation and to the treatment of personal data

Exclusion Criteria:

1. Typical vaso-vagal syncope with long prodromes and situational syncope
2. Any other form of syncope/T-LOC different from reflex syncope
3. Pregnant or breast-feeding patients -
Vıdeo-Assısted Stoma Care Traınıng Gıven To Patıents Wıth Stoma Adaptıng To Stoma and Complıcatıons

Objective: The aim of this study is to evaluate the effects of video-assisted stoma care training given to patients with stoma on postoperative anxiety, stoma compliance and complications.

Materials and Methods: This study was conducted as a double-blind randomized controlled interventional study within the scope of a doctoral thesis between January 2021 and September 2022 at the General Surgery Clinics of Aydın Atatürk State Hospital, Aydın State Hospital and Aydın Adnan Menderes University Practice and Research Hospital with 42 patients, 21 in the intervention group (who received video-assisted stoma care training in the postoperative period) and 21 in the control group, who met the sampling criteria. In the postoperative period, patients in the intervention group were given video-assisted stoma care training, while patients in the control group were given training using plain narration and demonstration methods. During the research process, patients were visited at 3 different time periods to determine the patients' anxiety levels, evaluate their compliance with the stoma and complications, and the patient follow-up was concluded.


Eligibility Criteria:
Inclusion Criteria:

* Having a stoma
* Being over 18 years old
* Having no complications from the stoma

Exclusion Criteria:

* Having developed any complications in the stoma
Study of Metabolic Homeostasis in Chinese

In this open-label, acute intervention study, we will recruit 120 sex-matched participants aged 20-70 years (100 normal or overweight/obese subjects and 20 Mets subjects). They will be assigned to one of the six groups according to age, BMI and with and without MetS and have a standardized mixed macronutrient tolerance test (MMTT) by orally administered a 400-ml beverage (75g glucose, 60g lipid, and 20g protein). Fasting and postprandial blood, and urine and fecal samples will be collected. The primary aim is to establish a more comprehensive system to quantify different aspects of metabolic health based on fasting and postprandial data. The study protocol has been approved by the Ethics Committee of Shanghai Institutes for Biological Sciences.

The recruited 120 subjects (60 men and 60 women aged 20-70 years) will be recruited according to the followings: 1) individuals aged 20-29 years with normal weight (18.5 kg/m2 ≤ BMI \< 24 kg/m2); 2) individuals aged 30-49 years with normal weight; 3) individuals aged 30-49 years with overweight/obesity (BMI ≥ 24 kg/m2); 4) individuals aged 50-70 years with normal weight; 5) individuals aged 50-70 years with overweight/obesity; and 6) individuals aged 30-70 years with MetS. A standard questionnaire will be use to collect Information like lifestyle factors, nighttime sleep duration; anthropometric measurements will be performed. Blood samples will be collected via a catheter at fasting state (t = 0 min) and 5 successive time points post-MMTT (t = 30, 60, 120, 180 and 240 min). At t = 0 ,1 and 2 h, the fingertip blood will be collected as well. Body composition will be measured by dual energy x-ray absorptiometry (DXA). All these samples will be used to the assessment of blood chemistry, metabolomics, single nucleotide polymorphism (SNP), gut microbiota etc.

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects: age 20-70 BMI ≥ 18.5 kg/m2
* Mets subjects:

age 30-70 BMI ≥ 18.5 kg/m2 and at least meet three of the following criterions(NCEP-ATPIII, for Asian Americans)

1. Waist circumference ≥ 90 cm (men), ≥ 80 cm (women).
2. Total triglyceride ≥ 1.7 mmol/L.
3. HDL-c \<1.03 mmol/L in men, \<1.3 mmol/L in women.
4. Systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg.
5. Fasting plasma glucose ≥ 5.6 mmol/L.

Exclusion Criteria:

1. clinically diagnosed diabetes or use of anti-diabetic medications;
2. clinically diagnosed cardiovascular, kidney, liver, pituitary, alimentary tract, and thyroid diseases, cancer(s), or mental illnesses;
3. pregnancy or lactation;
4. having gastrointestinal surgery within 1 year, excepting appendicitis or hernia;
5. current use of antidepressant(s);
6. alcohol consumption \> 40 g/d or other substance abuse;
7. severe diarrhea (watery stools ≥ 3 times/day ≥ 3 days or longer) in previous 3 months;
8. participating any other studies within previous 3 months.
ALA-induced PpIX Fluorescence During Brain Tumor Resection

Removing a tumor from a patients brain is hard to do because, very often, brain tumors do not have boundaries that are easy for the patients surgeon to find. In many cases, the surgeon can't tell exactly where the tumor begins or ends. The surgeon usually can remove most of the patient's tumor by looking at the MRI images that were taken of the patient's brain before surgery. However, the surgeon does not have any good way to tell if the entire tumor has been removed or not. Removing the entire tumor is very important because leaving tumor behind may allow it to grow back which could decrease the chances of survival.


Eligibility Criteria:
Inclusion Criteria:

* Preoperative diagnosis of either presumed first-time low or high grade glioma, or recurrent glioma, or metastasis, or meningioma
* Tumor judged to be suitable for open cranial resection based on preoperative imaging studies.
* Patient or LAR able to provide written informed consent.
* No serious associated psychiatric illnesses.
* Age \> 21 years old.

Exclusion Criteria:

* Pregnant women or women who are breast feeding
* History of cutaneous photosensitivity, porphyria, hypersensitivity to porphyrins, photodermatosis, exfoliative dermatitis.
* History of liver disease within the last 12 months.
* Elevated liver function levels greater than 2.5 times the normal limit from laboratory tests conducted within 30 days prior to surgery.
* Inability to comply with the photosensitivity precautions associated with the study.
* Plasma creatinine in excess of 180umol/L within 30 days prior to surgery
Exercise Training to Improve PTSD Symptoms and Health in Older Veterans

Posttraumatic stress disorder (PTSD) is prevalent among military Veterans and is more than just a psychological condition; PTSD has profound negative impacts on health, function, and quality of life. Older Veterans are the largest patient population served by the Veterans Health Administration (VHA), and many have lived with PTSD for 40+ years. Veterans with PTSD engage in low levels of physical activity and spend much of their time in sedentary activities, adding to their risk of physical disability. The benefits of exercise on mental health and physical well-being in older adults are well-substantiated, but the effects of exercise training on late-life PTSD symptoms is a new area of study. This study is designed to examine the effects of 6 months of supervised exercise training on PTSD symptoms and PTSD-related conditions (e.g., functional impairment, sleep) in 188 older Veterans with PTSD.


Eligibility Criteria:
Inclusion Criteria:

* Veteran status
* registered for care at Durham VA Health Care System (VAHCS)
* live within 50 miles of fitness facility
* meet diagnostic criteria for PTSD as assessed by the CAPS-5

Exclusion Criteria:

* history of any psychiatric disorder with severe psychotic features in the past 5 years (e.g., bipolar disorder, mania), as indicated by ICD-10 codes F20-F29 (ICD-9 category 298.9)
* prominent suicidal ideation or hospitalization for suicidality in the previous 6 months
* clinically significant: neurological disorder, systemic illness affecting central nervous system (CNS) function, or history of seizure disorder in the past 5 years
* uncontrolled diabetes defined as:

  * Abnormal fasting plasma glucose 126 mg/dL, random plasma glucose 200 mg/dL
  * no active medications for diabetes management (Metformin, insulin, etc.)
  * no clinical notes in the patient's electronic health record (EHR) indicating monitoring by primary care physician (PCP) or Endo for diabetes management)
  * end stage liver disease or currently receiving dialysis
  * physical disabilities precluding use of exercise equipment (assistive mobility devices acceptable)
  * significant cognitive impairment or diagnosis of Alzheimer's Disease or Dementia
  * hospitalization or ER visit in the past 6 months for conditions contraindicated for exercise (cardiac event; physical trauma)
Ascension PyroCarbon Radial Head Study

The proportion of patient successes with the Carbon Modular Radial Head at the 2-year evaluation is no lower than the proportion of patient successes with the Metal Radial Head.

This investigation will include 179 patients (119 study devices and 60 control devices) enrolled at 15 active centers. In addition a subset of 24 RA patients will be enrolled and analyzed separately. The trial is designed as a randomized, non-inferiority study comparing results of the CMRH to results of the MRH.

This will be a multi-site study with all patients either receiving the CMRH or the MRH. Sequential enrollment of all patients meeting inclusion criteria and agreeing to be in the study will be enrolled. The patients will sign an informed consent agreeing to accept either the investigational or control device. In addition, the surgeon will not know which device the patient is to receive until the day of surgery in an attempt to further reduce bias. The surgeon will open an envelope at the time of surgery to determine if a CMRH or MRH will be implanted.

Additional efforts to eliminate bias in the study will include a final radiographic analysis by an independent observer experienced in reporting on orthopedic devices. The independent reviewer will grade the surgical implant and determine radiographic success/failure for each patient.

Implants will be assigned to patients at the clinical sites in a block randomization fashion. The randomization will be site specific. At a given site, each consecutive block of six enrolled patients to be treated will receive random assignments of CMRH or MRH at a 2:1. The randomization schedule is generated by computer (NQuery) and is produced in blocks of 6, where 4 are study devices and 2 are control devices.

Eligibility Criteria:
Inclusion Criteria:

* Patients must need a radial head replacement for:

  * Degenerative, post-traumatic or rheumatoid arthritis
  * Primary replacement after fracture of the radial head
  * Relief of symptoms after radial head resection
  * Revision of failed radial head arthroplasty
  * Skeletally mature individuals ages 18 - 85

Exclusion Criteria:

* Inadequate bone stock or soft tissue coverage
* Previous open fracture or infection in the joint
* Individuals under age of 18 or over 85 years of age
* Physical interference with or by other prostheses during implantation or use
* Procedures requiring modification of the prosthesis
* Skin, bone, circulatory and/or neurological deficiency at the implantation site
* Prisoners
* Patients on chronic corticosteroid or non-steroidal anti-inflammatory therapy
Cryobiopsy vs. VATS in Diagnosis of Interstitial Lung Diseases

The purpose of this study is to assess efficiency and safety of cryobiopsy compared to video-assisted thoracoscopic lung biopsy (VATS) in diagnosis of interstitial lung diseases (ILD). To that end, this non-interventional study prospectively collects data from patients undergoing routine diagnosis of ILD. In some of those patients less invasive diagnostic approaches do not yield a definitive diagnosis. Thus, they will ultimately be subjected to VATS if this procedure is reasonable. The information gained by this study will help to assess the significance of cryobiopsy in contrast to VATS in this particular disease group.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Known or newly diagnosed interstitial lung disease (ILD)
* Indication for lung biopsy for definitive ILD diagnosis
* Informed Consent provided

Exclusion Criteria:

* Age \< 18 years
* Inability or contraindication to undergo any form of invasive diagnostic procedure associated with diagnosis of interstitial lung disease
* Severely restricted CO diffusion capacity (\<50%)
* Pregnancy, lactation
* Any medical, psychological or other condition restricting the patient's ability to provide informed consent
* Participation in another clinical trial
Effects of a Mat Pilates Exercise Program on Elderly Women With Chronic Nonspecific Low Back Pain

The technique of Pilates exercises on a mat has proven to be effective and practically applicable to patients with chronic back pain. However, its application in women over 65 years has not been adequately studied.

Objective: This assessor-blind randomized clinical trial aims to study the effect of a mat Pilates exercise program on pain and functional ability of elderly women with chronic nonspecific low back pain.

Methods: 60 elderly women with chronic nonspecific low back pain (duration of symptoms more than 12 weeks) are expected to participate in this study. Participants will be divided into two groups of 30 people each; one being intervention and one control. The intervention group will follow a custom mat Pilates program (twice per week) for 10 weeks, while the control group will not follow any treatment. Pain, functionality, balance, the number of painkillers administered, and adherence to exercise will be assessed at the beginning and end of the study and will be re-examined six months later.

The technique of Pilates exercises on a mat has proven to be effective and practically applicable to patients with chronic back pain. However, its application in women over 65 years has not been adequately studied.

Objective: This assessor-blind randomized clinical trial aims to study the effect of a mat Pilates exercise program on pain and functional ability of elderly women with chronic nonspecific low back pain.

Methods: 60 non-active elderly women with chronic nonspecific low back pain (duration of symptoms more than 12 weeks) are expected to participate in this study. Participants will be divided into two groups of 30 people each; one being intervention and one control. The intervention group will follow a custom mat Pilates program (twice per week), while the control group will not follow any treatment. Primary outcomes will include pain with the visual analog scale for pain and functionality with the Roland-Morris Questionnaire (RMQ). Secondary outcomes will include the balance with the Berg balance scale and the Timed Up and Go test, the number of painkillers administered, and the adherence to the exercise that will be evaluated at the beginning and at the end of the study and re-evaluated six months after the end of the intervention. The treatment period will be 10 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Symptoms of chronic back pain lasting more than 12 weeks
* Score on the Visual Analog Scale for pain less than 70mm
* Timed Up and Go test score less than 15sec

Exclusion Criteria:

* Low back pain due to a serious pathology that refers to a red flag such as malignancy, vertebral fracture, osteomyelitis, rheumatoid arthritis, Cauda Equina Syndrome (CES)
* Participation in another exercise program in the last six months
* Diagnosed with neurodegenerative disease (e.g., Parkinson's disease)
* Recent stroke
* Senile dementia
Induction Chemotherapy With Gemcitabine and Cisplatin Followed by CCRT for Unresectable Pancreatic Carcinoma

This phase II trial chose the induction chemotherapy with gemcitabine and cisplatin followed by Chemoradiotherapy (CRT) with gemcitabine to optimize the treatment for pancreas cancer patients with locally advanced disease and the purpose of this trial is to evaluate the efficacy of induction CT with gemcitabine and cisplatin followed by CRT for unresectable pancreatic carcinoma.

The primary endpoint is feasibility and compliance of induction chemotherapy with gemcitabine and cisplatin followed by CRT for locally advanced unresectable pancreatic cancer. Previous studies showed that approximately 20% of patients with locally advanced disease developed the early distant metastasis.\[6, 7\] Thus, it will be expected that at least 80% of total patients will be eligible for induction chemotherapy after completion of induction chemotherapy. An experimental arm that result a compliance of 80% would merit further study. If the true compliance rate of the patients who will eligible for CRT is ≤ 60%, null hypothesis will be rejected with a power of 80% and a type I error of 5%. Thus, the required number of evaluable patients is 24. Considering the 10% follow-up loss and 20% distant metastasis rate after induction chemotherapy, a total of 34 eligible patients will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed adenocarcinoma of the pancreas
* Unresectable locally advanced disease base on institutional standard criteria of unresectability disease following radical surgery. There is no evidence of metastatic disease in the major viscera and no peritoneal seeding
* Patients with biliary or gastroduodenal obstruction must have drainage prior to starting chemoradiation
* All malignant disease must be encompassable within a single irradiation field (15x15cm maximum)
* All patients must have radiographically assessable disease
* No previous irradiation to the planned field
* Age of ≥ 18 years
* performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) score
* Required Entry Laboratory Parameters WBC count ≥ 1,000/mm3; hemoglobin level ≥ 7.5 g/dL; platelet count ≥ 100,000/mm3; total bilirubin ≤ 3.0 mg/dL (Patients with elevated bilirubin due to obstruction should be stented and their bilirubin should be decrease ≤ 3.0 mg/dL prior to study entry); creatinine ≤ 3.0 mg/dL
* Oral intake (including J-tube feeding) of ≥ 1,500 calories/day should be maintained.
* Signed informed consent form prior to study entry

Exclusion Criteria:

* There is evidence of metastasis in the major viscera or peritoneal seeding.
* Age of \< 18 years
* Previous history of RT adjacent to planned field
* Poor performance status of 2 to 4 on the Eastern Cooperative Oncology Group (ECOG) score
* Pregnant or breast feeding status
* Previous history of uncontrolled other malignancies within 2 years
National Registry of Adult Heart Failure Patients With Complex Congenital Heart Disease: Systemic Right Ventricle and Single Ventricle Treated With Sacubitril/Valsartan

Heart failure in adults with congenital heart disease is a major cause of morbidity and mortality. Patients with systemic right ventricle (SRV) and single ventricle (SV) are particularly at risk1, 2, 3.

There are no specific recommendations for the management of heart failure in adults with congenital heart disease, whose management is based on "general cardiology" recommendations4,5.

Sacubitril/Valsartan is validated as a treatment for heart failure in adults with acquired pathological left ventricular dysfunction (left ventricular ejection fraction (LVEF) \< 40%, New York Heart Association (NYHA) functional class II and III despite optimal heart failure therapy)7. Although this molecule is used in current practice in patients with congenital heart disease, published data are limited 6-10.

The aim of our work is to describe the efficacy and tolerability of Sacubitril/Valsartan in the treatment of chronic heart failure on VDS and VU through an observational, prospective, multicenter registry.

The latest heart failure treatment guidelines, updated in 202111, recommend the addition of type 2 sodium-glucose co-transport inhibitors in heart failure patients with impaired ejection fraction (class IA recommendation). Two molecules are used in current practice: dapagliflozin and empagliflozin, at a single dosage of 10 mg/day.

We will also be collecting data on the efficacy and safety of iSGLT2. It should be noted that, for practical reasons, there may be a delay between the end of the 1st study period (ISACC1) of one year and the start of the 2nd study period (ISACC2).

Follow-up examinations carried out during the study period will not differ from those currently recommended in current practice5.


Eligibility Criteria:
Inclusion Criteria:

* - Patients ≥ 18 years of age
* Congenital heart disease with systemic right ventricle (D-TGV after atrial switch (Mustard or Senning surgery) or double mismatch), single ventricle of right or left morphology
* Systemic ventricular ejection fraction ≤ 40% (on cardiac magnetic resonance imaging (MRI) less than 12 months old).

In case of contraindication to MRI, LVEF ≤ 40% if systemic left ventricle or surface shortening fraction ≤ 35% if VDS12 (examination less than 12 months old).

* NYHA II or III
* On optimal heart failure therapy: ACE inhibitor or ARB2 for ≥ 4 weeks, at maximum tolerated dose. Whether or not combined with beta-blockers and maximum-tolerated-dose mineralocorticoid receptor antagonists.
* Cardiopulmonary exercise test (CPET) within the last 12 months

Exclusion Criteria:

* - Other congenital heart disease
* Inability to perform CPETH
* Immuno-allergic reaction, history of angioedema on ACE inhibitors or ARB2 inhibitors
* Symptomatic arterial hypotension or BPs \< 100 mHg
* Renal insufficiency (GFR \<30 mL/min/m²), hyperkalemia \> 5.4 mmol/l, severe hepatic insufficiency (Child-Pugh Class C)
* Pregnancy or breast-feeding
* Opposition to use of patient data
* Type 1 diabetes if on iSGLT2