cyrilzakka/clinical-trials huggingface dataset:
Enhancing Exercise and Psychotherapy to Treat Pain and Addiction in Adults With an Opioid Use Disorder (EXPO; R33 Phase)

This work will involve conducting a randomized trial that will evaluate preliminary efficacy of "assisted" rate cycling, voluntary rate cycling and psychotherapy for pain individually and in combination as adjunctive treatments on cravings (primary outcome) in adults with an opioid use disorder. The investigators will also evaluate the effects of "assisted" rate cycling, voluntary rate cycling and I-STOP on secondary outcomes including depression, anxiety and sleep.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years old
* Must be enrolled in a residential/inpatient drug treatment program at a collaborating drug treatment center
* Must be diagnosed with an Opioid Use Disorder (OUD; ICD-10 F11.20) or a Poly-substance Drug Use that includes an opioid component (ICD-10,F19.xx)
* Must have self-reported pain or a pain condition describing a non-cancer related chronic pain disorder
* Must be approved to exercise in the study by the drug treatment center (Medical Director, physician or other relevant clinical staff or primary care physician (PCP))

Exclusion Criteria:

* Any substantive contraindications to exercise
* Psychiatrically unstable
* Pregnant women
* Non-English speaking adults
* Adults unable to provide informed written consent
Dose-comparison Study of Prednisone in Heart Failure

The purpose of this study is to examine the efficacy of three doses of prednisone, a glucocorticoid, in treatment of patients with symptomatic heart failure.

Heart failure is a leading cause of cardiovascular morbidity and mortality in the world. Most patients with acute symptomatic heart failure are admitted with fluid overload. Intravenous loop diuretics are an essential component of current treatment in such patients. Newly emerging evidence showed that glucocorticoids could potentiate natriuretic peptides' action by upregulating the expression natriuretic peptide receptor A (NPR-A) in the kidney, and produce a potent diuresis. Therefore, the investigators designed this nonblinded, randomized dose comparison study to compare the efficacy of prednisone at 15, 30 and 60 mg/day in patients with in symptomatic heart failure.

Eligibility Criteria:
Inclusion Criteria:

* hospitalized for symptomatic heart failure
* dyspnea at rest or with minimal activity
* NT-proBNP \> 1000pg/ml
* LVEF ≤ 40%

Exclusion Criteria:

* any condition (other than CHF) that could limit the use of prednisone;
* acute decompensated heart failure
* active myocarditis
* obstructive or restrictive cardiomyopathy
* cardiac surgery within previous 3 months
* acute coronary syndrome
CRT Versus Surgery for Retroperitoneal or Paraaortic Lymph Node Recurrence of CRC

The study aims to compare the effects of chemoradiation versus radical surgery in treating retro-peritoneal or para-aortic lymph node metastasis in colorectal cancer. By prolonging patients' progression-free survival, local control rate and overall survival, investigators can conclude the best regimen for colorectal cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* A medical history of colorectal cancer
* Pathological or clinical diagnosis of retroperitoneal/para-vascular lymph node metastases, and located below the level of renal veins.
* The treatment target is no evidence of disease (NED), including 3 cohorts:

A. Initial treatment (primary lesion + retroperitoneal LN oligometastasis); B. Postoperative retroperitoneal/paravascular LN oligometastase; C. Postoperative retroperitoneal/paravascular LN metastasis with other organ metastases (up to NED)

* ECOG PS 0-2
* Ability to follow the program during the study period
* Signing written informed consent

Exclusion Criteria:

* Retroperitoneal LN metastasis is above the level of the renal vein.
* Unable to reach NED.
* Previous pelvic radiotherapy, the field of irradiation overlaps with this time.
* Pregnancy or breastfeeding women.
* Those with other history of malignant disease in the last 5 years, except for cured skin cancer and cervical carcinoma in situ.
* If there is an uncontrolled history of epilepsy, central nervous system disease or mental disorder, the investigator may determine that the clinical severity may hinder the signing of informed consent or affect the patient's oral medication compliance.
* Clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe arrhythmia requiring medication intervention, Or a history of myocardial infarction in the last 12 months
* Organ transplantation requires immunosuppressive therapy
* Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases
* Subjects Blood routine and biochemical indicators do not meet the following criteria: hemoglobin ≥ 90g / L; absolute neutrophil count (ANC) ≥ 1.5 × 109 / L; platelets ≥ 100 × 109 / L; ALT, AST≤2.5 times normal upper limit; ALP≤2.5 times normal upper limit; serum total bilirubin \<1.5 times normal upper limit; serum creatinine \<1 times normal upper limit; serum albumin ≥30g/L
Strength, Aging, and Memory in Prostate Cancer

The objective of this study is to compare changes in neurocognitive function across a 12-month period between three groups: (1) men treated with androgen deprivation therapy (ADT) for prostate cancer (PCa); (2) men under active surveillance for PCa; and (3) men without a history of cancer.

Aim 1: This study will examine differences in neurocognitive function (cognitive performance, brain structural integrity) from baseline (within 30 days of ADT initiation or 90 days of diagnosis) to 6- and 12-month follow-up.

Aim 2: Examine group differences in components of frailty (e.g., lean mass, muscle strength, physical function, fatigue, physical activity) from baseline to 6- and 12-month follow-up.

Men will be recruited for this study if they are (1) recently diagnosed with PCa and scheduled to receive 6-months or more of ADT (ADT+ group, n=20), (2) recently diagnosed with PCa and under active surveillance (ADT- group, n=20), or (3) healthy men without a history of cancer (PCa- group, n=20). Eligible men (N=60) will be scheduled for two or three testing appointments at each testing timepoint. To assess Aim 1, participants will complete measures at baseline (M0), 6-month follow-up (M6), and 12-month follow-up (M12). Aim 1 measures include: neurocognitive tasks, functional magnetic resonance imaging (optional; n=10 ADT+ and n=10 ADT- only), and questionnaires. To assess Aim 2, outcomes indicated as components of frailty syndrome will be measured, including: dual-energy X-ray absorptiometry (e.g., appendicular lean mass), upper and lower body dynamometry, physical function and functional capacity, questionnaires (i.e., fatigue surveys), and physical activity monitoring (i.e., accelerometry). Findings from this study will build upon the scientific framework for the potential frailty pathway of cancer-associated cognitive decline in PCa patients in order to develop future evidence-based interventions to manage cognitive impairment in men diagnosed with PCa.

Eligibility Criteria:
Inclusion Criteria:

* Telephone Interview of Cognitive Status (TICS-M) performance above impaired range (≥21)

Group-specific criteria:

* First time, primary diagnosis of prostate cancer (ADT+ and ADT-)
* Diagnosed within past 30 days (ADT-)
* Scheduled to receive ≥ 6-months androgen deprivation therapy and have not received \>30 days of androgen deprivation therapy (ADT+)
* Men without a history of cancer who are within one year of age of ADT+ participants (PCa-)

Exclusion Criteria:

* Second cancer diagnosis (excluding non-invasive skin cancers)
* History of stroke, transient ischemic attack, neurological disorder, or brain surgery involving tissue removal
* Unable to walk without assistance
* Unwilling to complete study requirements
* Body weight greater than 300 pounds (DXA requirement)
* Moderate-intensity physical activity ≥ 150 minutes per week
* Upper and lower body strength training ≥ 2 days per week
* Unable to read in English
Beta-Blocker Continuation Versus Interruption in Heart Failure Worsening

The objective of the B-Convinced study is to demonstrate the non-inferiority of beta-blocker continuation compared to its interruption in patients with congestive heart failure who are treated by a beta-blocker and present with an episode of heart failure worsening with pulmonary oedema requiring hospital admission.

162 patients will be randomized in cardiology centers in France. Clinical status (primary endpoint) will be evaluated with a standardized questionnaire 3 days after hospital admission.

Therapeutic strategy of beta-blocker treatment during an episode of heart failure worsening remains unclear. The objective of the B-Convinced study is to demonstrate that continuation of beta-blocker treatment in case of hospitalisation for heart failure worsening is as safe as the interruption of such treatment.

Hypothesis: The proportion of patients clinically improving within 3 days is not inferior when beta-blocker treatment is maintained compared to beta-blocker interruption in case of hospitalisation for heart failure worsening with pulmonary oedema.

Design: Open, randomized non-inferiority trial on two parallel groups of patients. Randomization performed centrally with a vocal server.

Tested Hypothesis: 90% of success in the interruption group, power of 80%, non-inferiority limit of 15% (relative reduction). 162 patients are required with such a hypothesis.

Primary Endpoint: Clinical improvement within 3 days of hospital admission evaluated by the investigator by a standardized questionnaire.

Secondary Endpoints: Clinical improvement at day 8 or at hospital discharge, morbidity-mortality at 4 months.

34 participating centres in France.

Eligibility Criteria:
Inclusion Criteria:

* Patients with heart failure treated with beta-blocker; hospitalisation for heart failure worsening with pulmonary oedema.
* Left ventricular ejection fraction less than 40%

Exclusion Criteria:

* Indication of intravenous positive inotropic treatment
* Indication to withdraw beta-blocker treatment
Cerebral Hypoperfusion at Transcranial Color-Coded Doppler.

Background. Cerebral ischemia is a major secondary factor contributing to worsening outcomes in patients with acute brain injuries. Transcranial Color-Coded Doppler (TCCD) is a reliable method for evaluating cerebral perfusion and is recommended for use in emergency settings to reduce secondary injuries. However, there is no established treatment protocol for managing cerebral hypoperfusion as detected by TCCD.

Objective. The primary objective of this study is to assess the efficacy of individual steps in a standardized treatment protocol to normalize TCCD parameters in patients with cerebral hypoperfusion. The secondary objective is to investigate the concordance between invasive intracranial pressure (ICP) measurements and those estimated through TCCD using the Czosnyka formula.

Methods. This prospective multicenter observational study will enroll patients with acute brain injury admitted in emergency or intensive care settings. Inclusion criteria include age over 18, Glasgow Coma Scale \<9, and evidence of cerebral hypoperfusion based on TCCD performed on M1 tract of at least one middle cerebral artery. The hypoperfusion is defined as the concurrent presence of at least two of the following parameters: mean velocity below 30 cm/s, diastolic velocity below 20 cm/s, pulsatility index above 1.4.

Patients will undergo a stepwise treatment approach involving normocapnia verification, autoregulation testing increasing mean arterial pressure by 10 mmHg, and hyperosmolar therapy. The effectiveness of each intervention will be assessed by TCCD readings.

Endpoints. The primary endpoint is the percentage of patients who normalize cerebral perfusion parameters at each step of the protocol. The secondary endpoint is the concordance between invasive ICP measurements and those estimated through TCCD.

Sample Size. The study aims to recruit 100 patients over 24 months. Data analysis will include descriptive statistics, with significant results considered at p \< 0.05.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Patients with intraparenchymal cerebral hemorrhage, subarachnoid hemorrhage, head trauma, or hydrocephalus
* Glasgow Coma Scale belowe 9
* Need for invasive mechanical ventilation
* Arterial catheter for invasive blood pressure monitoring and blood sampling
* Presence of Doppler parameters of cerebral hypoperfusion (concurrent presence of two or more of the following conditions: PI \> 1.4, diastolic velocity \< 20 cm/s, and mean velocity \< 30 cm/s detected in at least one middle cerebral artery)

Exclusion Criteria:

* Absence of transtemporal windows bilaterally on TCCD
* Documented severe aortic valve insufficiency
* Heart rate less than 40 bpm
* Patients with suspected vasospasm on TCCD
Retrospective Evaluation of the Radiographic Efficacy of Conventional and Biologic Treatment

This study involves review and analysis of disease activity in patients with rheumatoid arthritis who where treated with either conventional DMARDs (Disease Modifying Antirheumatic Drugs) or Biologics and have two existing, consecutive radiographs (x-ray images) of hand and feet taken as part of routine treatment monitoring within a time interval of 12 to 36 months.


Eligibility Criteria:
Inclusion Criteria:

* Secure diagnosis of rheumatoid arthritis
* Older than 18 years
* Two consecutive plain radiographs of the hands and feet with a time interval of 12 to 36 months are available. The radiographs are recorded 2003 or later and are in accordance with a defined X-ray protocol.

Exclusion Criteria:

- Patients who receive Anakinra, Rituximab or Abatacept
International Research Consortium on Dengue Risk Assessment, Management, and Surveillance

Improvements in diagnosis of dengue fever and prediction of which patients will get more severe disease are urgently needed to improve the treatment of patients with dengue. This is very important in places with many people who suffer from dengue but have limited health care resources. This study will enroll patients with fever which may be caused by dengue in 6 countries with high incidence of dengue over two continents (Brazil, Cambodia, El Salvador, Indonesia, Malaysia and Vietnam). All patients will be followed by a doctor with blood tests and exams until they recover. Symptoms and laboratory tests will be followed so that the cause of fever can be determined. For patients who have dengue, the investigators will look for symptoms and tests which indicate more serious disease. This study will help to determine how to identify patients with dengue fever based on symptoms and simple laboratory tests and those who will get more serious disease. It will also help to define a more standardized management of patients with dengue fever.

Improvements in clinical diagnosis of dengue and risk prediction for severe disease are urgently needed to improve overall clinical care, especially in settings with a high case burden where appropriate allocation of limited resources is crucial to outcome. In this work package 10,000 outpatients with undifferentiated fever, consistent with possible dengue, will be recruited within 3 days of fever onset in 6 endemic countries (Brazil, Cambodia, El Salvador, Indonesia, Malaysia and Vietnam), and will be followed daily until full recovery. Clinical features and simple laboratory parameters differentiating dengue from other febrile illness will be identified, and, among those with confirmed dengue, risk factors for progression to more severe disease will be evaluated. As well as contributing to the development of diagnostic and prognostic algorithms the clinical cohort has considerable potential towards standardisation of procedures for dengue management and reporting.

Eligibility Criteria:
Inclusion Criteria:

* \>= 5 years of age
* fever for less than 72 hours

Exclusion Criteria:

* presence of localizing signs suggestive of another diagnosis
* not likely to come back for daily follow-up
* complications or signs of severe disease
Effect of Saccharomyces Boulardii on Necrotizing Enterocolitis in Very Low Birth Weight Infants

Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Necrotizing enterocolitis incidence is 10-25% in newborn infants whose birth weights are \< 1500 gr. Although bifidobacterium and lactobacilli sp. have been used to reduce the incidence of NEC in clinical trials, Saccharomyces boulardii has not been used in the prevention of NEC in very low birth weight infants yet. The objective of this study is to evaluate the efficacy of orally administered S boulardii in reducing the incidence and severity of NEC in very low birth weight infants.

The primary outcome of this study is to evaluate the efficacy of orally administered S boulardii in reducing the incidence and severity of NEC in very low birth weight infants.

Eligibility Criteria:
Inclusion Criteria:

* Very low birth weight infants \< 1500 gr

Exclusion Criteria:

* Genetic anomalies
* Not willing to participate
* Allergy to S. boulardii components
Non-surgical Treatment of Peri-implant Mucositis

This a Randomized Controlled Clinical Trial comparing two techniques for the nonsurgical treatment of peri-implant mucositis. The main objective of the present randomized controlled clinical trial is to determine whether the application of a novel treatment strategy for peri-implant mucositis could lead to significantly improved clinical parameters as compared to standard treatment. Half of the patients receives treatment with manual instruments and chlorhexidine gel 1%, half receives treatment with submucosal biofilm removal by erythritol powder.


Eligibility Criteria:
Inclusion Criteria:

* Subjects should have at least one implant (Renvert et al. 2009),
* with bleeding on probing using a 0.2N probing force or spontaneous bleeding with local swelling (code 1, 2 or 3 as described in Corbella et al. 2011) and with bone resorption of no more of 1 mm (preferably no bone loss visible on radiographs) as evaluated through the use of standardized radiographs, taken with the use of an individualized radiograph holder in comparison with findings from radiographs taken immediately following placement of the implant prosthesis (similar to Renvert et al. 2009 and Algraffee et al. 2011).
* females and males 35 to 65 years old; (IV) full mouth bleeding score % lower than 20%.

Exclusion Criteria:

* systemic diseases that could affect the immune response or that could condition the bacterial colonization
* use of anti-inflammatory prescription medications, or antibiotics within the preceding respectively 1 week and 3 months or during the study,
* full-mouth plaque score (FMPS) \>20%;
* full-mouth bleeding score (FMBS) \>20%,
* smokers of more than 5 cigarettes a day,
* Documented allergy or intolerance towards the components of the products used in the study,
* Presence of active infection with suppuration.
* Absence of periodontitis in the rest of the mouth
* Pregnancy (certified by auto-declaration)
* Patients suffering from upper respiratory tract infections, from chronic bronchitis
* endocarditis, breast feeding, contagious disease, immune deficiency (neutropenia, angranulocytosis, diabetes, hemophilia), patients under treatment (radiotherapy, chemotherapy, antibiotics).
Cardiac Autonomic Function For Risk Stratification in the Emergency Room

The aim of the study is to test the hypothesis that impaired cardiac autonomic function predicts adverse outcome in unselected patients presenting in the emergency ward.


Eligibility Criteria:
Inclusion Criteria:

- presenting at the emergency department of the University Hospital of Tübingen
Effect of Functional Training and Isometric Exercises on Pain, ROM, and Functional Status in Patients With Neck Pain

Work-related musculoskeletal disorders have been rising fast around the globe leading to neck pain and scapular muscle dysfunction, contributing to a decrease in neck movements and functional limitations. This study aimed to determine the efficacy of scapular functional exercise (SFE) in combination with cervical isometric exercises (CIE) on neck pain, cervical range of motion, and functional limitations among participants with chronic mechanical neck pain.The study was based on a two-arm parallel group pretest-posttest randomized control trial design. Thirty participants (females 21 and males 9; average age 28.94±3.77 years) were randomly allocated to groups A and B (n=15/group). The group's A and B participants received a common intervention, such as CIE and hot packs. However, group A received the SFE in addition to common interventions. The outcomes, such as neck pain, cervical ROM, and functional limitations, were evaluated using a numeric pain rating scale (NPRS), standard universal goniometer, and neck disability index questionnaire at baseline and 4-week post-intervention. The paired and unpaired t-test was used to analyze the intervention effects on the outcomes within-group and between-group, keeping the significance level alpha set at p\<0.05.

The study hypothesised that adding the scapular functional training to the cervical isometric exercises will be equally effective than cervical isometric exercises alone on managing neck pain, cervical ROM, and functional limitations among participants with chronic mechanical neck pain. The present study is helpful for chronic mechanical neck pain patients and physiotherapist to better understand the effect of incorporation of the scapular functional training in the treatment of neck pain. Therefore, this protocol may be used as a treatment in chronic mechanical neck pain because it alleviates pain, neck disability, improving cervical range of motion in chronic mechanical neck pain.

Eligibility Criteria:
Inclusion Criteria:

* Both male and female with aged range 22-35 years
* Neck pain of more than 3 months in duration
* Having neck pain without symptoms distal to shoulder
* Participant had not received any clinical treatment for their neck pain within 1-months, and
* Willingness to participate in the study.

Exclusion Criteria:

* Having a diagnosis of cervical spinal stenosis
* Patients with serious pathology (e.g., neoplasm, fractures and inflammatory diseases, unilateral and bilateral upper extremity radicular symptoms (cervical radiculopathy)
* Prior surgery of cervical spine
* Evidence of nerve root compression
* Pregnant women, and
* Showed poor cooperation in the study
Post Marketing Surveillance And Special Surveillance for Mirapex® Tablet in Patients With Idiopathic Parkinson's Disease

The objectives of this study are to investigate issues or questions about MIRAPEX Tablets as shown below through the Post Marketing Surveillance (PMS) study upon approval.

* Unexpected adverse events (especially, serious adverse events (SAEs))
* To find out the status of incidence of adverse events under actual practice
* Factors on the safety profile
* Factors on the efficacy profile


Eligibility Criteria:
Inclusion Criteria:

* Among the patients with idiopathic Parkinson's disease, from those receiving MIRAPEX Tablets first after a contract of the study to the requested number of cases will be consecutively enrolled without skipping

Exclusion Criteria:

* Following patients are contraindicated.

  1. Patients who are hypersensitive to MIRAPEX or its ingredients
  2. Refer to the insert paper for other contraindication.
* Following patients should be carefully administered.

  1. Patient with renal impairment
  2. Refer to the insert paper for other precaution.