cyrilzakka/clinical-trials huggingface dataset:
Blood Flow Restriction With Aerobic Exercise in Frail Older Adults

Background:Frailty is most often defined as a syndrome of physiological decline in late life, characterized by marked vulnerability to adverse health outcomes. Exercise intervention including aerobic exercise training has been proven to be effective in improving aerobic capacity and frail condition in elderly. Recently a novel training method using blood flow restriction (BFR) combined with aerobic exercise has shown positive effects on muscles strength and physical function in healthy elderly. This training method only required lower exercise intensity compared with traditional aerobic exercise to observe improvement. However, it is still unclear whether aerobic exercise training combined with BFR could also improve aerobic capacity and physical function in frail older adults. Therefore, the aim of this study will be to investigate the effect of aerobic exercise combined with BFR on cardiopulmonary function and functional activities in frail older adults.

Method: This study will be an assessor-blind randomized controlled trial.Participants aged over 65 years old with more than one item positive of Fried frailty phenotype assessment results will be recruited from the hospital and nearby communities. The participants will be randomly assigned to one of two training groups, aerobic exercise with BFR and only aerobic exercise. The exercise will be executed 30 minutes/session, three sessions/week for six weeks. Cardiopulmonary function and performance of functional activities will be assessed at pre-training, 3 weeks after training, post-training, and 3- and 6-week follow-up.


Eligibility Criteria:
Inclusion Criteria:

* more than one positive item of Fried frailty phenotype assessment
* able to walk more than 8 meters independently
* can understand and follow more than three-step order

Exclusion Criteria:

* severe hypertension (\>160/100 mmHg)
* cardiovascular disease, such as myocardial infarction, New York Heart Association class III or IV heart failure, pulmonary hypertension
* deep vein thrombosis or peripheral vascular disease
* peripheral neuropathy due to diabetes
* neuromuscular diseases, such as stroke, Parkinson's disease, etc.
Pancreatic Metal Stents in Chronic Pancreatitis

The purpose of this study is to document the performance of a new Fully Covered Self Expanding Metal Stents (FCSEMS) for treatment of refractory pancreatic duct strictures in patients with painful chronic pancreatitis.

This study is a prospective, single arm, pre-approval study. Treatment of 10 patients will take place at 1-3 clinical centers in two phases. Phase 1 will include treatment of five patients with a three month stent indwell period at one clinical center. Phase 2 will include treatment of five additional patients with a 3-6 month stent indwell period at 1-3 clinical centers. Expected duration of participation for each patient is approximately 27 months for Phase 1 and approximately 27-30 months for Phase 2. All patients, regardless of phase, will be followed for 24 months after stent removal. Post-removal follow-up visits will occur at 1, 3, 6, 12, 18 and 24 months.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older
2. Willing and able to comply with study procedures and follow-up schedule and provide written informed consent to participate in study
3. Chronic pancreatitis of Cremer Type IV (Segmental pancreatitis of the head of the pancreas). See Appendix for Cremer classifications.
4. Improvement of pancreatic pain during previous placement of a single pancreatic plastic stent
5. At least one of the following:

   * Abdominal pain most probably related to chronic pancreatitis
   * Recurrent dominant main pancreatic duct stricture in the head of the pancreas after prior indwell of pancreatic plastic stent(s) if pain score was available prior to preceding stent therapy. Recurrent stricture to be visually assessed at endoscopy and confirmed by recurrent main pancreatic duct dilatation at MRCP.
   * Relapsing pain due to pancreatic duct stent blockage (with only one stent in place)
6. Prior endoscopic pancreatic sphincterotomy (EPS), historically or to be provided at time of SEMS placement with informed patient consent.

Exclusion Criteria:

1. Strictures caused by malignancies
2. Biliary strictures caused by chronic pancreatitis
3. Perforated duct.
4. Ansa pancreatica or H anatomy
5. Pancreatic duct stenoses not located in the head of the pancreas
6. Failed access during an attempted ERCP on a prior date
7. Prior pancreatic metal stent(s)
8. Concurrent ESWL (Extracorporeal Shock Wave Lithotripsy) during the same treatment session
9. Patients for whom endoscopic techniques are contraindicated.
10. Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor
11. Inability or refusal to comply with the follow-up schedule including subject living at such a distance from the investigational center that
Multicenter Comparison of Early and Late Vascular Responses to Everolimus-eluting Cobalt-CHromium Stent

To treat patients with stable coronary artery disease, elective percutaneous coronary intervention (PCI) will be performed with the use of an everolimus-eluting cobalt- chromium stent (everolimus-eluting stent: EES, Xience Prime, Xpedition), which is the current standard drug-eluting stent (DES). Vascular responses at the site of stent placement will be evaluated by optical coherence tomography (OCT) at 1 or 3 months and at 12 months after stent placement, along with observation of changes over time in the target vessel. The relationships between OCT findings and the time course of platelet aggregation and between OCT findings and the occurrence of major cardio- cerebrovascular events will also be elucidated.


Eligibility Criteria:
Inclusion Criteria:

* Patients having at least one de novo lesion in a coronary artery in whom PCI with a DES is indicated
* Patients aged 20 to less than 85 years at the time of informed consent
* Patients who have provided informed consent written by themselves
* Patients who are able to undergo OCT examinations of the site of stent placement at 1 or 3 months and at 12 months

Exclusion Criteria:

* If it is judged difficult to perform clinical and angiographic follow-up at 12 months (considering the patient's remote place of residence, etc.)
* Patients with acute myocardial infarction (AMI)
* Patients in a state of shock
* Patients with cardiac failure
* Patients having a culprit lesion in the left main coronary artery trunk
* Patients having a lesion with a reference vessel diameter of less than 2.0 mm or 4.5 mm or larger by visual estimate
* Patients having an in-stent restenosis lesion as the culprit lesion
* Patients having chronic renal failure with a serum creatinine level of 2.0 mg/dL or higher at a screening visit
* Patients on hemodialysis
* Cancer patients with a life expectancy of less than 2 years
* Patients who are scheduled to undergo elective surgery requiring discontinuation of antiplatelet therapy within the next 3 months
* Pregnant women or women expected to become pregnant
* Patients with a history of adverse reactions to aspirin or clopidogrel (however, it is acceptable to enroll patients in whom the safety of ticlopidine has been confirmed, even if they have a history of adverse reactions to clopidogrel)
Evolutionary Systems Therapy for Personality Pathology

Evolutionary Systems Therapy is a new form of therapy that has been previously tested in a randomized controlled trial and in a few cases of patients diagnosed with Cluster A personality disorders. The objective of the present study is to investigate the feasibility and preliminary efficacy of Evolutionary Systems Therapy in all forms of personality disorders. The study includes three project actions: (i) a case series on adolescents with personality disorders; (ii) a case series on young adults with personality disorders; (iii) an ecological momentary assessment study to confirm the conceptualization model on all the patients.

To explore the feasibility and preliminary efficacy of Evolutionary Systems Therapy, the present study includes three actions. In the first action investigators enroll 6 adolescents (16-19 years) with personality disorders, in the second 15 young adults (20-25 years) with personality disorders. All participants receive 6 months of psychotherapy. The two subsamples of patients (adolescents and young adults) are assessed based on the conceptualization model of Evolutionary Systems Therapy which envisages three macro-organizations of personality (consistently with dimensional and hierarchical models such as Hierarchical Taxonomy of Psychopathology): internalizing, externalizing, schizotypal. Investigators plan to recruit patients until the size of the sub-samples is reached (15 young adults divided into 3 groups of 5 patients, each for each of the three interpersonal patterns; 6 adolescents divided into 3 groups of 2 patients, each for each of the three patterns interpersonal). In the third action, an ecological momentary assessment study will investigate the consistency over time between the conceptualization model and the experiences of the young adult patients enrolled: investigators will explore whether the hypothesized conceptualization will be confirmed by collected data on the patients' interpersonal styles.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with personality pathology in accordance with Structured Clinical Interview for DSM-5 - Alternative Model of Personality Disorders Module I
* Being capable of read and sign the inform consent form

Exclusion Criteria:

* Being diagnosed with schizophrenia spectrum disorders and other psychosis
* Being diagnosed with bipolar disorders
* Being diagnosed with autism spectrum disorder
* Being diagnosed with intellectual disability
* Being under any psychopharmacological or psychosocial treatment
Effects of Terlipressin When Usual Somatostatin or Octreotide Dose Fails

To observe and access the Effects and safety of terlipressin or high dose somatostatin/octreotide when usual dose somatostatin/octreotide fail to achieve hemostasis in patients with acute variceal bleeding.

The prognosis information of the patients with acute variceal bleeding will be collected, including hemostasis rate, early rebleeding rate, mortality, complications, severity adverse events, economic burdens and quality of life, when terlipressin or high dose somatostatin/octreotide is used as salvation to patients fail to achieve initial hemostasis.The results may help gastroenterologists to make decisions when administering vasoactive medicines to those suffered from acute variceal bleeding.

Eligibility Criteria:
Inclusion Criteria:

* Cirrhosis patients admitted to Emergency Department because of acute variceal bleeding

Exclusion Criteria:

* No signs of variceal bleeding are found by endoscopy or portal hypertensive gastropathy is responsible for the bleeding
* Patients undergo endoscopy after 72h from the beginning of acute variceal bleeding
* Patients with hepatorenal syndrome
* Patients with ischemia organic cardiopathy (including myocardial infarction or unstable angina pectoris) or myocardial ischemia indicated by ECG in the past 6 months
* Patients allergic to/with contraindications of vasoactive drugs
Exploring Deployment Stress and Reintegration in Army National Guard Chaplains

The purpose of this 2-year pilot study is to explore the impact of deployment on the psychosocial and health characteristics and reintegration of Military Chaplains, specifically those of the Army National Guard (ARNG). This pilot will serve as the foundation for subsequent investigations of chaplains from multiple branches of the military. In addition to spiritual and religious support, Military Chaplains play a key role in the behavioral health of deployed service-members, routinely participating in suicide prevention training, conducting critical event debriefing, and identifying service-members at risk for combat and operational stress reactions1. A high risk group for exposure to trauma2, Military Chaplains have suffered brain injuries, gunshot wounds and blast injuries in OEF/OIF Theater3. In addition, many report combat related stress issues such as compassion fatigue, PTSD, and reintegration issues3. While the traumatic experiences of OEF/OIF deployed troops have been well documented, the effects on military chaplains caring for these service-members have received little attention in the research to date. We are collaborating with the National Guard Chaplain Corps Leadership on this program of research. The aims of this 2-year pilot cross-sectional study focus on describing and exploring deployment and its impact on psychosocial, health characteristics and reintegration of ARNG chaplains using a mixed method approach (web-based survey, in-depth interviews, social network analysis).


Eligibility Criteria:
Inclusion Criteria:

* current, active members of ARNG during timeframe of OIF/OEF/OND
* Chaplains
* able to be contacted by email for survey explanation and participation
* consent to participate in interview or network questionnaire

Exclusion Criteria:

* not current, active members of ARNG during timeframe of OIF/OEF/OND
* not Chaplains
* not able to be contacted by email for survey explanation and participation
* do not consent to participate in interview or network questionnaire
Teleassessment in Ataxic Multiple Sclerosis

Our aim is to compare ICARS and SARA scores with face-to-face and tele-assessment methods in ataxic multiple sclerosis patients.

The hypotheses on which this study is based are; H1: Tele-assessment and face-to-face assessment results of the ICARS differ in patients with ataxic MS.

H2: Tele-assessment and face-to-face assessment results of SARA differ in patients with Ataxic MS.

Patients will be evaluated both face-to-face and via tele-assessment (video conference call). In these evaluations, ICARS and SARA will be used. Face-to-face and tele-assessments will be applied on the same day, the order of administration will be decided by the randomization method, and a 10-minute rest will be given between the assessments.The interview will be recorded during the tele-assessment and a re-assessment will be made on the same recording 1 week later. Face-to-face assessment will be done as routinely done in the clinic. Face-to-face and tele-assessments will be made by 3 different assessors. Assessors will be blind to each other's assessment. All assessments will be carried out at Hacettepe University Faculty of Physical Therapy and Rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* be between the ages of 18-50 years
* Being diagnosed with MS by a neurologist
* Expanded Disability Status Scale (EDSS) score between 3-5
* EDSS pyramidal system score ≤ 3 and cerebellar functional system score ≥ 1
* Being clinically stable for the last 3 months
* agree to participate in the study

Exclusion Criteria:

* Having other systemic, orthopedic or neurological disease
* Having a history of attacks in the last 3 months
* having peripheral vestibular complaints
* being mentally affected (Montreal Cognitive Rating Scale Score \< 21)
* severe spasticity (Modified Ashworth Scale \> 3)
Proof-of-concept Study to Evaluate the Safety and Efficacy of Tryptophan in Patients with BPH.

Benign prostatic hyperplasia (BPH) is one of the most prevalent human diseases and a major cause of lower urinary tract symptoms (LUTS). Some men respond to current medical treatment (mainly α-1 adrenoreceptor antagonists and 5 α-reductase inhibitors), but a large proportion of patients continues to need a surgical procedure to treat resistant LUTS or even more serious complications of BPH, creating the emerging necessity for novel pharmacological therapies.

Oxitriptan may have a possible positive effect on BPH associated symptoms with probably no impact in sexual function (which is a common side effect of the current drugs for BPH associated symptoms). Also, improvement in symptoms could be higher than that of current drugs used for this condition.

This is a single-center parallel group, randomized clinical trial. The study will take place in Hospital de Braga (Urology department). Eligible patients will be randomized to receive tamsulosin 0.4mg (once a day, q.d.) or 5-HTP (5-hidroxitriptophan) 100mg (three times a day, t.i.d.), for 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent;
* Male patients with BPH for which tamsulosin is the therapeutic option per SoC;
* Aged ≥50 and less than 75 years old;
* With prostate volume ≥30 cm3 by TRUS;
* Diagnosed with LUTS defined by a stable IPSS total score ≥13 points.

Exclusion Criteria:

* Patients with post-void bladder residual volume ≥250 ml;
* Patients with intravesical obstruction from any cause other than BPH;
* History of any procedure considered an intervention for BPH;
* Patients with active urinary tract infection;
* History of recurrent urinary tract infections;
* Current prostatitis or diagnosis of chronic prostatitis;
* History of prostate or invasive bladder cancer;
* Use of 5 α-reductase inhibitors within 6 months;
* Phytotherapy within 2 weeks before entry;
* Use of serotonin reuptake inhibitors or monoamine oxidase inhibitors;
* Patients with acute or chronic kidney failure;
* Patients with diagnosed or suspicion of intolerance to lactose;
* Patients submitted to general anesthesia in the past 4 weeks;
* Known intellectual disability that may hampers giving informed consent and would make the patient inappropriate for entry into this study, in the judgment of the investigator.
Exalt D Single-use Duodenoscope in ERCP Procedures in China

Study Objective(s)：This study is to evaluate the feasibility, preliminary safety and performance of Exalt D Single-use Duodenoscope in ERCP procedures in China, to generate local real world data from a Chinese ERCP population.

Study Design：Prospective, single-arm study Planned Number of Subjects：Up to 35 to satisfy 30 treated cohort Primary Endpoint：Ability to complete the ERCP procedure for the intended indication(s) without crossing to reusable duodenoscope.

It is also considered as Exalt D's ability if the clinical effect is the same per the investigator's judgement in case of an endoscope change (non-Exalt D).

Device Description：The Exalt™ Model D Single-Use Duodenoscope is a sterile, single-use endoscope that facilitates access to the duodenum, delivery of accessories, and live video when connected to an Exalt™ Controller.

The Exalt™ Controller is an electronic device that:

* Receives video signals from a Boston Scientific single-use endoscope,
* Processes the video signals,
* Outputs video images to a video monitor, and
* Outputs electrical signal(s) that interface with external image capture systems.

Study Design：This is a prospective, single-arm study with up to 35 subjects to satisfy 30 treated cohort in up to 3 centers. The study duration is expected to be approximately 7 months, assuming 6 months enrollment and 1 month follow up. The study duration for each subject is expected to be approximately 30 days.

Data Analyses：All statistical analyses will be done using The SAS System software, version 8 or higher (Copyright © 2000 SAS Institute Inc., SAS Campus Drive, Cary, North Carolina 27513, USA. All rights reserved).

Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older
2. Willing and able to comply with the study procedures and provide written informed consent to participate in the study
3. Schedule for a clinically indicated ERCP

Exclusion Criteria:

1. Potentially vulnerable subjects, including, but not limited to pregnant women
2. Subjects for whom endoscopic techniques are contraindicated
3. Subjects who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor
4. Investigator discretion
Awareness, Care and Treatment in Obesity Management

This study aims to assess barriers that prevent obesity patients from receiving adequate care for their condition. The non-interventional study will be administered in the form of a 30-minute, cross-sectional, online survey to various respondents. There is no experimentation involved in the process of data collection, and each survey poses minimal human risk.

The study will evaluate lifestyle habits and weight management strategies perceived and/or practiced by each of 3 stakeholders in obesity: Patients (People with obesity), Providers, and Employers. A customized survey will be administered to each of the 3 stakeholders, and data will be analyzed based on respondents' answers.


Eligibility Criteria:
Inclusion criteria

The following inclusion criteria will be imposed for HCPs:

* Practice in Canada
* Spends at least 70% of time in direct patient care
* Seen at least 100 patients in past month
* Seen at least 10 patients in past month needing weight management
* In practice 2-35 years
* Not affiliated with Pharmaceutical, Market Research (MR) or Advertising Firms
* PCP - Physician, RN / NP / LPN, or PA, Dietitians
* PCP - Specialty is FP, IM, GP
* Obesity Specialist - Physician, RN / NP / LPN, or PA
* Obesity Specialist - Specialty is FP, IM, GP, endocrinology, bariatrics, or bariatric surgery
* Obesity Specialist - Currently practice as an obesity medicine or weight loss management specialist

The following inclusion criteria will be imposed for PwOs (people with obesity):

* Age at least 18 years
* Lives in Canada
* Recruitment will target a nationally representative Canada sample. Demographic indicators will be monitored throughout recruitment.
* Current BMI 30 kg/sqm or greater, not extremely fit/body building
* Sub-category - Maintaining weight loss: Lost at least 10% of body weight in the past 3 years and has kept weight off for at least a year
* Sub-category - Treatment Seeking: Has committed to a plan to lose weight, or has successfully lost weight (self-report) or has spoken to an HCP about weight loss plan in the last 6 months.

The following inclusion criteria will be imposed for employers:

* Age at least 18 years
* Works in a Canadian province
* Company offers health insurance
* Responsible for making or influencing decisions about health insurance or health and wellness programs
* Works in a company that has 20 or more employees
* Believes there is a weight issue (attitudinal agreement)
* Not affiliated with Pharmaceutical, Market Research (MR) or Advertising Firms

Exclusion criteria Any respondent who work works for a pharmaceutical, health insurance, research, or advertising company will be excluded; as there may be self-presentation effects that could alter the interview questions.