cyrilzakka/clinical-trials huggingface dataset:
Novel Modified Technique for Transcatheter Closure of Secundum Atrial Septal Defect: A Single Center Experience

Transcatheter closure of secundum atrial septal defects is widely approved worldwide, yet it still has multiple risks like perforation and radiation exposure. In this study, we proposed a modified rapid method for closure of secundum atrial septal defects, to avoid material manipulation inside your heart and decrease complication rate.

Delivery sheath can be advanced over multipurpose catheter instead of stiff wire

Eligibility Criteria:
Inclusion Criteria:

* Any patient with ostium secundum ASD \& RV volume overload

Exclusion Criteria:

* Any other type of atrial septal defects Any other associated congenital anomaly
Contextualized Neuropsychological Rehabilitation for CNS Cancer Survivors: The ImPACT Program

The aim of the present randomized-controlled study is to evaluate the feasibility, acceptability, and preliminary efficacy of a novel, context-sensitive neuropsychological rehabilitation intervention for brain cancer survivors.

Cognitive impairment is the most common late effect in brain cancer survivors, with profound negative effects on quality of life, work ability, and socioeconomic outcomes. Still, there is no gold standard approach to treating cognitive impairment in brain cancer survivors. Furthermore, there is a dearth of research on interventions to treat cognitive impairment in brain cancer survivors, and the relatively few studied interventions have proven limited effects. Arguably, four key elements are missing from a majority of studied interventions:1) transfer of learning to real-world functional outcomes, 2) awareness training to enhance compensatory strategy use, 3) inclusion of carers that could enhance transfer of learning to the home, and 4) recognition of the inter-related nature of cognitive, neurobehavioral, and psychological functions.

The "I'M aware: Patients and Carers Together (ImPACT)" program is a novel, context-sensitive neuropsychological rehabilitation intervention that targets the above mentioned missing elements in previous rehabilitation efforts. The present feasibility randomized-controlled study aims to evaluate the feasibility, acceptability, and preliminary efficacy of this program in brain cancer survivors with cognitive impairment in preparation for a subsequent large-scale randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of brain cancer
* Completed primary treatment at least 6 months ago
* Medically stable
* Speaks and understand Danish
* Living with a carer aged 18 or over, who also speaks and understands Danish and consents to participate in the study alongside the patient

Exclusion Criteria:

• Confounding diagnosed or suspected psychiatric or medical condition unrelated to the cancer or its treatment
Effectiveness and Feasibility of Delivering an Education Program to Patients With an Acute Exacerbation of COPD

The purpose of this study is to determine if it is effective and feasible to provide a chronic obstructive pulmonary disease (COPD) education program to patients admitted with an acute exacerbation of COPD.

Following an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) evidence strongly suggests that all patients should be discharged with an action plan, consisting of identified patient responsibilities for their ongoing care and advice on recognizing and seeking help in the event of future acute exacerbations. Despite these recommendations, structured chronic obstructive pulmonary disease (COPD) specific education is rarely offered within acute hospital settings and, in addition, research in this area is limited. This study aims to determine the effectiveness and feasibility of an introductory education program delivered during and shortly after an AECOPD hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* medically confirmed diagnosis of AECOPD (alone or combined with other conditions)
* capable of understanding the study information and giving informed consent

Exclusion Criteria:

* admitted due to lung diseases other than COPD
* received COPD education in the previous 6 months (in primary care, acute or rehabilitation hospitals)
* presence of diagnosis of dementia or incapacity to learn due to cognitive issues
* have medical, cognitive or language limitations to communicating in written or spoken English
* have participated or been asked to participate in the trial before
* in the intensive care unit
A Study to Test Long-term Treatment With Spesolimab in Patients With Fistulising Crohn's Disease Who Took Part in Previous Trials

The main objectives of this study are to evaluate the long-term safety of spesolimab in patients with perianal fistulising Crohn's disease who have completed treatment in parent trials and to evaluate the long-term efficacy of spesolimab in patients with perianal fistulising Crohn's disease, who have completed treatment in parent trials


Eligibility Criteria:
Inclusion Criteria:

1. Patient older than 18 years
2. Has completed all treatments (placebo or active treatment) and the end of treatment (EOT) visit in the parent induction trial in fistulising Crohn's Disease (CD) and is willing and able to continue treatment in 1368-0007
3. Has obtained an individual health benefit, per investigator judgement (such as fistula response or remission or other clinical improvement), from treatment in the parent trial
4. Signed and dated written informed consent for 1368-0007 in accordance with GCP and local legislation prior to admission into the trial
5. Women of childbearing potential (WOCBP) must be ready to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information

Exclusion Criteria:

1. Have experienced treatment-limiting adverse events during induction treatment with study drug
2. Have developed any condition which meets the exclusion criteria from the original induction study
3. Any condition which in the opinion of the investigator affects the safety or ability to participate in this trial
Evaluating Effects of Curcumin in Moderate to Severe Asthmatics

The purpose of this investigator-initiated study is to evaluate the effects of oral curcumin supplementation versus placebo in adult patients with moderate to severe asthma. Curcumin, a derivative of turmeric, has been shown in animal models to inhibit the secretion of pro-inflammatory cytokines and decrease airway constriction and hyperreactivity with only a few observational studies available in humans with discordant results.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 18 and older
4. Physician diagnosed moderate to severe asthma: (GINA 2018)

   a. Stable asthma that requires ICS/LABA and/or an additional controller agent (i.e. LTRA, LAMA)
5. Ability to take oral medication and be willing to adhere to the regimen
6. Ability to speak and read English
7. If female and sexually active, should use effective forms of birth control

Exclusion Criteria:

1. Current use of turmeric (curcumin) or use within the last 7 days
2. Current use of biologic therapy/ immunotherapy/ or bronchothermoplasty
3. Pregnancy or lactation
4. Known allergic reactions to components of turmeric (curcumin)
5. Current use of anticoagulants, and history of coagulopathy or liver disease
6. INR greater than 2.0, PTT greater than 45.0 seconds
Clinical Predictors of Pediatric OSAHS

The purpose of this study is to develop adequate and satisfactory tools using reliable clinical and physical factors in predicting pediatric obstructive sleep apnea/hypopnea syndrome (OSAHS) and allow greater access to appropriate therapy in children.

The prevalence of OSAHS is estimated to be about 1% to 4% in children, however, it is frequently underdiagnosed because of the difficulties for evaluation.Current diagnostic approaches are based on the patient's history, clinical presentation and physical examination, endoscopy, and radiological imaging examinations, and confirmation is made by the current gold standard of full-night polysomnography (PSG). Previous studies have reported the use of a clinical history, physical examination and questionnaires for predicting pediatric OSAHS but there were lacking of adequate and satisfactory results. Despite the potential diagnostic benefits, PSG for pediatric patients are not routinely used in clinical practice. Therefore, to obtain a reliable, valid, and easily-performed diagnostic or screening tool for the clinical assessment of pediatric OSAHS is essential for the cost-effective care of these patients.

Eligibility Criteria:
Inclusion Criteria:

* children (younger than 18 years old and older than 2 years old) with symptoms of snoring and then were confirmed to having obstructive sleep apnea/hypopnea syndrome by a comprehensive polysomnography

Exclusion Criteria:

* patients with substance abuse problems or the long-term usage of medications known to affect sleep, craniofacial abnormalities or neuromuscular disorders, Down syndrome, cerebral palsy, mucopolysaccharidoses, Prader-Willi syndrome, history of psychosis, central sleep apnea syndrome, or previous airway surgery including tonsillectomy and/or adenoidectomy were excluded from the study.
Mobilization With Neuromuscular Electrical Stimulation in Critical Care Patients

Neuromuscular electrical stimulation in pectoral muscles (fibres of the pectoralis major muscle bilaterally) and rectus abdominis muscles (bilaterally) preserves / decreases the loss of muscle mass.

Introduction: Neuromuscular electrical stimulation (NMES) has recently began to be used as an early treatment method for Intensive Care Unit (ICU) patients on invasive mechanical ventilation (IMV) to compensate for or reduce muscle mass losses and muscular atrophy.

Objective: To evaluate the effects of early mobilization with neuromuscular electrical stimulation in critical care patients on invasive mechanical ventilation.

Methods: Randomized clinical trial to be conducted in the ICU at the hospital de clínicas of Porto Alegre, RS, Brazil, with two groups, one intervention group (conventional physiotherapy and NMES) and one placebo group (conventional physiotherapy and placebo NMES). Patients on mechanical ventilation who meet the inclusion criteria will be recruited and the intervention will be administered using a 4-channel Ibramed® Neurodyn Functional Electrical Stimulation (FES) machine, every day for thirty minutes until extubation or death. Outcomes will be muscle thickness of pectoral and abdominal muscles and diaphragm excursion measured with ultrasound, before intervention, on the seventh day of intervention and soon after extubation. Additionally, blood lactate and heart rate variability will be assessed. Statistical analysis will be conducted using the Statistical Package for the Social Sciences (SPSS) 20.0 and the significance level will be p\<0.05.

Eligibility Criteria:
Inclusion Criteria:

This will be a randomized clinical trial recruiting patients of both sexes aged ≥ 18 years, no more than 15 days after admission to the intensive care unit at the hospital de clínicas de Porto Alegre, after transfer from the emergency department or wards and put on invasive mechanical ventilation for at least 24 hours

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Exclusion Criteria:

* Exclusion criteria will include neuromuscular diseases causing motor deficits, such as strokes, multiple sclerosis, amyotrophic lateral sclerosis, myasthenia gravis and Guillain Barré syndrome. Patients will also be excluded in the event of extubation less than 48 hours after enrolment on the study; complications during the protocol, such as pneumothorax, reintubation or delayed weaning (3 failed spontaneous ventilation tests); body mass index (BMI) \> 35 kg/m2; pacemaker use, history of epilepsy; or if a patient has undergone an operation involving abdominal or pectoral incisions.
Transversus Abdominus Plane Block

Transversus Abdominus Plane (TAP) block may reduce need for postoperative pain medications in patients undergoing laparoscopic hand assisted nephrectomy. Our hypothesis is that the TAP block will result in a significant reduction in pain scores and morphine requirements in the active group.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are ≥ 18 and ≤ 80 years of age.
* Patients scheduled to undergo hand assisted laparoscopic removal of a single kidney for either tumor or living donor transplantation.

Exclusion Criteria:

* Patients scheduled to undergo an open procedure for nephrectomy
* Patients who are converted from hand assisted laparoscopic surgery to open surgery due to intraoperative complications.
* Bilateral nephrectomy
* Pregnant or lactating patients
* Patients unable or unwilling to provide informed consent
* Patients unable to comprehend the use of a visual analog scale
* Patients desiring preemptive antiemetics
* Opioid tolerance
* Allergy to amide local anesthetics or any of the study drugs (morphine).
* Contraindication to regional nerve block (bleeding disorder, infection at site of block)
* Patients with history of dementia
Omega3 PUFA in Head Trauam

Traumatic brain injury (TBI) is major health problem that stands as a significant cause of death and permanent disability. TBI is considered as global public health epidemic. On pathophysiologic basis, TBI is described as occurring in two phases, primary and secondary. Once a primary insult occurs like trauma or ischemia, the secondary injury begins though main four mechanisms; ischemia, brain edema, axonal injury and neuro-inflammation. Omega-3 PUFAs (Polyunsaturated fatty acids) are postulated to have neuroregenerative properties with the ability to impact all four main mechanisms of the secondary injury Patients will be allocated into one of two groups through a random table generation; Control group in which patients will follow our local protocol for TBI management without SMOF-lipid infusion. SMOF-lipid group in which patients will receive 0.5 g/Kg SMOF lipid 10% emulsion (Lipid emulsion for intravenous nutrition containing; 6% soybean oil / 6% medium chain triglycerides / 5% olive oil / 3%fish oil) daily over 12 hours starting once admitted to ICU for 7 days


Eligibility Criteria:
Inclusion Criteria:

* mild to moderate head trauma

Exclusion Criteria:

* sensitivity to SMOF lipid severe head trauama
Novel Vascular Manifestations of Chronic Obstructive Pulmonary Disease

Cognitive impairment is a known consequence of cerebral small-vessel disease. Moderate to severe cognitive impairment has been shown in up to 60% of certain individuals with COPD and is likely to profoundly influence an individual's ability to manage their disease.

In addition to cerebral small vessel damage and cognitive dysfunction, other organs such as the heart, kidneys, and retina are likely to be susceptible to small-vessel damage in COPD. Several large population studies have shown that COPD is a significant independent risk factor for myocardial infarction, with the effect most marked in early, mild disease.

We propose to compare non-invasive MR brain imaging of white matter microstructure (diffusion tensor), cerebral perfusion (arterial spin labelling) and accumulated cerebral small vessel disease (cerebral microbleeds), in COPD patients to smokers without COPD. In addition we plan to explore mechanisms of cerebral small vessel disease in COPD by looking for associations between arterial stiffness, end organ vascular damage and cognitive function.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must give their signed and dated written informed consent
2. Subjects must be aged \>40 and ≤ 85
3. Subjects with a smoking history \> 10 pack years.
4. COPD group: Subjects with a FEV/FVC \<70%

Exclusion Criteria:

1. Resting oxygen saturations \<92% on room air.
2. Long term oxygen therapy
3. Recent exacerbation of COPD (4 weeks)
4. Ischaemic heart disease
5. Cerebrovascular disease
6. Uncontrolled hypertension
7. Diabetes mellitus
8. Hepatic failure
9. Neurological disease
10. Non-cured tumours
11. Obstructive sleep apnoea
12. Current of past alcohol/drug abuse
13. Known history of dementia
14. Visual or hearing impairment that precludes neuropsychological assessment
15. Neuropsychological tests undertaken outside the study
16. Pregnant women or women who are lactating
17. Known alpha 1 anti-trypsin deficiency as a cause of their COPD
18. History of psychiatric disorders, or other conditions that will impact on the validity of their consent or interfere with compliance to perform study procedures.
19. Contra indication to MRI scanning -
Virtual Reality Device for Rehabilitation of Stroke Patients

This study will evaluate the potential efficacy and safety of using virtual reality gaming in conjunction to standard therapy regimen care as an approach to promote upper-limb motor recovery, cognitive function and quality of life after stroke. The investigators believe that allowing users to interact with a computer-simulated reality environment will result in a pleasant experience, which will likely result in motivation and therapy engagement.


Eligibility Criteria:
Inclusion Criteria:

* Patient admitted to the UAB Hospital, older than 18 years old, with a diagnosis of stroke
* Patient with unilateral upper extremity weakness
* Patients that after evaluation by Physical and Occupational professionals were admitted to rehabilitation facility "Spain Rehabilitation Center".

Exclusion Criteria:

* Patients with severe cognitive impairment
* Patient with orthopedic impairment (i.e. marked arthritis)
* Patient with visual disorders limiting therapy session
* Those for whom voluntary arm movement would cause sufficient discomfort (\>4/10) that could prevent trial completion will be excluded from participation.
Effects of the Use of Multi Criterion Decision Analysis (MCDA) on Decision Quality in an Online Delphi

To examine the effects of using decision support tools during the online Delphi process.

The purpose of this exploratory work is to develop improved methods for building a protocol for a participatory randomized controlled trial. An online Delphi will be combined with an embedded trial testing the effectiveness of a decision support tool. This method provides for consensus building and collaborative problem-solving which is informed, and participatory. The online Delphi offers involvement and confidentiality thus sidestepping the complications of power imbalances and undue influence as respondents contribute anonymously.

The embedded trial was considered after the building of a database of existing online trials and conducting a descriptive analysis" Creating a database of Internet-based clinical trials to support a public-led research programme: A descriptive analysis, followed by the completion of a systematic overview of systematic overviews, "Patient and Public Involvement in Clinical Trials Design: An Overview of Systematic Reviews" and followed this with an analysis of "Self-Management Open Online Trials in Health"(In review). The results included a lack of standardization, insufficient guidance for implementation and significant research reporting weaknesses. Decision-making support tools may improve decision quality.

This embedded trial will be implemented in an online Delphi to come to the consensus about what declarations and methods to include when building a participatory online trials protocol.

Eligibility Criteria:
Inclusion Criteria:

Protocol lab online trialsl Delphi (PLOT-D) Participant

Exclusion Criteria:

* None if meets inclusion criteria
Impact of Six Patient Information Leaflets (PIL) on Doctor Patient Communication

The purpose of this "before-after" prospective multicenter study is to assess the impact of six Patient Information Leaflets (PILs) on Doctor Patient Communication scale (DPC) and adherence scale for common acute illnesses in emergency ward.

Assessing the impact of six Patient Information Leaflets (PILs) on Doctor Patient Communication scale (DPC) and adherence scale for common acute illnesses (infectious colitis, diverticulitis, pneumonitis, prostatitis, pyelonephritis , ankle sprain) in two emergency ward.

For "before" study without intervention : usual consultation without PIL .

For "after study" with intervention : the patient is given a PIL related to his disease during the consultation.

Data collection will take place the same day as the consultation by self-administered questionnaire for DPC scale and also between 7 to 10 days after the consultation by phone survey for DPC scale and adherence scale.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient.
* Minor aged over 15 years accompanied by a responsible adult.
* The patient must be reachable by telephone within seven to ten days following the consultation.

Exclusion Criteria:

* Illiterate patient.
* Patient refusing follow-up call.
* Patient with visual or hearing impairment.
* Patient non-Francophone.
* Private patient of liberty by judicial or administrative.
* Person being a measure of legal protection.
The Smart Pump Study

To demonstrate that the Impella® Hemodynamic Platform (the "Study Device") is safe, and measurements obtained are as good as currently used methods. These measurements include how much pressure the heart is generating and how much blood your heart is pumping during the PCI.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Subject presents for elective PCI
3. Subject or the subject's LAR has signed the informed consent
4. Subject indicated for Impella® support

Exclusion Criteria:

1. Any contraindication or inability to place an Impella® including tortuous vascular anatomy, femoral bruits or absent pedal pulses
2. Cardiogenic shock defined as systemic hypotension (SBP\<90mmHg or the need for inotropes/vasopressors to maintain an SBP \>90mmHg) plus one of the following:

   1. Any requirement for inotropes/vasopressors prior to arrival at the catherization lab
   2. Clinical evidence of end organ hypoperfusion
   3. Use of IABP or any other circulatory support device
3. Suspected systemic active infection
4. Suspected or known pregnancy
5. Known contraindication to heparin, pork, pork products, or contrast media
6. Subject has other medical, social, or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to give written informed consent and/or to comply with study procedures
7. Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device which has not reached its primary end point.
8. Subject belongs to a vulnerable population \[Vulnerable subject populations are defined as individuals with mental disability, persons in nursing homes, children, impoverished persons, homeless persons, nomads, refugees, and those permanently incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention