cyrilzakka/clinical-trials huggingface dataset:
Translation and Psychometric Properties of the Fatigue Severity Scale in Patients With Fibromyalgia

The study will employ a Cross-Sectional Validation Study design. The study will be conducted at the Department of Physical Therapy, University of Lahore Teaching Hospital, located on Defence Road, Lahore.

The anticipated duration of the study will be 09 months, commencing after the approval of the synopsis.

The sample size will be determined following the Kline Method, resulting in a total of 90 participants.

A Purposive Sampling Technique will be utilized to select the study participants.

Study Type: Cross-Sectional Validation Study Location: Department of Physical Therapy, University of Lahore Teaching Hospital, Defence Road, Lahore Duration: 06 months (post-synopsis approval) Sample Size: 90 participants Sampling Technique: Purposive Sampling Consent and Ethics: Participants will provide written informed consent. Ethics approval will be obtained from the University of Lahore Ethics Committee.

Translation of FSS:

The Fatigue Severity Scale (FSS) will be translated into Urdu for data collection.

Two independent bilingual translators will create reports on translation difficulties and rationale.

These reports will inform a consensus meeting to develop a unified Urdu version, with comments documented.

The unified version will be backtranslated into English by native English-speaking translators unaware of the questionnaire's concept.

Expert Committee:

An expert committee comprising physical therapists, linguists, and a methodologist will review both language versions.

The goal is to ensure semantic, idiomatic, experiential, and conceptual equivalence and reach consensus on the final Urdu version of the FSS.

Patient Involvement:

The final Urdu FSS version will be administered to 20 fibromyalgia patients. These patients will also be interviewed to assess their understanding of questionnaire items.

Participants will receive additional information about fibromyalgia to prevent confusion.

Data Collection:

Data will be collected from 100 fibromyalgia patients using the final Urdu FSS version.

A retest will be conducted after 48 hours.

Additional Assessment:

All 90 participants will complete the Multidimensional Fatigue Inventory (MFI).

Eligibility Criteria:
Inclusion Criteria:

* Both genders with age of 18 years and above
* Diagnosed and referred patients of fibromyalgia according to the American College of Rheumatology (ACR) criteria.
* The ability to provide informed consent and wiling to participate in the study.
* Fluency in the study language (i.e. Urdu in this case).

Exclusion Criteria:

* Any other chronic pain condition that could affect fatigue and sleep.
* Diagnosed sleep disorder (such as sleep apnea or insomnia) that could affect the results.
* History of a psychiatric disorder that could affect the results.
* History of substance abuse.
* Participation in any other study that could affect the results at the time of recruitment.
Bronchiolitis Clearance Airways With Seaserum

The objective of this study is to show that the use of electrodialyzed seawater reduces the duration (in days) of symptoms in acute infant bronchiolitis compared with the use of saline solution in infants aged 1 month to less than one year.

B-CLASS study is a multicenter, prospective, controlled, randomized, double label blind.

This is a multicenter, prospective, controlled, randomized in 2 parrallel arms, double blind study. The Infants will be included after written informed consent will be obtained from the patients' parents or legally authorized representatives. Patients will be randomized either in the experimental group (electrodialyzed seawater) or in the control group (saline solution).

Patients' parents will be call by phone at day 1, day 3, day 6, day 10 and day 21 after baseline.

Eligibility Criteria:
Inclusion Criteria:

* Infants aged more than 1 month and less than 1 year
* First episode of acute bronchiolitis
* Emergency consultation
* Existence of nasal obstruction
* Onset of symptoms \&amp;lt; 48 hours before emergency consultation
* Outpatient care after emergency consultation
* Mild to moderate bronchiolitis according to the \&amp;#34;Haute Autorité de Santé 2019\&amp;#34; criteria:

Respiratory rate over 1 minute \&amp;gt;30/minutes and \&amp;lt;60/minute ; Heart rate \&amp;gt;80/minutes and \&amp;lt;180/minutes; Absence of respiratory pauses; Absence of superficial breathing; Absence of signs of intense respiratory struggle: involvement of the lower intercostal accessory muscles, sternocleidomastoid muscles, thoracoabdominal swinging, or flapping of the wings of the nose; Feeding \&amp;gt;50% of the usual quantity over 3 consecutive doses; SpO2 \&amp;gt; 92% during sleep ; \&amp;gt;94% when awake; \&amp;gt;2 months corrected age

* Parental consent
* Affiliate to a social security system

Exclusion Criteria:

* Hospitalization (excluding short stay unit) after emergency consultation
* Oxygen therapy
* History of prematurity (birth \&lt;36 weeks of amenorrhea)
* History of invasive ventilation in the neonatal period
* History of chronic pulmonary or cardiac pathology
* History of immune deficiency
* History of polyhandicap or neuromuscular pathology
* History of malformative Ear Nose and Throat pathology affecting the upper airways
* Impossibility of ensuring the follow-up made necessary by participation in this study
Neurohumoral Control of Intestinal Electrical and Mechanical Activity

A collaborative research project with Dr. Kathleen Keef (Department of Physiology, University of Nevada School of Medicine, Reno, Nevada) studying the role of putative neurotransmitters in human intestine.

Segments of intestine from patients undergoing elective gastric bypass for morbid obesity or resections for non-obstructive neoplasms at the UC Davis Medical Center will be used. Samples will be taken from tissue normally removed and sent to Pathology or discarded. Full thickness segments of intestine (10 mm x 1 mm) will be prepared for recording either intracellular electrical activity or mechanical contraction. The effects of putative non-adrenergic, non-cholinergic neurotransmitters (e.g., nitric oxide) will be studied. The source of the tissue will not be identified either directly or indirectly through identifiers associated with the measured responses.

Eligibility Criteria:
Inclusion Criteria:

* All patients having elective bowel resection

Exclusion Criteria:

* Entire resected segment required for pathology
* Ischemic/necrotic disease
Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients

The purpose of this study is to test the effectiveness and tolerability of the combination of Nivolumab and Ipilimumab compared to Pemetrexed and Cisplatin or Carboplatin in patients with unresectable pleural mesothelioma.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Males and Females at least 18 years of age
* Histologically confirmed pleural malignant mesothelioma not eligible for curative surgery
* ECOG Performance status of 0 or 1
* Available tumor sample for testing
* Acceptable blood work

Exclusion Criteria:

* Primitive peritoneal, pericardial and tunica vaginalis testis mesotheliomas
* Prior chemotherapy for pleural mesothelioma
* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 oranti-CTLA-4 antibody
* History of other malignancy unless the subject has been disease-free for at least 3 years
* Active, untreated central nervous system (CNS) metastasis

Other protocol defined inclusion/exclusion criteria could apply
Bilateral Treatment of Medication Refractory Essential Tremor

The purpose of this study is to see if the MR-guided focused ultrasound (MRgFUS) thalamotomy procedure can be performed on both sides of the brain safely and effectively to reduce bilateral tremor.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women age 22 years or older
2. Diagnosis of medication-refractory Essential Tremor
3. Has previously underwent an Exablate index procedure in a clinical trial or in a commercial setting at least 9 months prior to enrolling in this trial
4. Able to communicate sensations during the Exablate thalamotomy procedure

Exclusion Criteria:

1. Has experienced any non-transient neurological event or worsening following the Exablate index procedure
2. Presence of unknown or MR unsafe devices anywhere in the body
3. Non-transient hemiparesis as determined by physical examination
4. Clinically significant abnormal speech function as determined by a speech pathologist
5. Pregnant or breastfeeding
6. Unstable cardiac status
7. Behavior(s) consistent with ethanol or substance abuse
8. History of bleeding disorder
9. Has received anticoagulants within one month of Exablate procedure
10. Cerebrovascular disease
11. Intracranial tumor
12. Active or suspected acute or chronic uncontrolled infection
13. Has previously had deep brain stimulation or a prior stereotactic ablation of the basal ganglia or thalamus
14. Implanted objects in the skull or the brain
15. Currently in a clinical trial involving an investigational product or non-approved use of a drug or device or in any other type of medical research
16. Unable to communicate with the investigator and staff
Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra

The purpose of this study is to further evaluate the long-term safety and effectiveness of the Biocor and Biocor Supra Valves.

The clinical investigation is a multi-center, prospective, non-randomized, observational, FDA-required post-approval study designed to further evaluate the safety and effectiveness of the Biocor and Biocor Supra Valves.

Eligibility Criteria:
Inclusion Criteria:

* Requires aortic or mitral valve replacement (heart surgery such as bypass is allowed at the same time)
* Legal age
* Signed informed consent prior to surgery
* Willing to complete all follow-up requirements

Exclusion Criteria:

* Pregnant or nursing women
* Already have had a valve replaced other than that for the scheduled replacement
* Needs another valve replaced
* Cannot return for required follow-up visits
* Have active endocarditis
* Acute preoperative neurological event (such as a stroke)
* Renal dialysis
* History of substance abuse within one year or is a prison inmate
* Participating in another study
* Had the Biocor or Biocor Supra valve implanted but then the device was explanted
* Life expectancy less than five years
The Effect of Reflective Breathing Therapy Compared With Conventional Breathing Therapy in Patients With Chronic Obstructive Pulmonary Disease (COPD) III-IV

The purpose of this study is to determine whether different types of breathing therapies in patients with COPD III-IV decrease dyspnea and increase activity.

In the treatment of COPD-Patients different kinds of breathing therapy techniques are used, but many of them are not reassessed yet.

Dyspnea is one of the predominant symptoms of COPD patients and has negative impacts on the activity of the patients. Dyspnea during exertion leads to avoiding activity and results in a deconditioning of muscles and of the cardiovascular system.

Thus breathing therapy techniques seem to be useful, which may lead to a decrease of dyspnea and an increase of activity.

The purpose of this study is to determine whether reflective breathing therapy is more effective on decreasing dyspnea and increasing activity than conventional breathing therapy.

Eligibility Criteria:
Inclusion Criteria:

* inpatient rehabilitation
* COPD (Gold stage III and IV)

Exclusion Criteria:

* severe exacerbation in the last four weeks
* acute infections
* fever
* neuritides
* severe osteoporosis
* skin disease
* manic depression
Flying Intervention Team for Endovascular Treatment of Acute Ischemic Stroke in Rural Areas

The aim of this study is to compare time delay and safety parameters of stroke patients initially admitted to a rural primary stroke center (PSC) who receive endovascular treatment (EVT) by a Flying Intervention Team with patients who receive EVT after secondary transfer to a comprehensive stroke center (CSC).

A novel health care concept was implemented in the telemedical stroke network TEMPiS (Telemedical Project for integrative Stroke Care) to reduce time delays to EVT in stroke patients with large vessel occlusion: After telemedicine-assisted identification of EVT candidates in a PSC, a Flying Intervention Team (neuroradiologist and angiography assistant) is flown from a CSC via helicopter to the PSC to perform EVT in the local angiography suite. Flying Intervention Team service runs from 8 a.m. to 10 p.m. Patients remain at local stroke unit for further treatment.

Analysis will include time delay to EVT, recanalization, symptomatic intracerebral hemorrhage, periprocedural complications, in-hospital complications, and mortality.

Eligibility Criteria:
Inclusion criteria:

* Admission to participating primary stroke center (PSC) with acute symptoms of stroke
* Telemedicine-supported decision for endovascular treatment (EVT)

Inclusion criteria for primary study population:

* Occlusion of M1, proximal M2, intracranial internal carotid artery (ICA) or basilar artery
* Decision for EVT between 8 a.m. an 10 p.m.
* Time from symptom onset to EVT decision within treatment window (0-6 h for M1, M2 and ICA occlusions, 0-24 h for basilar artery occlusions, 0-24 for M1, M2 and ICA occlusions with suitable mismatch in perfusion imaging performed in PSC)
* Endovascular treatment in PSC by Flying Intervention Team or in comprehensive stroke center after secondary transfer

Exclusion criteria for primary study population:

* Age \> 85 years
* Alberta Stroke Program Early CT score (ASPECTS) \< 6
* Premorbid severe or moderately severe disability (modified Rankin Scale \> 3)
* Premorbid serious or advanced illness with high mortality
Obinutuzumab in Chinese Real-world Patients With iNHL

This study aims to assess the clinical efficacy and safety of obinutuzumab in Chinese patients with indolent non-Hodgkin B-cell Lymphoma (predominantly Follicular lymphoma and Marginal zone lymphoma) in a real-world setting.

This study was a prospective, multicenter, non-interventional, real-world study. The study will be divided into two cohorts: Cohort 1 is the younger cohort (aged ≥ 18 and \< 60 years at the start of treatment); Cohort 2 is the older cohort (aged ≥ 60 years at the start of treatment). Patients in this study will receive obinutuzumab-contained regimens according to the investigators' clinical opinion.

Eligibility Criteria:
Inclusion Criteria:

* Age: Age ≥ 18 years at the start of treatment;
* Be diagnosed with grade 1-3a follicular Lymphoma, Marginal zone lymphoma;
* Previously untreated or relapsed or refractory patients;
* Patients who started treatment with otuzumab between June 2021 and April 2023.

Exclusion Criteria:

* Patients currently participating or planning to participate in any interventional clinical trial;
* Patients who, in the opinion of the investigator, are Discomfort for any other reason to participate in this study.
Oocyte Donor Application Discrepancies

Retrospective observational study comparing information received on Inception Central Donor Recruitment's standardized online egg donor application compared to information reported during a Genetic Risk Assessment (GRA) consultation with a certified genetic counselor with contracted third party genetic counseling service, GeneScreen. All donor applicants completing a full application with Inception's Central Donor Recruitment and a GRA consultation with GeneScreen will be included.

Background: Historically, it has been considered sufficient to have an egg donor applicant complete a written application that is reviewed by an egg donor program for acceptability. In 2021, ASRM put forth recommendations that "family history review and assessment of donors should be performed by a certified genetic counselor". In 2022, Inception Central Donor Recruitment (CDR) established a process for screening donor applicants that included Genetic Risk Assessment (GRA) with a certified genetic counselor. This study seeks to illustrate the discrepancies between personal and family history information documented on a standardized online application compared to a GRA consultation with a certified genetic counselor.

Objectives: Investigate the rate of new information obtained at GRA which was not included in the full application, as follows:

* New information with no change to health risk assessment (i.e. change in number of relatives)
* New information with a change to health risk assessment (i.e. known or suspected diagnoses for OD or family), with one of the following decisions

  * Still acceptable/approved for clinic (ie new multifactorial condition reported, such as diabetes)
  * Decline based on TPN internal guidelines alone (ie meets NCCN criteria for genetic testing)
  * Decline based on ASRM guidelines (ie first degree relative with a major malformation)

Hypothesis: Information obtained through GRA with a certified genetic counselor will lead to more detailed and accurate assessment of donor applicant eligibility. Some information obtained through GRA, which was not apparent on application, will lead to a donor applicant being declined based on internal Prelude Network Donor Screening Guidelines and/or guidelines set forth by the American Society of Reproductive Medicine.

Eligibility Criteria:
Inclusion Criteria:

* All oocyte donor applicants completing a full application with Inception's Central Donor Recruitment and a GRA consultation with GeneScreen will be included.

Exclusion Criteria:

* Not applicable
Perioperative Oral Nutrition Intervention for Patients Undergoing Radical Cystectomy

The current study is designed to assess the impact of an enriched oral nutritional shake (Ensure Plus®) to improve the nutritional status and patient outcome after surgery to remove a cancerous bladder (radical cystectomy). Radical cystectomy with urinary diversion using a segment of intestine is the standard of care for invasive bladder cancer. This operation has a high complication rate and several studies have shown that this may be directly related to poor nutrition.

The investigators believe that patients who consume an enriched nutritional shake before and after surgery will improve their nutrition status and experience fewer complications, shorter length of stay and less readmissions compared to those who do not.

Patients who are scheduled to undergo elective radical cystectomy will be eligible for enrollment. Once enrolled, they will be randomly assigned to one of two groups. One group will be offered Ensure Plus® twice daily for 2 weeks before and 4 weeks after their surgery and the other will be offered a daily over-the-counter multivitamin for the same period of time. The investigators will follow both groups for up to 30 days after their surgery and compare clinical outcomes such as: complication rates, length of stay, readmission rates and mortality as well as measure serum markers of nutrition status and assess changes in body composition.


Eligibility Criteria:
Inclusion Criteria:

* all patients eligible for elective radical cystectomy for bladder cancer at the sponsoring institution

Exclusion Criteria:

* inability to tolerate oral supplementation
Comparison of Robot-assisted Laparoscopic Myomectomy With Traditional Laparoscopic Myomectomy

This study is to reveal any potential advantage of Robot-assisted Laparoscopic Myomectomy (RLAM) over Traditional Laparoscopic Myomectomy (TLM) by comparing the perioperative variables and short-term outcome of RALM and TLM patients.

All patients with symptomatic uterine myomas who underwent traditional laparoscopic myomectomy or robotic laparoscopic myomectomy were enrolled.

Eligibility Criteria:
Inclusion Criteria:

* cases with uterine myoma
Postoperative VR for Recovery After Bariatric Surgery

The objective of this study is to investigate whether the addition of immersive virtual reality (VR) in the immediate postoperative period to an enhanced recovery after surgery (ERAS) protocol could improve postoperative recovery from bariatric surgery.

The investigators propose conducting a randomized, controlled, single-center clinical trial of patients recovering from laparoscopic bariatric surgery. The objective is to investigate whether the use of virtual reality (VR) during the immediate postoperative period could improve patient reported quality of recovery and potentially reduce opioid analgesic requirements as compared to an existing ERAS protocol.

The investigators hypothesize that immersive VR will improve subjective quality of recovery scores at time of Post Anesthesia Care Unit (PACU) discharge as compared to standard ERAS.

Eligibility Criteria:
Inclusion Criteria:

- Patients undergoing laparoscopic bariatric surgery at BIDMC under general anesthesia.

Exclusion Criteria:

* Age\<18
* Open wounds or active infection of the face or eye area
* History of seizures or other symptom linked to an epileptic condition
* Patients with hearing aids who are unable to tolerate wearing headphones with their hearing aids
* Patients with a pacemaker or other implanted medical device
* Droplet or airborne precautions (as determined by BIDMC infection control policy)
* Non English Speaking or non Spanish Speaking
* Chronic opioid dependence (existing oral opioid prescription for \>3 months, methadone, suboxone)

Drop Out Criteria: (after enrollment and randomization, before intervention)

- Surgery is converted to an open procedure (laparotomy), the patient will be withdrawn from the study as these patients are treated in a manner that is different than standard ERAS protocols
Music Listening to Lower Anxiety During ECT Treatment.

The purpose of this study is to assess whether music listening is helpful in lowering anxiety in patients about to start their ECT treatment.

In-patients at a psychiatric hospital referred to ECT treatment, is offered to participate in the study investigating whether listening to expert-curated playlists before-, during and after ECT treatment is helpful as a non-pharmacological intervention in lowering patients anxiety.

After written informed consent, participants will be randomised into two groups, one listening to playlists with music, one listening to sounds from nature (e.g. rain, ocean waves). Playlists will be administered by tablet+earphones in the waiting room, tablet+speaker in the room of procedure and tablet+bedside speaker in the recovery room.

Eligibility Criteria:
Inclusion Criteria:

* Capable in-patients of age at Aalborg University Hospital, Psychiatry - departments S7

  * S8, diagnosed with unipolar or bipolar depression, referred to ECT treatment.
* patients assessed to fit the study, by the head of departments S7 \& S8
* Voluntary participation in the study after written informed consent.
* Patients can withdraw their consent at any point during the treatment trajectory.

Exclusion Criteria:

* Patients not compliant with the study, as assessed by head of departments
* Non-capable patients
* Patients who withdraw their written informed consent
* Patients using hearing aid
* Patients with former ECT treatment experience
* Patients who receive acute ECT Treatment