louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05898542: Nature-based Therapies in Stroke Rehabilitation
Official title: Nature-based Therapies Supporting Conventional Therapies in Promoting Stroke Rehabilitation: a Randomised Controlled Pilot Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rehabilitation
Stroke
Keywords: rehabilitation
stroke
nature-based
therapy
microbiome
gut-brain axis
Lead sponsor: Joint Authority for Päijät-Häme Social and Health Care
Sponsor class: OTHER
Collaborators: name: Helsinki University Central Hospital
name: University of Jyvaskyla
name: Tampere University
name: University of Eastern Finland
name: Natural Resources Institute Finland
name: University of Helsinki
First posted: 2023-06-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled study, intervention and control groups
Primary purpose: TREATMENT

Brief summary: Stroke rehabilitation patients are subjected to additional nature-based therapies during a rehabilitation ward period.

Detailed description: Inward stroke rehabilitation patients are selected randomly into two groups: intervention and control groups in proportions 1-2:1. Blood samples and microbiome samples of saliva, skin and feces are taken from all patients prior to interventions. These are controlled after 4 weeks from the beginning of the study and 3 months after signing-off the ward. Questionnaires eg on moods, life quality and function deficits are conducted in the beginning of the study, after 4 weeks from the start and 3 months after signing-off. Physiological measurements will be done to observe autonomic nerve status. The interventions consisting of therapy sessions in the hospital nearby nature will be conducted thrice a week one of them being an individual nature-visit with the research worker, one in group and one with family-member or volunteer. The moods and quality of life of the family-member participating in the study will also be followed up. The control group is advised to do simple, more conventional rehabilitative tasks indoors.

Eligibility criteria: Inclusion Criteria:

* Acute/Subacute stroke
* Rehabilitation ward patient

Exclusion Criteria:

* Incapable of independent decision making
* Traumatic bleeding in brain tissue
* Severe aphasia
* Severe, malign ongoing disease

Primary outcomes:
measure: Functional ability
timeFrame: 0-30 days
Secondary outcomes:
measure: Quality of life by WHO Disability Assessment Schedule (WHODAS)
timeFrame: 0-30 days
measure: Assessment of the intervention impacts on rehabilitation
timeFrame: 0-120 days
measure: Psychological or psychotherapeutic effects
timeFrame: 0-30 days
measure: Intervention effects on microbiome
timeFrame: 0-120 days
measure: Intervention effect on the activity of autonomic nerve system
timeFrame: 0-30 days
Other outcomes:
Locations:
city: Lahti
country: Finland
facility: Joint Authority for Päijät-Häme Social and Health Care
Study officials:
affiliation: Päijät-Hämeen Hyvinvointialue
name: Hanna Haveri, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01079442: Coffee Trial - Does Coffee Intake Reduce Postoperative Ileus After Elective Colectomy?
Official title: Does Coffee Intake Reduce Postoperative Ileus After Elective Colectomy?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colectomy
Keywords: postoperative ileus after colonic resections
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2010-03-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the investigators study is to investigate the effects of coffee on the return of bowel function and appetite, length of hospital stay, and complications after elective open colectomy in a prospective randomized trial. The primary efficacy endpoint is time to first bowel movement.

Detailed description: Coffee is a popular beverage. Its effects on general well being, central nervous system and cardiovascular system are well known, but there is limited information regarding its effects on gastrointestinal function.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective open or laparoscopic colectomy
* Age equal or greater than 18 years
* Informed consent

Exclusion Criteria:

* Participation in concurrent intervention trials
* Need for a stoma
* Known hypersensitivity or allergy to coffee
* Expected lack of compliance
* Impaired mental state or language problems
* change in surgical procedure

Primary outcomes:
measure: Time to first bowel movement
timeFrame: patients postoperative in hospital stay (mean 6 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Salem Krankenhaus
city: Heidelberg
country: Germany
facility: University hospital
city: Sinsheim
country: Germany
facility: Kreiskrankenhaus GRN Sinsheim
Study officials:
References:
citation: Muller SA, Rahbari NN, Schneider F, Warschkow R, Simon T, von Frankenberg M, Bork U, Weitz J, Schmied BM, Buchler MW. Randomized clinical trial on the effect of coffee on postoperative ileus following elective colectomy. Br J Surg. 2012 Nov;99(11):1530-8. doi: 10.1002/bjs.8885. Epub 2012 Sep 14.
Clinical trial NCT04832542: Implantable Loop Recorder in Traumatic Syncope
Official title: Safety and Effectiveness of Implantable Loop Recorder in Patients With Recurrent, Unexplained, Traumatic Syncope
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Syncope
Lead sponsor: Azienda Ospedaliera Cardinale G. Panico
Sponsor class: OTHER
Collaborators: name: Università Politecnica delle Marche
name: University of Campania Luigi Vanvitelli
name: Azienda Ospedaliera Pugliese Ciaccio
name: Azienda Ospedaliero Universitaria Maggiore della Carita
name: Cardiology Department, Policlinico Riuniti University Hospital, Foggia, Italy
name: Cardiology Division, Villa Scassi Hospital, Genova ASL 3, Genova
name: San Giuseppe e Melorio Hospital, Santa Maria Capua Vetere
name: Nostra Signora di Bonaria Hospital, San Gavino Monreale
name: Istituto Nazionale di Ricovero e Cura per Anziani
First posted: 2021-04-06
Enrollment: 488
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients with recurrent, unexplained, traumatic syncope underwent implantable loop recorder implantation

Brief summary: Prospective, observational registry enrolling consecutive patients with recurrent, unexplained, traumatic syncope underwent implantable loop recorder implantation with the aim to evaluate the incidence of recurrence of traumatic syncope during follow-up.

Detailed description: This observational, prospective registry enrolled consecutive patients with recurrent, unexplained, traumatic syncope underwent implantable loop recorder implantation according to current clinical practice. The patients were evaluated every 6 months based on current clinical practice and the risk of recurrence of traumatic syncope was assessed during follow-up.

Eligibility criteria: Inclusion Criteria:

* patients with recurrent, unexplained, traumatic syncope
* patients underwent implantable loop recorder implantation

Exclusion Criteria:

* patients unable to attend scheduled outpatient visits

Primary outcomes:
measure: Traumatic syncope recurrence
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04858542: Evaluating the Impact of Vocal Health Education on Mask-wearing Workers During COVID-19
Official title: Developing Educational Modules to Improve Communication and Vocal Health Among Mask-wearing Healthcare Workers: Phase 2 of the COVID-19 Critical Community Challenge Grant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Keywords: voice
communication
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this clinical trial is to understand how viewing educational health modules impacts vocal health behaviors in mask-wearing healthcare workers.

Detailed description: Results of the investigators' previous work showed that mask-wearing healthcare workers have difficulty with voice and communication. Healthcare workers reported significant increases in vocal effort and dyspnea while wearing masks, and showed greater effort and poorer vocal quality at the end of the workday compared to the beginning of the day. Despite these negative changes, very few healthcare workers reported using any type of communication strategy (e.g., taking breaks, using gestures). Therefore, the investigators developed educational modules to address the voice and communication problems facing this population. This clinical trial plans to evaluate how these educational modules impact subjective/objective voice and communication measures in mask-wearing healthcare workers.

Eligibility criteria: Inclusion Criteria:

* English Speaker
* Occupational voice user who is required to wear a mask at work

Exclusion Criteria:

* History of neurological disorder or disease
* History of head/neck cancer
* Current speech, language, voice, or hearing problem/disorder
* Currently sick or have been sick within the last 14 days, or is waiting on a COVID-19 test result

Primary outcomes:
measure: Change in amount of Vocal Effort after 1 week
timeFrame: Assessed prior to module viewing and again 1-week later
measure: Learning of Health Information
timeFrame: Assessed immediately after viewing the modules
Secondary outcomes:
measure: Change in Relative fundamental frequency
timeFrame: Assessed prior to viewing modules, and then 1-week later
measure: Module Information Retention
timeFrame: Assessed at second session
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Victoria McKenna
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Victoria McKenna, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02073942: Cologne Register of Wearable Defibrillator (CRWD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Ventricular Dysfunction
Myocarditis
Lead sponsor: University of Cologne
Sponsor class: OTHER
Collaborators: name: Zoll Medical Corporation
First posted: 2014-02-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with an indication for wearable defibrillator

Brief summary: The wearable cardiac defibrillator (WCD) is an alternative to the implantation of cardioverter defibrillator (ICD) for patients at high risk for sudden cardiac death (mostly bridging therapy). The Cologne register of wearable defibrillator (CRWD) is a prospective register for all patient with an indication of wearable defibrillator.


Eligibility criteria: Inclusion Criteria:

* Adult patients with an indication for wearable defibrillator

Exclusion Criteria:

* childs

Primary outcomes:
measure: Number of arrhythmic events and arrhythmic risk factors during bridging therapy with wearable defibrillator
timeFrame: 3 years
Secondary outcomes:
measure: Total mortality
timeFrame: 1 months and 3 months
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University of Cologne
Study officials:
References:
Clinical trial NCT00529542: A Trial of Lipitor (Atorvastatin) for the Treatment of Polycystic Ovary Syndrome (PCOS) in Women With Elevated Low-density Lipoprotein (LDL) Cholesterol
Official title: A Six-week Double Blinded, Randomized Trial of Atorvastatin for the Treatment of PCOS Women With Elevated LDL Cholesterol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Polycystic Ovary Syndrome
Keywords: Polycystic Ovary Syndrome
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2007-09-14
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy of Lipitor (Atorvastatin) for the treatment of PCOS with elevated LDL cholesterol.

Detailed description: The investigators hypothesize that improving the lipid profile with atorvastatin will improve vascular function, increase the frequency of ovulation, decrease androgen levels, improve insulin sensitivity, and improve the lipid profile more efficiently than placebo.

Eligibility criteria: Inclusion Criteria: Women with PCOS

* 8 or fewer menstrual periods per year
* elevated serum total testosterone
* elevated LDL cholesterol

Exclusion Criteria:

* current pregnancy or breastfeeding
* current use of oral contraceptives, progestins
* insulin sensitizing medications
* thyroid disease, hyperprolactinemia, active liver disease, type 1 or type 2 diabetes

Primary outcomes:
measure: Brachial Artery Flow-mediated Dilation (FMD)
timeFrame: baseline and 6 weeks
Secondary outcomes:
measure: Peak Brachial Artery Conductance (BAC)
timeFrame: baseline and 6 weeks
measure: Total Cholesterol
timeFrame: baseline and 6 weeks
measure: LDL Cholesterol
timeFrame: baseline and 6 weeks
measure: HDL Cholesterol
timeFrame: baseline and 6 weeks
measure: Triglycerides
timeFrame: baseline and 6 weeks
measure: Fasting Glucose
timeFrame: baseline and 6 weeks
measure: Fasting Insulin
timeFrame: baseline and 6 weeks
measure: Area Under the Curve (AUC) for Glucose During OGTT
timeFrame: baseline and 6 weeks
measure: AUC for Insulin
timeFrame: baseline and 6 weeks
measure: Total Testosterone
timeFrame: baseline and 6 weeks
measure: Androstenedione
timeFrame: baseline and 6 weeks
measure: DHEAS
timeFrame: baseline and 6 weeks
Other outcomes:
measure: High-sensitivity C-reactive Protein (hsCRP)
timeFrame: baseline and 6 weeks
Locations:
city: Hershey
country: United States
facility: Penn State Milton S Hershey Medical Center, College of Medicine
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine
name: Richard S Legro, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Raja-Khan N, Kunselman AR, Hogeman CS, Stetter CM, Demers LM, Legro RS. Effects of atorvastatin on vascular function, inflammation, and androgens in women with polycystic ovary syndrome: a double-blind, randomized, placebo-controlled trial. Fertil Steril. 2011 Apr;95(5):1849-52. doi: 10.1016/j.fertnstert.2010.11.040. Epub 2010 Dec 8.
Clinical trial NCT02552342: Corticosteroid Therapy for Severe Community-Acquired Pneumonia
Official title: Efficacy of Methylprednisolone in Severe Community-acquired Pneumonia，A Multi-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Community Acquired Pneumonia
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: The Second Hospital of Hebei Medical University
name: Tianjin Medical University General Hospital
name: Cangzhou Central Hospital
name: Cangzhou People's Hospital
name: Affiliated Hospital of Hebei University
name: Nantong University
name: The First Affiliated Hospital of Anhui Medical University
name: Northern Jiangsu People's Hospital
name: First Affiliated Hospital of Wenzhou Medical University
name: Zhejiang University
name: Taishan Medical University Affiliated Hospital
name: Tianjin Third Central Hospital
name: Jinhua Central Hospital
name: Navy General Hospital, Beijing
First posted: 2015-09-17
Enrollment: 610
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the present study is to assess the efficacy of methylprednisolone as an adjuvant therapy in patients with severe community-acquired pneumonia (CAP) (PSI 4-5).

The hypothesis of the study is that methylprednisolone can decrease the mortality of severe CAP without any significant side effects,with reduction of the time to clinical stability and failure rate of treatment.


Eligibility criteria: Inclusion Criteria:

* community-acquired pneumonia
* PSI score：4-5
* with at least one of following conditions：①CRP ≥150 mg/L,②oxygen index ≤250 , ③bilateral or multi-lober infiltrates in chest image,④ area of pulmonary infiltrates increase \>50% with 48 hous,⑤fever higher than 39℃ exceed 72 hours

Exclusion Criteria:

* nosocomial Pneumonia
* aspiration pneumonia
* acute burn injury
* gastrointestinal bleeding within the past three months
* uncontrolled diabetes mellitus
* pregnant or breast feeding
* a condition requiring treatment with greater than 0.5 mg/kg/d of prednison or its equivalent
* severe immunosuppression (human immunodeficiency virus infection, immunosuppressive conditions or medications)
* active tuberculosis
* preexisting medical condition with a life expectancy of less than 3 months

Primary outcomes:
measure: All cause mortality
timeFrame: 30-days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Xuezhong Yu, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02804542: Fascia Iliaca Blocks and Pre-operative Opioid Requirements in Hip Fracture Patients
Official title: Pre-operative Fascia Iliaca Blocks and Opioid Requirements in Hip Fracture Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Fracture
Keywords: fascia iliaca blocks
Lead sponsor: Spectrum Health Hospitals
Sponsor class: OTHER
Collaborators: name: Grand Rapids Medical Education Partners
First posted: 2016-06-17
Enrollment: 29
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients \>65 years of age presenting to Spectrum Health Butterworth hospital with low-energy hip fractures (displaced and non-displaced femoral neck, pertrochanteric-type including subtrochanteric extension) will be screened for the study.

Brief summary: The purpose of this study is to determine if non-continuous local anesthetic fascia iliaca blocks performed in the emergency department are effective for preoperative analgesia in hip fracture patients. Investigators hypothesize that patients with these blocks will have lower opioid requirements than patients in a historical group in whom blocks were not performed.


Eligibility criteria: Inclusion Criteria:

* low energy femoral neck and pertrochanteric-type hip fractures
* age 65+
* intact cognition upon admission and ability to provide written informed consent

Exclusion Criteria:

* pathologic fractures (tumor)
* high energy fractures
* concomitant fractures besides hip fractures
* chronic home opioid exposure prior to hospitalization
* moderate to severe dementia
* pre-fracture hospitalization
* time from arrival to block \>6 hours
* time from arrival to OR \<6 hours or \>48 hours

Primary outcomes:
measure: Total Pre-op IV Morphine Equivalents (TIVME)
timeFrame: From Date of admission until date of surgery, approximately 48 hours
Secondary outcomes:
measure: Mean Pre-op Pain Score
timeFrame: From Date of admission until date of surgery, approximately 48 hours
measure: Length of Hospital Stay (LOS)
timeFrame: Through study completion, approximately 5 days
Other outcomes:
Locations:
Study officials:
affiliation: ECS
name: Matthew Flannigan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02291042: Effect of an Anti-spasmodic Suppository to Improve Comfort After Urologic Surgery
Official title: Pre-operative Administration of a Muscarinic Antagonist for Elective Cystoscopy Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Keywords: Bladder
Surgery
Lead sponsor: Southern New Hampshire Medical Center
Sponsor class: OTHER
First posted: 2014-11-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study evaluates the ability of a belladonna and opium suppository given prior to surgery to improve bladder comfort after surgery for patients who are having elective ureteroscopy surgery.

Detailed description: Belladonna and opium suppositories are administered postoperatively to relieve bladder discomfort usually caused by bladder spasms. The onset of action of the suppository is 30-60 minutes. Bladder spasms are more likely to occur following uteroscopy procedures. The spasms result in a felt desire to void, even when there is no urine in the bladder. The spasms can produce pain or a sense of severe urgency.

By administering a belladonna and opium suppository at the beginning of surgery, it is hoped that there will be a decrease in the incidence of bladder spasms, increased comfort and less need for additional medications.

Eligibility criteria: Inclusion Criteria:

* Patients from one urology practice schedule for elective uteroscopy.

Exclusion Criteria:

* Patients with pre-operative indwelling catheter or urinary stent.
* Patients who report any allergy to belladonna or opium.

Primary outcomes:
measure: Difference in mean bladder comfort (baseline at PACU admission to PACU discharge) between experimental and control groups
timeFrame: Length of postoperative stay from admission to PACU to discharge from PACU an expected average of 2 hours
Secondary outcomes:
measure: Duration of PACU length of stay
timeFrame: Time from admission to PACU to discharge from PACU an expected average of 2 hours
Other outcomes:
measure: Requirements for rescue therapy for pain and urgency
timeFrame: From PACU admission to PACU discharge an expected average of 2 hours
Locations:
Study officials:
affiliation: Southern New Hampshire Medical Center
name: Susan J Fetzer, PHD RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lukasewycz S, Holman M, Kozlowski P, Porter CR, Odom E, Bernards C, Neil N, Corman JM. Does a perioperative belladonna and opium suppository improve postoperative pain following robotic assisted laparoscopic radical prostatectomy? Results of a single institution randomized study. Can J Urol. 2010 Oct;17(5):5377-82.
citation: Scavonetto F, Lamborn DR, McCaffrey JM, Schroeder DR, Gettman MT, Sprung J, Weingarten TN. Prophylactic belladonna suppositories on anesthetic recovery after robotic assisted laparoscopic prostatectomy. Can J Urol. 2013 Jun;20(3):6799-804.