louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02874261: Whole Body Periodic Acceleration on Activity and Sleep In Parkinson's Disease
Official title: Effects of Whole Body Periodic Acceleration on Activity and Sleep In Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disorders
Physical Activity
Lead sponsor: New York Institute of Technology
Sponsor class: OTHER
First posted: 2016-08-22
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Whole-body periodic acceleration (WBPA) is a new, non-invasive, and promising therapy for a diverse and growing list of disorders including cardiovascular disease. During WBPA, patients lie in the supine position on a bed that is capable of translating back and forth parallel to the ground, along the head-to-foot axis of the patient. Thus, this treatment is best described as a form of "passive exercise." The frequency of the translation (up to 180 cycles/minute; cpm) as well as the distance traveled (2-24mm) by the bed can be adjusted by the patient or health care professional.

The science behind the therapeutic effects of WBPA still remains largely unknown.

The investigators are observing how WBPA may impact on sleep and activity in individuals with Parkinson's disease.

Detailed description: Sleep disturbances are common in individuals with Parkinson's Disease. Whole-body periodic acceleration (WBPA) is a new, non-invasive, and promising therapy for a diverse and growing list of disorders. During WBPA, patients lie in the supine position on a bed that is capable of translating back and forth parallel to the ground, along the head-to-foot axis of the patient. Thus, this treatment is best described as a form of "passive exercise." WBPA has been shown in previous studies to increase nitric oxide. Increased levels of nitric oxide have been shown to improve sleep patterns in other populations. The current pilot study will investigate how WBPA will impact upon sleep disturbances in subjects with Parkinson's disease who suffer from abnormal sleep patterns. The investigators will record sleep patterns and activity levels using a Jawbone U3® activity monitor.

Eligibility criteria: Inclusion Criteria:

* Healthy individuals between the ages of 50-80
* Individuals with Parkinsons disease between the ages of 50-80
* Individuals with a smart phone

Exclusion Criteria:

* Any condition that prevents you from lying flat on your back, any other neurological condition than Parkinson's disease.

Primary outcomes:
measure: Sleep patterns using an activity monitor on the wrist
timeFrame: 6 weeks
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: 6 weeks
measure: Physical Activity (steps per day using an activity monitor on the wrist)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Old Westbury
country: United States
facility: NYIT
state: New York
Study officials:
affiliation: NYIT
name: Veronica Southard, DPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07017361: ERAS Program Implementation for MIPD
Official title: A Multicenter Randomized Prospective Study on Establishing an ERAS Program and Optimized Clinical Protocol for Patients Undergoing Minimally Invasive Pancreatoduodenectomy (MIPD)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pancreaticoduodenectomy
ERAS
Minimally Invasive Surgery
Keywords: Pancreaticoduodenectomy
ERAS
Minimally Invasive Surgery
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: SMG-SNU Boramae Medical Center
name: Korea University Anam Hospital
First posted: 2025-06-12
Enrollment: 140
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the impact of an Enhanced Recovery After Surgery (ERAS) program on postoperative recovery in patients undergoing minimally invasive pancreatoduodenectomy (MIPD)


Eligibility criteria: Inclusion Criteria:

* Age ≥ 19 years, scheduled for standard minimally invasive (robotic or laparoscopic) pancreatoduodenectomy for periampullary tumors
* ECOG performance status of 0 or 1 at screening
* Able to provide written informed consent, understand study procedures, and complete patient-reported questionnaires
* ASA physical status classification I-III

Exclusion Criteria:

* Hypersensitivity to fentanyl or ropivacaine
* Cognitive impairment preventing independent use of patient-controlled analgesia or completion of questionnaires
* Major internal medical or psychiatric disorders affecting treatment response
* Severe hepatic or renal dysfunction
* Any condition deemed inappropriate for study participation by the investigator

Primary outcomes:
measure: Proportion of Participants Meeting Discharge Criteria by Post-operative Day 5 Afternoon
timeFrame: Up to the afternoon of Post-operative Day 5
Secondary outcomes:
measure: Length of Post-operative Hospital Stay (Days)
timeFrame: Post-operative Day 0 until hospital discharge (assessed up to Post-operative Day 30)
measure: Incidence of Major Complications (Clavien-Dindo ≥ Grade IIIa) Within 30 Days
timeFrame: Post-operative Day 0 to Day 30
measure: Total Direct Medical Costs per Participant (KRW) During Index Hospitalization
timeFrame: Post-operative Day 0 until hospital discharge (assessed up to Post-operative Day 30)
Other outcomes:
Locations:
city: Daehak-ro, Jongno-gu
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul
Study officials:
References:
Clinical trial NCT04508361: Test-retest Reliability for Fatigue Assessment Scale, Short Form 6 Dimension and King's Sarcoidosis Questionnaire
Official title: Test-retest Reliability for Fatigue Assessment Scale, Short Form 6 Dimension and King's Sarcoidosis Questionnaire
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sarcoidosis
Lead sponsor: University of East Anglia
Sponsor class: OTHER
Collaborators: name: Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
First posted: 2020-08-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with sarcoidosis and fatigue

Brief summary: This study aims to see if people's health related quality of life (how they feel about their health) changes over a 12 week period if they do not receive any change in their medicines. The investigators would like people to complete four questionnaires then repeat them after three months. The investigators need to do this to in order see what difference they should expect to detect if they give people treatment that works.

Detailed description: Study Design This will be a questionnaire study, which will involve administering questionnaires to patients with sarcoidosis at baseline and after six and 12 weeks.

Participants can either complete the questionnaires whilst they are attending clinic, or alternatively return the questionnaires via a pre-paid postal envelope. The questionnaires will be administered at the same time; no other study measures will be taken subsequently. Demographic and clinical information will be collected from the patients' medical records.

Eligibility criteria: Inclusion Criteria:

* Male or Female aged over 18
* Diagnosed with sarcoidosis by either; biopsy confirming non-caseating granulomas consistent with sarcoidosis, or multi-disciplinary interstitial lung disease meeting diagnosis of sarcoidosis
* Significant fatigue - defined as a FAS score of greater than 21 points
* Has mental capacity to complete the questionnaires

Exclusion Criteria:

* Presence of another significant cardio-respiratory disease, major organ disease (except where related to sarcoidosis) or chronic inflammatory condition

Primary outcomes:
measure: Fatigue Assessment Scale (FAS)
timeFrame: Change from baseline to 12 weeks
Secondary outcomes:
measure: Short Form 36 (SF-36)
timeFrame: Change from baseline to 12 weeks
measure: Kings' Sarcoidosis Questionnaire (KSQ)
timeFrame: Change from baseline to 12 weeks
measure: Global rating of concept scale
timeFrame: Change from baseline to 12 weeks
measure: The global rating of change
timeFrame: Change from 6 weeks to 12 weeks
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: Norwich Medical School
state: Norfolk
Study officials:
References:
Clinical trial NCT00669461: Lubiprostone as a Treatment for Constipation in Parkinson's Disease
Official title: Lubiprostone as a Treatment for Constipation in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Constipation
Parkinson's Disease
Keywords: Constipation
Parkinson's Disease
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: Takeda
First posted: 2008-04-30
Enrollment: 1
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Delayed colonic transient time secondary to a multi-degenerative process is the most likely cause of constipation in idiopathic PD. Since lubiprostone demonstrated its ability to accelerate colonic transit time in healthy volunteers in addition to activating the chloride channels in the intestinal cells, it has the potential to improve constipation in patients with PD with no subsequent adverse events on the control of the neurological manifestation of PD. So we hypothesize the following:

1. Lubiprostone will improve ratings on the Bristol stool form scale (BSFS) in patients with PD induced constipation compared to baseline.(primary)
2. Lubiprostone will increase the number of spontaneous bowel movements (SBM) per week, compared to baseline. (secondary)
3. Lubiprostone will improve health related quality of life in subjects with PD induced constipation. ( secondary)


Eligibility criteria: Inclusion Criteria:

1. Age 50-85 years
2. Diagnosis of Parkinson's disease
3. Constipation as defined by the Rome III committee
4. BSFS of more or equal to 1 and less or equal to 3
5. Normal colonoscopy in the last 5 years( normal defined as absence of obstructive lesions in the colon)
6. All women subjects will be post menopausal or surgically sterile.

Exclusion Criteria:

1. Known hypersensitivity reaction to Amitiza ( Lubiprostone)
2. Known significant adverse effects to previous treatment with Lubiprostone which include; new or worsening abdominal pain, severe diarrhea, nausea, vomiting, and severe headache.
3. Renal dysfunction with creatinine clearance less than 15 ml/min
4. Abnormal liver enzymes or history of chronic liver disorder
5. History of bowel obstruction, , or abdominal adhesions .
6. Abnormal Colonoscopy ( obstructive lesions within the colon)
7. Inability to give informed consent

Primary outcomes:
measure: Average Bristol Stool Form Scale (BSFS) at Baseline, End of 4 Weeks and End of 6 Weeks
timeFrame: up to 6 weeks
Secondary outcomes:
measure: Average Number of Spontaneous Bowel Movements (SBM) Per Week
timeFrame: up to 6 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Muhannad M Heif, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00375661: Low-dose Peg-interferon Plus Ribavirin (IFN/RBV) for Prevention of Hepatocellular Carcinoma (HCC) Recurrence in Patients Who Had Surgery to Remove Primary HCC
Official title: Phase 4 Study of Peg-interferon Plus Ribavirin Therapy for Prevention of Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C, Chronic
Keywords: hepatocellular carcinoma
Lead sponsor: Kyoto University Hospital
Sponsor class: OTHER
First posted: 2006-09-13
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether low-dose peg-interferon plus ribavirin therapy is effective in the prevention of hepatocellular carcinoma (HCC) in patients who had the curative resection of primary HCC.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Hepatocellular carcinoma due to Chronic Hepatitis C Virus Infection.
* Must be treated with curative treatment for primary tumor using either surgical resection or radiofrequency ablation therapy

Exclusion Criteria:

* No recurrence of hepatocellular carcinoma 3 months after the primary treatment
* Renal dysfunction

Primary outcomes:
measure: Incidence of adverse effect of interferon
timeFrame: During the treatment period
Secondary outcomes:
Other outcomes:
Locations:
city: Kyoto
country: Japan
facility: Department of Gastroenterology and Hepatology, Kyoto University Hospital
city: Osaka
country: Japan
facility: Osaka Red Cross Hospital
Study officials:
affiliation: Kyoto University Hospital
name: Tsutomu Chiba, M.D.,Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT00904761: Effects of Physical Training on Heart Rate Variability and Exercise Capacity in Diabetes With Autonomic Neuropathy
Official title: Effects of Physical Training on Heart Rate Variability and Exercise Capacity in Diabetes With Autonomic Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: diabetes mellitus
autonomic neuropathy
exercise training
exercise capacity
heart rate variability
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2009-05-20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study aimed to investigate effects of physical training on exercise capacity and changes of heart rate variability (HRV) at rest, during exercise, and post-exercise in the patient with diabetes with autonomic neuropathy (DAN).


Eligibility criteria: Inclusion Criteria:

* aged under 65 years old
* receiving regular treatment
* HbA1c \< 8.0
* decreased HR response in deep breathing maneuver

Exclusion Criteria:

* heart disease
* neuro-musculo-skeletal diseases
* taking any medication that may affect HRV (such as α or β-blockers)

Primary outcomes:
measure: heart rate variability
timeFrame: 8 weeks
measure: exercise capacity
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Ying-Tai Wu, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03220061: Effectiveness of Music Therapy on Blood Pressure and Anxiety Among Patients Undergoing Haemodialysis
Official title: Effectiveness of Music Therapy on Blood Pressure and Anxiety Among Patients Undergoing Haemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Diseases
Lead sponsor: Maharishi Markendeswar University (Deemed to be University)
Sponsor class: OTHER
First posted: 2017-07-18
Enrollment: 60
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: music therapy was soft and relaxing instrumental piano music which was given among haemodialysis patients for 30 minutes
Primary purpose: PREVENTION

Brief summary: Effectiveness of music therapy on blood pressure and anxiety among patients undergoing haemodialysis

Detailed description: Abstract Introduction:- dialysis is one of the technological innovation in medicine in which patients are being reported to face psychosocial and physiological problems such as anxiety, stress and hypertension etc. To relieve these problems, music therapy has been widely used as a non-pharmacological intervention with the aim to assess the effectiveness of music therapy on blood pressure and anxiety among haemodialysis patients.

Methods:- current study using true experimental pre-test post-test design was conducted among 60 haemodialysis patients which were randomly allocated to experimental (30) and control (30) group using simple random sampling. The data was collected through sample characteristics performa, blood pressure monitoring data sheet and beck anxiety inventory. Patients in experimental group were provided with 30 minutes of music therapy using slow and calm relaxing instrumental piano music whereas in control group only usual care was given.

Eligibility criteria: Inclusion Criteria:

* willing to participate in study
* alert, oriented and able to comprehend, speak and listen Hindi or English language.

Exclusion Criteria:

* altered sensorium
* hypotension
* unresponsiveness
* hearing disabilities

Primary outcomes:
measure: beck anxiety inventory
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ambala
country: India
facility: Maharishi Markandeshwar University
state: Haryana
Study officials:
affiliation: maharishi markandeshwar university
name: anu R panchal, nursing
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00154661: Evaluation of Clinical Efficacy of Pentoxifylline on Patients With Glomerulonephritis
Official title: Evaluation of Clinical Efficacy of Pentoxifylline on Patients With Glomerulonephritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Glomerulonephritis
Keywords: glomerulonephritis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: we hypothesize that PTX might be effective in lowering proteinuria by modulating renal MCP-1 production in human glomerulonephritis.

Detailed description: Pentoxifylline (PTX) is a phosphodiesterase inhibitor that is widely used for the treatment of peripheral vascular occlusive disorders. In addition, PTX has shown its ability to attenuate nephrotic syndrome secondary to membranous glomerulonephritis and lupus nephritis, and to reduce subnephrotic proteinuria due to early and advanced diabetic nephropathy. However, data with respect to its effect on non-nephrotic primary glomerular diseases are lacking. Moreover, while the anti-proteinuric effect of PTX has been largely attributed to down-regulation of TNF-a, it remains unknown whether other mediators, especially MCP-1, are also affected by PTX. Because our previous works have shown that PTX attenuates proteinuria and suppresses renal MCP-1 mRNA expression in experimental glomerulonephritis in rats, we hypothesize that PTX might be effective in lowering proteinuria by modulating renal MCP-1 production in human glomerulonephritis. This study was thereby conducted to investigate the potential anti-proteinuric and anti-MCP-1 effects of PTX in subnephrotic patients with primary glomerular diseases.

Eligibility criteria: Inclusion Criteria:

* glomerular diseases with subnephrotic proteinuria

Exclusion Criteria:

* DM, hepatitis, systemic immunologic renal diseases

Primary outcomes:
measure: proteinuria
Secondary outcomes:
measure: inflammatory mediators
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Yung-Ming Chen
Study officials:
affiliation: Professor and vice-Dean
name: Pan-Chyr Yang
role: STUDY_CHAIR
References:
Clinical trial NCT01323361: CA125 Levels and Other Inflammatory Markers in Laparoscopic Ventral Hernia Repair
Official title: Multi-centre Observational Pilot-study for Evaluation of Variation in CA-125 and Other Inflammatory Markers in the Perioperative Period of Laparoscopic Ventral Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernia
Keywords: inflammation
laparoscopy
hernia
incisional
trauma
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Sykehuset Innlandet HF
First posted: 2011-03-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study aims to show variation in CA-125 and other inflammatory markers assumed to be a response to trauma and peritoneal inflammation in the perioperative period of laparoscopic ventral hernia repair

Detailed description: CA-125 and other inflammatory markers as body temperature, CRP, PCT, leucocytes and neutrophils measured pre- and post-operatively - correlated to trauma size i.e. area of dissection, mesh size, number of fixation points etc.

Eligibility criteria: Inclusion Criteria:

* Adults admitted for ventral or incisional hernia repair

Exclusion Criteria:

* Loss-of-domain
* ASA above III
* Liver failure
* Abnormal CA-125 prior to surgery

Primary outcomes:
measure: Level of variation in inflammatory markers related to "trauma" impact
timeFrame: 6 weeks post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Rikshospitalet
state: Akershus
city: Gjøvik
country: Norway
facility: Sykehuset Innlandet HF
state: Oppland
Study officials:
affiliation: Sykehuset Innlandet HF
name: jan r lambrecht, md
role: STUDY_DIRECTOR
affiliation: Oslo University Hospital
name: ole m øyen, Dr. Med.
role: STUDY_CHAIR
affiliation: Oslo University Hospital
name: erik trondsen, Dr. Med.
role: STUDY_CHAIR
References: