louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05846698: The Effects of Luo-Bu-Fu-Ke-Bi-RI Pill
Official title: The Effects of Luo-Bu-Fu-Ke-Bi-RI Pill
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Climacteric Syndrome
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 276
Sex: FEMALE
Minimum age (years): 41
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: female

Brief summary: To investigate the effect of LBFKBRP on climacteric syndrome in women and explore its therapeutic mechanism.


Eligibility criteria: Clinical diagnosis of climacteric syndrome

Primary outcomes:
measure: Sex hormone
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
References:
Clinical trial NCT04144998: Central Sensitization and Outcome of Endometriosis Surgery
Official title: Substudy on Central Sensitization and Outcome of Endometriosis Surgery of the PROMPT Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2019-10-30
Enrollment: 71
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients scheduled for elective endometriosis surgery

Brief summary: This study will evaluate whether the degree of central sensitization as measured by the questionnaire "central sensitization inventory CSI" is related to the outcome of surgical endometriosis treatment


Eligibility criteria: Inclusion Criteria:

* Primary surgery because of pelvic/abdominal pain under suspected diagnosis of and with the aim to confirm endometriosis
* Elective abdominal surgery in women with pelvic/abdominal pain and confirmed endometriosis

Exclusion Criteria:

* Patient is unable to give consent
* Cognitive impairment
* Patient outcomes questionnaire is not available in a language that the patient knows.
* Secondary surgery due to complications
* Endometriosis Surgery due to infertility

Primary outcomes:
measure: endometriosis health profile EHP-30 pain subscale
timeFrame: 6 months
Secondary outcomes:
measure: other subscales of the endometriosis health profile EHP-30
timeFrame: 6 months
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires de Genève
Study officials:
References:
Clinical trial NCT00376298: Urology Database to Evaluate Clinical Information and Improve Patient Care.
Official title: Urology Database for Outcomes Research
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Incontinence
Prostate Cancer
Interstitial Cystitis
Urinary Retention
Pelvic Organ Prolapse
Keywords: incontinence
prostate cancer
interstitial cystitis
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
Collaborators: name: William Beaumont Hospitals
First posted: 2006-09-14
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and Women with conditions including radical prostatectomy, pelvic organ prolapse and neurostimulator implantation at William Beaumont Hospital

Brief summary: The purpose of initiating the Urology Database is to evaluate the outcomes of urology procedures and medical management to enhance the care and treatment of urology patients.

Detailed description: The current study population will include all patients having had a radical prostatectomy for the treatment of prostate cancer, surgical prolapse repair as well as patients having had InterStim sacral nerve stimulator implantation. The database will house data extracted from the medical records. Patient demographics, and preoperative, intra-operative, postoperative, and follow-up clinical data will be collected.

Eligibility criteria: Inclusion Criteria:

All patients undergoing radical prostatectomy, pelvic organ prolapse repair and neurostimulator (Interstim) implantation at William Beaumont Hospital beginning January 1, 1998, as well as other urology patients as research questions are identified. Only patients who have accepted William Beaumont Hospital's Privacy Notices will be included in the database.

Exclusion Criteria:

Patients not acknowledging acceptance of William Beaumont Hospital's Privacy Notices.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Kenneth Peters, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00542698: Changing Physical Activity Behavior in Individuals With Type 2 Diabetes Using Counceling and Information From Continuous Glucose Monitoring
Official title: Changing Activity Behavior With Glucose Sensor Feedback
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
Glucose Monitor graphs
Physical Activity
Lead sponsor: National Institute of Nursing Research (NINR)
Sponsor class: NIH
First posted: 2007-10-11
Enrollment: 52
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to develop a nurse counseling intervention to increase physical activity behavior in people with type 2 diabetes and to improve their health

Detailed description: Diabetes affects 20.8 million Americans and is the fifth leading cause of death in the United States. Although physical activity is a cornerstone in the treatment of diabetes, it is difficult to change physical activity behaviors and up to 60% of individuals with diabetes do not participate in regular physical activity. The use of a nurse counseling intervention based on established behavior change theory with technology-derived graphical representations of glucose information created a unique opportunity to test the feasibility of motivating people with type 2 diabetes to change physical activity behaviors. The consent form described the study protocol, participant expectations, benefits, risks, and the process of maintaining participant confidentiality.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Type 2 Diabetes Mellitus
* Three month blood sugar test (HbA1c) \> 7.5%
* Not receiving insulin to manage diabetes
* Not engaged in a physical activity program more than 2 days per week
* Able to read and speak English

Exclusion Criteria:

* Not able to walk ¼ mile in 10 minutes
* Taking glucocoricoids
* Serious health problems, such as heart problems, found on examination.

Primary outcomes:
measure: increased physical activity
timeFrame: 8 Weeks
Secondary outcomes:
measure: BP, BMI, & HgA1c (a long term measure of blood glucose)
timeFrame: 8 Weeks
Other outcomes:
Locations:
city: Pittsfield
country: United States
facility: Berkshire Health System
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Health System
state: Massachusetts
Study officials:
affiliation: University of Massachusetts Worcester Medical School
name: Nancy A Allen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abstract -OR 27: Effect of Counseling with Continuous Glucose Monitoring on Physical Activity Behaviors June 2006, Oral Presentation for American Diabetes Association 66th Scientific Session, Washington D.C
Clinical trial NCT04476498: Prospective Comparison of Pull-PEG and Pull-PEG With Gastropexy
Official title: Incidence of Peristomal Infection After Pull-PEG Compared to Pull-PEG With Gastropexy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peristomal Infection Rate
Postinterventional Bleeding
Postinterventional Mortality Rate
Keywords: Pull-PEG
Pull-PEG with gastropexy
Peristomal infection rate
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study is a randomised prospective monocentric study with a one to one allocation in two different treatment arms.
Primary purpose: TREATMENT

Brief summary: The study aims to compare the conventional pull-percutaneous endoscopic gastrostomy (pull-PEG) with a pull-PEG with gastropexy suture regarding the peristomal infection rate.

Detailed description: Pull-percutaneous endoscopic gastrostomy (Pull-PEG) is currently the standard technique for enteral nutrition in patients with swallowing disorders. Fistula and peristomal infection rates are one of the most common early complications which are caused by bacterial transmission through the oropharyngeal passage of the tube and by bacterial translocation out of the stomach into the abdominal wall. Retrospective data have shown that if pull-PEGs are attached with a gastropexy suture, the abdominal wall and stomach are fixed tightly and peristomal infection rates can be reduced significantly.

This randomised study wants to compare the peristomal infection rate of standard pull-PEGs and pull-PEGs with gastropexy suture. Peristomal infection rate is detected by classical inflammation rates including erythema, exsudates, and induration, development of pus, or focal peritonitis.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 and over with an indication for a PEG-insertion

Exclusion Criteria:

* ASA-classification \>4
* female patients who are pregnant or breast feeding
* existing contraindications for a PEG-implantation

Primary outcomes:
measure: Peristomal infection rate
timeFrame: 36 months
measure: Postinterventional bleeding
timeFrame: 36 months
measure: Postinterventional occurrence of fistulas
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Klinikum der J. W. Goethe-Universität
state: Hessen
Study officials:
affiliation: Johann Wolfgang Goethe University Hospital
name: Mireen Friedrich-Rust, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT02001298: Remifentanil and Nitroprusside for Controlled Hypotension
Official title: The Comparison of the Cardiovascular Effects of Remifentanil and Nitroprusside for Controlled Hypotension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypotension, Controlled
Keywords: remifentanil
nitroprusside
hypotension
Lead sponsor: Jeju National University School of Medicine
Sponsor class: OTHER
First posted: 2013-12-04
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is the comparison of the cardiovascular effects of remifentanil and nitroprusside for controlled hypotension


Eligibility criteria: Inclusion Criteria:

* Patients who underwent endoscopic sinus surgery

Exclusion Criteria:

* patient who took any drug to influence this study
* patient with cardiovascular disease, renal disease or liver disease

Primary outcomes:
measure: Cardiac index
timeFrame: Cardiac index was continuously measured during controlled hypotension, an average of 90 min
Secondary outcomes:
measure: Total peripheral resistance index
timeFrame: Total peripheral resistance index was continuously measured during controlled hypotension, an average of 90 min
Other outcomes:
measure: Stroke volume index
timeFrame: Stroke volume index was continuously measured during controlled hypotension, an average of 90 min
Locations:
city: Jeju-si
country: Korea, Republic of
facility: Jeju National University Hospital
state: Jeju Special Self-Governing Province
Study officials:
References:
Clinical trial NCT03566498: The Effect Of Immediate Versus Early Oral Hydration On Caesarean Section Post Operative Outcomes
Official title: The Effect Of Immediate Versus Early Oral Hydration On Caesarean Section Post Operative Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-06-25
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to evaluate the effect of immediate oral hydration initiated within 2 hours after uncomplicated Caesarean section

Detailed description: The aim of this study is to evaluate the effect of immediate oral hydration initiated within 2 hours after uncomplicated Caesarean section on the following post-operative outcomes:

1. Post-operative nausea, vomiting, abdominal distention and abdominal cramps.
2. Return of intestinal movements.
3. Duration of intravenous fluid administration.
4. Duration of hospital stay.
5. Participant satisfaction

Eligibility criteria: Inclusion Criteria:

* • Uncomplicated pregnancy.

  * Uncomplicated elective or emergency Caesarean section under regional anesthesia

Exclusion Criteria:

* • Having medical disorders in the form of: hypertension, DM, and Hepatic disorders.

  * Having bleeding disorders.
  * Having intraoperative bowel or bladder injury.
  * Having intraoperative or immediate postoperative severe bleeding.
  * Having chronic gastrointestinal problems, like chronic constipation, peptic ulcer, esophagitis, hiatus hernia or irritable bowel syndrome.
  * Having abdominal adhesions

Primary outcomes:
measure: Postpartum vomiting
timeFrame: 48 hours
Secondary outcomes:
measure: Return of intestinal movements
timeFrame: 24 hours
measure: Duration of intravenous fluid administration
timeFrame: 24 hours
measure: Duration of hospital stay
timeFrame: 48 hours
measure: Participant satisfaction
timeFrame: 48 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00798798: Effect of Externally Implantable Tissue Expansion Device on Scar Length
Official title: Effect of Externally Implantable Tissue Expansion Device on Scar Length
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Skin Lesion
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2008-11-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess whether brief use of an externally implantable tissue expansion device following excisional skin cancer surgery will significantly reduce the diameter of the final wound defect, and hence the length of the final linear primary closure. The secondary objective is to assess the functional benefits, if any, associated with use of the tissue expander.


Eligibility criteria: Inclusion Criteria

* Subjects ages 18-80 years old
* Subjects who are undergoing an excision of a large cutaneous lesion
* Subjects with an immediate post-excision wound defect at least 2.5 cm in diameter
* Subjects undergoing surgery on the trunk or extremities
* The subject has willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.
* Subjects who are willing to undergo no other treatments for the scars for the duration of the study.

Exclusion Criteria

* Subjects with scalp wounds
* Subjects who are unable to understand the protocol or give informed consent

Primary outcomes:
measure: Surface area (in cm2) of subject's scar
timeFrame: 3 months
Secondary outcomes:
measure: Treating physicians will note any adverse effects
timeFrame: 3 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02916498: Field Shape and Amplitude Sensitivity Exploratory Study (CONTOUR Study)
Official title: Field Shape and Amplitude Sensitivity Exploratory Study (CONTOUR Study)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Neuropathic Pain in the Low Back and Legs
Keywords: chronic neuropathic pain in the low back and legs
subperception spinal cord stimulation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2016-09-27
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The study aims to better understand how to program Spinal Cord Stimulation for the treatment of chronic low back and leg pain


Eligibility criteria: Key Inclusion Criteria:

* Documented average low back pain intensity of at least 6 out of 10 and greater or equal than average leg pain intensity over 7 days during screening (Numerical Rating Scale)
* Stable daily pain-related medication prescription and intake of ≤100mg morphine-equivalents
* Capacity to describe and rate pain intensity, complete study measurements, and use the study device (e.g. patient remote control, charger, diary ratings) (physician discretion)

Key Exclusion Criteria:

* Presence of pain or psychological condition that in the opinion of the investigator may interfere with the subject's ability to rate their pain and communicate such ratings
* Previous Spinal Cord Stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)

Primary outcomes:
measure: Patient Preferred Field Shape
timeFrame: 42 days post randomization
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St. Bartholomew's Hospital
city: Middlesborough
country: United Kingdom
facility: James Cook University Hospital
Study officials:
affiliation: James Cook University Hospital
name: Sam Eldabe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04913298: Prospective Study for the Application of Cytosorb® in Critically Ill Patients
Official title: Prospective Quality Assurance Study for the Application of Cytosorb® in Patients With Cytokine Storm, Rhabdomyolysis and Acute Liver Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rhabdomyolysis
Acute Liver Injury
Cytokine Storm
Keywords: Cytosorb
adsorption kinetics
saturation
critically ill patients
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2021-06-04
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The mortality of critically ill patients is persistently high and requires targeted therapy of pathophysiological disorders. One approach to optimize therapy is the use of the cytokine adsorber Cytosorb®, which has a CE certification for the indications hyperinflammation, rhabdomyolysis and liver failure and is therefore frequently used in patients with sepsis, polytrauma and acute liver failure. Although few clinical data describe the efficiency mostly retrospectively, there are no data on real-time elimination performance and saturation kinetics during the course of treatment. These questions should be answered by the present study.


Eligibility criteria: Inclusion Criteria:

* intensive care therapy
* hyperinflammation or acute liver dysfunction or rhabdomyolysis
* need of continuous renal replacement therapy
* treatment with Cytosorb (decision of the attending physician)

Exclusion Criteria:

- other reasons for Cytosorb application

Primary outcomes:
measure: Change (percentage) in different cytokines (measured as a cytokine panel) measured pre- and post-CytoSorb® (extracorporeal) in intensive care patients with hyperinflammation
timeFrame: 12 hours
measure: Change (percentage) in myoglobin measured pre- and post-CytoSorb® (extracorporeal) in intensive care patients with rhabdomyolysis
timeFrame: 12 hours
measure: Change (percentage) in bile acids (measured as a panel) measured pre- and post-CytoSorb® (extracorporeal) in intensive care patients with acute liver failure
timeFrame: 12 hours
Secondary outcomes:
measure: Change (percentage) in norepinephrine demand before and after the use of CytoSorb®
timeFrame: 2 years
measure: Change ( percentage ) of liver toxic substances (e.g. bile acids) in patients´ blood due to the use of CytoSorb®
timeFrame: 2 years
measure: Change ( percentage ) of myoglobin in patients´ blood due to the use of CytoSorb®
timeFrame: 2 years
measure: Difference (percentage) between predicted mortality and real mortality of patients treated with CytoSorb®
timeFrame: 2 years
Other outcomes:
Locations:
city: Munich
country: Germany
facility: LMU munich
state: Bavaria
Study officials:
References:
Clinical trial NCT01381198: Distal Rectus Femoris Transfer as a Part of Multilevel Surgery in Children With Spastic Diplegia
Official title: Distal Rectus Femoris Transfer as a Part of Multilevel Surgery in Children With Spastic Diplegia - a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: cerebral palsy
distal rectus femoris transfer
stiff knee gait pattern
gait analysis
single event multilevel surgery
randomized trial
crouch gait
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2011-06-27
Enrollment: 36
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of an additional distal rectus femoris transfer carried out as a part of single-event multilevel surgery in children with spastic diplegic cerebral palsy.


Eligibility criteria: Inclusion Criteria:

* cerebral palsy
* spastic diplegia
* ambulatory
* stiff knee gait

Exclusion Criteria:

* relevant previous surgery at the legs
* Botulinum-toxin-injections 6 months prior surgery

Primary outcomes:
measure: Range of knee flexion in swing phase
timeFrame: prior intervention (baseline) and 1 year post intervention
Secondary outcomes:
measure: Peak knee flexion in swing phase
timeFrame: prior to intervention (basline) and 1 year post intervention
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Orthopaedic Department, University of Heidelberg
Study officials:
References:
citation: Dreher T, Gotze M, Wolf SI, Hagmann S, Heitzmann D, Gantz S, Braatz F. Distal rectus femoris transfer as part of multilevel surgery in children with spastic diplegia--a randomized clinical trial. Gait Posture. 2012 Jun;36(2):212-8. doi: 10.1016/j.gaitpost.2012.02.017. Epub 2012 Mar 15.