louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01973010: Massage Therapy for Chronic Low Back Pain
Official title: Phase 1 Study of Massage Therapy for Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Low Back Pain
Keywords: massage
low back pain
Lead sponsor: Chengdu University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2013-10-31
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
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 whether massage is effective in the treatment of low back pain and to optimize clinical therapeutic schedule of massage for low back pain.

Detailed description: Chronic low back pain is a prevalent condition among adults. Large majority of the population suffer from Chronic low back pain in their lifetime. At present, there is still no standard treatment for chronic low back pain. Massage is commonly chose and widely used by sufferer as a complement to conventional treatment. However, its effectiveness is still not convinced. This trial is designed to assess the effectiveness of massage for chronic low back pain.

Eligibility criteria: Inclusion Criteria:

* In accordance of the diagnostic criteria of low back pain;
* Age between 20 and 55 years old;
* Not taking hormone drugs or antirheumatic drugs within the latest 2 months;
* No allergy history of hormone drugs Pain medicine;
* volunteer participation and signing an informed consent in writing.

Exclusion Criteria:

* Being pregnant or during lactation;
* Having suffered from serious psychiatric, neurologic, cardiovascular, respiratory, or renal illnesses, and so forth;
* Severe neurological deficits caused by severe lumbar disc protrusion, and operation indications;
* Receiving message therapy in past 3 months for releasing low back pain.

Primary outcomes:
measure: Change from baseline in Back function measured by Roland-Morris Disability Questionnaire at 2 months
timeFrame: At baseline, 4th, 6th, 8th week
Secondary outcomes:
measure: Japanese Orthopaedic Association Scores
timeFrame: At baseline, 4th, 6th, 8th week
measure: McGill pain questionnaire
timeFrame: At baseline, 4th, 6th, 8th week
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Acupuncture and Tuina college of Chengdu University of TCM
state: Sichuan
Study officials:
affiliation: Chengdu University of TCM
name: Fanrong Liang, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yang M, Feng Y, Pei H, Deng S, Wang M, Xiao X, Zheng H, Lai Z, Chen J, Li X, He X, Liang F. Effectiveness of Chinese massage therapy (Tui Na) for chronic low back pain: study protocol for a randomized controlled trial. Trials. 2014 Oct 29;15:418. doi: 10.1186/1745-6215-15-418.
Clinical trial NCT05983510: Outcomes After Visceral Aortic Coral Reef Surgery
Official title: Long Term Outcomes After Visceral Aortic Endarteriectomy for Coral Reef Lesion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Coral Reef
Lead sponsor: University Paul Sabatier of Toulouse
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who needed a coral reef surgery were included

Brief summary: Coral reef aorta is defined by a calcified stenosis of the visceral aorta which can cause leg claudication, renal failure and visceral ischemia depending the type and localisation of the stenosis.

This pathology is rare and is usually treated by open surgery with aortic endarteriectomy. Little is know about the outcomes after such aggressive surgery with short series and short follow up.

The authors propose a retrospective study from their institution to explore the post operative and long term outcomes after this surgery.

Detailed description: Coral reef aorta is defined by a calcified stenosis of the visceral aorta which can cause leg claudication, renal failure and visceral ischemia depending the type and localisation of the stenosis.

This pathology is rare and is usually treated by open surgery with aortic endarteriectomy.

Little is known in the literature regarding the outcomes of this aggressive surgery.

The authors propose a retrospective study from their institution describing the type of surgery realised. They describe the post operative outcomes of this surgery in term of cardiologic, respiratory, renal complication a,d surgical complication.

Moreover they follow the patients to present long term outcomes of this pathology with a description of the post operative recurrence of a coral reef, the permeability of the different target vessel and the cardiologic, respiratory and renal evolution of the different patients.

Eligibility criteria: Inclusion Criteria:

* Coral reef surgery
* Urgent intervention
* Claudication, renal, visceral involvement
* Thoracic aortic cross clamping (above coeliac trunk)

Exclusion Criteria:

* "simple" visceral aorto thrombectomy without opening laterally the aorta
* Pregnant

Primary outcomes:
measure: Major adverse cardiac event (MACE)
timeFrame: 1 month after surgery
measure: Reintervention
timeFrame: 1 month after surgery
Secondary outcomes:
measure: Long term follow up
timeFrame: 1 month, 1 year, yearly up to 5 years
measure: Target vessel patency
timeFrame: 1 month, 1 year, yearly up to 5 years
measure: Kidney function evolution
timeFrame: 1 month, 1 year, yearly up to 5 years
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Hostalrich Aurélien
Study officials:
References:
Clinical trial NCT02087410: Serum Ghrelin in Polycystic Ovary Syndrome
Official title: Ghrelin in Polycystic Ovary Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Polycystic Ovary
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2014-03-14
Enrollment: 84
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Forty two patients with polycystic ovarian syndrome and forty two healthy subjects will be recruited from the outpatient clinic Ain Shams University Maternity Hospital.

Brief summary: measuring serum gherlin in polycystic ovary syndrome patients and compare it to healthy levels

Detailed description: two groups one healthy and other with pco measure ghrelin level in both of them to find relation between pco and ghrelin

Eligibility criteria: Inclusion Criteria:pco women

* At least 12 months of infertility.
* Patients with polycystic ovarian syndrome according to Rotterdam criteria:

Exclusion Criteria:

* Patients with hyperprolactinemia
* Patients with Cushing's syndrome
* Patients with Congenital or non-classical adrenal hyperplasia
* Patients with hormone secreting tumors.
* Patients with hormonal treatment in the last 3 months.

Primary outcomes:
measure: relationships between circulating ghrelin and the clinical and biochemical manifestations of PCOS
timeFrame: after 6 monthes
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Maternity Hospital
Study officials:
affiliation: ain shams universty maternity hospital
name: amr eletrby, MBBCH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02337010: Continuous Central Venous Oxygen Saturation Assisted Intraoperative Hemodynamic Management
Official title: Continuous Central Venous Oxygen Saturation Assisted Intraoperative Hemodynamic Management During Major Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Abdominal Surgery
Perioperative Haemodynamic Monitoring
Perioperative Fluid Management
Perioperative Vasopressor Requirement
Postoperative Organ Function
Postoperative Complications
Lead sponsor: Szeged University
Sponsor class: OTHER
First posted: 2015-01-13
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Patients who are scheduled for: elective oesophageal tumour resection, total gastrectomy, pancreas resection, major vascular, total cystectomy will be recruited.To investigate effects of central venous pressure (CVP) and central venous saturation (ScvO2) guided fluid management on intraoperative haemodynamic parameters, volume and vasopressor requirement, and postoperative organ function and postoperative inflammatory response.


Eligibility criteria: Inclusion Criteria:

* patients undergoing the following elective major abdominal surgery: oesophagectomy, total gastrectomy, radical cystectomy, aorta-bifemoral bypass or elective operation of abdominal aortic aneurysm.
* after surgery patients were admitted to our intensive care unit.

Exclusion Criteria:

* patients younger than 18 years
* chronic organ insufficiency: "Acute Physiology and Chronic Health Evaluation (APACHE) II" scoring system: New York Heart Association Class IV, chronic hypoxia or hypercapnia, chronic renal failure requiring renal replacement therapy, biopsy proven cirrhosis or portal hypertension and immunodeficiency.
* preoperative anaemia (haemoglobin\<100g/L)
* coagulation abnormality
* and patients with chronic use of corticosteroids and non-steroid anti-inflammatory drugs
* patients requiring an operation due to malignant disease where the tumour then proved to be inoperable.

Primary outcomes:
measure: Incidence of postoperative complications.
timeFrame: 28 days
Secondary outcomes:
measure: Difference in the perioperative fluid requirement
timeFrame: postoperative 48 hours
measure: Difference in the perioperative vasopressor requirement
timeFrame: postoperative 48 hours
Other outcomes:
Locations:
city: Szeged
country: Hungary
facility: Department of Anaesthesiology and Intensive Therapy
state: Csongrád
Study officials:
References:
citation: Mikor A, Trasy D, Nemeth MF, Osztroluczki A, Kocsi S, Kovacs I, Demeter G, Molnar Z. Continuous central venous oxygen saturation assisted intraoperative hemodynamic management during major abdominal surgery: a randomized, controlled trial. BMC Anesthesiol. 2015 Jun 4;15:82. doi: 10.1186/s12871-015-0064-2.
Clinical trial NCT01346410: Stereotactic Body Radiotherapy for Unresectable Pancreatic Cancer
Official title: Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Unresectable Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cancer
Keywords: pancreatic cancer
Lead sponsor: Mercy Research
Sponsor class: OTHER
First posted: 2011-05-03
Enrollment: 1
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: This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of unresectable pancreatic cancer.

Detailed description: This is a single institution, non-randomized, prospective, phase IV trial of SBRT for unresectable pancreatic cancer.

Data collected will include patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose received by adjacent critical normal tissues, tumor recurrence data, and acute and late toxicities.

Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years.

Eligibility criteria: Inclusion Criteria:

* Patient age \>= 18 years
* Performance status of 0-3
* Unresectable pancreatic cancer
* Maximum tumor diameter \< 7.5 cm
* Signed study-specific consent form

Exclusion Criteria:

* Maximum tumor diameter \> 7.5 cm
* Prior radiotherapy to the upper abdomen
* Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females
* Patients with psychiatric or addictive disorder that would preclude obtaining informed consent

Primary outcomes:
measure: Local Control Rate
timeFrame: 5 years
Secondary outcomes:
measure: Late Toxicity Rate
timeFrame: 5 years
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: St. John's Mercy Medical Center
state: Missouri
Study officials:
References:
Clinical trial NCT03128710: Prostate Cancer Survey
Official title: Identifying Patient-relevant Adverse Events Following Prostate Radiotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Survey
Focus Group
Treatment Preferences
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2017-04-25
Enrollment: 224
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with prostate malignancies who consent to receiving Radiation treatment at the University of Maryland, Baltimore, will be offered this survey.

Brief summary: There have been calls from patients, payers, healthcare providers, and policy makers for an evaluation of newer, high-cost radiation technologies compared to conventional forms of radiation therapy. National attention has focused on the use of intensity modulated radiation therapy (IMRT) into routine daily clinical practice for prostate cancer. The goal of the present study is to determine whether the type of radiation treatment received by the patients can result in a reduction in patient-relevant side effects following prostate irradiation. The analysis will be performed by obtaining patient answered surveys looking at side effects.


Eligibility criteria: Inclusion Criteria:

* Participant is 18 years or older
* Has been diagnosed with prostate cancer
* Able to speak and read English

Exclusion Criteria:

* Participant is not being seen for prostate cancer
* Under the age of 18

Primary outcomes:
measure: To determine patient preference weights for side effect reduction in radiation treatment of prostate cancer
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: UMMC
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Mark Mishra, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04114110: RTLS Technology Study
Official title: A Retrospective, Observational Analysis Using Real Time Location Systems (RTLS) Technology to Explore the Effects of Clinical Staffing on Hospital Productivity and Patient Health Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inpatients
Staff
Lead sponsor: The Royal Wolverhampton Hospitals NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: La Trobe University
name: Cornell University
First posted: 2019-10-03
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All admitted inpatients between 1 April 2016 and 31 March 2019, and all staff members with RTLS badges, at The Royal Wolverhampton NHS Trust (RWT), Wolverhampton.

Brief summary: This study will examine the productivity of the hospital workforce utilizing a unique dataset that is stored at the Royal Wolverhampton Trust (RWT). The data is recorded by a Real Time Location System (RTLS) that tracks the second-by-second physical location of patients, staff, and medical equipment. Using this data, the plan is to measure the amount of time that clinical staff spend with patients and with other clinical staff, and then explore how these measures of contact time influence patient health outcomes. The data will also be used to measure the location and movement of patients during their hospital stay, and test the impact of moving patients between wards on their health outcomes. In light of the recent COVID-19 outbreak, impact of COVID19 on patient contact time, patient outcomes and professional working practices will also be examined.


Eligibility criteria: Inclusion Criteria:

* Patients admitted to inpatient departments at RWT and are present at RWT during the period of 1 April 2016 to 31 March 2019 inclusive.

Exclusion Criteria:

* Patients admitted to outpatient wards at RWT;
* Patients that were not admitted at or discharged from RWT between 1 April 2016 to 31 March 2019 inclusive.

Primary outcomes:
measure: Number of in-hospital deaths (RWT specific)
timeFrame: 30 days
measure: Number of readmissions (RWT specific)
timeFrame: 30 days
measure: Length of stay
timeFrame: 3 years
measure: Nurse sensitive indicators
timeFrame: 3 years
measure: Number of Adverse incidents affecting patient care
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Wolverhampton
country: United Kingdom
facility: The Royal Wolverhampton NHS Trust
state: West Midlands
Study officials:
References:
citation: Cannaby AM, Carter V, Hoe T, Strobel S, Tafti EA, Baker R, Nash C, Whatley V, Gray R. The feasibility and validity of using a real time location system (RTLS) to measure bedside contact time. J Res Nurs. 2022 Aug;27(5):421-433. doi: 10.1177/17449871211016169. Epub 2021 Nov 15.
Clinical trial NCT04534010: Decellularized, Whole Donor Nipple-Areola Complex Reconstruction Grafts
Official title: A Single Arm, Single Center Pilot Study Evaluating the Safety and Healing Time of a Decellularized, Whole Donor Nipple-Areola Complex Reconstruction Graft
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-09-01
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to evaluate safety and healing time after nipple-areolar complex (NAC) reconstruction with the BioAesthetics' decellularized human nipple-areolar complex (dcl-hNAC) graft in patients who have had autologous breast reconstruction for breast cancer. Secondary objectives will be to assess patient satisfaction, patient well-being, patient self-esteem, patient body image, patient psychological well-being, nipple dimensions and sensitivity following NAC reconstruction surgery with the BioAesthetics' dcl-hNAC graft.


Eligibility criteria: Inclusion Criteria:

* Patient age 18-65
* Patient desires NAC grafting ≥3 months after autologous breast reconstruction
* Patient agrees to sleep on back until grafts healed (6 weeks)
* Patient agrees to abstain from aspirin, alcohol, or excessive caffeine until grafts healed (6 weeks)
* Patient agrees to not undergo NAC tattooing until completing study (12 months)
* Patient is able to understand and willing to sign informed consent.

Exclusion Criteria:

* History of delayed wound healing
* history of Vitamin C deficiency
* history of diabetes (Type I or Type II)
* current BMI\<18.5 or \>40 kg/m,
* patient has any other uncontrolled comorbidity.
* Patient has a history of allergic reaction to any decellularized biologic matrix product.
* Patient is currently smoking or using tobacco or nicotine products (i.e. patch, gum, or nasal spray) or has used such products in the past 12 months.
* Patient is currently receiving radiation or chemotherapy or received radiation to the breast wall.
* Patient has a history of prior NAC reconstruction
* Patient has had NAC tattooing.
* Patient is pregnant, breastfeeding or planning to become pregnant during the study period.

Primary outcomes:
measure: Time to healing of implanted NACgraft
timeFrame: 14 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford Universiy
name: Geoffrey C Gurtner
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02875210: Comparative Study of Anterior Tibial Translation Measurement by Four Laximeters in Anterior Cruciate Ligament Ruptures
Official title: Comparative Study of Anterior Tibial Translation Measurement by Four Different Laximeters in Anterior Cruciate Ligament Ruptures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anterior Cruciate Ligament Rupture
Keywords: Anterior Cruciate Ligament
A02.835.583.512.100
Lead sponsor: Versailles Hospital
Sponsor class: OTHER
First posted: 2016-08-23
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Actually, there are several laximeters for measuring anterior tibial translational in case of anterior cruciate ligament rupture. The most commonly used are telos, KT-1000, GnrB and Rolimeter. Results of these instrumented tests, which expressed in differential (millimeters values), have a bad correlation between them and so are not comparable in current literature. The aim of this study was to compare results of these tests and establish a ratio (pathologic knee laxity/ healthy knee laxity) to reduce differences between each instrumented test.


Eligibility criteria: Inclusion Criteria:

* Obtaining a written informed consent of the patient,
* Affiliated with a Medicare (or rightful beneficiary),
* Disponibility of the patient,
* Patients ≥ 18 ans,
* Anterior cruciate ligament rupture concerned only one knee of the patient.

Exclusion Criteria:

* Patient is in the exclusion period for another study,
* Patient is under judicial protection, guardianship, or curators,
* Eligible patients who are refused to sign consent,
* It is impossible to give clear informations to the patient,
* Pregnant women,
* Nursing mother,
* Patient which has been already operate of the other knee,
* Patient present ligament lesions associated.

Primary outcomes:
measure: Comparison of anterior laxity measurement between pathologic and healthy knees.
timeFrame: 18 months
Secondary outcomes:
measure: Sensivity and specificity of each instrument
timeFrame: 18 months
measure: Correlation between the f4 laximeters results
timeFrame: 18 months
measure: Value of the ratio : pathologic (anterior knee laxity) versus healthy knee
timeFrame: 18 months
Other outcomes:
Locations:
city: Le Chesnay
country: France
facility: Centre Hospitalier de Versailles
Study officials:
affiliation: Central Hospital of Versailles
name: Nicolas PUJOL, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03816410: Natriuretic Peptides After Left Atrial Appendage Amputation
Official title: Influence of Left Atrial Appendage Amputation on Natriuretic Peptides - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: University of Giessen
Sponsor class: OTHER
First posted: 2019-01-25
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 Randomization
Primary purpose: SCREENING

Brief summary: Surgical amputation of the left atrial appendage (LAA) is an established intervention during surgical atrial fibrillation (AF) therapy. However, its effects on the endocrine function of the left atrium are unclear. This study aims to quantify the serum levels of natriuretic peptides in patients who undergo concomitant surgical AF ablation with or without LAA amputation.


Eligibility criteria: Inclusion Criteria:

* Indication for concomitant AF therapy during cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

* Lack of informed consent

Primary outcomes:
measure: Serum levels of proANP and BNP until 800days post surgery
timeFrame: 800days
Secondary outcomes:
Other outcomes:
Locations:
city: Giessen
country: Germany
facility: Department of Adult and Pediatric Cardiovascular Surgery
Study officials:
References: