louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00594295: Follow-up of Bone Quality in Long-Term Bone Marrow Transplant Survivors
Official title: Follow-up of Bone Quality in Long-Term Bone Marrow Transplant Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporotic Fractures
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2008-01-15
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Bone marrow transplant patients at least 6 years post transplant

Brief summary: Brittle and broken bones can occur after organ transplantation. However, the long-term effects of bone marrow transplantation on bone health and the risk of breaking bones are not well understood. This study will help to assess how common it is for those who have received a bone marrow transplant to have fractures. It will also investigate blood tests related to bone health. This will be done by measuring bone mineral density and obtaining blood tests.


Eligibility criteria: Inclusion Criteria:

* Participation in the initial "Assessment of skeletal status following allogeneic bone marrow transplantation" Study (HSC97-632-408).
* Able and willing to sign informed consent.

Exclusion Criteria:

* All of the contacted long-term BMT survivors that are willing to participate will be included in this study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospitals and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin - Institute on Aging
name: Neil C Binkley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00163995: Urotensin II and Vascular Tone in Cirrhosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Diseases
Cirrhosis
Keywords: Chronic Liver Disease
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
First posted: 2005-09-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: This study looks at the iontophoresis of urotensin II in chronic liver disease patients.


Eligibility criteria: Inclusion Criteria:

* Cirrhosis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
Study officials:
affiliation: The Alfred
name: William W Kemp, MBBS, FRACP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02522195: Meal Distribution Across the Day in Female Nurses Working Shifts
Official title: Meal Distribution Across the Day in Female Nurses Working Shifts and Their Relationship With Nutritional Status
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shift Work Type Circadian Rhythm Sleep Disorder
Imbalance of Constituents of Food Intake
Keywords: shift work
nutritional status
nursing professionals
meal distribution
food intake
Lead sponsor: Federal University of Uberlandia
Sponsor class: OTHER
First posted: 2015-08-13
Enrollment: 221
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Woman who were part of Nursing Staff of University Hospital, and agreed to participate in the study. Each volunteer provided a full, written informed consent.

Brief summary: This study assessed the meal distribution across the day (energy and macronutrient intake) and its relationship to the nutritional status of nursing professionals.

Detailed description: 221 female nursing professionals from Brazilian University hospital were classified in three shifts: day shift (n=112), night shift (n=55), and day-night shift (n=54).

Food intake assessment (3-day 24-hour recall); Anthropometric variables (weight, height, waist circumference and hip circumference); Sleep time on working days and day off.

Eligibility criteria: Inclusion Criteria:

* Eligible participants were regularly employed by the hospital, with 36-hours per week scheduke, not counting additional shifts and overtime work.

Exclusion Criteria:

* Volunteers who did not supply the necessary information for the development of the research and who were pregnant or lactating.

Primary outcomes:
measure: meal distribution
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of Uberlandia
name: Cibele Crispim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02113995: Clinical Evaluation, Organic Response in Obesity Patients Subjected to Vertical Videolaparoscopy Gastroplasty With or Without Perioperative Cares Recommended by the Acerto Project. Randomized Study.
Official title: Clinical Evaluation, Organic Response in Obesity Patients Subjected to Vertical Videolaparoscopy Gastroplasty With or Without Perioperative Cares Recommended by the Acerto Project.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: To Evaluate Clinical Results, Insulin Resistance and Inflammatory Response to Trauma in Morbidly Obese Patients
Keywords: Obesity, Morbid
Insulin Resistance
Acute-Phase Reaction
Gastroplasty
Length of Stay
Protocols
Randomized Controlled Trial.
Lead sponsor: Cuiaba University
Sponsor class: OTHER
First posted: 2014-04-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Background To evaluate clinical results, insulin resistance and inflammatory response to trauma in morbidly obese patients undergoing laparoscopic Sleeve gastrectomy who received either traditional preoperative care or treatment following the ACERTO protocol.

Detailed description: Methods The population of the study consisted of morbidly obese patients, who were operated on with the Sleeve procedure, from Cuiaba, MT, between April and October 2012. We studied the inflammatory response and insulin resistance by measuring levels of glucose, insulin, Homa IR, reactive C protein, albumin, pre-albumin, alpha 1 acid glicoprotein, interleukin 6 and glycosylated hemoglobin. We also studied hydration, nausea and vomiting, hypertension, and length of hospital stay.

Eligibility criteria: Inclusion Criteria: We included patients who are between 18 and 45 years of age, from both sexes, with an initial BMI (Body Mass Index) which is equal to or greater than 40 kg/m2, candidates for the sleeve surgery procedure through laparoscopy.

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Exclusion Criteria: We excluded the patients who didn't follow the fasting protocol and also those whose laboratory exams were lost.

-

Primary outcomes:
measure: ACERTO protocol
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cuiaba
country: Brazil
facility: ACERTO protocol
state: MT
Study officials:
affiliation: Cuiaba University
name: Gunther P Pimenta, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01245595: Aminophylline to Prevent Acute Kidney Injury in Children After Cardiac Surgery
Official title: A Randomized Placebo Controlled Trial of Aminophylline to Prevent Acute Kidney Injury in Children After Cardiac Surgery With Cardiopulmonary Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Keywords: Acute Kidney Injury (AKI)
Cardiopulmonary bypass (CPB)
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2010-11-22
Enrollment: 144
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Children with congenital heart defects often need cardiac surgery with cardiopulmonary bypass (the "heart-lung machine"). Approximately 35 to 50% of these children will have "acute kidney injury," or damage to the kidneys, after the procedure. We currently have few medications to prevent this kidney injury. The hypothesis of this study is that giving aminophylline after heart surgery can decrease the acute kidney injury.

Detailed description: Patients are randomized to receive aminophylline or placebo for 72 hours, in a blinded fashion. Serum theophylline levels monitor for safety of aminophylline dose. Goal theophylline levels is 5-7 mcg/ml. Laboratory results will be faxed directly to the pharmacy who will adjust subsequent aminophylline dosing to maintain appropriate theophylline levels. Urine output and serum creatinine levels will be monitored to assess acute kidney injury. Serum Neutrophil Gelatinase Associated Lipocalin (NGAL) levels will also be monitored.

Eligibility criteria: Inclusion Criteria:

* Less than 18 years old, undergoing cardiac surgery with bypass
* neonates must be at least 36 weeks gestational age

Exclusion Criteria:

* History of arrythmia or seizure, on extracorporeal membrane oxygenation (ECMO) support, already taking aminophylline/theophylline, liver failure, sepsis, on renal replacement therapy

Primary outcomes:
measure: Acute Kidney Injury Measured by Kidney Diseases: Improving Global Outcomes (KDIGO) AKI Serum Creatinine Criteria
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Childrens' Hospital
state: California
Study officials:
affiliation: Stanford University
name: david m axelrod, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01691495: ARIXTRA® Adherence in SVT Patients.
Official title: ARIXTRA® Physician Adherence to the Prescribing Information in Isolated Superficial Vein Thrombosis (SVT) Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thrombosis, Venous
Keywords: Physician Adherence
superficial vein thrombosis
Fondaparinux
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-09-24
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 12 clinical sites representative of geographical regions of several EU countries, targeting physician adherence to prescribing in approximately 840 patients with SVT.

Brief summary: Fondaparinux is an anticoagulant used in the prevention and treatment of thromboembolic disease. It has recently been approved in the European Union (EU) for the treatment of patients with isolated superficial vein thrombosis (SVT), i.e. without concomitant deep vein thrombosis (DVT), of the lower limbs. As part of EU approval, GlaxoSmithKline (GSK) committed to evaluate physicians' adherence to fondaparinux prescribing information regarding proper diagnosis and dosing for the treatment of SVT.

The primary objective is to evaluate physicians' adherence to fondaparinux prescribing information for the treatment of patients with SVT without concomitant DVT.

The study is designed as a non-interventional, retrospective chart review of patients prescribed fondaparinux to treat their SVT. The study will be conducted in several EU countries.

ARIXTRA® is a registered trademark of the GlaxoSmithKline group of companies.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of SVT
* Prescribed fondaparinux for the treatment of SVT
* Age 18 years or older

Exclusion Criteria:

* Patients should not have been involved in any clinical trial that could influence SVT treatment during the observational period.

Primary outcomes:
measure: The primary outcome will be a measure of physician adherence.
timeFrame: 2
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02580695: A Study to Assess Safety and Efficacy of Umbilical Cord-derived Mesenchymal Stromal Cells in Knee Osteoarthritis
Official title: A Phase I/II, Randomized, Double-blind, Controlled Study to Assess Safety and Efficacy of Umbilical Cord-derived Mesenchymal Stromal Cells (UC-MSCs) in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Osteoarthritis
Lead sponsor: Universidad de los Andes, Chile
Sponsor class: OTHER
First posted: 2015-10-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Knee-osteoarthritis (OA) is a common and disabling problem, that represents a global health issue since none of the current therapies are truly disease modifying. The use of mesenchymal stem cells (MSCs) in OA-preclinical models has been associated with a reduction in cartilage degradation, the attenuation of bone sclerosis and an effective anti-inflammatory response. Investigators have designed a randomized phase I/II placebo controlled trial of UC-MSCs in knee OA. Outcomes will be evaluated at 12 months, comparing monodosis versus double intra-articular injection, re-randomized at 6 months.


Eligibility criteria: Inclusion Criteria:

* Symptomatic Knee OA, Kellgren and Lawrence grade I, II, III on plain Rx films.
* Chondromalacia patella grade I-III on knee MRI. With or without meniscal tear.
* Stable knee and normal clinical exam of involved extremity
* Written informed consent for patients.

Exclusion Criteria:

* Bilateral symptomatic knee OA
* Local or systemic infection.
* Active neoplasia or immunosuppressive state
* Pregnancy or Breastfeeding
* Body Mass Index ≥ 30
* Presence of Pacemaker or Lower extremity metal implant
* Anticoagulant treatment other than aspirin.
* Recent use of oral (previous month) or intra-articular (previous 3 months) corticosteroids
* Concomitant inflammatory joint disease (cristal, connective tissue disease)
* Valgus (\>10o) or Varus (\>5o) deformity of involved extremity
* Condilar or Tibial plateau Generalized Bone Marrow edema on MRI
* Significant symptomatic hip or spine disease
* Significant abnormality in baseline lab tests

Primary outcomes:
measure: Proportion of patients who experience an adverse event
timeFrame: 12 months
Secondary outcomes:
measure: Physical function improvement measured by WOMAC OA index
timeFrame: 12 months
measure: Change in pain density measured by Visual analogue scale (VAS)
timeFrame: 12 months
measure: QoL improvement measured by SF-36
timeFrame: 12 months
measure: Changes in WORMS scale measured by knee MRI
timeFrame: 12 months
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Clinica Universidad de los Andes
Study officials:
affiliation: Universidad de Los Andes
name: Jose Matas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02749695: Efficiency of Placental Drug Melsmon® in Correction of Climacteric Symptoms in Premenopausal Women
Official title: The Prospective, Blind, Randomized, Placebo-controlled, 4 Months Study of Efficacy of Melsmon® for Correction of Insomnia and Other Climacteric Symptoms in Premenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Climacteric Syndrome
Keywords: menopause, climacteric syndrome, insomnia, placental extract
Lead sponsor: Scientific Center for Family Health and Human Reproduction Problems, Russia
Sponsor class: OTHER_GOV
First posted: 2016-04-25
Enrollment: 40
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The placental drug Melsmon® is effective for correction of insomnia and other climacteric symptoms in premenopausal women. Decrease of MMI is shown both in groups with Melsmon® and Placebo, but it was more significant in patients who used Melsmon®.

Detailed description: There were 40 women under the observation, with mild and moderate symptoms of climacteric syndrome with sleep disorders (for that the investigators evaluated modified Kupperman Index).

All patients were randomized with the help of the envelope method with the allocation ratio of 1:1 (one-to-one). 20 women were prescribed placenta extract Melsmon and 20 received placebo during 4 months.

Eligibility criteria: Inclusion Criteria:

* More than 40 years of age
* Irregular menstrual cycle
* Climacteric symptoms, including sleep disorders
* follicule-stimulating hormone \>20 milli international units/ml -

Exclusion Criteria:

* Non-controlled hypertension (more than 140 mm Hg)
* Decompensated chronic diseases of the cardiovascular system, myocardial infarction, history of stroke
* Diabetes mellitus
* Kidney and hepatic dysfunction
* Cancer
* Breast fibroadenomas, adenomas and cysts
* Uterine fibroids with dominant nodule diameter ˃ 2 cm,
* Endometrial hyperplasia
* Individual drug idiosyncrasy
* Intake of any drugs for correction of climacteric symptoms and sleep disorders

Primary outcomes:
measure: Treatment-Related Changes of Kupperman Index
timeFrame: 4 months after the treatment
Secondary outcomes:
measure: Treatment-Related Changes of Menstrual Function
timeFrame: 4 months after the treatment
measure: Treatment-Related Changes of Depression Symptoms
timeFrame: 4 months after the treatment
measure: Treatment-Related Improvement in Skin Conditions
timeFrame: 4 months after the treatment
measure: Treatment-Related Changes of Sleep Quality
timeFrame: 4 months after the treatment
Other outcomes:
Locations:
city: Irkutsk
country: Russian Federation
facility: Scientific Center for Family Health and Human Reproduction Problems, Russia
Study officials:
affiliation: Scientific Center for Family Health and Human Reproduction Problems, Russia
name: Larisa V. Suturina, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06016595: Chronic Prostatitis/Chronic Pelvic Pain Syndrome Patients
Official title: Retrospective Data Analysis in Chronic Prostatitis/Chronic Pelvic Pain Syndrome Patients: Evaluation of the Relationship Between Presence of Microorganism and Severity of Symptom
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Lead sponsor: Hisar Intercontinental Hospital
Sponsor class: OTHER
First posted: 2023-08-29
Enrollment: 112
Sex: MALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study is based on data from 112 CPPS patients aged 20-60 years. Various variables such as demographic information of the patients, International Prostate Symptom Score (I-PSS), which evaluates CPPS symptoms, inflammatory and non-inflammatory symptoms of CPPS, baseline scores of the International Index of Erectile Function (IIEF), which evaluates erectile function, and the presence of microorganisms in the prostate fluid were analyzed retrospectively.

Brief summary: Chronic prostatitis/chronic pelvic pain syndrome (CPPS) is a common health problem among men and can cause severe quality of life. The pathophysiology of CPPS is still poorly understood and effective treatments are a challenging issue. This study aims to investigate the possible relationship between the presence of microorganisms in the prostatic fluid and symptom severity by presenting a retrospective analysis based on data from CPPS patients.

Detailed description: This study is based on data from 112 CPPS patients aged 20-60 years. Various variables such as demographic information of the patients, International Prostate Symptom Score (I-PSS), which evaluates CPPS symptoms, inflammatory and non-inflammatory symptoms of CPPS, baseline scores of the International Index of Erectile Function (IIEF), which evaluates erectile function, and the presence of microorganisms in the prostate fluid were analyzed retrospectively.

Eligibility criteria: Inclusion Criteria:

* Patients who were diagnosed with chronic prostatitis/chronic pelvic pain syndrome and whose prostate fluid was taken with prostate massage and androflor testis were studied were included.

Exclusion Criteria:

* acute and/or chronic bacterial prostatitis, active history of genitourinary cancer, history of recent prostate surgery the diagnosis of neurological diseases affecting the bladder was determined

Primary outcomes:
measure: Correlation between androflor pcr positive patients and uopint and nih-cpsi
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Hisar Intercontinental Hospital
Study officials:
References:
Clinical trial NCT00906295: Establishment of Optimal Transfusion Threshold After Major Orthopedic Surgery
Official title: Establishment of Optimal Transfusion Threshold After Major Orthopedic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Arthroplasty
Replacement
Hip
Keywords: Hemoglobin
Ambulation
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: TrygFonden, Denmark
First posted: 2009-05-21
Enrollment: 67
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 this study is to determine whether a higher threshold for transfusion with red blood cells improves the postoperative ambulation.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Patients undergoing replacement of hip arthroplasty
* Be legally competent
* Read and understand Danish

Exclusion Criteria:

* Present malignant disease
* Known heart disease with functionality equivalent to NYHA II or CCS II or worse

Primary outcomes:
measure: Timed Up and Go-test (TUG)in seconds.
timeFrame: 30 days
Secondary outcomes:
measure: The postoperative day patients can walk ten meters
timeFrame: 30 days
measure: Length of stay at hospital
timeFrame: 30 days
measure: The day the patient is able to perform Timed Up and Go-test
timeFrame: 30 days
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
state: Copenhagen NV
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital, Rigshospitalet
state: Østerbro
Study officials:
affiliation: Rigshospitalet, Denmark
name: Kamilla Nielsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.
citation: Nielsen K, Johansson PI, Dahl B, Wagner M, Frausing B, Borglum J, Jensen K, Sturup J, Hvolris J, Rasmussen LS. Perioperative transfusion threshold and ambulation after hip revision surgery--a randomized trial. BMC Anesthesiol. 2014 Oct 10;14:89. doi: 10.1186/1471-2253-14-89. eCollection 2014.