louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00242489: Etoricoxib in the Treatment of Osteoarthritis (MK-0663-007)
Official title: A Placebo-Controlled, Parallel-Group, Double-Blind Study to Assess Safety and to Define the Clinically Effective Dose Range of MK0663 in Patients With Osteoarthritis of the Knee, Followed by a Double-Blind, Active-Comparator-Controlled Extension.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis
Keywords: Arcoxia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2005-10-20
Enrollment: 1167
Sex: ALL
Minimum age (years): 40
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 evaluate the safety and efficacy of etoricoxib in the treatment of osteoarthritis of the knee.


Eligibility criteria: Inclusion Criteria:

* At least 40 years of age with a clinical diagnosis of Osteoarthritis (OA)of the knee for 6 months prior to study entry (ARA class I, II, or III).
* Positive therapeutic effect from prior NSAID therapy.
* Worsening of symptoms upon withdrawal of prior treatment.
* With the exception of OA, in otherwise good health

Exclusion Criteria:

* Weight no more than 280 pounds (male or female).
* Recent, sustained use of gastroprotective agents.
* History of arthroscopy of the affected knee within 6 months prior to study entry.
* History of acute ligamentous or meniscal injury of the study joint within the previous 2 years.

Primary outcomes:
measure: WOMAC Pain Subscale, Investigator Global Assessment of Disease Status, and Patient Global Assessment of Response to Therapy (not a primary endpoint in extension periods)
Secondary outcomes:
measure: Physical Function Subscale (WOMAC), Stiffness Subscale (WOMAC), Patient Global Assessment of Disease Status, Investigator Global Assessment of Response to Therapy , Proportion of Patients Discontinued Due to Lack of Efficacy
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Gottesdiener K, Schnitzer T, Fisher C, Bockow B, Markenson J, Ko A, DeTora L, Curtis S, Geissler L, Gertz BJ; Protocol 007 Study Group. Results of a randomized, dose-ranging trial of etoricoxib in patients with osteoarthritis. Rheumatology (Oxford). 2002 Sep;41(9):1052-61. doi: 10.1093/rheumatology/41.9.1052.
citation: Curtis SP, Bockow B, Fisher C, Olaleye J, Compton A, Ko AT, Reicin AS. Etoricoxib in the treatment of osteoarthritis over 52-weeks: a double-blind, active-comparator controlled trial [NCT00242489]. BMC Musculoskelet Disord. 2005 Dec 1;6:58. doi: 10.1186/1471-2474-6-58.
Clinical trial NCT06925789: Influence of Standardized Perioperative Anesthetic, Analgesic Care on Outcome of Patients Undergoing Hip Fracture Surgeries
Official title: Influence of Standardized Peri-operative Anesthetic and Analgesic Care on the Outcome of Patients Undergoing Hip Fracture Surgeries
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Fractures, Hip
Local Anesthesia
Geriatric
Nerve Block
Keywords: Hip Fracture
Nerve blocks
Geriatric
Local anesthesia
Post operative outcomes
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2025-04-13
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this voluntary research study is to clarify whether or not a single injection nerve block done before surgery and after surgery nerve block catheter can effectively enhance recovery in elderly hip fracture patients in terms of reduced delirium, reduced length of stay and improved surgical and anesthesia outcomes. Delirium is a serious change in mental abilities. It results in confused thinking and a lack of awareness of someone's surroundings. The disorder usually comes on fast - within hours or a few days. Prolonged hospital stay is one of the risk factors for onset of delirium.


Eligibility criteria: Inclusion Criteria:

1. Undergoing anesthesia for hip fracture surgery.
2. Patients with fracture neck of femur fractures.
3. Geriatric patients. (65 years and older)

Exclusion Criteria:

1. Non-fracture hip patients
2. non-geriatric patients. (Below 65 years old)
3. Patients not able to consent themselves
4. Non- English-speaking patients

Primary outcomes:
measure: Pain Control
timeFrame: up to 48 hours post hospital admission.
measure: Opioid Use
timeFrame: up to 48 hours post hospital admission.
Secondary outcomes:
measure: Delirium score
timeFrame: up to 48 hours post hospital admission.
Other outcomes:
Locations:
Study officials:
affiliation: Penn State Health
name: Shubha Srinivasareddy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06379672: Resonance Breathing Training for Long Covid-related Myocardial Injury
Official title: An Investigation of the Efficacy of Resonance Breathing Training in the Rehabilitation of Patients with Long Covid-related Myocardial Injury
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Long COVID
Myocardial Injury
Keywords: 2D-STE
resonance breathing
Myocardial Injury
Long Covid-19
Lead sponsor: Chengdu Sport University
Sponsor class: OTHER
First posted: 2024-04-23
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An investigation of the efficacy of resonance breathing training in the rehabilitation of patients with Long covid-related myocardial injury


Eligibility criteria: Inclusion Criteria:

1. Age between 18 and 60 years;
2. According to the WHO definition: one or more systemic involvement present 3 months after the diagnosis of a new crown infection, and at least 2 of these months cannot be explained by other diseases
3. 2D-STE suggestive of GLSAVG: -17% ≤ men ≤ -10%, -18% ≤ women ≤ -10%;
4. Consent for enrollment based on the degree of myocardial injury, as diagnosed by a clinician;
5. Signing the informed consent form with the consent of the patient or his/her family members

Exclusion Criteria:

* (1) Previous history of coronary atherosclerotic heart disease and heart failure; (2) Combination of severe arrhythmia or cardiogenic shock; (3) Combination of severe hypertension, hypertrophic cardiomyopathy, valvular disease of moderate or higher grade, acute myocarditis or pericarditis; (4) Combination of any disease that severely affects limb movement, such as musculoskeletal system disease or severe hepatic or renal insufficiency; (5) Combination of progressive malignant tumors, infectious diseases, bleeding disorders, autoimmune diseases, etc; Those who have serious mental illness and are unable to cooperate

Primary outcomes:
measure: New YorkHeart Association (NYHA)
timeFrame: 12weeks
measure: left ventricle global longitudinal strain, LVGLS
timeFrame: 12weeks
Secondary outcomes:
measure: hypertension
timeFrame: 12weeks
measure: Average heart rate
timeFrame: 12weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00758472: ReCap Total Hip Resurfacing Prospective Data Collection
Official title: ReCap Total Hip Resurfacing Prospective Data Collection
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Arthritis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
Collaborators: name: Biomet U.K. Ltd.
First posted: 2008-09-25
Enrollment: 82
Sex: ALL
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 suitable for Total Hip Resurfacing

Brief summary: Prospective data collection on survivorship of ReCap Total Hip Resurfacing

Detailed description: Detailed protocol not available

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of hip joint arthritis

Exclusion criteria:

- less than 18 years of age

Primary outcomes:
measure: survival rate
timeFrame: 10 yr
Secondary outcomes:
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: Southmead Hospital
city: Oswestry
country: United Kingdom
facility: Robert Jones & Agnes Hunt Orthopaedic & District Hospital NHS Trust
Study officials:
affiliation: North Bristol NHS Trust
name: Evert Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01944072: Pulmonary Rehabilitation in COPD: Effects of Two Aerobic Exercise Intensity in Patient-centered Outcomes
Official title: Pulmonary Rehabilitation in COPD: Effects of Two Aerobic Exercise Intensity in Patient-centered Outcomes - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease
COPD
Pulmonary rehabilitation
Aerobic exercise
CEDOC
FCM
UNL
NOVA MEDICAL SCHOOL
Lead sponsor: Universidade Nova de Lisboa
Sponsor class: OTHER
Collaborators: name: Centro Hospitalar Lisboa Norte
name: Centro de Estudos de Doenças Crónicas
First posted: 2013-09-17
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Trial design: An equivalence/non-inferiority randomized controlled trial with parallel group design studied the effect of two aerobic exercise-training intensities in COPD patient-centered outcomes. Methods: Thirty-four COPD clinically stable patients stratified from mild to very severe GOLD stages, were blinded to 60 or 80%Wmax aerobic exercise training intensity in an outpatient pulmonary rehabilitation program, between 2009-2010. Outcomes were assessed with St.George's respiratory questionnaire (primary outcome), Mahler dyspnea index, London Chest activity of daily living scale, 6-minute walk, constant load and incremental exercise tests. Patient's allocation sequence was computer-generated, with consignment in a safe deposit box.


Eligibility criteria: Inclusion Criteria:

* Clinically stable COPD
* FEV1/FVC \< 70%
* Exercise training medical referral

Exclusion Criteria:

* Unable to attend 3-times/week program
* Infectious disease
* Metastatic cancer
* Unstable heart disease
* Neuromusculoskeletal disorder
* Cognitive or psychiatric disorder

Primary outcomes:
measure: Health-related quality-of-life measured by the St.George's respiratory questionnaire
timeFrame: 8 weeks (20 sessions)
Secondary outcomes:
measure: Symptoms control measured by the Mahler dyspnea index
timeFrame: 8 weeks (20 sessions)
measure: Exercise Tolerance
timeFrame: 8 weeks (20 sessions)
Other outcomes:
Locations:
Study officials:
affiliation: Centro Hospitalar Lisboa Ocidental
name: Catarina Santos, PT, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro Hospitalar Lisboa Norte
name: Fátima Rodrigues, MD, MSc
role: STUDY_CHAIR
affiliation: Centro Hospitalar Lisboa Norte
name: Cristina Bárbara, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Santos C, Rodrigues F, Santos J, Morais L, Barbara C. Pulmonary Rehabilitation in COPD: Effect of 2 Aerobic Exercise Intensities on Subject-Centered Outcomes--A Randomized Controlled Trial. Respir Care. 2015 Nov;60(11):1603-9. doi: 10.4187/respcare.03663. Epub 2015 Jul 28.
Clinical trial NCT04009772: Single Dose Cefepime Versus Cefuroxime Plus Metronidazole as a Prophylactic Antibiotic During Emergency Intrapartum Cesarean Section
Official title: Single Dose Cefepime Versus Cefuroxime Plus Metronidazole as a Prophylactic Antibiotic: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Emergency Cesarean Section
Infection Wound
Keywords: Cefepime, Cefuroxime, Metronidazole, Cesarean, Intrapartum
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: Yasser Esmat Mohammed
First posted: 2019-07-05
Enrollment: 500
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Compare between cefepime versus routine antibiotics as a prophylactic antibiotic during emergency cesarean section in a tertiary center of obstetric care

Detailed description: This is a randomized double blinded study which compare between single dose cefepime versus cefuroxime plus metronidazole during emergency intrapartum cesarean section.

Outcomes will include fever, wound infection, and urinary tract infection.

Eligibility criteria: Inclusion Criteria:

* intrapartum caesarean section

Exclusion Criteria:

* evidence of infection

Primary outcomes:
measure: Incidence of surgical site wound infection
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
Clinical trial NCT00568672: Optimal Duration of Olanzapine Add-on Therapy in Major Depression
Official title: Optimal Duration of Olanzapine Add-on Therapy in Major Depression: a Placebo-controlled, Randomized, Phase III, Pilot Study in Parallel Group Design
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Relapse Rate of a Major Depressive Episode
Safety of Olanzapine in Subjects With Major Depression
Keywords: Major Depression
Olanzapine
add-on therapy
antidepressant
atypical antipsychotic
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2007-12-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of olanzapine versus placebo in the continuation therapy of subjects with major depression who had a response with additional olanzapine to an antidepressant.


Eligibility criteria: Inclusion Criteria:

* informed consent
* age 18 - 80
* diagnosis of major depression according dsm-iv, unipolar course
* Hamilton-Depression-Rating-Scale (17 item score) \> 18 prior to inclusion
* response towards therapy with antidepressant and olanzapine as defined \> 50 % reduction of HAMDD score
* negative pregancy test
* highly effective contraceptive method in women
* no participation in other trial according to German Drug Laq
* normal liver function

Exclusion Criteria:

* pregnancy, lactation
* depressive episode secondary to somatic disease or substance dependency
* contraindication for olanzapine
* treatment with interacting substances (CYP1A2 inhibitors or inductors)
* comorbidity according to DSM-IV, axis I
* denail of consent
* hospital treatment by legal order
* hepatic insufficiency
* severe neurological or medical disease
* adipositas permagna
* HIV-infection
* active viral hapatitis

Primary outcomes:
measure: Relapse Rate, Hamilton Depression Rating Scale (17 item version)
timeFrame: 6 months
Secondary outcomes:
measure: Safety and side effect scales (SWN Scale, CGI), Beck Depression Inventory
timeFrame: 6 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Departement of Psychiatry and Psychotherapy, Charite, University Medicine Berlin, Campus Benjamin Franklin
Study officials:
affiliation: Charité - University Berlin, Campus Benjamin Franklin, Department of Psychiatry and Psychotherapy
name: Ion Anghelescu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite, University Berlin, Campus Benjamin Franklin, Department of Psychiatry and Psychotherapy
name: Arnim Quante, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05070572: Measuring Intraabdominal Pressure, Lactic Acid, and Urine Output
Official title: Measuring Intraabdominal Pressure, Lactic Acid, and Urine Output in Obese Individuals Undergoing Laparoscopic Inguinal Hernia Repair
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intra-Abdominal Hypertension
Inguinal Hernia
Lead sponsor: Maimonides Medical Center
Sponsor class: OTHER
Collaborators: name: Potrero Medical
First posted: 2021-10-07
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be derived from the elective, outpatient surgical practice of the department of general surgery at Maimonides Medical Center.

Brief summary: This study serves as a pilot study with the intention to to measure intraabdominal pressure, lactic acid, and urine output in obese individuals undergoing laparoscopic inguinal hernia repair. By measuring these values, the investigators aim to look for correlations between metrics and determine an accurate and precise measurement of IAP during laparoscopic hernia surgery using the Accuryn Monitoring System. By obtaining accurate and precise measurements of IAP during surgery the investigators will be to compare measurements to previous IAP data obtained during daily activities and strenuous movements and any associations with inguinal hernia recurrence.


Eligibility criteria: Inclusion Criteria:

* Obese with BMI \> 30
* Diagnosis of inguinal hernia
* Qualify for laparoscopic inguinal hernia repair

Exclusion Criteria:

* Previous bowel resections resulting in short bowel
* Extensive abdominal scarring
* BMI \< 30
* Fail to qualify for laparoscopic inguinal hernia repair

Primary outcomes:
measure: Intraabdominal Pressure
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
Study officials:
References:
Clinical trial NCT04414072: Local GIT Hormones After Bariatric Maneuvers
Official title: Effect of Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Morbid Obesity
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: surgeries
Primary purpose: TREATMENT

Brief summary: Background: Many of the beneficial metabolic effects of bariatric surgery have been attributed to altered peptide hormone profiles, especially involving pancreatic and gut peptides.

Objectives: assess the effects of bariatric procedures (sleeve gastrectomy, minigastric bypass and sleeve gastrectomy with loop bipartition) on GIT hormones. Methods: Prospective randomized study which was carried out in the department of General Surgery, Minia University hospital during the period from February 2018 to February 2019. This study included 3 groups subjected to different operations; each group consisted of 50 patients.

Detailed description: Prospective randomized study which was carried out in the department of General Surgery, Minia University hospital during the period from February 2018 to February 2019. This study included 3 groups subjected to different operations; each group consisted of 50 patients. Age ranging from 20 to 50 years old and body weight ranging from 100 to 200 Kg, and subjected to laparoscopic sleeve gastrectomy, mini gastric bypass and sleeve gastrectomy with loop bipartition. Each patient was thoroughly evaluated by a multidisciplinary team (Nutritionist, Endocrinologist, Psychologist, and Surgeon) using a standardized protocol. Follow up was done after two weeks and after 2 months.

Eligibility criteria: Inclusion Criteria:

All morbid obese patients

-

Exclusion Criteria:

GIT diseases

Primary outcomes:
measure: hormonal change
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia university
Study officials:
References:
Clinical trial NCT02092740: REtrospective Study of TESTIcular CAncer Patients at the University Magdeburg
Official title: Retrospective Analysis of Testicular Cancer Patients With Histopathological Analysis or Urological Treatment at the University Magdeburg 1960-2012.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Testicular Cancer
Keywords: Testicular cancer
Lead sponsor: University of Magdeburg
Sponsor class: OTHER
First posted: 2014-03-20
Enrollment: 2000
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Testicular cancer histopathologically diagnosed at the University Magdeburg 1960-2012

Brief summary: Retrospective analysis of treatment outcome and side effects of testicular cancer patients that had been diagnosed at the University Magdeburg from 1960 until 2012.

Detailed description: Creating an ACCESS Windows form based Data Registry for testicular cancer patients.

Relevant data for testicular cancer patients based on EAU-guidelines 2013 and EORTC/RTOG, Lent-SOMA, CTC. All testicular cancer patients who had been histopathologically diagnosed al the Institute of Pathology at the University Magdeburg. About 2000 patients from 1960 until 2012. Postgraduate students collecting data requesting hospital documents, cancer registry of Sachsen-Anhalt, family practitioners and urologists as well as patients. Statistically Analysis with ACCESS and IBM SPSS statistics.

Eligibility criteria: Inclusion Criteria:

* testicular cancer histopathologically diagnosed at the University Magdeburg Germany

Exclusion Criteria:

* none.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: Up to 52 years.
Secondary outcomes:
measure: Disease-specific survival.
timeFrame: Up to 52 years.
measure: Chronic side effects of testicular-cancer-specific radiation therapies.
timeFrame: Up to 52 years.
measure: Chronic side effects of testicular-cancer-specific chemotherapies.
timeFrame: Up to 52 years.
measure: Chronic side effects of testicular-cancer-specific surgical therapies.
timeFrame: Up to 52 years.
measure: Secondary Malignoma
timeFrame: Up to 52 years.
measure: Progressive-free survival (PFS).
timeFrame: Up to 52 years.
measure: Relapse-free survival (RLS).
timeFrame: Up to 52 years.
measure: Quality of Life (QoL).
timeFrame: Current situation.
measure: Cause of death.
timeFrame: Up to 52 years.
Other outcomes:
Locations:
city: Magdeburg
country: Germany
facility: Urology University Magdeburg
state: Sachsen-Anhalt
Study officials:
affiliation: Department of Urology University Magdeburg Germany
name: Johann J Wendler, Dr. Med.
role: PRINCIPAL_INVESTIGATOR
References: