louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00168896: A Study for Small Cell Lung Cancer (SCLC) in Extensive Disease Stage
Official title: A Randomised Phase II/III Study to Compare the Combination of Carboplatin Plus Irinotecan Vs. the Combination of Carboplatin Plus Etoposide for SCLC in Extensive Disease Stage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Small Cell Lung Cancer
Keywords: SCLC
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Pfizer
name: Aventis Pharmaceuticals
First posted: 2005-09-15
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of two combination chemotherapies in the treatment of patients with SLCL

Detailed description: Comparison of two combination chemotherapies in the treatment of patients with SLCL

The combination chemotherapies for this study are Carboplatin plus Irinotecan versus Carboplatin plus Etoposide.

Eligibility criteria: Inclusion Criteria:

* cytological or histological proven SCLC Stage I or II at 1st diagnosis
* no prior chemotherapy
* measurable tumor disease
* karnofsky performance 70

Exclusion Criteria:

* second malignancy ( except basal cell carcinoma, CA in situ Cervix uteri)
* NYHA III
* chronic diarrhea, obstructive bowel syndrome

Primary outcomes:
measure: Primary Endpoint:
measure: Documentation of the remission rate ( Phase II)
measure: Determination of progress free time (Phase III)
Secondary outcomes:
measure: Secondary Endpoint:
measure: Documentation of progress free time (Phase II)
measure: Documentation of objective remission rate ( Phase III)
measure: Documentation of 1-year survival rate
measure: Documentation of safety of the drug combination
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Hematology & Oncology Charité CBF Berlin, Germany
Study officials:
affiliation: Charité Campus Benjamin Franklin University Clinic
name: Ulrich Keilholz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04120896: Karate or Kung Fu?
Official title: Karate or Kung Fu? A Comparison of Japanese and Chinese Martial Arts Training for Enhancing Psychophysical Development in Asian Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Childhood ALL
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2019-10-09
Enrollment: 52
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sedentary lifestyle in Asian children together with aversive parenting style may compromise their physical and psychological health. The aim of the proposed stratified, randomized controlled study are to explore the beneficial effects of Japanese martial art (karate) and Chinese martial art (Ving Tsun kung fu) training on improving the psychophysical health in this population. Over fifty-two Asian children (age = 6-12 years) will be recruited from schools in Hong Kong and then randomly assigned to either a karate group or a Ving Tsun group. Children in both groups will receive the respective physical and spiritual martial art training for 3 months (3 times/week, one hour each). Outcomes will be evaluated at baseline and after the intervention by a blinded assessor. Primary outcomes include muscle power of the arms and legs as measured by a medicine ball throw test and a standing long jump test, respectively. Secondary outcomes include flexibility as quantified by a sit-and-reach test, aggression as measured by the Reactive-Proactive Aggression Questionnaire, and attention as measured by the Child Behavioral Checklist-Youth Self-Report. Both karate and Ving Tsun kung fu training programs are predicted to improve physical health of Asian children. It is expected that these training programs can be incorporated into the physical education classes or extracurricular activities in schools or in the community to improve project sustainability.


Eligibility criteria: Inclusion Criteria:

* 6-12 years old
* Asian ethnicity and reside in Hong Kong

Exclusion Criteria:

* any physical or psychological disorders that may affect test results
* previous experience in martial arts
* participate in regular sports training

Primary outcomes:
measure: Change in muscle power of the upper limbs
timeFrame: 0 and 3 months
measure: Change in muscle power of the lower limbs
timeFrame: 0 and 3 months
Secondary outcomes:
measure: Change in flexibility of the low back and hamstring
timeFrame: 0 and 3 months
measure: Change in aggression
timeFrame: 0 and 3 months
measure: Change in attention
timeFrame: 0 and 3 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: University of Hong Kong
Study officials:
References:
Clinical trial NCT00579696: The Queens Library HealthLink Project
Official title: The Queens Library HealthLink Project
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Diseases
Keywords: Multiple Diseases
Queens
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
name: QUEENS BOROUGH PUBLIC LIBRARY (QBPL)
name: Queens Health Network
name: Caritas Health Care, Inc
First posted: 2007-12-24
Enrollment: 2789
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Low-Income areas in the borough of Queens

Brief summary: To determine whether community based participatory action research leads to more effective cancer prevention and control in underserved communities compared to traditional, "topdown" programs.

Detailed description: To examine how communities engage in the participatory research process, in order to develop locally tailored initiatives for cancer education, prevention and control.

To examine whether and how long program effects are sustained after completion of the intensive collaborative program planning intervention.

Eligibility criteria: Inclusion Criteria:

* This project is intended to reach participants over the age of 18 within each sampled neighborhood, inclusive of both women and men of all ethnic and language groups. As such, our outcomes assessment strategy is similarly inclusive. Specific sources of data and sampling strategies for different measures are detailed in Section 7, as part of our assessment plan.

Exclusion Criteria:

* Individuals younger than 18 years of age will not be included in this study.

Primary outcomes:
measure: To determine whether community-based participatory action research leads to more effective cancer prevention and control in underserved communities compared to traditional, "topdown" programs.
timeFrame: 5 years
Secondary outcomes:
measure: To examine how communities engage in the participatory research process, in order to develop locally tailored initiatives for cancer education, prevention and control.
timeFrame: 5 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Bruce Rapkin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03885596: Open-Label CA-008 (Vocacapsaicin) in Bunionectomy
Official title: An Open-Label Study of Intraoperative CA-008 Administration in Subjects Undergoing Bunionectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Lead sponsor: Concentric Analgesics
Sponsor class: INDUSTRY
First posted: 2019-03-21
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A Phase 2, open-label study of CA-008 to evaluate post-surgical pain control with CA-008.

Detailed description: This is a Phase 2, single-center, open-label study evaluating a single dose of CA-008 4.2 mg administered with different standard-of-care anesthetic regimens during an elective unilateral transpositional first metatarsal osteotomy for the correction of hallux valgus deformity (bunionectomy).

Eligibility criteria: Inclusion Criteria:

1. Healthy adult aged 18 - 65 years old
2. American Society of Anesthesiology (ASA) physical Class 1, 2 or 3
3. Planning elective Bunionectomy repair
4. For both males and females: using an acceptable method of birth control
5. If a female: not pregnant or breastfeeding
6. Have a body mass index ≤ 36 kg/m2

Exclusion Criteria:

1. Have another painful condition, other than bunion-related pain, that may require pain treatment during the study period
2. Have active skin disease or another abnormality at the anticipated site of surgery that could interfere with the planned surgery.
3. Have a known allergy to study medications.
4. Have a history of significant medical, neuropsychiatric or other condition, including a clinically significant abnormal clinical laboratory test values
5. Have positive results on the alcohol test (breath or saliva) or urine drug screen.

Primary outcomes:
measure: Area Under the Curve (AUC) of Numerical Rating Scale (NRS) Scores (at Rest) Over 72h
timeFrame: 0-72 hours
measure: Pain Intensity Scores at 24 Hours at Rest Using Numerical Rating Scale (NRS)
timeFrame: 24 hours
measure: Pain Intensity Scores at 48 Hours at Rest Using Numerical Rating Scale (NRS)
timeFrame: 48 hours
measure: Pain Intensity Scores at 72 Hours at Rest Using Numerical Rating Scale (NRS)
timeFrame: 72 hours
Secondary outcomes:
measure: Opioid Consumption
timeFrame: 0-72 hours
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Lotus Clinical Research, LLC
state: California
Study officials:
affiliation: Concentric Analgesics
name: Nancy Wu
role: STUDY_DIRECTOR
References:
Clinical trial NCT01138696: Long Term Follow-up of the "Stryker Dacron and Trevira Ligament" for Anterior Cruciate Ligament (ACL) Repair
Official title: Long Term Follow-up of the "Stryker Dacron and Trevira Ligament" for ACL Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ACL Rupture
Replacement
Keywords: ACL
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2010-06-07
Enrollment: 80
Sex: ALL
Minimum age (years): 49
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that received a Stryker Dacron or Trevira ligament to replace there ACL.

Brief summary: About 20 years ago synthetic ligaments were used in orthopaedics / traumatology for the repairing and replacement of injuries of the anterior cruciate ligament. After less than 10 years it appeared that a relatively important number of patients showed complications on the basis of synovitis. The situation of another group of patients on the other hand evolved favourably without complications. The study to focuses on this group of patients and attempts to determine how the replacement without problems ab initio, evolved in the time.

It concerns a group of 57 patients who received an implantation in the UZ Ghent between November 85 and October 87 with the Stryker Dacron ligament and a group of 33 patients who received the Trevira ligament in the ASZ Aalst. The clinical result will be stipulated by means of standardized questionnaires and a clinical examination. The radiological result will be determined by the degree of integrity of the ligament that was implanted at the time. In this way the study could give an idea about the degree in which the technical success of the intervention correlates with the clinical success 20 years later.


Eligibility criteria: Inclusion Criteria:

* Patients that received a Stryker Dacron or Trevira ligament to replace there ACL.
* Max age: 75
* Min age: 49
* Minimum follow up: 22 years

Primary outcomes:
measure: to determine the evolution in pain, safety and tolerability of replacement of anterior cruciate ligament (ACL) after trauma or injury
timeFrame: 20 years after surgery
Secondary outcomes:
measure: A clinical and radiographical evaluation of the knee after implantation of a synthetic ligament.
timeFrame: 20 years after surgery
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Algemeen Stedelijk Ziekenhuis
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: René Verdonk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05489796: Bellomic PCA in Laparoscopic Gynecologic Surgery
Official title: Comparison of Postoperative Side Effects and Analgesic Quality According to the Combination of Fentanyl and Ketorolac Versus Fentanyl After Laparoscopic Gynecologic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Gynecological Surgery
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2022-08-05
Enrollment: 72
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In laparoscopic gynecological surgery, when intravenous patient-controlled analgesia (IV-PCA) device is used after surgery, the degree of postoperative side effects and pain control is compared when a combination of fentanyl and ketorolac is administered compared to when fentanyl alone is used.


Eligibility criteria: Inclusion Criteria:

* American society of anesthesiology physical status 1 or 2
* Patients scheduled for gynecological laparoscopic surgery under general anesthesia
* Patients who applied for the use of IV-PCA after surgery

Exclusion Criteria:

* Patients with side effects of opioids
* Patients with hypersensitivity to aspirin or non-steroid anti-inflammatory drugs
* Patients with alcohol or drug dependence
* Patients with peptic ulcers, patients with gastrointestinal bleeding
* Patients with suspected cerebrovascular hemorrhage, organic disorders, or damage to the head related to increased intracranial pressure
* Symptoms of bronchial asthma or bronchospasm
* Patients with severe respiratory depression
* Moderate to severe renal impairment
* Patients with reduced blood volume or dehydration
* polyps in the nose
* angioedema
* Patients with or a history of the convulsive disease
* Patients for whom the use of neuromuscular blocking agents is contraindicated

Primary outcomes:
measure: Change in the occurrence of postoperative nausea
timeFrame: postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour
measure: Change in the occurrence of postoperative vomiting
timeFrame: postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour
Secondary outcomes:
measure: Change in the use of rescue antiemetics
timeFrame: postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour
measure: Change of postoperative pain score
timeFrame: postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour
measure: Change in the use of rescue analgesics
timeFrame: postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National Univ. Bundang Hospital
state: Gyeonggi
Study officials:
References:
Clinical trial NCT01503996: Drinking Habits of Glaucoma Patients and Age Matched Controls
Official title: Clinical Study to Evaluate the Drinking Habits of Glaucoma Patients and Age Matched Controls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dehydration
Glaucoma
Keywords: dehydration
risk factor
glaucoma
Controls
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2012-01-04
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Glaucoma patients who are hospitalized for diurnal intraocular pressure measurements and glaucoma assessment.

Controls who are hospitalizes because of an other ophthalmic disease and do not suffer from glaucoma.

Brief summary: The purpose of this study is to examine if a chronic dehydration is a risk factor for the developement or progression of some forms of glaucoma.

Detailed description: Glaucoma patients who are hospitalized for diurnal intraocular pressure measurements and glaucoma assessment are asked about their drinking habits. Objective evaluation of hydration status is assessed with the Body Composition Monitor (Fresenius). Retinal Vessel Analysis and Laser Doppler Flowmetry are investigated in subgroups.

The control group are also hospitalized patients who do not suffer from glaucoma.

Eligibility criteria: Inclusion Criteria:

* glaucoma patients
* controls

Exclusion Criteria:

* psychiatric disease,
* epilepsy, pregnancy,
* nutritional disorder,
* malfunction of blood clotting and wound healing,
* pacemaker,
* metallic stents

Primary outcomes:
measure: Dehydration
timeFrame: 4 years
Secondary outcomes:
measure: microvascular changes
timeFrame: 4 years
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: University Eye Clinic Dresden
Study officials:
affiliation: University Eye Clinic Dresden
name: Karin R Pillunat, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pillunat KR, Ventzke S, Spoerl E, Furashova O, Stodtmeister R, Pillunat LE. Central retinal venous pulsation pressure in different stages of primary open-angle glaucoma. Br J Ophthalmol. 2014 Oct;98(10):1374-8. doi: 10.1136/bjophthalmol-2014-305126. Epub 2014 May 12.
Clinical trial NCT04048096: Krill Oil and Muscle in Older Adults
Official title: Effects of Krill Oil Supplementation on Muscle Function in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Sarcopenia
Lead sponsor: University of Glasgow
Sponsor class: OTHER
First posted: 2019-08-07
Enrollment: 102
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the effects of krill oil supplementation on muscle mass in function in older adults. Half of the participants will receive krill oil supplements and the other half a placebo.


Eligibility criteria: Inclusion Criteria:

* BMI less than 35kg/m2

Exclusion Criteria:

* Diabetes
* severe cardiovascular disease
* seizure disorders
* uncontrolled hypertension (\>150/90mmHg at baseline measurement)
* cancer or cancer that has been in remission \<5 years
* ambulatory impairments which would limit ability to perform assessments of muscle function
* dementia
* taking medication known to affect muscle (e.g. steroids)
* have an implanted electronic device (e.g. pacemaker/defibrillator/insulin pump)
* on anticoagulant therapy
* allergies to seafood
* regular consumption of more than 2 portions of oily fish per week.

Primary outcomes:
measure: Change in Muscle strength
timeFrame: Change from baseline to 6 months
Secondary outcomes:
measure: Change in Grip strength
timeFrame: Change from baseline to 6 months
measure: Change in Muscle thickness
timeFrame: Change from baseline to 6 months
measure: Change in Short performance physical battery test
timeFrame: Change from baseline to 6 months
measure: Change in Body Fat
timeFrame: Change from baseline to 6 months
measure: Change in Lean Mass
timeFrame: Change from baseline to 6 months
measure: Change in Fasting glucose
timeFrame: Change from baseline to 6 months
measure: Change in Blood lipids
timeFrame: Change from baseline to 6 months
measure: Change in CRP
timeFrame: Change from baseline to 6 months
measure: Change in Erythrocyte fatty acid profile
timeFrame: Change from baseline to 6 months
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Stuart Robert Gray
Study officials:
affiliation: University of Glasgow
name: Stuart Gray, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alkhedhairi SA, Aba Alkhayl FF, Ismail AD, Rozendaal A, German M, MacLean B, Johnston L, Miller AA, Hunter AM, Macgregor LJ, Combet E, Quinn TJ, Gray SR. The effect of krill oil supplementation on skeletal muscle function and size in older adults: A randomised controlled trial. Clin Nutr. 2022 Jun;41(6):1228-1235. doi: 10.1016/j.clnu.2022.04.007. Epub 2022 Apr 20.
Clinical trial NCT00661596: Assessment of Efficacy of Vardenafil, Influence on Self-esteem and Self-confidence in Subjects With Erectile Dysfunction
Official title: Multi-centre, Randomised, Double-blind, Parallel, Placebo-controlled Clinical Study to Assess the Efficacy of Vardenafil and Its Influence on Self-esteem and Self-confidence in Patients With Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction
Vardenafil
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-04-18
Enrollment: 129
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Erectile problems may lead to anxiety, loss of self-esteem and depression and/or stress. The purpose of this national study was to determine if vardenafil is effective in treating impotent men (erectile dysfunction) and evaluate its influence in self-esteem and self-confidence. During the visits the patients was asked some questions about erections, and he fill different questionnaires about sexuality, mood, feelings, self-esteem and sexual activity.


Eligibility criteria: Inclusion Criteria:

* Age: 18 years and older
* Males with erectile dysfunction
* Stable heterosexual relationship

Exclusion Criteria:

* Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
* Nitrate use
* Other exclusion criteria apply acc. to Summary of Product Characteristics

Primary outcomes:
measure: International Index of Erectile Function - Erectile Function Domain
timeFrame: 12 weeks
Secondary outcomes:
measure: Global Assessment Questionnaire
timeFrame: 12 weeks
measure: IIEF-EF domain score
timeFrame: 12 weeks
measure: Other diary based variables
timeFrame: 12 weeks
measure: Safety and tolerability
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Oviedo
country: Spain
state: Asturias
city: Sabadell
country: Spain
state: Barcelona
city: Barcelona
country: Spain
state: Cataluña
city: Hondarribia
country: Spain
state: Guipuzcoa
city: Leganés
country: Spain
state: Madrid
city: Móstoles
country: Spain
state: Madrid
city: Vigo
country: Spain
state: Pontevedra
city: Alicante
country: Spain
city: Granada
country: Spain
city: Málaga
country: Spain
city: Sevilla
country: Spain
city: Valencia
country: Spain
city: Valladolid
country: Spain
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: