louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00655447: Examining the Long-Term Risks of Oophorectomy
Official title: Ovarian Conservation: Long-Term Health Outcomes From the Nurse's Health Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Heart Disease
Stroke
Breast Cancer
Ovarian Cancer
Cancer
Hip Fracture
Death
Keywords: oophorectomy
ovarian conservation
stroke
breast cancer
ovarian cancer
other cancer
hip fracture
Lead sponsor: Parker, William H., M.D.
Sponsor class: OTHER
Collaborators: name: Ethicon, Inc.
First posted: 2008-04-09
Enrollment: 32175
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nurses' Health Study I, which included 122,701 married registered nurses living in 11 U.S. states and who were ages 30 to 55 in 1976

Brief summary: At the time of hysterectomy for benign disease, the overall health benefits of preserving ovarian function in a large population of women have not been established.

Detailed description: We are conducting a prospective, observational study of 32,175 women participants of the Nurse's Health Study who had a hysterectomy with or without removal of both ovaries. We are evaluating mortality and morbidity due to the following conditions: coronary heart disease, stroke, breast cancer, ovarian cancer, other cancer, hip fracture and death from all causes.

Eligibility criteria: Inclusion Criteria:

* Women who had hysterectomies were classified into simple hysterectomy or hysterectomy with both ovaries removed.

Exclusion Criteria:

* Evidence of cancer, coronary heart disease (MI or Angina Pectoris), stroke, or hip fracture before entering the study were excluded. Cancer as an indication for hysterectomy also excluded.
* Women reporting unilateral oophorectomy, unknown oophorectomy status, unknown age of hysterectomy, or those who had oophorectomy before hysterectomy were excluded.

Primary outcomes:
measure: mortality and morbidity due to the following conditions: coronary heart disease, stroke, breast cancer, ovarian cancer, other cancer, hip fracture and death from all causes.
timeFrame: 28 years
Secondary outcomes:
measure: The effect of postmenopausal hormone use on mortality and morbidity due to the following conditions: coronary heart disease, stroke, breast cancer, ovarian cancer, other cancer, hip fracture and death from all causes.
timeFrame: 28 years
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Parker, Rosenman, Rodi Gynecology Group
state: California
Study officials:
affiliation: Saint John's Cancer Institute
name: William H Parker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parker WH, Broder MS, Liu Z, Shoupe D, Farquhar C, Berek JS. Ovarian conservation at the time of hysterectomy for benign disease. Obstet Gynecol. 2005 Aug;106(2):219-26. doi: 10.1097/01.AOG.0000167394.38215.56.
Clinical trial NCT00372047: Evaluation of Excessive UV Irradiation on Skin Aging by Multiphoton Laser Imaging and Biophysical Methods
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Skin Aging
Lead sponsor: University of Jena
Sponsor class: OTHER
First posted: 2006-09-06
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: RETROSPECTIVE

Brief summary: In this study, test persons with chronic excessive UV radiation and a control group are examined by multiphoton laser imaging and biophysical methods in order to evaluate the dermal fiber network. We expect to observe signs of advanced skin aging in the test group.


Eligibility criteria: Inclusion Criteria:

* non smokers
* contraception
* 12 subjects with chronic excessive UV irradiation
* 12 normal subjects

Exclusion Criteria:

* dermatological and other severe disorders
* pregnancy and lactation
* dermatological topical therapy
* internal medication
* cosmetical intervention at test area

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Department of Dermatology, FSU Jena
state: Thuringia
Study officials:
affiliation: Dept. of Dermatology, FSU Jena
name: Martin Kaatz, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04210947: Effect of Foam Rolling on Muscle Mechanical Properties
Official title: Effects of Different Variation of Myofascial Release Application Speed on Muscle Mechanical Properties
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sports Physical Therapy
Keywords: sports physiotherapy
self-myofascial release
foam-roller
muscle biomechanical properties
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will use a foam roller at three different paces in a randomized sequence with a week between,
Primary purpose: TREATMENT

Brief summary: This study evaluates effect of self-myofascial release in different paces on muscle biomechanics. All participants will use foam roller in different paces once in a week with weeks apart.

Detailed description: Foam-roller is a widely used self-myofascial release method in sports. Although, effects of foam-roller has been shown, there is no defined speed of usage. Using foam-roller in different paces could cause different changes.

Eligibility criteria: Inclusion Criteria:

* Being a professional athlete with at least 2 years of sport history

Exclusion Criteria:

* Having a chronic-systemic disease
* Having a lower extremity injury

Primary outcomes:
measure: Viscoelastic measurement Change
timeFrame: baseline and 15 minutes
Secondary outcomes:
measure: Hip Flexors Tightness
timeFrame: baseline and 15 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Atilla Çağatay Sezik, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Curran PF, Fiore RD, Crisco JJ. A comparison of the pressure exerted on soft tissue by 2 myofascial rollers. J Sport Rehabil. 2008 Nov;17(4):432-42. doi: 10.1123/jsr.17.4.432.
citation: Kumka M, Bonar J. Fascia: a morphological description and classification system based on a literature review. J Can Chiropr Assoc. 2012 Sep;56(3):179-91.
citation: Chaitow L. Somatic dysfunction and fascia's gliding-potential. J Bodyw Mov Ther. 2014 Jan;18(1):1-3. doi: 10.1016/j.jbmt.2013.11.019. Epub 2013 Dec 3. No abstract available.
citation: Stecco A, Meneghini A, Stern R, Stecco C, Imamura M. Ultrasonography in myofascial neck pain: randomized clinical trial for diagnosis and follow-up. Surg Radiol Anat. 2014 Apr;36(3):243-53. doi: 10.1007/s00276-013-1185-2. Epub 2013 Aug 23.
citation: Stecco C, Stern R, Porzionato A, Macchi V, Masiero S, Stecco A, De Caro R. Hyaluronan within fascia in the etiology of myofascial pain. Surg Radiol Anat. 2011 Dec;33(10):891-6. doi: 10.1007/s00276-011-0876-9. Epub 2011 Oct 2.
citation: MacDonald GZ, Penney MD, Mullaley ME, Cuconato AL, Drake CD, Behm DG, Button DC. An acute bout of self-myofascial release increases range of motion without a subsequent decrease in muscle activation or force. J Strength Cond Res. 2013 Mar;27(3):812-21. doi: 10.1519/JSC.0b013e31825c2bc1.
Clinical trial NCT01802047: Impact of Different Electric Pumping Modalities on Milk Volume Production in Mothers of Preterm Infants
Official title: Milk Volume Production in Mothers of Preterm Infants: Electric Pumping Modalities
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Prematurity
Keywords: Mothers of Preterms
Breastfeeding Mothers of Preterm infants
mother milk feeding
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-03-01
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Initiating and sustaining breastfeeding are common challenges in neonatal units.

It is known that hindmilk expressed at the end of the expression session has a higher fat content.

Previous studies have shown that simultaneous pumping is more effective at producing milk than sequential pumping. However this approach is often felt uncomfortable by the mothers, and sequential pumping is preferred.

The purpose of this study is to determine which modality of milk expression by electric pump is the most efficient and productive when sequential pumping is used.This is done by assessing the milk volume expressed per expression and its macronutrients content.

Detailed description: The study will last for 6 days. Each mother will express breast milk following two designed modalities in a random fashion, for two days each.

The two designed modalities are:

1. Complete pumping of one breast (first left) for 15 min, followed by complete pumping of the right breast for 15 min, until the breast is empty.
2. Pumping both breast simultaneously for 15 min.

At day one of the study, the mothers will follow the standard pumping modality in practice at our department.

In between the two studied procedures at day 4 of the study, the mothers will again follow the standard pumping modality.

On each day of the study, in the morning after the first expression of the day, a sample of 2 ml of pumped breastmilk will be taken, and the total volume of the daily expressed milk will be recorded.

Eligibility criteria: Inclusion Criteria:

* Mothers of Preterms

Exclusion Criteria:

* HIV infected mothers

Primary outcomes:
measure: Daily volume of expressed breast milk under a specific electric pumping modality
timeFrame: after 15 minutes of electric expression of each breast
Secondary outcomes:
measure: Composition of expressed milk under a specific electric pumping modality
timeFrame: after the first morning session of electric milk expression
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Department of Neonatology Tel Aviv Medical Center
Study officials:
affiliation: Tel Aviv Medical Center
name: Shaul Dollberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06623747: Low Energy Availability and Recovery from Resistance Exercise
Official title: Low Energy Availability and Recovery from Resistance Exercise
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Resistance Exercise
Lead sponsor: South Dakota State University
Sponsor class: OTHER
Collaborators: name: South Dakota State University
First posted: 2024-10-02
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This research project will determine how restricting Calories to lose weight affects your ability to recover between weightlifting exercise sessions.


Eligibility criteria: Inclusion Criteria:

* 3 years of resistance training experience

Exclusion Criteria:

* 1+ American College of Sports Medicine sign(s) or symptom(s) of cardiovascular, metabolic or renal disease(s)
* musculoskeletal disorder(s)
* lactose intolerance; soy or dairy allergies

Primary outcomes:
measure: Vertical Jump Performance
timeFrame: At enrollment (baseline), wait 1-2 weeks, before and after first 2-day condition, wait 1-2 weeks, before and after second 2-day condition
measure: Knee Extension and Flexion Repetitions to Failure
timeFrame: At enrollment (baseline), wait 1-2 weeks, before and after first 2-day condition, wait 1-2 weeks, before and after second 2-day condition
measure: Bench Press One-Repetition Maximum
timeFrame: At enrollment (baseline), wait 1-2 weeks, before and after first 2-day condition, wait 1-2 weeks, before and after second 2-day condition
measure: Peak Knee Extension and Flexion Torques
timeFrame: At enrollment (baseline), wait 1-2 weeks, before and after first 2-day condition, wait 1-2 weeks, before and after second 2-day condition
Secondary outcomes:
Other outcomes:
Locations:
city: Brookings
country: United States
facility: South Dakota State University
state: South Dakota
Study officials:
affiliation: South Dakota State University
name: Chaise A Murphy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02696447: Radiation Impact on Thromboembolic Events
Official title: Radiation Therapy and Venous Thromboembolic Events
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Neoplasm
Keywords: Radiation therapy
Thrombosis
Lead sponsor: Institut de Cancérologie de la Loire
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire de Saint Etienne
name: CH Roanne
First posted: 2016-03-02
Enrollment: 450
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: patient with a solid (all locations) treated with radiation therapy and / or brachytherapy as curative intent

Brief summary: The aim of the present study is to determine the frequency and to identify main risk factors for venous thromboembolism of venous thromboembolic complications in a population of cancer patients treated with a curative intent by ionizing radiation.


Eligibility criteria: Inclusion Criteria:

* patient with a solid cancer (all locations) treated with radiation therapy and / or brachytherapy as curative intent
* to be 18

Exclusion Criteria:

* Patient with metastatic cancer,
* Patients whose follow-up at 6 months is not possible
* Patient receiving an anti-coagulative medication (curative doses)
* Pregnant or breastfeeding women,
* Person under protection of justice or unable to give consent

Primary outcomes:
measure: Venous Thromboembolism event
timeFrame: 6 months
Secondary outcomes:
measure: Dosage of D-dimer
timeFrame: 6 months
measure: C-reactive protein
timeFrame: 6 months
measure: Complete blood count
timeFrame: 6 months
measure: Time of occurrence of VTE
timeFrame: 6 months
measure: Symptomatic VTE
timeFrame: 6 months
Other outcomes:
Locations:
city: Roanne
country: France
facility: CH de Roanne
city: Saint-Priest-en-Jarez
country: France
facility: Institut de cancérologie Lucien Neuwirth
Study officials:
References:
citation: Daguenet E, Maison M, Tinquaut F, Giroux EA, Bertoletti L, Suchaud JP, Rancoule C, Guy JB, Magne N. Venous thromboembolism and radiation therapy: The final radiation-induced thrombosis study analysis. Cancer Med. 2022 Apr;11(8):1753-1762. doi: 10.1002/cam4.4559. Epub 2022 Feb 24.
Clinical trial NCT04214847: The Outcome of Ahmed Glaucoma Valve in Difficult Glaucoma Cases
Official title: One- Year Follow up of Two Models of Ahmed Glaucoma Valves (S2 and FP7) in Refractory Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma, Open-Angle
Glaucoma Secondary
Glaucoma, Neovascular
Keywords: glaucoma-ahmed-valve-S2-FP7-IOP-encapsulation
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 1
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: comparing clinical outcome variables (IOP, number of glaucoma medications, visual acuity, and complications) after using S2 and FP7 models of Ahmed Glaucoma Valves.
Primary purpose: TREATMENT

Brief summary: The clinical difference (mean IOP, success rate, and complications) on using S2 and FP7 models of Ahmed Glaucoma Valve that had similar dimensions and different materials used for their construction in one year follow up was evaluated.

Detailed description: Refractory glaucoma is a difficult subject; many glaucoma devices are tried to reduce IOP. Glaucoma devices is now an integral part of glaucoma surgery. AGV is commonly used. The investigators need to compare the efficiency and failure rate of two models of AGV. The point that is the biological reaction around capsule can affect the efficiency.

Eligibility criteria: Inclusion Criteria:

1. primary glaucoma patients with repeated failed trabeculectomy or other intraocular surgery.
2. patients had secondary glaucoma known to have a high failure rate with trabeculectomy such as neovascular, uveitis, post keratoplasty glaucoma or iridocorneal endothelial syndrome-associated glaucoma.

Exclusion Criteria:

1. patients lacked light perception, unwilling or unable to give informed consent, lived out of the area and were expected to be unavailable for follow-up visits,
2. patients had previous aqueous shunt implanted in the same eye, other external impediment to supero-temporal drainage device implantation.
3. patients had silicone oil, vitreous in the anterior chamber sufficient to require a vitrectomy.
4. patients had uveitis associated with a systemic condition like juvenile rheumatoid arthritis.
5. patients had nanophthalmos, Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure.

   -

Primary outcomes:
measure: the postoperative mean IOP in both groups compared with the baseline IOP baseline IOP .
timeFrame: one-year follow up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Elbaklish KH, Gomaa WA. A One-Year Follow-Up of Two Ahmed Glaucoma Valve Models (S2 and FP7) for Refractory Glaucoma: A Prospective Randomized Trial. Clin Ophthalmol. 2020 Mar 4;14:693-705. doi: 10.2147/OPTH.S224653. eCollection 2020.
Clinical trial NCT02103647: Clinical Trial to Compare The Pharmacokinetics of A Pregabalin Controlled Release Tablet 300mg and Immediate Release Formulation
Official title: A Randomized, Open-label, Crossover Clinical Trial to Compare The Pharmacokinetics of A Pregabalin Controlled Release Tablet 300mg and Immediate Release Formulation After Multiple Dosing Under Fasted Condition in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Neuropathic pain
pregabalin
Lead sponsor: IlDong Pharmaceutical Co Ltd
Sponsor class: INDUSTRY
First posted: 2014-04-04
Enrollment: 24
Sex: MALE
Minimum age (years): 19
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the pharmacokinetics profiles of pregabalin sustained release tablet (300mg) to immediate release capsule(150mg \* 2) while multiple dosing.


Eligibility criteria: Inclusion Criteria:

* 19\~44 aged healthy adult.
* someone tho has at least 50kg body weight and ideal body weight ±20%

Exclusion Criteria:

* someone has acute symptom at screening phase
* someone has any disease or symptoms which is clinically significant
* someone had been determined during healthy examination in screening period
* AST or ALT \> 1.25 times than normal
* Total bilirubin \> 1.5 times than normal
* someone who has a history of allergy, anaphylaxis, drug abuse or misuse.
* someone who had enrolled to other clinical trial within the last 60 days.
* someone who had donated blood within the last 60 days.
* someone who can't take a meal derived from this trial.
* someone who has taken abnormal meals like which can affect to drug ADME
* someone who has taken other ETC drugs or oriental drugs within the last 14 days, Or OTC drugs within the last 7 days
* someone who has taken caffein continuously (coffee or green tea more than 5 cups per a day) or took caffein since 24hours before.
* someone who has taken alcohol more than 30g/day or smoked more than 10 piece of tobacco/day.
* someone who has galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

Primary outcomes:
measure: Measure blood concentration of pregabalin
timeFrame: 0~4day / 14~18day
Secondary outcomes:
measure: Safety evaluation
timeFrame: 0~25day
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Catholic medical center
state: Seocho-gu
Study officials:
References:
Clinical trial NCT03447847: Effect of Composition and Timing of Ingestion of Fluids on the Urinary Excretion of Lithogenic Substances
Official title: Effect of Composition and Timing of Ingestion of Fluids on the Urinary Excretion of Lithogenic Substances
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2018-02-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Interventional crossover study on healthy volunteers aimed at evaluating the effect of the composition and timing of ingestion of different types of water on the urinary excretion of lithogenic substances; the study will also analyze the effect of potassium citrate on urine pH and lithogenic substances


Eligibility criteria: Inclusion Criteria:

* Age \>18 years

Exclusion Criteria:

* Chronic malabsorption
* Recurrent urinary tract infections
* History of kidney stones

Primary outcomes:
measure: Urine composition
timeFrame: Assessed the same day of water ingestion
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Divisione di Nefrologia, Fondazione Policlinico Gemelli
Study officials:
References:
citation: Ferraro PM, Baccaro R, Baroni S, D'Alessandri L, Carpenito C, Di Daniele N, Urbani A, Gambaro G. Effect of water composition and timing of ingestion on urinary lithogenic profile in healthy volunteers: a randomized crossover trial. J Nephrol. 2021 Jun;34(3):875-881. doi: 10.1007/s40620-020-00769-2. Epub 2020 Jun 8.