louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00202163: ANDRO 2002: Dehydroepiandrosterone (DHEA) or Testosterone Versus Placebo in Men With Sexual Dysfunction
Official title: A Randomized Double-Blind Placebo-Controlled Study Comparing the Safety and Efficacy of Dehydroepiandrosterone (DHEA) or Testosterone Versus Placebo in Men With Sexual Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Erectile Dysfunction
Keywords: ED
DHEA
testosterone
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 120
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: Androgen deficiency in the aging male is poorly understood. The objective of this study will be to determine the role of testosterone and DHEA in enhancing sexual interest and sexual performance.

Detailed description: 120 men with a diagnosis of Erectile dysfunction (ED) will be randomized to one of three arms in the study, DHEA (50 mg), testosterone \[T\] (80 mg) or placebo. Patients will be evaluated after starting blinded medication at 30 day intervals for a total of 90 days. Response will be evaluated with blood parameters, physical examination including rectal examination, validated questionnaires and global assessment scales.

Eligibility criteria: Inclusion Criteria:

* Erectile dysfunction (ED)

Exclusion Criteria:

* Prior use of DHEA or T

Primary outcomes:
measure: Patient satisfaction
Secondary outcomes:
measure: Responder rates based upon questionnaires
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Centre for Advanced Urological Research
state: Ontario
Study officials:
affiliation: Queen's University
name: Alvaro Morales, MD FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03099863: Cytoscopic Antibiotic Irrigant to Reduce Postoperative Urinary Tract Infection
Official title: Cytoscopic Antibiotic Irrigant to Reduce Postoperative Urinary Infection: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Tract Infections
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 242
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postoperative urinary tract infections (UTIs) affect 20-30% of patients undergoing elective gynecologic surgery and have a significant socioeconomic impact and cost. Preoperative antibiotics, sterile operating techniques, postoperative antibiotic and non-antibiotic medical therapies have been utilized to attempt to decrease this rate with little improvement. Utilization of an intraoperative antibiotic cystoscopic irrigant may decrease postoperative UTIs. The investigators have designed a prospective randomized controlled study to evaluate the effectiveness of an antibiotic cystoscopic fluid in preventing postoperative urinary tract infections in women undergoing elective pelvic floor surgery with cystoscopy.


Eligibility criteria: Inclusion Criteria:

* Adult women at least 18 years of age
* Elective Female Pelvic Medicine and Reconstructive Surgery or Gynecologic Minimally Invasive surgeries including hysterectomy, suburethral sling, and pelvic organ prolapse repair that require cystoscopy.

Exclusion Criteria:

* Surgeries that include: intradetrusor Botox, vaginal mesh excision, and fistula repair
* Pregnancy
* History of nephrolithiasis
* Allergy to study medications
* Congenital urogenital anomaly
* Neurogenic bladder

Primary outcomes:
measure: Urinary Tract Infection
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
Study officials:
References:
Clinical trial NCT00883363: Reduction of Myocardial Infarction by Preconditioning in Patients With Ruptured Abdominal Aortic Aneurysm
Official title: Reduction of Myocardial Infarction by Preconditioning in Patients With Ruptured Abdominal Aortic Aneurysm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Keywords: precondition
ruptured abdominal aortic aneurysm
myocardial infarction
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Aarhus University Hospital Skejby
First posted: 2009-04-17
Enrollment: 200
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: Preconditioning in patients treated for elective abdominal aneurysm showed that the rate of perioperative myocardial infarction could be reduced by 80 %(ARR from 27% to 5%). Precondition where performed by 10 minutes of clamping of each iliac arteries before clamping the abdominal aorta. Human studies in cardiac patients have shown promising results with precondition. Instead of clamping arteries they have all performed the procedure by inflating a blood pressure cuff above arterial pressure on a arm.

The investigators want to investigate if preconditioning induced by a blood pressure cuff on a arm can reduce the perioperative rate of myocardial infarction in patients open operated for ruptured abdominal aortic aneurysm.


Eligibility criteria: Inclusion Criteria:

* Patients with ruptured abdominal aortic aneurysm offered surgery
* Age \> 18 years

Exclusion Criteria:

* Technical inoperable

Primary outcomes:
measure: Reduction in myocardial infarction
timeFrame: 4 to 5 years
Secondary outcomes:
measure: Improvement in survival Description on inflammatory response
timeFrame: 4 to 5 years
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus university hospital skejby department of cardio thoracic and vascular surgery
state: Region Midt
Study officials:
affiliation: Aarhus University Hospital Skejby
name: Nikolaj Eldrup, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pedersen TF, Budtz-Lilly J, Petersen CN, Hyldgaard J, Schmidt JO, Kroijer R, Gronholdt ML, Eldrup N. Randomized clinical trial of remote ischaemic preconditioning versus no preconditioning in the prevention of perioperative myocardial infarction during open surgery for ruptured abdominal aortic aneurysm. BJS Open. 2018 Mar 26;2(3):112-118. doi: 10.1002/bjs5.55. eCollection 2018 Jun.
Clinical trial NCT04212663: A Study on the Treatment of Recurrent Clubfoot With the Tendon Release of Musculi Tibialis Posterior
Official title: A Multicenter Study on the Treatment of Recurrent Clubfoot With the Tendon Release of Musculi Tibialis Posterior
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Recurrent Clubfoot
Keywords: Musculi tibialis posterior
Tendon release
Anterior tibial tendon transfer
Lead sponsor: Guangzhou Women and Children's Medical Center
Sponsor class: OTHER
First posted: 2019-12-27
Enrollment: 80
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The musculi tibialis posterior can adduct the foot, so releasing the tedon of the muscle can help to correct the deformity of the forefoot adduction.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of recurrent idiopathic clubfoot
* The initial treatment was treated with the ponseti method
* Dynamic supination
* The max-dorsiflexion of angle \<5°
* The fore foot is adduct
* The sole is cavus

Exclusion Criteria:

* Symptomatic recurrent clubfoot
* Tarsal fusion
* Rigid recurrent clubfoot

Primary outcomes:
measure: The adduction of foot.
timeFrame: Six months after the operation
measure: The adduction of foot.
timeFrame: 1 year after operation
Secondary outcomes:
measure: The dorsiflextion of ankle.
timeFrame: Six months after the operation
measure: The dorsiflextion of ankle.
timeFrame: 1 year after operation
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02718963: Treatment of Dysphagia by Using a Synchronized Electrical Stimulation Device
Official title: Treatment of Dysphagia by Using a Synchronized Electrical Stimulation Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deglutition Disorders
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-03-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the synchronized electrical stimulation device effective in the treatment of dysphagia.

Detailed description: * Design: Prospective study
* Inclusion criteria of the patient group: who has a dysphagia symptom and confirmed by video-fluoroscopic swallowing study(N=10)
* Inclusion criteria of the control group: who does not have any dysphagia symptoms, and does not have any underlying disease(N=10)
* Setting: Hospital rehabilitation department
* Intervention: Participants are applied electrical stimulation by a "Synchronized Electrical Stimulation Device(SESD)"

Eligibility criteria: Inclusion Criteria:

* who have dysphagia symptoms and verified deglutition disorder by video fluoro swallowing study

Exclusion Criteria:

* who reject the checkup their deglutition function by high resolution manometry
* who reject apply "Synchronized Electrical Stimulator"

Primary outcomes:
measure: Pressure and Timing Change of Velopharynx, Tongue Base, Low Pharynx and Upper Esophageal Sphincter.
timeFrame: During the electrical stimulation and electrical stimulation effects of Velopharynx, tongue base, lower pharynx and upper esophageal sphincter
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jusuk Ryu, M.D. PhD
role: STUDY_DIRECTOR
References:
citation: Park D, Suh JH, Kim H, Ryu JS. The Effect of Four-Channel Neuromuscular Electrical Stimulation on Swallowing Kinematics and Pressures: A Pilot Study. Am J Phys Med Rehabil. 2019 Dec;98(12):1051-1059. doi: 10.1097/PHM.0000000000001241.
Clinical trial NCT01880463: Dry Eye Disease in the Vitamin D and Omega-3 Trial (VITAL)
Official title: Dry Eye Disease in the Vitamin D and Omega-3 Trial (VITAL)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dry Eye Disease
Keywords: Dry eye disease
incidence
progression
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2013-06-19
Enrollment: 25875
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The VITamin D and OmegA-3 Trial (VITAL; NCT 01169259) is a randomized clinical trial in 25,875 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. This ancillary study is being conducted among participants in VITAL and will examine whether omega-3 fatty acids or vitamin D3, compared to placebo, reduce the incidence and/or progression of dry eye disease.

Detailed description: This ancillary study to VITAL will examine the efficacy of omega-3 fatty acids and vitamin D3 in prevention of dry eye disease. The primary aims are to test whether omega-3 fatty acid supplementation (1) reduces the incidence of dry eye disease, and (2) improves the natural history of dry eye disease by relieving symptoms and other impacts on quality of life. Secondary aims are to estimate the incidence of dry eye disease in the US, prospectively examine the natural history of dry disease, explore factors that could modify or influence the impact of omega-3 fatty acid supplementation, evaluate the interrelationship of dry eye disease and depression, and test for possible independent or joint effects of vitamin D3 supplementation in the incidence and natural history of dry eye disease.

Eligibility criteria: Inclusion Criteria:

* All participants in VITAL (NCT 01169259) are eligible to participate in this ancillary study.

Exclusion Criteria:

* None

Primary outcomes:
measure: Dry Eye Disease
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Christen WG, Cook NR, Manson JE, Buring JE, Lee IM, Bubes V, Friedenberg G, Dushkes R, Smith D, Schaumberg DA; VITAL Research Group. Efficacy of Marine omega-3 Fatty Acid Supplementation vs Placebo in Reducing Incidence of Dry Eye Disease in Healthy US Adults: A Randomized Clinical Trial. JAMA Ophthalmol. 2022 Jul 1;140(7):707-714. doi: 10.1001/jamaophthalmol.2022.1818.
Clinical trial NCT06256263: Stapler Versus Conventional Pharyngeal Repair After Total Larygectomy
Official title: Linear Stapler Versus Conventional Repair of the Pharynx After Total Laryngectomy: Functional and Oncological Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Tumor of the Larynx
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 58
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was done to investigate the efficacy and safety of the linear stapler closure of the pharynx after total laryngectomy.


Eligibility criteria: Inclusion Criteria:

* All consecutive patients undergoing total laryngectomy for advanced laryngeal carcinoma in the study duration .

Exclusion Criteria:

* Infiltration of the safety margins proved by postoperative histopathology .
* Patients with tumor extension to the tongue base, or the hypopharynx .
* Patients who are unfit for surgery .
* Patients refusal to surgical treatment

Primary outcomes:
measure: incidence of pharyngocutaneous fistula after total laryngectomy
timeFrame: four weeks
Secondary outcomes:
measure: assessment of the swallowing function after surgery
timeFrame: 6 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University faculty of Medicine
Study officials:
References:
citation: Sansa-Perna A, Casasayas-Plass M, Rovira-Martinez C, Lopez-Vilas M, Garcia-Lorenzo J, Quer-Agusti M, Leon-Vintro X. Pharyngeal closure after a total laryngectomy: mechanical versus manual technique. J Laryngol Otol. 2020 Jul;134(7):626-631. doi: 10.1017/S0022215120001371. Epub 2020 Jul 29.
citation: Sannikorn P, Pornniwes N. Comparison of outcomes for staple and conventional closure of the pharynx following total laryngectomy. J Med Assoc Thai. 2013 Mar;96 Suppl 3:S89-93.
citation: Shan H, Gao Y, Liu L, Li M, Gao X, Li Y, Wang X, Ouyang D, Guo Z. Magnifying endoscopy with narrow-band imaging to assist the linear stapler closure of the pharynx during total laryngectomy. Am J Otolaryngol. 2018 Sep-Oct;39(5):511-514. doi: 10.1016/j.amjoto.2018.05.014. Epub 2018 May 28.
Clinical trial NCT01918163: Anti-oxidative Influence From Pomegranate Tablets on Male Sperm Quality in Couples Undergo Infertility Treatments Due to Male Infertility.
Official title: Anti-oxidative Influence From Pomegranate Tablets on Male Sperm Quality in Couples Undergo Infertility Treatments Due to Male Infertility.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Male Infertility With Severe Oligo-terato-asteno-spermia
Keywords: pomegranate pills, male infertility, pregnancy rate, semen analysis, ROS, oxidative stress
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-08-07
Enrollment: 55
Sex: MALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Some animal studies revealed that the pomegranate juice may improve sperm quality in terms of concentration, motility and morphology, as well as in fertilization rate.

Minor data is available regarding the influence on male sperm.

Detailed description: Pomegranate contains a high concentration of vitamins ( C, B1, B2, B3, B5), potassium, Magnesium , Zinc and is a good source for polyphenols .Polyphenols molecules have been found to possess antioxidant properties and may effects the expression of different genes . Recent studies indicate that among foods that contain polyphenols, juice extracted from the pomegranate has the highest concentration of measurable polyphenols . Pomegranates have shown inhibitory effect on NF-κB and the MAP kinases JNK and ERK, which are critical steps in the cascade of events leading to inflammatory response. The NF- κB pathway is activated in response to bacterial infection and initiates the inflammatory cascade, which may explain the protective effect of Pomegranates on bacterial infections.

Eligibility criteria: Inclusion Criteria:

* TMC of less than 5 million spermatogonia in native sperm and morphology less than 4% by Kruger criteria.

Exclusion Criteria:

* sensitivity to Pomegranate

Primary outcomes:
measure: pregnancy
timeFrame: 24 month
Secondary outcomes:
measure: ROS (reactive oxidative stress )and Interleukins level in semen fluid
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical center, IVF unit, Hadera, Israel
name: Einat Shalom-Paz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06979063: Health Education for Women With Suspeced Infertility Waiting for Specialized Care
Official title: Impact of Regulation Strategies and Health Education for Managing Infertility in Primary Health Care in Rio Grande do Sul
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Infertility
Health Education
Telemedicine
Telehealth
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Telessaúde RS
First posted: 2025-05-18
Enrollment: 206
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an open-label, superiority, randomized controlled trial with two parallel groups. Participants will be assigned to either a control group, which follows standard care, or an intervention group, which receives remote counseling and education about infertility and healthcare system navigation.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Introduction: Infertility is defined as a couple's inability to achieve pregnancy after 12 months or more of regular unprotected intercourse. In Brazil, it affects around eight million people. While health services provide resources for contraception, little attention is given to supporting conception and preserving fertility.

Objective: To evaluate the effectiveness of a remote educational and counseling intervention on infertility.

Method: Open-label randomized clinical trial. Couples referred for infertility will be identified in the electronic referral system. For inclusion, the woman of the couple must be 34 years old or less, no previous in-vitro fertilization attempts, and have access to telephone or internet. The control group will follow standard care, awaiting in-person consultation. The intervention group will also wait for in-person evaluation but receive additional education and counseling via video call.

The primary outcome is the proportion of correct referrals according to local protocols. A total of 206 participants will be included to detect a difference between success rates of 50% and 30%, with 80% power and a 5% significance level.


Eligibility criteria: Inclusion Criteria:

* Individuals referred to specialized infertility care in Porto Alegre.
* Age up to 33 years and 11 months.

Exclusion Criteria:

* Lack of access to the internet or telephone.
* Prior specialized infertility treatment in the private healthcare system.

Primary outcomes:
measure: Correct referral
timeFrame: Six months after randomization
Secondary outcomes:
measure: Proportion of patients with conception plan achieved.
timeFrame: Six months after randomization
measure: FertiQoL
timeFrame: Six months after randomization
measure: Time to regulation decision
timeFrame: Six months after randomization
measure: Time for in-person consulting
timeFrame: Six months after randomization
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre (HCPA)
state: Rio Grande do Sul
Study officials:
References: