louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02179138: Paper Applicator Acceptability Study
Official title: EVALUATION OF A USER-FILLED, PAPER APPLICATOR FOR DELIVERY OF TENOFOVIR 1% GEL AMONG WOMEN IN RURAL KWAZULU-NATAL, SOUTH AFRICA
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: HIV Prevention
Lead sponsor: CONRAD
Sponsor class: OTHER
First posted: 2014-07-01
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: To assess the acceptability of a user-filled, paper, applicator for delivery of tenofovir (TFV) gel among women at high risk of acquiring human immunodeficiency virus (HIV) in rural KwaZulu-Natal, South Africa.

Detailed description: CAPRISA 070 is designed to enroll rural women who exit from CAPRISA 008 - an ongoing trial assessing implementation, effectiveness and safety of TFV gel in KwaZulu-Natal, South Africa. All study participants in CAPRISA 008 have also participated in CAPRISA 004 and thus have several years of experience using TFV gel with the prefilled, plastic applicator. CAPRISA 070 will allow us to assess acceptability of the user-filled, paper applicator among women who have had extensive experience with the pre-filled, plastic applicator and are well-positioned to provide feedback and comparisons on a new gel delivery method.

Eligibility criteria: Inclusion Criteria:

* Age 18 years and older
* Women who previously participated in CAPRISA 008
* Able and willing to provide first person informed consent to be screened for, and to enroll in, the study
* Allow access to their CAPRISA 008 data, including study exit data
* Able and willing to provide adequate locator information for study retention purposes
* Sexually active (at least one coital act in the last 3 months prior to screening)
* HIV negative
* Negative pregnancy test \*
* Agree to use a non-barrier form of contraceptive
* Agree to adhere to study visits and procedures

  * breastfeeding is not exclusionary but participants must be informed of the presence of TFV in breast milk in negligible amounts

Exclusion Criteria:

* Has creatinine clearance ,\<50ml/min, as estimated using the method of Cockcroft and Gault
* Has any other condition, that based on the opinion of the investigator or designee would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of the study outcome data, or otherwise interfere with achieving the study objectives

Primary outcomes:
measure: Overall acceptability
timeFrame: over 3 months of use
measure: context of use
timeFrame: over three months
measure: challenges encountered
timeFrame: over three months
measure: Applicator Preference
timeFrame: Over three months
Secondary outcomes:
Other outcomes:
Locations:
city: Pietermaritzburg
country: South Africa
facility: CAPRISA Vulindlela Clinical Research Site
state: KwaZulu-Natal,
Study officials:
affiliation: Centre for the AIDS Programme of Research in South Africa
name: Leila E Mansoor, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03245138: Endoscopic Third Ventriculostomy Versus Ventriculo-peritoneal Shunting in Idiopathic Normal Pressure Hydrocephalus
Official title: Endoscopic Third Ventriculostomy Versus Ventriculo-peritoneal Shunting in Idiopathic Normal Pressure Hydrocephalus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Normal Pressure Hydrocephalus
Keywords: endoscopic third ventriculostomy
ventricular peritoneal shunt
communicating hydrocephalus
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2017-08-10
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An endoscopic third ventriculostomy is considered to be successful in idiopathic normal pressure hydrocephalus (iNPH) in some literature reports, but there is a lack of high quality data. The aim of the present study is to compare the treatment options of iNPH (Endoscopic third ventriculostomy versus ventriculo-peritoneal shunt) in a randomized, controlled, multicenter study.

Detailed description: The traditional treatment for communicating hydrocephalus is a ventriculo-peritoneal shunt insertion and the endoscopic third ventriculostomy (ETV) is reserved for patients with obstructive hydrocephalus. However, in the last decade several reports highlighted an success of an ETV in communicating hydrocephalus as well. Thus, the aim of the present study is to compare ventriculo-peritoneal shunting against ETV in patients with an idiopathic normal pressure hydrocephalus, an subset of communicating hydrocephalus, in a randomized, controlled multicenter study.

Eligibility criteria: Inclusion Criteria:

* Age over 50 years
* gait disturbances typical for iNPH
* symptoms Duration less than 36months
* exclusion of obstructive hydrocephalus
* positive spinal TAP-test

Exclusion Criteria:

* no informed consent
* malignant disease
* other diseases of the CNS (Parkinson, dementia)
* secondary communicating hydrocephalus

Primary outcomes:
measure: Kiefer Index
timeFrame: 1 year
measure: Recovery Index
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: University Medicine Greifswald
city: Göttingen
country: Germany
facility: University Medicine Göttingen
city: Neubrandenburg
country: Germany
facility: Klinikum Neubrandenburg
Study officials:
References:
Clinical trial NCT04763538: Quality and Outcome Measurements of Urological Patients
Official title: Quality and Outcome Measurements of Urological Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urologic Diseases
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Hospital Centre Biel/Bienne
First posted: 2021-02-21
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Entire patient population that is treated at the study sites

Brief summary: Prospectively, all available parameters of urologic patients treated at the study sites will be acquired and stored in multilayered databases. Upon a given samples size, neuronal networks will be trained to define clinical endpoints. Beside uro-oncological patients also patients with other urological diseases will be enrolled.


Eligibility criteria: Inclusion Criteria:

* All patients treated at the study sites, signed informed consent

Exclusion Criteria:

* No consent to record medical history

Primary outcomes:
measure: Disease specific primary endpoint
timeFrame: 4-5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Biel
country: Switzerland
facility: Roland Seiler
city: Biel
country: Switzerland
facility: Department of Urology, Hospital Center Biel
Study officials:
affiliation: Department of Urology, University Hospital Bern
name: Roland Seiler, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT06298838: High-resolution Intra-operative PSMA PET-CT in Prostate Cancer
Official title: Perioperative Assessment of Intraoperative Margins and Lymph Node Invasion Using High-resolution 18F-PSMA-PET-CT in Prostate Cancer: a Pilot Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Prostate Cancer
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients affected by Prostate cancer (PCa) with a risk of lymph node invasion (LNI) higher than 5% and candidates for a robot-assisted radical prostatectomy (RARP) with an extended pelvic lymph node dissection (ePLND) according to the European Association of Urology (EAU) guidelines.

Brief summary: This is a Single-center, diagnostic open-label prospective, pilot study in a total of 10 patients affected by Prostate cancer (PCa) with a risk of lymph node invasion (LNI) higher than 5% and candidates for a robot-assisted radical prostatectomy (RARP) with an extended pelvic lymph node dissection (ePLND) .

The aim of the trial is to evaluate the feasibility and accuracy and clinical value of a novel high-resolution perioperative PET-CT-scan for intraoperative margin and lymph node invasion assessment, after 18F-PSMA injection, using histopathology as the gold standard.


Eligibility criteria: Inclusion Criteria:

1. Male patient, 18 years of age or older.
2. Patient is confirmed with high risk prostate cancer.
3. Patient is indicated to undergo radical prostatectomy and ePLND.
4. Patient is estimated compliant for study participation by the investigator.
5. Patient has freely given his/her informed consent to participate in this study.

Exclusion Criteria:

1. Patient has general or local contra-indications for radical prostatectomy.
2. Patient has active viral or fungal infection.
3. Patient previously received radiotherapy of the prostate.
4. Patient participated in other clinical studies with radiation exposure of more than 1 mSv in the past year.

Primary outcomes:
measure: To investigate the performance characteristics (sensitivity and specificity) of a novel high-resolution perioperative PET-CT-scan for intraoperative margins and lymph node invasion assessment after 18F-PSMA using histopathology as the gold standard
timeFrame: 1 YEAR
Secondary outcomes:
measure: Reporting positive lymph nodes detection rate at intraoperative imaging after 18-PSMA injection
timeFrame: 1 YEAR
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03974438: Acupuncture as Treatment of Post-herpetic Neuralgia: A RCT A Double-blinded Randomized Clinical Trial.
Official title: Acupuncture (Dry-needling) as Treatment of Post-herpetic Neuralgia: A Double-blinded Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Herpetic Neuralgia
Keywords: post-herpetic neuralgia
pain
post herpetic neuralgia
shingles
autologous fat grafting
autologous fat transplant
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2019-06-05
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants will be divided into two groups, group A, the intervention group, will receive SDN in the area of pain. Group B, the control group will receive a sham procedure.
Primary purpose: TREATMENT

Brief summary: The aim of this study is to perform the first RCT investigating the possible effect of superficial dry-needling (SDN) - a special kind of acupuncture used for PHN. The participants will be divided into two groups. Group A, the intervention group will receive SDN in the area of pain. Group B, the control group will receive a sham procedure.

Detailed description: The aim of this study is to investigate the possible effect of SDN on PHN. The study population consists of patients with chronic pain after herpes zoster.

The study is a controlled double-blinded randomized study. The participants will be divided into two groups, group A, the intervention group, will receive SDN in the area of pain. Group B, the control group will receive a sham procedure. The procedure will take place at the out-patient clinic at Odense University Hospital. The plan is to include 40 patients (20 in each group).

Eligibility criteria: Inclusion Criteria:

* Age between 50-75 years.
* Pain in the dermatomal area of the previous outbreak of HZ.
* Pain located to a dermatome originating from the thoracic or lumbar spine.
* At least six months since the outbreak.
* Understands the purpose of the study and is able to give consent.

Exclusion Criteria:

* A psychiatric illness affecting participation in the study.
* Active cancer
* Pregnancy

Primary outcomes:
measure: Dermal pain [LEVEL OF PAIN]
timeFrame: 1 month
Secondary outcomes:
measure: Neuropathic pain [LEVEL OF PAIN]
timeFrame: 1 month
measure: Quality of life [QUALITY OF LIFE/ SATISFACTION]
timeFrame: 1 month
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
state: Funen
Study officials:
References:
Clinical trial NCT04898738: Prospective COVID-19 Cohort Study, Dominican Republic
Official title: Prospective COVID-19 Cohort Study to Assess the Epidemiology, Transmission and Control of SARS-CoV-2 in the Dominican Republic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: SARS-CoV-2 Infection
Covid19
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: London School of Hygiene and Tropical Medicine
name: The University of Queensland
name: Yale University
name: Broad Institute of MIT and Harvard
name: Ministerio de Salud Publica y Asistencia Social, Republica Dominicana
First posted: 2021-05-24
Enrollment: 2000
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective cohort study that aims to prospectively monitor 2,000 community-based study participants with serial serological screening for SARS-CoV-2 and enhanced molecular surveillance for active infection. Nested within this cohort is a randomized trial that will allocate study participants into two arms: thoe that receive versus do not receive alcohol-based hand sanitizer (ABHS) through the course of the study.
Primary purpose: PREVENTION

Brief summary: This project will build on an existing CDC funded cooperative agreement in the Dominican Republic with the Brigham and Women's Hospital (2018-2023) that includes (i) prospective COVID-19 and AFI surveillance at two health facilities and (ii) a nationally representative cross-sectional community-based serological survey of approximately 7,000 healthy adults and children targeting SARS-CoV-2 and other AFI pathogens to be conducted between April and June 2021. This linked study will establish a nested cohort of 2,000 participants enrolled in the national serological survey and prospectively monitor them for COVID-19 symptoms, conduct serial serological testing, implement molecular surveillance for SARS-CoV-2 and sequencing for variants of concern, implement and evaluate WASH mitigation measures, and monitor uptake and perceptions of COVID-19 vaccines.


Eligibility criteria: Inclusion Criteria:

* Previously enrolled in a linked national community-based seroepidemiological study in the Dominican Republic
* Agreed and consented to be recontacted to participate in additional research studies at the time of enrollment in #1
* ≥2 years of age
* Agree to participate

Exclusion Criteria:

* Ward of the State

Primary outcomes:
measure: Hand hygiene practices
timeFrame: 1 year
Secondary outcomes:
measure: Acceptability of hand hygiene technology
timeFrame: 1 year
measure: SARS-Cov-2 seroconversion
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Brigham and Women's Hospital
name: Eric J Nilles, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01300338: Blood Pressure Telemonitoring and Goal Blood Pressure in Diabetes
Official title: Does Home Telemonitoring Increase the Number of Diabetic Patients at Goal Blood Pressure in a Primary Care Practice?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Hypertension
Keywords: Diabetes
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2011-02-21
Enrollment: 50
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: HEALTH_SERVICES_RESEARCH

Brief summary: Does home telemonitoring increase the number of diabetes patients at goal blood pressure in a primary care practice?

Detailed description: This is a randomized control trial, two arms with block randomization. Primary care patients with diabetes and elevated blood pressure randomized to intervention or control. Intervention arm: home telemonitoring using the Ideal Life blood pressure cuff and telephone or internet transmission device to transmit blood pressure information to the Primary care manager team with otherwise normal care manager care. Control arm: Omron (off the shelf) home blood pressure monitor (no transmission of data) and usual care. We will be comparing blood pressure control between groups and provider contacts.

Eligibility criteria: Inclusion criteria:

* Age 18-75 (inclusive
* Blood pressure in hypertensive range (systolic \>= 140 or diastolic \>=90
* Diabetes

Exclusion criteria:

* Pregnancy
* Lack of computer with internet access or phone line
* Lack of English language literacy
* Arm size to large or small for cuff

Primary outcomes:
measure: Mean Change in Systolic Blood Pressure
timeFrame: Baseline, 6 months
measure: Mean Change in Diastolic Blood Pressure
timeFrame: Baseline, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Frederick North, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05243238: Hesperidin and Diosmin Effect on Metabolic Syndrome
Official title: Hesperidin-Diosmin Effect on Metabolic Syndrome and Diabetic Neuropathy Among Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome and Diabetic Neuropathy
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2022-02-17
Enrollment: 129
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: The components of metabolic syndrome (MetS), particularly obesity and dyslipidemia, are linked to peripheral neuropathy (PN) among patients with diabetes or even without diabetes. Several studies revealed that complementary and herbal medicine could provide a potential for PN management and MetS components. Thus, designing clinical trials with interventions combinations to achieve a considerable improvement is highly recommended. Hesperidin and diosmin, citrus-derived flavonoids, have been reported to possess anti-hyperlipidemic, anti-inflammatory, analgesic, antioxidant, antidiabetic, and anti-hypertensive effect with high tolerability and safety profile


Eligibility criteria: Inclusion Criteria:

Type 2 diabetes adult patients who meet metabolic syndrome criteria and with diabetic neuropathy

Exclusion Criteria:

patients without any parameter of inclusion criteria

Primary outcomes:
measure: metabolic syndrome components
timeFrame: 12 weeks
measure: metabolic syndrome components
timeFrame: 12 weeks
measure: metabolic syndrome components
timeFrame: 12 weeks
measure: metabolic syndrome components
timeFrame: 12 weeks
measure: metabolic syndrome components
timeFrame: 12 weeks
measure: MNSI score for neuropathy
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: University
Study officials:
References:
citation: Osama H, Hamed EO, Mahmoud MA, Abdelrahim MEA. The Effect of Hesperidin and Diosmin Individually or in Combination on Metabolic Profile and Neuropathy among Diabetic Patients with Metabolic Syndrome: A Randomized Controlled Trial. J Diet Suppl. 2023;20(5):749-762. doi: 10.1080/19390211.2022.2107138. Epub 2022 Aug 10.
Clinical trial NCT00816738: Evaluation of the Treatment of Recurrent Corneal Erosions by Anterior Stromal Puncture With Nd: YAG Laser
Official title: Evaluation of the Treatment of Recurrent Corneal Erosions by Anterior Stromal Puncture With Nd: YAG Laser
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent Corneal Erosion
Trauma
Keywords: Nd: YAG laser
recurrent corneal erosions
trauma
anterior stromal puncture
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2009-01-05
Enrollment: 33
Sex: ALL
Minimum age (years): 20
Maximum age (years): 71
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: to evaluate the clinical outcomes after anterior stromal puncture with Nd:YAG laser in a consecutive series of 33 eyes in 33 patients with unilaterally recurrent corneal erosion.

Brief summary: To evaluate the clinical outcomes in patients with recurrent corneal erosions who received anterior stromal puncture by use of neodymium:yttrium-aluminum-garnet (Nd:YAG) laser.

Detailed description: Participants: From 2000 to 2005, thirty-three eyes in 33 patients with unilaterally recurrent corneal erosions who showed poor response to conservative managements and were treated with Nd:YAG laser were studied.

Intervention: Anterior corneal stromal puncture with Nd:YAG laser was performed in the loosened epithelium or epithelial defect area. The causes and frequency of corneal erosions and the spot numbers and total energy of the Nd:YAG laser were recorded. Slit-lamp biomicroscopic examination, refraction, corneal topography, and times of laser were reviewed. A questionnaire regarding the preoperative and postoperative difference in the intensity of pain and frequency of corneal erosion was provided.

Main Outcome Measures: Rate of recurrence and pain assessment by numerical rating scale.

Eligibility criteria: Inclusion Criteria:

* patients with recurrent corneal erosions who showed poor response to conservative managements and were treated with Nd:YAG laser.

Exclusion Criteria:

* Slit-lamp biomicroscopic examination in both eyes of patient showed any evidence of anterior basement membrane dystrophy.

Primary outcomes:
measure: Cure rate of recurrent corneal erosions (frequency of attack and numbers of Nd: YAG laser treatment), intensity of pain relief and visual acuity.
timeFrame: Before treatment, weekly after the treatment, and monthly after symptom relief
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yu-Chih Ho, MD
role: STUDY_DIRECTOR
affiliation: National Taiwan University Hospital
name: Tzu-Hsun Tsai, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan University Hospital
name: Tzu-Yun Tsai, MD
role: PRINCIPAL_INVESTIGATOR
References: