louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01176331: Outcomes of 20 and 23-gauge Combined Transconjunctival Pars Plana Vitrectomy
Official title: Outcomes of 20 and 23-gauge Combined Transconjunctival Pars Plana Vitrectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitrectomy
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2010-08-06
Sex: ALL
Minimum age (years): 44
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were in the range 44 to 80 years, who had to undergo vitrectomy operation with different diagnosis were included in the study. Each participant had a complete ophthalmological examination which included best-corrected visual acuity (BCVA), slit lamp examination with and without pupil dilation, intraocular pressure (IOP) measurement with applanation tonometry and stereoscopic evaluation of the ocular fundus before decision of operation.

Brief summary: In a retrospective study, a combined 20 and 23-gauge pars plana vitrectomy procedure was performed in 21 eyes for various indications and proposed as a transition procedure to 23-gauge transconjunctival vitrectomy. Through use of combination of procedures postoperative complications, surgical trauma and healing time was decreased; operating time was reduced; costs were decreased.


Eligibility criteria: Inclusion Criteria:

* eyes requiring pars plana vitrectomy for various indications: such as dropped lens, intraocular blood, retinal detachments...etc.

Exclusion Criteria:

* patients who did not observed periodically during postoperative period.

Primary outcomes:
measure: visual acuity
Secondary outcomes:
measure: postoperative complications
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Department of ophthalmology,Hospital of Faculty of Medicine, Kocaeli University
Study officials:
References:
Clinical trial NCT01273831: Effect of Cisatracurium Versus Atracurium on Intraocular Pressure in Patients Underwent General Anesthesia
Official title: Study of Effects of Cisatracurium and Atracurium on Intraocular Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Intraocular Pressure
Keywords: intraocular pressure, anesthesia,cisatracurium,atracurium.
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-01-11
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine which drug makes lower intraocular pressure

Detailed description: Increase in intraocular pressure (IOP) following tracheal intubation during general anesthesia can be troublesome. The investigators compared the influence of cisatracurium and atracurium on IOP in patients undergoing general anesthesia.

Eligibility criteria: Inclusion Criteria:

ASA class of I or II baseline IOP of lower than 20 mmHg stable hemodynamics no history of ophthalmic diseases not using drugs affecting IOP (e.g. anticholinergics, sympathomimetics) no contraindication for atracurium or cisatracurium administration.

Exclusion Criteria:

difficulty in mask ventilation or in tracheal intubation end expiratory CO2 of below 35 mmHg or over 45 mmHg O2 saturation of below 90%

Primary outcomes:
measure: intraocular pressure
timeFrame: at 2 minutes after intubation
Secondary outcomes:
measure: systolic blood pressure
timeFrame: at 2 minutes after intubation
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Al-zahra university hospital
Study officials:
affiliation: Associate Professor,Anesthesiology department
name: Mitra Jabalameri, A.Professor
role: STUDY_CHAIR
References:
Clinical trial NCT00193531: Paclitaxel, Carboplatin, and Oral Etoposide Followed by Weekly Paclitaxel in High Grade Neuroendocrine Carcinoma
Official title: Phase II Study of Paclitaxel, Carboplatin, and Oral Etoposide Followed by Weekly Paclitaxel in the Treatment of High Grade Neuroendocrine Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neuroendocrine Carcinoma
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2005-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: carboplatin and etoposide, followed by maintenance therapy with weekly paclitaxel in patients with poorly differentiated neuroendocrine carcinomas. We hope to identify a "standard treatment" for this unusual group of patients who are not usually eligible for clinical trials.

Detailed description: Upon determination of eligibility, patients will be receive:

* Paclitaxel + Carboplatin + Etoposide

Eligibility criteria: Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Metastatic poorly differentiated neuroendocrine carcinoma
* Unknown primary site
* Able to perform activities of daily living with minimal assistance
* Measurable or evaluable disease
* Adequate bone marrow, liver functions and kidney function
* No previous treatment with chemotherapy
* Understand the nature of this study and give written informed consent.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Age \< 18 years
* Previous malignancy within five years
* Women pregnant or lactating
* Recent history of cardiovascular disease
* Meningeal metastases

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Primary outcomes:
measure: Overall response
Secondary outcomes:
measure: Overall survival
measure: Time to progression
measure: Overall toxicity
Other outcomes:
Locations:
Study officials:
affiliation: SCRI Development Innovations, LLC
name: John D. Hainsworth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hainsworth JD, Spigel DR, Litchy S, Greco FA. Phase II trial of paclitaxel, carboplatin, and etoposide in advanced poorly differentiated neuroendocrine carcinoma: a Minnie Pearl Cancer Research Network Study. J Clin Oncol. 2006 Aug 1;24(22):3548-54. doi: 10.1200/JCO.2005.05.0575.
Clinical trial NCT05424731: Expanded Access Protocol of Viaskin® Peanut (DBV712) in Peanut-allergic Children
Official title: Viaskin® Peanut (DBV712) Compassionate Use in Peanut-allergic Children Previously Enrolled in a DBV712 Clinical Study
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Peanut Allergy
Keywords: EPIT
Epicutaneous
Immunotherapy
Viaskin
Lead sponsor: DBV Technologies
Sponsor class: INDUSTRY
First posted: 2022-06-21
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD

Brief summary: This is an open label expanded access program for male and female patients 2 years or older, to provide continued desensitization treatment with DBV712 250 mcg.

Detailed description: This study is an open-label Expanded Access Protocol to provide continued treatment with DBV712 for individuals completing a DBV clinical study. Participation is by invitation according to the inclusion criteria.

For individuals who have received DBV712 for longer than one year prior to entry into this protocol, where treatment allocation is unblinded, safety assessment and resupply of DBV712 will occur at 6-month intervals. There will be no other scheduled study visits. For individuals who have been on blinded treatment, a safety assessment will be conducted at Months 1 and 3. Visits for safety assessment and resupply of DBV712 will occur at 3-month intervals during the first 12 months. After a year, visits will occur at 6-month intervals. DBV712 will be supplied to participants at study visits to suffice until the next visit. For individuals who have been on blinded treatment, or off DBV712 treatment for more than 14 days prior to entry into this protocol, dosing consists of approximately 6 hours for the first week, 12 hours for the second week, then once daily, at approximately the same time of day.

Treatment with DBV712 will continue until, in the clinical judgement of the treating physician, the participant is no longer benefiting from continuation of the treatment, DBV712 is approved and available by prescription, or the study is terminated.

Eligibility criteria: Inclusion Criteria:

* Participation is by invitation, limited to individuals completing clinical study V712-303 (PEOPLE), previous Expanded Access Program or a DBV clinical study initiated after 31-Jan-2022
* Male and females; ages ≥ 2 years old at Visit 1 or current or prior studies.
* Negative urine pregnancy test for female participants of childbearing potential.

Exclusion Criteria:

* Early withdrawal from a DBV712 clinical study.
* History of non-compliance during the primary clinical study or unable to follow the protocol requirements.
* Generalized dermatologic disease extending widely on the skin.
* History of intolerance or who developed hypersensitivity to excipients of the DBV712 patches.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: Early Access Care, LLC
state: Connecticut
Study officials:
References:
Clinical trial NCT00898131: Collecting Tissue Samples for Future Research From Women Undergoing Surgery for Breast Cancer
Official title: Specialized Program of Research Excellence (SPORE) in Breast Cancer: Tissue and Specimen Collection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: breast cancer
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 10000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing biopsy or surgical procedures for the diagnosis, treatment, or prevention of breast cancer.

Brief summary: RATIONALE: Collecting and storing samples of tumor tissue from patients with breast cancer to study in the laboratory may help doctors learn more about cancer.

PURPOSE: This phase I study is collecting tissue samples for future research from women undergoing surgery for breast cancer.

Detailed description: OBJECTIVES:

Primary

* Collect breast tissue for future research from women undergoing surgery for breast cancer.

Secondary

* Create microarrays by tumor type for internal use by Specialized Program of Research Excellence.

OUTLINE: Tumor tissue is collected and analyzed to create microarrays by tumor type for future research studies.

PROJECTED ACCRUAL: A total of 1,250 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Undergoing surgery for breast cancer

Primary outcomes:
measure: Collect human breast tissues and associated clinical-pathologic data
timeFrame: At time of diagnosis, surgery, and throughout standard care and clinical follow-up.
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center at Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Piotr Kulesza, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05210231: Effects of Transcranial Direct Current Stimulation (tDCS) on Rotator Cuff Fatigue.
Official title: Effects of Transcranial Direct Current Stimulation (tDCS) on Rotator Cuff Fatigue. A Randomized, Sham-controlled, Double-blind, Crossover Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asymptomatic Condition
Keywords: Brain stimulation
tDCS
Fatigue
Rotator cuff
Lead sponsor: University of Gran Rosario
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The aim of this study will be to determine the effects of active tDCS on rotator cuff fatigue. This study will be a randomized, double-blind, sham-controlled, cross-over clinical trial based on non-probabilistic sampling for convenience, comprising a sample of 20 active asymptomatic subjects of all genders and aged between 18 and 35 years old. Subjects will be recruited via social networks, WhatsApp and emails and must be currently engaged in moderate physical activity (assessed by the IPAQ questionnaire) and asymptomatic at the time of assessment. In addition, participants will be asked not to perform any type of strenuous exercise and do not drink alcoholic or caffeinated beverages during the time the work is performed. The study will consist of three sessions, with an interval of 72 hours between them.


Eligibility criteria: Inclusion Criteria:

* Age ranging between 18 to 35 years, all genders.
* Healthy subjects
* Moderate physical activity (evaluated by IPAQ questionnaire)
* Do not perform any exhausting exercise and do not drink alcoholic or caffeinated beverages during the time the work is performed.

Exclusion Criteria:

* Subjects with trauma in the last three weeks or previous surgeries on the upper extremity, patients with pre-existing neurological or rheumatic conditions, pregnancy, medical history of epilepsy the convulsive event, subjects under analgesic drug treatment or have ingested drugs with central action in the last 72 hours.

Primary outcomes:
measure: Change in Time to Exhaustion (TTE)
timeFrame: At baseline, after 3 and 6 days
measure: Change in Maximum Voluntary Contraction (MVC)
timeFrame: At baseline, after 3 and 6 days
measure: Change in Rating of Perceived Exertion (RPE)
timeFrame: At baseline, after 3 and 6 days
Secondary outcomes:
measure: Change in Global Rating of Change Scale (GRCS)
timeFrame: After 3 and 6 days
measure: Change in Electromyographic recordings (sEMG)
timeFrame: At baseline, after 3 and 6 days
Other outcomes:
Locations:
city: Rosario
country: Argentina
facility: University of Gran Rosario
state: Santa Fe
Study officials:
affiliation: University of Gran Rosario
name: Cristian Mendoza, MsC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02198131: Pulsed Dye Laser in Treating Patients With Post Radiation Dysphonia
Official title: Pulsed Dye Laser for Treatment of Post Radiation Dysphonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Complications of Radiation Therapy
Stage I Laryngeal Cancer
Stage II Laryngeal Cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-07-23
Enrollment: 9
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This pilot trial studies pulsed dye laser in treating patients with post radiation dysphonia. Dysphonia, or vocal cord scarring, can include trouble with the voice when trying to talk, such as hoarseness, change in voice pitch, and poor voice quality, and it commonly happens after radiation therapy for laryngeal cancer. Pulsed dye laser may improve post radiation dysphonia.

Detailed description: PRIMARY OBJECTIVES:

I. To evaluate the use of pulsed dye laser in treatment of the dysphonia that commonly results after radiation therapy for laryngeal carcinoma.

OUTLINE:

Patients undergo pulsed dye laser monthly for three months.

After completion of study treatment, patients are followed up at 1, 3, and 6 months.

Eligibility criteria: Inclusion Criteria:

* Patients suffering from dysphonia after radiation therapy for glottic carcinoma will be included in the study
* Patients will be included if their initial stage was T1 N0 M0 or T2 N0 M0

Exclusion Criteria:

* Patients having previously undergone large surgical resections of the larynx or hypopharynx will be excluded
* Patients fewer than 1 year out from completion of radiation therapy will be excluded
* Patients with local disease recurrence would be excluded from the trial
* Patients in whom the transnasal endoscope is poorly tolerated or patients in whom transnasal endoscopic laryngoscopy is contraindicated will be excluded

Primary outcomes:
measure: Videostroboscopy rates
timeFrame: Up to 6 months post-treatment
measure: Change in Voice Handicap Index (VHI)-10 score
timeFrame: Baseline to 6 months post-treatment
measure: Change in jitter
timeFrame: Baseline and at 6 months post-treatment
measure: Voice quality using the patient self-assessment questionnaire
timeFrame: Up to 6 months post-treatment
measure: Change in shimmer
timeFrame: Baseline and at 6 months post-treatment
measure: Change in noise to harmonic ratio
timeFrame: Baseline and at 6 months post-treatment
measure: Change in mean phonatory flow
timeFrame: Baseline and at 6 months post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Carter Wright
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04765631: Type 2 Diabetes and Bone Microarchitecture
Official title: Type 2 Diabetes and Bone Microarchitecture in Men and Women: a Case-control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 582
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women included in the 3 cohorts (QUALYOR, OFELY, STRAMBO)

Brief summary: Type 2 diabetes is a major public health problem, associated with an increased risk of fractures. Diabetes even appears to be the most important predictor of low kinetic fractures in men and women, and the risk of hip fracture in type 2 diabetics is increased by 40 to 50%, with often more serious consequences (post-operative complications, longer hospital stays, increased mortality rate).

Currently, the risk of fractures is estimated by the measure of areal bone mineral density (aBMD) and T-score. However, in diabetics aBMD is not decreased, and even paradoxically increased. Indeed, aBMD is 5-10% higher in type 2 diabetic patients compared to non-diabetic subjects, which suggests that the assessment of fracture risk in these patients is underestimated. The High Resolution peripheral Quantitative Computed Tomography (HR-pQCT) 3D bone imaging technique has a resolution close to the size of the bone trabeculae. It is used to assess volumetric bone mineral density (vBMD) and bone microarchitecture at the tibia and distal radius, and enables a better estimation of the fracture risk compared to the measurement of aBMD. Our hypothesis is that bone microarchitecture is altered in type 2 diabetic patients, explaining the increased risk of fracture in this population compared to non-diabetics.

We propose to set up a descriptive case control study, nestled in 3 cohorts of men and women (QUALYOR, OFELY and STRAMBO), to compare the bone micro-architecture measured by HR-pQCT at the level of the tibia and distal radius, in type 2 diabetics compared to non-diabetic subjects from the same cohorts.


Eligibility criteria: Inclusion Criteria:

* Men and women included in the 3 cohorts (QUALYOR, OFELY, STRAMBO) presenting type 2 diabetes
* Age- and sex-matched control patients from the same cohorts without type 2 diabetes ; two control were age- and sex-matched to one type 2 diabetes patient.

Exclusion Criteria:

-

Primary outcomes:
measure: The main outcome is the comparison of total volumetric bone mineral density (vBMD) at the tibia and distal radius, in type 2 diabetics compared to non-diabetic subjects.
timeFrame: at inclusion for Qualyor patients. (the HRpQCT measure considered in this study is realised at the first visit just after inclusion of the patient for the Qualyor patients)
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: INSERM U1033, pavillon F, Hôpital E. Herriot. 5, place d'Arsonval
Study officials:
References:
Clinical trial NCT01732731: Effects of Intensive Locomotor Treadmill Training on Gross Motor Function in Young Children With Neuromotor Impairment
Official title: Effects of Intensive Locomotor Treadmill Training on Gross Motor Function in Young Children With Neuromotor Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral palsy
treadmill training
Lead sponsor: University of the Pacific
Sponsor class: OTHER
First posted: 2012-11-26
Enrollment: 12
Sex: ALL
Minimum age (years): 9
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this project is to examine if early exposure to intensive, short-term locomotor treadmill training (LT) in young children with neuromotor impairment will help develop walking skills earlier, decrease the amount of outside assistance needed (such as a walker or crutches) as compared to children with neuromotor impairment who receive traditional physical therapy intervention.


Eligibility criteria: Inclusion Criteria:

* a diagnosis of CP with GMFCS levels I and II
* ages 9 to 36 months
* the ability to sit for at least 30 seconds unsupported in ring-sitting or W-sitting
* the ability to take ten consecutive steps when held on hands

Exclusion Criteria:

* a diagnosis of a genetic syndrome
* independent ambulation without an assistive device
* previous or current use of treadmill intervention during physical therapy
* a medical contraindication for standing or walking defined by the physician 5) uncontrolled seizures
* a history of orthopedic surgery
* use of medication to control spasticity in the past 6 months

Primary outcomes:
measure: Gross Motor Function Measure Dimension D and E
timeFrame: up to 4-months post-intervention
Secondary outcomes:
measure: Peabody Developmental Motor Scales-2
timeFrame: pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention
measure: timed 10 meter walk test
timeFrame: pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention
measure: Pediatric Evaluation of Disability Inventory
timeFrame: pre-intervention, 6-week post-intervention, 1-month post-intervention, 4-month post-intervention
Other outcomes:
Locations:
Study officials:
affiliation: University of the Pacific
name: Katrin Mattern-Baxter
role: PRINCIPAL_INVESTIGATOR
References: