louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01097161: Stuttering and Apraxia of Speech: the Efficacy of an Intervention Program
Official title: The Speech Prosody of People With Stuttering and Developmental Apraxia: the Efficacy of an Intervention Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stuttering
Developmental Apraxia of Speech
Keywords: Stuttering
Apraxia of speech
Motor control
Prosody
Pitch range
Speech rate
fluency disorders
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do estado de Minas Gerais
First posted: 2010-04-01
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Subjects' utterances were submitted to acoustic analysis before and after the intervention program applied on prosodic basis.

Detailed description: The study has the aim of developing knowledge, methodology and technique in the prosody area, for its application on the speech therapy, with the assistance of a feedback system - with WinpitchPro (Philippe Martin). A database was constituted on the basis of a patterned corpus (EUROM1) by its translation, recording and editing on .wav format. Throughout model-sentences, an experimental intervention program initiates with the participation of 2 adults with stuttering problem and 2 with apraxia of speech. The efficacy of the therapeutic procedure is tested on the basis of the acoustical and the statistical analyses which have compared the first and the second speech samples taken before and after the twenty (20) therapy sessions held in a prosody approach only.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of stuttering
* Clinical diagnosis of apraxia of speech
* 18 years of age or older
* Portuguese native language
* Agreement by the participant to enroll on 20 therapy sessions scheduled in a 3 month period

Exclusion Criteria:

* History of major medical illness unrelated to primary diagnosis of developmental stuttering and developmental apraxia of speech
* Significant abnormalities on general physical and neurological examination unrelated to primary diagnosis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: R. Grão Pará, 85/404
state: Minas Gerais
Study officials:
References:
Clinical trial NCT00994461: Study Of Celecoxib In Healthy Subjects
Official title: A Randomized, Placebo-Controlled, Double-Blind, Phase 4 Study To Compare The Effect Of Celecoxib 100 Mg BID, Loxoprofen 60 Mg TID And Placebo On The Gastroduodenal Mucosa In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy Volunteers
Keywords: Endoscopy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-10-14
Enrollment: 190
Sex: ALL
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to confirm the superiority of celecoxib 100 mg BID to loxoprofen 60 mg TID in the incidence of gastroduodenal endoscopic ulcers after 2 weeks treatment.


Eligibility criteria: Inclusion Criteria:

* Healthy Volunteers

Exclusion Criteria:

* Endoscopic evidence of ulceration, erosion or active bleeding etc. in the esophagus, stomach, pylorus and/or duodenum prior to treatment endoscopy
* A history of gastrointestinal ulcer
* Any use of celecoxib, nonsteroidal anti-inflammatory drugs (including aspirin), anti-ulcer medication, antacids, systemic steroids or antibiotics within four weeks prior to the first dose of study medication

Primary outcomes:
measure: Incidence of Gastroduodenal Ulcers
timeFrame: 2 weeks
Secondary outcomes:
measure: Incidence of Any Gastric, and Duodenal Ulcers
timeFrame: 2 weeks
measure: Incidence of Any Gastroduodenal, Gastric, and Duodenal Ulcers and/or Erosions
timeFrame: 2 weeks
measure: Post-treatment Gastroduodenal Endoscopic Scores (According to Mucosal Grading Scale)
timeFrame: 2 weeks
measure: Number of Gastroduodenal Ulcers in Each Subject
timeFrame: 2 weeks
measure: Number of Gastroduodenal Erosions in Each Subject
timeFrame: 2 weeks
measure: Incidence of Treatment-emergent, All-causality GI Body System Adverse Events
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Yokohama
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Minato-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Sakamoto C, Kawai T, Nakamura S, Sugioka T, Tabira J. Comparison of gastroduodenal ulcer incidence in healthy Japanese subjects taking celecoxib or loxoprofen evaluated by endoscopy: a placebo-controlled, double-blind 2-week study. Aliment Pharmacol Ther. 2013 Feb;37(3):346-54. doi: 10.1111/apt.12174. Epub 2012 Dec 10.
Clinical trial NCT00543361: Study MK0767 and Metformin in Type 2 Diabetic Patients (0767-020)
Official title: A Double-Blind, Randomized, Active-Controlled MK0767 and Metformin Comparator Study in Type 2 Diabetic Patients Inadequately Controlled on Diet and Exercise
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-10-15
Enrollment: 382
Sex: ALL
Minimum age (years): 21
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess how MK0767, compared to Metformin, performs in lowering blood glucose levels in patients whose Type II diabetes is not controlled by diet and exercise.


Eligibility criteria: Inclusion Criteria:

* Patients are men and non-pregnant women ages 21 to 78 years
* Patients either not on antihyperglycemic medications (\>8 weeks), or being treated with a single oral antihyperglycemic agent \& willing to discontinue therapy for the duration of the study

Exclusion Criteria:

* Patient has history of type 1 diabetes mellitus and or history of ketoacidosis
* Patients undergoing surgery within 30 days of Visit 1
* Patients taking Warfin or Warfin-like anticoagulants
* Patients on a weight loss program with on-going weight loss or starting an intensive exercise program within 4 weeks of Visit 1/Week 9

Primary outcomes:
measure: This study will assess the lipid lowering effectiveness of MK0767 compared to metformin over the course of 52 weeks.
timeFrame: over the course of 52 weeks
Secondary outcomes:
measure: MK0767 will be safe and well tolerated.
timeFrame: over the course of 52 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01003561: Hemodynamic Changes of Upper and Lower Extremities After Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Keywords: ultrasonographic exam on upper and lower extremities
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2009-10-28
Enrollment: 40
Sex: MALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of this study is to evaluate the changes of venous flow, volume, and resistance in upper (basilic v.) and lower (popliteal v.) extremities of the elderly healthy patients compared with elderly hypertensive patients who undergoing spinal anesthesia for transurethral prostatectomy.


Eligibility criteria: Inclusion Criteria:

* \> 65yr men
* who undergoes spinal anesthesia for elective TURP
* normotensive/hypertensive

Exclusion Criteria:

* vascular disease
* contraindications for spinal anesthesia

Primary outcomes:
measure: Blood flow
timeFrame: during 30 min after spinal anesthesia
measure: Blood volume
timeFrame: during 30 min after spinal anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University
Study officials:
References:
Clinical trial NCT00288561: Study of Ranibizumab Administered in Conjunction With Photodynamic Therapy With Verteporfin in Patients With Subfoveal Choroidal Neovascularization and Age-Related Macular Degeneration
Official title: Open-Label, Multicenter, Phase II Study Assessing the Safety of Ranibizumab Administered in Conjunction With Photodynamic Therapy With Verteporfin in Patients With Occult or Predominately Classic Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (ARMD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Age-Related Macular Degeneration (ARMD)
Keywords: ARMD, ranibizumab, verteporfin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-02-08
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Ranibizumab is derived from a murine monoclonal anti- vascular endothelial growth factor (VEGF) antibody and can penetrate through the many retinal cell layers following intravitreal injection. The present study is directed towards the assessment of ranibizumab administered on the same day in combination with verteporfin in patients with subfoveal CNV secondary to ARMD


Eligibility criteria: Inclusion Criteria:

* Patients 50 years of age or greater who have provided written informed consent

  * Patients with subfoveal choroidal neovascularization lesions secondary to AMD, either predominantly classic or occult with no classic component
  * Patients who have a BCVA score between 73 and 24 letters, inclusively, in the study eye using ETDRS (approximately 20/40 to 20/320)
  * Willing to return for all scheduled visits

Exclusion Criteria:

* - Patients who have a BCVA of \< 34 letters in both eyes (legally blind is defined as bilateral vision below 20/200 or less than 34 letters)
* Prior treatment in the study eye with verteporfin, external-beam radiation therapy, subfoveal focal laser photocoagulation, vitrectomy, or transpupillary thermotherapy
* Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis
Study officials:
affiliation: Novartis - Including Sites in Germany
name: Novartis Customer Information
role: STUDY_CHAIR
References:
Clinical trial NCT02220361: Dexmedetomidine on Prevention of Side Effects of Hemabate
Official title: Phase 4 Study of Effects of Dexmedetomidine on Prevention of Side Effects of Hemabate in Cesarean Section Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Gynecological Patient
Lead sponsor: Guangzhou Women and Children's Medical Center
Sponsor class: OTHER
First posted: 2014-08-19
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hemabate is often used for gynecological patients. Hemabate is associated with many side effects, including a burning sensation in the stomach, nausea, vomiting, diarrhea etc. It is reported that dexmedetomidine reduce gastrointestinal reaction during perioperative period. We design this clinical trial to find if dexmedetomidine can prevent the side effects of hemabate in Cesarean Section patients.


Eligibility criteria: Inclusion Criteria:

gynecological patients

Exclusion Criteria:

* Neuromuscular and endocrine diseases
* Allergic reactions to a2-adrenergic agonist
* Previous abdominal surgery including prior caesarean section.

Primary outcomes:
measure: SpO2 Change
timeFrame: participants will be followed for the duration of surgery, an expected average of 2 hours
measure: systolic blood pressure and diastolic blood pressure change
timeFrame: participants will be followed for the duration of surgery, an expected average of 2 hours
measure: Heart rate change
timeFrame: participants will be followed for the duration of surgery, an expected average of 2 hours
measure: nausea
timeFrame: 24 h postoperatively
measure: vomiting
timeFrame: 24h postoperatively
measure: fever
timeFrame: 24h postoperatively
measure: diarrhea
timeFrame: 24h postoperatively
measure: headache
timeFrame: 24h postoperatively
measure: elevated blood pressure
timeFrame: 24h postoperatively
measure: chest congestion
timeFrame: 24h postoperatively
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05137561: Robotic-arm Assisted 68 Ga PSMA PET/CT Guided Prostate Biopsy Versus MR Directed TRUS Guided Prostate Biopsy
Official title: Comparison of Robotic-arm Assisted 68 Ga PSMA PET/CT Guided Prostate Biopsy Versus MR Directed TRUS Guided (Cognitive Fusion) Prostate Biopsy: A Pilot Study to Assess Diagnostic Performance and Patient Safety
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Prostate Neoplasm
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2021-11-30
Enrollment: 100
Sex: MALE
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Simple randomization using RRApp
Primary purpose: DIAGNOSTIC

Brief summary: The present study aimed to compare the diagnostic accuracy, radiation exposure, complication rates between 68Ga-PSMA PET/CT guided robotic arm assisted prostate biopsy and MRI directed TRUS guided prostate biopsy.

Detailed description: To compare the diagnostic yield of Robotic-arm assisted 68Ga PSMA PET/CT guided prostate biopsy and MRI directed TRUS guided prostate biopsy in patients with PIRADS grading 4/5.

To compare the visual pain index of the patients between two arms during the procedure.

To compare the complication rates between the two arms during and after the procedure for a period of 2 weeks

Eligibility criteria: Inclusion Criteria:

1. PIRADS 4 and 5 prostate lesions and PIRADS \</= 3 prostate lesions with high clinical suspicion.
2. Patients who are included in the study will be randomly allocated into either PSMA PET/CT guided biopsy or TRUS guided biopsy using simple randomization in RRApp

Exclusion Criteria:

1. Patients with acute prostatitis/ urine culture positive.
2. Patients with pre-existing bleeding diathesis like hemophilia, coagulopathy defined by INR ≥ 1.2, and Platelet counts ≤ 80,000/mm3
3. Patients who refuse to provide the written informed consent
4. Non-cooperative patients

Primary outcomes:
measure: Diagnostic yield of mpMRI directed vs PET/CT directed prostate biopsy
timeFrame: 12 months
measure: Diagnostic performance of mpMRI directed vs PET/CT directed prostate biopsy
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of procedure related complications
timeFrame: three months
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: PGIMER
state: Chandīgarh
Study officials:
References:
Clinical trial NCT00792961: Real Time Microscopic Imaging During Robot Assisted Prostate Cancer Surgery
Official title: In Vivo Confocal Endomicroscopy During da Vinci Robot Assisted Prostatectomy: Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate cancer
Robotic surgery
Endomicroscopy
Lead sponsor: Optiscan Pty Ltd
Sponsor class: INDUSTRY
Collaborators: name: Hospital at Westlake
First posted: 2008-11-18
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study involves use of a device called an endomicroscope to obtain high resolution images of microscopic structures during robot-assisted prostate cancer surgery. This feasibility study is largely descriptive, and will use endomicroscopy to document the cellular and architectural appearance of tissue during minimally invasive prostate surgery for later comparison with features seen upon conventional histopathological examination of biopsies or resection specimens.

Detailed description: Prostate surgery requires meticulous dissection around nerves and associated structures such as the bladder, seminal vesicles and vas deferens. Nerve damage during prostatectomy can result in undesirable outcomes such as impotence and urinary incontinence. Robot assisted minimally invasive prostatectomy offers enhanced visualisation of the surgical field. Superior clinical outcomes in terms of length of hospital stay, blood loss, and oncologic margins compared with open surgery are reported. Confocal endomicroscopy provides high resolution subsurface cellular imaging in real time and is already in clinical use in gastroenterology and under investigation in other surgical applications. A potential role exists for confocal endomicroscopy to enhance microscopic nerve identification intra-operatively and guide surgical decision making during robot-assisted prostatectomy.

Eligibility criteria: Inclusion Criteria:

* Males diagnosed with prostate cancer and undergoing da Vinci radical prostatectomy

Exclusion Criteria:

* Patients under 18 years of age
* Patients with allergy or prior adverse reaction to Fluorescein Sodium
* Patients unable to give informed consent

Primary outcomes:
measure: Endomicroscopy images captured from prostate and surrounding tissues
timeFrame: During surgery
Secondary outcomes:
measure: Comparison with conventional histology from corresponding biopsies or resection specimens
timeFrame: Post-surgery, after pathologist's review
Other outcomes:
Locations:
city: Austin
country: United States
facility: The Hospital at Westlake Medical Center
state: Texas
Study officials:
affiliation: The Hospital at Westlake Medical Center
name: Randy Fagin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Optiscan Pty Ltd
name: Peter Delaney, BSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT06298461: Bowel Preparation for Colonoscopy Among Individuals With Crohn's and Ulcerative Colitis Disease.
Official title: Bowel Preparation for Colonoscopy Among Individuals With IBD: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Crohn Disease
Ulcerative Colitis
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Canadian IBD Research Consortium (CIRC)
First posted: 2024-03-07
Enrollment: 418
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: The purpose of this study is to compare how effective and how tolerable two different bowel preparation laxatives are for colonoscopy. The aim is to compare oral sulfate solution (OSS) to another laxative called 2L polyethylene glycol (PEG) solution to see which is more effective and more tolerable by individuals with IBD (Crohn's disease or Ulcerative colitis).


Eligibility criteria: Inclusion Criteria:

1. Crohn's disease or ulcerative colitis patients scheduled or about to be scheduled for colonoscopy.
2. Age \> 18 years
3. Out-patients

Exclusion Criteria:

1. Prior subtotal or total colorectal resection
2. Contraindications to use of 2L polyethylene glycol (2L-PEG) or Oral Sulfate Solution (OSS): Known renal insufficiency, congestive heart failure, cirrhosis, severe electrolyte imbalance.
3. Colonoscopy being repeated because of poor preparation in the preceding six months.
4. Allergies to the employed bowel preparations
5. Toxic megacolon, ileus, suspected or diagnosed bowel obstruction.
6. IBD patients thought to be too sick to undergo a full colonoscopy preparation in the opinion of the investigator/treating physician; hospitalized crohn's disease or ulcerative colitis patients.
7. Pregnancy

Primary outcomes:
measure: Quality of bowel cleanliness
timeFrame: 1 year
measure: Quality of bowel cleanliness
timeFrame: 1 year
Secondary outcomes:
measure: Volume of laxative intake
timeFrame: 1 year
measure: Endoscopic Outcomes
timeFrame: 1 year
measure: Endoscopic Outcomes
timeFrame: 1 year
measure: Endoscopic Outcomes
timeFrame: 1 year
measure: Endoscopic Outcomes
timeFrame: 1 year
measure: Patient experience data
timeFrame: 1 year
measure: Crohn's disease or ulcerative colitis flares after colonoscopy
timeFrame: One month
measure: Endoscopic Outcomes
timeFrame: 1 year
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
References:
Clinical trial NCT01104961: Studying the Relationship Between Contact Lens Packaging Solutions and Bacterial Binding to Surface Eye Cells
Official title: A Masked, Randomized, Prospective, Single Center Crossover Clinical Trial on the Relationship Between Chemically Preserved Contact Lens Packaging Solutions and Bacterial Binding to Corneal Epithelial Cells
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Corneal Ulcer
Keywords: Bacterial infection
Loss of epithelial cells
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2010-04-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this study is to investigate the overall theory that the use of chemically preserved solutions associated with contact lenses promotes an increase in bacterial infection.

Detailed description: The purpose of this study is to investigate the theory of bacterial binding to surface eye cells through the use of chemically preserved solutions.

Eligibility criteria: Inclusion Criteria:

* Age range: 18-38 years
* Any sex, race or national origin accepted as with our past studies. Minority representation will be proactively encouraged.
* No prior history of any contact lens wear within one month of entry into the study.
* No history of allergic eye disease either seasonal or associated with previous contact lens wear.

Exclusion Criteria:

* Any patient that is a current contact lens wearer.
* Patients with active ocular infection or inflammatory disease, history of herpetic keratitis, glaucoma, etc.
* Uncontrolled systemic disease or the presence of any significant illness or condition that could, in the judgment of the investigator, interfere with interpretation of the study results.
* Any patient using ocular tears, anti-histamine based ocular therapies, glaucoma therapy, vasoconstricting drops, etc.

Primary outcomes:
measure: Bacterial binding of Pseudomonas Aeruginosa
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Danielle Robertson, OD, PhD
role: PRINCIPAL_INVESTIGATOR
References: