louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03379363: Retrospective Chart Review Study of Pediatric Patients Treated With Korlym for Cushing Syndrome
Official title: Retrospective Chart Review Study of Pediatric Patients Treated With Korlym for Cushing Syndrome
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hypercortisolism
Cushing Syndrome
Keywords: cushing syndrome, hypercortisolism
Lead sponsor: Corcept Therapeutics
Sponsor class: INDUSTRY
First posted: 2017-12-20
Enrollment: 2
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients who have been treated with Korlym for Cushing's syndrome

Brief summary: This retrospective, multi-center, chart review study will collect patient data from medical charts of pediatric patients who have been treated with Korlym for Cushing's syndrome.

Detailed description: This retrospective chart review study seeks to collect data from pediatric patients treated with Korlym (mifepristone) to help provide clinicians with some insight on the potential role of mifepristone in the treatment of pediatric patients with Cushing syndrome.

Only sites that have been identified to have patients appropriate for this protocol will be invited to participate and contribute data on their patients

Data to be collected from a retrospective chart review will include:

* Patient demographics
* Medical history
* Pre and post treatment clinical assessments and laboratory results
* Radiologic findings (if available)
* Adverse events

Data will be collected for all follow-up visits, up until the most recent encounter prior to IRB approval.

Eligibility criteria: Inclusion Criteria:

* Pediatrics (age≤21 years) at time Korlym initiation
* Considered to have a diagnosis of endogenous Cushing's syndrome by the healthcare provider
* Received at least one dose of Korlym
* Availability of pre-treatment (baseline) and follow-up data

Exclusion Criteria:

* None

Primary outcomes:
measure: Drug utilization patterns as assessed by chart review
timeFrame: Length of Korlym therapy, up to 5 years
Secondary outcomes:
measure: Weight as assessed by chart review
timeFrame: Length of Korlym therapy, up to 5 years
measure: Blood Pressure as assessed by chart review
timeFrame: Length of Korlym therapy, up to 5 years
Other outcomes:
Locations:
city: Menlo Park
country: United States
facility: Corcept Therapeutics
state: California
Study officials:
References:
Clinical trial NCT04145063: Ureteric Stenting Versus Non-stenting Following Uncomplicated Ureteroscopic Lithotripsy
Official title: Ureteric Stenting Versus Non-stenting Following Uncomplicated Ureteroscopic Lithotripsy: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ureter Stone
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2019-10-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare three groups of patients who underwent uncomplicated ureteroscopic lithotripsy (URSL) to evaluate whether stents could be eliminated after the procedure


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* unilateral ureteric stones managed by ureteroscopy

Exclusion Criteria:

* Stone size \< 2 cm
* bilateral ureteral stones
* incomplete stone removal due to impacted stones
* failed ureteroscopic access to the stone
* stone migration to the kidney
* pregnancy
* active urinary tract infection
* solitary kidney
* ureteral stent placed preoperatively
* severe mucosal injury or perforation
* suspected additional ureteral pathology such as ureteral stricture
* urothelial carcinoma or polyp.

Primary outcomes:
measure: Visual Analog Score (VAS)
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Jordan University Hospital
Study officials:
References:
Clinical trial NCT00034463: ALIMTA (Pemetrexed) in Patients With Locally Advanced or Metastatic Cancer
Official title: A Phase 1 Trial of ALIMTA (Pemetrexed) in Patients With Locally Advanced or Metastatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metastases
Cancer
Keywords: metastatic cancer
chemotherapy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2002-04-30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: This is a non-randomized, phase 1, study with the primary objective of determining the toxicities and establishing the maximum tolerated dose of ALIMTA when administered as a 10 minute infusion every 21 days with folic acid or multi-vitamin supplementation therapy in lightly or heavily pre-treated patients with locally advanced or metastatic cancer.


Eligibility criteria: Inclusion Criteria:

* Histologic or cytologic diagnosis of metastatic or locally advanced cancer
* Prior chemotherapy is allowed
* Adequate bone marrow, liver and kidney function

Exclusion Criteria:

* Prior treatment with ALIMTA
* Brain metastasis
* Pregnancy or breast feeding

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
state: Texas
Study officials:
References:
Clinical trial NCT00729963: Sibutramine Versus Continuous Positive Airway Pressure (CPAP)in Obstructive Sleep Apnea (OSA) Patients
Official title: Efficacy of Sibutramine-induced Weight Loss vs. Continuous Positive Airway Pressure (CPAP) in the Treatment of Obese Patients With Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obstructive Sleep Apnea
Obesity
Hypertension
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2008-08-08
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to observe if Sibutramine is effective in improving the symptoms and signs of sleep apnea in obese patients. The secondary objectives are to document the effects of Sibutramine on heart rate variability and 24-h arterial pressure values. We hypothesized that sibutramine will improve sleep disordered breathing, cardiac autonomic function and systemic blood pressure in obese patients with obstructive sleep apnea (OSA).


Eligibility criteria: Inclusion Criteria:

* Eligible participants with non-treated OSA syndrome were aged between 18 to 65 years, with a body-mass index (BMI) ≥ 30 kg/m2 or ≥ 27 kg/m2 in the presence of other risk factors such as controlled systemic hypertension, type 2 diabetes, dyslipidemia and/or visceral obesity (as defined by a waist circumference ≥ 102 cm in men and ≥ 88 cm in women).

Exclusion Criteria:

* Exclusion criteria were uncontrolled systemic hypertension defined as blood pressure \> 145/90 mm Hg, previous pharmacological or surgical treatment for weight loss, had already used CPAP or had severe diurnal hyper somnolence requiring immediate treatment.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Ferland A, Poirier P, Series F. Sibutramine versus continuous positive airway pressure in obese obstructive sleep apnoea patients. Eur Respir J. 2009 Sep;34(3):694-701. doi: 10.1183/09031936.00167308. Epub 2009 Apr 8.
Clinical trial NCT05153863: C Scope Visualization System Prospective Study
Official title: Performance and Safety of the C Scope Visualization System in Arthroscopic Procedures - A Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Injuries and Disorders
Shoulder Disease
Shoulder Injuries
Keywords: Visualization
Illumination
Arthroscopic Procedures
Lead sponsor: CIT Ortho
Sponsor class: INDUSTRY
First posted: 2021-12-10
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Evaluation of the performance and safety of the C Scope Visualization System in the illumination and visualization of joints during diagnostic procedures
Primary purpose: DIAGNOSTIC

Brief summary: Evaluation of the performance and safety of the C Scope Visualization System

Detailed description: The C Scope Visualization System Prospective Study is a post-market, single-arm, prospective, multicenter study conducted in the United States.

The purpose of the study is to evaluate the performance and safety of the C Scope Visualization System in the illumination and visualization of joints from diagnostic procedure through 1-week and 1-month follow-up.

Eligibility criteria: Inclusion Criteria:

* Subject is 18 years of age or older
* Subject can fluently speak and read English
* Subject is able to provide informed consent
* Subject agrees to all protocol-required follow-ups
* Subject meets the C Scope Indications for Use according to approved labeling

Exclusion Criteria:

* History of open surgery to the index joint resulting in scarring that might inhibit evaluation with the C Scope Visualization System
* Suspected fracture of joint structures
* Subject has any contraindications listed in the approved labeling including active infection
* In the opinion of the investigator, it is not in the subject's best interest to participate in the study

Primary outcomes:
measure: Physician-rated procedural (diagnostic only) illumination and visualization with the C-Scope Visualization System
timeFrame: Peri procedure
Secondary outcomes:
measure: Physician-rated confidence of diagnosis with the C-Scope Visualization System
timeFrame: Peri procedure
measure: Physician-rated needle arthroscopy procedural ease with the C-Scope Visualization System
timeFrame: Peri procedure
measure: Procedure time with the C-Scope Visualization System
timeFrame: Peri procedure
Other outcomes:
measure: Safety Adverse Events
timeFrame: 1 week and 1 month post procedure
Locations:
city: Henderson
country: United States
facility: Desert Orthopaedic Center
state: Nevada
Study officials:
affiliation: Desert Orthopaedic Center
name: Chad M Hanson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02331563: Adjuvant Effect of Dexmedetomidine in Ultrasound (USG) Guided Transvers Abdominis Plane Block
Official title: Adjuvant Effect of Dexmedetomidine for the Ultrasound Guided Transversus Abdominis Plane Block in Patients Undergoing Laparascopic Cholecystectomy: a Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Postoperative Nausea and Vomiting
Keywords: dexmedetomidine
Lead sponsor: Kırıkkale University
Sponsor class: OTHER
First posted: 2015-01-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A total of 60 adult patients American Society of Anesthesiologists physical status I,II, III were randomized to Group B (n = 30) receiving TAP block with 0.25% bupivacaine and Group D (n = 30) with 0.5 mcg/kg dexmedetomidine added to 0.25 % bupicavaine followed by general anaesthesia. Total local anaesthetic volume was standardised with 20 ml each sides of the abdomen. Hemodynamic responses to surgical incision and intraoperative fentanyl consumption were noted. Visual analog scale (VAS) scores were assessed on the emergence, at 1, 2, 3, 4, 5, 6 and 24 h. Time to first rescue analgesic (when VAS ≥4 cm or on demand), duration of postoperative analgesia, incidence of postoperative nausea-vomiting were also noted.

Detailed description: Transversus abdominis plane (TAP) block has been shown to provide postoperative pain relief following various abdominal and inguinal surgeries. The aim of this randomised controlled trial was to assess the effect of transversus abdominis plane (TAP) blocks on opioid requirements and median hospitai stay, postoperative nause and vomitting in patients undergoing laparoscopic cholecystectomy.

Eligibility criteria: Inclusion Criteria:

* The patients undergoing laparascopic cholecystectomy

Exclusion Criteria:

* Story of allergy to bupivacaine and dexmedetomidine
* The surgery preceeded to laparatomy
* Recent abdominal operation history

Primary outcomes:
measure: opioid requirement
timeFrame: 24 hr
Secondary outcomes:
measure: postoperative nause and vomiting
timeFrame: 24 hrs
Other outcomes:
Locations:
city: Kırıkkale
country: Turkey
facility: Kırıkkale University School of Medicine Department of Anaesthesiology and Reanimation
state: Yahşihan
Study officials:
affiliation: Kırıkkale University School of Medicine
name: Ferda Yaman, assist prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00294086: A Study of Valsartan Administered Once Daily Versus Twice Daily, in Patients With Stable, Chronic Heart Failure
Official title: A 12-Week Multicenter, 2-Arm Regimen, Exploratory Study to Evaluate the Tolerability and Safety of Valsartan Administered Once Daily vs Daily, in Patients With Stable, Chronic Heart Failure (NYHA Class Ll-lll)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Heart Failure
Keywords: valsartan,
chronic heart failure,
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-02-20
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the tolerability and safety of valsartan in patients with stable, chronic heart failure (NYHA Class ll-lll). The 12-week double blind study has a 2-week (maximum) screening, and a 10-week active treatment phase. In each of the treatment arms (QD and BID), patients are up-titrated to a maximum valsartan total daily dose of 320 mg. Patients remain on their prior CHF standard care therapy throughout the study period, and the up-titration of valsartan is based on patient tolerability.


Eligibility criteria: Inclusion Criteria

* Males or females aged 18 years or older
* Diagnosis of chronic heart failure (CHF), in NYHA Class ll-lll beginning at least 3 months prior to Visit 1
* Patients must remain on their prior standard care CHF therapy

Exclusion Criteria

* Diagnosis of severe hypertension (SBP\>180 and DBP\>110 mm Hg)
* Right heart failure due to pulmonary disease
* Presence of rapidly deteriorating heart failure
* MI or cardiac surgery, including PTCA within 3 months of Visit 1
* Unstable angina or coronary artery disease likely to require CABG or PTCA
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Tolerability as assessed by laboratory tests for potassium, creatinine, and on systolic blood pressure, symptoms of low blood pressure, and symptoms of heart failure
Secondary outcomes:
measure: Patients reaching target dose at 10 weeks
measure: Change from baseline in systolic blood pressure at each study visit
measure: Change from baseline in diastolic blood pressure at each study visit
measure: Change from baseline in blood potassium at each study visit
measure: Change from baseline in blood creatinine at each study visit
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Anand IS, Deswal A, Kereiakes DJ, Purkayastha D, Zappe DH. Comparison of once-daily versus twice-daily dosing of valsartan in patients with chronic stable heart failure. Vasc Health Risk Manag. 2010 Aug 9;6:449-55.
Clinical trial NCT00232986: A Comparison of Survey Methodologies to Elicit Sensitive Information From Adolescents in Urban India
Official title: A Comparison of Survey Methodologies to Elicit Information on Sexual and Reproductive Health From Adolescents in Urban India
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Unmarried Male and Female Adolescents in the Age Group 15-19 Years in Pre-Identified Slums in Delhi, India
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Hopkins Population Center's Mellon Grant
name: Bill and Melinda Gates Foundation
name: The Woodrow Wilson- Johnson & Johnson Dissertation Fellowship in Women's Health.
First posted: 2005-10-05
Enrollment: 960
Sex: ALL
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The goal of this study is to use three different survey methodologies to evaluate whether adolescents report on their knowledge, attitudes and behaviors on sexual and reproductive health issues differently based on the manner in which questions are asked.

Detailed description: Specific Aims and Research Questions Aim 1: To compare adolescents' levels of reporting of their own reproductive health knowledge, attitudes and behaviors using three survey methodologies: (1) Face-to-face interview (2) Audio-CASI (Computer Assisted Self Interview) and (3) a culturally appropriate interactive methodology.

The following hypothesis will be tested:

• Overall, adolescents will be more likely to divulge their own reproductive knowledge, attitudes and behaviors with Audio-CASI and the interactive method as compared to face-to-face interviews. Levels of knowledge, attitudes and behaviors will vary by education, age and gender.

Aim 2: To compare respondents' levels of comfort, accuracy and honesty with the survey methodologies (i.e. face to face, audio-CASI and interactive methodology) to their reporting of knowledge, attitudes and behaviors related to sexual and reproductive health.

Eligibility criteria: Inclusion Criteria:

Unmarried male and female adolescents in the age group 15-19 in pre-identified slums in Delhi, India

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Michelle J Hindin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03252886: Videolaryngoscopy During CPR for Trauma Patients
Official title: The Efficacy of Videolaryngoscopy During Cardiac-pulmonary Resuscitation (CPR) for Trauma Patients With Suspect Neck Injuries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiopulmonary Arrest
Neck Injury Multiple
Keywords: intubation
Cardiopulmonary Resuscitation
neck injury
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2017-08-17
Enrollment: 30
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: This is a clinical study based on collected video-clip data of cardiopulmonary resuscitation for patients with suspected neck injury in multiple trauma between 2011 and 2015. The study aimed to compare all possible factors relating to ETI performance during CPR for truma patients between experienced video-laryngoscopy and direct- laryngoscopy users.

Detailed description: Endotracheal intubation (ETI) is considered to be the best method of airway management during cardiopulmonary resuscitation (CPR). However ETI during CPR is a highly skill-dependent procedure, then it should be attempted only highly trained physicians. Especially, cervical immobilization by neck collar in truamatic patients is a great obstacle to successful ETI during CPR.

Because of technical difficulty in using direct laryngoscopy (DL), various types of videolaryngoscopy (VL) devices have been developed to overcome the problems of DL. VL may be more useful to perform ETI during CPR for trauma patients with cervical immobilization.

This study tried to compare the success rate of endotracheal intubation (ETI), speed of ETI, incidence of complications, and chest compression interruptions during cardiopulmonary resuscitation for trauma patients with suspected neck injury between intubators using the DL and the VL in a real clinical setting.

Eligibility criteria: Inclusion Criteria:

* Multiple trauma patients with suspected neck injuries
* Arrest Patients

Exclusion Criteria:

* Case of requesting the do-not attempt resuscitation before ETI
* already intubated case before arrival to hospital
* Cardiac arrest from non-traumatic causes

Primary outcomes:
measure: First attempt successful ETI
timeFrame: within 1 hour after emergency department visit
Secondary outcomes:
measure: the time to complete ETI from the beginning
timeFrame: within 1 hour after emergency department visit
measure: Occurance of complication
timeFrame: within 1 hour after emergency department visit
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Emergency Medicine, Konkuk University Medical center
Study officials:
affiliation: School of Medicine, Konkuk University
name: Sang O Park, M.D,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06015386: Clear Aligner Versus Removable Inclined Plane in Treatment of Anterior Crossbite
Official title: Clear Aligner Versus Removable Inclined Plane in Treatment of Anterior Crossbite
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anterior Crossbite
Keywords: clear aligner , anterior crossbite , inclined plane
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-08-29
Enrollment: 24
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the study is carried in faculty of dentistry Mansoura university to compare the efficiency and health quality life improvement between clear aligner and inclined plane in treatment of anterior crossbite

Detailed description: the study \*include 24 patient each group include 12 patient where randomly allocated and intra-oral scanning is done for them followed by software designing ,printing using PETG sheets of 0.75 in aligner group while in inclined plane the appliance is formed in conventional way.

Eligibility criteria: Inclusion Criteria:1. Patients age (7-12) years. 2. anterior crossbite 3. More than one tooth in a crossbite. 4. Favorable oral hygiene 5. No oral habits 6. ANB within the normal range i.e. (The crossbite will be diagnosed as functional or dental)

-

Exclusion Criteria:

1. Systemic conditions that may interfere with the treatment.
2. Bad habits that might jeopardize the appliance.
3. Transverse discrepancy.
4. Previous orthodontic treatment

Primary outcomes:
measure: (OHRQoL (Oral Health-related Quality of Life)
timeFrame: 4 month
Secondary outcomes:
measure: cephalometric analysis of data
timeFrame: 4 month
measure: 3D model measurements
timeFrame: 4 month
Other outcomes:
Locations:
city: El Mansura
country: Egypt
facility: Faculty of Dentistry
Study officials:
References: