louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01869517: Myoring Versus Keraring Implantation for Keratoconus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Keratoconus
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-06-05
Enrollment: 23
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Various approaches, including surgical and non-surgical management have been proposed for keratoconus. One of the surgical procedures is Intrastromal Corneal Ring implantations that have been designed to achieve refractive readjustment by flattening the cornea. There are different models of Intrastromal Corneal rings available: intrastromal corneal ring segments (ICRS) such as Keraring and intrastromal corneal continuous ring (ICCR) like Myoring.

Most studies of these two types of ring implantation outcomes are retrospective case series. Thus, this Randomized Clinical Trial study was designed with the aim of Comparing visual and refractive outcomes and complications of insertion Myoring versus Keraring using Femtosecond laser. Keratoconus patients with compound myopic astigmatism who meet the inclusion criteria will randomly allocated to the Keraring and Myoring groups. Subsequently, the clinical outcomes of two groups will be compared at one,3 and 6 months after surgery.


Eligibility criteria: Inclusion Criteria:

* keratoconus patients and :
* age between 20 to 40
* corneal thickness\> 380 microns
* mean keratometry between 44 to 60 D
* clear central cornea
* Patients should be discontinued their contact lenses for 3 weeks prior to the exams
* contact lenses in tolerance
* 20/200\<visual acuity \<20/30

Exclusion Criteria:

* Positive pregnancy test
* Breast-feeding
* History of glaucoma, cataract, vernal and atopic keratoconjunctivitis
* History of previous ophthalmologic surgery, keratorefractive surgery on the operative eye
* Dry eye
* Corneal stromal disorders
* History of herpetic keratitis
* Pellucid marginal degeneration
* Corneal grafts
* Retinal disorders
* Nystagmus and uncooperative disposition
* Neuro-ophthalmologic disorders
* Intraocular pressure \<10 mmHg or \>21 mmHg
* Patients with autoimmune, connective tissue disorders, diabetes and immunosuppressive drugs users
* Hyperopia

Primary outcomes:
measure: uncorrected visual acuity
timeFrame: 6 months
Secondary outcomes:
measure: Corneal thickness
timeFrame: 6months
measure: Corneal irregularities (3, 5 and 7 mm of central cornea)
timeFrame: 6 months
measure: Front & back corneal elevation
timeFrame: 6 months
measure: Corneal aberrometry
timeFrame: 6 months
measure: Corneal eccentricity
timeFrame: 6 months
measure: Corneal hysteresis & corneal resistance factor
timeFrame: 6 months
measure: Intra and postoperative complications (glare, night vision problem, migration, extrusion, infection)
timeFrame: Intra and post operatien
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Islamic Republic OF Iran
Study officials:
References:
Clinical trial NCT01665417: Icotinib as First-line and Maintenance Treatment in EGFR Mutated Patients With Lung Adenocarcinoma
Official title: Randomized, Open Label, Positive Controlled, Multicenter Trial to Evaluate Icotinib as First-line and Maintenance Treatment in EGFR Mutated Patients With Lung Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: EGFR Positive Non-small Cell Lung Cancer
Adenocarcinoma
Keywords: Icotinib
EGFR positive mutation
First-line treatment
Maintenance treatment
Lead sponsor: Betta Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-08-15
Enrollment: 100
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: This study is designed to compare the efficacy and safety of first-line icotinib treatment and first-line chemotherapy followed by maintenance treatment with icotinib.

Detailed description: This study is designed to compare the efficacy and safety of first-line icotinib treatment and first-line chemotherapy followed by maintenance with icotinib.

Primary endpoint:

Progression-free survival between first-line icotinib treatment and first-line chemotherapy followed by maintenance with icotinib

Secondary endpoint:

1. Overall survival between icotinib and chemotherapy
2. Time to Progression between icotinib and chemotherapy
3. Objective response rate and disease control rate between icotinib and chemotherapy

Eligibility criteria: Inclusion Criteria:

* Pathologic confirmation of lung adenocarcinoma with measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded on CT); Patients must have previously untreated locally advanced or metastatic NSCLC; Patients must have lung cancer with a documented EGFR activating mutation (exon 19 deletion, L858R).

Exclusion Criteria:

* Prior chemotherapy Prior treatment with gefitinib, erlotinib, or other drugs that target EGFR Patients must not be receiving any other investigational agents Any evidence of interstitial lung disease

Primary outcomes:
measure: Progression-free survival
timeFrame: 8 months
Secondary outcomes:
measure: Overall survival
timeFrame: 24 months
measure: Time to Tumor Progression
timeFrame: 8 months
measure: Objective response rate
timeFrame: 3 months
measure: Number of participants with adverse events
timeFrame: 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese People's Liberation Army (PLA) General Hospital
state: Beijing
Study officials:
affiliation: Chinese People's Liberation Army (PLA) General Hospital
name: Jiao Shunchang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Cancer Hospital & Institute
name: Fang Jian, MD
role: STUDY_DIRECTOR
affiliation: Peking Union Medical College Hospital
name: Bai Chunmei, MD
role: STUDY_DIRECTOR
affiliation: Hebei Provincal Tumor Hospital
name: Liu Wei, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01535417: Efficacy and Safety of Shinbaro Capsule
Official title: A 12 Weeks, Randomized, Double-blind, Multi-centers, Phase III Study to Evaluate the Efficacy and Safety of Shinbaro Capsule Compared With Celebrex Capsule in Patients With Osteoarthritis of Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: Osteoarthritis
Lead sponsor: GC Biopharma Corp
Sponsor class: INDUSTRY
First posted: 2012-02-17
Enrollment: 198
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
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 evaluate the efficacy and safety of 'Shinbaro Capsule', a new herbal anti-arthritic agent, in patients with osteoarthritis of the knee.


Eligibility criteria: Inclusion Criteria:

* age between 35 and 80
* diagnosed with Knee OA based on criteria of ACR and showed ont through I \~ III of Kellgren Stage on radiography
* wuffered constantly with Knee OA for more than 6 months prior to begining the study
* scored more than 30 on total WOMAC scale

Exclusion Criteria:

* had other comorbid orthopedic disease
* had OA of index knee from significant trauma or surgery

Primary outcomes:
measure: WOMAC change
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: 100mm Pain VAS on walking
timeFrame: Baseline, 12 weeks
measure: PGART
timeFrame: 12 weeks
measure: Adverse Events
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02033317: An Open-Label, Multiple Dose Study to Evaluate the Pharmacology, Safety, and Tolerability of Patiromer in Participants on Hemodialysis
Official title: An Open-Label, Multiple Dose Study to Evaluate the Pharmacology, Safety, and Tolerability of Patiromer in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hyperkalemia
Lead sponsor: Vifor Pharma
Sponsor class: INDUSTRY
First posted: 2014-01-10
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study assessed the pharmacodynamic effects of patiromer on serum potassium in participants on hemodialysis.

Detailed description: The initial intent was to enroll 12-24 adult male and female participants on hemodialysis into the study. Due to significant recruitment challenges, the study was discontinued after six participants were enrolled in the study.

This was an open-label, multiple-dose, adaptive-design study in participants on hemodialysis. Eligible participants on hemodialysis were to remain in the Clinical Research Unit for 2 weeks (Day -7 to Day 8) and were required to consume a potassium, magnesium, calcium and sodium-controlled diet.

Eligibility criteria: Inclusion Criteria:

* Participants on hemodialysis between the ages of 18 and 70 years, with serum potassium levels of at least 5.5 mmol/L
* Adequately dialyzed (Kt/V ≥ 1.2)

Exclusion Criteria:

* History of bowel obstruction, swallowing disorders, severe gastrointestinal disorders or major gastrointestinal surgery.
* Severe constipation or irregular bowel habits.
* Unable to consume or tolerate the study-specific diet.

Primary outcomes:
measure: Change in Serum Potassium (Day 1 to Day 8)
timeFrame: Day 1 and Day 8
measure: Change From Baseline in Fecal Potassium Excretion (Day -7 Through Day -1) and Treatment (Day 1 Through 7)
timeFrame: Day -7 Through Day -1 and Day 1 Through Day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Investigator Site
state: Florida
city: Minneapolis
country: United States
facility: Investigator Site
state: Minnesota
Study officials:
affiliation: Relypsa, Inc.
name: VP Clinical Development
role: STUDY_DIRECTOR
References:
Clinical trial NCT00564317: KIDNET vs Meditation/Relaxation - a Dissemination Randomized Controlled Trial for the Treatment of Traumatized Children After War in Sri Lanka
Official title: KIDNET vs Meditation/Relaxation - a Dissemination Randomized Controlled Trial for the Treatment of Traumatized Children After War in Sri Lanka
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post-Traumatic Stress Disorders
Keywords: PTSD
Depression
Suicidality
trauma-focussed treatment
KIDNET
Narrative Exposure Therapy for Children
Meditation
Relaxation
War
Lead sponsor: University of Konstanz
Sponsor class: OTHER
Collaborators: name: NGO vivo e.V.
name: GTZ-German Technical Cooperation, Germany
name: European Refugee Fund
name: German Research Foundation
First posted: 2007-11-27
Enrollment: 48
Sex: ALL
Minimum age (years): 11
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy of KIDNET versus a Meditation/Relaxation protocol in treating traumatized children when applied by locally trained teacher counsellors as well as the effectiveness and adequacy of such a treatment in a south-asian war affected stayee child community.

Detailed description: Outcome measures include PTSD symptom score, Depression score, Suicidal ideation and related functioning measures (including school grades)

Eligibility criteria: Inclusion Criteria:

* all children with PTSD Diagnosis from six surveyed schools in Vallikamam/Jaffna educational zones age range 11-15

Exclusion Criteria:

* none

Primary outcomes:
measure: PTSD-Symptoms according to CAPS-CA (DSM-IV)
timeFrame: pre-test, 5-months, 14-months
Secondary outcomes:
measure: Depression score & Suicidality according to M.I.N.I. KID A and B
timeFrame: pre-test, 5-months, 14-months
Other outcomes:
Locations:
city: Jaffna/Vallikamam
country: Sri Lanka
facility: University of Konstanz/vivo e.V. Germany & Vallikamam/Jaffna Educational Zones, Sri Lanka
Study officials:
affiliation: University of Konstanz
name: Brigitte Rockstroh, Prof Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Konstanz
name: Elisabeth Schauer, MA/MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01346917: Effect of Intravenous Lidocaine on the Tolerability of Early Oral Feeding After Laparoscopic Colorectal Surgery
Official title: Prospective Randomized Controlled Study for the Effect of Intravenous Lidocaine on the Tolerability of Early Oral Feeding After Laparoscopic Colorectal Surgery in Patients With Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Colorectal cancer
Laparoscopic surgery
Postoperative ileus
Lidocaine
Early oral feeding
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2011-05-03
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether intravenous lidocaine increase the tolerability of early oral feeding after laparoscopic colorectal surgery in patients with colorectal cancer.

* Degree of nausea/vomiting.
* Degree of postoperative pain and opioids requirement.
* Time to first flatus, time to first stool, time to tolerance of regular diet, rate of postoperative complications and duration of postoperative hospital stay.


Eligibility criteria: Inclusion Criteria:

* Elective laparoscopic colorectal surgery for colorectal cancer.
* Age \> 18 years.
* Informed consent.

Exclusion Criteria:

* Allergy to local anesthetics.
* Severe cardiovascular, hepatic, or renal diseases.
* Pregnant or lactating patients.
* Emergency surgery.
* American Society of Anesthesiologists (ASA) class IV

Primary outcomes:
measure: Prevalence of postoperative nausea and vomiting.
timeFrame: From day of surgery to sixth postoperative day.
Secondary outcomes:
measure: Time to first flatus.
timeFrame: From day of surgery to sixth postoperative day.
measure: Time to first passage of stool.
timeFrame: From day of surgery to sixth postoperative day.
measure: Degree of postoperative pain.
timeFrame: From day of surgery to sixth postoperative day.
measure: Postoperative opioid consumption.
timeFrame: From day of surgery to sixth postoperative day.
measure: Time to tolerance of regular diet
timeFrame: From day of surgery to sixth postoperative day.
measure: Postoperative complications
timeFrame: From day of surgery to thirtieth postoperative day.
measure: Duration of postoperative hospital stay.
timeFrame: From day of surgery until discharge, an expected average of nine days.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hyung Ook Kim
Study officials:
affiliation: Kangbuk Samsung Hospital
name: Hyung Ook Kim, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim HO, Lee SR, Choi WJ, Kim H. Early oral feeding following laparoscopic colorectal cancer surgery. ANZ J Surg. 2014 Jul-Aug;84(7-8):539-44. doi: 10.1111/ans.12550. Epub 2014 Feb 24.
Clinical trial NCT04679324: The Role of Mucosal Microbiome in the Development, Clearance and Recurrence of Clostridioides Difficile Infection
Official title: The Role of Mucosal Microbiome in the Development, Clearance and Recurrence of Clostridiodes Difficile Infection
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Clostridioides Difficile Infection
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-12-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients recently diagnosed with C. difficile infection (not defined as recurrent) without underlying inflammatory GI conditions

Brief summary: The study is being done to identify types of bacteria associated with the lining of the large intestine in people who have recently been diagnosed with C. difficile infection to determine if there are features associated with development, clearance, and recurrence of disease.

Detailed description: Patients who were recently diagnosed with C. difficile infection will undergo assessment of both before treatment and after completing treatment to study the presence of C. difficile in the colonic mucosa pre as well as assessment for microbiome and patient/clinical factors that may contribute to disease recurrence. Assessment will include sigmoid colon biopsies, blood draw, stool samples and surveys.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 and over
* Confirmed C. difficile infection based on positive C. difficile toxin PCR testing and clinical evidence of diarrhea

Exclusion Criteria:

* Known active pregnancy
* Prior diagnosis of C. difficile infection within 2 months of this diagnosis
* Other known active gastrointestinal infectious process
* Vulnerable adults
* Any other disease(s), condition(s) or habit(s) that would interfere with completion of study, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes

Primary outcomes:
measure: Disease recurrence
timeFrame: 8 weeks post treatment of C.difficile infection
Secondary outcomes:
measure: Change in mucosal presence of C. difficile
timeFrame: Baseline, approximately 1-14 days post treatment of C. difficile infection
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Purna Kashyap, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00484224: Audiological Disturbances in Vitiligo
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vitiligo
Hearing Loss
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2007-06-08
Sex: ALL
Minimum age (years): 3
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The purpose of this study is to determine wether vitiligo patients have more audiological abmnormalities, than the healthy population.


Eligibility criteria: Inclusion Criteria:

* vitligo patients under 50. healthy patients under 50 for control group

Exclusion Criteria:

* above age 50. systemic disease. exposure to loud noise in past. familial history of deafness use of autotoxuc drugs or steroids. autoimmune/metabolic/neurologic/vascular disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Arieh Ingber, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aydogan K, Turan OF, Onart S, Karadogan SK, Tunali S. Audiological abnormalities in patients with vitiligo. Clin Exp Dermatol. 2006 Jan;31(1):110-3. doi: 10.1111/j.1365-2230.2005.02004.x.
Clinical trial NCT04561024: Evaluation of a COVID-19 Pneumonia CXR AI Detection Algorithm
Official title: Evaluation of a Chest X-Ray AI Neural Network (RadGen SARS-CoV2 Detection System) for the Detection of RT-PCR Confirmed SARS-Cov2 Covid-19 Pneumonia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Lead sponsor: Ensemble Group Holdings, LLC
Sponsor class: INDUSTRY
First posted: 2020-09-23
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: There will be three subsets of study population in this study; patients who were

1. RT-PCR confirmed COVID-19 positive
2. RT-PCR confirmed COVID-19 negative
3. either had a diagnosis of pneumonia before the 1st January 2020.

Brief summary: This study investigates the diagnostic performance of an AI algorithm in the detection of COVID-19 pneumonia on chest radiographs.

Detailed description: This is an international multi-center study. Chest radiographs (CXR) from different participating centers will be collected to develop an AI algorithm to detect COVID-19 pneumonia. This will be tested on external hold out datasets from different centers using SARS-CoV-2 by Real-Time Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) Assay as ground truth.

Eligibility criteria: Inclusion Criteria:

* All adult patients \>18 years of age
* Attended any of the participating institutes between February 1, 2020 until September, 2020
* Underwent both RT-PCR testing and frontal CXR (within 48 hours of PCR testing) for COVID-19 infection
* frontal CXR of patients pre-covid pandemic

Exclusion Criteria:

* Unavailability of patient demographics and clinical data
* Inconclusive RT-PCR results
* CXR considered to be of non-diagnostic quality by the clinical radiology research team at each site
* CXR not in a retrievable or processable format for AI inference

Primary outcomes:
measure: Diagnostic Performance of AI model
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: University of Hong Kong
Study officials:
References:
Clinical trial NCT02759224: A Study to Compare the Pharmacokinetics of Lafutidine and Irsogladine Maleate Tablet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gastric Ulcer
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2016-05-03
Enrollment: 34
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: An Open-Label, Randomized, Single-dose, 2x2 Crossover Study to Compare the Pharmacokinetics of BRI-1501 Tablet and Coadministration of Lafutidine and Irsogladine maleate as Individual Tablets in Healthy Adult Volunteers


Eligibility criteria: Inclusion Criteria:

* Healthy subject, aged 19- 50 years

Exclusion Criteria:

* History of clinically significant and active disease
* History of gastrointestinal disease
* History of clinically significant hypersensitivity to study drug, any other drug
* Laboratory test serum AST or ALT \> 1.25 times of upper normal range serum total bilirubin \> 1.5 times of upper normal range eGFR \< 60 ml/min/1.73m² serological test(HBsAg, HCV Ab, HIV Ag/Ab, Syphilis reagin) positive
* Hypotension or hypertension
* Pregnant or nursing women
* Participation in any other study within 90 days

Primary outcomes:
measure: Maximum observed concentration(Cmax) of Lafutidine and Irsogladine maleate
timeFrame: 0~36 hour after medication
measure: Area under the plasma drug concentration-time curve(AUClast) of Lafutidine and Irsogladine maleate
timeFrame: 0~36 hour after medication
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St.Mary's Hospital
Study officials:
References: