louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02921711: TRAIL: Treatment of Intracranial Aneurysms With LVIS® System
Official title: TRAIL: Treatment of Intracranial Aneurysms With LVIS® System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Aneurysms
Lead sponsor: Microvention-Terumo, Inc.
Sponsor class: INDUSTRY
First posted: 2016-10-03
Enrollment: 90
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 aged minimum of 18 years with an intracranial aneurysm in whom stent-assisted coiling has been determined to be the appropriate treatment strategy.

Brief summary: A prospective, multicenter, observational assessment of the safety and effectiveness of the LVIS® device in the treatment of wide necked intracranial aneurysms.


Eligibility criteria: Inclusion Criteria:

1. Patient or patient's legally authorized representative has been informed about the confidentiality of the study and has agreed to the collection of his/her personal data
2. Patient has a ruptured or unruptured intracranial aneurysm for which:

   * The parent artery has a diameter ≥ 2.0mm and ≤ 4.5 mm;
   * The aneurysm neck size is ≥ 4mm or its dome-to-neck ratio is \< 2 (wide neck)
   * Endovascular treatment with coils and one or more LVIS® devices has been determined necessary for the patient by the multidisciplinary team
3. Patient is aged ≥ 18 years
4. Patient presents with a WFNS score between 0 and 3
5. Patient has agreed to attend follow-up appointments

Exclusion Criteria:

1. The use of an endovascular stent other than LVIS® has been determined necessary
2. Patient presents with medical or surgical co-morbidities limiting his/her life expectancy to less than one year
3. Patient has a contraindication to platelet inhibition treatment
4. Patient requires retreatment of an aneurysm previously treated with a stent
5. Patient is pregnant
6. Patient has multiple aneurysms to be treated in one procedure

Primary outcomes:
measure: Anatomical stability of aneurysm treatment compared to the initial occlusion rate of the aneurysm
timeFrame: 6 months
measure: Anatomical stability of aneurysm treatment compared to the initial occlusion rate of the aneurysm
timeFrame: 18 months
measure: Retreatment rate
timeFrame: 6 months
measure: Retreatment rate
timeFrame: 18 months
measure: Morbidity rate
timeFrame: 6 months
measure: Morbidity rate
timeFrame: 18 months
measure: Mortality rate
timeFrame: 6 months
measure: Mortality rate
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CHU Limoges; Limoges, France
name: Charbel Mounayer, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondation Rothschild; Paris, France
name: Michel Piotin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02787811: Predictors of Success of IUI in Unexplained Infertility
Official title: Factors Affecting Success of IUI in Women With Unexplained Infertility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Assisted Reproductive Techniques
Keywords: IUI
Pregnancy rate
predictors
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-06-01
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Superovulation will be conducted with 100 mg of oral clomiphene citrate (Clomifene; Young Poong Pharmaceutical, Incheon, Korea) for 5 days starting on day 3 of the menstrual cycle, followed by daily injection of 150 IU of human menopausal gonadotropin (hMG;Menogon; FerringPharamceutical Co, Germany). When more than 2 dominant follicles reached a diameter of 17 mm or the urinary specimen showed positive results for luteinizing hormone (LH) surge, 5000 IU of hCG (Pregnyl; Organon, Oss, the Netherlands) was injected intramuscularly.

Detailed description: Superovulation will conducted with 100 mg of oral clomiphene citrate (Clomifene; Young Poong Pharmaceutical, Incheon, Korea) for 5 days starting on day 3 of the menstrual cycle, followed by daily injection of 150 IU of human menopausal gonadotropin (hMG;Menogon; FerringPharamceutical Co, Germany). When more than 2 dominant follicles reached a diameter of 17 mm or the urinary specimen showed positive results for luteinizing hormone (LH) surge, 5000 IU of hCG (Pregnyl; Organon, Oss, the Netherlands) was injected intramuscularly. Successful pregnancy after IUI was confirmed by ultrasound as one or more visible gestational sacs in the uterine cavity.

Eligibility criteria: Inclusion Criteria:

* These patients had at least 1 tube patent
* there were no significant intrauterine or pelvic abnormalities demonstrated on pelvic-abdominal ultrasonography, hysteroscopy, and/or laparoscopy
* serum follicular stimulating hormone (FSH) level of12 mIU/mL or less

Exclusion Criteria:

* A woman's age of more than 40 years,
* ovarian cyst detected in the ultrasound examination
* uterine lesions such as submucosal leiomyoma, and a previous diagnosis of moderate to severe pelvic endometriosis.
* women with body mass index \> 35 kg/m2,
* PCOS/anovulatory patients
* signs of hyperandrogenemia

Primary outcomes:
measure: chemical pregnancy rate
timeFrame: 14 days after IUI
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Ahmed Maged, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03756311: Expanded Access to NanoPac
Official title: Expanded Access to NanoPac
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Locally Advanced Pancreatic Carcinoma
Prostate Cancer
Lung Cancer
Lead sponsor: NanOlogy, LLC
Sponsor class: INDUSTRY
Collaborators: name: US Biotest, Inc.
First posted: 2018-11-28
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: NanOlogy may consider offering expanded access to NanoPac for patients who do not meet the enrollment criteria of clinical trials in progress.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00414011: Comparison of the Effect of 4th Generation Fluoroquinolones, Gatifloxacin and Moxifloxacin, on Epithelial Healing Following Photorefractive Keratectomy (PRK), A Substudy of: Initial Evaluation of Excimer Laser Keratorefractive Surgery in U.S. Army Personnel (WU # 2335-99)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epithelium, Corneal
Keywords: Removal of corneal epithelium followed by excimer laser treatment during prk
Lead sponsor: Walter Reed Army Medical Center
Sponsor class: FED
First posted: 2006-12-20
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is a prospective,double-blinded, randomized trial to compare the rate of healing following PRK after the use of two commercially available 4th generation fluoroquinolones, moxifloxacin and gatifloxacin.


Eligibility criteria: Inclusion Criteria:

* Manifest refraction spherical equivalent (MSE) of up to -6.00 diopters (D) at the spectacle plane with refractive cylinder up to 3.00D.

Exclusion Criteria:

* Concurrent topical or systemic medications that may impair healing including corticosteroids, antimetabolites, isotretinoin, amiodarone hydrochloride and/ or sumatripin.
* Patients with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course.
* Anterior basement membrane dystrophy.
* History of recurrent epithelial erosion.
* Significant dry eye (symptomatic sith Schirmer \<5mm at 5 minutes)
* Other corneal epithelial disorder or healing abnormality

Primary outcomes:
measure: Corneal Epithelial Healing Time
timeFrame: 3 to 4 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
Study officials:
affiliation: Walter Reed Army Medical Center
name: KRAIG S. BOWER, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03320811: Interpretation of Serological Tests in the Diagnosis of Celiac Disease: Anti-deamidated Gliadin Peptide Antibodies Revisited
Official title: Interpretation of Serological Tests in the Diagnosis of Celiac Disease: Anti-deamidated Gliadin Peptide Antibodies Revisited
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Celiac Disease
Keywords: Celiac disease
serological tests
anti-deamidated gliadin peptide antibodies
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2017-10-25
Enrollment: 2026
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: All patients attending the Reims University Hospitals, for whom serological tests for celiac disease were prescribed.

Brief summary: Celiac disease is an autoimmune disorder characterized by a chronic inflammation of the small bowel mucosa, triggered by the ingestion of gluten-containing grains.

The diagnosis of celiac disease was initially based on duodenal biopsies obtained from upper endoscopy. Since 1990, the availability of serological tests has contributed to a different perception of the disease. Serological testing is now considered fundamental for celiac disease screening, even if duodenal biopsies remain the gold standard. Celiac markers usually include anti-TG2 antibodies, anti-endomysium antibodies, anti-gliadin antibodies and anti-reticulin antibodies. Recently, several studies showed that deamidated products of gliadin may enhance T-cell stimulatory activity and improve the reactivity of anti-gliadin antibodies. Thus, detection of anti-deamidated gliadin peptide antibodies has been introduced into the wide spectrum of serological tests for celiac disease.

Detailed description: The aim was to assess the clinical relevance of anti-deamidated gliadin peptide antibodies compared with the other common celiac markers.

Eligibility criteria: Inclusion Criteria:

- patients attending the Reims University Hospitals, for whom serological tests for celiac disease were prescribed between 1 april 2012 to 31 december 2014

Primary outcomes:
measure: celiac disease
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References:
Clinical trial NCT06378411: Development and Application of a Musical Game for Motor Rehabilitation
Official title: Development and Application of a Musical Game for Motor Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Health People
Survivors of Stroke
Keywords: music intervention
rehabilitation
stroke
motor coordination
adults
Lead sponsor: Universidade da Madeira
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 45
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to develop, adapt a musical game for residents of RAM, and evaluated the usability and correlation between this game with the improvement of motor coordination in short time.


Eligibility criteria: Inclusion Criteria:

* Health people
* Survivors of Stroke

Exclusion Criteria:

* Dementia
* Visual Defict
* People who already knows how to play piano

Primary outcomes:
measure: Motor Coordination
timeFrame: 1 month
measure: Usability
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Funchal
country: Portugal
facility: Universidade da Madeira
Study officials:
References:
Clinical trial NCT01311011: Study of the Clinical Efficacy of Autologous SCT in Patients With Critical Limb Ischemia
Official title: Phase II Prospective Study of the Clinical Efficacy of Autologous SCT in Patients With Critical Limb Ischemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critical Limb Ischemia
Keywords: Critical Limb Ischemia
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2011-03-09
Enrollment: 26
Sex: ALL
Minimum age (years): 14
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Critical Limb Ischemia

Brief summary: Phase II Prospective Study of the Clinical Efficacy of Autologous SCT in patients with Critical Limb Ischemia

Detailed description: Phase II Prospective Study of the Clinical Efficacy of Autologous SCT in patients with Critical Limb Ischemia

Eligibility criteria: Inclusion Criteria:

* Patients with Critical Limb Ischemia

Exclusion Criteria:

* Patients with other than Critical Limb Ischemia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Kfsh & Rc
Study officials:
affiliation: KFSH & RC
name: H Al-Zahrani, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06927011: Chronic Loose Stools Following Right-sided Hemicolectomy for Colon Cancer and the Association With Bile Acid Malabsorption and Small Intestinal Bacterial Overgrowth Using a Novel Sampling Device
Official title: Chronic Loose Stools Following Right-sided Hemicolectomy for Colon Cancer and the Association With Bile Acid Malabsorption and Small Intestinal Bacterial Overgrowth Using a Novel Sampling Device
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Colon Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MD Anderson Cancer Center

Brief summary: The goal of this clinical research study is to learn about gastrointestinal symptoms in participants who have undergone SC or RC and their impact on the quality of life of these participants.

Detailed description: To estimate the microbiota and bile acid profiles at multiple levels of the small intestine and proximal neo-colon in patients after RC and participants after SC.

Eligibility criteria: Inclusion Criteria:

* Both men and women of all races and ethnic groups are eligible for this trial who meet the above criteria.

Exclusion Criteria:

* Children will not be enrolled in this study.
* Pregnant women will not be enrolled in this study.
* Cognitively impaired subjects will not be enrolled in this study.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Through study completion; an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
References:
Clinical trial NCT02820311: Thorough QT (TQT) Study of TD-4208 in Healthy Subjects
Official title: A Phase 1, Randomized, Double-Blind, Placebo- and Positive-Controlled, 4-Period Crossover Thorough QT Study to Evaluate the Effect of a Single Dose of TD-4208 on Cardiac Repolarization in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cardiac Repolarization in Healthy Subjects
Keywords: Thorough QT (TQT)
cardiac safety
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
Collaborators: name: Theravance Biopharma
First posted: 2016-06-30
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate if TD-4208, an investigational drug being developed to treat people with chronic obstructive pulmonary disease (COPD), has any effect on the electrical activity of the heart.


Eligibility criteria: Inclusion Criteria:

* Subject has a body mass index (BMI) of 19 to 32 kg/m2, inclusive, and weight of at least 55 kg.
* Subject is able to communicate well with the investigator and to comply with the study procedures, requirements, and restrictions.

Exclusion Criteria:

* Subject has a prior history of myocardial infarction, acute coronary syndrome, cerebrovascular accident, transient ischemic attack, ventricular tachycardia, atrial fibrillation, personal or known family history of congenital long QT syndrome or known family history of sudden death with unknown cause, a pacemaker or implantable cardioverter defibrillator, cardiac or cerebral stent placement or angioplasty, or clinically significant valvular heart disease.
* Subject has evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematologic, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.

Primary outcomes:
measure: Change-from-baseline in corrected QT
timeFrame: Predose to 24 hours postdose
Secondary outcomes:
measure: Maximum Plasma Concentration Cmax
timeFrame: Predose to 24 hours postdose
measure: Adverse Events
timeFrame: Predose to 24 hours postdose
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion
state: Arizona
Study officials:
affiliation: Theravance Biopharma
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04284111: A Multi-center Study of the Effect of Orthokeratology on Myopia Progression
Official title: A Prospective, Multi-center Study of the Effect of Orthokeratology on Myopia Progression in Chinese Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myopia
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-02-25
Enrollment: 1000
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1,000 children from 8 hospitals in China plan to wear orthokeratology lenses for myopia control.

Brief summary: This is a prospective study to validate an algorithm for predicting the effect of orthokeratology on myopia progression in children from 8 hospitals in China.

Detailed description: Orthokeratology (ortho-K) is thought to be an effective way to control the progression of Myopia in children, but its effectiveness may vary among different individuals. The investigators therefore conducted a prospective, multi-center study to use an algorithm to predict the progression of myopia among Chinese children wearing Orthokeratology lenses.

Eligibility criteria: Inclusion Criteria:

* -6.0D≤SER≤-0.5D
* Astigmatism≤2.0D

Exclusion Criteria:

* Contraindications of wearing Ortho-K.
* Diagnosis of strabismus, amblyopia and other refractive development of the eye or systemic diseases.
* Currently involved in other clinical studies.

Primary outcomes:
measure: AUROC of the prediction algorithm for identifying fast progressing myopes
timeFrame: 1 year
Secondary outcomes:
measure: Sensitivity and specificity of the prediction algorithm for identifying fast progressing myopes
timeFrame: 1 year
measure: Performance of an algorithm for predicting AL
timeFrame: 1 year
measure: Performance of an algorithm for predicting spherical equivalent refractive error
timeFrame: 1 year
Other outcomes:
Locations:
city: Hefei
country: China
facility: Hefei Bright Eye Hospital
state: Anhui
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center (Haizhu Branch), Sun Yat-sen University
state: Guangdong
city: Wuhan
country: China
facility: Wuhan Bright Eye hospital
state: Hubei
city: Nanchang
country: China
facility: Nanchang Bright Eye Hospital
state: Jiangxi
city: Jinan
country: China
facility: Jinan Bright Eye Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Bright Eye Hospital
state: Shanghai Province
city: Chengdu
country: China
facility: Chengdu Bright Eye Hospital
state: Sichuan
city: Kunming
country: China
facility: Kunming Bright Eye hospital
state: Yunnan
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Xialin Liu, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang D, Ding X, Liu B, Zhang J, He M. Longitudinal changes of axial length and height are associated and concomitant in children. Invest Ophthalmol Vis Sci. 2011 Oct 10;52(11):7949-53. doi: 10.1167/iovs.11-7684.
Clinical trial NCT04557111: Remote Care for CIED Patients in Korea
Official title: Quality and Satisfaction in CIED Remote Monitoring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arrhythmias, Cardiac
Keywords: pacemaker
Implantable Cardioverter Defbrillator
Cardiac resynchronization therapy
Lead sponsor: Saint Vincent's Hospital, Korea
Sponsor class: OTHER
Collaborators: name: Biotronik SE & Co. KG
First posted: 2020-09-21
Enrollment: 102
Sex: ALL
Minimum age (years): 20
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study includes Biotronic CIED implanted patients in St. Vincent's Hospital, Catholic University of Korea, Republic of Korea. Study population are included if they are more than 20year old, followed up at outpatient clinic \> 6 months after CIED implantation, and are literate and have perceptibility on questionnaire.

Brief summary: This trial is for monitoring the quality and satisfaction of CIED patients who are naive with remote device monitoring.

Detailed description: Patient satisfaction (using questionnaire) before and after wireless/wired monitoring and outpatient treatment time, variables in heart transplantation devices for wireless/wired monitoring, presence of heart failure, cardiovascular events such as arrhythmia, myocardial infarction or cerebral infarction, thromboembolism and admission related to cardiovascular cause. The questionnaire was adopted and modified from modified Korean version of HoMASQ (by YouMi Hwang,2021 from HoMASQ; Europace (2010))

Eligibility criteria: Inclusion Criteria:

1. Patients with Biotronic CIED implanted in St. Vincent's Hospital, Catholic University of Korea, Republic of Korea
2. Patients who are literate and have perceptibility on questionnaire
3. Patients who followed up more than 6 months after CIED implantation
4. Patients with age of \>20 years

Exclusion Criteria:

1. Patients with \< 2 outpatient clinic visits during \>6 months
2. Illiterate patients or inapprehensive of questionnaire
3. Patients with life expectancy of \<1 year

Primary outcomes:
measure: Satisfaction measurement before and after remote monitoring
timeFrame: 1 year
Secondary outcomes:
measure: Any changes in prescription or patient visit schedule
timeFrame: 1 year
measure: Out patient clinic time consumption per patient
timeFrame: 1 year
measure: Changes in CIED parameters
timeFrame: 1 year
measure: Any cardiocerebrovascular events, deaths
timeFrame: 1 year
measure: Admission for heart failure or any cardiovascular intervention
timeFrame: 1 year
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: St. Vincent's Hospital
state: Kyonggi Do
Study officials:
affiliation: The Catholic University of Korea
name: YouMi Hwang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: