louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02299258: Gastric Outlet Obstructions Tailored Covered Stents for GOO
Official title: A Multicenter Randomized Controlled Trial of Malignant Gastric Outlet Obstruction: Tailored Partially Covered Stents (Placed Fluoroscopically) Versus Standard Uncovered Stents (Placed Endoscopically)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Outlet Obstruction
Lead sponsor: The First People's Hospital of Yuhang District
Sponsor class: OTHER
First posted: 2014-11-24
Enrollment: 63
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: gastric outlet obstruction tailored versus standard stents for malignant gastric outlet obstruction treatments

Detailed description: To determine the shape of the GOOs, stomach opacifications were performed using contrast media before stenting. In the GOO tailored group (33 cases), the distal stents were semi-spherical with a length of 20 mm and a diameter of 28 mm. The middle stent segments had diameters of 20 mm. The proximal ends of large cup-shaped stents had 53.3 ± 5.5 mm diameters and were 15 or 20 mm long, whereas the large funnel-shaped stents had 33.6 ± 3.6 mm diameters and were 25 or 30 mm long. The control group (32 cases) received standard uncovered stents (semi-spherical, with diameters of 28 mm and 20 mm long).Our hypothesis was that unresectable GOO tailored covered stents are superior to the standard uncovered ones in terms of stent re-obstruction and stent migration. In the current study the efficacy and safety of GOO tailored covered stents for the treatment of non-resectable GOOs caused by distal gastric cancer was compared with standard uncovered stents.

Eligibility criteria: Inclusion Criteria:

GOO defined by symptoms resulting in decreased oral intake (nausea, vomiting and inability to eat),the obstruction was caused by primary distal stomach cancer and the site of stenosis was between the gastric body and duodenum bulb

Exclusion Criteria:

the presence of only mild symptoms in patients who could tolerate a liquid diet, clinical evidence of perforation or peritonitis, evidence of multiple small-bowel obstructions because of peritoneal seeding as well as diabetes or other diseases that affect gastric motility and use of promotility agents.

Primary outcomes:
measure: Efficiency of Stents
timeFrame: up to 5 years
Secondary outcomes:
measure: Adverse Events
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First People's Hospital of Yuhang District
Study officials:
affiliation: The First People's Hospital of Yuhang District
name: Ding Shi
role: STUDY_DIRECTOR
References:
Clinical trial NCT01016158: Umbilical Cord Serum Eye Drops
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent Corneal Erosion
Keywords: Umbilical cord serum
Recurrent corneal erosion
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
First posted: 2009-11-19
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the present study, the investigators investigated the efficacy of umbilical cord serum eye drops for the treatment of patients with recurrent corneal erosions. Group A were treated with 20% umbilical cord serum eye drops 3 to 4 times a day in addition to artificial tears, and group B were treated with artificial tears only. Ophthalmic examinations including visual acuity measurement and slit lamp biomicroscopy were performed before and every month after treatment. Recurrence was defined as the presence of clinical symptoms accompanied by epithelial defects in the cornea.


Eligibility criteria: Inclusion Criteria:

* patients with recurrent corneal erosions

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Gwang-Ju
country: Korea, Republic of
facility: Chonnam National University Hospital
Study officials:
References:
citation: Yoon KC, Im SK, Park YG, Jung YD, Yang SY, Choi J. Application of umbilical cord serum eyedrops for the treatment of dry eye syndrome. Cornea. 2006 Apr;25(3):268-72. doi: 10.1097/01.ico.0000183484.85636.b6.
citation: del Castillo JM, de la Casa JM, Sardina RC, Fernandez RM, Feijoo JG, Gomez AC, Rodero MM, Sanchez JG. Treatment of recurrent corneal erosions using autologous serum. Cornea. 2002 Nov;21(8):781-3. doi: 10.1097/00003226-200211000-00010.
citation: Yoon KC, You IC, Im SK, Jeong TS, Park YG, Choi J. Application of umbilical cord serum eyedrops for the treatment of neurotrophic keratitis. Ophthalmology. 2007 Sep;114(9):1637-42. doi: 10.1016/j.ophtha.2006.12.014. Epub 2007 Mar 26.
Clinical trial NCT02732535: Natural Killer (NK) Cells Following Bariatric Surgery
Official title: The Natural Killer Cells Regulatory Role Against Hepatic Fibrosis Following Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Natural Killer Cell Deficiency, Familial Isolated
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2016-04-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: obese patient with BMI above 30 with comorbidity or BMI above 35 with or without comorbidity, that have evidence of hepatic fibrosis on the routine preoperative US

Brief summary: This study will determine the role of the NK cells before and after bariatric surgery. The investigators selected patients with NAFLD.

A Fibroscan evaluation will be assessed as a new modality to evaluate liver fibrosis.

Detailed description: All morbidly obese patients who are candidates for a bariatric procedure in the investigators institution who has a fatty liver in their routine preoperative US will undergo a fibroscan to assess the degree of liver fibrosis preoperatively in addition to a blood sample that will be withdrawn from those participants to isolate the NK cells and to assess their activities by the assessment of the active form of NK cells (CD107a) using the spectrometry (FACS) analysis.

The investigators will also collect other clinical data including comorbidities (hypertension, diabetes mellitus and hyperlipidemia) in addition to the following routine blood test( complete blood count, creatinine, urea, International normalized ratio, liver function test, HBa1C, cholesterol, HDL, LDL, triglycerides, vitamin D, vitamin B12, potassium, sodium, albumin, bilirubin, C- reactive protein, iron, ferritin and transferrin).

All of the above mentioned tests including the NK cells and the fibroscan will be examined for all participants in 3, 6, 12 months postoperatively.

Eligibility criteria: Inclusion Criteria:

* age from 18-65
* body mass index above 30 with comorbidity or above 35 with or without comorbidity
* evidence of hepatic fibrosis in routine preoperative US

Exclusion Criteria:

* patient with known other liver disease such as autoimmune or alcoholic hepatitis
* patient that take hepatotoxic medication or hormonal treatment
* active alcohol abuse above 20 gram per day
* Drug abuse
* patient refusal
* pregnancy

Primary outcomes:
measure: Determine Natural Killer (NK) cell phenotype and alterations prior and following Bariatric surgery
timeFrame: 1 year
Secondary outcomes:
measure: To assess the fibrosis downstaging by fibroscan prior and following Bariatric surgery
timeFrame: 1 year
Other outcomes:
Locations:
city: Jerusalem 91120
country: Israel
facility: Hadassah Medical Organization,Jerusalem,Israel
Study officials:
affiliation: israel ministrty of health
name: Abed Khalaileh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02001935: Association Between CytochromeP4501A2 and CytochromeP4502E1 Gene Polymorphisms and Metabolism of Theophylline
Official title: Association Between CytochromeP4501A2(CYP1A2) and CytochromeP4502E1(CYP2E1) Gene Polymorphisms and Metabolism of Theophylline in a Chinese Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
theophylline
CYP1A2
CYP2E1
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2013-12-05
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The aim of this study is to determine whether common CYP1A2 and CYP2E1 gene polymorphisms effect metabolism of theophylline in chronic obstructive pulmonary disease patients.


Eligibility criteria: Inclusion Criteria:

* Aged 18-75 years,COPD patients, male or female;
* regularly visiting our hospital;
* taking a sustained-release preparation of theophylline continuously for at least 2 weeks

Exclusion Criteria:

* patients with renal or hepatic dysfunction;
* patients with congestive heart failure;
* patients with hypothyroidism or hyperthyroidism;
* patients currently taking drugs likely to affect theophylline metabolism or who had taken such drugs in the preceding week;
* patients with extreme obesity
* patients with very severe Chronic Obstructive Pulmonary Disease(COPD)

Primary outcomes:
measure: Theophylline clearance
timeFrame: Blood samples will be taken after receiving oral thoephylline for 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital,Southern Medical Universtiy
state: Guangdong
Study officials:
affiliation: Zhujiang Hospital,Southern Medical Unversity
name: Wang Liqing, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01371435: Drug Use Investigation for PAXIL Tablet
Official title: Drug Use Investigation for PAXIL Tablet
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mental Disorders
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-06-10
Enrollment: 3708
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Japanese subjects with depression/depressed state or panic disorder who were indicated for PAXIL

Brief summary: This post-marketing surveillance study is designed to detect adverse events (particularly clinically significant adverse drug reactions) occurring in clinical settings and to examine factors likely to affect the safety and efficacy of paroxetine.


Eligibility criteria: Inclusion Criteria:

* Patients with depression/depressed state or panic disorder

Exclusion Criteria:

* Patients who had been taking PAXIL since before the start of the survey
* Patients with hypersensitivity to paroxetine
* Patients taking monoamine oxidase inhibitors (MAOIs) or within 2 weeks of stopping treatment with MAOIs
* Concomitant use in patients taking pimozide

Primary outcomes:
measure: Incidence of adverse events in Japanese subjects treated with paroxetine tablet based on prescribing information under the conditions of general clinical practice
timeFrame: 8 weeks
measure: Presence/absence of concomitant use of drugs metabolized by CYP2D6
timeFrame: Within 2 weeks after discontinuation or completion of treatment
measure: Presence/absence of concomitant use of products containing Saint John's Wort (Hypericum perforatum; "SJW", hereinafter)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06609135: Relationship Between EIT and Respiratory Status in Very Preterm Infants
Official title: Relationship Between Electrical Impedance Tomography (EIT) Measurements and Parameters of Respiratory Status in Very Preterm Infants: An Observational Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Lung Disease of Prematurity
Bronchopulmonary Dysplasia
Premature Lungs
Keywords: Electrical Impedance Tomography (EIT)
Prematurity
Pulmonary Function Testing
Noninvasive ventilation
Continuous Positive Airway Pressure (CPAP)
Transcutaneous CO2 monitor (TCOM)
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: SenTec AG, Ringstrasse 39, CH-4106 Therwil
First posted: 2024-09-24
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Electrical Impedance Tomography (EIT) is a non-invasive imaging technique that can measure lung function in real time. This study will follow premature infants to see if EIT can help predict which infants will be successful in weaning off respiratory support by 32-33 weeks gestational age. If successful, EIT could be used to develop new guidelines for respiratory support in premature infants.


Eligibility criteria: Inclusion Criteria:

* Infants admitted to the UMass Memorial Medical Center (UMMMC) Neonatal Intensive Care Unit (NICU)
* Born between 25+0- and 29+6-weeks of gestation

Exclusion Criteria:

* Infants with major congenital anomalies
* Infants with severe hemodynamic instability

Primary outcomes:
measure: Discontinuation of respiratory support at 32 weeks corrected gestational age
timeFrame: At 32 weeks corrected gestational age
measure: Discontinuation of respiratory support at 33 weeks corrected gestational age
timeFrame: At 33 weeks corrected gestational age
measure: Change in EIT measurements with titration of noninvasive respiratory support
timeFrame: Until positive end expiratory pressure support is discontinued, approximately 3 weeks
measure: Correlation between EIT measurements and TCOM measurements
timeFrame: Through study completion, an average of 8 weeks
measure: Correlation between EIT measurements and time to full oral feeding
timeFrame: Through study completion, an average of 8 weeks
measure: Correlation between EIT measurements and BPD status at 36 weeks
timeFrame: At 36 weeks corrected gestational age
Secondary outcomes:
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMASS Memorial Medical Center
state: Massachusetts
Study officials:
affiliation: UMASS Chan Medical School
name: Lawrence Rhein, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05622435: Clinical Investigation to Evaluate the Tolerance of T10070 on Healthy Volunteers
Official title: Clinical Investigation to Evaluate the Tolerance of T10070 on Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
First posted: 2022-11-18
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this clinical trial investigation is to evaluate the tolerance of the T10070 on healthy volunteers by clinical examination under ophthalmological control.

Participants will attend 2 visits (inclusion at day 0 and follow-up/final at D7/D9. After inclusion, subjects will have to apply T10070 6 times a day during 7 to 9 days. The following tasks will be asked to participants:

* ophtalmological examination
* diary completion to record T10070 applications, potential discomfort/reactions observed and medication taken.
* complete subject questionnaire about usability of the product


Eligibility criteria: Inclusion Criteria:

* Informed consent signed and dated
* Subject ≥ 18 years old
* Healthy volunteer
* Normal ocular examination in both eyes
* Normal skin examination in both eyes

Main Exclusion Criteria:

* Far best-corrected visual acuity (BCVA) ≥ +0.1 LogMar (e.g., ≤ 0.8 in decimal value or ≤ 80/100 Snellen equivalent)
* Known or suspected hypersensitivity to one of the components of the T10070
* History of trauma, infection, clinically significant inflammation within the 3 previous months
* Ongoing or know history of ocular allergy and/or uveitis and/or viral infection
* Diagnosed keratoconus
* Any palpebral abnormality

Primary outcomes:
measure: Change from baseline in clinical examination on eyes and peri-ocular skin
timeFrame: signs assessment at Day 0 and Day 7/Day 9
measure: Change from baseline in subjective evaluation of ocular and cutaneous signs by subjects
timeFrame: Signs assessment at Day 0 and Day 7/Day 9
measure: Local tolerance assessed by Investigator
timeFrame: Local tolerance assessed at Day 7/Day 9
Secondary outcomes:
measure: Subject questionnaire on product usability
timeFrame: Day 7/Day 9
measure: Adverse Events
timeFrame: Day 7/Day 9
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Eurofins Dermscan Poland
Study officials:
affiliation: Eurofins Dermscan Poland
name: Ewa Paw, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05331235: Blood Transfusions in Preterm Infants
Official title: Effect of Blood Transfusions on the Outcome of Low Birth Weight Preterm Infants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Red Blood Cells
Preterm
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Preterm infants admitted to the "grower ward", directly after birth or after transfer from NICU

Brief summary: A cross sectional study to assess the effect of blood transfusions on the outcome of preterm infants

Detailed description: This is a cross sectional study carried on preterm infants who are staying in the hospital as "growers"; to gain weight. We will assess blood transfusion received by these preterm infants in details.

Eligibility criteria: Inclusion Criteria:

* Grower preterm infants

Exclusion Criteria:

* Severe illness, Hypovolemic shock, Hypoxia, Oxygen therapy, Surgical intervention

Primary outcomes:
measure: Change in heart rate
timeFrame: immediately before and immediately after blood transfusion
measure: Change in respiratory rate
timeFrame: immediately before and immediately after blood transfusion
measure: Change in weight gain
timeFrame: within 4 days before and within 4 days after blood transfusion
measure: Change in hemoglobin
timeFrame: immediately before and immediately after blood transfusion
measure: Change in hematocrit value
timeFrame: immediately before and immediately after blood transfusion
Secondary outcomes:
measure: Acute blood loss
timeFrame: in the previous 24 hours before blood transfusion
measure: Mechanical ventilation
timeFrame: in the previous 24 hours before blood transfusion
measure: Supplemental oxygen
timeFrame: in the previous 24 hours before blood transfusion
measure: Doubling of oxygen requirements
timeFrame: in the previous 2 days before blood transfusion
measure: Tachycardia
timeFrame: in the previous 24 hours before blood transfusion
measure: Tachypnea
timeFrame: in the previous 24 hours before blood transfusion
measure: Poor weight gain
timeFrame: in the previous 4 days before blood transfusion
measure: Metabolic acidosis
timeFrame: in the previous 24 hours before blood transfusion
measure: Apnea and bradycardia
timeFrame: in the previous 24 hours before blood transfusion
measure: Length of stay in the NICU
timeFrame: from date of birth until the date of transfer to the "grower ward" or date of death from any cause, whichever came first, assessed up to 3 months.
measure: Length of stay in the hospital
timeFrame: from date of birth until the date of discharge home or date of death from any cause, whichever came first, assessed up to 3 months.
measure: Mortality
timeFrame: from the date of transfer to grower ward, assessed up to 3 months.
Other outcomes:
Locations:
Study officials:
affiliation: Kasralainy hospital, Faculty of medicine, Cairo University
name: Dahlia El Sebaie, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03183635: Rapid Movement Therapy for Stroke Rehabilitation
Official title: A Randomized Controlled Trial of Rapid Movement Therapy With Real-time Feedback to Improve Balance Recovery for Fall Prevention After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2017-06-12
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stroke survivors have higher risks of falling compared to other healthy non-stroke adults. Stroke patients' balance can be trained by Kinect-based training that enable user friendly and interactive training.


Eligibility criteria: Inclusion Criteria:

1. have single stroke with onset \>1 year,
2. have unilateral paresis,
3. are 50 years of age or older,
4. able to stand without aid for at least 15min,
5. have moderate level of motor impairment in the affective upper limb, i.e. 15≤ Fugl-Meyer Assessment for upper-extremity(FMA-UE) ≤ 45,
6. have some level of deficit in balance control, i.e. Berg Balance Scale(BBS)\< 52/56,
7. have a minimum Snellen visual acuity of 20/40 with/without spectacles,
8. have a minimum Mini-Mental-Status-Examination score of 22/30, and
9. have to be able to follow the training procedures.

Exclusion Criteria:

1. enrolled in other rehabilitation program in the study duration,
2. have other neurological conditions in addition to stroke (e.g. Parkinson's disease),
3. have unstable cardiovascular disease (e.g. history of heart disease, or poorly controlled hypertension, i.e. blood pressure \>160mmHg/100mmHg), or
4. have other serious diseases or conditions (e.g. osteoporosis, recent joint replacement surgery, amputation) that preclude them from participating in the study.

Primary outcomes:
measure: Berg Balance Scale (BBS)
timeFrame: 3-month follow-up
measure: Timed Up and Go (TUG)
timeFrame: 3-month follow-up
Secondary outcomes:
measure: Fugl-Meyer Assessment (FMA) of Motor Recovery after Stroke
timeFrame: 3-month follow-up
measure: Activities-specific Balance Confidence (ABC) Scale
timeFrame: 3-month follow-up
measure: Barthel Index of Activities of Daily Living
timeFrame: 3-month follow-up
measure: Electromyography (EMG)
timeFrame: 3-month follow-up
measure: "lean-and-release" postural system
timeFrame: 3-month follow-up
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Biomedical Engineering, The Chinese University of Hong Kong
Study officials:
affiliation: Department of Biomedical Engineering, CUHK
name: Raymond Kai-yu Tong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Junata M, Cheng KC, Man HS, Lai CW, Soo YO, Tong RK. Kinect-based rapid movement training to improve balance recovery for stroke fall prevention: a randomized controlled trial. J Neuroeng Rehabil. 2021 Oct 11;18(1):150. doi: 10.1186/s12984-021-00922-3.