louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00880984: Compression Anastomosis Using the Compression Anastomosis Ring (CAR™ 27)
Official title: Compression Anastomosis Using the CAR™ 27
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Surgery
Keywords: Colon Anastomosis
Rectum Anastomosis
Intestine
Colorectal Surgery
Colorectal Anastomosis
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
Collaborators: name: novoGI
First posted: 2009-04-14
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Purpose:

Evaluation of the CAR™ 27 for the creation of compression anastomoses.

Indication:

Compression Anastomosis Ring (CAR™ 27) device for creation of circular anastomoses during colonic or colorectal resection.

Study Design:

Prospective, open labeled study.

Patient Population:

Male or female subjects 18 years of age or older who are scheduled for non emergency laparoscopic or open colonic or colorectal resections. A temporary loop ileostomy/colostomy can be preformed up to the discretion of the surgeon.

No. of Subjects:

15 patients estimated up to three months to enroll.

Duration of Treatment:

During the operation - creation of the anastomosis.

Duration of Follow-up:

Follow-up evaluation will be performed daily while hospitalized, during a post-op clinic visit at approximately 1 month (30 days ± 5 days) including a proctoscopic exam and by phone after 3 months.

Endpoints:

To evaluate the creation of a safe and functioning anastomosis and the occurrence of adverse events related to the use of the CAR™ 27 device.


Eligibility criteria: Inclusion Criteria:

1. Patient is over 18 years old.
2. Patient is scheduled for a non-emergency procedure.
3. Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures.

Exclusion Criteria:

1. Patient has an allergy to nickel.
2. Patient has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis or extensively spread inflammatory bowel disease.
3. Patient is participating in another clinical trial which may affect this study's outcomes.
4. Patient has been taking regular steroid medication.
5. Patient has contraindications to general anesthesia.
6. Patient has preexisting sphincter problems or evidence of extensive local disease in the pelvis.

Primary outcomes:
measure: Complications during and post procedure including leaks, bleeding, strictures, device failure, re admission, re operation, extra colonic complications etc
timeFrame: 3-months
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: AHEPA University Hospital of Thessaloniki
Study officials:
affiliation: AHEPA University Hospital of Thessaloniki
name: Spiros Papavramidis, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03683784: Type 2 Diabetes in Fayoum
Official title: Prevalence of Type 2 Diabetes in Fayoum Governorate
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 3500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: obese persons,dyslipidemics ,apparently healthy individuals

Brief summary: study the prevalence of type II diabetes mellitus, prevalence of newly diagnosed type II diabetic patients

Detailed description: study the prevalence of type II diabetes mellitus, prevalence of newly diagnosed type II diabetic patients, status of glycemic control and associated risk factors and complications of diabetes among population of Fayoum governorate

Eligibility criteria: Inclusion Criteria:

* community sample as obese persons,family history of diabetes,diabetics,hypertensives,dyslipidemics

Exclusion Criteria:

* subjects known to have:chronic liver disease,CKD,Cushing

Primary outcomes:
measure: Prevalence of diabetes in Fayoum
timeFrame: 11 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fayoum University
name: Ahmed A Hammad, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00370084: Itopride Hydrochloride in Diabetes: Effects on Gastric Emptying and Glycemia
Official title: Effects of Itopride Hydrochloride on Gastric Emptying, Glycaemia and "Meal-related" Symptoms in Patients With Type 1 and Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Gastroparesis
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2006-08-30
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Itopride is a new compound that is already marketed in Japan and in some countries of Eastern Europe under the name of Ganaton. It is used to treat symptoms associated with gastroparesis. Due to inadequate gastric emptying, these patients often have symptoms of bloating, nausea and vomiting following ingestion of a meal. The goal of this study is to evaluate the effects of Itopride on gastric motor function and glycemia in patients with diabetes.

Detailed description: This is a mechanistic study evaluating in a cross-over design the effects of Itopride hydrochloride.

The primary objective of this study is to evaluate the acute effects of itopride hydrochloride (200 mg three times daily) on gastric emptying of solid and liquid meal components in patients with type 1 and type 2 diabetes mellitus. Secondary objectives are to evaluate the effects of itopride hydrochloride on the glycaemic response to a meal, "meal-related" upper gastrointestinal symptoms and intragastric meal distribution.

Eligibility criteria: Inclusion Criteria:

* Type-1 and Type-2 diabetic patients
* 18 to 65 years old
* Glycated haemoglobin level (HbA1c) below 9%
* Body mass index (BMI) between 18 and 35 kg/m2

Exclusion Criteria:

* Use of medications potentially influencing upper gastrointestinal motility or appetite within one week of the study (e.g. prokinetic drugs, macrolide antibiotics)
* Exposure to radiation for research purposes during the previous 12 months

Primary outcomes:
measure: Gastric emptying assessment
timeFrame: weekly
Secondary outcomes:
measure: Glycemia, relief of upper gastrointestinal symptoms, intragastric meal distribution
timeFrame: weekly
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: University of Adelaide, Department of Medicine
state: South Australia
Study officials:
affiliation: Royal Adelaide Hospital
name: Michael Horowitz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04049084: An Observational LTFU Study for Patients Previously Treated With Autologous ex Vivo Gene Therapy for ADA-SCID
Official title: An Observational Long-term Follow-up Study for Patients Previously Treated With Autologous ex Vivo Gene Therapy for Severe Combined Immunodeficiency Due to Adenosine Deaminase Deficiency (ADA-SCID)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Adenosine Deaminase Deficiency
Severe Combined Immunodeficiency (SCID)
Keywords: OTL-101
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Great Ormond Street Hospital for Children NHS Foundation Trust
First posted: 2019-08-07
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This observational LTFU study is open for enrollment to ADA-SCID patients previously treated with autologous ex vivo gene therapy products based on the EFS-ADA lentiviral vector as part of the OTL-101 clinical development program. Patients treated in clinical trials as part of IND #15440, study OTL-101-5 (EudraCT No 2017-001275-23) or study 10-MI-29 (EudraCT No 2010-024253-36), as well as in Expanded Access or Compassionate Use Programs, will be eligible for enrollment.

Brief summary: This observational long-term follow-up study is designed to collect safety and efficacy data from ADA-SCID patients previously treated with autologous ex vivo gene therapy products based on the EFS-ADA LV encoding for human adenosine deaminase (ADA) gene (EFS-ADA LV), as part of the OTL-101 clinical development program. No investigational medicinal product will be administered to these patients as part of the OTL-101-6 study.


Eligibility criteria: Inclusion Criteria:

A patient is eligible for enrollment in the study if all of the following criteria are met:

1. the patient has been treated with an autologous ex vivo gene therapy product based on the EFS-ADA LV, as part of the OTL-101 clinical development program;
2. the patient displays persistent detectable gene marking, as determined by the Investigator;
3. the patient or, if applicable, the patient's parent(s)/legal guardian(s), are able and willing to provide informed consent.

Exclusion Criteria:

* There are no exclusion criteria for participation in this observational LTFU study.

Primary outcomes:
measure: Overall Survival
timeFrame: 15 years post-treatment
measure: Event-Free Survival
timeFrame: 15 years post-treatment
measure: Incidence of Adverse Events
timeFrame: 15 years post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Mattel Children's Hospital UCLA/Ronald Reagan UCLA Medical Center
state: California
city: London
country: United Kingdom
facility: UCL Great Ormond Street Institute of Child Health
Study officials:
affiliation: Orchard Therapeutics
name: Orchard Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05337384: Sonographic Venous Doppler Imaging in End-Stage Renal Disease
Official title: The Value of Venous Doppler Imaging in Predicting the Indication of Emergency Dialysis in Patients With End-Stage Renal Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergent Dialysis
Venous Doppler Ultrasound
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Emergency department patients with end-stage renal disease

Brief summary: Patients with end-stage renal disease (ESRD) may visit to emergency services for urgent hemodialysis or other reasons. Hemodialysis application in emergency conditions is generally not as optimal as in dialysis units. It takes time to provide suitable conditions (personnel and equipment), the length of stay of patients in the emergency services is prolonged, and this may cause disruption of patient care in these areas where rapid patient care is provided. Therefore, the management of ESRD patients continues to be one of the serious problems faced by emergency physicians.

Sonographic evaluation of the venous system (vena cava inferior, hepatic, portal and renal vein) may be an alternative diagnostic method for need for urgent hemodialysis. Hereby, patients who don't need hemodialysis safely can be discharged from emergency services. Studies conducted so far have generally been based on predicting cardiorenal AKI and renal poor outcomes and have been designed in general ICU conditions.

In this study, the researchers aimed to determine the diagnostic value of sonographic venous Doppler imaging the need for urgent hemodialysis in ESRD patients in the emergency services.


Eligibility criteria: Inclusion Criteria:

* Patients with end-stage renal disease

Exclusion Criteria:

* Who are pregnant,
* With cirrhosis and liver malignancy,
* Who do not give consent for the study,
* Arrest presentation
* Unable to scan in the first six hours

Primary outcomes:
measure: The diagnostic accuracy of sonographic venous Doppler imaging for the need for urgent hemodialysis
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Faculty of Medicine
Study officials:
References:
Clinical trial NCT00405184: Ig NextGen 10% in Patients With Primary Immune Deficiency (PID)
Official title: A Multi-centre, Open-label, Cross-over Study to Compare the Pharmacokinetics, Safety and Tolerability of Ig NextGen 10% With Intragam P in Patients With Primary Immune Deficiency (PID)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Immune Deficiency (PID)
Keywords: PID
IVIg
IntragamP
Lead sponsor: CSL Limited
Sponsor class: INDUSTRY
First posted: 2006-11-29
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to assess the safety, tolerability and pharmacokinetics of Ig NextGen 10% in patients with primary immune deficiency currently being treated with Intragam P. Eligible patients will switch from 3 to 4 weekly intravenous Intragam P therapy to receive seven cycles of Ig NextGen 10% treatment administered intravenously at three- to four-weekly intervals. Patients will be monitored on the study for up to 36 weeks.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of PID
* = or \>6 month use of Intragam P at three- or four-weekly intervals
* = or \>6 month history of IgG trough levels of ≥ 5 g/L

Exclusion Criteria:

* Newly diagnosed PID within six months prior to Screening
* Known selective IgA deficiency or antibodies to IgA
* Immunosuppressive treatment other than topical and/ or inhaled steroids and/ or low dose oral steroids
* Protein-losing enteropathies, or kidney diseases
* History of malignancies of lymphoid cells
* Any of the following laboratory results at Screening:
* Serum Creatinine \> 1.5 times the upper normal limit (UNL)
* AST or ALT concentration \> 2.5 times the UNL
* Albumin \< 25 g/L

Primary outcomes:
measure: IgG Trough Pharmacokinetics
timeFrame: one month
Secondary outcomes:
measure: Safety and tolerability, Pharmacokinetics
timeFrame: 9 months
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Melbourne
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
Study officials:
affiliation: Melbourne Health
name: Karl Bleasel, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bleasel K, Heddle R, Hissaria P, Stirling R, Stone C, Maher D. Pharmacokinetics and safety of Intragam 10 NF, the next generation 10% liquid intravenous immunoglobulin, in patients with primary antibody deficiencies. Intern Med J. 2012 Mar;42(3):252-9. doi: 10.1111/j.1445-5994.2011.02712.x.
Clinical trial NCT00789984: Corneal Specular Microscopy in Infectious and Noninfectious Uveitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uveitis
Keywords: Keratic precipitates
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2008-11-13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with infectious and noninfectious uveitis who were attended at local ophthalmology center.

Brief summary: The purpose of this study is to determine whether some endothelium morphologic variables are different between infectious and noninfectious uveitis group using a noncontact specular microscopy device.


Eligibility criteria: Inclusion Criteria:

* Patients with infectious and noninfectious uveitis in any activity level and presence of keratic precipitates.

Exclusion Criteria:

* Patients with previous ocular surgery, trauma, contact lens history, corneal dystrophy, corneal edema and high intraocular pressure
* Any other anterior segment disorders affecting the corneal endothelium.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Federal University of Sao Paulo
state: SP
Study officials:
References:
citation: Oliveira Fd, Oliveira Motta AC, Muccioli C. Corneal specular microscopy in infectious and noninfectious uveitis. Arq Bras Oftalmol. 2009 Jul-Aug;72(4):457-61. doi: 10.1590/s0004-27492009000400006.
Clinical trial NCT04195984: Mi-thos® Transcatheter Mitral Valve Replacement Study
Official title: Evaluation of the Efficacy and Safety of the Mi-thos® Transcatheter Mitral Valve Replacement System in Patients with Severe Mitral Valve Disease At High Surgical Risk.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mitral Valve Regurgitation
Lead sponsor: Shanghai NewMed Medical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-12-12
Enrollment: 122
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and performance of the Mi-thos® Mitral Heart Valve with the Mi-thos® Transcatheter Delivery System.

Detailed description: The Mi-thos® study is an multicenter, single-arm, prospective, safety and performance clinical study.

Eligibility criteria: Inclusion Criteria:

* Severe mitral valve regurgitation ≥ 3+;
* High surgical risk fot open mitral valve surgery;
* Age ≥ 65 years old;
* Life expectancy \> 12 months;
* As assessed by multidisciplinary cardiac team, patients who are not eligible for surgery;
* Patients sign an informed consent form.

Exclusion Criteria:

* Previous cardiac mitral valve surgery;
* Active infections requiring antibiotic therapy;
* Clinically significant untreated Coronary Artery Disease (CAD);
* Pulmonary hypertension （Pulmonary systolic pressure \> 70 mmHg）;
* Patients with severe right heart failure;
* Left ventricular ejection fraction \<25%;
* Diagnosis of hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis;
* Dialysis patient;
* Patients with severe coagulopathy;
* Patients with contraindications to anticoagulant drugs;
* Patients with stroke or transient ischemic within 30 days;
* Echocardiography found any intracardiac mass, left ventricle or atrial thrombus;
* Patients who require surgery or interventional therapy for other valvular lesions;
* Patients with severe macrovascular disease requiring surgical treatment;
* Patients with more than 70% of carotid stenosis;
* To be allergic to contrast agents, nickel-titanium memory alloys or bovine-derived products;
* Patients with severe neurological disorders affecting cognitive ability;
* Patients with severe thoracic deformities.

Primary outcomes:
measure: Freedom from all-cause mortality
timeFrame: 1 year
Secondary outcomes:
measure: Freedom from all-cause mortality
timeFrame: 30 days, 6months, 2-5 years
measure: Severe adverse event rate
timeFrame: 30 days, 6months, 1 year, 2-5 years
measure: NYHA Heart Function Rating
timeFrame: 30 days, 6months, 1 year, 2-5 years
measure: Kansas City Cardiomyopathy score
timeFrame: 30 days, 6months, 1 year, 2-5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai hospital
state: Beijing
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
city: Xi'an
country: China
facility: Xijing hospital
state: Shanxi
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Wang chunsheng, Chief
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00331084: Efficacy/Safety of Antibiotic Steroid Combination in Prevention of Postoperative Inflammation in Cataract Surgery
Official title: Efficacy of Antibiotic Steroid Combination Compared With Individual Administration in Prevention of Postoperative Inflammation in Patients Having Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation Following Cataract Surgery
Keywords: prevention of post inflammation in cataract surgery
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2006-05-29
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having cataract surgery

Detailed description: Study of 15 +-1 day, double-masked, randomized, two arms, parallel groups to confirm the efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having cataract surgery

Eligibility criteria: Inclusion Criteria:

* patients having cataract surgery

Exclusion Criteria:

* Uncontrolled glaucoma or intraocular hypertension;
* Use of any ocular anti-infectious drugs or any topical or systemic ocular NSAIDs during the study but study drugs;
* A history of chronic or recurrent ocular inflammatory disease;
* Uncontrolled diabetes mellitus and diabetic retinopathy ;
* Patients with sight in a single eye;
* Iris atrophy in the eye to be operated;
* Pregnant or lactating women, or women of childbearing potential who are not using proper birth-control methods;
* Known or suspected allergy or hypersensitivity to any component of study medication;
* A history or any other evidence of severe systemic disease

Primary outcomes:
measure: day 15 evaluation of anterior chamber
timeFrame: 15 days pos-op
Secondary outcomes:
measure: day 15 evaluation of ocular pain, physician´s follow-up impression of inflammatory reaction score
timeFrame: 15 days pos-op
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Dept of Opthalmology - Rua Botucatu 824
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Rubens Belfort Jr, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: