louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04186702: New Concepts in Diabetic Macular Edema (DME)
Official title: New Concepts in Diabetic Macular Edema (DME) Ranibizumab and Focal/Direct Laser for Chronic Diabetic Macular Edema With Vision Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, With Complications
Keywords: macula-injection- laser- ranibizumab-edema-thickness
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-12-05
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: interventional model
Primary purpose: TREATMENT

Brief summary: Intravitreal ranibizumab injection procedure is simple and effective. In management of chronic DME there is no clear anatomical endpoint. Visual stability is the primary aim. Argon focal laser therapy can be the safe second choice. The combined therapy is successful and practical for chronic DME patients.

Detailed description: Settings and Design: Randomized clinical study

Subjects and Methods:

investigators randomly assigned 150 adults (the average age was 59.32 years ±2.79) with chronic diabetic macular edema involving the macular center for repeated ranibizumab injections (group A-75) or focal/direct argon laser after repeated ranibizumab injections (group B-75). The outcomes were the changes in visual acuity letter score and the central subfield thickness (CST) from baseline to one year. visual-acuity Letter score, and CST were analyzed with independent t-test and Mann Whitney-test. General linear model with multivariate analysis was used for visual acuity letter score, and CST in both groups.

Eligibility criteria: Inclusion Criteria:

* focal maculopathy
* diffuse macular edema
* diffuse macular edema with ischemic changes

Exclusion Criteria:

* ischemic maculopathy that was associated with grades of non-proliferative changes, or capillary drop out zones presented in the periphery of the macula
* patients with history of stroke or transient ischemic attack
* hypersensitivity to ranibizumab or any component of the ranibizumab formulation
* uncontrolled glaucoma in either eye (intraocular pressure \[IOP\] \>24 mmHg with medication)
* evidence of vitreomacular traction (in either eye)
* active proliferative diabetic retinopathy (study eye)

Primary outcomes:
measure: visual acuity letter score
timeFrame: one-year follow up
measure: central subfield thickness (CST)
timeFrame: one-year follow up
Secondary outcomes:
measure: patient compliant-complications
timeFrame: one-year follow up
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04422002: Survival Analysis of Frail Patients With Localised Colorectal Cancer
Official title: Survival Analysis of Frail Patients With Localised Colorectal Cancer: Multicentre Observational Study, Comparing Surgical vs Palliative Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Surgery
Frailty
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults with a recent diagnostic of localised colorectal cancer and a positive frailty screening

Brief summary: The purpose of this study is to analyse the survival of frail patients with localized colorectal cancer who undergo surgical treatment in comparison with those with palliative treatment

Detailed description: Patients with localized colorectal cancer will be visited by a colorectal surgeon who will explain the disease and the surgical treatment. In this visit the patient will be screened for frailty and asked for informed consent. Patients who meet the eligibility criteria will be sent to the internal medicine consultant to frailty evaluation, risk assessment and counselling in order to help patient decision process.

Eligibility criteria: Inclusion Criteria:

* Localised colorectal cancer
* Positive frailty screening

Exclusion Criteria:

* None

Primary outcomes:
measure: Survival
timeFrame: 1 year
Secondary outcomes:
measure: Surgical complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Corporacio Parc Tauli
state: Barcelona
Study officials:
References:
Clinical trial NCT01850602: A Phase III Study of PA21 in Hemodialysis Patients With Hyperphosphatemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hemodialysis
Hyperphosphatemia
Keywords: Hemodialysis
Hyperphosphatemia
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-05-09
Enrollment: 213
Sex: ALL
Minimum age (years): 20
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 PA21 in hemodialysis patients with hyperphosphatemia


Eligibility criteria: Inclusion Criteria:

* Patients age 20 or older, regardless of gender.
* Receiving stable maintenance hemodialysis 3 times a week.
* Patients not having changed their phosphate binder agent dose, for 4 weeks or more before their observation period start.

Exclusion Criteria:

* Patients having history of a pronounced brain / cardiovascular disorder.
* Patients having severe gastrointestinal disorders.
* Patients having severe hepatic disorders.

Primary outcomes:
measure: Adjusted Mean of Serum Phosphorus Concentrations at the End of Treatment
timeFrame: 12 weeks
Secondary outcomes:
measure: Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value)
timeFrame: 12 weeks
measure: Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value)
timeFrame: 12 weeks
measure: Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
Study officials:
References:
Clinical trial NCT02657902: Does an Additional Antirotation U-Blade (RC) Lagscrew Improve Treatment of AO/OTA (Orthopaedic Trauma Association) 31 A1-3 Fractures With Gamma 3 Nail?
Official title: Does an Additional Antirotation U-Blade (RC) Lagscrew Improve Treatment of AO/OTA (Orthopaedic Trauma Association) 31 A1-3 Classified Fractures With Gamma 3 Nail?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Fractures
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2016-01-18
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with OTA/AO 31A1-3 fractures treated with Gamma 3® Nail (Stryker Trauma Germany) and either with standard lagscrews or with the Gamma3 ® RC Lag Screw (Stryker Trauma Germany)

Brief summary: The purpose was to evaluate whether the additional use of the Gamma3 ® RC Lag Screw is associated with a reduced cutout rate in patients with OTA/AO 31A1-3 inter-trochanteric fractures.


Eligibility criteria: Inclusion Criteria:

* OTA/AO 31A1-3 fractures treated with Gamma 3® Nail (Stryker Trauma Germany) and either with standard lagscrews or with the Gamma3 ® RC Lag Screw (Stryker Trauma Germany)

Exclusion Criteria:

* Patients with pathological fractures
* Patients treated with a long gamma nail were excluded

Primary outcomes:
measure: Cutout rate
timeFrame: 3 months after intervention
Secondary outcomes:
measure: Mobility
timeFrame: 3 months after intervention
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04276402: Effect of Photobiomodulation by 808nm Diode Laser on the Stability of Orthodontic Mini-implants.
Official title: Effect of Photobiomodulation by 808nm Diode Laser on the Stability of Orthodontic Mini-implants: A Randomized Clinical Split-Mouth Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion, Angle Class II
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
First posted: 2020-02-19
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aimed to evaluate the influence of a 635nm diode laser on the stability of orthodontic mini-implants in vitro, as well as mini-implants failure rate (mini-implant loss) and patients pain level after the treatment. A randomized clinical split-mouth trial was concluded with 22 subjects (14 women, 8 men), 44 orthodontic mini-implants with a diameter 1.4mm and length of 10mm. Mini-implants were placed between teeth 3 and 4; and 13 and 14 (Universal Numbering System), in the area of the attached gingiva, 2 mm below mucogingival junction.


Eligibility criteria: Inclusion Criteria:

* patients with class II malocclusion defect requiring lateral maxillary teeth distillation based on the use of orthodontic mini-implant;
* the patients were treated first time using fixed orthodontic appliance;
* no systemic diseases;
* were not using anti-inflammatory drugs;

Exclusion Criteria:

* had used antibiotics in the previous 24 months;
* smokers;
* had history of radiotherapy,
* taking bisphosphonate medication

Primary outcomes:
measure: stability of orthodontic mini-implants
timeFrame: 60 days
Secondary outcomes:
measure: Pain level (NRS scale)
timeFrame: 24 hours
measure: mini-implants loss
timeFrame: 60 days
Other outcomes:
Locations:
city: Kościan
country: Poland
facility: Private Dental Healtcare
Study officials:
References:
Clinical trial NCT00327821: The Effectiveness of Commercial Weight Loss Programmes
Official title: A Randomised Control Trial of Commercial Weight Loss Programme in a Community Based Sample of Obese Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of Surrey
Sponsor class: OTHER
Collaborators: name: British Broadcasting Corporation
First posted: 2006-05-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The objective is to compare the effectiveness of 4 different commercial weight-loss diets available to adults in the UK.

This is achieved with a 6 month multi-centre randomised unblinded controlled trial of

* Dr Atkins' New Diet Revolution,
* The slimFast Plan,
* The weight Watchers Pure Points Programme,
* Rosemary Conley's "Eat Yourself Slim" Diet \& Fitness Plan.
* No diet (control)

Subjects are a community based sample of 300 (60 per group) otherwise healthy overweight and obese adults.

Main outcome measures are weight and body fat change over 6 months.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) \> 27 and \< 40 kg/m2.

Exclusion Criteria:

* History of coronary heart disease
* Type 1 or Type 2 diabetes
* Renal, liver or respiratory failure
* Gout
* Taking lipid lowering or anti-hypertensive drugs
* History of obesity with known cause (i.e. Cushings disease, hypothyroidism)
* Previous gastric or weight loss surgery
* Taking any weight loss drug (including Orlistat or Sibutramine)
* Clinical depression
* Eating disorders
* Drug or alcohol abuse
* Any malabsorptive state (including lactose intolerance)
* Being treated for a malignancy
* Being pregnant
* Breastfeeding

Primary outcomes:
measure: Weight loss
measure: Fat loss
Secondary outcomes:
Other outcomes:
Locations:
city: Guildford
country: United Kingdom
facility: University of Surrey
state: Surrey
Study officials:
affiliation: University of Surrey
name: D J Millward, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Surrey
name: H A Truby, PhD SRD
role: STUDY_DIRECTOR
References:
citation: Truby H, Baic S, deLooy A, Fox KR, Livingstone MB, Logan CM, Macdonald IA, Morgan LM, Taylor MA, Millward DJ. Randomised controlled trial of four commercial weight loss programmes in the UK: initial findings from the BBC "diet trials". BMJ. 2006 Jun 3;332(7553):1309-14. doi: 10.1136/bmj.38833.411204.80. Epub 2006 May 23.
citation: Truby H, Hiscutt R, Herriot AM, Stanley M, Delooy A, Fox KR, Baic S, Robson PJ, Macdonald I, Taylor MA, Ware R, Logan C, Livingstone M. Commercial weight loss diets meet nutrient requirements in free living adults over 8 weeks: a randomised controlled weight loss trial. Nutr J. 2008 Sep 2;7:25. doi: 10.1186/1475-2891-7-25.
Clinical trial NCT03164421: N-Acetylcysteine and L-carnitine in Pcos
Official title: N-Acetylcysteine Versus L-carnitine in Clomiphene Citrate Resistant Pcos Women. a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: PCOS
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2017-05-23
Enrollment: 164
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: N-Acetylcysteine and L-carnitine were used in pcos patients

Detailed description: N-Acetylcysteine was compared to L-carnitine in clomiphene citrate in Pcos women to detect the hormonal and metabolic effect

Eligibility criteria: Inclusion Criteria:

* pco
* infertile

Exclusion Criteria:

* no medical disorders
* no hormonal treatment in the previous 3 months

Primary outcomes:
measure: pregnancy rate
timeFrame: 3 momths
Secondary outcomes:
measure: ovulation rate
timeFrame: 3 momths
measure: abortion rate
timeFrame: 3 momths
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University
Study officials:
affiliation: FACULTY OF MEDICINE ,ZAGAZIG UNIVERSITY
name: ibrahim A EL sharkwy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: El Sharkwy IA, Abd El Aziz WM. Randomized controlled trial of N-acetylcysteine versus l-carnitine among women with clomiphene-citrate-resistant polycystic ovary syndrome. Int J Gynaecol Obstet. 2019 Oct;147(1):59-64. doi: 10.1002/ijgo.12902. Epub 2019 Jul 17.
Clinical trial NCT00593021: Diagnostic Evaluation of Obscure Gastrointestinal Bleeding
Official title: Diagnostic Evaluation of Obscure Gastrointestinal Bleeding
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Obscure Gastrointestinal Bleeding
Keywords: Obscure Gastrointestinal Bleeding
Occult Gastrointestinal Bleeding
Overt Gastrointestinal Bleeding
Capsule Endoscopy
CT Enterography
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2008-01-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults over the age of 18 and able to give consent who are referred to the Brigham and Women's Hospital Endoscopy Center or GI Clinic for the evaluation of obscure gastrointestinal bleeding

Brief summary: Up to 5% of patients with recurrent gastrointestinal (GI) bleeding remain undiagnosed by EGD and colonoscopy, the presumed source of bleeding in these patients being the small intestine. These patients fall under the category of "obscure gastrointestinal bleeding," and frequently require an extensive diagnostic work-up. For these reasons, most patients who present with obscure or occult gastrointestinal bleeding typically undergo multiple endoscopic evaluations, including capsule endoscopy and various radiologic imaging studies, including enteroclysis, small bowel series, CT scan, angiography, and radionuclide scan. Recently, many centers (included the Brigham and Women's Hospital) have begun using capsule endoscopy and CT enterography (CTE) for evaluation of suspected small bowel pathology. This is an observational study enrolling patients referred to the Brigham and Women's Hospital for obscure gastrointestinal bleeding designed to compare the diagnostic yield of various diagnostic modalities, in particular capsule endoscopy and CT enterography in the evaluation of obscure gastrointestinal bleeding.


Eligibility criteria: Inclusion Criteria:

* Anemia, hematochezia, melena, Hematemesis, heme positive stool with negative EGD+/-colonoscopy

Exclusion Criteria:

* Under the age of 18
* Unable to give consent
* IV Contrast Allergy (excluded from CT)
* Renal insufficiency (excluded from CT)
* Unable to swallow (excluded from capsule)
* Small bowel obstruction or stricturing disease (excluded from capsule)

Primary outcomes:
measure: Diagnostic yield of capsule endoscopy and CT Enterography in patients with obscure GI bleeding
timeFrame: Continuous
Secondary outcomes:
measure: Hospital course, clinical improvement
timeFrame: 120 days from enrollment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: John R Saltzman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03033121: Three-times-weekly Versus Daily Growth Hormone (GH) Treatment in naïve GH-deficient Children
Official title: More Favorable Metabolic Impact of Three-times-weekly Versus Daily Growth Hormone (GH) Treatment in naïve GH-deficient Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Growth Hormone Treatment
Keywords: growth hormone
children
metabolism
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2017-01-26
Enrollment: 32
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Growth hormone (GH) treatment in patients with GH deficiency (GHD) is commonly administered daily, although the pulsatile GH secretion is unlikely to be achieved and this regimen is often not complied. The auxological effect of three injections per week (TIW) regimen is controversial, while the metabolic effects were never evaluated in children. The objective of this study was to evaluate whether two different regimens of weekly injections could lead to similar auxological and metabolic effects in children with GHD.

Detailed description: Thirty-two children with growth hormone (GH) deficiency (25 males, mean age 10.5 ± 2.2 yr) were randomly assigned to receive daily (group A, No 16) or three injections per week (group B, No 16) GH therapy for 12 months.

Auxological parameters, insulin-like growth factor-I (IGF-I), glucose and insulin during an oral glucose tolerance test, glycosylated hemoglobin, lipid profile, the oral disposition index (DIo), the homeostasis model assessment estimate of insulin resistance (Homa-IR), the quantitative insulin sensitivity check index (QUICKI) and the insulin sensitivity index (ISI) were evaluated in the two groups of patients.

Eligibility criteria: Inclusion Criteria:

* Growth hormone deficiency clinically and biochemically demonstrated

Exclusion Criteria:

* Children affected by multiple pituitary hormone deficiency or receiving any other kind of hormonal replacement therapy or drug and GHD children with a shorter follow-up

Primary outcomes:
measure: height
timeFrame: 12 months
measure: weight
timeFrame: 12 months
measure: body mass index
timeFrame: 12 months
measure: Insulin growth factor-I
timeFrame: 12 months
measure: glucose
timeFrame: 12 months
measure: insulin
timeFrame: 12 months
measure: glycated hemoglobin
timeFrame: 12 months
measure: ISI Matsuda
timeFrame: 12 months
measure: Oral disposition index
timeFrame: 12 months
measure: Homa IR
timeFrame: 12 months
measure: LDL cholesterol
timeFrame: 12 months
measure: Triglycerides
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Endocrinology - University of Palermo
Study officials:
References:
citation: Ciresi A, Ciccio F, Radellini S, Guarnotta V, Calcaterra AM, Giordano C. More Favorable Metabolic Impact of Three-Times-Weekly versus Daily Growth Hormone Treatment in Naive GH-Deficient Children. Int J Endocrinol. 2017;2017:8469680. doi: 10.1155/2017/8469680. Epub 2017 May 28.
Clinical trial NCT04108221: Study Comparing Two Methods of TransversusAbdominis Plane
Official title: Randomised Study of Noninferiority Comparing a TransversusAbdominis Plane Block Surgical (c-TAP Block) to the Ultrasound-guided Abdominis Plane Block Transversus (Us-TAP Block) in Postoperative Analgesia After Laparoscopy or Laparotomy
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Institut Jean-Godinot
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two arms : arm A : c-TAP Block performed by surgeon arm B : us-TAP Block performed by anesthetist
Primary purpose: OTHER

Brief summary: Interventional, randomised, prospective, multicentric study

Detailed description: Interventional, randomised, prospective, multicentric and single blind study

Primary objective :

demonstrate the equivalence of c-TAP Block to us-TAP Block in postoperative analgesia

Secondary objective :

* Assess the effectiveness of c-TAP block on us-TAP Block in the obese and/or malnourished patient subgroup
* Compare the running time of the c-TAP Block to the us-TAP Block
* Assess the safety of the c-TAP Block gesture in terms of trauma to the intraperitoneal organs by the injection needle two groups:
* Arm A : c-TAP Block performed by the surgeon
* Arm B : us-TAP Block performed by the anesthesist under ultrasound control

Schedule :

* Inclusions start at: 16/09/2019
* End date of inclusions: 31/03/2022
* End date of follow-up: 01/04/2022
* Study report: 30/09/2022

Eligibility criteria: Inclusion Criteria:

Patient over 18 years old

* Patient undergoing laparoscopic or laparotomic abdominal surgery at the investigator hospital.
* Patient mastering the French language
* Patient who received informed information about the study and signed a consent
* Patient affiliated to a social security scheme.

Exclusion Criteria:

* Patients with chronic pain
* Patients with opioid dependence
* Patients allergic to local anesthetic
* Patient who has not signed the consent of the study.

Primary outcomes:
measure: Evolution pain intensity scores, assessed by the numerical pain scale (EN), postoperative and need for systemic analgesics (intravenously or by mouth) during the 24 hours following the end of the procedure
timeFrame: 24 hours
Secondary outcomes:
measure: Failure rate in the obese and / or malnourished patient subgroup
timeFrame: 24 hours
measure: Time in minutes of each of the TAP Block techniques
timeFrame: 24 hours
measure: Occurrence of trauma to the intra-abdominal organs caused by the injection needle
timeFrame: 24 hours
Other outcomes:
Locations:
city: Reims
country: France
facility: Institut Godinot
Study officials:
affiliation: Institut GODINOT
name: Jean Christophe EYMARD, PI
role: PRINCIPAL_INVESTIGATOR
References: