louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00690768: Pars Plana Vitrectomy (PPV) Versus Preoperative Intravitreal Bevacizumab Plus PPV to Treat Diabetic Tractional Retinal Detachment (IBETRA)
Official title: Pars Plana Vitrectomy (PPV) Versus Preoperative Intravitreal Bevacizumab Plus PPV for Diabetic Tractional Retinal Detachment (IBETRA Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Retinopathy
Retinal Detachment
Keywords: Diabetic Retinopathy
Retinal detachment
Vitreous Hemorrhage
Bevacizumab
preoperative
pars plana vitrectomy
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2008-06-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the amount of intraoperative intraocular bleeding during 23-gauge pars plana vitrectomy (PPV) for diabetic traction retinal detachment (TRD) with and without preoperative intravitreal bevacizumab treatment.


Eligibility criteria: Inclusion Criteria:

* Macular traction retinal detachment lasting three months or less secondary to diabetic retinopathy.

Exclusion Criteria:

* Massive vitreous hemorrhage preventing from detailed posterior pole examination;
* Previous intra-ocular surgery other than cataract surgery
* Hemodialysis, known bleeding disorders or use of anticoagulants drugs other than aspirin
* Prothrombin time, partial thromboplastin time or platelet count without normal limits
* History of previous thromboembolic events

Primary outcomes:
measure: amount of intraoperative intra-ocular bleeding
timeFrame: three weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP
state: São Paulo
Study officials:
References:
citation: da R Lucena D, Ribeiro JA, Costa RA, Barbosa JC, Scott IU, de Figueiredo-Pontes LL, Jorge R. Intraoperative bleeding during vitrectomy for diabetic tractional retinal detachment with versus without preoperative intravitreal bevacizumab (IBeTra study). Br J Ophthalmol. 2009 May;93(5):688-91. doi: 10.1136/bjo.2008.151233. Epub 2009 Feb 10.
Clinical trial NCT06700668: Active Knee Prosthesis Study
Official title: Active Knee Prosthesis Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Transfemoral Amputation
Lead sponsor: Massachusetts Institute of Technology
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research and Development Command
First posted: 2024-11-22
Enrollment: 7
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to investigate the clinical and functional outcomes of a powered knee prosthesis for people with a transfemoral amputation in the domain of gait, free space control, and embodiment


Eligibility criteria: Inclusion Criteria:

* Male or Female age 22-65.
* The patient must have a unilateral transfemoral amputation .
* The patient must have the ability to ambulate at variable cadence (an expected lower extremity prosthesis functional level of K3 or above).
* The patient must have adequate socket to support the device.

Exclusion Criteria:

* Women who are pregnant.
* Severe co morbidity, atypical skeletal anatomy, or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectancy, vulnerable patient population, BMI \>40, etc.).

Primary outcomes:
measure: Metabolic cost
timeFrame: An average of 2 sessions in the span of 1 week
Secondary outcomes:
measure: Ground reaction force
timeFrame: An average of 2 sessions in the span of 1 week
measure: Gait kinematics
timeFrame: An average of 2 sessions in the span of 1 week
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: MIT Media Lab
state: Massachusetts
Study officials:
affiliation: Massachusetts Institute of Technology
name: Hugh Herr, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00129168: Zosuquidar in Combination With Daunorubicin and Cytarabine in Patients Ages 55-75 With Newly Diagnosed Acute Myeloid Leukemia (AML)
Official title: An Open-Label, Phase I/II, Multicenter Dose Escalation Study of Zosuquidar, Daunorubicin, and Cytarabine in Patients Ages 55-75 With Newly Diagnosed Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Leukemia, Myeloid
Keywords: Leukemia, Myeloid
Relapse
Chemotherapy
Zosuquidar
Daunorubicin
Cytarabine
Acute
AML
Adult AML
Lead sponsor: Kanisa Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-08-11
Enrollment: 100
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Chemotherapy drugs use different ways to stop cancer cells from dividing so they stop growing or die. Zosuquidar may help daunorubicin and cytarabine kill more cancer cells by making cancer cells more sensitive to the drugs. It is not yet known whether daunorubicin and cytarabine are more effective with or without zosuquidar in treating acute myeloid leukemia.

Detailed description: Purpose:

Phase I:

To Evaluate the safety of different doses of zosuquidar.

Phase II:

This study is designed to study the safety and effectiveness of zosuquidar when given with daunorubicin and cytarabine in newly diagnosed AML patients.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed acute myeloid leukemia
* Ages 55-75 years

Exclusion Criteria:

* Acute promyelocytic leukemia (FAB M3)
* Patients must not have received prior chemotherapy for AML.
* Prior exposure to anthracycline
* Use of any investigational agent within 4 weeks prior to enrollment into the study

For Phase II:

* Patients must be P-glycoprotein positive

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05713968: Swallowing Evaluation by HRIM in Patients With Cervical Spondylosis
Official title: Using High Resolution Impedance Manometry and Videofluoroscopic Measurements of Swallowing Function in Patients Undergoing Cervical Spine Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Upper Esophageal Sphincter Relaxing Pressure
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cervical spondylolysis patients with swallowing difficulty feelings could attend this study. The researchers will hope to help these patients to find the dysphagia mechanisms. If they have to receive early swallowing rehabilitation, we could transfer them and give the rehabilitation physicians advices.

Brief summary: patients with cervical spondylolysis may have swallowing or eating difficulty. In this study, we will use high resolution impedance manometry to evaluate these patients' detailed swallowing mechanisms.

Detailed description: This study will aim to evaluate swallowing function in patients with cervical spondylolysis by using high resolution impedance manometry (HRIM) along with oral frailty and dysphagia questionnaires. Researchers will plan to enroll 50 patients to investigate this issue. The inclusion criteria will be as following:1) age higher or equal to 20 years old; 2) patients with cervical spondylolysis or associated symptoms. The exclusion criteria will be as following: major organ dysfunction, including chronic kidney disease, bleeding tendency. The primary outcome will be the upper esophageal sphincter relaxing pressure. The researchers will hope to find the swallowing dysfunction mechanisms in these patients.

Eligibility criteria: Inclusion Criteria:

* patients with cervical spondylosis associated symptoms or expected to undergo cervical spine surgery
* patients with associated swallowing difficulty symptoms

Exclusion Criteria:

* major organ dysfunction, such as renal insufficiency or bleeding tendency

Primary outcomes:
measure: upper esophageal sphincter pressure
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06839768: Safety and Efficacy of MILEP Versus Standard EEP
Official title: The MILES Trial: Prospective Randomized Trial of Safety and Efficacy of Minimally-invasive Versus Standard Laser Enucleation of the Prostate
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Benign Prostate Hypertrophy(BPH)
LUTS(Lower Urinary Tract Symptoms)
Lead sponsor: Sechenov University
Sponsor class: OTHER
Collaborators: name: Hospital Pompeia
First posted: 2025-02-21
Enrollment: 340
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Endoscopic enucleation of the prostate (EEP) is a standard treatment for benign prostatic hyperplasia (BPH), with modifications such as MiLEP that utilizes smaller instruments. The reduced resectoscope diameter in MiLEP may help decrease rates of stress urinary incontinence (SUI) and urethral strictures.

Objective: to compare the efficacy and safety of MiLEP and standard EEP with a thulium fiber laser (TFL).


Eligibility criteria: Inclusion Criteria:

LUTS presence, proven by:

1. IPSS questionnaire (Score \>20);
2. OR uroflowmetry result (Qmax \<10 ml/s);

Exclusion Criteria:

* Prostate volume \> 120 cc
* Prostate cancer on pathology;
* Urethral strictures;
* Bladder calculi;
* Prior prostate surgery;
* Neurogenic bladder dysfunction.

Primary outcomes:
measure: The rate of SUI
timeFrame: 1 month
Secondary outcomes:
measure: Rate of urethral strictures
timeFrame: 6-12 months
measure: Rate of intra- and perioperative adverse events
timeFrame: the day of operation, at 1, 6,12 months post-operative
measure: Operative time
timeFrame: participants will be followed for the duration of the intervention, an expected average of 1 hour
measure: Blood loss (blood levels of haemoglobin and haematocrit)
timeFrame: 1 day before and 1 day after surgery
measure: Catheterization time
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 1,5 days
measure: Hospital stay
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 1,5 days
measure: International Prostate Symptom Score (IPSS)
timeFrame: 1 month
measure: Qmax
timeFrame: 1 month
measure: PVR
timeFrame: 1 month
measure: International Index of Erectile Function (IIEF-5)
timeFrame: 1 month
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Institute for Urology and Reproductive Health, Sechenov University
Study officials:
References:
Clinical trial NCT02089568: Prophylaxis Of Wound Infections- Antibiotics in Renal Donation
Official title: Are Prophylactic Antibiotics Necessary Before Laparoscopic Living Kidney Donation? A Double Blind, Randomised, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infection
Keywords: Living donation
Antibiotics
Laparoscopic surgery
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
First posted: 2014-03-18
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to see whether antibiotics given at the start of laparoscopic kidney donation surgery prevent infection.

Detailed description: Subjects undergoing laparoscopic donor nephrectomy will be randomised to either a single dose of intravenous co-amoxiclav or placebo prior to surgery. Outcome measures include any infections, length of stay and costs

Eligibility criteria: Inclusion Criteria:

* All adult patients (over 18 years) undergoing hand-assisted laparoscopic donor nephrectomy, who have given written informed consent, will be included.
* Patients whose first language is not English will be included; they comprise a significant part of our patient population and we will use translation services as is our normal practice.
* Women of child-bearing age taking adequate contraception will be included.

Exclusion Criteria:

* Patients with a known allergy to penicillin or other antibiotics.
* Patients with MRSA colonisation.
* Participation in another investigational study within the previous 90 days.
* Pregnant or breast-feeding women.

Primary outcomes:
measure: Rate of infection after surgery
timeFrame: 24 months
Secondary outcomes:
measure: Ultrasonic evidence of wound healing
timeFrame: 24 months
measure: Length of hospital stay
timeFrame: 24 months
measure: Readmission rates
timeFrame: 24 months
measure: Antibiotic associated side effects
timeFrame: 24 months
measure: Return to work and normal activities
timeFrame: 24 months
measure: Quality of life
timeFrame: 24 months
measure: Relative costs
timeFrame: 24 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
Study officials:
affiliation: Guy's and St Thomas' NHS Foundation Trust
name: Nizam Mamode
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04194268: Pancreatic Cancer and Carbon Ion Radiotherapy
Official title: Pancreatic Cancer and Carbon Ion Radiotherapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pancreatic Cancer
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2019-12-11
Enrollment: 25
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: Irradiation of non-operable pancreatic cancer with carbon ions (C12). This therapy is expected to be more effective than the current Gold Standard of photon irradiation applied in the case of non-operable pancreatic cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed, inoperable primary or local recurrent pancreatic cancer
* Written informed consent (must be available before enrollment in the trial)
* Karnofsky performance score \> 60 or ECOG-status 0/1 (at least: patient should be able to take care of himself, although daily-life activity or work is not possible)
* Age ≥ 18 years

Exclusion Criteria:

* No clear difference between tumor edge and upper gastrointestinal tract in baseline imaging
* Extensive lymphatic metastases
* Disability of subject to understand character and individual consequences of the clinical trial
* Distant metastases
* Previous radiotherapy of the upper abdomen
* Active medical implants (e.g. pacemaker, defibrillator), contradicting radiotherapy at HIT
* Participation in another clinical study or observation period of competing trials, respectively

Primary outcomes:
measure: survival
timeFrame: 12 month after radiation
Secondary outcomes:
measure: toxicity outcomes
timeFrame: 48 Month after radiatoin
measure: survival
timeFrame: 12 month after radiation
measure: Blood Parameters Ca 19-9
timeFrame: 48 Month after radiation
measure: Blood Parameters CEA
timeFrame: 48 Month after radiation
measure: Quality of life (QLQ) EORTC QLQ C30
timeFrame: 48 Month after radiation
measure: Quality of life EORTC QLQ Pan26
timeFrame: 48 Month after radiation
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hopsital Heidelberg
Study officials:
References:
citation: Liermann J, Naumann P, Hommertgen A, Pohl M, Kieser M, Debus J, Herfarth K. Carbon ion radiotherapy as definitive treatment in non-metastasized pancreatic cancer: study protocol of the prospective phase II PACK-study. BMC Cancer. 2020 Oct 1;20(1):947. doi: 10.1186/s12885-020-07434-8.
Clinical trial NCT00707668: Chung-ju Metabolic Disease Cohort (CMC) Study
Official title: Chung-ju Metabolic Disease Cohort (CMC) Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metabolic Diseases
Keywords: Diabetes
metabolic syndrome
dyslipidemia
osteoporosis
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2008-07-01
Enrollment: 10000
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults over 30 years of age living in Chung-ju city

Brief summary: This is an observational study on the prevalence and incidence of diabetes and osteoporosis in a rural area of Korea.

Detailed description: Diabetes, metabolic syndrome and dyslipidemia are common and rapidly increasing in Asia. Our group constructed a cohort in Chung-ju city, a rural area in Korea, to observe the prevalence of metabolic diseases and its risk factors since 2003. About 12,000 subjects participated in this cohort study till 2006. Now, we are planning to follow-up these subjects and provide health examinations from May, 2007 to Feb, 2011. The prevalence and incidence of metabolic diseases including diabetes, hypertension, metabolic syndrome, dislipidemia and osteoporosis will be observed.

Eligibility criteria: Inclusion Criteria:

* Adults over 30 years of age living in Chung-ju city (who participated in 2003-2006 cohort study)

Exclusion Criteria:

* age under 30
* subjects with known diabetes

Primary outcomes:
measure: The incidence of diabetes
timeFrame: 4 years
Secondary outcomes:
measure: The prevalence of metabolic syndrome, dyslipidemia and osteoporosis
timeFrame: 4 years
measure: Insulin sensitivity and resistance of Korean subjects
timeFrame: 4 years
Other outcomes:
Locations:
city: Chung-ju
country: Korea, Republic of
facility: Chung-ju health care center
state: Chungchungbook-do
Study officials:
affiliation: Kangnam St.Mary's hospital
name: Kun-Ho Yoon, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
citation: Kwon HS, Park YM, Lee HJ, Lee JH, Choi YH, Ko SH, Lee JM, Kim SR, Kang SY, Lee WC, Ahn MS, Noh JH, Kang JM, Kim DS, Yoon KH, Cha BY, Lee KW, Kang SK, Son HY. Prevalence and clinical characteristics of the metabolic syndrome in middle-aged Korean adults. Korean J Intern Med. 2005 Dec;20(4):310-6. doi: 10.3904/kjim.2005.20.4.310.
Clinical trial NCT02216968: Increasing Vegetable Intake in Children
Official title: Increasing Vegetable Intake in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Behavior
Food Habits
Keywords: vegetables
Head Start
preschool
children
theater
puppet
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2014-08-15
Enrollment: 600
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to test the feasibility of an innovative approach to increase the amount of vegetable's (V) intake consumed by preschool children who are predominately African-American (AA) and Hispanic-American (HA).

Detailed description: The purpose of this study is to test the feasibility of an innovative approach to increase the amount of vegetable's (V) intake consumed by preschool children who are predominately African-American (AA) and Hispanic-American (HA).The primary endpoint will be changes in V consumption in high school children with the hypothesis that a puppet intervention will increase their V consumption by preschool children. To achieve the project goal, our specific aims (SA) are to: SA1: Successfully recruit 6 preschool (PS) centers and 168 AA and 168 HA children 3 to 5 y enrolled there. SA2: Conduct individual interviews for formative assessment of the PUPPET shows. SA3: Develop the manual of operation and intervention protocols SA4: Develop 4 videotaped theatre-based PUPPET shows that are developmentally and cognitively appropriate for use with 3- to 5-year-old AA and HA children SA5: Pilot-test the feasibility of the PUPPET intervention with 3 intervention and 3 control HS centers. SA6: Use the data collected in Aim 5 to estimate parameters required to conduct a group randomized trial for an evaluation of the efficacy of the intervention. The primary hypothesis (H1) to be tested is that children who receive the PUPPET intervention will demonstrate increased V consumption in HS compared to children in the control group.

Eligibility criteria: Inclusion Criteria:

* Healthy
* non-patient
* normals
* African-american
* Hispanic-american
* 3 to 5 y olds

Exclusion Criteria:

* pregnant woman
* neonates
* dietary restrictions
* chronic disease
* developmental disabilities
* special education
* does not read or write in spanish or english

Primary outcomes:
measure: Vegetable Intake in Preschool Children
timeFrame: 1 year 11 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Theresa A Nicklas, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nicklas T, Lopez S, Liu Y, Saab R, Reiher R. Motivational theater to increase consumption of vegetable dishes by preschool children. Int J Behav Nutr Phys Act. 2017 Feb 7;14(1):16. doi: 10.1186/s12966-017-0468-0.