louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01685853: Bowel Cleansing for Colonoscopy: Comparison Between a Same Day Low-Volume Preparation and a Conventional 4L Split One
Official title: Bowel Cleansing for Colonoscopy: Comparison Between a Same Day Low-Volume Preparation and a Conventional 4L Split One. A Randomized, Observer-blind, Parallel Group, Comparative Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colonoscopy
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2012-09-14
Enrollment: 164
Sex: ALL
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: The present study is intended to evaluate the effectiveness, tolerability, compliance, and feasibility of the low volume bowel preparation, bisacodyl tablets followed by 2L Polyethylene glycol (PEG) with citrate and simethicone (CS) given the same day of colonoscopy, vs the standard 4L split PEG solution.

Detailed description: Eligible patients will be informed about the aims, procedures, benefits and possible risks of the study prior to sign the informed consent form from day -30 to day-3. They will provide medical history and undergo a physical examination. Patients will be evaluated by a Physician other than the blind Endoscopist. The same responsible person will instruct the patients about administration procedures in both oral and written form. The patients will be assigned to receive one of the dosing schedule bowel preparation according to a computer generated block-randomisation list. Patients will take the study treatment at home according to the given instructions. Patients will return to the clinic for colonoscopy. The colonoscopy will be performed by an Endoscopist who will be unaware of the bowel dose-regimen preparation taken by the patient. Completed colonoscopic exam will be performed with time recorded (intubation and withdrawal from ceacum). The unblind Investigator will ask the patients about safety, tolerability, overall acceptance and compliance.

Eligibility criteria: Inclusion Criteria:

* Out-patients undergoing a complete colonoscopy
* Patient written informed consent

Exclusion Criteria:

* Pregnant or lactating women or at a risk of becoming pregnant
* Known or suspected gastrointestinal obstruction or perforation; toxic megacolon; major colonic resection Known or suspected hypersensitivity to the active principle and/or formulations' ingredients

Primary outcomes:
measure: Efficacy
timeFrame: 20 min
Secondary outcomes:
measure: Efficacy
timeFrame: 20 min
measure: Efficacy
timeFrame: 20 min
measure: Safety
timeFrame: 24 hours
measure: Tolerability
timeFrame: 24 hours
measure: Acceptability
timeFrame: 24 hours
measure: Compliance
timeFrame: 24 hours
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: European Institute of Oncology
name: Cristiano Crosta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04007653: Long-term Outcome After Edoxaban Versus Vitamin K Antagonists for Acute VTE
Official title: Long-term Outcome After Edoxaban Versus Vitamin K Antagonists for Acute VTE
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Venous Thromboembolic Disease
Post Thrombotic Syndrome
Chronic Thromboembolic Pulmonary Hypertension
Quality of Life
Keywords: Post thrombotic syndrome
Edoxaban
Vitamin K antagonist
Chronic Thromboembolic Pulmonary Hypertension
Quality of Life
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 1200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who were included in the HOKUSAI VTE trial for treatment of their DVT or PE.

Brief summary: The HOKUSAI post VTE study contains of two different research questions; one on the long term outcomes of deep vein thrombosis and one on the long term effects of pulmonary embolism, post thrombotic syndrome (PTS) and chronic thromboembolic pulmonary hypertension (CTEPH) respectively. Our aim of the study is to compare the long term outcomes along with the quality of life assessment of VTE in a group treated with heparin+VKA versus a group treated with heparin+edoxaban in the acute setting.


Eligibility criteria: Inclusion Criteria:

* Participant in the HOKUSAI VTE trial

Exclusion Criteria:

* None

Primary outcomes:
measure: Post thrombotic syndrome (PTS)
timeFrame: up to 10 years
Secondary outcomes:
measure: Chronic thromboembolic pulmonary hypertension (CTEPH)
timeFrame: up to 10 years
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
Study officials:
References:
Clinical trial NCT06614153: Pharmacokinetics,Pharmacodynamics,Efficacy and Safety of HRG2010 in Parkinson's Disease Patients With Motor Fluctuations
Official title: A Randomized, Open-label, Controlled, Single-dose, Multiple-dose Phase II Study to Evaluate the Pharmacokinetics,Pharmacodynamics,Efficacy and Safety of HRG2010 in Parkinson's Disease Patients With Motor Fluctuations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-09-26
Enrollment: 61
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study is a multicenter, randomized, open-label, active-controlled, Phase II clinical study. The aim of this trial is to evaluated the pharmacokinetics, pharmacodynamics,efficacy and assessed the safety of HRG2010 compared with a sustained-release cabridopa-levodopa formulation in Parkinson's Disease Patients With Motor Fluctuations.


Eligibility criteria: Inclusion Criteria:

1. Male or female participants diagnosed at age ≥ 40 years with PD, consistent with the International Parkinson and Movement Disorder Society Clinical Diagnostic Criteria and who are being treated with stable regimens of DDCI+LD but experiencing motor fluctuations.
2. Mini Mental State Examination (MMSE) ≥ 25 at Screening Visit.
3. Hoehn and Yahr Stage II-IV when "on" at Screening Visit.
4. At Screening, the participant has predictable "Off" periods.
5. Able and willing to provide a written informed consent.

Exclusion Criteria:

1. Diagnosed with atypical or secondary parkinsonism.
2. History of narrow angle glaucoma、peptic ulcer disease or upper gastrointestinal hemorrhage.
3. Had prior functional neurosurgical treatment for PD or if such procedure(s) are planned or anticipated during the study period.
4. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method.
5. In the opinion of the clinical investigator, Subjects who should not participate in the study.

Primary outcomes:
measure: Change from baseline in average percent "Off" time during waking hours at Day 33
timeFrame: Last three days collected at the end of treatment period
Secondary outcomes:
measure: "Off" and"On" time hours during in clinic observation
timeFrame: Days 1 and 13
measure: MDS-UPDRS Part III
timeFrame: Days 1 and 33
measure: Change from baseline in "Off" time at Day 33
timeFrame: Last three days collected at the end of treatment period
measure: Change from baseline in the Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at Day 33
timeFrame: Day 33
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT06056453: Interpersonal Psychotherapy in Adolescents With Polycystic Ovary Syndrome
Official title: Interpersonal Psychotherapy in Adolescents With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Interpersonal Psychotherapy
Polycystic Ovary Syndrome
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: American Psychological Association (APA)
First posted: 2023-09-28
Enrollment: 30
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to find out whether taking part in a group-based interpersonal psychotherapy (IPT) program designed to improve mood and lessen stress in girls with PCOS will improve depression, unhealthy eating behaviors, weight, and insulin resistance.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with PCOS duration \> 3 months
* 12-17 years old
* BMI \> 75th percentile
* CESD \> 16

Exclusion Criteria:

* Weekly or bi-weekly therapy with licensed behavioral health provider
* Inability to speak, read, or write in English (teen)
* Major medical conditions
* HbA1c \> 7.0%
* Hormonal contraception \< 3 months
* Metformin \< 3 months
* Antidepressants/psychotropic medications \< 4 weeks

Primary outcomes:
measure: Center for Epidemiologic Studies-Depression Scale
timeFrame: Baseline
measure: Center for Epidemiologic Studies-Depression Scale
timeFrame: 6-Week Follow-Up Assessment
measure: Center for Epidemiologic Studies-Depression Scale
timeFrame: 6-Month Follow-Up Assessment
Secondary outcomes:
measure: Emotional Eating Scale Adapted for Children
timeFrame: Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment
measure: Loss-of-Control Eating Disorder Questionnaire
timeFrame: Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment
measure: Reward Based Eating Drive Scale
timeFrame: Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment
measure: BMI
timeFrame: Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment
measure: Insulin Resistance
timeFrame: Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment
measure: Dysglycemia
timeFrame: Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment
measure: Dyslipidemia
timeFrame: Baseline, 6-Week Follow-Up Assessment, 6-Month Follow-Up Assessment
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: Colorado State University
name: Lauren Gulley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01897753: Retrospective Study Of The Influence Of Age At Start Of Growth Hormone Treatment On Height Gain In Children Born Small for Gestational Age
Official title: Retrospective Study Of The Influence Of Age At Start Of Growth Hormone (Gh) Treatment On Height Gain In Children Born Small for Gestational Age (SGA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Small For Gestational Age (SGA)
Keywords: SGA
Growth hormone
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-07-12
Enrollment: 264
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: SGA children treated with GH at least 36 months

Brief summary: The purpose of this protocol is to retrospectively study the influence of age at start of growth hormone (GH) treatment on height gain in children born small for gestational age (SGA).


Eligibility criteria: Inclusion Criteria:

* SGA children.

  * Treated with GH at least 36 months.

Exclusion Criteria:

* Patients treated with GH for other indications (not SGA).

Primary outcomes:
measure: height SDS
timeFrame: 36 months
Secondary outcomes:
measure: height increase
timeFrame: 36 months
measure: Change from Baseline in Lipid Parameters at Month X
timeFrame: 36 months
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: H. Germans Trias i Pujol
state: Barcelona
city: Esplugues de Llobregat
country: Spain
facility: H. Sant Joan de Déu
state: Barcelona
city: Santander
country: Spain
facility: H.Marqués de Valdecilla
state: Cantabria
city: El Palmar
country: Spain
facility: Hospital Virgen de la Arrixaca
state: Murcia
city: Pamplona
country: Spain
facility: Hospital Virgen del Camino
state: Navarra
city: Barcelona
country: Spain
facility: Capio H.Universitario Sagrat Cor
city: Barcelona
country: Spain
facility: H. Vall d'Hebron
city: Madrid
country: Spain
facility: H.Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital La Paz
city: Málaga
country: Spain
facility: Hospital Carlos Haya
city: Valladolid
country: Spain
facility: H.Clinico Universitario Valladolid
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04631653: Verisee Software for Diabetic Retinopathy Screening
Official title: The Clinical Benefit of an Artificial Intelligence Software Implementation on Diabetic Retinopathy Screening
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Retinopathy
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2020-11-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Examine the diagnostic accuracy in referred participants
Primary purpose: SCREENING

Brief summary: The investigators aim to improve the diagnostic accuracy and the clinical referral rate for diabetic retinopathy by using a deep learning-based software.

Detailed description: Diabetic retinopathy (DR) is the leading cause of blindness among working-age patients with type 2 diabetes. According to previous studies, early screening and timely treatment can reduce the risk of worsening DR and blindness. International guidelines recommend that screening for DR be performed at least once every year for patients with type 2 diabetes. The investigators will implement a validated deep learning-based software, VeriSee®, in clinics, and evaluate the benefits on diagnostic accuracy and the clinical referral rate for diabetic retinopathy after implementation of this software.

Eligibility criteria: Inclusion Criteria:

* Adults
* Patients with diabetes
* Cooperation to fundal scopic examination

Exclusion Criteria:

* Diabetic duration \< 5 years in patients with type 1 diabetes
* Pregnancy

Primary outcomes:
measure: diagnostic accuracy
timeFrame: 12 months
Secondary outcomes:
measure: Screening rate of diabetic retinopathy
timeFrame: 12 months
measure: Changes in HbA1c
timeFrame: 3 months
measure: Referral rate of diabetic retinopathy
timeFrame: 12 months
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Division of Endocrinology and Metabolism in Taichung Veterans General Hospital
Study officials:
affiliation: Taichung Veterans General Hospital
name: I-Te Lee, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04795453: Assessment of Score System of Surgery in Necrotizing Enterocolitis(NEC) Patients
Official title: Assessment of Score System to Predict the Need for Surgery in Newborn Infants With Two and More Grades of NEC
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Necrotizing Enterocolitis
Neonate
Surgery
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Chongqing Medical University
First posted: 2021-03-12
Enrollment: 800
Sex: ALL
Minimum age (years): 1
Maximum age (years): 44
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: two and more of NEC is diagnosed in newborn infants during hospitalization

Brief summary: Necrotizing enterocolitis(NEC) is one of the most serious disease in the newborn infants, and two and more grades of NEC usually lead to surgery, even death. But, it is difficult to predict when to operate the surgery.

Detailed description: Necrotizing enterocolitis(NEC) is characterized by vomit, abdominal distention, hypoactive bowel sounds and bloody stools, even shock, disseminated intravascular coagulation(DIC) and sepsis. X-ray is shown Intestinal wall gas and/or portal vein pneumatosis and pneumoperitoneum.

Two and more grades of NEC in newborn infant is a urgent condition, and whether or not operation is difficult to predict.

Here, the investigators develop a score system including five parameters(abdominal circumference, base excess, heart rate, severities of respiratory distress, sepsis) in one retrospective cohort, and the score system is used and assessed to predict the need for surgery in another prospective cohort.

Eligibility criteria: Inclusion Criteria:

* two and more of NEC is diagnosed in the newborn infants
* on the time of diagnosis for NEC both the surgery and non-surgery are reasonable according the surgeon's suggestions

Exclusion Criteria:

* pneumoperitoneum
* refusing to take part in the study according to parents' decision

Primary outcomes:
measure: sensitivity of the score system for predicting the need of surgery
timeFrame: before surgery
measure: specificity of the score system for predicting the need of surgery
timeFrame: before surgery
measure: accuracy of the score system for predicting the need of surgery
timeFrame: before surgery
measure: positive likelihood ratio of the score system for predicting the need of surgery
timeFrame: before surgery
measure: negative likelihood ratio of the score system for predicting the need of surgery
timeFrame: before surgery
measure: positive predictive value of the score system for predicting the need of surgery
timeFrame: before surgery
measure: negative predictive value of the score system for predicting the need of surgery
timeFrame: before surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chen（陈）
state: Chongqing
Study officials:
References:
Clinical trial NCT04094753: Think Dry: Optimalisation of Diagnostic Process of Urinary Incontinence in Older People
Official title: Think Dry: Optimalisation of Diagnostic Process of Urinary Incontinence in Older People
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Incontinence, Urge
Incontinence Stress
Incontinence, Daytime Urinary
Incontinence, Nighttime Urinary
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2019-09-19
Enrollment: 202
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older, cognitive intact people (\>= 65 years) of both sexes with all types of urinary incontinence

Brief summary: Urinary incontinence is an increasing medical and socio-economical problem. 44% of the elderly (\>65 years) women and 28% of the elderly men suffer from unwilling urine loss. Moreover, this percentages increase with age. Incontinence is a problem with multiple physical, psychological, and financial effects. In addition incontinence has a important impact on the family and healthcare professionals surrounding the elderly.

The problem of urinary incontinence is complex and multifactorial. Moreover, diagnostic guidelines are inconsistent leading to a high amount of technical interventions to diagnose and to specify the type of incontinence.

Aim of this study is to create a short form of necessary technical investigations to diagnose and evaluate urinary incontinence.


Eligibility criteria: Inclusion Criteria:

* \>= 65 years
* Every type of incontinence: stress, urge, mixed.

Exclusion Criteria:

* Patients with an indwelling urinary catheter are doing clean intermittent catheterization are excluded from the study protocol
* Patients with dementia are excluded from the study, based on N-Cog evaluation

Primary outcomes:
measure: Decreasing the amount of necessary technical investigations to diagnose incontinence
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Department of Urology, Ghent University Hospital
Study officials:
References:
Clinical trial NCT05796453: Post Market Clinical Follow-up (PMCF) Study of Clareon Vivity & Clareon PanOptix
Official title: Long-term Evaluation of Safety and Performance of Clareon Presbyopia-Correcting Intraocular Lenses (IOLs)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aphakia
Astigmatism
Presbyopia
Keywords: Cataract surgery
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2023-04-03
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this Post-Market Clinical Follow-up study is to describe the long-term safety and performance of the Clareon Vivity and Vivity Toric and Clareon PanOptix and PanOptix Toric IOLs.

Detailed description: Subjects will be recruited from a population that has already undergone lens implantation. Retrospective data will be collected from the pre-operative and surgical visits and any safety outcomes reported prior to enrollment. Prospective data will be collected from time of study enrollment through the Year 3 follow-up visit.

Eligibility criteria: Key Inclusion Criteria:

* Subject or legally authorized representative must be able to understand and sign an approved Informed Consent Form.
* Subject must have had bilateral implantation of Clareon Vivity, Clareon Vivity Toric, Clareon PanOptix, or Clareon PanOptix Toric IOLs between 3-6 months prior to enrollment.
* Subject must have a documented medical history and required pre-operative baseline information available for retrospective data collection.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Subject is currently participating in another investigational drug or device study.
* Subject has had corneal refractive surgery after Clareon Vivity, Clareon Vivity Toric, Clareon PanOptix, or Clareon PanOptix Toric IOL implantation.
* Subject is pregnant at the time of enrollment.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Binocular Best Corrected Distance Visual Acuity (BCDVA) at each prospective visit
timeFrame: Up to Year 3
measure: Rate of Adverse Events
timeFrame: Up to Year 3
measure: Rate of Device Deficiencies
timeFrame: Up to Year 3
Secondary outcomes:
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Wolstan & Goldberg Eye Associates
state: California
city: Jacksonville
country: United States
facility: Levenson Eye Associates
state: Florida
city: Liverpool
country: United States
facility: Eye Surgeons of CNY
state: New York
city: Tulsa
country: United States
facility: Tulsa Ophthalmology
state: Oklahoma
city: Fort Worth
country: United States
facility: Chu Eye Institute
state: Texas
city: Salt Lake City
country: United States
facility: The Eye Institute of Utah
state: Utah
city: San Juan
country: Puerto Rico
facility: Centro Oftalmologico Metropolitano
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, Surgical
role: STUDY_DIRECTOR
References: