louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01755078: Long Term Evaluation of Sevelamer HCl vs. Calcium-based Phosphate Binder in the Treatment of Hyperphosphatemia in Hemodialysis Patients
Official title: Long Term Evaluation of Sevelamer HCl vs. Calcium-based Phosphate Binder in the Treatment of Hyperphosphatemia in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemodialysis
Hyperphosphatemia
Cardiovascular Events
Keywords: Phosphate binder
Lead sponsor: Chugai Pharma Taiwan
Sponsor class: INDUSTRY
First posted: 2012-12-21
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is designed to compare sevelamer vs. calcium-based phosphate binder in hemodialysis patients to achieve full-scale of medical care, including reduction of atherosclerotic risk factors, reduction of vascular access reconstruction rate, and pharmacoeconomic analysis.


Eligibility criteria: Inclusion Criteria:

* Males or females aged between 18-70 years old
* Subject with hyperphosphatemia (5.5 - 8.5 mg/dL) at both WK(-2) and WK0
* On stable TIW hemodialysis for 3 months or longer

Exclusion Criteria:

* Patients with hypercalcemia (corrected serum calcium \> 10.5 mg/dL)
* Any of the following abnormalities: ALT or AST \> 3X ULN; iPTH \> 1000 or \< 150 pg/mL
* History of dysphagia or swallowing disorders
* History of GI motility disorder or GI bleeding within 3 months prior to entry

Primary outcomes:
measure: Composite end-point of Ca, P, Ca*P within K/DOQI recommendation
timeFrame: 12 months
Secondary outcomes:
measure: Change from baseline, Ca, P, Ca*P
timeFrame: 12 months
measure: Change from baseline, lipid profile
timeFrame: 12 months
measure: Change from baseline, CRP
timeFrame: 12 months
measure: Change from baseline, iPTH (stragified)
timeFrame: 12 months
measure: Change from baseline, homocysteine, folate and Vit B12
timeFrame: 12 months
measure: CV-related event rate (OPD admission and hospitalization)
timeFrame: 12 months
measure: Comparison of medical-related expenses between group
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: China Medical University Hospital
name: Chiu-Ching Huang, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lin HH, Liou HH, Wu MS, Huang CC. Factors associated with serum fetuin-A concentrations after long-term use of different phosphate binders in hemodialysis patients. BMC Nephrol. 2016 Mar 23;17:33. doi: 10.1186/s12882-016-0245-3.
Clinical trial NCT02823678: Pancreas Volume and Diabetes Status Following Pancreatectomy
Official title: Using Pancreatic Volumetric to Determine the Onset of Diabetes Mellitus and Postoperative Outcomes After Pancreatectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Neoplasms
Lead sponsor: Florida Hospital Tampa Bay Division
Sponsor class: OTHER
First posted: 2016-07-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 100 patients scheduled to undergo a pancreatectomy for a pancreatic neoplasm

Brief summary: This study will enroll 100 patients scheduled to undergo a pancreatectomy.

The primary objective is to develop a scoring system using pancreatic volume measured by CT scan and intraoperative measurements of the pancreas parenchyma to predict the onset of diabetes mellitus after a pancreatectomy. The investigators will also monitor patients with pre-existing diabetes to see if their diabetes worsens or improves.

Detailed description: The primary objective is to develop a scoring system using pancreatic volume measured by CT scan and intraoperative measurements of the pancreas parenchyma to predict the onset of diabetes mellitus after a pancreatectomy. The investigators will also monitor patients with pre-existing diabetes to see if their diabetes worsens or improves. Patients will be followed up to one year to track their diabetes status, postoperative outcomes and quality of life.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing pancreatectomy at our institution (e.g., pancreaticoduodenectomy, distal pancreatectomy, distal pancreatectomy and splenectomy, central pancreatectomy).

Exclusion Criteria:

* All patients who are on steroids or other medications whose potential side effects include development of diabetes mellitus or elevated blood glucose.
* Pregnant or nursing women.
* Patients with uncontrolled diabetes (HbA1c \>8%).

Primary outcomes:
measure: Percent resected volume of pancreas and diabetes development
timeFrame: Postoperative up to one year
Secondary outcomes:
measure: QLQ-C30 Quality of Life Health Questionnaire
timeFrame: Postoperative up to one year
measure: Blood glucose control
timeFrame: Postoperative up to one year
Other outcomes:
Locations:
Study officials:
affiliation: Florida Hospital Tampa
name: Alexander Rosemurgy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03961178: A Cohort Study for the Following up of Conization
Official title: Oncologic and Obstetric Outcomes After Conization for Uterine Cervical Lesion: A Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Precancerous Lesions
Conization
High Grade Intraepithelial Neoplasia
Uterine Cervical Cancer
Fertility
Pregnancy
Human Papillomavirus Infection
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-05-23
Enrollment: 10000
Sex: FEMALE
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: The study population consists of patients accepting conization in the study center who were aged 18 years or older.

Brief summary: This study is to investigate the oncologic and obstetric outcomes in patients with conization for uterine cervical lesions from January 1, 2000 to January 1, 2019 in Peking Union Medical College Hospital.

The primary objectives consist of following:

1. The cumulative incidences of precancerous lesions and cancers of lower genital tract in patients who accepted conization for high grade intraepithelial neoplasia (HSIL), carcinoma in situ and stage IA1 cancer (FIGO 2009)
2. The cumulative pregnancy rates in patients sparing the fertility

The secondary objectives consist of following:

1. The effects of surgical protocols (modified Sturmdorf method and "8" figure suture) and energy equipment (cold knife and monopolar electrical cautery) on the oncologic and obstetric outcomes, and on the histological components.
2. A full description of histological components of the conization specimens
3. The cytological and virus outcomes after conization, based on the thin prep liquid-based cytology test (TCT) and high-risk human papillomavirus (HPV) testing


Eligibility criteria: Inclusion Criteria:

* Accepting conization in the study center
* Aged 18 years or older

Exclusion Criteria:

* Not meeting any of the inclusion criteria

Primary outcomes:
measure: The cumulative incidences of precancerous lesions or cancers
timeFrame: Five years
measure: The cumulative pregnancy rates
timeFrame: Five years
Secondary outcomes:
measure: The cytological results after conization
timeFrame: Five years
measure: The virus outcomes after conization
timeFrame: Five years
measure: The cumulative pregnancy loss rates
timeFrame: Five years
measure: The cumulative live birth rates
timeFrame: Five years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04466878: Prognostic Value of Implementing VCE on Top in Constitutional VWD-patients With GI-bleeding
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Von Willebrand Diseases
Keywords: Gastrointestinal bleeding
Videocapsule endoscopy
Angiodysplasia
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-07-10
Enrollment: 50
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - VWD-patients fulfilling the inclusion criteria of the French reference center for VWD

Brief summary: Inclusion criteria: Only constitutional VWD-patients fulfilling the inclusion criteria of the French reference center for VWD will be included. Patients with acquired von Willebrand syndrome will not be included.

Material and Methods: A 15-items survey that will be sent to the 30 centers involved in the French network for bleeding disorders (MHEMO) to identify VWD-patients referred for endoscopic exploration of at least one GI-bleeding from January 2015 to December 2017. Only constitutional VWD-patients fulfilling the inclusion criteria of the French reference center for VWD will be included. Constitutional VWD diagnosis will be confirmed confirmed centrally in all patients by the French reference center for von Willebrand disease. A GI-bleeding episode will be defined as any overt or occult GI-bleeding (unexplained chronic iron deficiency anemia causing a drop of hemoglobin level by more than 2 g/dL from baseline). We will analyze patient characteristics, GI-bleeding pattern, VWD type/subtype, nature (gastroscopy, colonoscopy or VCE) and results of the endoscopic exploration and management that was applied: endoscopic therapy by argon plasma coagulation, on-demand/prophylactic-VWF replacement therapy, use of antiangiogenic drugs. If angiodysplasia without another bleeding source is identified, GI-bleeding will be categorized as angiodysplasia, if another lesion is identified GI-bleeding will be categorized as "no-angiodysplasia" and if no bleeding source is identified, GI-bleeding will be categorized as obscure GI-bleeding. Recurrence will be defined as evidence of overt GI-bleeding or a drop of hemoglobin level by more than 2 g/dL from baseline.


Eligibility criteria: Inclusion Criteria:

- At least one overt or occult GI-bleeding (unexplained iron deficiency anemia causing a drop of hemoglobin level by more than 2g/dL from baseline) episode between January 1st 2015 and December 31th 2017

Exclusion Criteria:

* acquired Von Willebrand syndrome

Primary outcomes:
measure: Diagnosis yield of an endoscopic strategy including video capsule on top of conventional endoscopy
timeFrame: 3-years follow-up
Secondary outcomes:
measure: Risk prediction of GI-bleeding recurrence with videocapsule endoscopy
timeFrame: 2-years follow-up
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00871078: Anatomic and Visual Function Assessments on Asymptomatic HIV-positive Patients
Official title: Anatomic and Visual Function Assessments on Asymptomatic HIV-positive Patients Using Optical Coherence Tomography and Frequency Doubling Technology Perimetry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Acquired Immunodeficiency Syndrome
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2009-03-30
Enrollment: 90
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV infected patients

Brief summary: The purpose of this study is to assess retinal nerve fiber layer thickness and macular thickness measured with optical coherence tomography (OCT) on patients infected by HIV virus without ocular manifestations and to correlate these results with perimetric findings assessed by frequency doubling technology perimetry (FDT).


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of AIDS
* Best-corrected visual acuity 20/25 or better
* Refractive error of 0±5.0 diopters and astigmatism of 0±3.0 diopters
* Normal intraocular pressure (≤21mmHg)

Exclusion Criteria:

* Cataract or any visible media opacity
* HIV-related infectious retinopathy
* Risk factors for the development of glaucoma

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Federal University of São Paulo (UNIFESP/EPM)
Study officials:
affiliation: Federal University of São Paulo
name: Tiago Arantes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01275378: Comparative Effectiveness Research for Two Medical Home Models for Attention Deficit Hyperactivity Disorder
Official title: COMPARATIVE EFFECTIVENESS RESEARCH FOR TWO MEDICAL HOME MODELS FOR ATTENTION DEFICIT HYPERACTIVITY DISORDER
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit/Hyperactivity Disorder
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Codman Square Health Center
name: Dorchester House Health Center
First posted: 2011-01-12
Enrollment: 156
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to compare the effectiveness of two care models on ADHD outcomes: one, a model of basic care management and structured communication with specialists, consistent with conventional descriptions of a patient-centered Medical Home; and another, which combines the Medical Home with theory-based care management strategies to address common reasons for ADHD treatment failure.


Eligibility criteria: Inclusion Criteria:

* Child is being evaluated for a potential diagnosis of ADHD by a primary care pediatrician at one of our sites.
* Child is 6 to 12 years of age
* Family plans to remain in the Boston area for the duration of the follow-up period
* Mother is comfortable in English or Spanish

Exclusion Criteria:

* Child already has a confirmed diagnosis of ADHD
* Child already receives ongoing specialty care in one or more of the following clinics: pediatric psychiatry, developmental behavioral pediatrics

Primary outcomes:
measure: ADHD Symptoms
timeFrame: 6 mo
measure: ADHD Symptoms
timeFrame: 12 mo
measure: Patient Medication Adherence
timeFrame: 6 mo
measure: Patient Medication Adherence
timeFrame: 12 mo
Secondary outcomes:
measure: ODD Symptoms
timeFrame: 6 mo
measure: Social Skills
timeFrame: 6 mo
measure: Time to Symptom Improvement
timeFrame: 12 mo
measure: ODD Symptoms
timeFrame: 12 mo
measure: Social Skills
timeFrame: 12 mo
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Michael Silverstein, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Silverstein M, Hironaka LK, Walter HJ, Feinberg E, Sandler J, Pellicer M, Chen N, Cabral H. Collaborative care for children with ADHD symptoms: a randomized comparative effectiveness trial. Pediatrics. 2015 Apr;135(4):e858-67. doi: 10.1542/peds.2014-3221.
Clinical trial NCT00279578: Clot Formation and Clot Stability in Patients With Severe Haemophilia A
Official title: Clot Formation and Clot Stability in Patients With Severe Haemophilia A - Effect of Recombinant Factor VIII and Tranexamic Acid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemophilia A
Keywords: haemophilia A
thrombelastography
recombinant factor VIII
thrombin generation
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2006-01-19
Enrollment: 8
Sex: MALE
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: In the present study we are examining the clot formation and clot stability in patients with severe haemophilia A after they receive recombinat factor VIII and after addition of tranexamic acid. Our hypothesis is that addition of tranexamic increases the clot stability. The perpective of the study is to document whether it is relevant to use traneksamic acid in surgery in patients with severe haemophilia A.

Detailed description: In the present study we are examining the clot formation and clot stability in patients with severe haemophilia A after they receive recombinat factor VIII and after addition of tranexamic acid. Our hypothesis is that addition of tranexamic increases the clot stability. The perpective of the study is to document whether it is relevant to use traneksamic acid in surgery in patients with severe haemophilia A.

Eligibility criteria: Inclusion Criteria:

* Severe haemophilia A
* Above 17 years old
* Thrombocyt count above 100 x 109/l within the past two years

Exclusion Criteria:

* Received recombinant factor VIII with in the past 3 days
* Inhibitor against recombinant factor VIII
* HIV-positive
* Ongoing treatment for hepatitis C
* Known kidney disease
* Allergy against Tranexamic acid
* Not able to give informed consent

Primary outcomes:
measure: Clot stability
Secondary outcomes:
measure: clot formation,thrombine generation
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Clinical Biochemistry, Center for Haemophilia and Thrombosis
Study officials:
affiliation: Aarhus University Hospital
name: Anne-Mette Hvas, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01398878: Assessing the Impact of a Change to the Work Schedule of Resident Physicians: a Mixed Methods Study
Official title: Assessing the Impact of a Change to the Work Schedule of Resident Physicians: a Mixed Methods Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patient Safety
Resident Work Hours
Keywords: Medical education, graduate
Patient care
Outcome assessment (Health care)
Work schedule tolerance
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Michael Smith Foundation
First posted: 2011-07-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine the impact of eliminating traditional resident work shifts (i.e. greater than 24 hours in length) on patient safety and resident educational outcomes. In addition, the investigators will explore with key stakeholders (patients and their families, nurses, resident physicians and attending physicians) their experiences when residents are undertaking shifts greater than 24 hours in length as compared to 16 hours or less.


Eligibility criteria: Inclusion Criteria:

* Residents completing Intensive Care Unit rotations
* For focus groups and interviews, patients and families members admitted during the study period and nurses and attending physicians working during the study period

Exclusion Criteria:

* None

Primary outcomes:
measure: Preventable adverse events
timeFrame: Occurring during course of ICU admission and within first 72 hours of ICU discharge if event is attributable to process of care in the ICU
Secondary outcomes:
measure: Quantity of scheduled and unscheduled learning activities residents participate in
timeFrame: End of each 28 day rotation
measure: Resident leisure time, sleep, and time spent in the hospital
timeFrame: End of each 28 day rotation
measure: Professionalism
timeFrame: End of each 28 day rotation
measure: Nursing impact
timeFrame: Over course of study (12 months)
measure: Attending physician workload
timeFrame: Over course of study (12 months)
measure: Perceived continuity of care
timeFrame: Over course of study (12 months)
measure: Quality of life
timeFrame: End of each 28 day rotation
measure: Resident knowledge acquisition and retention
timeFrame: End of each 28 day rotation
measure: Patient satisfaction
timeFrame: Within two weeks of ICU discharge
measure: Job satisfaction/Stress
timeFrame: End of each 28 day rotation
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St Paul's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Najib Ayas, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03487978: Longitudinal Changes of Brain Functional Connectivity in Migraine
Official title: The Migrainous Brain: a Prospective Research for Longitudinal Changes of Brain Networks in Migraine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Migraine
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: National Research Foundation of Korea
name: Sungkyunkwan University
First posted: 2018-04-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Controls and migraineurs who visited to a single university hospital

Brief summary: The purpose of this study is to identify a core fMRI feature that determines migrainous brain and plastic fMRI features that changes with longitudinal courses of migraine.

Detailed description: Migraine is associated with functional alterations in specific brain networks. The investigators aimed to identify network abnormalities which remain unchanged throughout the longitudinal course of migraine. The investigators also aimed to identify networks which change in association with changes in migraine frequency and associated psychiatric conditions. The investigators expect these can serve as neuroimaging biomarkers for diagnosis of migraine brain and monitoring of disease severity.

Eligibility criteria: Inclusion Criteria:

Migrainuers :

1. age 18-50 years
2. migraine with or without aura as defined by the third edition of the International Classification of Headache Disorders (ICHD-3 beta)
3. if female, before the onset of menopausal

Controls:

1. age 18-50 years
2. no headache disorder other than Infrequent episodic tension-type headache as defined by the ICHD-3 beta

Exclusion criteria:

1. contraindicated to MRI
2. pregnancy
3. require sedation treatment because of claustrophobia when performing MRI
4. predicted to be unable to write the headache diary due to cognitive decline
5. refuse study procedure

Primary outcomes:
measure: Core fMRI features for migraine brain
timeFrame: 1-year follow-up (2nd year)
Secondary outcomes:
measure: Candidate fMRI features for migraine
timeFrame: Baseline (1st year)
measure: Dynamic fMRI features for disease severity
timeFrame: 1-year follow-up (2nd year)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center, Sungkyunkwan University School of Medicine
name: Mi Ji Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: