louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00803374: Combination of Anti-CD137 & Ipilimumab in Patients With Melanoma
Official title: A Phase I, Multiple Ascending Dose Study of BMS-663513 (Anti CD137) in Combination With Ipilimumab (BMS-734016/Anti-CTLA-4) in Subjects With Unresectable Stage III or Stage IV Melanoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2008-12-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if BMS-663513 administered in combination with ipilimumab to patients with advanced malignant melanoma is safe and tolerable


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed malignant melanoma
* Stage III (unresectable) or Stage IV disease which may have been treated with up to one prior cytotoxic chemotherapy and/or up to 3 other therapeutic regimens
* Willing to undergo up to 3 biopsies of an accessible lesion

Exclusion Criteria:

* Active/symptomatic brain metastases
* Primary ocular melanoma or primary tumor of unknown origin
* Concurrent autoimmune disease
* Previous treatment with a CD137 agonist or CTLA-4 inhibitor

Primary outcomes:
measure: Evidence of safety and tolerability as determined by analysis of adverse event reports and results of vital sign measurements, physical examinations, and clinical laboratory tests
timeFrame: During the course of the each subject's treatment and up to 70 days after his or her last dose of study medication is received
Secondary outcomes:
measure: Evidence of clinical improvement in tumor burden confirmed by CT or MRI
timeFrame: Weeks 12, 18, 24, 30, 36, 42, 48, and every 12 weeks thereafter
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Local Institution
state: California
city: New Haven
country: United States
facility: Local Institution
state: Connecticut
city: Tampa
country: United States
facility: Local Institution
state: Florida
city: Boston
country: United States
facility: Local Institution
state: Massachusetts
city: Boston
country: United States
facility: Local Institution
state: Massachusetts
city: Boston
country: United States
facility: Local Institution
state: Massachusetts
city: New York
country: United States
facility: Local Institution
state: New York
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT02992665: Can Calcium Ionophore Application Enhance the ICSI Outcomes in Severe Male Factor Infertility?
Official title: Can Calcium Ionophore Application Enhance the ICSI Outcomes in Severe Male Factor Infertility?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: In Vitro Fertilization
Male Factor Infertility
Keywords: Calcium ionophore
Fertilization
Sperm
Oocyte
ICSI
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-12-14
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the impact of the use of calcium ionophore on the ICSI outcomes in couples with severe male factor infertility. Investigators conduct a randomized controlled trial on the sibling oocyte to justify the use of calcium ionophore in these cases.

Detailed description: Elevation of calcium levels inside the oocyte is one of the most initial steps which takes place during normal fertilization (1). The interaction between the sperm and oocytes surface protein receptors may be the triggering event for oocyte activation during the process of fertilization (2). It is suggested that the process of intracellular Calcium elevation is triggered by binding of the sperm to the oocyte oolemma and hence the fertilization starts (3). Severe male factor couples might have compromised fertilization and pregnancy outcomes (4).

A prospective multicenter non-randomized study indicated that calcium ionophore could improve the fertilization as well as the clinical pregnancy rates in these patients (5). On the other hand, a randomized controlled trial did not find any significance for the use of calcium ionophore in the couples with poor ovarian reserve with regards the fertilization and clinical pregnancy rates (6). The purpose of this study is to determine the impact of the use of calcium ionophore on the ICSI outcomes in couples with severe male factor infertility. Investigators conduct a randomized controlled trial on the sibling oocyte to justify the use of calcium ionophore in these cases.

Eligibility criteria: Inclusion Criteria:

* Severe male factor infertility, Average response to COH,

Exclusion Criteria:

* Poor responders,

Primary outcomes:
measure: Fertilization rate
timeFrame: 18 hours after injecting the sperms in the oocytes
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Osama Abdalmageed
Study officials:
affiliation: Women health center, Assiut University
name: Osama Abdalmageed
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01739465: Comparison of Endoscopic Radiofrequency Ablation Versus Photodynamic Therapy for Inoperable Cholangiocarcinoma
Official title: A Randomized Controlled Trial Comparing Endoscopic Biliary Radiofrequency Ablation With Photodynamic Therapy for Inoperable Cholangiocarcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Cholangiocarcinoma
Keywords: Cholangiocarcinoma
Pathologic
Digestive System
Neoplasms
Neoplasms by Site
Digestive System Diseases
Bile Duct Diseases
Biliary Tract Diseases
Pathological Conditions
Constriction
Adenocarcinoma
Carcinoma
Lead sponsor: Guangzhou Medical University
Sponsor class: OTHER
First posted: 2012-12-03
Enrollment: 120
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 purpose of this study is to compare endoscopic radiofrequency ablation with photodynamic therapy for inoperable cholangiocarcinoma


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old
* Pathologically or radiologically confirmed biliary malignant
* Inoperability by staging

Exclusion Criteria:

* Cholangiocarcinoma with widespread metastasis
* Coagulopathy (INR \> 2.0 or prothrombin time \> 100 sec or platelet count \< 50,000)
* Prior SEMS placement
* Pregnancy
* Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3 )
* Life expectancy \< 3months

Primary outcomes:
measure: stent patency
timeFrame: 6 months
Secondary outcomes:
measure: overall survival rate
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Second Hospital of Guangzhou Medical College
state: Guangdong
city: Guangzhou
country: China
facility: The second hospital of Guangzhou Medical college
state: Guangdong
Study officials:
References:
Clinical trial NCT01760265: DARK STUDY "DysbetalipoproteinemiA and atheRoma Risk"
Official title: Dysbetalipoproteinemia and Atheroma Risk : Assessment of Cardiovascular Risk in Dysbetalipoproteinemic Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dysbetalipoproteinemia
Keywords: dysbetalipoproteinemia
artery calcium score
carotid intima media
ankle brachial index
dysbetalipoproteinemic patients
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2013-01-04
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Dysbetalipoproteinemia patients with APOE2/E2 or heterozygous mutation (negative dominance) and hypercholesterolemia, ratio CT VLDL/Tg VLDL \>0.40

Brief summary: Dysbetalipoproteinemia (type III, Fredrickson's classification) is a rare metabolic disorder. It results from a defect in the clearance of VLDL and chylomicron remnants due to homozygous APOE2 variants or heterozygous APOE mutations, and there is an elevated plasma cholesterol and triglycerides.

As a consequence of the derangements in lipoprotein metabolism, dysbetalipoproteinemia predispose to the premature development of atherosclerosis.

However among this population there is heterogeneity in development of cardiovascular complications and the determinants remain unclear actually.

The aim of the investigators study is to evaluate the intensity of clinical atherosclerosis, and identify its determinants.


Eligibility criteria: Inclusion Criteria:

- apo E gene sequencing in CBE (Centre de Biologie Est / Hospices Civils de Lyon / France) laboratory in Lyon until December 2012

Exclusion Criteria:

* age \< 40 years
* refused participation

Primary outcomes:
measure: Computed tomographic measurements for coronary-artery calcium
timeFrame: Day one : the coronary calcium score is assessed on the date of measurement
Secondary outcomes:
measure: Measurement of carotid intima-media by ultrasonography
timeFrame: Day one : on the date of measurement
measure: Measurement of ankle brachial index
timeFrame: Day one : on the date of measurement
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon - Groupement Hospitalier Est
Study officials:
affiliation: Hospices Civils de Lyon
name: Philippe MOULIN, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00174265: 6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptoms Patients Who Completed the First 6- Month Trial (A7501014)(COMPLETED)(P05772)
Official title: A Multicenter, Double-Blind, Flexible-Dose, 6-Month Extension Trial Comparing the Safety and Efficacy of Asenapine With Olanzapine in Subjects Who Completed Protocol A7501013
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an extension study of A7501013 (P05771/NCT00145496) to further test

the efficacy and safety of Asenapine compared with a

marketed agent (olanzapine) in the treatment of patients with

persistent negative symptoms of schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Continue to meet all demographic and procedural

inclusion criteria of the A7501013 trial to enter into

this extension trial.

* Have demonstrated an acceptable degree of compliance

and completed the A7501013 trial, and would benefit

from continued treatment according to the investigator.

Exclusion Criteria:

* Have an uncontrolled, unstable clinically significant

medical condition.

* Have been judged to be medically noncompliant in the

management of their disease.

Primary outcomes:
measure: Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score
timeFrame: Baseline of A7501013 to Day 365
Secondary outcomes:
measure: Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score
timeFrame: Baseline of A7501013 to Day 365
Other outcomes:
Locations:
Study officials:
References:
citation: Buchanan RW, Panagides J, Zhao J, Phiri P, den Hollander W, Ha X, Kouassi A, Alphs L, Schooler N, Szegedi A, Cazorla P. Asenapine versus olanzapine in people with persistent negative symptoms of schizophrenia. J Clin Psychopharmacol. 2012 Feb;32(1):36-45. doi: 10.1097/JCP.0b013e31823f880a.
Clinical trial NCT01127165: Low and High Dose Zonisamide in Children as Monotherapy
Official title: A Multi-center Comparative Trial of Low and High Dose Zonisamide in Children as Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epilepsy
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2010-05-20
Enrollment: 125
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to confirm the adjustment dosage of zonisamide as monotherapy in children with epilepsy.


Eligibility criteria: Inclusion criteria:

1. Pediatric patients with epilepsy whose age is 2\~15 years old.
2. Patients had at least two seizures for the last 6 months before entry.
3. Patients who had never taken antiepileptic drugs.
4. Patients with no chance of progressive disease based on the result of magnetic resonance imaging (MRI) or electroencephalogram (EEG).
5. Agreement of the guardian is needed.

Exclusion criteria:

1. Patients who have progressive central nervous system (CNS) disease.
2. Patients with serious disorder.
3. Patients who have abnormal liver function (serum glutamic oxaloacetic transaminase \[SGOT\]) or (serum glutamic pyruvic transaminase \[SGPT\]) values more than twice the normal values.
4. Patients who have abnormal renal function (blood urea nitrogen (BUN) or Creatinine) values more than three times the normal values.
5. Hemolytic anemia.

Primary outcomes:
measure: Percentage of Participants Who Were Assessed As Seizure Free
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in Cognitive Assessment Korean-Wechsler Intelligence Scale for Children (K-WISC-Ⅲ)
timeFrame: Baseline and 24 weeks
measure: Change in Behavior Assessment Korea-Child Behavior Checklist (K-CBCL)
timeFrame: Baseline and 24 weeks
measure: Change in Korean-Quality of Life Childhood Epilepsy (K-QOLCE)
timeFrame: Baseline and 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Dongsan Medical Center of Keimyung Univ.
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Inje Univ. Ilsan-Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Inje Univ. Sanggye-Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Korea Univ. Ansan Hospital
city: Seoul
country: Korea, Republic of
facility: Korea Univ. Guro Hospital
city: Seoul
country: Korea, Republic of
facility: National Health Insurance Corporation Ilsan Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang Univ. Cheonan Hospital
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang Univ. Hospital
city: Seoul
country: Korea, Republic of
facility: Yeungnam University Medical Center
Study officials:
affiliation: Medical Department, Eisai Korea Inc.
name: Jihee Mun
role: STUDY_DIRECTOR
References:
Clinical trial NCT05548465: Long-term-opioid-free Anesthesia in Anterior Cervical Surgery
Official title: The Safety and Efficacy of Long-term-opioid-free Anesthesia in Anterior Cervical Surgery: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Long-term-opioid-free Anesthesia
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 100
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: We design this randomized controlled trial to explore the safety and efficacy of the long-term-opioid-free anesthesia in anterior cervical surgery, to reduce the dosage of perioperative long-acting opioids and promoting patients'rehabilitation.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing anterior cervical surgery., sign the "informed consent form"
* Age above 18 years old
* ASA Ⅰ-Ⅲ.

Exclusion Criteria:

* Pregnant or lactating women.
* Patients with history of drug abuse, including but not limited to opioids, amphetamines, ketamine, etc
* Allergic to the materials or drugs used in this study.
* Patients with current/previous gastrointestinal bleeding and gastric ulcers;
* Have history of nervous system diseases such as peripheral neuropathy, or psychiatric mental illness.
* Other conditions that the investigators consider unsuitable for participation in the study, such as deaf, Parkinson's disease, and difficult to communication etc.

Primary outcomes:
measure: Postoperative numerical rating scales (NRS) at rest.
timeFrame: Up to 48 hours after operation.
Secondary outcomes:
measure: Incidence of post operative nausea and vomiting (PONV).
timeFrame: Up to 30 days after operation.
measure: Postoperative NRS on movement.
timeFrame: Up to 48 hours after operation.
measure: Postoperative complications.
timeFrame: Up to 30 days after operation.
measure: Incidence of intraoperative adverse events.
timeFrame: Intraoperative .
measure: Postoperative recovery of cervical spine function
timeFrame: Up to 48 hours after operation.
measure: Analgesic medication use before discharge。
timeFrame: Up to 48 hours after operation.
measure: Length of stay (LOS) in hospital
timeFrame: Up to 30 days after operation.
measure: Postoperative LOS
timeFrame: Up to 30 days after operation.
measure: Total in-hospital cost.
timeFrame: Up to 30 days after operation.
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Department of Anesthesiology, West China Hospital, Sichuan University
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Ren Liao, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02315365: Real-World Outcome Research Study on Quality of Life, Work Productivity and Health Care Resource Utilization in Metastatic Breast Cancer
Official title: Real-World Outcome Research Study on Quality of Life, Work Productivity and Health Care Resource Utilization in Metastatic Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Breast Cancer
Lead sponsor: PeriPharm
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2014-12-11
Enrollment: 202
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post-menopausal women with ER+/HER2- locally advanced or metastatic breast cancer.

Brief summary: This real-life Health Economics and Outcome Research (HEOR) study will enable to assess the impact of current therapies on quality of life (QoL), productivity loss and health care resource utilization in metastatic breast cancer (mBC). This prospective study will estimate patient-reported outcomes (PROs) and resource utilization data for mBC patients stratified according to treatment type, treatment line and disease status (progression vs. progression free) in a real-life setting.

To estimate QoL, work productivity and health care resource utilization of post-menopausal patients with ER+/HER2- locally advanced or metastatic breast cancer in a real-life setting. The secondary objective is to estimate QoL and work productivity of mBC patients' caregivers.

During the course of the study, data will be collected on quality of life and work productivity. Patients and caregivers will be asked to fill a set of questionnaires at their recruitment in the study, at 3 months and at 6 months after recruitment.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of locally advanced or metastatic breast cancer
* Post-menopausal women
* ER+/HER2- mBC
* Signature of informed consent form
* Ability to read and understand English or French

Exclusion Criteria:

* Participation to a clinical trial

Primary outcomes:
measure: Pharmacoeconomic impact of current therapies for the treatment of mBC in a real-life setting.
timeFrame: 6-month follow-up after recruitment
Secondary outcomes:
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Greenfield Park
country: Canada
facility: CISSS de la Montérégie-Centre (Hôpital Charles Lemoyne)
state: Quebec
city: Lévis
country: Canada
facility: CSSS Alphonse-Desjardins
state: Quebec
city: Montreal
country: Canada
facility: CIUSSS de l'Est-de-l'Île-de-Montréal (Hôpital Maisonneuve-Rosemont)
state: Quebec
city: Québec
country: Canada
facility: CHU de Québec (Hôpital du Saint-Sacrement)
state: Quebec
Study officials:
affiliation: PeriPharm
name: Jean Lachaine, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04802265: EpiRetinal Membrane Peeling and Internal Limiting Membrane
Official title: To Compare Anatomical and Functionnal Outcomes in Patients Undergoing Epiretinal Membrane Surgery With and Without Internal Limiting Membrane Peeling
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Epiretinal Membrane
Macular Pucker
Internal Limiting Membrane
Keywords: Epiretinal membrane
Epiretinal membrane peeling
Macular pucker
Internal limiting membrane (ILM) peeling
Pars plana vitrectomy
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult diagnosed for epiretinal surgery

Brief summary: To study and compare visual acuity in patients undergoing removal of the epiretinal membrane with and without the removal of the internal limiting membrane at baseline versus 6 month.

Detailed description: This prospective cohort study includes 2 arms : with and without internal limiting membrane (ILM) peeling.

Each patient undergo the same procedure : first of all pars plana vitrectomy, then internal limiting membrane peeling is performed and facilitated by the use of dye, which aids in better visualization of the ILM.

If the ILM is removed in same time : the patient is ranked in the "ILM peeling" group If the ILM is not removed : the patient is ranked in the "non ILM peeling" group.

If the ILM is partially removed, the patient is not enrolled.

The outcomes are recorded for 6 months : at baseline, day 15, 1, 3 and 6 months.

Eligibility criteria: Inclusion Criteria:

* adult up to 18 years old,
* diagnosed and treated surgically

Exclusion Criteria:

* proliferative diabetic retinopathy,
* ocular trauma,
* central veinous occlusion,
* intra-ocular tumor, total retinal detachment,
* central visual field loss in glaucomatous patients

Primary outcomes:
measure: Best corrected visual acuity (BCVA) (metric : LogMAR)
timeFrame: prior to surgery
measure: Best corrected visual acuity (BCVA) (metric : LogMAR)
timeFrame: Day 180
Secondary outcomes:
measure: BCVA at day 15, 1, 3 month.
timeFrame: Day 15, Day 30, Day 90
measure: near visual acuity measured at baseline, day 15, 1, 3 and 6 month
timeFrame: Day 180
measure: central retinal thickness (CRT)
timeFrame: Day 180
measure: peeling initiation retinal thickness
timeFrame: Day 180
measure: 10° visual field
timeFrame: Day 180
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
state: Aura
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Isabelle Sillaire
role: PRINCIPAL_INVESTIGATOR
References: