louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01630187: Comparison of Two Doses of Carbetocin for Prevention of Uterine Atony, During Elective Cesarean Section
Official title: Comparison of Two Doses of Carbetocin for Prevention of Uterine Atony During Elective Cesarean Section: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Uterine Atony
Post-partum Hemorrhage
Keywords: Carbetocin
Uterotonic drug
elective cesarean section
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2012-06-28
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of two doses of carbetocin (50 mcg vs 100 mcg) in preventing uterine atony during elective cesarean section.

Detailed description: Postpartum hemorrhage is a major cause of mortality and morbidity in the world, and it is most often caused by uterine atony. To prevent this complication, uterotonic medication is used during elective cesarean section.

Carbetocin, a long-acting synthetic analogue of oxytocin, has been used for this purpose for many years. This medication has numerous side effects: hypotension, tachycardia, nausea, vomiting, chest pain, etc. Using a smaller dose of carbetocin might lower the incidence of these side effects, without compromising prevention of uterine atony in a low-risk group of patient.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years old
* ≥ 37-week pregnancy
* singleton pregnancy
* elective cesarean section with a low transverse incision
* ASA I or II

Exclusion Criteria:

* Personal history of uterine atony or postpartum hemorrhage
* Abnormal placental implantation (known or suspected)
* \> 3 cesarean sections in the past
* Personal history of a classic uterine incision
* Estimated fetal weight \> 4500g
* Hemoglobin \< 100 g/L
* Regular use of tocolytic drugs
* Cesarean section under general anesthesia
* Known allergy to carbetocin
* Refusal
* Inability to obtain informed consent

Primary outcomes:
measure: Utilization of a second uterotonic drug
timeFrame: First 48 hours of the postpartum
Secondary outcomes:
measure: Incidence of side effects
timeFrame: During the fifteen minutes following the administration of carbetocin
measure: Incidence of major complications
timeFrame: First 48 hours of the postpartum
measure: Drop in hemoglobin measurement
timeFrame: on the second post-partum day
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Hôpital Saint-François-d'Assise (CHUQ)
Study officials:
affiliation: Laval University
name: Julie Bédard
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02021487: Prokinecitine in Acute Myocardial Infarction
Official title: Pilot Study Prok-Idm: Interest of Dosage of Prokinecitine in Acute Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: ST Elevatation Myocardial Infarction (STEMI)
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2013-12-27
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute St elevation myocardial infarction of less than 6 hours

Brief summary: The study aims to investigate the presence of a substance in the blood called prokinecitine, which is released by the heart when a heart attack occurs. Several venous blood samples at the arm are withdrawn at admission, H6, H12, H24, H48 and H72 in order to measure the concentration of this substance in the blood. The usefulness of this new blood marker is going to be determsined to seek if it would be of help to better diagnose or estimate the gravity of heart infarction after a heart attack.


Eligibility criteria: Inclusion Criteria:

* Patients with acute St elevation myocardial infarction of less than 6 hours
* Age\>18 y/o

Exclusion Criteria:

* Previous myocardial infarction
* LBB, RBB
* Renal Insuffiency MDRD\<30 mL/min
* Patient with Pace-Maker or ICD.

Primary outcomes:
measure: Infarct size by MRI necrotic myocardial mass
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Patrick OHLMANN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00002587: Paclitaxel Plus Topotecan in Treating Patients With Solid Tumors
Official title: A PHASE I STUDY OF PROLONGED LOW-DOSE TOPOTECAN INFUSION COMBINED WITH PACLITAXEL (TAXOL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Keywords: unspecified adult solid tumor, protocol specific
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-05-11
Enrollment: 20
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: Phase I trial to study the effectiveness of paclitaxel plus topotecan in treating patients who have solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

Detailed description: OBJECTIVES:

I. Determine the maximum tolerated dose and quantitative and qualitative toxic effects of topotecan and paclitaxel in patients with solid tumors.

II. Determine the antitumor activity of this regimen in these patients.

OUTLINE: This is a dose escalation study of topotecan and paclitaxel.

Patients receive paclitaxel IV over 3 hours on day 1 followed 2-6 hours later by topotecan IV continuously on days 1-14. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of topotecan and paclitaxel until the maximum tolerated dose (MTD) of each drug is determined. The MTD is defined as the highest dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: Approximately 10-20 patients will be accrued for this study within 8-12 months.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically proven solid tumor
* Measurable or evaluable disease
* Measurable disease defined as tumor outside prior radiotherapy fields and reproducibly measurable in 2 dimensions on physical exam, x-ray, CT, or MRI

PATIENT CHARACTERISTICS:

* Age: 18 and over
* Performance status: 0 or 1
* Life expectancy: At least 12 weeks
* WBC at least 4,000/mm3
* Platelet count at least 100,000/mm3
* Bilirubin no greater than 1.5 mg/dL
* AST less than 3 times normal
* Alkaline phosphatase less than 3 times normal
* Creatinine no greater than 1.5 mg/dL
* No poorly controlled angina
* No history of congestive heart failure
* No myocardial infarction within the past 6 months
* Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

* No concurrent prophylactic hematopoietic growth factors
* No concurrent medications altering cardiac conduction

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU School of Medicine's Kaplan Comprehensive Cancer Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: Howard S. Hochster, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01626287: Reduction of Perineal Pain After Vaginal Birth With Black Tea: Pilot Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perineal Pain
Keywords: perineal
postpartum
pain
treatment
ice and black tea
maternal satisfaction
Lead sponsor: Fraser Health
Sponsor class: OTHER
First posted: 2012-06-22
Enrollment: 43
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Perineal trauma is common during vaginal birth. The discomfort this causes can interfere with a woman's recovery and early motherhood.Mothers are offered a standard treatment after childbirth, water soaked frozen peri pads (ice packs), to alleviate the discomfort. However, a Cochrane review questions the efficacy of ice packs treatment. An alternative treatment that may be more comfortable and effective for women is warm water soaked black tea bags. Medicinal use of black tea bags has been based on their astringent (shrinking or constricting) properties and have been used for various medical applications.

The investigators will conduct a pilot randomized controlled trial (RCT) of 40 pregnant mothers randomized to either intervention group (tea bags; n=20) or control group (ice packs; n=20). The goal of this pilot is to test the feasibility of a larger RCT by assessing recruitment, testing the protocol, and evaluating a proposed primary outcome objective of analgesic use during hospitalization as an indicator of pain. The investigators expect this pilot study to demonstrate feasibility for a large scale RCT to formally evaluate the efficacy of black tea bags to reduce perineal pain in this patient population.


Eligibility criteria: Inclusion Criteria:

* Primiparous women (delivering their first baby) over the age of 19 who have delivered vaginally at Abbotsford Regional Hospital and Cancer Centre

Exclusion Criteria:

* multiparity (women who have delivered vaginally more than once), VBAC (Vaginal Birth after Cesarean Section), active sexually transmitted infection lesions, vulvar varicosities, third and forth degree perineal tear, hematoma, retained placenta/products, substance abuse, and other medical conditions requiring frequent analgesia

Primary outcomes:
measure: use of analgesia during hospitalization
timeFrame: 24 hours post partum
Secondary outcomes:
Other outcomes:
Locations:
city: Abbotsford
country: Canada
facility: Abbotsford Regional Hospital and Cancer Centre
state: British Columbia
Study officials:
affiliation: Fraser Health Authority
name: Karmjit Kaur Sandhu, MScN
role: PRINCIPAL_INVESTIGATOR
References:
citation: East CE, Dorward ED, Whale RE, Liu J. Local cooling for relieving pain from perineal trauma sustained during childbirth. Cochrane Database Syst Rev. 2020 Oct 9;10(10):CD006304. doi: 10.1002/14651858.CD006304.pub4.
Clinical trial NCT03357887: Prognostic Value of Three New Biomarkers of Multiple Sclerosis in Patients With Radiologically Isolated Syndrome
Official title: Prognostic Value of Three New Biomarkers of Multiple Sclerosis Compared to Reference Biomarker in Patients With Radiologically Isolated Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Radiologically Isolated Syndrome
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2017-11-30
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from whom prospective samples have been collected and conserved in the biobank at Nice as part of the RISC (Radiologically Isolated Syndrome Consortium).

100 patients with Radiologically Isolated Syndrome as diagnosed by MRI using the Okuda 2009 criteria (65 RIS-: not converted after at least 2 years of follow-up; 35 RIS+).

30 patients with recurrent-remittent multiple sclerosis 30 symptomatic control patients 20 control patients with inflammatory disease 20 control patients with non-inflammatory neurological disease

Brief summary: To look at the prognostic value of new biomarkers in CSF and serum for characterisation of multiple sclerosis


Eligibility criteria: Inclusion criteria

* Patients have given their free consent for use of their samples in research
* Patients have at least 2 years of clinical and radiological follow-up data available Exclusion criterion
* No follow-up of patients

Primary outcomes:
measure: Level of tumour necrosis factor receptor in cerebrospinal fluid
timeFrame: Baseline
measure: Level of Neurofilament in cerebrospinal fluid
timeFrame: Baseline
measure: Level of GFAP in cerebrospinal fluid
timeFrame: Baseline
measure: Level of secreted glycoprotein in cerebrospinal fluid
timeFrame: Baseline
Secondary outcomes:
measure: Level of tumour necrosis factor receptor in serum
timeFrame: Baseline
measure: Level of Neurofilament in serum
timeFrame: Baseline
measure: Level of GFAP in serum
timeFrame: Baseline
measure: Level of secreted glycoprotein in serum
timeFrame: Baseline
measure: Comparison of the conversion time according to the threshold value of each biomarker for Radiologically Isolated Syndrome patients
timeFrame: Baseline
measure: Compare prognostic value of all four markers of the high risk criteria (age below 37, male, myelitis).
timeFrame: Baseline
measure: Biomarker levels in CSF and serum in different patient subpopulations (Radiologically Isolated Syndrome, recurrent remittent MS, symptomatic controls, central nervous system inflammatory disease controls, non-inflammatory disease controls)
timeFrame: Baseline
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU Nimes
Study officials:
affiliation: CHU Nimes
name: Eric Thouvenot
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06073587: The CARDIO-TTRansform Scintigraphy Sub-study
Official title: CARDIO-TTRansform ION-682884-CS2-Scintigraphy Sub-study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)
Keywords: TTR
Amyloidosis
Cardiomyopathy
Lead sponsor: Ionis Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
First posted: 2023-10-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants who were randomized in Study ION-682884-CS2 (NCT04136171) and who signed informed consent for the Scintigraphy sub-study will participate in this sub-study.

Brief summary: The purpose of this study is to examine the changes in amyloid myocardial burden in a subset of the population participating in the ION682884-CS2 (NCT04136171) study, up to 150 participants, after treatment with eplontersen or placebo based on scintigraphy scans performed at Week 140 using the Perugini grade score method.

Detailed description: Participants who were randomized in Study ION-682884-CS2 (NCT04136171) and have had a baseline scintigraphy scan will be offered the opportunity to participate in this sub-study which involves optional scintigraphy scans.

Eligibility criteria: Inclusion Criteria:

* Participants must have been properly randomized into the ION-682884-CS2 study (NCT04136171) and should have had a baseline scintigraphy scan (99mTc-DPD, 99mTc- PYP, and 99mTc-HMDP) within 12 months prior to screening for ION-682884-CS2 with planar and SPECT or SPECT/CT images that can be read by the central reader.

Exclusion criteria:

* Must not meet any of the exclusion criteria of the study protocol ION-682884-CS2 (NCT04136171).
* Must not have weight or body girth that exceeds the limits of the equipment specifications.
* Should not have any previously reported hypersensitivity reaction to Technetium-99m.

Primary outcomes:
measure: Changes From Baseline in Perugini Grading Score From Scintigraphy Scan Images at Week 140
timeFrame: Baseline up to Week 140
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Main Campus
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
Study officials:
References:
Clinical trial NCT02004587: Influence of Hepatic Impairment on Pharmacokinetic (PK) and Pharmacodynamic (PD) of Gemigliptin PK and PD After Multiple Oral Doses in Healthy White Volunteers
Official title: A Single-center, Open-label Trial, Investigating the Pharmacokinetics, Pharmacodynamics and the Safety Profile After a Single Oral Dose of Gemigliptin (Investigational Product) in Healthy Subjects and Subjects With Mild or Moderate Hepatic Impairment and After Multiple Oral Dose in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Impairment
Keywords: Hepatic impairment
Pharmacokinetics
Pharmacodynamics
Gemigliptin
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2013-12-09
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The trial will investigate the influence of hepatic function on the PK of gemigliptin. In an additional treatment period, the PK and safety of multiple dosing of gemigliptin in healthy White subjects will be investigated.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects who are able to understand and follow instructions during the study and available for study participation.
* Signed informed consent.
* White

Exclusion Criteria:

* Unwilling or unable to give informed consent.
* As a result of the medical screening process, a study physician considers the subject unfit for the study.
* The subject has a history of drug or other allergy which contraindicated study participation.
* Female subjects who are pregnant or lactating.
* Any other condition (surgical or medical) or history of severe disease with sequelae which increases the risk to the subject or affected absorption, distribution, metabolism or excretion of the study drug or otherwise

Primary outcomes:
measure: AUC
timeFrame: Several time points until 72hr
Secondary outcomes:
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: CRS Clinical Research Services
state: Schleswig-Holstein
Study officials:
References:
Clinical trial NCT03361787: A Multi-dimensional Program for Parents of Adolescents With High-functioning Autism
Official title: Efficacy of a Multi-dimensional Program for Parents of Adolescents With High-functioning Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: adolescents
parents
coaching
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Hebrew University of Jerusalem
First posted: 2017-12-05
Enrollment: 10
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to examine the initial efficacy of a multi-dimensional coaching intervention ("Parentship") for parents of adolescents with High Functioning Autism (HFASD).

The "Parentship" protocol is a short-term intervention program in occupational therapy that aims to promote parental resilience and enhance adolescents' participation in daily life.

Detailed description: "Parentship" is a structured occupational therapy intervention for promoting parental resilience and enhance adolescents' participation in daily life The Parentship protocol uses OPC (Graham \& Rodger, 2010) as the primary treatment approach. Its primary goal is to lead parents into recognition and understanding of their adolescent's multi-dimensional personal profile that includes sensorimotor, cognitive-behavioral, and social-communicative and personal factors, as required by the International Classification of Functioning (ICF) model (WHO, 2007).

The intervention will be administered by occupational therapists on an individual (or both parents) basis, once a week, over 3-4 months.

10-15 families will be recruited through community advertising. Data will be collected at the onset and completion of the intervention. Data will be analysed using quantitative and qualitative methods.

Adverse events, if occur, will be reported to supervising neurologist and the Helsinki Committee.

Eligibility criteria: Inclusion Criteria:

* ASD diagnosed by certified medical practitioner
* parent report regarding barriers to occupational performance/participation
* SP2 or BRIEF-Parent or SSIS scores reflecting at least 1 SD from typical

Exclusion Criteria:

* Diagnoses of severe neurological or psychiatric health condition.
* Instability in pharmacological treatment

Primary outcomes:
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: 3-4 months
measure: Autism: Parenting Questionnaire (APQ)
timeFrame: 3-4 months
Secondary outcomes:
measure: Clinical Assessment of Therapeutic Responses (CATR)
timeFrame: 1.5 months and 3 months
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah medical organization, Jerusalem Israel
Study officials:
References:
Clinical trial NCT01045187: Feasibility Study Using the Xoft System for the Treatment of Endometrial Cancer
Official title: Feasibility Study Using the Xoft Axxent Electronic Brachytherapy System for the Treatment of Endometrial Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Cancer
Keywords: endometrial cancer
Uterine cancer
electronic brachytherapy
Xoft
Lead sponsor: Xoft, Inc.
Sponsor class: INDUSTRY
First posted: 2010-01-08
Enrollment: 15
Sex: FEMALE
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: Multicenter, non-randomized, feasibility study to evaluate the treatment and assess acute safety of the FDA Cleared Axxent Electronic Brachytherapy System and vaginal applicator for intracavitary vaginal cuff treatment according to the physician's current standard of care.


Eligibility criteria: Inclusion Criteria:

* Most types of endometrial (uterine) cancer Stage I and Stage II (see exclusion criteria below)
* Post hysterectomy

Exclusion Criteria:

* Endometrial (uterine) cancer Stage IA Grade 1
* Scleroderma
* Collagen vascular disease
* Active Lupus

Primary outcomes:
measure: Assess Number of Patients Who Were Able to Complete Treatment Delivery Using the Axxent Electronic Brachytherapy System
timeFrame: through completion of radiation therapy
Secondary outcomes:
measure: Assess Acute Safety Outcomes in Patients During and After Vaginal Cuff Brachytherapy Treatment With the Axxent Electronic Brachytherapy System as Incorporated in to the Physician's Current Standard of Practice
timeFrame: through 3 month post treatment
measure: Assess Occurence Rate of Toxicities
timeFrame: through 3 month follow up post treatment
Other outcomes:
Locations:
city: Casa Grande
country: United States
facility: Cancer Treatment Services Arizona
state: Arizona
city: Phoenix
country: United States
facility: Southwest Oncology Center
state: Arizona
city: Montebello
country: United States
facility: Beverly Oncology & Imaging Medical Center, Inc
state: California
city: Chicago
country: United States
facility: Swedish Covenant Hospital
state: Illinois
city: Evergreen Park
country: United States
facility: Little Company of Mary Hospital
state: Illinois
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Little Company of Mary
name: Adam Dickler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dickler A, Puthawala MY, Thropay JP, Bhatnagar A, Schreiber G. Prospective multi-center trial utilizing electronic brachytherapy for the treatment of endometrial cancer. Radiat Oncol. 2010 Jul 20;5:67. doi: 10.1186/1748-717X-5-67.