louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00549484: Thrombopoietin Levels and Platelet Transfusion in Neonates
Official title: Thrombopoietin Levels Following Platelet Transfusion in Neonates With Thrombocytopenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thrombocytopenia
Keywords: Thrombocytopenia
Thrombopoietin
Platelet Transfusion
Platelet Factor 4
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
First posted: 2007-10-25
Enrollment: 20
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infants who require platelet transfusion

Brief summary: Infants who have low platelets and who require a platelet transfusion are included in this study. Platelet transfusions are routinely given to infants when their platelet count falls below a certain level. The study will look at the amount of platelets transfused. The purpose of the study is to evaluate the effect of platelet transfusions on the level of a protein (thrombopoietin) which is known to help control platelet production.

Detailed description: Thrombocytopenia, defined as a platelet count \< 150,000/mm3, is a very common hematologic problem in the neonatal period. Multiple etiologies are known to be associated with thrombocytopenia in neonates. Thrombopoietin (TPO) is known to be the central regulator of megakaryocyte and platelet production in adults and infants. However, the role of TPO in neonatal platelet regulation is not well understood. TPO levels have been shown to be higher in neonates with thrombocytopenia, with a decrease in TPO after resolution of the thrombocytopenia. The response of TPO levels in neonates after platelet transfusion has never been studied. In addition, the optimal volume of platelet transfusions has never been studied in neonates. This study will evaluate the response to 2 different volumes of platelet transfusion.

We hypothesize that a decrease in plasma TPO levels will be seen following a platelet transfusion in a population of neonates with thrombocytopenia. We also hypothesize that a platelet transfusion of 15 mL/kg will result in a greater rise in platelet count than a transfusion pf 10 mL/kg of platelets.

Eligibility criteria: Inclusion Criteria:

* Preterm infants with thrombocytopenia
* Decision made by medical team to transfuse with platelets

Exclusion Criteria:

* Infants with major congenital malformations

Primary outcomes:
measure: Reduction in TPO levels following platelet transfusion
timeFrame: Within 36 hours of transfusion
Secondary outcomes:
measure: Platelet rise following platelet transfusion in 10 mL/kg versus 15 mL/kg.
timeFrame: Within 36 hours after platelet transfusion
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Hospital
state: Delaware
Study officials:
affiliation: Christiana Hospital
name: Alex Kline, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Christiana Hospital
name: David A. Paul, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01299584: ULTIVA Post Marketing Surveillance
Official title: A Post Marketing Surveillance to Monitor the Safety of ULTIVA (Remifentanil) Adminstered in Korean Subjects According to the Prescribing Information
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Analgesia
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-02-18
Enrollment: 775
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The subjects are patients prescribed for Remifentanil by the investigators at the sites based on prescription information in normal clinical practices.

Brief summary: This study is a post-marketing surveillance to monitor safety and efficacy of remifentanil during various surgeries and identify SAEs, adverse drug reactions, and unexpected AEs not described as precautions or warnings and to identify prognostic factors that have an effect on the AEs and to assess effectiveness of remifentanil in real clinical practices after marketing.

The subjects are patients prescribed for remifentanil by the investigators at the sites based on prescription information in normal clinical practices.


Eligibility criteria: Inclusion Criteria:

* Patients requiring general anesthesia

Exclusion Criteria:

* According to precautions or warnings on PI, remifentanil should not be administered to the following patients
* Patients with any allergic reaction to any ingredients of remifentanil or other fentanyl analogues

Primary outcomes:
measure: Number of Participants With an Unexpected Serious Adverse Event
timeFrame: 24 hours
Secondary outcomes:
measure: Number of Participants With an Adverse Event
timeFrame: 24 hours
measure: Number of Participants With a Serious Adverse Event
timeFrame: 24 hours
measure: Number of Participants With the Indicated Unexpected Adverse Event
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02667184: The Effect of a Low FODMAP Oral Nutrition Supplement On Breath Hydrogen Response In Healthy Human Subjects
Official title: The Effect of a Low FODMAP Oral Nutrition Supplement On Breath Hydrogen Response In Health Human Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Selection
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2016-01-28
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The goal of this study is to determine subjective gastrointestinal tolerance response and differences in breath hydrogen response following the consumption of different types of low FODMAP oral nutrition supplements. This randomized, crossover study requires participants to arrive to the lab 12 hours fasted, consume an oral liquid supplement and complete gastrointestinal tolerance questionnaires as well as produce samples for breath hydrogen analysis at various time points over a 4 hour time period.

Detailed description: This randomized, crossover study requires participants to arrive to the lab 12 hours fasted, consume an oral liquid supplement and complete gastrointestinal tolerance questionnaires as well as produce samples for breath hydrogen and methane analysis at various time points over a 4 hour time period. Subjects will also be asked to rate gastrointestinal symptoms via a questionnaire at various time points throughout the study.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 18-65 years with a body mass index between 18-29 kg/m2.
* Demonstrates spoken and written English literacy and able to provide written, informed consent after review of study protocol and procedures.

Exclusion Criteria:

* Use of enemas, proton pump inhibitors, or antibiotics within the past 3 months
* Smoker
* Not a regular breakfast eater
* Self-reported history of a past or current gastrointestinal disease
* High fiber eater (\> or = to 3 servings of high fiber foods per day)
* Concurrent or recent (within 30 days) participation in an intervention trial
* Recent weight fluctuations
* Allergies to any of the test products

Primary outcomes:
measure: Breath hydrogen response
timeFrame: baseline
measure: Breath hydrogen response
timeFrame: 60 minutes
measure: Breath hydrogen response
timeFrame: 120 minutes
measure: Breath hydrogen response
timeFrame: 240 minutes
Secondary outcomes:
measure: Gastrointestinal tolerance
timeFrame: 48 hours
Other outcomes:
Locations:
city: St. Paul
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Joanne Slavin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Erickson J, Korczak R, Wang Q, Slavin J. Gastrointestinal tolerance of low FODMAP oral nutrition supplements in healthy human subjects: a randomized controlled trial. Nutr J. 2017 May 25;16(1):35. doi: 10.1186/s12937-017-0256-3.
Clinical trial NCT00005684: Oral Anticoagulant Therapy for Venous Thrombosis - SCOR in Thrombosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thrombosis
Cardiovascular Diseases
Venous Thromboembolism
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE

Brief summary: To perform a randomized clinical trial comparing continuing one month of treatment with heparin in patients with deep venous thrombosis to standard care using heparin for five days and oral warfarin for three months.

Detailed description: BACKGROUND:

The study, a subproject within a SCOR in Thrombosis, should help to improve the long-term clinical outcome of patients with proximal deep-vein thrombosis (popliteal, femoral or iliac vein thrombosis) by improving their survival and reducing morbidity from recurrent thromboembolic events, and should help to determine if one or more specific biochemical measures, including antiphospholipid antibodies and activated factor VII, will define a subset of patients at increased risk of recurrent venous thromboembolism.

The study is part of a SCOR in Hemostatic and Thrombotic Diseases, the RFA for which was released by the NHLBI in April 1994.

DESIGN NARRATIVE:

Warfarin Trial

A multicenter, randomized clinical trial was conducted from March 1996 through January 2001 comparing warfarin therapy for three years to warfarin therapy for three months. The study was performed at thirteen participating hospitals in Oklahoma. The 600 hundred patients were recruited, randomized to either warfarin therapy for three years or warfarin therapy for three months and followed for at least three years. The primary outcome measure was total mortality. Secondary outcome measures included vascular death, objectively documented recurrent venous thromboembolism, and bleeding complications (major and minor). Additional specific aims included: determining the prevalence of antiphospholipid antibodies, antithrombomodulin antibodies, and activated protein C resistance in consecutive patients with proximal-vein thrombosis; determining if these measures, and/or the level of activated factor VII were associated with an increased risk of recurrent venous thromboembolic events, and if so, whether these events were reduced by continuing long term warfarin treatment. These latter specific aims were achieved by performing the laboratory parameters concurrently in patients entered into the clinical trial, and relating these measures to the clinical outcomes on long-term follow-up.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Oklahoma Medical Research Foundation
name: Gary Raskob
References:
Clinical trial NCT05332184: Cardiac T1 Mapping Enables Risk Prediction of LV Dysfunction After Surgery for Aortic Regurgitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Regurgitation
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2022-04-18
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 40 consecutive AR patients referred for aortic valve surgery were included.

Brief summary: To assess whether cardiac T1 mapping for detection of myocardial fibrosis enables preoperative identification of patients at risk for early left ventricular dysfunction after surgery of aortic regurgitation.

Detailed description: We hypothesized that a diffuse interstitial myocardial fibrosis may be present in AR patients who experience early systolic LV dysfunction after aortic valve surgery. We aimed to evaluate the association between preoperative cardiac T1 mapping for detection of myocardial fibrosis and early systolic LV dysfunction after surgery for aortic regurgitation.

Eligibility criteria: Inclusion Criteria:

* Consecutive patients with severe aortic regurgitation referred for aortic valve surgery were prospectively enrolled in the study.

Exclusion Criteria:

* history of coronary artery disease
* acute aortic valve disease (i.e., type A aortic dissection or infectious endocarditis)
* common contraindications for MRI such as severe obesity and metallic foreign bodies.

Primary outcomes:
measure: Native T1
timeFrame: baseline (Prior surgery)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06901284: Graded Exercise Hypoxia Testing
Official title: Graded Exercise Hypoxia Testing
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypoxia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 50 participants (25 female, 25 male) will be recruited for this study. Participants will be recruited from the general population.

Brief summary: The purpose of this study is to develop a single, standardized test to determine how individuals tolerate acute hypoxia in a stepwise fashion. We aim to evaluate the association between multiple factors, such as ventilatory compensation, heart rate response, acid-base changes, sex, pulmonary function, etc, which may explain why some individuals tolerate exercise in hypoxia better than others. Identifying these factors of association will inform future pharmacological and non-pharmacological attempts to combat acute hypoxic exercise.


Eligibility criteria: Inclusion Criteria:

• Physically active (≥150 minutes of moderate physical activity per week)

Exclusion Criteria:

* Contraindications to exercise testing
* Currently pregnant
* Musculoskeletal or metabolic disease
* Allergies to lidocaine
* Body-mass index ≤18 or ≥35 kg·m-2
* Pacemaker
* No confounding cardiorespiratory disease
* Persistent tobacco use (\>15 pack years)

Primary outcomes:
measure: PaO₂/FiO₂ Ratio
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Rochester
country: United States
facility: St. Mary's Hospital
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Michael Joyner, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03807284: Regaining Confidence After Stroke a Feasibility Randomised Controlled Trial
Official title: Evaluating the Feasibility of a Regaining Confidence After Stroke Course (RCAS) to Facilitate Adjustment for People With Stroke Discharged From Rehabilitation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Feasibility
Confidence
group intervention
Psycho-social intervention
Stroke recovery
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2019-01-16
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A parallel group two arm feasiblity randomised controlled trial with 1:1 allocation in a single centre, comparing eleven week RCAS Course in addition to usual care, to usual care alone.
Primary purpose: TREATMENT

Brief summary: The Regaining Confidence after Stroke Course (RCAS) is a group therapy intervention to evaluate the feasibility of conducting a definitive trial, aimed to facilitate adjustment for people with stroke discharged from rehabilitation, compared with usual care. The study also aimed to evaluate the feasibility of improving mood and coping in carers of the course participants.

Detailed description: The Regaining Confidence after Stroke Course (RCAS) is an is an eleven week group intervention that is designed to help stroke survivors when they have finished rehabilitation to improve confidence in daily life. This feasibility study aimed to evaluate the acceptability of the course in improving confidence, mood, adjustment and increasing activity levels in stroke survivors as well as improving mood and coping in their carers.

Eligibility criteria: Inclusion Criteria:

* A clinical diagnosis of stroke within two years
* Discharged from all other rehabilitation therapies
* Not involved in trials of other psychological interventions
* Not previously attended an RCAS course

Exclusion Criteria:

* Score of \<10 on the Barthel Index (sufficiently independent to cope in a group setting)
* Score \<8 on the Sheffield Screening test for Acquired Language Disorders so that participants would be able to understand the materials being presented
* Unable to speak English
* Unable to give informed consent

Primary outcomes:
measure: Number of participants recruited to the trial
timeFrame: One year recruitment period
measure: Number of participants who completed the trial
timeFrame: End of Study
Secondary outcomes:
measure: Mood
timeFrame: Baseline, 3 and 6 months follow up
measure: Activity
timeFrame: Baseline, 3 and 6 months follow up
measure: Level of Confidence
timeFrame: Baseline, 3 and 6 months follow up
measure: Coping
timeFrame: Baseline, 3 and 6 months follow up
measure: Carers strain
timeFrame: Baseline, 3 and 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02652884: Steroids in the Postoperative Transient Hypoparathyroidism Total Thyroidectomy
Official title: Evaluation of Potential Benefits of Using Steroids in the Postoperative Transient Hypoparathyroidism Total Thyroidectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Transient Hypoparathyroidism
Keywords: transient hypoparathyroidism
steroids
total thyroidectomy
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2016-01-12
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The incidence of thyroid cancer (TC) has increased exponentially worldwide. The increase in diagnosed cases brings about an increase in the number of surgeries performed on the thyroid gland, especially total thyroidectomy (TT), given that at present is still the gold standard of treatment.

Transient postoperative hypoparathyroidism (HPT) is one of the most frequent complications, with an incidence of between 10 and 46% according to different sources. HPT involves longer hospital stay, serial measurements of blood glucose, treatment with calcium and vitamin D (with potential risk of hypercalcemia) and therefore an increase in terms of the costs of the health system.

While the investigators know the analgesic, anti-inflammatory, immunomodulatory and anti emetic of corticosteroids in thyroid surgery, the literature available to date is discordant in the use of steroid and its interaction with the HPT making clear the need for randomized clinical trials specific to analyze these variables more accurately.

As inflammation and edema constitute a proposed surgical manipulation in the pathogenesis of HPT component, investigators decided t conduct a prospective randomized, triple-blind, in order to assess the potential benefits of the most common postoperative complication reported in TT.

Our primary objective is to evaluate the safety and efficacy of single-dose corticosteroids deposit immediately postintubation in preventing the development of transient hypoparathyroidism (PTH, serum calcium and symptoms) in patients after TT.

Detailed description: Triple-blind randomized clinical trial

Eligibility criteria: Inclusion Criteria:

* adult
* thyroidectomy postoperative
* prepaid affiliate patients

Exclusion Criteria:

* allergy
* CKD
* idiophatic thrombocytopenic purpura
* hyperthyroidism
* chronic use of corticoids
* no follicular cancer, nonpapillary
* refusal to participate

Primary outcomes:
measure: Postoperative Hypocalcemia
timeFrame: 3 days
Secondary outcomes:
measure: Related Adverse Events
timeFrame: 30 days
Other outcomes:
Locations:
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
Study officials:
affiliation: Hospital Italiano de Buenos Aires
name: Juan Achaval, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Italiano de Buenos Aires
name: Figari Marcelo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03672084: Allo-HSCT as First-line Consolidation in High-risk PTCL
Official title: Allogeneic Hematopoietic Stem Cell Transplantation Following Conventional Chemotherapy in High Risk Peripheral T Cell Lymphoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: T Cell Lymphoma
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2018-09-14
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Mature T-cell lymphoma patietnts, stage 2-4, or stage 1 with aa IPI\>=0

* age \<= 60 years
* KPS\>=70

Brief summary: Results of conventional therapy in patients with peripheral T-cell lymphoma(PTCL) are poor. Allogeneic hematopoietic stem cell transplantation(allo-HSCT) gave excellent results in PTCL after failure of conventional therapy and in many cases also of HDT/ASCT. A disadvantage of allo-HSCT is high TRM rate, especially in refractory or relapsed patients. Another limitation to the use of allo-HSCT is the availability of a HLA matched donors. Haploidentical family donors have been successfully used in treatments of hematologic malignancies, including malignant lymphomas. Thus, allo-HSCT could be used as first-line consolidation following conventional chemotherapy in high-risk PTCL patients. The study hypothesis: Using allo-HSCT as consolidation following chemotherapy in high-risk PTCL exerts a strong anti-lymphoma effect and could increase response rate and improve long term survival.

Detailed description: After primary diagnosis eligible patients receive 2 to 3 courses of CHOEP-21 with formal restaging after course 2. Patients with CR, PR or no change proceed to allo-HSCT. Donor selection: Matched sibling donor(MSD) is the first choice. An unrelated donor or haploidentical family donor search is performed in patients without sibling donor. The primary end point was 1 year progression-free survival. The secondary end points were complete commission rate, transplant-related mortality, overall survival, relapse rate and graft-versus-host disease (GVHD) . Following time is 2 years

Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of mature T-cell lymphoma, stage 2-4, or stage 1 with aa IPI\>=0
* age \<= 60 years
* KPS\>=70

Exclusion Criteria:

* stage I with aaIPI 0, ALCL ALK positive, T-lymphoblastic lymphoma, cutaneous T-cell lymphoma
* HIV positivity
* major organ dysfunction
* pregnancy
* patient unable to give informed consent

Primary outcomes:
measure: 1 year PFS
timeFrame: participants will be follow for an expected average of 365 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
Study officials:
affiliation: Peking University
name: Xiao-Jun Huang, MD
role: PRINCIPAL_INVESTIGATOR
References: