louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00705692: Effect of Levamisole Supplementation on Tetanus Vaccination Response Rates in Hemodialysis Patients
Official title: Effect of Levamisole Supplementation on Tetanus Vaccination Response Rates in Hemodialysis Patients: A Randomized Double-Blind Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Dialysis
Keywords: Tetanus
Vaccines
Renal Dialysis
Levamisole
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2008-06-26
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Levamisole as an immunomodulator drug has been demonstrated to improve the immune response to Hepatitis B virus (HBV) vaccination in hemodialysis patients. The aim of this study was to evaluate the effect of levamisole supplementation on tetanus-diphtheria (Td) vaccine response rate in hemodialysis patients.

Detailed description: Levamisole as an immunomodulator drug has been demonstrated to improve the immune response to HBV vaccination in hemodialysis patients. The aim of this study was to evaluate the effect of levamisole supplementation on Td vaccine response rate in hemodialysis patients. In this randomized double-blind placebo-controlled trial 40 hemodialysis patients who had not received tetanus vaccination in a year before investigation and had unprotective anti-tetanus immunoglobulin G (IgG) levels (\<0.1 International Unit \[IU\]/ml) were enrolled. These patients were randomized into two equal groups to receive one dose of intramuscular Td vaccine supplemented with either levamisole 100 mg or placebo daily, six days before and six days after vaccination. The anti-tetanus IgG levels were measured 1 and 6 months after vaccination.

Eligibility criteria: Inclusion Criteria:

* being under regular hemodialysis for more than 3 months
* unprotective baseline levels of antitetanus IgG

Exclusion Criteria:

* tetanus diphtheria (Td) vaccination in past year
* leukopenia (WBC\<1500 cells/mcL)
* immunosuppressive drug exposure in past 2 months
* recent hospitalization or history of transfusion of blood products in the past 3 months.

Primary outcomes:
measure: tetanus seroconversion rate
timeFrame: 1 month and 6 month post vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Faghihi Hospital Hemodialysis Center, Shiraz University of Medical Sciences
state: Fars
Study officials:
affiliation: Shiaz University of Medical Sciences
name: Mohamad Mahdi Sagheb, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fallahzadeh MK, Sajjadi S, Singh N, Khajeh M, Sagheb MM. Effect of levamisole supplementation on tetanus vaccination response rates in haemodialysis patients: a randomized double-blind placebo-controlled trial. Nephrology (Carlton). 2014 Jan;19(1):27-31. doi: 10.1111/nep.12158.
Clinical trial NCT02200692: Allergic Transfusion Reactions in Plasma Transfusion
Official title: Risk Factors for Allergic Transfusion Reactions in Patients Receiving Plasma Transfusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergy
Transfusion Reaction
Keywords: plasma transfusion
allergic transfusion reaction
transfusion reaction
blood transfusion
Solvent detergent plasma
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2014-07-25
Enrollment: 38
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: Patients receiving plasma transfusion, mainly in relation to cardiac surgery

Brief summary: Allergic transfusion reactions are a common complication of transfusion by blood components containing plasma. This study aims to investigate passive transfer of Immunoglobin E antibodies as a risk factor of allergic reactions to plasma transfusion by use of Solvent Detergent plasma.

Detailed description: Prospective observation study, aiming to measure transfer of Immunoglobin E antibodies and other factors associated with allergic complications in patients receiving plasma transfusion. Samples from patients and plasma units will be investigated. Samples frozen until investigation. To assess biological relevance of findings, additional analysis of basophil reactivity will be performed and information on clinical allergy collected by use of a questionaire .

In-patients will be recruited if receiving plasma transfusion during surgery or if an allergic transfusion complication occurs.

Eligibility criteria: Inclusion Criteria:

* Patients receiving plasma transfusion

Exclusion Criteria:

- Patients not able to complete sampling procedure

Primary outcomes:
measure: Change from baseline in concentration of allergen specific Immunoglobin E antibodies
timeFrame: Baseline and up to 8 weeks
Secondary outcomes:
measure: Change from baseline in basophil reactivity measured by flow cytometry
timeFrame: Baseline and up to 8 weeks
Other outcomes:
measure: Number of patients with Serious and Non-Serious Adverse Events
timeFrame: Up to 8 weeks after transfusion
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: Helse Bergen HF, Haukeland University Hospital
name: Torunn O Apelseth, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02643992: Per-procedural Concentration of Direct Oral Anticoagulants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Per-procedural Concentrations of Oral Anticoagulants
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2015-12-31
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient undergoing invasive procedure and treated with DOAC

Brief summary: Background: Peri-procedural management of direct oral anticoagulants (DOAC) is challenging. The optimal duration of pre-procedural discontinuation that guarantees a minimal DOAC concentration (\[DOAC\]) at surgery is unknown. The usual 48-hour discontinuation might not be sufficient for all patients.

Objectives: To investigate the factors associated with per-procedural \[DOAC\]. To test the hypothesis that a 48-hour DOAC discontinuation is not sufficient to ensure a minimal perprocedural \[DOAC\], defined as \[DOAC\] \< 30 ng/mL.

Methods: Patients treated with DOAC, and requiring any invasive procedure will be included in this multicentre, prospective, observational study. \[DOAC\], will be measured during invasive procedure.


Eligibility criteria: Inclusion Criteria:

* patient over 18 years-old
* undergoing invasive procedure
* treated with DOAC

Exclusion Criteria:

* none

Primary outcomes:
measure: DOAC concentration
timeFrame: beginning of invasive procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild (FOR)
Study officials:
References:
citation: Godier A, Martin AC, Lessire S, Mullier F, Leblanc I, Gouin-Thibault I. Concentrations of direct oral anticoagulants according to guidelines for the periprocedural management of low bleeding risk procedures. Anaesth Crit Care Pain Med. 2020 Feb;39(1):121-122. doi: 10.1016/j.accpm.2019.04.004. Epub 2019 Apr 13. No abstract available.
Clinical trial NCT02131792: Early Results of Slanted Recession of the Lateral Rectus Muscle for Intermittent Exotropia With Convergence Weakness
Official title: Early Results of Slanted Recession of the Lateral Rectus Muscle for Intermittent Exotropia With Convergence Weakness; A Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intermittent Exotropia
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2014-05-06
Enrollment: 31
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was conducted to evaluate results of slanted recession of the lateral rectus muscle for intermittent exotropia with convergence weakness

Detailed description: This prospective study included 31 patients who underwent slanted lateral rectus muscle recession for intermittent exotropia with convergence weakness. Measurements of preoperative and postoperative deviation angle, stereopsis was performed.

Eligibility criteria: Inclusion Criteria:

* Patients with intermittent exotropia greater at near than at distance by 10 prism diopters or more
* Patients with follow up duration greater than 6 months

Exclusion Criteria:

* Patients with previous ocular or strabismus surgery
* Patients with ocular or neurologic pathologic conditions
* Follow up duration less than 6 months

Primary outcomes:
measure: Changes from baseline of exodeviations angle after slanted recession surgery at 6 months.
timeFrame: preop, 6months postop
Secondary outcomes:
measure: Changes from baseline of near-distance difference after slanted recession surgery at 6 months
timeFrame: preop, 6 months postop
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Bo Young Chun
state: Kyungsangpookdo
Study officials:
affiliation: Kyungpook National University Hospital
name: Bo Young Chun, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02831192: Microtransplantation in Older Patients With Acute Myeloid Leukemia
Official title: International Multi-center Clinical Study on Microtransplantation for Treatment of Newly Diagnosed Elderly Acute Myeloid Leukemia (EAML)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Lead sponsor: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Sponsor class: OTHER
First posted: 2016-07-13
Enrollment: 150
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see whether HLA-mismatched donor cells infusion with chemotherapy (microtransplantation，MST) could increase complete remission (CR) and improve survival in older patients with acute myeloid leukemia (AML)，the investigators conducted a prospective, multicenter clinical trial of HLA-mismatched MST to estimate outcomes and toxicities.


Eligibility criteria: Inclusion Criteria:

* de novo acute myeloid leukemia
* age 60-90
* have HLA mismatched donor

Exclusion Criteria:

* have no suitable donor or donor refused
* patient refused to accept donor cells

Primary outcomes:
measure: Graft versus host disease
timeFrame: 1 month
Secondary outcomes:
measure: overall survival
timeFrame: 2 years
measure: leukemia free survival
timeFrame: 2 years
measure: complete remission rate
timeFrame: 2 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Affiliated Hospital of Academy of Military Medical Sciences ,
state: Beijing
Study officials:
affiliation: Affiliated Hospital of Academy of Military Medical Sciences
name: AI huisheng, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00541892: Sibling Oocyte Study of Medium for In Vitro Fertilization/Intracytoplasmic Sperm Injection (IVF/ICSI) With no Human Serum Albumine
Official title: Sibling Oocyte Study of Medium for IVF/ICSI With no Human Serum Albumine
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: In Vitro Fertilization
Infertility
Keywords: Cell Culture Techniques
Lead sponsor: Sykehuset Telemark
Sponsor class: OTHER_GOV
Collaborators: name: Cellcura AS
name: Vekst i Grenland
name: Innovation Norway
First posted: 2007-10-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 38
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 if a new medium with no human serum albumine added is as good as the media conventionally used for IVF/ICSI.

Detailed description: Cells attained in IVF/ICSI procedures are kept in a medium that nurture the cells. Until now all such media have contained human serum albumine. The purpose of this study is to determine if a new medium with no human serum albumine added is as good as the media conventionally used for IVF/ICSI.

Eligibility criteria: Inclusion Criteria:

* Couples seeking IVF/ICSI.
* Female under 38 years of age.
* No more than two previous IVF/ICSI treatments without pregnancy.
* Regular menstruation periods.
* No endocrine disease that requires treatment in the female.
* BMI below 30 in the female.
* At least 8 mature follicles upon monitoring or 6 MII oocytes upon ICSI.
* Written informed consent.

Exclusion Criteria:

* Low responders to FSH.
* Females in danger of developing OHSS.
* Sperm sample below ICSI-quality.

Primary outcomes:
measure: Fertilization
timeFrame: 24 hours
measure: Cleavage
timeFrame: 48 hours
measure: Embryo score
timeFrame: 48 hours
measure: Embryos used
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Porsgrunn
country: Norway
facility: Fertilitetsklinikken Sør
state: Telemark
Study officials:
affiliation: Fertilitetsklinikken Sør
name: Jarl Kahn, Dr. Med
role: STUDY_DIRECTOR
References:
Clinical trial NCT00092092: Study of Montelukast and Its Effect on Lower Leg Growth in Children With Asthma (MK-0476-254)
Official title: A Double-Blind, Double-Dummy, Randomized, Placebo-Controlled, 2-Arm, 2X2 Crossover Study Comparing the Effects of Montelukast, Inhaled Budesonide, and Placebo on Lower Leg Growth in Children (Prepubertal, Tanner Stage I) With Mild Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma, Bronchial
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2004-09-24
Enrollment: 71
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of montelukast, an approved medication, on the lower leg growth rate in children with mild asthma. The primary hypothesis is that the lower leg length (LLL) growth rate for children treated with montelukast compared to placebo will be established.

Detailed description: This is a crossover study that consists of a 2-week placebo run-in period, then a first 3-week treatment period, then a 2-week washout period, and then a second 3-week treatment period. Participants will be randomized to treatment with either montelukast and placebo or budesonide and placebo. The duration of treatment is 6 weeks.

Eligibility criteria: Inclusion Criteria:

* A 6-month history of asthma with periodic episodes requiring treatment.

Exclusion Criteria:

* Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection.

Primary outcomes:
measure: Short-term lower-leg growth rate (LLGR)
timeFrame: Baseline and Week 3
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Pedersen S, Agertoft L, Williams-Herman D, Kuznetsova O, Reiss TF, Knorr B, Dass SB, Wolthers OD. Placebo-controlled study of montelukast and budesonide on short-term growth in prepubertal asthmatic children. Pediatr Pulmonol. 2007 Sep;42(9):838-43. doi: 10.1002/ppul.20666.
Clinical trial NCT01064492: A Phase 1 Study To Estimate The Relative Bioavailability And Food Effect Of PF-04620110 In Healthy Adult Subjects
Official title: A Phase 1, Cross-Over, Single-Dose, Open-Label Study To Estimate The Relative Bioavailability And Food Effect Of PF-04620110 In Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-02-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: PF 04620110 is an acylCoA:diacylglycerol acyltransferase 1 (DGAT1) inhibitor that is being developed for the treatment of type 2 diabetes mellitus (T2DM). It is anticipated that PF 04620110 will have anti diabetic effects through inhibition of intestinal triglyceride absorption and potentially weight loss. The primary purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of multiple oral formulations of PF 04620110 administered to healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
* Women must be of non childbearing potential.
* Body Mass Index (BMI) of 17.5 to 35.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* A positive urine drug screen.

Primary outcomes:
measure: Pharmacokinetic Endpoints: Cmax, Tmax, AUClast, AUCinf, and half life, as the data permit.
timeFrame: following each treatment
Secondary outcomes:
measure: Safety Endpoints: Safety and tolerability of PF 04620110 will be assessed by physical examinations, adverse event monitoring, 12 lead ECGs, vital sign, and clinical safety laboratory measurements.
timeFrame: before, during, and following treatment
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01405092: Continuous Versus Conventional Volume Management During CRRT (Continuous Renal Replacement Therapy)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Continuous Renal Replacement Therapy
Keywords: volume
acute kidney injury
continuous renal replacement
Lead sponsor: Dallas VA Medical Center
Sponsor class: FED
First posted: 2011-07-29
Enrollment: 28
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Use of on-line blood volume monitoring during continuous renal replacement therapy can improve volume management in acute kidney injury patients requiring renal replacement


Eligibility criteria: Inclusion Criteria:

* Patients with kidney injury requiring continuous renal replacement therapy and volume removal

Exclusion Criteria:

* unable to provide or obtain patient consent
* not expected to survive 48 hours

Primary outcomes:
measure: compare number of hypotensive events in treatment versus control arms
timeFrame: 24 hour for each arm
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
Study officials:
References:
Clinical trial NCT03054792: Molecular-Functional Imaging of Hypoxia in Childhood Sarcomas
Official title: Molecular-Functional Imaging of Hypoxia in Childhood Sarcomas: Feasibility Steps Toward Personalized Medicine.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
Conditions: Rhabdomyosarcoma
Non-Rhabdo. Soft Tissue Sarcoma
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2017-02-16
Enrollment: 18
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study will test the feasibility of using novel/existing imaging technologies focused on hypoxia measurements to determine "response to therapy" in pediatric soft tissue sarcomas as a pilot study. Specifically, the investigators will compare the sensitivity of Blood Oxygen Level Dependent \[BOLD\], Diffusion-Weighted \[DW\] MRI and Magnetic Resonance Spectroscopy (MRS) with that of conventional MRI to detect measurement changes between the start and completion of neoadjuvant therapy ("response to therapy") in children and adolescents (6-18 years) with suspicion of sarcoma tumors. Clinicians and scientists may use results of the proposed hypoxia-imaging surrogate markers to adjust/modify therapeutic schemes to patients on a personalized basis.


Eligibility criteria: Inclusion Criteria:

* Referred with a confirmed or suspected sarcoma tumor (rhabdomyosarcoma \[RMS\] or non-rhabdomyomatous sarcoma) presenting with an extra-osseous component;
* Candidate for neoadjuvant therapy that will consist of standard systemic chemotherapy with or without radiation therapy

Exclusion Criteria:

* Patients with general contraindications for an MRI scan (metal foreign body, pacemaker, inability to tolerate an examination without sedation);
* Patients with a known immunodeficiency/sickle cell disease/collagen vascular disease/another malignancy;
* Patients with no clinical indication for neoadjuvant therapy prior to surgery;
* Patients with chronic pulmonary disease;
* Patients with other diagnosis confirmed after initial suspicion of RMS or non-RMS.

Primary outcomes:
measure: Number of participants with response to therapy
timeFrame: 1 year
Secondary outcomes:
measure: Associations between post-neoadjuvant therapy imaging measurements and surgical / histochemical outcomes in the residual tumor.
timeFrame: 1 year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
References: