louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00004744: Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
neurologic and psychiatric disorders
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Mayo Clinic
First posted: 2000-02-25
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Determine whether high-dose intravenous immune globulin (IVIG) is more effective than placebo in restoring neurologic function (muscle strength) in patients with multiple sclerosis.

II. Determine the time to recovery following IVIG.

Detailed description: PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are treated with intravenous immune globulin or placebo. In the absence of a hypersensitivity reaction to a test dose, a total of 11 doses is administered: daily for 5 days, then every 2 weeks for 12 weeks.

Patients are followed at 3 months.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Clinically or laboratory-supported definite multiple sclerosis
* Disease relapsing-remitting or relapsing-progressive (i.e., secondary- progressive)
* Targeted neurologic deficit as follows: 25% or more loss of power in at least 1 limb Severity -1 or greater on Mayo Clinic rating scale OR Between 3+/5 and 4-/5 on Medical Research Clinic muscle power scale
* Documented by Mayo Clinic Department of Neurology as neither progressing nor improving for 4 to 18 months prior to entry No clinical evidence of spontaneous or corticosteroid-induced improvement
* Able to cooperate with isometric strength testing requirements

--Prior/Concurrent Therapy--

* No concurrent experimental drug therapy
* No concurrent intravenous immune globulin At least 3 months since immunosuppressive therapy, e.g., corticosteroids and corticotropin
* At least 3 months since plasma exchange

--Patient Characteristics--

* Hepatic: No coagulation defect, e.g., hyperviscosity syndrome
* Renal: Creatinine no greater than 1.5 times normal
* Cardiovascular: No unstable or advanced ischemic or cerebrovascular disease, e.g.: angina congestive heart failure transient ischemic attack stroke
* Immunologic: No human gamma globulin or albumin sensitivity No hypergammaglobulinemia No known antibody deficiency syndrome, especially IgA deficiency

Other:

* No condition interfering with neurologic exam, e.g.:
* Major amputation
* Deforming arthritis
* Major psychiatric illness
* Superimposed lower motor neuron deficit
* No intellectual impairment precluding study participation
* No pregnant or nursing women
* Adequate contraception required of fertile patients

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: John H. Noseworthy
role: STUDY_CHAIR
References:
Clinical trial NCT01639144: Use of Platelet-Rich Plasma (PRP) and Platelet-Poor Plasma (PPP) to Prevent Infection and Delayed Wound Healing
Official title: Use of Platelet-Rich Plasma (PRP) and Platelet-Poor Plasma (PPP) to Prevent Infection and Delayed Wound Healing After Elective Foot and Ankle Surgery in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elective Foot and Ankle Surgery.
Keywords: Infection
delayed wound healing
platelet-rich plasma
Lead sponsor: UHZ Sports Medicine Institute
Sponsor class: OTHER
First posted: 2012-07-12
Enrollment: 515
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: PREVENTION

Brief summary: The purpose of this study is to see if applying PRP and PPP to surgical sites and the closing incision helps prevent infection and slow wound healing.

Detailed description: This will be a prospective, randomized study with patients blinded to either receiving platelet-rich plasma (PRP) and platelet-poor plasma (PPP) treatment or no treatment. We hypothesize that the antimicrobial properties of PRP and barrier properties of PPP (acting like a tissue sealant) will serve to inhibit deep incisional surgical site infection and help prevent delayed wound healing within 60 days of surgery. Thus, the incidence of infection and delayed wound healing will be lower in patients receiving PRP and PPP compared to patients who do not receive PRP and PPP. However, due to clinical equipoise, we do not know for certain that PRP and PPP is truly effective. The cost of preparing PRP and PPP is substantial, and involves a blood draw that would not otherwise be done. Thus, it is important to know if this treatment is effective or not.

Eligibility criteria: Inclusion Criteria:

* Elective foot and ankle surgery.

Exclusion Criteria:

* Younger than 18 years, older than 80 years of age.

Primary outcomes:
measure: Postoperative Infection and Delayed Wound Healing.
timeFrame: Infection: 30 days after surgery. Delayed wound healing: 60 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: UHZ Sports Medicine Institute
state: Florida
Study officials:
affiliation: Center for Research & Grants
name: Gary M Kiebzak, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01542944: TevaGastrim for Stem Cell Mobilization Sibling Donors
Official title: TevaGastrim for Stem Cell Mobilization of HLA Matched Sibling Donors for Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndrome (MDS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Myelodysplastic Syndrome
Keywords: Acute myeloid leukemia
Myelodysplastic syndrome
Stem Cell Mobilization
Allogeneic Stem Cell Transplantation
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-03-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the efficacy of TevaGastrim which is a biosimilar version of Filgrastim recombinant human G-CSF (G-CSF) in mobilizing sufficient number of stem cells from normal sibling donors for allogeneic stem cell transplantation.


Eligibility criteria: Inclusion Criteria:

1. Age between 18 and 70 years.
2. Normal sibling donor that is HLA matched to a patient with AML or MDS that needs and is eligible for allogeneic stem cell transplantation
3. Written informed consent.

Exclusion Criteria:

1. Inability to tolerate PBPC harvest.
2. Peripheral venous access not possible.
3. Positive pregnancy test for female donors.
4. Positive serology for hepatitis C and/or HBSAg, unless negative for antigen PCR.
5. Psychiatric, addictive, or any disorder which compromises ability to give truly informed consent for participation in this study.
6. Treatment with other investigational drugs.
7. Known sensitivity to CHO derived products.
8. HIV positive.
9. History of malignant disease or current malignancy.

Primary outcomes:
measure: Mobilisation success rate
timeFrame: 4 weeks
Secondary outcomes:
measure: engraftment after transplantation
timeFrame: 100 days
measure: Donor safety
timeFrame: 100 days
Other outcomes:
Locations:
city: Tel-Hashomer
country: Israel
facility: Chaim Sheba Medical Center
Study officials:
affiliation: Chaim Sheba Medical Center
name: Arnon Nagler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01034644: Pharmacogenetic Trial and Long-term Follow-up of the PRISMS Trial (PRISMS-15)
Official title: A Multinational, Multicenter, Single Visit, Exploratory Pharmacogenetic Trial and Long-term Follow-up of the PRISMS (Prevention of Relapses and Disability by Interferon Beta-1a Subcutaneously in Multiple Sclerosis) Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Biomarkers
Genetic markers
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2009-12-17
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Group of patients coming from the PRISMS 6789 study

Brief summary: This study, PRISMS-15 is a single visit, exploratory pharmacogenetic trial and long-term follow-up of the PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) trial.

The aim of this trial is to provide additional data on the driving factors of IFN beta response and the long-term outcomes of Rebif® treatment.

This is a Phase IV trial involving subjects who previously participated in the PRISMS trial. To address the trial objectives, a single visit will be performed, at least 3 months after the onset of the last relapse.


Eligibility criteria: Inclusion Criteria:

* Was randomized in the PRISMS study
* Is willing and able to comply with the protocol
* Written informed consent given before any trial-related activities are carried out

Exclusion Criteria:

* Is unwilling or unable to participate in the study

Primary outcomes:
measure: The proportion of responders by group as defined by SNP (Single Nucleotide Polymorphism) markers
timeFrame: 1 day
Secondary outcomes:
measure: Current course of MS: RRMS or SPMS
timeFrame: 1 day
measure: Current EDSS score
timeFrame: 1 day
measure: Change in EDSS since randomization
timeFrame: 1 day
measure: Immunogenicity assessment
timeFrame: 1 day
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Please call/email Central Contact for Recruiting Information in
Study officials:
affiliation: Merck Serono S.A., Geneva
name: Elisabetta Verdun di Cantogno, MD
role: STUDY_DIRECTOR
References:
citation: Sormani MP, Freedman MS, Aldridge J, Marhardt K, Kappos L, De Stefano N. MAGNIMS score predicts long-term clinical disease activity-free status and confirmed disability progression in patients treated with subcutaneous interferon beta-1a. Mult Scler Relat Disord. 2021 Apr;49:102790. doi: 10.1016/j.msard.2021.102790. Epub 2021 Jan 22.
Clinical trial NCT00255944: Effectiveness of an Online Prevention Program in Reducing the Risk of STD Infection in Young Adults
Official title: Internet-based Efficacy Trial of an HIV Prevention Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Sexually Transmitted Diseases
Keywords: HIV Prevention
Internet Intervention
STDs
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-11-21
Enrollment: 2622
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate the effectiveness of a tailored interactive online risk reduction program versus a standard online risk reduction program in reducing the risk of Sexually Transmitted Diseases (STD) infection in young adults.

Detailed description: Adolescents and young adults are at the greatest risk for acquiring an STD. Approximately 3 million people between the ages of 18 and 24 become infected each year. Education about the risks and consequences of unprotected sex is a powerful tool that can be used to prevent or reduce the risk of infection. The program in this study will deliver messages to educate participants about condom use and the risk of STD infection. This study will evaluate the effectiveness of a tailored interactive online risk reduction program versus a standard online risk reduction program in reducing the risk of STD infection in young adults.

Participants in this 1-year open-label study will be recruited exclusively via the internet. Participants will be randomly assigned to receive internet-based messages from either the Youthnet program or the control program. Messages from the Youthnet program will be interactive and tailored specifically to Human Immunodeficiency Virus/Sexually Transmitted Diseases (HIV/STD) risk reduction. The control program will deliver standard STD/HIV prevention messages. Participants will be assessed at baseline and a follow-up session 4 months after enrollment. Frequency of condom use and attitudes toward condom use will be assessed using behavioral scales.

Eligibility criteria: Inclusion Criteria:

* Has access to the internet
* Has an e-mail address

Exclusion Criteria:

* Colorado resident

Primary outcomes:
measure: Efficacy of Internet-based Program for Increasing Condom Use With Non-main Sex Partners
timeFrame: Month 2 post baseline
Secondary outcomes:
measure: Efficacy of Internet-based Program for Increasing Condom Use Attitudes, Norms, and Intentions With Non-main Sex Partners
timeFrame: Month 2 post baseline
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Internet-Based, accessible from anywhere
state: Maryland
Study officials:
affiliation: University of Colorado, Denver
name: Sheana Bull, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06264544: Trial to Evaluate the Efficacy of a Zinc, Selenium, and L-Tyrosine Supplement in the Prevention of Thyrotoxicosis in Subjects With r25191G/A SEPP1 Polymorphism
Official title: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy of a Zinc, Selenium, and L-Tyrosine Supplement in the Prevention of Thyrotoxicosis in Subjects With r25191G/A SEPP1 Polymorphism
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Thyrotoxicosis
Keywords: Thyrotoxicosis Prevention
SEPP1 Polymorphism
Zinc, Selenium, and L-Tyrosine Supplementation
supplementation
Nutrigenomics
Thyroid Peroxidase Antibodies (TPOAb)
Lead sponsor: S.LAB (SOLOWAYS)
Sponsor class: OTHER
Collaborators: name: Center of New Medical Technologies
First posted: 2024-02-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This randomized, double-blind, placebo-controlled trial evaluates the efficacy of a zinc, selenium, and L-tyrosine supplement in preventing thyrotoxicosis among adults aged 18-85 with elevated TPOAb levels and the r25191G/A SEPP1 polymorphism. The study excludes those with thyroid disease, pregnant/breastfeeding women, and individuals allergic to the supplement. Key endpoints include changes in thyroid antibodies and hormones over a 6-month period. With an estimated sample size of 150 participants per group, accounting for a 20% dropout rate, the trial seeks to demonstrate the supplement's potential in reducing thyrotoxicosis risk through a genetically-informed approach.


Eligibility criteria: Inclusion Criteria:

* Confirmed presence of one or more specified gene polymorphism r25191G/A SEPP1
* TPOAb levels \> 300 IU/mL

Exclusion Criteria:

* Age \< 18 years and \>85
* Pregnant or breastfeeding woman
* Subjects with allergy to any of the supplementation component patients with any established diagnosis of thyroid disease

Primary outcomes:
measure: Percent change of Thyroid Peroxidase Antibodies (TPOAb) in subjects with r25191 SEPP1 polymorphism
timeFrame: 6 months
Secondary outcomes:
measure: Percent change in Thyroglobulin Antibodies (TgAb) in subjects with r25191 SEPP1 polymorphism
timeFrame: 6 months
measure: Free Thyroxine (Free T4) change in subjects with r25191 SEPP1 polymorphism
timeFrame: 6 months
measure: Free Triiodothyronine (Free T3) change in subjects with r25191 SEPP1 polymorphism
timeFrame: 6 months
measure: Thyroid Receptor Antibodies (TRAb) change in subjects with r25191 SEPP1 polymorphism
timeFrame: 6 months
measure: TSH Receptor Antibodies (TSHR-Ab) change in subjects with r25191 SEPP1 polymorphism
timeFrame: 6 months
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Center of New Medical Technologies
state: Novosibisk Region
Study officials:
References:
Clinical trial NCT00805844: Motor Evoked Potentials and SedLine
Official title: Monitoring Depth of Anesthesia With the SedLine Facilitates Motor Evoked Potential (MEP) Monitoring During Corrective Spinal Surgery
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Spine Surgery
Keywords: Spine
Motor Evoked Potentials
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2008-12-10
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing corrective spinal procedures, for whom MEP monitoring has been requested by the surgeon.

Brief summary: To determine if using usual clinical practice plus a depth of anesthesia monitor, SedLine, to guide anesthetic administration improves the quality and ease of MEP monitoring in patients undergoing corrective spinal procedures.

Detailed description: Motor Evoked Potential (MEP) monitoring during spine surgery is now used routinely. However it is affected by a variety of anesthetics including fluctuating and/or excessively deep or light levels of anesthesia. A common problem is maintaining an overall constancy and adequacy of anesthesia. Individual patients' responses to anesthesia can differ greatly from population means and can complicate the interpretation of MEPs. False alarms can have significant consequences. One strategy to minimize the anesthetic induced variability of MEPs, and thereby improve the monitoring overall, is to keep the patient's anesthetic state (or "depth") in a narrow range during surgery. This study tests whether using a commercially available depth of anesthesia monitor in addition to usual clinical practice improves the quality of MEPs.

The hypothesis of this study is that the SedLine Monitor, which uses an EEG derived assessment of anesthetic depth, may facilitate MEP monitoring if it is kept within a narrow range during spine surgery. Because SedLine recommends maintaining their Index between 30 and 40 during surgical anesthesia, this is the range used in the primary hypothesis.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing corrective spinal procedures, for whom MEP monitoring has been requested by the surgeon.
* 18 yrs of age or older

Exclusion Criteria:

* Minors, prisoners and those unable to consent for themselves.

Primary outcomes:
measure: The primary outcome of this study is a composite measure of the motor evoked responses over the duration of the surgical procedure utilizing the "area under the curve" (AUC, volt-seconds) of the response time series
timeFrame: End of study
Secondary outcomes:
measure: Secondary outcomes include i) Stimulation threshold ii) MEP fade index and iii) Facilitation necessity and stability.
timeFrame: end of study
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
References:
Clinical trial NCT06662344: Nutrition Tubes on Sleep Quality in Stroke-related Dysphagia
Official title: A Randomly Controlled Study to Explore the Effect of Oral Tube Feeding on Sleep Quality in Stroke-related Dysphagia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dysphagia
Lead sponsor: Buraidah Central Hospital
Sponsor class: OTHER_GOV
First posted: 2024-10-28
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Palliation to stroke-related dysphagia continues to be a challenge. Although nasogastric tube feeding (NGT) has been adopted widely, the weaknesses have yet to be improved by another enteral nutrition support mode.

This study aims to observe the clinical efficacy of intermittent oro-esophageal tube feeding (IOE) in the treatment of stroke-related dysphagia on sleep quality. This is a prospective study with patients with dysphagia after stroke. Patients enrolled are randomly divided equally into 2 groups. All patients receive conventional care, and the observation group received IOE while the control group received NGT for enteral nutrition support.

Their sleep quality are compared at baseline and after study.

Detailed description: This study lasts 15 days for each patient. Palliation to stroke-related dysphagia continues to be a challenge. Although nasogastric tube feeding (NGT) has been adopted widely, the weaknesses have yet to be improved by another enteral nutrition support mode.

This study aims to observe the clinical efficacy of intermittent oro-esophageal tube feeding (IOE) in the treatment of stroke-related dysphagia on sleep quality. This is a prospective study with patients with dysphagia after stroke. Patients enrolled are randomly divided equally into 2 groups. All patients receive conventional care, and the observation group received IOE while the control group received NGT for enteral nutrition support.

Their sleep quality are compared at baseline and after study.

Eligibility criteria: Inclusion Criteria:

* Age\>18 years.
* Meeting the diagnostic criteria for ischemic stroke .
* Dysphagia confirmed by Videofluoroscopic Swallowing Study.
* Clear consciousness.
* No history of prior stroke.
* Stable vital signs.

Exclusion Criteria:

* Dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, myasthenia gravis, etc.
* Complicated with severe liver and kidney failure, tumors, or hematological disorders.
* Simultaneously in need to undergo other therapy that might affect the outcomes of this study.
* Pregnant or nursing females.

Primary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: day1 and day15
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: