louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03303716: ASXL-Related Disorders Natural History Study
Official title: Natural History Study for the ASXL-Related Disorders and Chromatinopathies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bohring-Opitz Syndrome
ASXL1 Gene Mutation
Shashi-Pena Syndrome
ASXL2 Gene Mutation
Bainbridge-Ropers Syndrome
ASXL3 Gene Mutation
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Boston Children's Hospital
name: Children's Hospital Medical Center, Cincinnati
name: Duke University
First posted: 2017-10-06
Enrollment: 200
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: All patients with molecularly proven or suspected ASXL related disorders

Brief summary: A registry focused on the natural history, management and treatment of patients with Bohring-Opitz Syndrome (ASXL1), Shashi-Pena Syndrome (ASXL2) and Bainbridge-Ropers Syndrome (ASXL3).

Detailed description: Study participants will be asked to complete a series of brief surveys over time about their medical condition. The researchers will also attain primary medical records.The registry is based at UCLA as the IRB of record with collaborating sites at Boston Children's Hospital, Cincinnati Children's Hospital, and Duke University in a partnership with the Bohring-Opitz Syndrome (BOS) Foundation and ASXL-Rare Research Endowment (ARRE). The BOS Foundation and ARRE are non-profit organizations run by families of patients with ASXL-related disorders that are focused on supporting research. The data is co-managed by the researchers and the family groups. Aggregate data from the Registry will be shared with the participants as well as used for publication. The Registry is HIPPA compliant and follows all the IRB requirements regarding securing and managing patient data.

Eligibility criteria: Inclusion Criteria:

* Clinical or molecular diagnosis of an ASXL related disorder

Exclusion Criteria:

* No clinical or molecular diagnosis of an ASXL related disorder

Primary outcomes:
measure: Natural history, treatment and management strategies of ASXL-related disorders
timeFrame: 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: Boston Children's Hospital
name: Wen-Hann Tan, BMBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital Medical Center, Cincinnati
name: Loren Pena, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Vandana Shashi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Bianca Russell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01356524: Relationship Between Mid-luteal Serum Progesterone Levels to Pregnancy Rates in Assisted Reproductive Techniques (ART)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-05-19
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In Assisted Reproductive Techniques (ART) there is a need for luteal support using progesterone, estrogen and probably human chorionic gonadotropin (HCG). The optimal route of administration and dose has not yet been determined.

The aim of the study is to investigate whether high levels of mid-luteal serum progesterone are related to higher pregnancy rates in ART cycles. We also plan to investigate whether using higher doses of vaginal progesterone results in higher pregnancy rates.


Eligibility criteria: Inclusion Criteria:

* Mid-luteal serum progesterone levels below 15 ng/dl

Exclusion Criteria:

* Does not sign consent form

Primary outcomes:
measure: Pregnancy rates
timeFrame: One week
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT05006924: Symptoms and Outcome Measures for Upper- Limb Function in Myotonic Dystrophy Type 1
Official title: Symptoms and Outcome Measures for Upper- Limb Function in Myotonic Dystrophy Type 1
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myotonic Dystrophy 1
Keywords: Outcome measure
Patient reported outcome
Upper limb function
arm- and hand function
Symptoms
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: Haukeland University Hospital
First posted: 2021-08-16
Enrollment: 89
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: Adults with Myotonic Dystrophy type 1 in Norway

Brief summary: Myotonic Dystrophy type 1 (DM1) is a multisystem disease that causes muscle weakness and myotonia. As a result upper limb function might become impaired. In this study we will examine patients with DM1 and record their upper limb function. We will will use a battery of patient reported outcomes (PROs) and Outcome measures (OMs) in order to evalute which ones are suitable for use in clinical practise and research studies.


Eligibility criteria: Inclusion Criteria:

• Genetically confirmed Myotonic Dystrophy type 1

Exclusion Criteria:

* Unable to answer or understand questionnaires due to language barriers or cognitive status
* Unable to perform functional tests

Primary outcomes:
measure: Motor Function Measures (MFM)
timeFrame: 30-45 minutes
measure: Nine Hole Peg Test
timeFrame: 1-3 minutes
measure: Myogrip/Dynamometer
timeFrame: 1-3 minutes
measure: Myopinch
timeFrame: 1-3 minutes
measure: ABILHAND Questionnaire
timeFrame: 5 min
measure: ACTIVLIM Questionnaire
timeFrame: 5 min
Secondary outcomes:
measure: Trunk Impairment Scale - modified Norwegian version
timeFrame: 8-15 minutes
measure: Four Square Step Test
timeFrame: 1-3 minutes
measure: PROMIS29
timeFrame: 5-10 minutes
measure: Starkstein Apathy Scale
timeFrame: 5 minutes
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 10 minutes
measure: Lung function test
timeFrame: 10 minutes
measure: Lung function test
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Oslo
country: Norway
facility: Oslo University Hispital
city: Siggerud
country: Norway
facility: Frambu Centre for Rare Disorders
Study officials:
affiliation: Oslo University Hospital
name: Kristin L Ørstavik, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oslo
name: Hilde S Robinson, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03956524: Safety and Tolerability of Typhoid Conjugate Vaccine (EuTCV) in Healthy Adults
Official title: An Open-label, Comparative, Clinical Phase 1 Study to Assess the Safety and Tolerability of Typhoid Conjugate Vaccine (EuTCV) in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Typhoid Fever
Lead sponsor: EuBiologics Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2019-05-20
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Healthy adult volunteers will be randomized in a 1:1:1 ratio to receive single dose of test or the comparator vaccines.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerability of EuTCV, in comparison to TCV (Typbar-TCV™, Bharat Biotech) and Vi-Polysaccharide vaccine (Typhim Vi®, Sanofi Pasteur) in healthy adult volunteers.


Eligibility criteria: Inclusion Criteria:

1. Subjects aged between and including 18 and 45 years at time of Visit 1
2. Subjects willing to give written informed consent to participate in the trial
3. Subjects who are healthy as determined by medical history, with no clinically significant abnormalities in clinical examination and laboratory tests

Exclusion Criteria:

1. Subjects unwilling to give his/her consent to participate in the trial
2. Subjects who have received Typhoid containing vaccines
3. Subjects who have past history of Typhoid
4. Subjects already immunized with any licensed vaccine within 4 weeks
5. Subjects with known hypersensitivity to any component of the study vaccine
6. Subjects who are pregnant, lactating or childbearing age not using a reliable method of contraception
7. Subjects with any abnormality or chronic disease
8. Subjects with evidence of acute illness within past 7 days requiring systemic antibiotic or antiviral therapy
9. Subjects who have experienced transient thrombocytopenia or neurological complications following an earlier immunization against diphtheria and/or typhoid
10. Subjects who have known history of immune function disorders
11. Subjects who have known history of administration of blood or blood-derived products
12. Subjects who have history of alcohol or substance abuse

Primary outcomes:
measure: Local and systemic solicited adverse events
timeFrame: Day 7
measure: Unsolicited adverse events
timeFrame: up to 6 weeks
measure: Serious adverse events
timeFrame: up to 6 weeks
Secondary outcomes:
measure: Proportion of subjects with seroconversion
timeFrame: Baseline to Day 42
Other outcomes:
Locations:
city: Dasmariñas
country: Philippines
facility: De La Salle Health Sciences Institute
state: Cavite
Study officials:
References:
citation: Choi SK, Baik YO, Kim CW, Kim SK, Oh IN, Yoon H, Yu D, Lee C. An open-label, comparative, single dose, clinical Phase Ⅰ study to assess the safety and immunogenicity of typhoid conjugate vaccine (Vi-CRM197) in healthy Filipino adults. Vaccine. 2021 May 6;39(19):2620-2627. doi: 10.1016/j.vaccine.2021.03.089. Epub 2021 Apr 10.
Clinical trial NCT00714324: Simplified Nutritional Screening for Patient Use
Official title: Validation of Nutritional Screening for Patient Use
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malnutrition
Keywords: Nutrition
Screening
Lead sponsor: University of Southampton
Sponsor class: OTHER
Collaborators: name: University Hospital Southampton NHS Foundation Trust
First posted: 2008-07-14
Enrollment: 2200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: PROBABILITY_SAMPLE
Study population: Patients attending general outpatient clinics

Brief summary: The purpose of this study is to determine if patients are able to reliably screen themselves for nutrition risk.


Eligibility criteria: Inclusion Criteria:

* Male or female
* Adults aged \> 18years
* Able to complete screening and provide written informed consent
* Willingness to take part

Exclusion Criteria:

* Children (\<18years)
* Pregnant women
* Inpatients
* Unable to complete screen due to physical or mental incapacity
* Unable to comprehend oral and written English language
* Participation in other nutrition studies

Primary outcomes:
measure: To validate the use of a screening tool for patient use
timeFrame: 1 year
Secondary outcomes:
measure: To assess prevalence of malnutrition in outpatients
timeFrame: 1 year
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: Southampton University Hospitals NHS trust
state: Hampshire
Study officials:
affiliation: University of Southampton
name: Marinos Elia, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cawood AL, Elia M, Sharp SK, Stratton RJ. Malnutrition self-screening by using MUST in hospital outpatients: validity, reliability, and ease of use. Am J Clin Nutr. 2012 Nov;96(5):1000-7. doi: 10.3945/ajcn.112.037853. Epub 2012 Oct 3.
Clinical trial NCT00018824: Treating Alcohol Use In Older Adults With Depression
Official title: The Treatment of Late Life Major Depression Complication by Alcohol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alcoholism
Depression
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-07-05
Enrollment: 74
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the efficacy combining a treatment for depression with a treatment for alcohol dependence.

Detailed description: This study aims to study 80 patients with comorbid alcohol dependence and a depressive syndrome. After appropriate detoxification, patients are started on either naltrexone 50 mg or placebo. After one week, sertraline is added in an open label fashion. It is hypothesized that those patients receiving combination therapy will last 3 months with follow-up tracking lasting 1 year.

Eligibility criteria: Inclusion Criteria:

* Age \> 55
* Current depressive syndrome
* Current alcohol dependence
* No psychosis
* No opioid or cocaine abuse or dependence

Exclusion Criteria:

Primary outcomes:
measure: Alcohol use'
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: David W. Oslin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oslin DW. Treatment of late-life depression complicated by alcohol dependence. Am J Geriatr Psychiatry. 2005 Jun;13(6):491-500. doi: 10.1176/appi.ajgp.13.6.491.
Clinical trial NCT04954924: Effect of Kinesio Tape on Motor Function in Subjects With ACL Rupture
Official title: Acute and Long Term Effect of Kinesio Tape on Motor Function, Proprioception and Balance in Subjects With ACL Rupture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ACL Rupture
Rehabilitation
Lead sponsor: Lithuanian Sports University
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Thirty-two participants with ACL rupture were included in the study. All participants were divided in two groups - control and experimental. In the experimental group (n=16) participants received 4 weeks standardized physiotherapy and Kinesio tape, in the control group - standardized physiotherapy.

Experimental measurements: Anthropometric measurements, pain intensity, static and dynamic balance, proprioception, knee flexion and extension muscle torque, level of activity


Eligibility criteria: Inclusion Criteria:

1. 18 - 35-year-old men;
2. a normal contralateral knee,
3. not a longer period than 3 months after ACL rupture.

Exclusion Criteria:

Participants were excluded if either knee had previously been injured or had undergone surgery, if they had concurrent osteoarthritis, if they had injured the posterior cruciate ligament, lateral collateral ligament, or posterolateral complex of the knee, or if they had a grade III tear of the medial collateral ligament.

Primary outcomes:
measure: Static and dynamic balance
timeFrame: 4 weeks
measure: Muscle torque
timeFrame: 4 weeks
measure: Joint position sense test
timeFrame: 4 weeks
Secondary outcomes:
measure: The Lysholm scale
timeFrame: 4 weeks
measure: The Tegner scale
timeFrame: 4 weeks
measure: VAS scale
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Lithuanian Sports University
Study officials:
References:
citation: Kiele D, Solianik R. Four-Week Application of Kinesiotaping Improves Proprioception, Strength, and Balance in Individuals With Complete Anterior Cruciate Ligament Rupture. J Strength Cond Res. 2023 Jan 1;37(1):213-219. doi: 10.1519/JSC.0000000000004245. Epub 2022 Apr 13.
Clinical trial NCT01229124: RNA Biomarkers in Tissue Samples From Infants With Acute Myeloid Leukemia
Official title: SCOR in Targeted Therapies for Infant Leukemias Project 4: MicroRNA Sequencing of Infant AML
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: childhood acute myeloid leukemia/other myeloid malignancies
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-10-27
Enrollment: 20
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosis of acute myeloid leukemia.

Brief summary: RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in RNA and identify biomarkers related to cancer.

PURPOSE: This research study is studying RNA biomarkers in tissue samples from infants with acute myeloid leukemia.

Detailed description: OBJECTIVES:

* Sequence the microRNAs present in 20 infant AML samples as a pilot study.
* Compare microRNAs present in infant AML samples to infant ALL samples that are being concurrently sequenced in a separate study to identify lineage- and translocation-specific microRNAs.

OUTLINE: This is a multicenter study.

Previously collected cryopreserved cells from diagnosis are sequenced using reverse transcriptase-PCR.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of acute myeloid leukemia
* Available cryopreserved cells from diagnosis

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Sequence of the microRNAs present in 20 infant acute myeloid leukemia (AML) samples
measure: Comparison of microRNAs present in infant AML samples to infant acute lymphoblastic leukemia samples to identify lineage- and translocation-specific microRNAs
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: Michael Cleary, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01174524: Improvement of Quality of Life in Patients Using Low-dose Pills in the Different Phases of Menacme
Official title: Improvement of Quality of Life in Patients Using Low-dose Pills in the Different Phases of Menacme
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Quality of Life
Menopause
Contraception
Keywords: Quality of life
Menopause
Contraception
Lead sponsor: Hospital Geral de Fortaleza
Sponsor class: OTHER_GOV
Collaborators: name: Medley S∕A Indústria Farmacêutica
First posted: 2010-08-03
Enrollment: 100
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 46
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether low-dose contraceptive pills are effective in the improvement of quality of life in patients in the different phases of menacme.


Eligibility criteria: Inclusion Criteria:

* Fertile women with indication of use of contraceptive pills

Exclusion Criteria:

* Fertile women with any surgical contraceptive method
* Women in menopause
* Diseases the forbidden the use of the drug

Primary outcomes:
measure: Quality of life
timeFrame: eleven months
Secondary outcomes:
measure: Quality of life in differents phases of menacme
timeFrame: eleven months
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Hospital Geral de Fortaleza
state: Ceara
Study officials:
affiliation: Hospital Geral de Fortaleza
name: joao MM Silva, PhD Student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01265524: Evaluation of CLP in Heart Failure Patients With Chronic Kidney Disease
Official title: A Phase 2, Randomized, Double-Blind, Multi-center Study Comparing CLP Versus Placebo in Heart Failure Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Failure
Lead sponsor: Sorbent Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Pharmaterra
First posted: 2010-12-23
Enrollment: 113
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: The purpose of this study is to determine the effects of CLP on serum potassium and signs and symptoms of fluid overload in heart failure patients with chronic kidney disease.


Eligibility criteria: Inclusion Criteria:

* Heart failure with New York Heart Association (NYHA) Classification III or IV
* Hospitalization for heart failure decompensation associated with fluid overload within the last six months
* Chronic kidney disease
* Must be able to understand study procedures and willing and able to provide written informed consent

Exclusion Criteria:

* No hospitalization within 4 weeks of Baseline Visit
* In the investigator's judgment, any cardiovascular, renal, hepatic, endocrine, gastrointestinal, neurological or other disease or condition that makes the patients study participation unsafe
* History or presence of gastrointestinal conditions such as severe constipation or gastrointestinal tract strictures
* Current dialysis patient, or anticipated need for dialysis during study participation

Primary outcomes:
measure: Change in Serum Potassium
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Weight Loss at Week 1
timeFrame: Baseline and 1 week
measure: Weight Loss at Week 2
timeFrame: Baseline and 2 weeks
measure: Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 4
timeFrame: 4 weeks
measure: Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 8
timeFrame: 8 weeks
measure: Number of Patients Improving by at Least One NYHA Functional Class From Baseline to Week 8
timeFrame: Baseline and 8 weeks
measure: 6MWT Distance at Week 8
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Yerevan
country: Armenia
city: Tbilisi
country: Georgia
city: Chisinau
country: Moldova, Republic of
Study officials:
affiliation: Sorbent Therapeutics
name: Detlef Albrecht, MD
role: STUDY_CHAIR
References:
citation: Costanzo MR, Heywood JT, Massie BM, Iwashita J, Henderson L, Mamatsashvili M, Sisakian H, Hayrapetyan H, Sager P, van Veldhuisen DJ, Albrecht D. A double-blind, randomized, parallel, placebo-controlled study examining the effect of cross-linked polyelectrolyte in heart failure patients with chronic kidney disease. Eur J Heart Fail. 2012 Aug;14(8):922-30. doi: 10.1093/eurjhf/hfs074. Epub 2012 May 21.