louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04823143: Natural History Study of Patients With VCP-related Disease
Official title: Natural History of Disease Progression in Individuals With a Confirmed Diagnosis of Disease Caused by Mutation of the Valosin Containing Protein (VCP) Gene
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: IBMPFD
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2021-03-30
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients meeting eligibility criteria and able to travel to Columbus Ohio for onsite visits.

Brief summary: A natural history study to understand the expected progression of disease in patients with confirmed mutations in the VCP gene over 1 year.

Detailed description: This is a single site, prospective natural history study to evaluate the utility of strength, functional, and patient reported outcomes in quantifying disease progression over 1 year in patients with mutations in the VCP gene.

Patients will complete a remote and onsite visits at baseline, a remote visit at 6 months, and then a final remote and onsite visit at 12 months. All strength, functional, and patient reported measures will be completed at each visit to assess reliability, consistency of results across testing environments, and sensitivity to change over time.

Additionally, patients may opt in to provide blood, serum, and urine samples for biobanking.

Eligibility criteria: Inclusion Criteria:

* Genetically confirmed mutation in the VCP gene
* Age ≥18 years
* Willing and able to provide informed consent and follow all study procedures

Exclusion Criteria:

* Participation in an interventional clinical trial
* Any concomitant illness or comorbid condition that would interfere with a patient's ability to complete study procedures safely at the discretion of the site PI.

Primary outcomes:
measure: 100 meter timed test
timeFrame: 12 months
measure: North Star assessment for limb girdle type dystrophies (NSAD)
timeFrame: 12 months
measure: Timed Up and Go
timeFrame: 12 months
measure: 4 stair climb
timeFrame: 12 months
measure: Performance of Upper Limb (PUL) 2.0
timeFrame: 12 months
measure: 9 hole peg test
timeFrame: 12 months
measure: Forced Vital Capacity
timeFrame: 12 months
measure: PROMIS Global Health scale
timeFrame: 12 months
measure: Neuro-QOL Upper Extremity Function
timeFrame: 12 months
measure: Neuro-QOL Lower Extremity Function (Mobility)
timeFrame: 12 months
measure: Rasch Overall ALS Disability Scale (ROADS)
timeFrame: 12 months
measure: Neuro-QOL Cognition Function
timeFrame: 12 months.
measure: EAT-10
timeFrame: 12 months
measure: Communicative Participation Item Bank (CPIB)
timeFrame: 12 months
measure: Speech Handicap Index
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Lindsay Alfano
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04087343: Strength on Wheels: A Meal Delivery and Exercise Intervention for Homebound Older Adults
Official title: Strength on Wheels: A Meal Delivery and Exercise Intervention for Homebound Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Keywords: homebound patients
exercise
nutrition
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2019-09-12
Enrollment: 9
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to implement a home-based exercise program, administered through Interfaith Ministries of Greater Houston Meals on Wheels (MOWGH), and evaluate its effects on frailty status and nutritional markers in homebound older adults.


Eligibility criteria: Inclusion Criteria:

* enrolled in UT-Health Harris Health House Call Program (HCP)
* Frail or pre frail by FFP
* medically stable

Exclusion Criteria:

* robust by FFP
* Mini-Cog score \<3 and/or are unable to follow instructions
* pre-diagnosed terminal illness
* unable to ambulate,and/or are unable to use their upper extremities

Primary outcomes:
measure: Overall Frailty Status as Assessed by the Fried Frailty Phenotype (FFP) Screening Test.
timeFrame: baseline
measure: Overall Frailty Status as Assessed by the Fried Frailty Phenotype (FFP) Screening Test.
timeFrame: 12 weeks after study initiation
Secondary outcomes:
measure: Levels of Plasma Vitamin C
timeFrame: baseline
measure: Levels of Plasma Vitamin C
timeFrame: 12 weeks from baseline
measure: Levels of Serum Folate
timeFrame: Baseline
measure: Levels of Serum Folate
timeFrame: 12 weeks from baseline
measure: Levels of Vitamin B12
timeFrame: Baseline
measure: Levels of Vitamin B12
timeFrame: 12 weeks from baseline
measure: Levels of Vitamin 25-OHD
timeFrame: Baseline
measure: Levels of Vitamin 25-OHD
timeFrame: 12 weeks from baseline
measure: Levels of Methylmalonic Acid (MMA)
timeFrame: Baseline
measure: Levels of Methylmalonic Acid (MMA)
timeFrame: 12 weeks from baseline
measure: Levels of Homocysteine (HCy)
timeFrame: Baseline
measure: Levels of Homocysteine (HCy)
timeFrame: 12 weeks from baseline
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Jessica Lee, MD,MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02293343: 24 Hrs Histamine Profile in Healthy Persons and Patients With Food Intolerance
Official title: 24 Hrs Histamine Profile in Healthy Persons and Patients With Food Intolerance: Correlations Between Subjective Affliction and Measured Histamine Parameter
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergy
IBS
Keywords: histamine profile
IgE Antibodies
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2014-11-18
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: healthy subjects, patients with high IgE level and patients with afflictions, but no high IgE level

Brief summary: Over 24 hrs serum and plasma samples were collected every 3 hrs. With this a day histamine profile was created. 15 healthy persons with 20 patients with a high level of IgE in serum and 20 patients with afflictions but no high IgE level were compared. Measurment of histamine in plasma, urine and stool were realized. In addition to that Diaminoxidase, TNF alpha and IgE Antibodies were measured.


Eligibility criteria: Inclusion Criteria:

* healthy subjects
* appropriate invalid persons

Exclusion Criteria:

* pregnant and weaning persons

Primary outcomes:
measure: Histamine
timeFrame: 24 hrs
Secondary outcomes:
measure: diaminoxidase
timeFrame: 24 hrs
Other outcomes:
measure: TNF alpha
timeFrame: 24 hrs
measure: IgE
timeFrame: 24 hrs
Locations:
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
Study officials:
References:
citation: Pinzer TC, Tietz E, Waldmann E, Schink M, Neurath MF, Zopf Y. Circadian profiling reveals higher histamine plasma levels and lower diamine oxidase serum activities in 24% of patients with suspected histamine intolerance compared to food allergy and controls. Allergy. 2018 Apr;73(4):949-957. doi: 10.1111/all.13361. Epub 2017 Dec 15.
Clinical trial NCT01224743: Effect of Fruit and Vegetable Concentrates on Endothelial Function in Persons With Metabolic Syndrome
Official title: Effect of Fruit and Vegetable Concentrates on Endothelial Function in Persons With Metabolic Syndrome: A Randomized, Controlled, Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Metabolic Syndrome
Lead sponsor: Griffin Hospital
Sponsor class: OTHER
Collaborators: name: NSA, LLC
First posted: 2010-10-20
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Dehydrated fruit and vegetable concentrates provide an accessible form of phytonutrient supplementation that may offer cardioprotective effects. This study assessed the effects of encapsulated fruit and vegetable juice powder concentrates on endothelial function and cardiac risk markers in subjects in a randomized, double blind, placebo controlled crossover clinical trial with three treatment arms.


Eligibility criteria: Inclusion Criteria:

* metabolic syndrome defined by AHA/NHLBI criteria
* nonsmoker
* not taking any other vitamins or dietary supplements
* able to have blood pressure measured bilaterally at the brachial artery

Exclusion Criteria:

* any unstable medical condition that would limit the ability to participate fully in the trial
* rheumatologic disease requiring regular use of NSAIDs
* preexisting cardiovascular disease
* diagnosed eating disorder
* inability to complete endothelial function assessment.
* use of insulin, glucose sensitizing medication, vasoactive medications (including glucocorticoids, antineoplastic agents, psychoactive agents, or bronchodilators), nutriceuticals, fiber supplements, and tobacco.

Primary outcomes:
measure: Endothelial Function
timeFrame: 8-weeks
Secondary outcomes:
measure: Weight
timeFrame: 8-weeks
measure: Lipid panel
timeFrame: 8-weeks
measure: Insulin
timeFrame: 8-weeks
Other outcomes:
Locations:
city: Derby
country: United States
facility: Griffin Hospital
state: Connecticut
Study officials:
affiliation: Yale-Griffin Prevention Research Center
name: David L Katz, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ali A, Yazaki Y, Njike VY, Ma Y, Katz DL. Effect of fruit and vegetable concentrates on endothelial function in metabolic syndrome: a randomized controlled trial. Nutr J. 2011 Jun 29;10:72. doi: 10.1186/1475-2891-10-72.
Clinical trial NCT02345343: Early Post-Marketing Study of ELIQUIS (Apixaban) in Mexico
Official title: Early Post-Marketing Study of Eliquis (Apixaban), in Treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE), and Prevention of Recurrent DVT and PE in Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deep Vein Thrombosis
Pulmonary Embolism
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2015-01-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The sentinel site for the CNFV in Mexico

Brief summary: The primary objective of the study is to report adverse events of on-treatment AEs by the treating physicians during a specified 24-month study period in patients with venous thromboembolism at the sentinel site(s) for the National Center of Pharmacovigilance (CNFV) in Mexico.


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Patients 18 years old with DVT and PE at the sentinel site who received at least 1 dose of apixaban for the treatment and/or prevention of recurrence of DVT and PE during the specified 24-month study period

Exclusion Criteria:

* Subjects who received apixaban as part of a clinical trial
* Subjects who received apixaban for any indication other than local approved
* Contraindications included in the approved Mexican prescribing information

Primary outcomes:
measure: The number of adverse events (AEs) notified to health authorities (HAs) of on-treatment AEs by the treating physicians
timeFrame: Up to 24-month study period
Secondary outcomes:
measure: The AEs reported to HA in a table format identifying the report number, patient ID number, and type of AE
timeFrame: Up to 24-month study period
Other outcomes:
Locations:
city: Queretaro
country: Mexico
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT03720743: Effect of Biodanza on Desire, Excitation and Sexual Inhibition
Official title: Effect of a Biodanza Program on Desire, Excitation and Sexual Inhibition in Young Adults. A Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Desire Disorder
Sexual Arousal Disorder
Sexual Inhibition
Keywords: Biodanza
libido
sexual excitement
sexual inhibition
young adults
dance therapy
complementary therapies
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
First posted: 2018-10-25
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the objective of this study was to examine the effects of a 10 weeks biodanza program on the sexual desire and inhibition/arousal of a sample of healthy young adults.

A randomized clinical study was carried out, involving a total of 86 young adults divided into Intervention Group (BG) and Control Group (CG), carrying out biodanza sessions during 10 weeks. The Sexual Desire Inventory (SDI) and the Sexual Inhibition/Sexual Arousal-Short Form Scale (SIS/SES-SF) were completed before and after the intervention.


Eligibility criteria: Inclusion Criteria:

* at least 18 years old
* having correctly completed the online questionnaire.
* to attend a minimum of eight Biodanza sessions.

Exclusion Criteria:

* exceed 30 years old.
* the presence of some type of physical or mental disability that could prevent their participation in the therapy or the completion of the questionnaires.

Primary outcomes:
measure: Sexual desire
timeFrame: 3 months
measure: Sexual excitement/sexual inhibition
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Almería
country: Spain
facility: Universidad de Almería
Study officials:
References:
Clinical trial NCT05212038: An Iliopsoas Plane Block After Total Hip Arthroplasty
Official title: An Iliopsoas Plane Block for Pain Management After Total Hip Arthroplasty: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Hip Arthroplasty
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 56
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: SUPPORTIVE_CARE

Brief summary: Nielsen et al. reported that when iliopsoas plane block was performed on healthy volunteers, the injection solution in Hip MRI was confined to the myofascial compartment, which was known to include all sensory branches of the femoral nerve that control the hip joint. The maximal muscle strength of knee extension did not decrease before and after Iliopsoas plane block in Volunteer. Since there is no clinical study conducted on patients after the volunteer study, the investigators intend to evaluate the analgesic and motor preserving effects of the iliopsoas plane block in a group of patients undergoing total hip arthroplasty.


Eligibility criteria: Inclusion Criteria:

1. Patients 19 years of age or older who are expected to undergo unilateral hip arthroplasty
2. ASA PS 1-3

Exclusion Criteria:

1. Revision total hip arthroplasty
2. Allergy to drugs used in the study
3. Patients with moderate or more hepatic impairment (AST/ALT is more than 2.5 times the upper limit of normal)
4. Estimated glomerular filtration rate \< 30 mL/min/1.73m2
5. Opioid dependence
6. Prolongation of PT and aPTT more than twice the upper limit of normal
7. Pre-existing neurological or anatomical disorders of the lower extremities
8. Serious psychiatric disorders

Primary outcomes:
measure: Numeric rating scale pain score at rest
timeFrame: up to 48 hours after the surgery
Secondary outcomes:
measure: Numeric rating scale pain score at movement
timeFrame: up to 48 hours postoperatively
measure: Postoperative opioid consumption
timeFrame: postoperative 24, 48hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ji Yeong Kim
Study officials:
References:
Clinical trial NCT00244738: The Use of Castor Oil as a Labor Initiator in Post-date Pregnancies
Official title: The Use of Castor Oil as a Labor Initiator in Post-date Pregnancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prolonged Pregnancy
Keywords: pregnancy
post-date
induction of labor
castor oil
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2005-10-27
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether castor oil is effective in inducing labor.

Detailed description: Castor oil is traditionally given by midwives in order to induce labor. Its efficacy as an initiator of labor was previously tested only in one clinical trial. Unfortunately this study (by Garry et al.) was not sufficiently controlled.

We intent to recruit 84 healthy pregnant women with no contraindication to vaginal delivery that had past their due date. Women will be randomly and blindly divided into equal sized intervention group and control group. Intervention group will be given 60 mL of castor oil in 140 mL of orange juice, while control group will be given a placebo with similar texture. Primary outcome to be tested is the percentage of women entering active labor within 24 hours of administration.

Eligibility criteria: Inclusion Criteria:

* Pregnant women at 40-42 weeks gestation
* Good obstetrical dating
* Singleton
* Intact membranes
* Preinterventional Bishop score less than or equals 4
* No evidence of effective uterine contractions by external tocography
* Living close to hospital

Exclusion Criteria:

* Multiple gestation
* Oligohydramnios or Polyhydramnios
* Abnormal FHR tracing
* Obstetric complication (hypertension, bleeding)
* Ruptured membranes
* Suspected intrauterine growth restriction
* Biophysical score \< 8
* Previous cesarean section / myomectomy / Other uterine operation
* Fever, malaise at recruitment
* Chronic illness (renal, hepatic, endocrine)

Primary outcomes:
measure: Delivery within 24 hours of administering castor oil/placebo
timeFrame: two weeks
Secondary outcomes:
measure: Neonatal apgar scores
timeFrame: 1 minute and 5 minute after delivery
measure: Umbilical artery pH and Base Excess
timeFrame: Immediately at birth
measure: Neonatal complications including hospitalization in NICU
timeFrame: immediately after birth
measure: Mode of delivery (ie. Normal delivery Vs. Cesarean delivery)
timeFrame: Within two weeks of enrollment
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Shay Porat, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hadassah Medical Organization
name: Drorit Hochner-Celnikier, MD
role: STUDY_DIRECTOR
References:
citation: Garry D, Figueroa R, Guillaume J, Cucco V. Use of castor oil in pregnancies at term. Altern Ther Health Med. 2000 Jan;6(1):77-9.
Clinical trial NCT01819038: Early Renal Replacement Therapy and the Outcome of Acute Kidney Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Renal Failure
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2013-03-27
Enrollment: 60
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: This research project is a prospective study to compare mortality between early renal replacement therapy (RRT) and late renal replacement therapy by using plasma neutrophil gelatinase associated lipocalin (pNGAL) as a tool in decision- making.


Eligibility criteria: Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* patients with acute kidney injury in the intensive care ward.

Exclusion Criteria:

* The patient refuses to sign the consent
* The patient is pregnant, parturient, or breastfeeding
* End stage renal disease
* Chronic renal failure
* previous kidney transplant

Primary outcomes:
measure: mortality rate
timeFrame: 28 day
Secondary outcomes:
measure: ventilator free-days
timeFrame: 28 days
Other outcomes:
measure: hemodialysis free-days
timeFrame: 28 days
Locations:
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
Study officials:
affiliation: Chulalongkorn University
name: Nattachai Srisawat, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05240638: Lymph Drainage in Heart Failure
Official title: Feasibility of Transcatheter Cannulation and Drainage of the Thoracic Duct in Patients With Congestive Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: heart catheterization
heart failure
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This study aims to test the safety and efficacy of lymph fluid drainage on heart congestion and shortness of breath symptoms among patients participants with heart failure.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Subjects with informed consent to participate
* NYHA III- IV patients
* Patients with heart failure volume overload
* Planned for elective right heart catheterization

Exclusion Criteria:

* Active coronary syndrome (type I myocardial infarction)
* Local infection or ongoing systemic infection(s)
* Thrombotic coagulation disorder
* On continuous blood thinners that cannot be discontinued or held
* Allergy or contraindications to the use of iodine-based contrast agents
* Subjects deemed to be high risk for performing a cardiac catheterization by study investigator

Primary outcomes:
measure: Technical success for access
timeFrame: At the time of the procedure
measure: Safety defined as the absence of serious adverse events
timeFrame: Up to 24 hours post-procedure
measure: Technical success for drainage
timeFrame: At the time of the procedure
Secondary outcomes:
measure: Total fluid output (measured in mL) as measured by fluid collection
timeFrame: Up to 24 hours post-procedure
measure: Change in body weight
timeFrame: Pre-procedure, Post-procedure (up to 4 hours)
measure: Change in blood N-terminal Pro-BNP as measured by lab test
timeFrame: Baseline, 12 hours, 24 hours post initiation of drainage
measure: Number of HF-related hospitalizations as measured by medical record review
timeFrame: 30 days post-discharge
Other outcomes:
Locations:
city: Durham
country: United States
facility: Marat Fudim
state: North Carolina
Study officials:
affiliation: Duke University
name: Marat Fudim, MD
role: PRINCIPAL_INVESTIGATOR
References: