louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01031615: Evaluation of the Child and Family Traumatic Stress Intervention
Official title: Evaluation of the Child and Family Traumatic Stress Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Posttraumatic Stress Disorder
Keywords: School age children and adolescents exposed to a potentially traumatic event
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2009-12-14
Enrollment: 112
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the efficacy of the Child and Family Traumatic Stress Intervention (CFTSI) in preventing the development of Posttraumatic Stress Disorder (PTSD) when implemented within 30 days of a potentially traumatic event.


Eligibility criteria: Inclusion Criteria:

* Youth exposed to a potentially traumatic event within the last 30 days who have one new symptom on the Posttraumatic Checklist (PCL)

Exclusion Criteria:

* Already receiving mental health treatment
* Autism or Developmental Disability
* Diagnosed with psychosis or bipolar disorder
* Non-english speaking

Primary outcomes:
measure: UCLA Posttraumatic Reaction Index (PTSD-RI)
timeFrame: 3 months post-intervention
Secondary outcomes:
measure: Trauma Symptom Checklist for Children (TSCC)
timeFrame: 3 Months post-intervention
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University Child Study Center
state: Connecticut
Study officials:
affiliation: University of Pennsylvania
name: Steven Berkowitz, M.D.
role: STUDY_DIRECTOR
References:
citation: Berkowitz SJ, Stover CS, Marans SR. The Child and Family Traumatic Stress Intervention: secondary prevention for youth at risk of developing PTSD. J Child Psychol Psychiatry. 2011 Jun;52(6):676-85. doi: 10.1111/j.1469-7610.2010.02321.x. Epub 2010 Sep 24.
Clinical trial NCT03357315: Mix Vaccine for Metastatic Sarcoma Patients
Official title: Safety and Efficacy Study of Mix Vaccine in Sarcoma Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Metastatic Sarcoma
Reaction - Mixed Vaccine
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
Collaborators: name: Jinan University Guangzhou
First posted: 2017-11-29
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is the safety and efficacy of mix vaccine to small metastases of sarcoma.

Detailed description: By enrolling patients with small metastases of sarcoma adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of mix vaccine.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility criteria: Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 2 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Primary outcomes:
measure: Relief degree of tumors
timeFrame: 3 months
Secondary outcomes:
measure: Progress free survival（PFS）
timeFrame: 1 year
measure: Overall survival（OS）
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Fuda cancer institute of Fuda cancer hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT06758115: Central Motor Mechanisms in AIS Via HD-sEMG, EEG and Neuromuscular Coupling Analysis
Official title: Study on the Central Motor Regulation Mechanism in Adolescent Idiopathic Scoliosis (AIS) Patients Based on HD-sEMG, EEG, and Neuromuscular Coupling Analysis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adolescent Idiopathic Scoliosis
Lead sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adolescent Idiopathic Scoliosis Patients

Brief summary: 1. Verifying the Motor Control Effects of Spinal Manipulation on AIS Using outpatient and inpatient AIS patients from our department as the study subjects, standardized spinal manipulation treatment is applied. The efficacy is evaluated through a combination of clinical outcome measures, HD-EMG for paraspinal muscle function assessment, and Pro-Kin balance system for trunk stability analysis. This establishes an AIS efficacy platform to further clarify the effectiveness of spinal manipulation in motor control regulation of AIS.
2. Investigating the Central Motor Network's Response to Spinal Manipulation in AIS Utilizing high-density sEMG-EEG technology, synchronized brain and muscle electrical signals are collected before and after treatment. By employing a neuromuscular synchronization and coupling analysis approach that integrates linear and nonlinear methods, the characteristic indices of information interaction between the central system and muscles are identified. This further explores the motor control and response characteristics of the muscle-cortex network to spinal manipulation in AIS.


Eligibility criteria: Inclusion Criteria:

1. Patients aged ≥10 years;
2. Risser sign grade 0-3;
3. Cobb angle between 10° and 40°;
4. No prior treatment;
5. Female patients within 1 year after menarche or before menstruation;
6. The patient's guardian signs the informed consent form for treatment.

Exclusion Criteria:

1. Those who do not meet the diagnostic criteria for AIS or inclusion criteria;
2. Patients with severe primary diseases such as cardiovascular, cerebrovascular, liver, kidney, and hematopoietic system disorders, or those with mental illnesses;
3. Patients with thrombocytopenia, coagulation disorders, or a tendency to bleed;
4. Patients who are afraid of the treatment and cannot tolerate it;
5. Those who have already received other treatments that may affect the study's outcome measures.

Primary outcomes:
measure: HD-EMG
timeFrame: Before treatment, and at 4 weeks and 12 weeks after treatment.
Secondary outcomes:
measure: Pro-Kin Balance System
timeFrame: Before treatment, and at 4 weeks and 12 weeks after treatment.
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the First Affiliated Hospital of Zhejiang Chinese Medical University
Study officials:
References:
Clinical trial NCT02326415: Clinical Pathway With "Fast-Track" In Uncomplicated Acute Appendicitis
Official title: Prospective Randomised Study Comparing Clinical Pathway With "Fast-Track" Versus Usual Protocol In Uncomplicated Acute Appendicitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Uncomplicated Acute Appendicitis
Keywords: Acute Appendicitis
Appendectomy
Fast-Track
Clinical Pathway
Lead sponsor: Hospital Universitario Virgen de la Arrixaca
Sponsor class: OTHER
First posted: 2014-12-29
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to reduce the postoperative hospital stay, without increasing morbidity and mortality postoperative, expressed in terms of rate of complications and readmissions.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with uncomplicated acute appendicitis urgently.
* Signing the consent of participation and commitment to attend reviews.

Exclusion Criteria:

* Suspected liver disease.
* Coagulation disorders.
* Patients in septic shock.
* Pregnant patients.
* Patients with symptoms compatible with acute uncomplicated appendicitis (plastron appendix, perforated appendicitis or diffuse peritonitis), or had 5 to more days of evolution).
* No sign consent for participation in it.

Primary outcomes:
measure: Postoperative Hospital Stay
timeFrame: From the first moment after surgery within 3 months
Secondary outcomes:
measure: Overall satisfaction (Study the degree of satisfaction that the patient has received assistance as)
timeFrame: From the first moment after surgery within 3 months
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de La Arrixaca
Study officials:
affiliation: Hospital Universitario Virgen de la Arrixaca
name: Juan A. Luján Mompean
role: STUDY_DIRECTOR
References:
Clinical trial NCT01884415: Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis
Official title: Open-label, Phase III, Randomized, Clinical Trial to Evaluate the Efficacy of Two Different Hepatitis B Virus (HBV) Vaccination Schemes in Patients With Hepatic Cirrhosis Candidates to Liver Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Cirrhosis
Awaiting Organ Transplant
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2013-06-24
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this clinical trial is to compare the response rate obtained with two different vaccination schemes against HBV in cirrhotic patients. These patients must be candidates for liver transplantation, who have failed seroconversion (anti-HBs \< 10 IU/ml) after three intramuscular doses of 40 µg.


Eligibility criteria: Inclusion Criteria:

1. Cirrhotic patients, potential candidates for liver transplantation, with indication to HBV vaccination (HBsAg negative and anti-HBs negative).
2. Patients under treatment with HBVAXPRO® who do not show a response after the first cycle of vaccination of three intramuscular doses of 40 µg at 0, 1 and 2 months.
3. Patients over 18 years old.
4. Negative pregnancy test.
5. Patients who have given their consent to participate in the study.

Exclusion Criteria:

1. Absolute contraindication to HBV vaccine.
2. Medical history of allergy to any component of the vaccine.
3. Chronic renal failure on hemodialysis.
4. Presence of antibodies against Human Immunodeficiency Virus.
5. Patients with seroconversion (anti-HBs \> 10 IU /ml) after the first three doses of vaccine.
6. Lack of consent to participate in the study.

Primary outcomes:
measure: Post-vaccination serological response
timeFrame: At 35 ± 5 days after administration
Secondary outcomes:
measure: Association of serological response to HBV vaccination to etiology and severity of cirrhosis
timeFrame: After 6 months
measure: Association of serological response to HBV vaccination to diabetes presence
timeFrame: After 6 months
measure: Association of serological response to HBV vaccination to body mass index
timeFrame: At baseline
measure: Association of serological response to HBV vaccination to anti-Hepatitis B core antigen positive presence
timeFrame: At baseline
measure: Association of serological response to HBV vaccination to obesity
timeFrame: After 6 months
Other outcomes:
Locations:
city: Seville
country: Spain
facility: Virgen del Rocío Hospital
Study officials:
affiliation: Virgen del Rocío Hospital
name: Juan Manual Pascasio Acevedo, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06595615: Health App Data Collection Study
Official title: Health App Data Collection Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cardiac Disease
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
Collaborators: name: Huntsville Hospital Health System
First posted: 2024-09-19
Enrollment: 80
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 indicated for cardiac implantable medical devices

Brief summary: Utilization of additional wearable data to improve clinical outcome

Detailed description: In addition to information available from cardiac implantable medical devices, health related data available from commercially approved wearables and devices such as Apple watch, blood pressure monitor and scales could be used to improve predictive analytics of impending clinical events. This study is to merge implantable medical device data with wearable data to evaluate the added benefit of extra data.

Eligibility criteria: Inclusion Criteria:

* Patients are willing to be compliant with daily measurements required 18 years of age or older
* Patients who have been implanted with ABT CRT-D devices connected to Merlin.net
* Patients who had at least one HF clinical event during past 12 calendar months
* Must provide written informed consent prior to the commencement of this clinical feasibility study
* Patients are willing to be compliant with daily measurements required

Exclusion Criteria:

* Pregnant and/or lactating mothers will be excluded from the study or have a plan to be pregnant in the next 12 months
* Patients with a life expectancy less than the duration of the study, as per clinician's discretion.
* Patients who will not be able to complete the daily survey questions due to inability to read

Primary outcomes:
measure: Acquisition of additional health data using patient App
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01346215: Study of Clinical Non-inferiority of Actparin® (Laboratorio Bergamo) Compared to Heparin Sodium (APP Pharmaceuticals), in Patients With Chronic Renal Failure
Official title: Study of Clinical Non-inferiority of Actparin® (Laboratorio Bergamo) Compared to Heparin Sodium (APP Pharmaceuticals), in Patients With Chronic Renal Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chronic Renal Failure
Keywords: heparin
renal insufficiency, chronic
extracorporeal dialysis
fibrinolytic agents
anticoagulants
aPTT
Lead sponsor: Laboratório Químico Farmacêutico Bergamo Ltda.
Sponsor class: INDUSTRY
Collaborators: name: Azidus Brasil
First posted: 2011-05-02
Enrollment: 132
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 investigate clinical non-inferiority, pharmacodynamic effect and safety of Actparin® (heparin sodium - Laboratório Químico Farmacêutico Bergamo Ltd.) compared to Heparin Sodium (APP Pharmaceuticals) in patients with renal failure under hemodialysis treatment.


Eligibility criteria: Inclusion Criteria:

* Patients research that agree to participate in the study and sign the informed consent form;
* Patients aged over 18 years, both sexes, regardless of color or social class;
* Patients with impaired renal function in chronic hemodialysis schedule of at least 3 times a week and giving the use of heparin in the prophylaxis of thrombosis in the system;
* Patients with laboratory results within specified acceptance criteria.

Exclusion Criteria:

* Patients who are taking part or took part in another clinical investigational study within 12 months;
* Hypersensitivity to heparin sodium and/or benzyl alcohol;
* History of active hemorrhage with alteration of blood coagulation, such as genetic disorders of coagulation system;
* History of disease that could aggravate or terminate the clinical manifestations, such as active peptic or gastric ulcer;
* Severe liver disease;
* Patients in cancer treatment;
* Pregnant and lactating women;
* Use of glucocorticoids over physiological dose;
* Use of other anticoagulants;
* Patients undergoing any surgery performed less than 15 days;
* History of non response or exacerbated response to heparin sodium;
* Patients who do not adapt to 150 UI/kg dose.

Primary outcomes:
measure: Effectiveness in prevention of clotting in the extracorporeal circuit during hemodialysis
timeFrame: 4 weeks (12 consecutive sessions)
Secondary outcomes:
measure: Pharmacodynamic activity of heparin observed through aPTT marker
timeFrame: 4 weeks (sessions 1, 6 and 12)
measure: Safety in use of heparin by monitoring adverse events
timeFrame: 5 weeks (12 consecutive sessions + 1 post treatment session)
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Instituto de Nefrologia de Campinas
state: São Paulo
Study officials:
affiliation: Instituto de Nefrologia de Campinas
name: Marcelo A. C. Orlandi, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01920815: Bicuspid Valve Aortopathy Feasibility Study
Official title: Bicuspid Valve Aortopathy: Feasibility of a Comparative Effectiveness Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bicuspid Aortic Valve
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Emory University
name: University of Colorado, Denver
name: Baylor College of Medicine
name: University of California, Los Angeles
name: Penn State University
First posted: 2013-08-12
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a bicuspid aortic valve.

Brief summary: In order to determine the effectiveness of medical therapy options to prevent enlargement of the aorta in patients with a bicuspid aortic valve, a randomized study will be planned. This feasibility study will gather accurate data on number needed to screen, changes in medication use over time, and variance of the intended study endpoint.

Detailed description: The study will consider all patients with a bicuspid aortic valve and 1) determine the number of patients needed to be screened for a clinical trial, based on patient eligibility percentages applying specific inclusion and exclusion criteria, 2) for those meeting these criteria, follow changes in and compliance with medical therapy over two years, and 3) in a limited subset of eligible patients, perform MRI at baseline and after 2 years to measure the change in aortic area over time.

Eligibility criteria: Inclusion Criteria:

* Bicuspid aortic valve
* Aortic measurement of 35 - 49 mm on prior imaging study

Exclusion Criteria:

* Prior aortic valve or thoracic aortic surgery
* Prior aortic dissection
* Other condition associated with enlarged aorta including Coarctation, Marfans, Turner syndrome, Loeys-Dietz, etc.
* Severe aortic stenosis or regurgitation
* Contraindication to MRI such as claustrophobia or implanted pacer/defibrillator
* Anticipated pregnancy, surgery, or move outside the area within 2 years

Primary outcomes:
measure: Change in aortic area measured by MRI
timeFrame: 24 months
Secondary outcomes:
measure: Clinical events involving the aorta, including change in medical therapy
timeFrame: 24 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California
state: California
city: Denver
country: United States
facility: University of Colorado
state: Colorado
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Hershey
country: United States
facility: Penn State
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References:
Clinical trial NCT00239915: Safety and Efficacy Study of the Investigational Drug Pagoclone, in the Treatment of Persistent Developmental Stuttering (PDS)
Official title: An 8-week, Double-Blind, Randomized, Multicenter, Flexible-Dose, Placebo-Controlled Pilot Study of Pagoclone in Patients With Persistent Developmental Stuttering Followed by a 52-week Open-Label Extension.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Persistent Developmental Stuttering
Lead sponsor: Pharmacology Research Institute
Sponsor class: OTHER
First posted: 2005-10-17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a research study of the investigational drug, Pagoclone, in the treatment of persistent developmental stuttering (PDS), which includes frequent repetitions or prolongations of sounds or syllables or words, or frequent hesitations or pauses that disrupt the flow of speech. Pagoclone is an investigational drug, so it is not approved by the United States Food and Drug Administration.


Eligibility criteria: Inclusion Criteria:

* PDS defined as DSM-IV-TR criteria
* Symptoms starting before age 8
* Total overall score of 18-36 on the SSI-3
* English speaking, with an 8th grade education
* Able to understand and cooperate with study requirements with assistance
* Not pregnant or breastfeeding
* Able to provide consent

Exclusion Criteria:

* No diagnoses of other CNS/Mental health disorders in the last 6 months
* No use of psychotropic medication or other medication for stuttering within 4 weeks prior to screening
* No use of non-medicinal stuttering treatments for 5 months prior to the study
* No use of illicit drugs or opiates of any kind

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Riverside
country: United States
facility: Pharmacology Research Institute
state: California
Study officials:
affiliation: Pharmacology Research Institute
name: Jon F. Heiser, M.D.
role: PRINCIPAL_INVESTIGATOR
References: