louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00013169: Patient-Centered Alternative to Psychiatric Hospitalization for Veterans
Official title: Patient-Centered Alternative to Psychiatric Hospitalization for Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Veterans
Acute Hospitalization
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-03-16
Enrollment: 220
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: A variety of models of psychiatric hospital alternative care have been developed over the past several decades. San Diego�s Short-Term Acute Residential Treatment (START) model is one of the best established of these alternatives, comprising a network of 6 facilities with a total of 77 beds. Although veterans have been among those served at START programs for many years, no previous study of START or any other model has focused specifically on veterans.

Detailed description: Background:

A variety of models of psychiatric hospital alternative care have been developed over the past several decades. San Diego�s Short-Term Acute Residential Treatment (START) model is one of the best established of these alternatives, comprising a network of 6 facilities with a total of 77 beds. Although veterans have been among those served at START programs for many years, no previous study of START or any other model has focused specifically on veterans.

Objectives:

The study tested the hypotheses that veterans treated in a START program would demonstrate greater improvement in symptoms and quality of life, as well as greater satisfaction with treatment and lower costs of care than veterans treated at the VA inpatient unit.

Methods:

This study includes elements of both efficacy and effectiveness studies. VA psychiatric unit treatment and START are compared in a randomized trial, with follow up of subjects at 2, 6, and 12 months as they experience real-world treatment-as-usual. Symptoms, functioning, quality of life, and satisfaction with services are assessed on multiple standardized measures, as well as by qualitative assessments.

Status:

Final report is under preparation.

Eligibility criteria: Inclusion Criteria:

Have to a veteran and in need of acute hospitalization, but able to take care of themselves. (Max Age is 59)

Exclusion Criteria:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego, CA
name: James B Lohr, MD BA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ta S, Goldzweig C, Juzba M, Lee M, Wenger N, Yano EM, Asch S. Addressing physician concerns about performance profiling: experience with a local Veterans Affairs quality evaluation program. Am J Med Qual. 2009 Mar-Apr;24(2):123-31. doi: 10.1177/1062860608330828. Epub 2009 Feb 19.
Clinical trial NCT02203669: Occupational/Physical Therapy to Reduce Morbidity Post-Operative Bilateral Breast Reconstruction
Official title: The Use of Occupational/Physical Therapy to Reduce Upper Extremity Morbidity Post-Operative Bilateral Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Occupational/Physical Therapy
Post-operative Breast Reconstruction
Keywords: breast reconstruction
occupational therapy
physical therapy
upper extremity morbidity
Lead sponsor: University of Tennessee
Sponsor class: OTHER
First posted: 2014-07-30
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
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 demonstrate the benefits of a structured occupational/physical therapy program on upper extremity morbidity for patients who have received bilateral breast reconstruction in comparison to a home therapy program and no post-operative therapy.

Hypothesis: Patients who engage in therapist-supervised occupational therapy following bilateral breast reconstruction have less upper extremity morbidity than those patients who complete a home therapy program or no therapy program.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years of age
* Women who have had bilateral breast reconstruction
* All cancer stages will be included
* Physically and mentally able to participate in the study within the required time-frame
* Able to voluntarily give full informed consent to participate in the study

Exclusion Criteria:

* Women undergoing unilateral breast reconstruction
* Unable to provide informed consent in English
* Physically unable to engage in the protocol

Primary outcomes:
measure: Change in DASH: Disabilities of the Arm, Shoulder and Hand score
timeFrame: Week 1 and Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Chattanooga
country: United States
facility: The Plastic Surgery Group, P.C.
state: Tennessee
Study officials:
affiliation: The University of Tennessee
name: Mark Brzezienski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00834769: Chronic Pain After Thoracotomy, an Incidence Study in a Single Surgical Center
Official title: Chronic Pain After Thoracotomy, an Incidence Study in a Single Surgical Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracotomy
Chronic Pain
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2009-02-03
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: thoracotomized patients

Brief summary: Investigation of chronic pain frequency after thoracotomy for lung cancer. Risk factors for development of chronic pain are investigated. Questionnaire survey.


Eligibility criteria: Inclusion Criteria:

* thoracotomized patients

Exclusion Criteria:

* mental incapacity,
* poor understanding of French,
* pre-existing chronic pain before surgery,
* redo-surgery

Primary outcomes:
measure: Pain and pain score
timeFrame: one year postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
References:
Clinical trial NCT01716169: Treatment of Chronic and Non-Chronic Wounds in Patients With Recessive Dystrophic Epidermolysis Bullosa Using Helicoll Collagen Dressings Versus Standard of Care
Official title: Treatment of Chronic and Non-Chronic Wounds in Patients With Recessive Dystrophic Epidermolysis Bullosa Using Helicoll Collagen Dressings Versus Standard of Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epidermolysis Bullosa Dystrophica
Epidermolysis Bullosa
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2012-10-29
Enrollment: 10
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the effectiveness of Helicoll (a collagen wound dressing) in treating chronic and non-chronic wounds of recessive dystrophic epidermolysis bullosa (RDEB) patients. Helicoll will be compared to standard wound dressings.


Eligibility criteria: Inclusion criteria:

1. Written consent must be obtained from subjects over age 18, or from a parent or legally authorized representative if subject is under 18. Assent will be obtained from subjects age 7 - 17.
2. Subjects with a clinical diagnosis of RDEB by a dermatologist.
3. Have at least three target wounds that meet the following criteria:

   * One chronic wound, of approximately 6 months or more duration. If the subject has an additional chronic wound of similar size and duration, this additional wound will be treated with standard dressings and followed in the study. A wound in an area that consistently heals and then breaks down again will be considered a chronic wound.
   * Two non-chronic wounds, of approximately 3 months or less duration, of similar size, and able to be dressed separately. Both wounds should have approximately the same duration.

   All wounds must be:
   * Open, and not scabbed or crusted over
   * Not actively infected
   * Not requiring surgical intervention
4. A parent or legally authorized representative must be willing and able to ensure subject is present for all required study visits (for minor subjects).
5. The subject or caregiver (or a parent or legally authorized representative for subjects under 18) must be able to follow instructions.
6. Subject must be age 7 or older.

Exclusion criteria:

1. Inability to travel to Stanford for study visits.
2. Complicating illness as determined by study investigators to be exclusionary including any infection requiring systemic antibiotics.
3. Presence or history of squamous cell carcinoma at target wound site.
4. Known bovine (cow) or ovine (sheep) sensitivity.
5. Therapy with an investigational agent during the study.

Primary outcomes:
measure: Percentage of Wound Surface Area Change From Baseline to Week 8
timeFrame: Baseline and Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Alfred Lane, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00234910: Efficacy of Simplified Two Drug Kaletra Regimen vs. Kaletra Triple Drug Standard of Care Regimen in Treatment naïve HIV Infected Patients
Official title: A Phase III, Open Label, Randomized, Comparative Study of the Antiviral Efficacy of ARV Therapy With Lopinavir/Ritonavir (LPV/r-Kaletra) in Combination With Tenofovir (TDF) Versus Standard of Care (Kaletra in Combination With 2 Nucleoside RTIs) in naïve-HIV-1 Positive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infection
Keywords: Lopinavir
Ritonavir
Kaletra
Tenofovir
HIV infection
Treatment Naive
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2005-10-10
Enrollment: 152
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: The purpose of this study is to obtain a preliminary assessment of the antiviral activity and tolerability of simplified Kaletra dual agent therapy as initial treatment for HIV infection, relative to a Kaletra three drug standard of care reference arm.


Eligibility criteria: Inclusion Criteria:

* HIV positive
* \>18 years of age
* HIV RNA\> 400 copies/mL
* Any CD 4 cell count
* Antiretroviral naïve
* No acute illness

Exclusion Criteria:

-

Primary outcomes:
measure: Antiviral efficacy by HIV RNA
timeFrame: 72 wks
measure: Incidence of adverse events
timeFrame: 72 wks
Secondary outcomes:
measure: Adherence and quality of life
timeFrame: 72 wks
Other outcomes:
Locations:
city: Abbott Park
country: United States
facility: Global Medical Information-Abbott
state: Illinois
Study officials:
affiliation: Abbott
name: Umberto di Luzio Paparatti, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06645210: Multicenter Registration Study on Allergic Bronchopulmonary Aspergillosis
Official title: A Multicenter Retrospective Cohort Study on Allergic Bronchopulmonary Aspergillosis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Allergic Bronchopulmonary Aspergillosis
Keywords: cohort study
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Guangxi Medical University
name: Guangzhou Institute of Respiratory Disease
name: Tongji Hospital
name: Nanfang Hospital, Southern Medical University
name: The First Affiliated Hospital with Nanjing Medical University
name: Qianfoshan Hospital
name: The First Affiliated Hospital of Shanxi Medical University
name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: West China Hospital
name: Second Affiliated Hospital of Xi'an Jiaotong University
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Xiangya Hospital of Central South University
name: Peking Union Medical College Hospital
name: Ruijin Hospital
First posted: 2024-10-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who were diagnosed with ABPA

Brief summary: To understand the current diagnosis and treatment status of ABPA patients, observe their clinical characteristics, prognosis, and treatment outcomes, and identify the relevant factors for poor prognosis in patients.


Eligibility criteria: Inclusion Criteria:

Meeting the diagnosis of ABPA according to the ABPA diagnostic criteria specified by the ISHAM-ABPA working group in 2024

Exclusion Criteria:

ABPA patients who are not first diagnosed in the center

Primary outcomes:
measure: Clinical classification and treatment response criteria for ABPA
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT05141110: Evaluation of Pharmacokinetic and Safety of NVP-1705 and NVP-1705-R in Healthy Subjects
Official title: A Phase 1 Clinical Trial, Open-label, Randomized Study in Healthy Subjects to Evaluate Pharmacokinetic Characteristics and Safety of NVP-1705 and NVP-1705-R in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: NVP Healthcare
Sponsor class: INDUSTRY
First posted: 2021-12-02
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: single-dose, crossover study
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the pharmacokinetics and safety of NVP-1705 and NVP-1705-R.

Detailed description: Evaluate the pharmacokinetics and safety of NVP-1705 compared to NVP-1705-R

Eligibility criteria: Inclusion Criteria:

* Healthy subject, 19 years of age or older
* Subjects who signed informed consent
* Body mass index(BMI) of 18 to 30.0 kg/㎡

Exclusion Criteria:

* Subject who has clinically significant medical history
* Inadequate subject for the clinical trial by the investigator's decision
* Subjects participated in another clinical trial within 6 months prior to the first administration of investigational product

Primary outcomes:
measure: Evaluation of Area under the plasma drug concentration-time curve(AUCt)
timeFrame: 0 ~ 48 hours
measure: Evaluation of Maximum observed plasma concentration(Cmax)
timeFrame: 0 ~ 48 hours
Secondary outcomes:
measure: Evaluation pf Area under the plasma drug concentration-time curve from time 0 to infinity(AUC∞)
timeFrame: 0 ~ 48 hours
measure: Evaluation of AUCt/AUC∞
timeFrame: 0 ~ 48 hours
measure: Evaluation of Time of peak concentration(Tmax)
timeFrame: 0 ~ 48 hours
measure: Evaluation of Terminal phase of Half-life(t1/2)
timeFrame: 0 ~ 48 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: H Plus Yangji Hospital
state: Nambusunhwan-ro
Study officials:
affiliation: H+ Yangji hospital
name: Jae Woo Kim, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01489410: Comparing Lipiodol/Ethanol With Drug-eluting Beads (DEB) for Hepatocellular Carcinoma
Official title: Prospective Study Comparing Lipiodol Plus Ethanol Solution Compared With Drug-Eluting Beads for Trans-arterial Chemoembolization of Liver in Treatment of Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2011-12-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Chemoembolization of hepatocellular carcinoma lesions is an accepted and frequently used method for the palliative or curative treatment of these lesions. These attempts are being made to make these patients a better candidate for liver transplant or to provide palliation for their condition.

Detailed description: This is a randomized prospective study with two arms, Drug-Eluting Beads with doxorubicin (DEB) and lipiodol ethanol mixture (LEM), with the goal to show non-inferiority of LEM, which if true will facilitate a simple alternative to DEBs. Patients will be randomized to one arm of the study and will remain in that arm if they need to have more embolization in the future. Both of the mentioned methods (DEB and LEM) fall within the standard of care.

Eligibility criteria: Inclusion Criteria:

* Child-Pugh class A or B
* Biopsy proven HCC or hypervascular mass per European Association for the Study of the Liver (EASL) criteria
* Patient not a candidate for surgical resection or percutaneous ablation
* age \> 18 years old and able to consent

Exclusion Criteria:

* Child-Pugh class C
* Model for End-Stage Liver Disease (MELD) score \>16
* Extrahepatic disease
* Bilateral or main portal vein thrombus
* Total bilirubin \> 2.2
* Serum albumin \< 2.6
* Life expectancy \< 2 months
* Uncorrected INR \> 2
* Eastern Cooperative Oncology Group (ECOG) status \> 2
* Tumor burden \> 50% liver volume
* Hepatofugal portal venous flow

Primary outcomes:
measure: Number of Patients with Post-Embolization Syndrome
timeFrame: Week 6 Post Intervention
Secondary outcomes:
measure: Patients with Encephalopathy After Embolization
timeFrame: Week 6 Post Intervention
measure: Changes in Quality of Life
timeFrame: Baseline and Week 6 After Intervention
measure: Comparison of Liver Function Tests Results
timeFrame: Day 0 and Week 6 Post Intervention
measure: Imaging Response
timeFrame: Week 6 Post Intervention
measure: Number of Patients with Successful Liver Transplant
timeFrame: Week 6 After Intervention
measure: Overall Survival
timeFrame: Week 6 After Intervention
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center, University of Minnesota
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Erik Cressman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03742310: The Relationship Between VDR Gene Polymorphism and Children's Physical and Intellectual Development
Official title: Multi-Center Clinical Study on the Relationship Between Vitamin D Receptor Gene Polymorphism and Children's Physical and Intellectual Development
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Development, Child
Keywords: Vitamin D Receptor gene
physical development
intelligent development
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Xian Children's Hospital
name: The First Affiliated Hospital of Zhengzhou University
First posted: 2018-11-15
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was used to determine the relationship between vitamin D receptor gene polymorphism and children's physical and intellectual development, further adjust the doses of vitamin D supplementation after birth, and provide individualized vitamin D and calcium supplements.

Detailed description: High risk children aged 0-3 years old who visited the pediatrics clinic and ward of the first affiliated hospital of Xi'an Jiaotong university and other cooperative hospitals from 2018 to 2020 were randomly selected. Personal information of the children and parents who were enrollment was collected by questionnaire survey and a follow-up file was established. 500 to 1,000 people are planned to participate in the study, were randomly divided into research group and the control group. Then collect the sample(saliva) of children to examine Vitamin D Receptor(VDR) genotype, according to results, divide the research group into high, medium and low risk, given individual vitamin D and calcium supplement. Monitor the children's weight, body length, head circumference, the Neonatal Behavioral Assessment Scale(NBAS), bailey rating scale respectively, up to 3 years old. All sample analyses were performed by the Gene Medical Laboratory. Laboratory personnel were blinded to mother and infant outcomes.

Eligibility criteria: Inclusion Criteria:

* infant age from 0 to 3 years old
* enjoy good health, there is no history of specific diseases

Exclusion Criteria:

* this time or always exists serious lung infection, or with nervous system disease, kidney disease, malignant tumor, etc
* has bone metabolic diseases or other genetic metabolic disease
* taking affect bone metabolism of drugs for a long time

Primary outcomes:
measure: body weight
timeFrame: From date of randomization until the date of three year-old
measure: body height
timeFrame: From date of randomization until the date of three year-old
measure: head circumference
timeFrame: From date of randomization until the date of three year-old
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Hui Li, PHD,MD
role: STUDY_CHAIR
References: