louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00680719: Preventing HIV/Aids in Drug Abusing Youth
Official title: Preventing HIV/Aids in Tx-Resistant Drug-Abusing Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: substance abuse
HIV risk
Behavior and Mental Disorders
HIV Seronegativity
Lead sponsor: Oregon Research Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2008-05-20
Enrollment: 111
Sex: ALL
Minimum age (years): 15
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project involves two studies focusing on the engagement and treatment of adolescents diagnosed with substance use disorders. Study 1 will evaluate a promising parent-based engagement intervention, Community Reinforcement Training, designed to facilitate the entry of resistant drug-abusing adolescents in treatment. The approach will be compared with an Engagement As Usual intervention condition. Study 2 involves a controlled clinical trial evaluating the efficacy of an HIV/AIDS prevention intervention embedded in family-based drug abuse treatment for reducing HIV/AIDS risk behaviors and substance use. Adolescents who are successfully engaged in treatment through Study 1 will be randomly assigned to receive either family therapy alone or family therapy with the integrated HIV/AIDS prevention intervention. Both studies are being conducted in Portland, Oregon.


Eligibility criteria: Inclusion Criteria:

* Parents have an adolescent in the ages of 15-20 years.
* Have had contact with the adolescent on at least 40% of the past 90 days.
* Have some knowledge or evidence that the adolescent would meet DSM-IV diagnostic criteria for a substance abuse disorder.
* Adolescent has explicitly refused to attend any intake or therapy sessions.
* All parents' efforts to enter adolescent into treatment have failed, despite therapist's assistance.
* Residence in Portland vicinity.
* Sufficient residential stability to permit probable contact at follow-up. (e.g. not homeless at time of intake)

Exclusion Criteria:

* Evidence of psychotic or organic state of sufficient severity to interfere with understanding of study instruments and procedures.
* Adolescent has received residential drug treatment longer than a 2-week period in the past 90 days.

Primary outcomes:
measure: Changes in adolescent's substance use.
timeFrame: 12 months
Secondary outcomes:
measure: Changes in HIV risk behaviors.
timeFrame: 12 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Research Institute Center for Family and Adolescent Research
state: Oregon
Study officials:
affiliation: Oregon Research Institute
name: Holly B Waldron, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05633719: Multicenter, Prospective Observational Study for Early Diagnosis, and Development of Follow-up Protocol and Hearing Rehabilitation Program for Ototoxic Hearing Loss After Chemotherapy for Pediatric Solid Cancer
Official title: Multicenter, Prospective Observational Study for Early Diagnosis, and Development of Follow-up Protocol and Hearing Rehabilitation Program for Ototoxic Hearing Loss After Chemotherapy for Pediatric Solid Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Solid Tumor, Childhood
Keywords: Pediatric solid tumor, Chemotherapy, Hearing loss
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-12-01
Enrollment: 300
Sex: ALL
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are diagnosed as solid cancer and receive platinum chemotherapy

Brief summary: More than half of all pediatric cancer in Korea are solid cancer. For the treatment of solid cancer, multidisciplinary methods such as surgery, chemotherapy, and radiation therapy are applied, and with the development of the treatment method, the treatment performance has improved dramatically, and the 5-year survival rate of more than 80% is currently recorded. Due to the improvement in survival rate, interest in side effects caused by cancer treatment itself is gradually increasing, and efforts to reduce them are increasing. Accordingly, it aims to contribute to improving the quality of life of pediatric solid cancer survivors. by developing a Korean-type early diagnosis and follow-up protocol of ototoxic hearing loss, which commonly occurs in pediatric solid cancer who have undergone chemotherapy.


Eligibility criteria: Inclusion Criteria:

① Solid cancer patients under the age of 19 receiving Platinum chemotherapy

② Solid cancer patients under the age of 19 receiving 30 Gy or more head and neck radiation therapy

Exclusion Criteria:

① Those who have received chemotherapy or radiation in the past

* Those who have difficulty understanding the clinical trial due to mental retardation or unable to read the consent form, such as illiteracy or foreigners ③ Those who have difficulty in hearing test due to neurological factors, etc. ④ Other cases judged to be inappropriate for this study by the judgment of the person in charge of the clinical trial

Primary outcomes:
measure: Proportion of patients with ototoxic hearing loss
timeFrame: 1 year after the initiation of chemotherapy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06294119: Multivariate Approach to the Numerical Assessment of Cortical - Autonomic - VAscular Dynamic Interplay
Official title: Multivariate Approach to the Numerical Assessment of Cortical - Autonomic - VAscular Dynamic Interplay
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiac Disease
Depression
Lead sponsor: IRCCS Policlinico S. Donato
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: MANCAVA sets out fundamental methodologies for characterizing human fundamental physiological system interactions at a whole-body level, particularly focusing on the interplay among cortical brain activity, autonomic function, and cerebrovascular autoregulatory mechanisms. By investigating the complex, time-varying mechanisms underlying the multisystem dynamic interactions, novel methods linking various brain areas and reflex functions to target organs and districts such as heart and circulatory system are proposed with the clinical aim linked to the emerging topic of depression.

In this scenario, proper new mathematical tools will allow a significant leap from the current state of the art, paving the way towards a new understanding of leading comorbid contributors to global diseases such as cardiac and cerebrovascular morbidity in mood disorders. In turn, this will provide an integration among physiological and psychological dimensions for a more holistic view on depression.

Researchers, professionals, and patients will all benefit from a comprehensive assessment of brain-mind-body interplay, leading to the new extended definition of default mode/mood network, neurovascular-evoked responses to autonomic stimuli, brain-autonomic consequences of emotional responses, and physiological substrates of depressive states.


Eligibility criteria: Inclusion Criteria:

* age older than 18 years
* spontaneous sinus rhythm
* signed informed consent
* indication to heart surgery

Exclusion Criteria:

* age lower than 18 years
* absence of sinus rhythm
* pregnancy
* impossibility of informed consent

Primary outcomes:
measure: Autoregulation index (ARI)
timeFrame: 24 months
measure: number of patients developing depression
timeFrame: 24 months
measure: Baroreflex sensitivity
timeFrame: 24 months
measure: Cortical activity
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
state: Milan
Study officials:
References:
Clinical trial NCT00129519: A Study to Evaluate the Effectiveness of Imiquimod 5% Cream for Basal Cell Carcinoma Recurrence
Official title: Open-label Study to Evaluate the Use of Imiquimod 5% Cream for Reducing Postsurgical Recurrence or Persistence of Basal Cell Carcinoma Following Excision by Curettage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Basal Cell Carcinoma
Keywords: BCC curettage
Lead sponsor: Graceway Pharmaceuticals, LLC
Sponsor class: INDUSTRY
First posted: 2005-08-12
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess whether basal cell carcinoma (BCC) lesions surgically treated with curettage, followed by imiquimod 5% cream as postsurgical adjuvant therapy, will have an improved cure rate over the ED/C historical norm of approximately 70% at 1-year posttreatment follow-up. A secondary objective is to assess cosmetic outcome.

Detailed description: This was an open-label, phase IIIb, multicenter, single arm, historical-controlled study. Biopsy-confirmed BCC lesions (1 per subject) were excised by curettage, with no electrodessication. Approximately 1 week later, treatment with imiquimod 5% cream was initiated. Imiquimod was applied to the target BCC once daily, 5 times per week (5x/week) for up to 6 weeks. Rest periods were allowed as needed. Subjects reported to the study center at treatment weeks 1, 2, and 6, and posttreatment at weeks 12, 26, and 52. At treatment week 6 and all posttreatment visits, the investigator clinically assessed the target site for tumor clearance and cosmetic outcome. A template made at initiation and created from clear plastic overlay aided in locating the target tumor site. If the investigator identified a lesion that had occurred or recurred at the target site, the subject was discontinued from the study and counted as a recurrence/persistence (R/P).

Eligibility criteria: Inclusion Criteria:

* Basal cell carcinoma

Exclusion Criteria:

* Psoriasis

Primary outcomes:
measure: Number of subjects with recurrence
timeFrame: 1 year posttreatment
Secondary outcomes:
measure: Cosmetic outcome of the target lesion
timeFrame: 1 year posttreatment
Other outcomes:
Locations:
city: Grass Valley
country: United States
state: California
city: Loma Linda
country: United States
state: California
city: New York
country: United States
state: New York
Study officials:
References:
citation: Rigel DS, Torres AM, Ely H. Imiquimod 5% cream following curettage without electrodesiccation for basal cell carcinoma: preliminary report. J Drugs Dermatol. 2008 Jan;7(1 Suppl 1):s15-6.
Clinical trial NCT02920619: The ULTRA Study: Cross-Comparison of Ultrasound Systems
Official title: The ULTRA Study: Cross-Comparison of Muscle Composition Measures in Multiple Ultrasound Systems
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Keywords: ultrasound
muscle
Lead sponsor: Washington D.C. Veterans Affairs Medical Center
Sponsor class: FED
First posted: 2016-09-30
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Thirty adult Veterans (20-85 years) will be recruited for the study from the DC VAMC.

Brief summary: The purpose of this study is to develop computational methods for cross-comparison of muscle composition measurements in three laboratory ultrasound systems.

Detailed description: The purpose of this study is to develop computational methods for cross-comparison of muscle composition measurements in three laboratory ultrasound systems. We propose a cross-sectional study to obtain ultrasound images of selected muscles in Veteran participants. These data will be used to develop conversion models for each system. Evaluation of neuromuscular symptoms such as muscle weakness and fatigue is crucial to improving quality of life among Veterans. These symptoms may be related to progressive changes in muscle tissue composition, including increased intramuscular fat and atrophy. Quantitative musculoskeletal ultrasound is a diagnostic imaging application used to characterize muscle tissue composition. Despite its non-invasiveness and relative low cost, quantitative musculoskeletal ultrasound has not been widely adopted by the medical community due in part to technical barriers that impede generalization of measurements across ultrasound systems. Unfortunately, few techniques have been proposed to reliably compare system measurements. Development of new cross-comparison methods could expand quantitative musculoskeletal ultrasound applications and improve neuromuscular symptoms diagnosis.

Eligibility criteria: Inclusion Criteria:

* Male or female Veteran who receives medical care at the Washington DC VA Medical Center
* Ages 20-85

Exclusion Criteria:

* Limb amputation (upper or lower extremity)
* Lower extremity joint replacement
* Severe cognitive impairment
* Edema
* Inability to read, speak, or understand English

Primary outcomes:
measure: Echogenicity
timeFrame: 1 day
Secondary outcomes:
measure: Muscle thickness
timeFrame: 1 day
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington DC VA Medical Center
state: District of Columbia
Study officials:
affiliation: Washington DC VA Medical Center
name: Michael Harris-Love, D.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Harris-Love MO, Seamon BA, Teixeira C, Ismail C. Ultrasound estimates of muscle quality in older adults: reliability and comparison of Photoshop and ImageJ for the grayscale analysis of muscle echogenicity. PeerJ. 2016 Feb 22;4:e1721. doi: 10.7717/peerj.1721. eCollection 2016.
Clinical trial NCT06864819: Role of Phosphatidylethanol in Predicting Perioperative Outcomes of Admitted Patients at UHCMC
Official title: Role of Phosphatidylethanol in Predicting Perioperative Outcomes of Admitted Patients at UHCMC
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postoperative Complications
Alcohol Use Disorder
Keywords: alcohol consumption
surgical outcomes
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 170
Sex: ALL
Minimum age (years): 21
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing elective surgery at UHCMC.

Brief summary: This study aims to see if there's a link between a substance called phosphatidylethanol (PEth) and how patients who have surgery at University Hospitals do after surgery. PEth levels reflect the amount of alcohol use by someone over the past few weeks. This study is checking PEth levels on all patients who are planned to stay in the hospital for three or more days after surgery regardless if they drink alcohol. Specifically, it will look at if PEth levels are connected to problems that might come up during and after surgery, like confusion, lung or heart issues, needing blood transfusions, infections, unexpected intensive care unit (ICU) stays, and longer hospital stays. While there are reports of moderate alcohol consumption being good for the heart, there are other data that alcohol consumption can be harmful. Since there's not much information on how drinking alcohol affects health outcomes during and after surgery, especially for patients who are planned to be admitted to the hospital ward or ICU after surgery, this study will hopefully see if PEth levels before surgery can predict how patients do after the surgery.


Eligibility criteria: Inclusion Criteria:

* 1. Age range: 21-79
* 2. Patients undergoing elective surgery at UHCMC with planned ICU admission
* 3. Patients undergoing elective surgery at UHCMC with expected in-hospital admission for three or more days

Exclusion Criteria:

* 1. Patients undergoing same day outpatient surgeries or expected to be admitted less than three days post-operatively
* 2. Subjects who have received a blood transfusion within the past month before surgery
* 3. Pregnant subjects

Primary outcomes:
measure: Phosphatidylethanol level as measured by blood draw.
timeFrame: Baseline
measure: Length of ICU stay measured in days
timeFrame: Up to 7 days
measure: Length of hospital stay measured in days
timeFrame: Up to 2 weeks
measure: Number of perioperative complications as measured by medical record review.
timeFrame: Up to six months
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospital
state: Ohio
Study officials:
affiliation: University Hospitals
name: Salim Hayek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06382519: Thalidomide Therapy for VEOIBD
Official title: Thalidomide Therapy for Very Early Onset Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 40
Sex: ALL
Minimum age (years): 28
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children diagnosed with very early onset inflammatory bowel disease who were seen at the Children's hospital of Fudan university who met the inclusion and exclusion criteria would be enrolled in this study.

Brief summary: This is a single center, observational study to investigate the clinical outcomes of thalidomide treatment for very early onset inflammatory bowel disease

Detailed description: Very early onset inflammatory bowel disease (VEOIBD) refers to IBD diagnosed before 6 years of age. VEOIBD comprises a distinct subset of pediatric IBD characterized by stronger genetic predisposition, predominant colonic involvement, more extensive inflammation, more severe course, and peculiar response to treatments. Previous studies have been demonstrated that thalidomide, an oral molecule with immunomodulatory, antiangiogenic, and TNF-suppressing properties, is an effective and safe treatment for adults and children with IBD refractory to conventional therapies. This study is aimed to evaluate the efficacy and tolerance of thalidomide in VEOIBD.

Eligibility criteria: Inclusion Criteria:

* diagnosed with inflammatory bowel disease
* disease onset less than 6 years old
* Pediatric Crohn's disease Activity Index (PCDAI)\>30 or Pediatric Ulcerative Colitis Activity Index (PUCAI)\>35
* patients and their legal guardians were willing to receive thalidomide treatment and participate in this study.

Exclusion Criteria:

* liver dysfunction
* allergy to thalidomide
* with Neuropathy
* with thrombosis
* thalidomide treatment in the previous 30 days
* biologics treatment in the previous 8 weeks
* not suitable participated in this study

Primary outcomes:
measure: endoscopic response rate
timeFrame: week 52
Secondary outcomes:
measure: clinical response rate
timeFrame: week8, week26, week52
measure: biomarker remission rate
timeFrame: week8, week26, week52
measure: growth development
timeFrame: week52
measure: clinical remission rate with steroid-free
timeFrame: week26
measure: adverse event
timeFrame: within one year
measure: treatment persistence
timeFrame: within one year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Lin Wang
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: Ying Huang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00459719: A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Liver Transplantation
Official title: A Multicenter, Randomized, Open Label, Parallel Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf® in Combination With Steroids in Patients Undergoing Liver Transplantation and a Pharmacokinetics Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Liver Transplantation
Keywords: Liver Transplantation
Tacrolimus
Methylprednisolone
Prednisolone
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2007-04-12
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The patients about to undergo liver transplantation will be randomized to one of the following two group:

Group FK506MR: FK506MR/steroid; Group Prograf® : Prograf® /steroid The treatment period is 3 months(12 weeks


Eligibility criteria: Inclusion Criteria:

* Written informed consent with the date of the patient must be obtained.
* Patient between 18-70 years of age receiving the primary liver.
* Female patients must have a negative pregnancy test prior to the enrolment.
* Female patients of child bearing potential must agree to practice effective birth control during the study

Exclusion Criteria:

* Liver re-transplantation patients or received an organ transplantation other than a liver.
* Living-related liver transplantation patient.
* Patient has received an AB0 incompatible donor liver.
* Patient who needs antibody induction therapy.
* Patient with sever infection requiring treatment.
* Patient has any history of severe cardiovascular, respiratory disease; or history of malignancy, liver cancer not included.

Primary outcomes:
measure: Event rate of patients with acute rejections
timeFrame: 12 Weeks
Secondary outcomes:
measure: Incidence of and time to acute rejections
timeFrame: 12 Weeks
measure: Overall frequency of acute rejections
timeFrame: 12 Weeks
measure: Rate of patient and graft survival following transplantation.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
state: Beijing
city: Guangzhou
country: China
state: Guangdong
city: Shanghai
country: China
state: Shanghai
city: Hangzhou
country: China
state: Zhejiang
city: Tianjin
country: China
Study officials:
affiliation: Department of Hepatobiliary surgery
name: Prof. Leng Xisheng
role: PRINCIPAL_INVESTIGATOR
References: