louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05350904: Hybrid Telehealth in Pediatric Physical Therapy
Official title: Does Hybrid Telehealth Physical Therapy for Children With Moderate to Severe Disability Improve Function in the Home Environment Better Than In-person Services Alone?--A Mixed Methods Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Disorder
Disability, Developmental
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The control group will receive usual physical therapy care. The experimental group will receive a hybrid of in-person and telehealth services to address in-home functional skills.
Primary purpose: TREATMENT

Brief summary: The purposes of this study are to compare the impact of a hybrid of telehealth and in-person physical therapy services to in-person services alone on the in-home functional skills of children with moderate to severe disability. This is a mixed methods study.

Detailed description: The purposes of this study are to compare the impact of a hybrid of telehealth and in-person physical therapy services to in-person services alone on the in-home functional skills of children with moderate to severe disability. Research questions include:

Is a hybrid of telehealth and in-person physical therapy service better than in-person services alone for improving in-home functional skills in children with moderate to severe disability?

Is there a difference in the satisfaction of caregivers and children with physical therapy services which consist of a hybrid of telehealth and in-person physical therapy services compared to in-person services alone?

What is the experience of children and caregivers who receive a hybrid of telehealth and in-person physical therapy services during an episode of care?

Eligibility criteria: Inclusion Criteria:

* Children 2-17 years old with moderate to significant disability.
* Families have access to minimum technology necessary to participate in a telehealth visit. ---The child's insurance covers telehealth visits.

Exclusion Criteria:

-Caregiver does not speak English

Primary outcomes:
measure: Change in Canadian Occupational Performance Measure
timeFrame: after physical therapy episode of care an average of 12 weeks
measure: Measures of Processes of Care (MPOC)
timeFrame: after physical therapy episode of care, an average of 12 weeks
measure: Change in Pediatric Evaluation of Disability Inventory
timeFrame: after physical therapy episode of care, an average of 12 weeks
measure: Semi-structured interviews with caregivers and children in experimental group
timeFrame: after physical therapy episode of care, an average of 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
References:
Clinical trial NCT03176004: Attention Training to Modify Error-related Negativity and Risk for Anxiety in Adolescence
Official title: Attention Training to Modify Error-related Negativity and Risk for Anxiety in Adolescence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: San Diego State University
First posted: 2017-06-05
Enrollment: 600
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Adolescents are randomized to either a game that trains attention away from threat (attention bias modification), a game that trains attention but unrelated to threat (control condition), or a wait list group.
Primary purpose: BASIC_SCIENCE

Brief summary: This is a multi-site study to examine error-related brain activity (i.e., the error-related negativity) and anxiety symptoms in 11 to 14 year-olds (N=600) at two time points separated by two years. The study examines the degree to which error-related negativity can predict anxiety prospectively over two years, and whether a computerized game that alters attention to threat can alter error-related negativity and trajectories of anxiety.

Detailed description: Approximately 600 youths between the ages of 11 and 14 and their parents will be assessed. Adolescents will be evaluated at baseline using event-related potentials, self-report, and interview-based measures. The error-related negativity will be evaluated immediately (it takes less than 5 minutes to process and score a single subjects' error-related negativity ), and adolescents with good error-related negativity data (\~90%, based on scorable error-related negativity data) will be randomly assigned to either an 8-week (i.e., 16 session) adaptive attention bias modification (N=180) or control condition (N=180) or a waitlist condition (N=180) group. Each session lasts 20 minutes, and participants will be asked to complete two 20-minute sessions per week. Participants will be assessed immediately at post, using the same measures from the baseline assessment. All participants will complete a 2-year follow-up lab visit using the same measures from the baseline assessment.

Eligibility criteria: Inclusion Criteria:

* children and parent must speak English well enough to complete the study assessments

Exclusion Criteria:

* current threat of harm to self or others, bipolar illness, psychosis, thought disorder, pervasive developmental disorder, mental retardation, neurological diseases that impair cognition, or significant head injuries (past 3 months).

Primary outcomes:
measure: Change in Anxiety Symptoms
timeFrame: Baseline to 8 week
measure: Change in Anxiety Symptoms
timeFrame: baseline to 2 year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego State University
state: California
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
Study officials:
References:
Clinical trial NCT00002004: A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 (rCD4) in Patients With AIDS and AIDS-Related Complex
Official title: A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 (rCD4) in Patients With AIDS and AIDS-Related Complex
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: Recombinant Proteins
Acquired Immunodeficiency Syndrome
Antigens, CD4
AIDS-Related Complex
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To determine the safety profile and maximum tolerated dose (MTD) of recombinant soluble human CD4 (rCD4) therapy in patients with AIDS or AIDS related complex (ARC). To assess pharmacokinetic properties of rCD4 in humans. To obtain a preliminary indication of the antiviral effects of rCD4 in patients with AIDS and AIDS related complex (ARC).


Eligibility criteria: Inclusion Criteria

Patients must have:

* HIV-1 seropositivity.
* Diagnosis of AIDS or AIDS related complex (ARC).
* Failure to tolerate or respond to zidovudine (AZT) or decided to decline AZT therapy.
* The ability to sign a written informed consent form prior to treatment.
* A willingness to abstain from all other experimental therapy for HIV infection during the entire study period.
* A life expectancy of at least 3 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Serious active opportunistic infections.
* Malignancies other than Kaposi's sarcoma.

Concurrent Medication:

Excluded:

* Zidovudine (AZT).
* Corticosteroids.
* Nonsteroidal anti-inflammatory agents (NSAI).
* Other experimental therapy.

Patients with the following are excluded:

* Serious active opportunistic infections.
* Malignancies other than Kaposi's sarcoma.

Prior Medication:

Excluded within 3 weeks of study entry:

* Zidovudine (AZT).
* Chemotherapy.
* Immunomodulators.
* Other experimental therapy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: South San Francisco
country: United States
facility: Genentech Inc
state: California
Study officials:
References:
Clinical trial NCT03439904: Individualized Pharmaceutical-care in Outpatients With Cancer Pain
Official title: Impact of Individualized Pharmaceutical-care on Medication Adherence and Outcome of Cancer Pain in Opioid-tolerant Outpatients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer Pain
Keywords: pharmaceutical care
adherence
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2018-02-20
Enrollment: 200
Sex: ALL
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 the study is to investigate the impact of pharmaceutical care on cancer pain treatment for opioid-tolerant outpatients

Detailed description: This study is a prospective multicenter randomized controlled study to investigate the impact of pharmaceutical care on cancer pain treatment for opioid-tolerant outpatients treated with sustained released morphine, oxycodone, and transdermal fentanyl.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or older;
* Histologically confirmed solid tumor;
* Diagnosed chronic cancer pain;
* Opioid-tolerant patients;
* Overall survival is expected to be over 3 months;
* Karnofsky performance score≥50;
* Willing and able to comply with the protocol

Exclusion Criteria:

* Patients aged 18 years or older;
* Histologically confirmed solid tumor;
* Diagnosed chronic cancer pain;
* Opioid-tolerant patients;
* Overall survival is expected to be over 3 months;
* Karnofsky performance score≥50;
* Willing and able to comply with the protocol

Primary outcomes:
measure: Change in medication adherence
timeFrame: Change from baseline at 1 month
Secondary outcomes:
measure: Change in pain score
timeFrame: Change from baseline pain score at 1 month
measure: Change in quality of life
timeFrame: Change from baseline quality of life at 1 month
measure: Change in patients' knowledge of cancer pain and analgesics
timeFrame: Change from baseline knowledge at 1 month
measure: Incidence of adverse events [safety and tolerability]
timeFrame: Up to 1 month
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References:
citation: Ding H, Song Y, Wu N, Zheng X, Wei Q, Sun Y, Xie R, Zhai Q, Xu S, Qi Y, Wang Y, Li H, Yang L, Fan Q, Zhao Q, Chen J, Shi J, Duan C, Du Q, Zhang Y, Song Z, Fu S, Cai Y, Huang X, Fang L, Liu Y, Huang P. Impact of individualized pharmaceutical care on efficacy and safety of opioid-tolerant outpatients with cancer pain: a multicenter randomized controlled trial. Ann Transl Med. 2022 Sep;10(18):989. doi: 10.21037/atm-22-4091.
Clinical trial NCT00154804: CCRT With Twice Weekly Paclitaxel and Cisplatin Followed by Surgery for Locally Advanced Esophageal Cancer
Official title: A Phase II Study of Concurrent Chemoradiotherapy With Twice Weekly Paclitaxel and Cisplatin (Twice Weekly TP) Followed by Surgery for Locally Advanced Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Cancer
Keywords: Concurrent Chemoradiotherapy
Esophageal Cancer
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 40
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: CCRT with twice weekly paclitaxel and cisplatin in patient with locally advanced esophageal cancer.

Detailed description: The purpose of this study is to find out the clinical and pathological response rates of pre-operative concurrent chemoradiotherapy (CCRT) with twice weekly paclitaxel and cisplatin in patient with locally advanced esophageal cancer.

Eligibility criteria: Inclusion Criteria:

1. Pathologically proven SCC or adenocarcinoma of esophagus .
2. Locally advanced esophageal cancer , defined as T3 and/or N1 disease.( AJCC 1998)
3. M1a disease defined ( AJCC 1998) , including celiac lymph node for lower thoracic esophageal cancer and cervical lymph node involvement for upper thoracic esophageal cancer .
4. Age ≧ 18 ys
5. KPS ≧ 60%
6. Hemogram : WBC ≧ 4000/mm3 or ANC ≧ 2000 /mm3 and Platelet ≧ 100,000/mm3 . Biochemistry : GOT/GPT ≦ 3.5 times , Cr ≦ 1.5 mg/dl and Bilirubin ≦ 2.0 mg/dl .

Exclusion Criteria:

1. Invasion to surrounding organ ( T4 disease ) .
2. Distant metastasis , except M1a disease .
3. Patients who refuse operation .

Primary outcomes:
measure: Clinical and pathological response rates
timeFrame: 2000~2004
Secondary outcomes:
measure: Progression free survival
timeFrame: 2000~2004
measure: overall survival
timeFrame: 2000~2004
measure: Toxicity
timeFrame: 2000~2004
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Oncology, Nationa Taiwan University Hospital
Study officials:
affiliation: Department of Oncology, National Taiwan University Hospital
name: Chih-Hung Hsu, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Oncology, National Taiwan University Hospital
name: Ann-Lii Cheng, M.D.,Ph.D
role: STUDY_CHAIR
References:
citation: Guo JC, Huang TC, Lin CC, Hsieh MS, Chang CH, Huang PM, Lee JM, Hsu FM, Chia-Hsien Cheng J, Wang HP, Yeh KH, Cheng AL, Hsu CH. Postchemoradiotherapy Pathologic Stage Classified by the American Joint Committee on the Cancer Staging System Predicts Prognosis of Patients with Locally Advanced Esophageal Squamous Cell Carcinoma. J Thorac Oncol. 2015 Oct;10(10):1481-9. doi: 10.1097/JTO.0000000000000651.
Clinical trial NCT06986304: Characterizing the Microvascular Environment of Bladder Cancer With Super-Resolution Ultrasound Localization Microscopy
Official title: Characterizing the Microvascular Environment of Bladder Cancer With Super-Resolution Ultrasound Localization Microscopy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Bladder Cancer
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 30
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 seen at the clinic with bladder cancer for which a radical cystectomy is recommended.

Brief summary: The project will include 30 patients with bladder cancer who are candidates for bladder removal. After signing the consent form, the study team will collect some clinical data, such as age, past medical history, past surgical history, and information about your current disease.

At the day of surgery, after putting participants into sleep and before surgery begins, the study team will do a novel ultrasound called "Super-Resolution Ultrasound Localization Microscopy" to check if there is still disease in the bladder. The team will then compare the results of this investigational ultrasound with the final pathology and other imaging studies.


Eligibility criteria: Inclusion Criteria:

* Adults \> 18 years
* Histological evidence of urothelial cancer of the bladder for which radical cystectomy is recommended as per the treating physician (e.g., MIBC or high-risk NMIBC, such as high-grade T1 BCG refractory and worrisome histological variants)

Exclusion Criteria:

* Known or suspected hypersensitivity to sulfur hexafluoride lipid microsphere or its components, such as polyethylene glycol (PEG).
* Pregnancy or breastfeeding
* Decline to participate in the study
* Participants who had serious allergic reactions to COVID-19 vaccination.
* Participants with unstable conditions such as hospital in-patients, ICU patients, or high-risk cardiac diseases.

Primary outcomes:
measure: Presence and stage of residual bladder cancer at the time of RC.
timeFrame: From enrollment to first post-cystectomy follow-up visit (1 month)
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Michael Abern, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01431404: Safety and Pharmacokinetic Characteristics of HD203 Liq. in Healthy Subjects
Official title: Randomized,Double-blind,Single-dosing,Crossover Study to Compare the Safety and Pharmacokinetic Characteristics of HD203 With Active Comparator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Hanwha Chemical
Sponsor class: INDUSTRY
First posted: 2011-09-09
Enrollment: 44
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is compare the safety and pharmacokinetic characteristics of HD203 liquid with those of etanercept (enbrel) prefilled injection after subcutaneous injection.

Detailed description: A randomized, double-blind, single-dosing, crossover study to compare the safety and pharmacokinetic characteristics of HD203 Liquid 25 mg with those of Enbrel Prefilled® injection 25 mg after subcutaneous injection.

Eligibility criteria: Inclusion Criteria:

* 20 to 40 years of healthy volunteers
* Weight over 55kg
* Subject who signed on ICF

Exclusion Criteria:

* Subject who had been treated with Etanercept before

Primary outcomes:
measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity
timeFrame: up to 49days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Kyung-Sang Yu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00667004: Efficacy Study of Ecabet Ophthalmic Solution in Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Disease
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2008-04-25
Enrollment: 183
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: Efficacy study of ecabet ophthalmic solution in dry eye disease


Eligibility criteria: Inclusion Criteria:

* Diagnosed with dry eye disease

Exclusion Criteria:

* Dry eye disease secondary to surgery

Primary outcomes:
measure: Mean Change From Baseline in Lacrimation Assessed by Schirmer's Test
timeFrame: 43 days
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: ISTA Pharmaceuticals, Inc.
state: California
Study officials:
affiliation: ISTA Pharmaceuticals, Inc.
name: Tim McNamara, PharmD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01597804: Bathing Bundle Regimen in Reducing Gynecological Surgical Site Infection in Patients Undergoing Surgery
Official title: A "Bathing Bundle" Regimen to Reduce the Risk of Gynecological Surgical Site Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Female Reproductive System Neoplasm
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2012-05-14
Enrollment: 435
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This pilot clinical trial studies bathing bundle regimen in reducing gynecological surgical site infection in patients undergoing surgery. A bathing bundle regimen may reduce the risk of wound infection, extended length of hospital stay, readmission into the hospital, and the overall healthcare costs in patients undergoing surgery.

Detailed description: PRIMARY OBJECTIVES:

I. To investigate whether gynecology surgical patients using a Bathing Bundle using chlorhexidine gluconate (CHG) 4% skin prep solution (Intervention Group A) have a lower incidence of surgical site infection (SSI) than patients treated with the current standard of care (patient's choice of antibacterial soap). Standard of care results will be based on historical information gathered on Roswell Park Cancer Institute (RPCI) gynecology (GYN) patients prior to July 1, 2010 (Historical Control Group B).

OUTLINE:

Patients undergo preoperative preparation with the "Bathing Bundle" comprising CHG 4% skin prep solution and disposable wash cloths to bathe or shower with the night before and morning of surgery.

After completion of study treatment, patients are followed up for 2 years.

Eligibility criteria: Inclusion Criteria:

* GYN surgical patients scheduled for abdominal surgery

Exclusion Criteria:

* Patients with known hypersensitivity to chlorhexidine
* GYN non-surgical patients or surgical patients that will not have an abdominal incision (i.e. vaginal procedures)

Primary outcomes:
measure: Presence of a site infection, compared with historical SSI rates among RPCI GYN surgery patients treated with the standard of care before July 1, 2010
timeFrame: Within 30 days following surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Barbra Dodds
role: PRINCIPAL_INVESTIGATOR
References: