louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02749643: Functional Outcome Measures With Vibrotactile Feedback to Prostheses
Official title: The Effects of Adding Vibrotactile Feedback to Prostheses on Functional Outcome Measures of Transradial Amputation Prosthetic Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unilateral Transradial Amputation
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Tel Aviv University
First posted: 2016-04-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Investigators wish to evaluate the effects of adding VTF to upper limb prostheses on functional outcome measures of upper limb prosthetic users.

Detailed description: Investigators will perform three experiments:

1. Investigators will add vibrotactile feedback to prosthetic users during the execution of a standardized functional test and performance of simple grasping tasks, with a disruption to the normal visual feedback, and examine whether their performance and arm kinematics are improved with tactile feedback;
2. Investigators will examine the effects of adding the feedback to a prosthesis on the performance and visual attention during a dual task assignment in prosthetic users, and
3. Investigators will provide prosthetic users with the feedback, to use it at their natural surroundings for a week, and study the reported activity and satisfaction levels.

Eligibility criteria: Inclusion Criteria:

* Unilateral transradial amputee
* Using a transradial myoelectric prosthesis
* Ability to follow simple instructions, understand and sign an informed consent form
* Normal or corrected eyesight

Exclusion Criteria:

* Elbow or wrist disarticulation or partial hand amputations
* Neuropathy or skin ulcers on the amputated limb

Primary outcomes:
measure: Orthotics and Prosthetics User Survey-Upper Extremity Functional Status
timeFrame: 2 weeks
Secondary outcomes:
measure: Modified Box & Blocks test
timeFrame: 2 weeks
measure: Time to complete dual tasking test
timeFrame: 2 weeks
measure: Activity
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
affiliation: Hadassah Medical Organization
name: Sigal Portnoy, PhD
role: STUDY_DIRECTOR
References:
citation: Clemente F, D'Alonzo M, Controzzi M, Edin BB, Cipriani C. Non-Invasive, Temporally Discrete Feedback of Object Contact and Release Improves Grasp Control of Closed-Loop Myoelectric Transradial Prostheses. IEEE Trans Neural Syst Rehabil Eng. 2016 Dec;24(12):1314-1322. doi: 10.1109/TNSRE.2015.2500586. Epub 2015 Nov 13.
citation: Raveh E, Portnoy S, Friedman J. Myoelectric Prosthesis Users Improve Performance Time and Accuracy Using Vibrotactile Feedback When Visual Feedback Is Disturbed. Arch Phys Med Rehabil. 2018 Nov;99(11):2263-2270. doi: 10.1016/j.apmr.2018.05.019. Epub 2018 Jun 20.
Clinical trial NCT00416143: Bed Rest for Idiopathic Sudden Sensorineural Hearing Loss
Official title: Bed Rest for Idiopathic Sudden Sensorineural Hearing Loss
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Sudden Loss of Hearing
Keywords: Bed rest for idiopathic sudden sensorineural hearing loss
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-12-27
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: sudden sensorineural hearing loss:

* idiopathic in most cases
* 5-20/100,000 new cases annually in the U.S
* no establishes pathogenesis
* treated with oral steroids in most cases
* \~50% improvement in hearing levels
* bed rest - acceptable treatment, not well investigated


Eligibility criteria: Inclusion Criteria:

* patients with sudden sensorineural hearing loss

Exclusion Criteria:

* age less than 16 years
* contraindication for oral steroid treatment
* prior steroid treatment for hearing loss
* pregnent women

Primary outcomes:
measure: hearing improvement
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Eldar Carmel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03534843: A Comparison Between Child-Pugh and Albumin-Bilirubin Scores
Official title: A Comparison Between Child-Pugh and Albumin-Bilirubin Scores in Patients With Spontaneous Rupture of Hepatocellular Carcinoma: A Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rupture, Spontaneous
Rupture Liver
Hepatocellular Carcinoma
Hepatic Impairment
Keywords: Spontaneous rupture
survival
hepatocellular carcinoma
Child-Pugh
Albumin-bilirubin
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2018-05-23
Enrollment: 230
Sex: ALL
Minimum age (years): 15
Maximum age (years): 76
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From January 2005 to August 2015, all patients complied with the criteria mentioned above who received surgical treatment or non-surgical treatment at the investigator's center were included in this study.

Brief summary: To compare Child-Pugh and Albumin-Bilirubin scores in patients with spontaneous rupture of hepatocellular carcinoma

Detailed description: To compare Child-Pugh and Albumin-Bilirubin scores in patients with spontaneous rupture of hepatocellular carcinoma. And to determine which is better in predicting long-term survival and short-term survival.

Eligibility criteria: Inclusion Criteria:

* Be diagnosed as hepatocellular carcinoma pathologically; had a tumor rupture confirmed by Intraperitoneal exploration or clinical signs and symptoms in combination with imaging examination.

Exclusion Criteria:

* Be diagnosed as not hepatocellular carcinoma pathologically；had repeated transcatheter arterial chemoembolization(TACE) or a long history (more than 1 year) of cancer treatment; loss of follow up or without complete data.

Primary outcomes:
measure: Overall survival of all patients
timeFrame: 5 years
Secondary outcomes:
measure: Short-term mortality of all patients
timeFrame: Ninety days
measure: Short-term mortality of surgical subgroup
timeFrame: Ninety days
measure: Short-term mortality of non-surgical subgroup
timeFrame: Ninety days
Other outcomes:
Locations:
Study officials:
affiliation: Huazhong University of Science and Technology
name: Xiao-ping Chen, Prof. PHD
role: STUDY_CHAIR
References:
citation: Wu JJ, Zhang ZG, Zhu P, Mba'nbo-Koumpa AA, Zhang BX, Chen XP, Shu C, Zhang WG, Feng RJ, Li GX. Comparative liver function models for ruptured hepatocellular carcinoma: A 10-year single center experience. Asian J Surg. 2019 Sep;42(9):874-882. doi: 10.1016/j.asjsur.2018.12.015. Epub 2019 Jan 28.
Clinical trial NCT05751343: TACE-HAIC Plus Atezolizumab and Bevacizumab for Unresectable HCC: a Phase 2 Clinical Trial
Official title: Transarterial Chemoembolization Plus Hepatic Artery Infusion Chemotherapy and Atezolizumab Plus Bevacizumab for Unresectable Hepatocellular Carcinoma: a Single-arm Phase 2 Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The TACE-HAIC which was performed using 30 mg/m2 of epirubicin mixed with 2-5 mL lipiodol, followed by pure lipiodol. Then, a catheter was placed and fixed in the tumor feeding artery for the FOLFOX-based chemotherapy infusion at the following dosage: 85 mg/m2 of oxaliplatin infusion for 2 hours; leucovorin, 400 mg/m2 infusion for 2 hours; 400 mg/m2 of 5-FU bolus; and 1200mg/m2 of continuous 5-FU infusion for 23 hours, respectively. Repeated TACE-HAIC was performed at intervals of 3-4 weeks
Primary purpose: TREATMENT

Brief summary: Transartial chemobolization plus hepatic artery infusion chemotherapy showed performance for unresectable hepatocellular carcinoma (HCC). Whether the additional of atezolizumab plus bevacizumab will improve the response rate for those patients is still unknown. This phase 2 clinical trial aims to investigate the objective response rate for unresectable hepatocellular carcinoma.


Eligibility criteria: Inclusion Criteria:

* (a) patients were diagnozied with unresectable HCC,
* (b) Child-Pugh A or B liver function;
* (d) Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
* (e) adequate hematologic blood counts (white blood cell count \>3ⅹ109/L, absolute neutrophil count \>1.5ⅹ109/L, platelet count \>10ⅹ109/L, hemoglobin concentration \>85 g/L);

Exclusion Criteria:

* (a) severe underlying cardiac, pulmonary, or renal diseases;
* (b) history of a second primary malignant tumor;
* (c) contraindication to either atezolizumab and bevacizumab.

Primary outcomes:
measure: Objective response rate
timeFrame: 12 months
Secondary outcomes:
measure: progress-free survival
timeFrame: 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References:
Clinical trial NCT04689243: Low Concentration ALA-PDT in Treatment of Skin Ulcer
Official title: Clinical Study of Low Concentration ALA-PDT in Treatment of Skin Ulcer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Skin Ulcer
Photodynamic Therapy
Lead sponsor: Sichuan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Skin ulcer is a common disease with complicated etiopathogenes, which makes it hard to be cured. It has been reported that photodynamic therapy (PDT) can be used to treat skin ulcers which were caused by different diseases. However, PDT is an expensive treatment and patients always experience obvious pain during or after the treatment, which hinders the application of PDT in skin ulcer. Our previous study found that PDT using a low concentration of 5-Aminolevulinic acid (ALA) could promote the healing of skin ulcer without obvious adverse reactions, which suggests us that low concentration ALA-PDT might be an efficient and cost effective treatment in skin ulcer. To further investigate the use of low concentration ALA-PDT in skin ulcer, we plan to recruit patients with skin ulcers caused by different diseases, and divide these patients into different groups according to their causes of disease, and then treat them using low concentration ALA-PDT to observe the healing process of skin ulcer. This study could further optimize and promote the use of low concentration ALA-PDT in skin ulcer.


Eligibility criteria: Inclusion Criteria:

* chronic skin wounds that involved the dermis and did not heal in three months or did not exhibit a tendency toward healing

Exclusion Criteria:

* allergies to photosensitizers and their solvents, serious medical illnesses, such as severe heart disease, severe liver or kidney dysfunction, systemic infection or any concomitant infection that would require treatment with an additional antimicrobial agent, the use of topical or systemic antibiotics within one month prior to treatment. Pregnant or lactating women were also excluded.

Primary outcomes:
measure: ulcer area size
timeFrame: Change from Baseline ulcer area size at 24 hours after the last treatment.
Secondary outcomes:
measure: total bacterial load
timeFrame: Change from Baseline total bacterial load at 24 hours after the last treatment.
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
Study officials:
References:
Clinical trial NCT04349943: Effect of Standardized Nutritional Therapy on Clinical Prognosis and Cost-effectiveness of Inflammatory Bowel Disease
Official title: Effect of Standardized Nutritional Therapy on Clinical Prognosis and Cost-effectiveness of Inflammatory Bowel disease--a Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammatory Bowel Disease
Lead sponsor: The Third Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2020-04-16
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To construct a standardized stepped nutritional treatment process for inpatients with inflammatory bowel disease, including nutritional risk screening and assessment, standardized nutritional treatment implementation, therapeutic effect follow-up and monitoring, family nutritional treatment follow-up, etc.

Detailed description: Nutrition therapy of inflammatory bowel disease should follow the principle of sequential treatment of nutrition, which is the preferred scheme with enteral nutrition, from slow to fast, from weak to strong, from the elements to the whole protein on the steps of the gradual transition, in order to improve enteral nutrition in patients with tolerance and compliance and improve patient quality of life and long-term survival rate, reduce the social burden of disease, patients with good economic and social benefits.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with inflammatory bowel disease

Exclusion Criteria:

* nothing

Primary outcomes:
measure: Improvement of nutritional status
timeFrame: 2 years
measure: Improvement of quality of life
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: the Third Xiangya Hospital of Central South University
state: Hunan
Study officials:
References:
Clinical trial NCT04777643: Sex Differences in Neural Response to Cannabidiol
Official title: Sex Differences in Neural Response to Cannabidiol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: CBD
Neural Responses
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2021-03-02
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This is a randomized, double-blind, within-subjects, cross-over design to assess neural changes following a single dose of cannabidiol (CBD) (600mg) versus placebo among healthy female volunteers.


Eligibility criteria: Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Female, aged 18-65
4. In good general health as evidenced by medical history and medically eligible to receive CBD, as determined by the licensed physician, Dr. Ayana Jordan
5. Body Mass Index between 18.5 and 30
6. For females of reproductive potential: agreement to use highly effective contraception during study participation and/or negative pregnancy test prior to fMRI scanning

Exclusion Criteria:

1. Recent use of cannabis (any past month use)
2. Lifetime history of cannabis use disorder
3. Lifetime history of chronic pain disorder
4. Current DSM-5 disorder, as determined via Structured Clinical Interview (SCID-5)
5. Presence of any contraindication to MRI scanning
6. Known allergic reactions to cannabidiol
7. Lifetime use of Epidiolex
8. Currently taking any medications that could interact with cannabidiol
9. Current smoker or tobacco use \>1x/week
10. Not fluent in English
11. Less than 6th grade reading level

Primary outcomes:
measure: Amygdala activation during stress
timeFrame: fMRI will begin 2 hours post-drug administration and will last no more than 1 hour.
measure: Insula activation during social exclusion
timeFrame: fMRI will begin 2 hours post-drug administration and will last no more than 1 hour.
Secondary outcomes:
measure: Patterns of amygdala functional connectivity during stress
timeFrame: fMRI will begin 2 hours post-drug administration and will last no more than 1 hour.
measure: Patterns of insula functional connectivity during social exclusion
timeFrame: fMRI will begin 2 hours post-drug administration and will last no more than 1 hour.
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Sarah D. Lichenstein, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02513043: Feasibility of Medical Abortion by Direct-to-Consumer Telemedicine
Official title: Feasibility of Medical Abortion by Direct-to-Consumer Telemedicine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
First posted: 2015-07-31
Enrollment: 1470
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women seeking abortion

Brief summary: This pilot study is designed to obtain preliminary data on the safety, acceptability, and feasibility of direct-to-consumer telemedicine abortion.

Detailed description: The objective of this pilot study is to obtain preliminary data on the safety, acceptability, and feasibility of direct-to-consumer telemedicine abortion.

Eligibility criteria: Inclusion Criteria:

* desires abortion

Exclusion Criteria:

* medically ineligible for procedure

Primary outcomes:
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Planned Parenthood of the Rocky Mountains
state: Colorado
city: Washington
country: United States
facility: Carafem
state: District of Columbia
city: Atlanta
country: United States
facility: Carafem
state: Georgia
city: Honolulu
country: United States
facility: The University of Hawaii Women's Options Centers
state: Hawaii
city: Skokie
country: United States
facility: Carafem
state: Illinois
city: Iowa City
country: United States
facility: Emma Goldman Clinic
state: Iowa
city: Augusta
country: United States
facility: Maine Family Planning
state: Maine
city: Chevy Chase
country: United States
facility: Carafem
state: Maryland
city: Saint Paul
country: United States
facility: Planned Parenthood Minnesota, North Dakota, South Dakota
state: Minnesota
city: Billings
country: United States
facility: Planned Parenthood of Montana
state: Montana
city: New Mexico
country: United States
facility: Planned Parenthood of the Rocky Mountains
state: New Mexico
city: Jamaica
country: United States
facility: Choices Women's Medical Center
state: New York
city: New York
country: United States
facility: Maine Family Planning
state: New York
city: Portland
country: United States
facility: Planned Parenthood Columbia Willamette
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Sciences University Women's Health Research Unit
state: Oregon
city: Washington
country: United States
facility: Planned Parenthood Columbia Willamette
state: Washington
city: Washington
country: United States
facility: Oregon Health and Sciences University Women's Health Research Unit
state: Washington
Study officials:
affiliation: Gynuity Health Projects
name: Erica Chong, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Gynuity Health Projects
name: Elizabeth Raymond, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05309343: Cohort Study on Treatment of Cardiovascular Diseases With Traditional Chinese Medicine
Official title: Cohort Study on Treatment of Cardiovascular Diseases With Traditional Chinese Medicine
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Lead sponsor: Tianjin University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 20000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The collaboration network of coronary heart disease research medical units formed by the research group, including The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, The Second Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin Chest Hospital, Tianjin Hospital of ITCWM Nankai Hospital and Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital#a total of 6 hospitals.

Brief summary: This is a cohort study performed in patients with cardiovascular diaeases who were treated with oral Chinese medicine and Western medicine. Collect indicators such as the incidence of cardiovascular events, all due to readmission, all due to death. To hospital using clinical samples to detect genomics, proteomics, metabolomics, intestinal flora and sclerotia.To explore the clinical efficacy of Chinese patent medicine in the treatment of cardiovascular diseases, and provide reliable data support for its clinical application.


Eligibility criteria: Inclusion Criteria:

All patients admitted to the Department of Cardiovascular Medicine at The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, The Second Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin Chest Hospital, Tianjin Hospital of ITCWM Nankai Hospital and Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital were considered for inclusion in this study, and all Western medical diagnoses were identified and classified according to the International Classification of Diseases, 11th Revision (ICD-11).

Exclusion Criteria:

No exclusion criteria.

Primary outcomes:
measure: Cardiovascular Events Cardiovascular Events Cardiovascular Events
timeFrame: one year
measure: All due to readmission
timeFrame: one year
measure: All due to death
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin University of Traditional Chinese Medicine
Study officials:
References: