louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02787564: Offering Free Fruits and Vegetables to Men at Risk of Poverty
Official title: Studie Zum Einfluss Der Bereitstellung Von Kostenlosem Favorisiertem Obst Und Gemüse Auf Das Ernährungsverhalten
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Habits
Keywords: fruit, vegetables
Lead sponsor: University of Hohenheim
Sponsor class: OTHER
First posted: 2016-06-01
Enrollment: 61
Sex: MALE
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study aims to investigate whether the provision of free fresh fruits and vegetables to middle-aged men at risk of poverty increases their fruit and vegetable intake over a period of 4 weeks.

Detailed description: A total of 100 men (\> 30 years, living alone) with a low SES will be randomly assigned to a control or intervention group while controlling for food bank use. The intervention group will receive free fresh fruits and vegetables consisting of 2 daily portions of their favorite variety over a period of 4 weeks which will be provided to them once per week.

All participants will be asked to fill out a demographic questionnaire as well as a Food Frequency Questionnaire (FFQ), a questionnaire on variety of fruits and vegetables consumed and a 24-h-food-recall questionnaire. All questionnaires will be administered by trained interviewers. During the study period, the 24h-food recall questionnaire will be administered four more times; two times before the 4-week intervention period and two times after the intervention period. After the 4-week intervention period, interviewers will administered the FFQ and the questionnaire on variety.

Participants assigned to the control group will receive a fruit and vegetable basket after 4 weeks after baseline.

All participants will receive gift certificates for local supermarkets in the amount of 35,00 €.

Eligibility criteria: Inclusion Criteria:

* income below 980 € per month
* \> 30 years of age
* living alone
* without regular food delivery service (except for e.g. meals on wheels once a day)
* born in Germany
* speaks German

Exclusion Criteria:

* lives in assisted living accommodations

Primary outcomes:
measure: Variety of Fruits and Vegetables
timeFrame: baseline and 4 weeks
measure: Amount of Fruits and Vegetables
timeFrame: baseline and 4 weeks
Secondary outcomes:
measure: Variety of Fruits and Vegetables Among Food Bank Users
timeFrame: baseline and 4 weeks
measure: Amount of Fruits and Vegetables Among Food Bank Users
timeFrame: baseline and 4 weeks
measure: Variety of Fruits and Vegetables Among Non-Food Bank Users
timeFrame: baseline and 4 weeks
measure: Amount of Fruits and Vegetables Among Non-Food Bank Users
timeFrame: baseline and 4 weeks
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Institute of Nutritional Medicine, University of Hohenheim
Study officials:
affiliation: Institute of Nutritional Medicine, University of Hohenheim
name: Nanette Stroebele-Benschop, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00001064: A Pilot Study of Immunization With HIV-1 Antigen Pulsed Allogenic Dendritic Cells in HIV-Infected Asymptomatic Patients With CD4+ T Cells > 350 Cells/mm3
Official title: A Pilot Study of Immunization With HIV-1 Antigen Pulsed Allogenic Dendritic Cells in HIV-Infected Asymptomatic Patients With CD4+ T Cells > 350 Cells/mm3
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: HIV Infections
Keywords: HIV Antigens
Immunotherapy, Adoptive
Dendritic Cells
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
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 define the safety and efficacy of sibling-supplied, HIV antigen-pulsed dendritic cells in increasing the immune response in HIV-infected patients.

Dendritic cells are a type of white blood cell used by the body to fight infection. They are instrumental in presenting antigens (such as HIV antigens) to the body's immune system. Since dendritic cells are not functioning maximally in HIV-infected patients, infusion of dendritic cells from an HIV-negative sibling may enable the affected sibling's immune system to recognize foreign particles more readily and increase immune response against the virus.

Detailed description: Dendritic cells are a type of white blood cell used by the body to fight infection. They are instrumental in presenting antigens (such as HIV antigens) to the body's immune system. Since dendritic cells are not functioning maximally in HIV-infected patients, infusion of dendritic cells from an HIV-negative sibling may enable the affected sibling's immune system to recognize foreign particles more readily and increase immune response against the virus.

Dendritic cells from an HIV-negative sibling are obtained and treated with various viral proteins (HIV vaccines) or immunomodulators. The treated dendritic cells are infused into the HIV-infected patient monthly for 6 months. Siblings must be able to donate on multiple occasions, and patients are followed every 2-4 weeks during the study. Patients are screened over 3 months prior to study entry.

Eligibility criteria: Inclusion Criteria

Patients must have:

* HLA A2+.
* Same cell type as donor sibling.
* CD4 count \> 350 cells/mm3.
* HIV asymptomatic status.
* No HIV antivirals during study.
* Normal labs and chest x-ray.

Donor siblings must have:

* HLA A2+.
* HIV negativity.
* Ability to donate cells on multiple occasions.
* Negative status for hepatitis B and C.

Exclusion Criteria

Concurrent Medication:

Excluded:

* Antiviral therapy (unless CD4 count declines to \< 350 cells/mm3).

Prior Medication:

Excluded:

* Antiviral therapy within 90 days prior to study entry.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Univ School of Medicine
state: California
Study officials:
References:
Clinical trial NCT05043064: Robotic Cardiac Surgery Wet Lab Simulation Study
Official title: Validity Evidence for Simulation-based Assessment of Robotic Cardiac Surgical Skills and Examination of Learning Curves in Wet Labs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Robotic Cardiac Surgery Simulation
Keywords: Robotic Cardiac Surgery
Wet Lab Simulation
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2021-09-13
Enrollment: 19
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this study is to investigate validity of the wet lab robotic cardiac surgery model used for training in robotic cardiac surgery and to evaluate learning curves in trainees of different surgical specialities. The investigators hope to recruit experienced robotic cardiac surgeons (experts) and cardiac and non-cardiac surgeons with minimal robotic experience (trainees). Participants will perform three predetermined tasks common in the wet lab robotic cardiac surgery training. Participants will be evaluated at baseline for each task. From experts' performance the mastery learning level will be calculated. Trainees will perform the tasks until mastery is achieved. The investigators will then be able to evaluate validity of the wet lab model and analyze learning curves in all participants by rating their performance.


Eligibility criteria: Inclusion Criteria:

* Experienced robotic cardiac surgeons: robotic surgeons with total volume \> 50 robotic cardiac operations and at least 20 robotic cases annually
* Cardiac surgeons with limited robotic experience (robotic novices): on-going or completed cardio-thoracic residency
* Non-cardiac surgeons with limited robotic experience (robotic novices): on-going or completed surgical specialty residency (general surgery, urology, gynaecology, ENT surgery)

Exclusion Criteria:

* Robotic novices with \> 5 hours experience of any robotic system

Primary outcomes:
measure: Time-based Score
timeFrame: 6 months
Secondary outcomes:
measure: Modified Global Evaluative Assessment of Robotic Skills (mGEARS)
timeFrame: 6 months
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
Study officials:
affiliation: Aalborg University Hospital
name: Gennady V Atroshchenko, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01146964: Comparison of Manual Super Small Incision Cataract Surgery and Phacoemulsification
Official title: Comparison of Manual Super Small Incision Cataract Surgery and Phacoemulsification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Phacoemulsification
Keywords: Age related cataract
Phacoemulsification
Manual super small incision cataract surgery
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2010-06-22
Enrollment: 100
Sex: ALL
Minimum age (years): 50
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 compare the safety and efficacy of manual super small incision cataract surgery (MSSICS) and Phacoemulsification.


Eligibility criteria: Inclusion Criteria:

* Age related cataract patients
* Cataract density grade II-III according to the Emery-Little system classification system

Exclusion Criteria:

* Legal guardian(s) is/are not present for permission
* Other eye diseases impairing visual acuity (ie. glaucoma)
* patients with severe systemic diseases not good for ocular surgery

Primary outcomes:
measure: Corneal endothelial cell loss
timeFrame: 3 months postoperatively
Secondary outcomes:
measure: postoperative astigmatism
timeFrame: 3 months postoperatively
measure: visual acuity
timeFrame: 3 month postoperatively
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Eye Hospital, Wenzhou Medical College
state: Zhejiang
Study officials:
affiliation: Eye Hospital, Wenzhou Medical College, China
name: Wei Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01022164: Use of Fibrin Glue in Vitreoretinalsurgery
Official title: Safety and Efficacy in the Use of Fibrin Glue in Vitreoretinal Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Surgery
Keywords: fibrin glue
vitrectomy
safety and efficacy of fibrin glue
Lead sponsor: Asociación para Evitar la Ceguera en México
Sponsor class: OTHER
First posted: 2009-12-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: To study the Safety and Efficacy of the use of fibrin glue in vitreoretinal surgery


Eligibility criteria: Inclusion Criteria:

* Vitreorretinal procedures that require suture

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Asociacion para Evitar la Ceguera en Mexico
Study officials:
References:
Clinical trial NCT01455064: Navigator II Continuous Glucose Monitor Home Use Study
Official title: FreeStyle Navigator II Continuous Glucose Monitor Home Use Evaluation (FSNv2)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Lead sponsor: Abbott Diabetes Care
Sponsor class: INDUSTRY
First posted: 2011-10-19
Enrollment: 31
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 with type 1 or 2 diabetes requiring multiple daily insulin injections or using an insulin pump

Brief summary: This research study will test a new investigational continuous glucose monitoring system (System). The purpose of this study is to find out about the performance of the System in a home use environment over a 15 day period, in people with diabetes.


Eligibility criteria: Inclusion Criteria:

The subject must:

* Have type 1 or 2 diabetes for at least 2 years prior to enrollment.
* Require insulin therapy administered through an insulin pump or multiple daily injections (MDI) for at least 6 months prior to enrollment.
* Be at least 18 years of age.
* Be able to read and understand English.
* In the investigator's opinion, be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.
* Be available for all study visits.
* Be willing to provide written signed and dated informed consent.

Exclusion Criteria:

The subject must not:

* Be pregnant or likely to become pregnant during the study duration.
* Have skin abnormalities at the insertion sites.
* Have known allergy to medical grade adhesive or skin disinfectant.
* Be using a continuous glucose monitor currently or within the past 6 months
* Have a concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject.
* Be participating in another clinical trial.

Primary outcomes:
measure: Clarke Error Grid Analysis
timeFrame: 15 days sensor wear
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Santa Fe
country: United States
facility: Southwest Clinical Research Center
state: New Mexico
Study officials:
affiliation: Abbott Diabetes Care
name: Shridhara A Karinka, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03788564: The Association of Cardiac Ion Channel Related Gene Polymorphism and Prolonged QTc Interval After Endotracheal Intubation
Official title: The Association of Cardiac Ion Channel Related Gene Polymorphism and Prolonged QTc Interval After Endotracheal Intubation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergence Delirium
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-12-27
Enrollment: 315
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20-65 years old, scheduled for general anesthesia requiring direct laryngoscopy

Brief summary: The QTc interval is affected by heart rate, medications and changes in the autonomic nervous system. The endotracheal laryngoscopy, the necessary step during general anesthesia, prolongs QTc interval. Changes in the flow of ion currents could result from the genetic variation of myocardial ion channels by gene polymorphism. This study is to investigate the association of cardiac ion channel related gene polymorphism and prolonged QTc interval after endotracheal intubation in adult patients.


Eligibility criteria: Inclusion Criteria:

1. 20-65 years old
2. scheduled for general anesthesia requiring direct laryngoscopy

Exclusion Criteria:

1. Patients taking antihypertensive medication (beta-blocker, CCB)
2. patients taking other medications known to affect QTc interval
3. Patients with abnormal ECG and prolonged QTc (\>500 msec)
4. Diabetes, liver disease, kidney disease, heart failure, congenital heart disease
5. Severe electrolyte imbalance
6. illiterate, foreigners who cannot understand the consent form

Primary outcomes:
measure: QTc interval
timeFrame: Before anesthesia, Before laryngoscopy, Right after laryngoscopy, 5 minutes after laryngoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Study officials:
References:
Clinical trial NCT05241964: Platelet-rich Plasma(PRP) Injection in ED
Official title: A Prospective Trial of Autologous Platelet-rich Plasma Injection in Erectile Dysfunction Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Erectile Dysfunction
PRP
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-02-16
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RPR contains rich-in growth factors and has the properties of helping tissue regeneration and nerve repair. In theory, it is possibility of curing ED.

Detailed description: There are many reasons of erectile dysfunction(ED). If left untreated, there is a major impact on relationships, self-esteem, and overall health. RPR contains rich-in growth factors and has the properties of helping tissue regeneration and nerve repair. Its mechanism is to promote the regeneration of blood vessels in the cavernous body of the penis, increase blood circulation, and then help erection, increase penile stiffness and improve the phenomenon of premature ejaculation. The main purpose of this study is to study the safety and effectiveness of PRP injection for the treatment of ED.

Eligibility criteria: Inclusion Criteria:

* Male
* Between 20 and 70 years old
* Sexual dysfunction exists for at least 6 months
* IIEF-5 score 8-2
* Sign an informed consent form

Exclusion Criteria:

* Ever radical prostatectomy or extensive pelvic surgery
* Radiation therapy to the pelvic area within 12 months before recruiting
* Cancer
* Nervous system diseases that affect erectile function
* Have any blood disease
* History of coronary artery disease

Primary outcomes:
measure: International Index of Erectile Function(IIEF-5)
timeFrame: Change from 0 week at 4,8,12,24,48 weeks
Secondary outcomes:
measure: Erection Hardness Score(EHS)
timeFrame: Change from 0 week at 4,8,12,24,48 weeks
measure: Duplex - Peak systolic velocity(PSV)
timeFrame: 0,16 weeks
measure: Duplex - Resistance index(RI)
timeFrame: 0,16 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Taipei Veteran General hospital
name: I-Ni Chiang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01221064: Effect of Early vs Late Drainage Removal in Women After Radical Mastectomy With Axillary Clearance
Official title: Prospective Randomised Clinical Trial Comparing the Effect of Early and Late Drainage Removal in Female Patients After Radical Mastectomy With Axillary Clearance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
Axillary clearance
lymphorrhoea
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
First posted: 2010-10-14
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study is to assess whether early drainage removal in patients with less than 150ml of lymph in postoperative day 1 can reduce total lymphorrhoea

Detailed description: Patients with early drainage removal will be compared with patients in whom drainage will be kept until daily lymphorrhoea is 30ml

Eligibility criteria: Inclusion Criteria:

* Stage IIA and IIB breast cancer treated with radical mastectomy
* Obtaining informed consent
* Total amount of lymph in postoperative day 1 \<150ml

Exclusion Criteria:

* Stage I, III-IV breast cancer
* History of benign breast neoplasm or malignant disease of any origin
* Any breast surgery in the past
* Weight \<50kg

Primary outcomes:
measure: Total lymph volume and time
timeFrame: 3 months
Secondary outcomes:
measure: Post operative pain assessment
timeFrame: 30 days
Other outcomes:
Locations:
city: Gdansk
country: Poland
facility: Medical University of Gdansk, Department of Surgical Oncology
state: Pomorskie
Study officials:
affiliation: Medical University of Gdansk
name: Janusz Jaśkiewicz, MD, PhD
role: STUDY_DIRECTOR
affiliation: Medical University of Gdansk
name: Jacek Zielinski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01016964: Treatment of Androgenetic Alopecia in Females, 12 Beam
Official title: A Randomized, Double-Blind Clinical Trial to Evaluate the Safety and Efficacy of the HairMax LaserComb 2009, 12 Beam Model For The Treatment of Androgenetic Alopecia in Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Androgenetic Alopecia
Hair Loss
Female Pattern Baldness
Keywords: Androgenetic Alopecia
Hair Loss
Female Pattern Baldness
Lead sponsor: Lexington International, LLC
Sponsor class: INDUSTRY
First posted: 2009-11-20
Enrollment: 63
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of the HairMax LaserComb 2009 12 beam model for androgenetic alopecia in females when treatment is applied as directed.

Detailed description: This is a randomized double-blind, sham controlled clinical study, evaluating changes in terminal hair count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair).

The trial with 63 female subjects, who have been diagnosed with androgenetic alopecia, who are between 25 and 60 years of age, have Fitzpatrick Skin Types I-IV, with classifications of Ludwig I-4, II-1, II-2, or frontal, have active hair loss within the last 12 months.

Subjects will use the device on three non-concurring days a week as directed per device for 26 weeks duration.

Initial efficacy endpoint for each subject will be assessed at visit 4 (week 16).

Safety analysis will be assessed based on the reports of adverse events during study.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of androgenetic alopecia
* Fitzpatrick Skin types I-IV
* Ludwig I-4, II-1, II-2, or frontal
* Active hair loss within last 12 months

Exclusion Criteria:

* Photosensitivity to laser light
* Malignancy in the target area
* Pregnancy
* Lactating females

Primary outcomes:
measure: Change in Hair Count at 16 and 26 Weeks Over Baseline
timeFrame: Baseline, 16 weeks, 26 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Miller School of Medicine - Dermatology
state: Florida
city: Minneapolis
country: United States
facility: University of Minnesota, Department of Dermatology
state: Minnesota
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation - Department of Dermatology
state: Ohio
Study officials:
affiliation: University of Minnesota
name: Maria Hordinsky, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Wilma Bergfeld, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Lawrence Schachner, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leavitt M, Charles G, Heyman E, Michaels D. HairMax LaserComb laser phototherapy device in the treatment of male androgenetic alopecia: A randomized, double-blind, sham device-controlled, multicentre trial. Clin Drug Investig. 2009;29(5):283-92. doi: 10.2165/00044011-200929050-00001.