louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01592682: Creating Smokefree Living Together for Chinese Household Pairs
Official title: "Creating Smokefree Living Together": Smokefree Counseling Intervention for Chinese Smokers and Household Nonsmokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Smoke Exposure
Keywords: tobacco
secondhand smoke
Chinese
NNAL
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
First posted: 2012-05-07
Enrollment: 410
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a trial of household pairs of a Chinese smoker and nonsmoker randomized either to a smoke-free educational intervention or self-help control group. The smokefree educational intervention includes group education about smokefree environments and smoking cessation, follow-up phone calls, and tobacco exposure lab reports. The control group is referred to usual care with local in-language smoking cessation classes or quitline, and is otherwise assessment only. The investigators hypothesize that pairs in the intervention group will have higher rates of tobacco cessation and elimination of smoke exposure, compared to the control group.


Eligibility criteria: Inclusion Criteria:

* Self-identified Chinese Americans who primarily speak Chinese
* Self-identified current smoker men and nonsmoker women
* Pair lives in same household

Exclusion Criteria:

* Current smoker women
* Nonsmoker men

Primary outcomes:
measure: Smoking cessation
timeFrame: 12 months
measure: Elimination of secondhand smoke exposure
timeFrame: 12 months
measure: Urine NNAL (4-(Methylnitrosamine)-1-(3-pyridyl)-1-butanol)
timeFrame: 12 months
Secondary outcomes:
measure: Cigarette consumption
timeFrame: 12 months
measure: Rule for no smoking in home
timeFrame: 12 months
measure: Reduction in secondhand smoke exposure
timeFrame: 12 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Chinatown Public Health Center
state: California
Study officials:
affiliation: University of California, Davis
name: Elisa K Tong, MD, MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chang E, Dove M, Saw A, Tsoh JY, Fung LC, Tong EK. Home Smoking Bans and Urinary NNAL Levels to Measure Tobacco Smoke Exposure in Chinese American Household Pairs. Int J Environ Res Public Health. 2021 Jul 20;18(14):7682. doi: 10.3390/ijerph18147682.
Clinical trial NCT03267082: Evaluation the Role of Laparoscopic Management of Perforated Appendicitis
Official title: Evaluation the Role of Laparoscopic Management of Perforated Appendicitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Perforated Appendicitis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-08-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A laparoscopic appendectomy (LA) was first reported by Semm in 1983. Since then, its advantages, such as the aesthetic appearance of the wound, less postoperative pain, and faster recovery which facilitates early discharge, have been highlighted, and the number of procedures performed has been continuously increasing.

Detailed description: The LA was performed mostly on uncomplicated appendicitis due to negative opinions about its safety when it was first introduced. However, the application of the procedure has been extended to complicated appendicitis (CA), and it is now considered as an alternative procedure to an open appendectomy (OA) as its safety record has improved . Nevertheless, it is still controversial because there are still concerns about surgical difficulties in managing CA with laparoscopy, overall surgery time, possible post-op complications and conversion to an OA during the surgery.

this study aimed to evaluate the safety and the efficacy of LA for managing perforated appendicitis.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of acute perforated appendicitis
* fit for laparoscopy and general anesthesia.
* written informed consent.
* short term outcome data and agree to provide contact information.

Exclusion Criteria:

* high risk for general anesthesia.
* Appendicular abscess and appendicular mass .
* ongoing infections including chest infections .
* Children and pregnant females .

Primary outcomes:
measure: early recovery
timeFrame: 2 day
Secondary outcomes:
measure: wound cosmetic appearance
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
citation: Semm K. Endoscopic appendectomy. Endoscopy. 1983 Mar;15(2):59-64. doi: 10.1055/s-2007-1021466.
citation: Frazee RC, Bohannon WT. Laparoscopic appendectomy for complicated appendicitis. Arch Surg. 1996 May;131(5):509-11; discussion 511-3. doi: 10.1001/archsurg.1996.01430170055010.
Clinical trial NCT01748682: Very Low Calorie Liquid Diet for Pre op Patients
Official title: Use of Very Low Calorie Liquid Diet in the Preoperative Phase of Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Steatosis
Keywords: Very low calorie diet
liquid diet
visceral fat
liver fat.
Lead sponsor: Gastrocirurgia, Brazil
Sponsor class: OTHER
Collaborators: name: Gastrocirurgia, Brazil
name: University of Brasilia
First posted: 2012-12-12
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Despite the relative consensus on the benefits of pre-surgical weight loss, i.e., the reduction of comorbidities associated with surgical act, such as decreased visceral fat, liver volume, hemorrhage perioperative and surgical time, the characteristics of the diet to be employed in this period need to be defined more clearly. As there is no description of comparative studies on diet of normal consistency, using solids and liquids, there are doubts as to the real need for consistency liquid diet in preoperative bariatric surgery. The lack of robust evidence has made nutrition professionals adopt different procedures. There is still a belief that these patients are unable to lose weight in the preoperative period, the ongoing history of previous attempts without success.


Eligibility criteria: Inclusion Criteria:

* To be clinically severe obese; To be in preoperative phase of bariatric surgery.

Exclusion Criteria:

* Pregnancy and minors under 18 and adults over 60 years of age.

Primary outcomes:
measure: Loss of body weight
timeFrame: 2 weeks
Secondary outcomes:
measure: Total body, visceral and liver fat loss, resting metabolic rate and changes in blood and urinary parameters
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: Gastrocirurgia de Brasilia
state: Distrito Federal
Study officials:
affiliation: Gastrocirurgia of Brasilia
name: Silvia L Faria, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04841382: Physician Assessment of the Clinical Utility of a Patient-Specific 3D Electro-Anatomical Heart Model in VT Ablation
Official title: Physician Assessment of the Clinical Utility of a Patient-Specific 3D Electro-Anatomical Heart Model in VT Ablation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Ischemic Monomorphic Ventricular Tachycardia
Lead sponsor: CardioSolv Ablation Technologies
Sponsor class: INDUSTRY
First posted: 2021-04-12
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with monomorphic VT secondary to ischemic cardiomyopathy scheduled for a VT ablation procedure will be considered for enrollment.

Brief summary: ACE-VT is a clinical pilot study designed to evaluate the ability of the CardioSolv Software System to generate an output for the physician to review in a timely fashion, consistent with the standard of care VT ablation workflow. This study will assess the acute effectiveness of using the CardioSolv Software System output as additional supporting information during ablation.


Eligibility criteria: Inclusion Criteria:

1. Participant meets standard criteria for VT ablation and is scheduled for VT ablation by their cardiologist or electrophysiologist
2. 18 to 85 years of age
3. VT and ischemic cardiomyopathy
4. A pre-procedure MRI with LGE is available (performed within 1 year of procedure, unless an MI has occurred since MRI) with adequate image for analysis
5. Participant is able and willing to provide written informed consent

Exclusion Criteria:

1. Contradiction to MRI (except those with MRI compatible pacemaker/ICD/CRT devices implanted or site has approved procedure for MRI of non-compatible devices).
2. Participant implanted with an LVAD.
3. Enrolled in another non-imaging intervention assignment study that could confound the results of this study.

Primary outcomes:
measure: Time to Receipt of 3D Heart Model
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Upenn
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Saman Nazarian, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06605482: Early Fixation for Diaphyseal Humeral Shaft Fractures in the Elderly Patients
Official title: Early Fixation for Diaphyseal Humeral Shaft Fractures in the Elderly Patients: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Humerus Shaft Fracture
Elderly (People Aged 65 or More)
Keywords: patient outcomes
Lead sponsor: Fraser Orthopaedic Research Society
Sponsor class: NETWORK
First posted: 2024-09-20
Enrollment: 94
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who present to the Royal Columbian Hospital or the investigators clinic with a diaphysial humeral shaft fracture.

Brief summary: The study purpose is to evaluate whether early surgical fixation of upper arm fractures in elderly patients' age 65 years and older improves patient functional and psychological outcome scores compared to the standard of care with non-operative management.

Detailed description: A prospective cohort study following patients that are 65 years or older after they have suffered a humeral shaft fracture. Follow up will continue until 1 year post treatment to see functional and psychological outcomes.

Eligibility criteria: Inclusion Criteria:

1. Diaphyseal humeral shaft fracture (as defined as superior border of insertion of pectoralis major proximally, to the distal diaphysis)
2. Ambulatory (with or without the use of walking aides)

Exclusion Criteria:

1. Fractures with intra-articular extension
2. Ipsilateral upper extremity injury
3. Patients with vascular injury
4. Brachial plexus injury
5. Compartment syndrome
6. Pathological fractures
7. Open fractures
8. Periprosthetic fracture
9. BMI \&amp;gt;40
10. Dementia or cognitive impairment that inhibits the collection of outcome measures
11. Likely problems, in the judgement of the investigator, with maintaining follow-up (i.e. patients with no fixed address, not mentally competent to give consent, intellectually challenged, patients without adequate support, etc.)
12. Inability to provide informed consent

Primary outcomes:
measure: American Shoulder and Elbow Score
timeFrame: Enrolment to 12 months post treatment
Secondary outcomes:
measure: 12-Item Short Form Survey
timeFrame: Enrolment to 12 months post treatment
measure: Range of Motion
timeFrame: 3 months post treatment
Other outcomes:
Locations:
city: New Westminster
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
Study officials:
References:
Clinical trial NCT02995031: Sun Protection Factor Assay (318/2016)
Official title: Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sunscreening Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-12-16
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female.
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form).
* Signed and dated Informed Consent Form
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose).

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnosed by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma, diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.

Primary outcomes:
measure: Minimal Erythema Dose (MED)
timeFrame: Up to 15 minutes
measure: Minimal Persistent Pigment Darkening Dose (MPPD)
timeFrame: Up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
References:
Clinical trial NCT05487131: Neuromodulation and Fatigue
Official title: Neuromodulation and Fatigue
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Aging
Fatigue
Keywords: Transcutaneous spinal direct current stimulation
TsDCS
Fatigability
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2022-08-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: In this project, we aim to determine any potential effects of a weak electrical current applied to the neck or thoracic area on functional capacity and muscle activation. Healthy individuals will participate in one familiarization followed by three experimental sessions. Fatigability and motor function will be assessed in each test session.


Eligibility criteria: Inclusion Criteria:

Healthy individuals between 18 and 50 years old

Exclusion Criteria:

Metal implants or joint replacement. Presence of neuromuscular disease. Skin hypersensitivity.

Primary outcomes:
measure: Force
timeFrame: Each session will take approximately 2 hours (total of 4 test sessions)
measure: Perception of effort
timeFrame: Each session will take approximately 2 hours (total of 4 test sessions)
measure: Muscle activation
timeFrame: Each session will take approximately 2 hours (total of 4 test sessions)
Secondary outcomes:
Other outcomes:
Locations:
city: Norman
country: United States
facility: University of Oklahoma
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Hugo Pereira, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03814031: Hepatic Vein Flow During Orthotopic Liver Transplantation as Predictive Factor for Postoperative Graft Function
Official title: Hepatic Vein Flow Assessment With Transesophageal Echocardiography for Postoperative Graft Function Prediction in Orthotopic Liver Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Graft Function
Keywords: TEE
orthotopic liver transplant
EAD
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 97
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: OLT with piggy back technique

Brief summary: Hepatic vein flow (HVF) assessment using transesophageal echocardiography (TEE) has a potential to predict postoperative graft function in orthotopic liver transplant (OLT). Investigators will measure HVF using TEE and assess the correlation with postoperative graft function indices such as early allograft dysfunction(EAD), prolonged INR, platelet, and total bilirubin.

Detailed description: During OLT, intraoperative TEE assessment of HVF (systolic and diastolic) were measured, and adjusted with donor graft weight. This index, HVF index, was assessed for correlation with EAD. HVF was calculated with hepatic vein area (cm2) x hepatic vein velocity (ml/s) in systole and diastole during the neohepatic phase. Investigators did ROC analysis to assess the predictive power for EAD, prolonged INR, platelet, and total bilirubin.

Eligibility criteria: Inclusion Criteria:

Orthotopic liver transplants which uses TEE intraoperatively Must be Piggy back technique

-

Exclusion Criteria:

TEE absolute contraindication patient refusal

Primary outcomes:
measure: EAD
timeFrame: EAD met at any point within the first 7 days status post OLT
Secondary outcomes:
measure: Acute Rejection
timeFrame: Acute rejection noted at any point within 6-8 weeks post transplant
measure: Prolonged (>Seven Days) Time to Normalize Total Bilirubin (TIME T-bil)
timeFrame: postoperative day 7 assessment
measure: Prolonged (>Seven Days) Time to Normalize INR (TIME Inr)
timeFrame: postoperative day 7 assessment
measure: Prolonged (>Seven Days) Time to Normalize Platelet Count (TIME Plt).
timeFrame: postoperative day 7 assessment
Other outcomes:
Locations:
city: Detroit
country: United States
facility: HFHS
state: Michigan
Study officials:
affiliation: Henry Ford Hospital
name: Yoshihisa Morita, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04699331: Individualized Brain Stimulation Using Transcranial Direct Current Stimulation Simulation in Stroke Patients
Official title: Individualized Brain Stimulation Using Transcranial Direct Current Stimulation Simulation in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Pusan National University Yangsan Hospital
First posted: 2021-01-07
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is to investigate the effect of transcranial direct current stimulation (tDCS) simulation-based individualized stimulation compared to conventional stimulation and sham stimulation.


Eligibility criteria: Inclusion Criteria:

* Unilateral stroke patients
* Chronic patients over 6 months after onset
* Patients with motor evoked potential of the first dorsal interosseous muscle
* Patients with the movement of fingers

Exclusion Criteria:

* History of psychiatric disease
* Significant other neurological diseases except for stroke
* Difficult to perform this experiment
* Patients who are deemed difficult to participate in this research by the investigator
* Patients with metal implants and medical devices
* History of epilepsy
* Pregnancy
* Skin defect at the site of electrode attachment

Primary outcomes:
measure: Changes in motor evoked potential
timeFrame: Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
Secondary outcomes:
measure: Jebsen-Taylor hand function test
timeFrame: Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
measure: 9-hole peg test
timeFrame: Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
measure: Grip & Tip pinch strength test
timeFrame: Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
measure: Box & Block test
timeFrame: Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
measure: Fugl-Meyer Assessment
timeFrame: Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
measure: Sequential motor test
timeFrame: Baseline, 1 day (immediately after one brain stimulation session), 5 days (immediately before and after three brain stimulation sessions), and about 14 days (immediately before and after five brain stimulation sessions)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT05442931: Comparison Between Pregabalin and Magnesium Sulfate in Hypotensive Anaesthesia
Official title: Comparison Between Single Dose Pregabalin and Magnesium Sulfate in Controlled Hypotension During Functional Endoscopic Sinus Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Functional Endoscopic Sinus Surgery
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2022-07-05
Enrollment: 60
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: OTHER

Brief summary: Comparison between pregabalin and magnesium sulfate in hypotensive anaethesia

Detailed description: compare the effect of a single-dose 150 mg oral pregabalin and 2 grams intravenous magnesium sulfate given 30 minutes before induction of anesthesia on the total nitroglycerine used in patients undergoing functional endoscopic sinus surgery

Eligibility criteria: Inclusion Criteria:

* ASA: class 1 or 2
* Sex: male and female
* Age: from 18 to 70 years
* Patients scheduled for functional endoscopic sinus surgery

Exclusion Criteria:

* Patient on diuretics, corticosteroid, pregabalin
* Patients with a history of allergy to the study drug
* Pregnancy or breastfeeding women Patients with hypertension, cardiac, renal endocrinal diseases
* uncooperative patients (cant does not administer oral tablet)

Primary outcomes:
measure: Dose of nitroglycerine
timeFrame: an hour and half
Secondary outcomes:
measure: quality of surgical field
timeFrame: an hour and half
measure: surgeon satisfaction
timeFrame: an hour and half
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of medicine
Study officials:
affiliation: Minia University
name: Sarah Omar, M.D.
role: STUDY_DIRECTOR
References: