louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02033681: Optimal Time Delay of Epinephrine Injection With "One-per-mil" Tumescent Solution
Official title: Optimal Time Delay of Epinephrine Injection With "One-per-mil" Tumescent Solution to Visualize Operation Field in Hand Surgery Without Tourniquet
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemia
Keywords: epinephrine
hand
ischemia
lidocaine
upper extremity
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2014-01-13
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to know the characteristic of "one-per-mil" tumescent solution in regards of the optimal time delay to achieve optimal visualization of operation field in hand and digit surgery.

Hypothesis:

1. Epinephine in "one-per-mil" concentration by tumescent injection technique will provide faster decrease in oxygen saturation compared to normal saline solution injected by tumescent technique.
2. Epinephrine in "one-per-mil" concentration by tumescent injection technique will provide effectiveness in vasoconstriction longer than 10 minutes as the optimal time delay.
3. Epinephine in "one-per-mil" concentration by tumescent injection technique causes no finger necrosis as normal saline solution injected by tumescent technique.

Detailed description: This is a prospective, randomized, double-blind study to measure the optimal time delay of 1:1,000,000 epinephrine in saline solution injected by tumescent technique until maximum vasocontriction in the distal finger is achieved.

Subjects will be injected in both his ring fingers(distal phalanges, volar side) with randomized solutions, one containing "one-per-mil" tumescent solution and the other containing only normal saline solution; information which both the injector and examiner are blinded from. Maximum vasoconstriction of the finger injected is depicted by the lowest oxygen saturation (recorded every minute until 45 minutes using pulse oxymeter).

Eligibility criteria: Inclusion Criteria:

* Willing to join the research
* BMI 18.5-23
* Healthy individual, no history of blood or coagulation disorders

Exclusion Criteria:

* BMI \<18.5 or \>23
* History of blood or coagulation disorder, diabetes mellitus, heavy smoker

Primary outcomes:
measure: Time to achieve lowest oxygen saturation
timeFrame: 45 minutes
Secondary outcomes:
measure: Pain Sensation
timeFrame: 45 minutes
measure: Tactile Sensation
timeFrame: 45 minutes
measure: Complication
timeFrame: 6 hours
measure: Decrease in fingertip's temperature
timeFrame: 45 minutes
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: DKI Jakarta
Study officials:
affiliation: Plastic Surgery Division, Faculty of Medicine University of Indonesia/Cipto Mangunkusumo Hospital
name: Theddeus OH Prasetyono, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05401981: Disjunction Between Patient Narrative and Formulaic Thinking in the Doctor
Official title: Disjunction Between Patient Narrative and Formulaic Thinking in the Doctor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Musculoskeletal Diseases
Keywords: Orthopedics
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: This study is seeking whether giving or not giving a clinician a card with talking points in the form of a checklist about the patient's story affects the patients care experience or not

Detailed description: During an office visit, the clinician and the patient engage in dialogue and begin a relationship. This traditionally starts with the patient telling their story, which conveys why they decided to seek care. This study will determine the influence of a checklist specifically about the patient's narrative. The checklist will be used during the interview portion of the visit, to remind the clinician to stay curious about the person before them, their experience of the illness, and their explanatory model, and to help ensure that empathic opportunities are not missed.

Eligibility criteria: Inclusion Criteria:

* New patients
* Orthopedic visit

Exclusion Criteria:

* Languages other than English or Spanish.
* Cognitive dysfunction precluding completion of questionnaires.

Primary outcomes:
measure: Patient Experience Measure questions
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Perceived empathy (JSPPPE)
timeFrame: through study completion, an average of 6 months
measure: Guttman
timeFrame: through study completion, an average of 6 months
measure: Guttman CEQ
timeFrame: through study completion, an average of 6 months
measure: PROMIS PF CAT
timeFrame: through study completion, an average of 6 months
measure: NRS pain intensity assessment
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Austin
country: United States
facility: Austin Regional Clinic
state: Texas
city: Austin
country: United States
facility: Texas Orthopedics
state: Texas
city: Austin
country: United States
facility: HTB Musculoskeletal Institute
state: Texas
city: Austin
country: United States
facility: Orthopedic Specialists of Austin
state: Texas
city: Austin
country: United States
facility: ATX Ortho
state: Texas
Study officials:
affiliation: The University of Texas at Austin
name: David Ring, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02645981: Efficacy and Safety of Donafenib in Patients With Advanced Hepatocellular Carcinoma
Official title: Efficacy and Safety of Donafenib in Patients With Advanced Hepatocellular Carcinoma: a Controlled,Multicentre,Randomised, Phase 3 Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: HCC
Keywords: Donafeinb
Sorafenib
Phase 3
Overall Survival
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
Collaborators: name: Tigermed Consulting Co., Ltd
First posted: 2016-01-05
Enrollment: 668
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: Donafenib versus sorafenib for advanced hepatocellular cancer.

Detailed description: This phase 3 study of donafenib, an oral multikinase inhibitor that targets Raf kinase and receptor tyrosine kinases, is to assess efficacy and safety in patients wiht advanced hepatocellular carcinoma (HCC).The study is a randomised,controlled,multicentre study.The controlled drug is sorafenib(Nexavar).The primary endpoint is overall survival.

Eligibility criteria: Inclusion Criteria:

* Above 18 years old;
* Patients with measurable, histologically or clinical proven, inoperable HCC;
* Patients wtih measurable lesion and proved by independent radiology committee(IRC);
* Child-Pugh (CP) score of 7 or less；
* Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less;
* Patients had not received prior systemic treatments for HCC;
* Life expectancy at least 3 months;
* Adequate hepatic and renal function;
* Adequate hematologic function (platelet count,≥75×109per liter;hemoglobin ≥9.0g per deciliter;neutrophil≥1.5×109per liter,);
* Prothrombin time international normal.

Exclusion Criteria:

* Patients received operate in 3 months;
* Patients received transcatheter arterial chemoembolization（TACE） in 4 weeks;
* Patients had received systemic therapy;
* Patients had prior treatment with sorafenib;
* Central nervous system(CNS) involvement;
* Severe or mild-degree ascitic fluid;
* Main portal vein tumor thrombus;
* Inferior venae cava tumor thrombus.

Primary outcomes:
measure: Overall Survival
timeFrame: 3 years
Secondary outcomes:
measure: Progress Free Survival
timeFrame: 2 years
measure: Percentage of adverse events
timeFrame: 3 years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The PLA 81 Hospital
state: Jiangsu
city: Chengdu
country: China
facility: West China Hospital Sichuan University
state: Sichuan
Study officials:
affiliation: The PLA 81 Hospital
name: Shukui Qin, MD
role: STUDY_CHAIR
affiliation: West China Hospital
name: Feng Bi, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00894881: The Effect of Colonoscopy on Resting Energy Expenditure
Official title: The Effect of Colonoscopy on Resting Energy Expenditure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Keywords: colonoscopy
Healthy individuals before colonoscopy
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-05-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy individuals before colonoscopy

Brief summary: The Effect of Gut Cleaning as a Preparation to Colonoscopy on resting energy expenditure (REE).


Eligibility criteria: Inclusion Criteria:

* Healthy individuals before colonoscopy

Exclusion Criteria:

* None

Primary outcomes:
measure: To measure the Effect of Gut Cleaning as a Preparation to Colonoscopy on resting energy expenditure (REE).
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Nachum Vaisman, Prof'
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00822081: Comparison of the Fixed Combinations of Brimonidine/Timolol and Dorzolamide/Timolol in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Open-Angle Glaucoma
Ocular Hypertension
Lead sponsor: Bp Consulting, Inc
Sponsor class: NETWORK
Collaborators: name: Allergan
First posted: 2009-01-14
Enrollment: 140
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: This study compares the efficacy and tolerability/comfort of brimonidine/timolol and dorzolamide/timolol in patients with open-angle glaucoma or ocular hypertension. In an investigator masked randomization process, each subject is allocated to recieve either brimonidine/timolol or dorzolamide/timolol as fixed-combination monotherapy or as an adjuctive to a prostoglandin analogue for a period of 12 weeks. After screening, patient returns at baseline, Month 1, and Month 3 for ophthalmic evaluations.


Eligibility criteria: Inclusion Criteria:

* Male or female over 18 yrs.
* Female subjects of childbearing potential must have negative pregnancy test and provide contraception.
* Subjects must have confirmed diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes.
* Subjects who are or have been insufficiently responsive to IOP reducing monotherapy and use of either study medication is deemed appropriate.
* Subjects able to complete questionnaires and provide informed consent.

Exclusion Criteria:

* Female subjects who are pregnant, planning to become pregnant during study period, breast feeding or not practicing a reliable method of birth control.
* Subjects wherein the study drugs are containdicated.
* Subjects who have had introcular surgery with 6 months (3 months for laser).
* Subjects with known side effects/ allergy or sensitivity to any component of study treatments.
* Subjects with any uncontrolled systemic disease.

Primary outcomes:
measure: Change from baseline in mean IOP.
timeFrame: 12 weeks
Secondary outcomes:
measure: Patient tolerability/comfort measured by Likert scale.
timeFrame: Month 1
Other outcomes:
Locations:
city: Barrie
country: Canada
state: Ontario
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Nixon DR, Yan DB, Chartrand JP, Piemontesi RL, Simonyi S, Hollander DA. Three-month, randomized, parallel-group comparison of brimonidine-timolol versus dorzolamide-timolol fixed-combination therapy. Curr Med Res Opin. 2009 Jul;25(7):1645-53. doi: 10.1185/03007990902994041.
Clinical trial NCT04321681: Diaphragm Ultrasound to Predict Posteroperative Residual Blockade
Official title: Diaphragm Ultrasound to Predict Posteroperative Residual Blockade
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ultrasonography
Residual Curarization
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-03-25
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for elective non-abdominal and non-thoracic surgery in Peking Union medical college hospital. All were among age of 19-65 years and American Society of Anesthesiologists Physical Status Classification(ASA) I or II.

Brief summary: This study is a prospective observational research approved by the Ethics Committee of the Peking Union medical college Hospital. Patients scheduled for elective non-abdominal and non-thoracic surgery among age of 19-65 years and American Society of Anesthesiologists Physical Status Classification(ASA) I or II were inrolled. Diaphragm ultrasonogram was measured pre and post operation. Diaphragm excursion and diaphragm thickening fraction during quiet breathing as well as deep breathing were assessed. Neuromuscular monitor was performed during operation, after proper calibration.


Eligibility criteria: Enrollment criteria：

1. Patients who were scheduled for elective non-abdominal and non-thoracic surgery in Peking Union medical college hospital.
2. age of 19-65 years
3. American Society of Anesthesiologists Physical Status Classification(ASA) I or II.
4. Agree to informed consent

Exclusion criteria ： Patients with neuromuscular diseases, diaphragmatic palsy, thoracic malformation, hand disabilities, chronic obstructive pulmonary disease, severe liver or kidney diseases, electrolyte or acid-base disorders, morbid obesity (body mass index ≥30 kg/m2), pregnancy, allergy to drugs used in the study, use of medication interfering neuromuscular transmission within 72hours and patients with predicted difficulty in maintenance of airway were excluded from this study. Written informed consent will be obtained before preoperative evaluation by an anesthesiologist.

Primary outcomes:
measure: TOFr at extubation
timeFrame: within1 min before extubation
measure: Diaphragm ultrasound parameter
timeFrame: within 1 min after extubation
Secondary outcomes:
measure: reintubation rate
timeFrame: within 24 hour
measure: Posteroperative pulmonary complication
timeFrame: 1 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Anesthesiology, Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT05972746: Telemonitoring Program in the Vulnerable Phase After Hospitalization for Heart Failure
Official title: Telemonitoring Program With Electronic Alerts to Improve Outcomes in the Vulnerable Phase After Hospitalization for Heart Failure: A Pragmatic Clinical Trial TREAT - Vulnerable HF
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Acute Heart Failure
Keywords: telemonitoring
Heart Failure
Vulnerable phase
Lead sponsor: Instituto Cardiovascular de Buenos Aires
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 110
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: This pragmatic clinical trial aims to evaluate the impact of a telemonitoring program with an electronic alert system compared to standard treatment on the perception of self-care in patients after hospitalization for decompensated HF at 3 months post-discharge. And secondarily to evaluate its impact on clinical events, NT-proBNP and efficacy and safety to facilitate the use and titration of the recommended drugs in patients with reduced ejection fraction at 90 days.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Hospitalized for acute heart failure (regardless of the level of left ventricular ejection fraction) within 24 hours of discharge, or with a history of hospitalization for acute HF within 10 days prior to randomization.
* Own a smartphone (Smartphone) with internet Ability to speak and read Spanish.
* Residence in the metropolitan area of Buenos Aires

Exclusion Criteria:

* Pregnancy
* Alcohol or drug abuse
* Kidney failure in hemodialysis,
* Inability to use the app (Ex: cognitive impairment, lack of social support, lack of ability to communicate)
* Active cancer
* Life expectancy less than 1 year
* Candidates for care home or institutional end of life
* Severe psychiatric illness
* Planned cardiac surgery
* Patient unable or unwilling to give informed consent to participate.

Primary outcomes:
measure: Self-care behavior
timeFrame: 90 days
Secondary outcomes:
measure: NT pro BNP
timeFrame: 90 days
measure: Medication adherence
timeFrame: 90 days
measure: Quality of life
timeFrame: 90 days
measure: First readmission for heart failure
timeFrame: 90 days
measure: Total number of readmissions for heart failure
timeFrame: 90 days
measure: Time to achieve the use of Guideline-Directed Medical Therapy
timeFrame: 90 days
measure: Proportion of patients with heart failure and reduced ejection fraction who have an increase in the number of Guideline-Directed Medical Therapy
timeFrame: 90 days
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Instituto Cardiovascular de Buenos Aires
state: Ciudad Autónoma De Buenos Aires
Study officials:
References:
Clinical trial NCT00837746: Analysis of Iliac Crest Biopsies From Patients Receiving Risedronate
Official title: Bone Histomorphometry, Microarchitecture, and Matrix Structure in Patients Receiving Risedronate Daily or Weekly
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2009-02-05
Enrollment: 29
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This study analysed and reported on the study data from three similar, risedronate studies, 1996052, 2003073, and 2003096. The objective of the study was to determine the differences in the iliac crest bone histomorphometry and bone quality in postmenopausal women who had received long term therapy with risedronate.


Eligibility criteria: Inclusion Criteria:

* Completed month 36 of Study RVN-008993.
* Underwent an iliac crest bone biopsy at month 36.

Exclusion Criteria:

* Was less than 60% compliant with regard to taking study drug from the start of the study drug to month 24 of study RVN-008993.

Primary outcomes:
measure: Differences in iliac crest bone histomorphometry and bone quality in patients receiving risedronate
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Palm Desert
country: United States
facility: Maria Greenwald, MD
state: California
city: Lakewood
country: United States
facility: Paul Miller, MD
state: Colorado
city: Decatur
country: United States
facility: Grattan Woodson, MD
state: Georgia
city: Gainesville
country: United States
facility: Christopher Recknor, MD
state: Georgia
city: Omaha
country: United States
facility: Robert Recker, MD
state: Nebraska
city: Cincinnati
country: United States
facility: Nelson Watts, MD
state: Ohio
city: Wyomissing
country: United States
facility: Ronald D Emkey, MD
state: Pennsylvania
city: Montreal
country: Canada
facility: Louis-Georges Ste-Marie, MD
state: Quebec
Study officials:
affiliation: Procter and Gamble
name: Ana M Balske, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00980746: Efficacy and Safety of Eslicarbazepine Acetate as Therapy for Patients With Painful Diabetic Neuropathy
Official title: Efficacy and Safety of Eslicarbazepine Acetate (BIA 2 093) as Therapy for Patients With Painful Diabetic Neuropathy: a Double-blind, Double-dummy, Randomised, Placebo-controlled, Parallel-group, Multicentre Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Painful Diabetic Neuropathy
Keywords: pain diabetes neuropathy
Lead sponsor: Bial - Portela C S.A.
Sponsor class: INDUSTRY
First posted: 2009-09-21
Enrollment: 557
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: The primary objective of the study is to assess the efficacy of eslicarbazepine acetate (ESL) as therapy for patients with painful diabetic neuropathy.


Eligibility criteria: Inclusion Criteria:

* Written informed consent to participate in the study
* Men and women aged 18 years or older
* Diagnosis of diabetes mellitus Type 1 or 2
* Diagnosis of pain attributed to diabetic neuropathy for more than 1 year prior to enrolment
* Stable glycemic control: (total glycated haemoglobin \[HbA1c\] level ≤ 11% at screening)
* Cooperation and willingness to complete all aspects of the study
* Completion of at least 4 daily diaries during the week preceding randomisation
* A minimum average daily pain score of 4 on the Numeric rating pain scale (NRPS) in the last 4 diary entries before randomisation.

Exclusion Criteria:

* Pain of other origin that might confound the assessment of neuropathic pain of diabetic origin
* Significant or unstable medical or psychiatric disorders
* Drug or alcohol abuse in the preceding 2 years
* Peripheral vascular disease with a history of amputation, except amputation of toes
* Severe renal function impairment, as shown by calculated creatinine clearance values \< 30 mL/min at screening
* Relevant clinical laboratory abnormalities (e.g., Na+ \<130 mmol/L, alanine (ALT) or aspartate (AST) transaminases \>2.0 times the upper limit of normal, white blood cell count (WBC) \<2,500 cells/mm3)
* Previous participation in any study with eslicarbazepine acetate
* Pregnancy or breast feeding
* History of hypersensitivity to the investigational products or to drugs with a similar chemical structure
* History of non-compliance
* Likelihood of requiring treatment during the study period with drugs or other interventions not permitted by the clinical study protocol.
* Participation in a clinical study within 3 months prior to screening
* Any clinically significant concomitant condition, which might influence the assessments or conduct of the trial

Primary outcomes:
measure: Change From Baseline to Endpoint in Mean Pain, Scored Daily on a on an 11-point (0-10) Numeric Rating Pain Scale (NRPS), Where 0 = no Pain and 10 = Worst Possible Pain
timeFrame: 17 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: