louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01444274: Pilot Study to Evaluate A Novel Gastric Space Occupying Device
Official title: A Single-Center 60-day Observational, Non-randomized Study to Evaluate Safety and Preliminary Efficacy of a Novel Gastric Space Occupying Device as an Aid for Weight Loss
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: Obalon Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2011-09-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Overweight or obese individuals who have failed routine dieting in the past

Brief summary: This will be an observational, prospective, non-randomized, pilot study to gain initial device experience on a novel space-occupying device in persons who are overweight or obese. No formal hypothesis testing will be conducted.


Eligibility criteria: Inclusion Criteria:

1. Age between 21-64 years
2. BMI 27-40 Kg/m2
3. No history of weight reduction of more than 5% of total body weight in the past 6 months

Exclusion Criteria:

1. Have unstable angina, myocardial infarction within the past year, or heart disease classified within the New York Heart Association's Class III or IV functional capacity;
2. Be taking chronic aspirin or other non steroidal anti-inflammatory agents, or other medications known to be gastric irritants, and unwillingness to discontinue the use of these concomitant medications, antiarrythmics, anti-anginal medications, anticoagulants or medications for congestive heart failure;
3. Be taking blood pressure medications, unless their blood pressure is controlled and they have been at stable dose for at least 3 months;
4. Have type 1 diabetes or type 2 diabetes requiring oral medications or insulin;
5. History or symptoms of thyroid disease which is not controlled by medication;
6. Have severe renal, hepatic, pulmonary disease or cancer;
7. Past history of gastrointestinal surgery (excluding uncomplicated appendectomy);
8. Have a history of adhesive peritonitis;
9. History or symptoms of esophageal and/or gastric varices;
10. Have history or congenital or acquired GI anomalies (e.g. atresias, stricture, and /or diverticula);
11. History or symptoms of inflammatory bowel disease, such as Chron's disease;
12. History of/ signs and /or symptoms of duodenal or gastric ulcer;
13. Have gastroparesis;
14. Pregnant or breastfeeding or intention of becoming pregnant during the study (if female of childbearing potential);
15. Currently using pharmaceutical agents for weight loss;

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tijuana
country: Mexico
facility: Obesity Control Center
state: Baja California
Study officials:
affiliation: Obesity Control Center
name: Ariel Ortiz Lagardere, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04228874: Effect of Stent Size on Dyssynchrony
Official title: The Short Term Effect of Stent Size and Number on Left Ventricular Mechanical Dyssynchrony After Elective PCI to Left Anterior Descending Artery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Left Ventricular Function
Keywords: Stent length
Stent diameter
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2020-01-14
Enrollment: 265
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult patients with electively stented LAD lesion with DES were enrolled in the study

Brief summary: the effect of stent size and number on left ventricular mechanical dyssynchrony after PCI using drug eluting stent is not clear enough

Detailed description: Background: the effect of stent size and number on left ventricular mechanical dyssynchrony after PCI using drug eluting stent is not clear enough Aim: to study short term effect of stent size and number on left ventricular mechanical dyssynchrony after elective PCI to LAD artery.

Patients and methods: the study included 150 adult patients with electively stented LAD lesion with DES. Patients were evaluated pre PCI then follow up at 1m and 3m using tissue synchronization image (TSI).

Eligibility criteria: Inclusion Criteria:

* adult patients with electively stented LAD lesion with DES were enrolled in the study. Patients were evaluated pre PCI then follow up at 1m and 3m after PCI using TSI.

Exclusion Criteria:

* patients with Bundle branch block (BBB),
* Previous percutaneous coronary intervention (PCI),
* Previous coronary artery bypass graft (CABG),
* Rhythm other than sinus,
* Rheumatic heart disease,
* Prosthetic valve,
* Complicated or unsuccessful procedure,
* Patients with significant degenerative changes,
* Patients with previous STEMI,
* and dropped patients from follow up were excluded from the study.

Primary outcomes:
measure: left ventricular systolic function
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: shaimaa Mostafa
Study officials:
References:
Clinical trial NCT05335174: Hypotension Prediction Index in Postoperative Surgical Patients
Official title: Hypotension Prediction Index in Postoperative Surgical Patients in the Post-anesthetic Recovery Room - a Feasibility Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Surgery
Lead sponsor: Sir Mortimer B. Davis - Jewish General Hospital
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Surgical patients with cardiovascular disease risk factors undergoing colorectal, hepatobiliary, or vascular surgery.

Brief summary: PACU-HPI study evaluates the use of a hemodynamic monitor in the post-anesthetic recovery room on patients undergoing colorectal, hepatobiliary, and vascular surgery, to determine the feasibility of recruiting this surgical population.

Detailed description: Postoperative vascular complications, including myocardial infarction (MI), myocardial injury after noncardiac surgery (MINS), stroke, and death occur in up to 18% of surgical patients.1 Hypotension is a frequent occurrence in the postoperative period and can increase the risk of postoperative vascular complications.2 Therefore, accurate prediction of postoperative hypotension can identify patients at risk for postoperative vascular complications who would benefit from early intervention. The investigators propose a feasibility study to determine the accuracy of the hypotension prediction index (HPI) parameter of the HemoSphere monitor and Acumen IQ sensor (Edwards Lifesciences, Irvine, CA) to predict postoperative hypotension in surgical patients.

Eligibility criteria: Inclusion Criteria:

1. Patient ≥45 years old
2. Will undergo open colorectal, hepatobiliary, or vascular surgery;
3. Is expected to have an arterial cannula inserted intraoperatively;
4. Has an anticipated stay in PACU for at least 2 hours;
5. Able to provide written informed consent

Exclusion Criteria:

1. Planned admission to ICU;
2. Refusal to participate;
3. Previously enrolled in the study

Primary outcomes:
measure: Incidence of intraoperative hypotension
timeFrame: in 12 months
measure: Incidence of postoperative hypotension
timeFrame: in 12 months
measure: Hemodynamic changes with treatment of hypotension
timeFrame: in 12 months
Secondary outcomes:
measure: Sensitivity and Specificity of HPI
timeFrame: in 12 months
measure: Cardiovascular outcomes
timeFrame: in 12 months
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Jewish General Hospital, Anesthesia Department
state: Quebec
Study officials:
affiliation: Jewish General Hospital
name: Stephen Yang, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03677674: The Effects of Dehydration on the Performance of Judoka
Official title: The Effects of Dehydration on the Performance of Judoka
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dehydration
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
First posted: 2018-09-19
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Dehydration is a common phenomenon in judo that can lead to negative performance such as a decline in strength, a decline in anaerobic performance, a reduced body fluid balance, glycogen depletion and worsened psychological parameters. Therefore, we want to simulate several judo combats and look at the performances whether they change during a competition day. We also want to see if the results are different in a dehydrated versus euhydrated state.


Eligibility criteria: Inclusion Criteria:

* judoka
* minimum 18 years
* men and women
* only dehydration: sauna, warm bath, sweat suit

Exclusion Criteria:

* injured
* sick
* not underaged (18 years)

Primary outcomes:
measure: Sterkowicz test
timeFrame: Up to 3 weeks
Secondary outcomes:
measure: heart rate
timeFrame: Up to 3 weeks
measure: Body weight
timeFrame: Up to 3 weeks
measure: Borg Rating of Perceived Exertion Scale
timeFrame: Up to 3 weeks
measure: body temperature
timeFrame: Up to 3 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05056974: A Proof-of-concept Trial to Evaluate the Safety and Efficacy of UB-421 Plus Chidamide in Changing HIV Reservoirs
Official title: A Phase II Proof-of-concept Trial to Evaluate the Safety and Efficacy of UB-421 Plus Chidamide in Changing HIV Reservoirs Among ART Stabilized HIV-1 Patients Who Undergo ART Interruption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV-1 Infection
Lead sponsor: United BioPharma
Sponsor class: INDUSTRY
First posted: 2021-09-27
Enrollment: 11
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase II proof-of-concept trial study to assess the safety and efficacy of UB-421 monotherapy plus chidamide in changing the latent HIV reservoir among ART-treated HIV-1 adults with stably viral suppression who undergo ART interruption.


Eligibility criteria: Inclusion Criteria:

1. HIV-1 sero-positive, with documented HIV-1 infection by official, signed, written history
2. Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg, aged 20 years or older.
3. No breastfeeding or pregnancy for women.
4. Have been receiving ART for more than 3 years by screening visit 1 (SV1).
5. Both male and female patients and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception
6. Subjects must sign the informed consent before undergoing any study procedures.

Exclusion Criteria:

1. Subjects with active systemic infections, except for HIV-1
2. Any exposure to a monoclonal antibody within 12 weeks prior to the first dose of study drug.
3. Current receiving treatment regimen for hepatitis B, hepatitis C or latent tuberculosis
4. Any alcohol or illicit drug use
5. Receipt of any other investigational study agent(s) within 90 days before SV2.
6. Currently on the treatment for diabetes.

Primary outcomes:
measure: HIV cell-associated RNA levels
timeFrame: Post-treatment weeks up to 48 weeks
Secondary outcomes:
measure: HIV-1 Total DNA levels
timeFrame: Post-treatment weeks up to 48 weeks
Other outcomes:
Locations:
city: Kaohsiung City, Taiwan
country: Taiwan
facility: Kaohsiung Veterans General Hospital
Study officials:
References:
Clinical trial NCT06164574: Immunotherapy in Uncommon and 20ins EGFR-mut Lung Cancers
Official title: Distinct Survivals and Optimal Combination of Immunotherapy Plus Immunophenotype in Uncommon and 20ins EGFR-mut Lung Adenocarcinoma: a Retrospective Multi-center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 627
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: EGFR-mutant LUAD patients receiving anti-PD-(L)1 therapies

Brief summary: Immunotherapy effectiveness and optimal combination strategy in lung cancers with EGFR uncommon and 20ins mutations was unclear. Based on 627 lung adenocarcinoma patients harboring EGFR mutations and receiving immunotherapy, we reported that patients with EGFR uncommon mutations had better response to immunotherapy, than EGFR 19del/L858R or 20in mutations. Immunotherapy monotherapy or plus chemotherapy was identified as better combination strategy for EGFR uncommon or 20ins mutations, respectively. Higher tumor mutation burden, more M1 macrophage, less Tregs and M2 macrophages infiltration, but not PD-L1 expression was found to be associated with EGFR uncommon mutations, compared to EGFR 19del/L858R or 20in mutations. These findings revealed diverse response and optimal combination strategy of lung adenocarcinoma patients harboring EGFR mutation subtypes, promoting rethinking about current immunotherapy application and prolonging survivals of them.


Eligibility criteria: Inclusion Criteria:

1. age≥18 years,
2. advanced or recurrent LUAD confirmed by pathology,
3. harboring EGFR mutations confirmed by super amplification refractory mutation system (super-ARMS) or next-generation sequencing (NGS),
4. receiving anti-PD-(L)1 antibody therapy at least once,
5. Radiologically evaluable according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)

Exclusion Criteria:

-

Primary outcomes:
measure: Tumor response
timeFrame: From date of initial treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary outcomes:
measure: Progression-free survivals
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Chaoqiang Deng
state: Please Select
Study officials:
References:
Clinical trial NCT00543465: 12-Week No-Rofecoxib Plus Aspirin Endoscopy Study (0782-003)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Arthritis, Rheumatoid
Osteoarthritis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-10-15
Enrollment: 49
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will look at the incidence of gastric and/or duodenal ulcers in patients with osteoarthritis or rheumatoid arthritis in four different treatment groups (a) MK0782 21 mg plus enteric-coated aspirin, (b) MK0782 42 mg plus enteric-coated aspirin, (c) celecoxib 200 mg plus enteric-coated aspirin, and enteric-coated aspiring alone.

This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).


Eligibility criteria: Inclusion Criteria:

* Has osteoarthritis or rheumatoid arthritis for at least 6 months prior to start of study
* Osteoarthritis (OA): must have diagnosis of OA in knee, hip, hand or spine

Patient is not on chronic aspirin therapy (taking aspirin at any dose, on a daily basis, for a minimum of 4 weeks prior to Visit 2 for any medical condition

* Must be willing to limit alcohol use to no more than 2 drinks per day
* Avoid strenuous physical activity

Exclusion Criteria:

* Mentally or legally incapacitated
* Has systemic lupus erythematosus, Paget's disease
* Has a history of esophageal, gastric biliary, or small intestine surgery (hiatal surgeries and any GI surgery that causes clinical malabsorption or delayed gastric emptying
* Has uncontrolled hypertension
* Has uncontrolled diabetes
* Has had heart attack, unstable angina, coronary angioplasty, stent placement, coronary artery bypass grafting in the last 6 months
* Has congestive heart failure
* Has had active liver disease within the last 2 years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00886665: The Evaluation of Safety and Efficacy of JWHGWT on Diabetic Neuropathy
Official title: The Evaluation of Safety and Efficacy of JWHGWT on Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Diabetic Neuropathy
Keywords: Diabetic Neuropathy
Nerve Conduction Studies
Clinical Trial
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2009-04-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In order to provide a alternative treatment for relieving the pain and numbness of Diabetes Mellitus patients,Traditional Chinese Medicine powder was tested by subjective questionnaire and objective nerve conduction velocity study. Liver and kidney functions were tested to provided safety profiles.

Detailed description: 120 participants with diabetic neuropathy were screened in endocrine and metabolism clinics of Taichung Veterans General Hospital and Chinese Medical University Hospital . Subjects were randomly distributed into a double-blind, 12 weeks, placebo-controlled procedure. Subjects were measured by MNSI, SF-BPI, SF-36, SF -MCQ, NCV, AC sugar, HbA1c, lipid profiles, liver and kidney functions.

Safety evaluations including GPT and creatinine revealed no deterioration after treatment. Several domains in MNSI, SF-BPI, SF-36, SF -MPQ questionnaires revealed significant improvements. F-wave in peroneal, tibial nerves and distal latency in tibial nerve in objective nerve conduction studies revealed significant improvements.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of DM
* Must have the symptoms of pain or numbness

Exclusion Criteria:

* Patient with pregnancy (or child bearing potential),or in lactation
* Patient currently taking concomitant TCM medications.
* Patient with Drug or alcohol addiction
* Patient with medical history of myocardial infarction, cerebro-vascular disease, major trauma, operation 6 months prior to enrollment
* Patient with liver dysfunction (SGOT or SGPT\>2x ULN)
* Patient with renal insufficiency (serum creatinine\>1.3mg/dL)

Primary outcomes:
measure: Short-form (sf)- McGill pain questionnaire (SF-MPQ)
timeFrame: 0, 4, 8,12 weeks
Secondary outcomes:
measure: Nerve conduction study
timeFrame: 0,12 weeks
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
state: Taichung / Taichung
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
affiliation: Taichung Veterans General Hospital
name: Chia-I Tsai, master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02632565: Intra-Articular 0.5 % Lidocaine Injection for Osteoarthritis
Official title: Intra-Articular 0.5 % Lidocaine Injection Under Ultrasound Guidance in Chronic Knee Pain Due To Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Pain
Keywords: osteoarthritis
lidocaine
pain
ultrasound
Lead sponsor: Baskent University
Sponsor class: OTHER
Collaborators: name: Baskent University
First posted: 2015-12-16
Enrollment: 52
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, investigators compared the efficacy of intra-articular 0.5% lidocaine and saline injection on pain, stiffness and physical function in patients with osteoarthritis.

Detailed description: Patients with osteoarthritis were randomly allocated into two groups. Group I (n=26) received intra-articular injection of 7 mL 0.5% lidocaine and Group II (n=26) received 7 mL saline into painful knee for 3 times with one week intervals under USG guidance. VAS and WOMAC scale including pain, stiffness and physical function was used for the assessment of patients with osteoarthritis. Analgesic requirements were also recorded.

The primary outcome parameter of this study was the pain scores. The sample size for the primary variable was calculated based on a standard deviation of 20 mm estimated from a previous study. A power analysis with a type II error of 20% at a two-sided 5% significance level estimated 22 patients per group to be included. Investigators included 26 patients per groups for possible missing date. χ2 test for categorical data and independent samples t-test for the comparison of VAS and WOMAC scores between groups were used for statistical analysis.

Eligibility criteria: Inclusion Criteria:

* knee pain for more than 25 of the past 30 days, morning stiffness or less than 30 minutes, crepitation in the knee
* pain for more than 25 of the past 30 days and osteophytes on x-ray examination of the knees indicating knee OA

Exclusion Criteria:

* the knees with a history of mechanical derangement, fibromyalgia, skin lesions and other risk factors of infection, therapy with anticoagulants and trauma/surgery

Primary outcomes:
measure: Pain scores according to visual analog scale
timeFrame: 3 months after the treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Coordinator
name: Anis Aribogan, Prof
role: STUDY_CHAIR
References:
citation: Elhakim M, Nafie M, Eid A, Hassin M. Combination of intra-articular tenoxicam, lidocaine, and pethidine for outpatient knee arthroscopy. Acta Anaesthesiol Scand. 1999 Sep;43(8):803-8. doi: 10.1034/j.1399-6576.1999.430804.x.
citation: Pietruck C, Grond S, Xie GX, Palmer PP. Local anesthetics differentially inhibit sympathetic neuron-mediated and C fiber-mediated synovial neurogenic plasma extravasation. Anesth Analg. 2003 May;96(5):1397-1402. doi: 10.1213/01.ANE.0000060454.34258.D3.