louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04637529: Efficacy and Safety of S (+) - Ibuprofen in Osteoarthritis Pain
Official title: National, Multicentre, Randomized, Double-blind, Double-dummy Phase II Clinical Trial to Evaluate the Efficacy and Safety of S (+) - Ibuprofen for Pain Control in Individuals With Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis
Keywords: Nonsteroidal anti-inflammatory
Pain
Ibuprofen
Inflammation
Anti-inflammatory
Pain control
Osteoarthritis
Pain relief
Enzyme Inhibitors
Lead sponsor: Apsen Farmaceutica S.A.
Sponsor class: INDUSTRY
First posted: 2020-11-19
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 evaluate the efficacy of S (+) - ibuprofen compared to an active treatment for pain control in individuals diagnosed with osteoarthritis.


Eligibility criteria: Main Inclusion Criteria:

* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
* Patients aged from 18 to 75 with a diagnosis of knee and/or hip osteoarthritis according to American College of Rheumatology (ACR) criteria.

Main Exclusion Criteria:

* Known hypersensitivity to the formula components used during the clinical trial;
* Previous history of alcohol or drugs abuse diagnosed by DSM-V;
* Current or previous history (less than 12 months) of smoking;
* Have clinically relevant abnormal laboratory results according to medical evaluation;
* Women who are pregnant, lactating, or positive for β - hCG urine test;

Primary outcomes:
measure: Mean reduction of pain measured by the WOMAC Osteoarthritis Index (pain)
timeFrame: Baseline (day 0) and Week 4 (day 28)
Secondary outcomes:
measure: Patient Global Impression of Improvement-I (PGI-I)
timeFrame: Week 4 (day 28)
measure: Proportion of participants among the groups to discontinue the trial due to treatment non-tolerability
timeFrame: From Baseline (day 0) to Week 4 (day 28)
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Apsen Farmacêutica S.A.
Study officials:
References:
Clinical trial NCT04568629: ADJUST: A Study on MDT Prognostication
Official title: Study of Advice and Decision-making on Prognosis Using the Judge-advisor System Within Multi-disciplinary Teams (ADJUST)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Terminal Illness
Keywords: Prognostication
Multidisciplinary teams
Judge-Advisor System
Palliative Care
End-of-life
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2020-09-29
Enrollment: 323
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were randomly assigned to one of two study arms and received advice reportedly from either a prognostic algorithm, or another clinician.
Primary purpose: OTHER

Brief summary: This study investigates how clinicians form intuitive judgements about the prognoses of palliative care patients after receiving advice perceived as coming from either a team member or an algorithm.

Detailed description: Using the Judge-Advisor System, the investigators will recruit clinicians working in palliative care for adults. Participants will be asked to complete an online survey and review five patient summaries ("vignettes") based on real cases derived from a previous study. Clinicians will be presented with key prognostic information and will be asked to provide an estimate of the probability that the patient will survive for two weeks (0-100%). After providing this initial estimate, participants will receive prognostic advice. While in reality all participants will receive the same advice, participants will be randomised into two groups and these groups will be informed that the advice is either: (1) provided by an algorithm; or (2) provided by a team colleague. Participants will then be given the opportunity to give a second, possibly revised estimate in the light of the advice received.

Eligibility criteria: Inclusion Criteria:

* Clinicians working in an adult palliative care service
* Willing and able to provide written informed consent

Exclusion Criteria:

* None

Primary outcomes:
measure: Probability of survival estimate
timeFrame: Participants will have up to 7 months (until the study closes) to provide an estimate for each vignette
Secondary outcomes:
measure: Participants' weighting policies (characteristics of the participants)
timeFrame: Participants will have up to 7 months (until the study closes) to provide an estimate for each vignette
measure: Participants' weighting policies (the advice itself)
timeFrame: Participants will have up to 7 months (until the study closes) to provide an estimate for each vignette
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London
Study officials:
affiliation: UCL (University College London)
name: Patrick Stone, MA MD FRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05862129: Association of Intestinal Microbiota and the Onset of Perianal Abscess Based on 16S RDNA Amplicon Sequencing
Official title: Association of Intestinal Microbiota and the Onset of Perianal Abscess Based on 16S RDNA Amplicon Sequencing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perianal Abscess
Lead sponsor: Xi'an Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteers who did not keep the specimens as required

Brief summary: The goal of this observational study is tolearn the association of gut microflora with the onset of perianal abscesses. The main questions it aims to answer are:

Question 1: To understand the structure of rectal microbial community composition and its relationship with pathogenic bacteria in patients with perianal abscess.

Question 2: Understand the structure of rectal microbial community composition in healthy people.

Participants will be collected with rectal secretions and stool specimens.In addition, patients with perianal abscess should also collect pus samples.


Eligibility criteria: Inclusion Criteria:

* Observation group: ① Age between 18-60 years, local resident of Xi'an; ② met the diagnostic criteria for perianal abscess and underwent surgical treatment in our hospital; ③ did not use antibiotics before treatment; ④ himself and his family members were willing to participate in this study and signed informed consent.

Control group: ① Age between 18-60 years, permanent residents in Xi'an; ② had no serious chronic disease, no abnormality in physical examination in the last 1 week; ③ did not use drugs that may affect intestinal flora in the last one month; ④ himself and his family members are willing to participate in the study and sign the informed consent.

Exclusion Criteria:

* Failing to retain the specimens as required

Primary outcomes:
measure: Observation group: the structure and changes of rectal flora before and after treatment
timeFrame: Two months
measure: Control group: the structure and changes of rectal flora in healthy population
timeFrame: Two months
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an City
country: China
facility: Xi'an Hospital of Traditional Chinese Medicine
state: Shaanxi
Study officials:
References:
Clinical trial NCT00526929: Fixed Dose NESP Study in Subjects With CRI
Official title: A Pilot Study Evaluating Once Every Other Week Administration of Fixed Doses of Novel Erythropoiesis Stimulating Protein (NESP) to Subjects With Chronic Renal Insufficiency (CRI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pre-Dialysis
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2007-09-10
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Multicenter, open-label, single-arm, fixed dose study of darbepoetin alfa in subjects with Chronic Renal Insufficiency (CRI). Subjects will be screened for 2 weeks during which time blood will be drawn and vital signs will be taken. Upon enrollment, subjects will receive SC darbepoetin alfa administered once every other week for 24 weeks. Darbepoetin alfa will be titrated in fixed-dose steps to maintain a hemoglobin of 11.0 - 13.0. During the study, laboratory assessments will be completed and vital signs will be taken. Subjects will enter a 1-week post-treatment observation and evaluation period after the last dose of study drug.


Eligibility criteria: Inclusion Criteria:

* Greater than or equal to 18 years of age
* CRI with a creatinine clearance of less than 40 mL/min
* Hemoglobin less than 11.0 g/dL
* Serum vitamin B12 and folate levels above the lower limit of normal and iron replete

Exclusion Criteria:

* Received rHuEPO therapy in the last 12 weeks
* Expected to initiate renal replacement therapy within 24 weeks or a recipient of a renal transplant
* Uncontrolled hypertension
* Seizure activity, CHF, hyperparathyroidism, major surgery, HIV-positive Pregnant or breast-feeding

Primary outcomes:
measure: To determine the effectiveness of fixed dose(s) of NESP, administered once every other week, in the treatment of anemia in subjects with CRI
timeFrame: entire study - 24 weeks
Secondary outcomes:
measure: To assess the safety and tolerability of chronic NESP therapy
timeFrame: entire study - 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Suranyi MG, Lindberg JS, Navarro J, Elias C, Brenner RM, Walker R. Treatment of anemia with darbepoetin alfa administered de novo once every other week in chronic kidney disease. Am J Nephrol. 2003 Mar-Apr;23(2):106-11. doi: 10.1159/000068041.
Clinical trial NCT00000329: Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-1 - 4
Official title: Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-1
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Heroin Dependence
Opioid-Related Disorders
Keywords: drug dependence
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the abuse liability and examine the reinforcing effects of intravenous buprenorphine and buprenorphine/naloxone combinations in buprenorphine-naloxone maintained volunteers

Detailed description: Ongoing study - results not available at this time

Eligibility criteria: Inclusion Criteria:

Individuals must be at least 18 yrs of age, currently opioid dependent and meet FDA criteria for narcotic maintenance treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency and have a history of IV opioid use.

Exclusion Criteria:

Individuals with evidence of anti active Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I psychiatric disorder (e.g. psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.

Primary outcomes:
measure: Subjective dose estimate
measure: Observed withdrawal rating
measure: Opioid agonist rating
measure: Opioid antagonist rating
measure: Pupil diameter
measure: Analog rating scale for drug effects
measure: Drug effect characteristics
measure: Drug/Money Preferences
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Leslie Amass, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05697029: Tetrandrine Tablets Used in Hospitalized Adults With COVID-19
Official title: Tetrandrine Tablets Used in Hospitalized Adults With COVID-19: a Double-blind, Placebo-controlled, Randomised Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: COVID-19
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 0
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: The primary objective of this study is to evaluate the effectiveness of tetrandrine tablets in preventing the progression of COVID-19 from severe to critical.

Detailed description: The primary objective of this study is to evaluate the effectiveness of tetrandrine tablets in preventing the progression of COVID-19 from severe to critical. The secondary objective is to evaluate the clinical indicators of COVID-19 with tetrandrine tablets treatment.

Eligibility criteria: Inclusion Criteria:

1. Sign informed consent form voluntarily for the trial.
2. Male or female aged between 18 and 85 years (inclusive).
3. Clinically or laboratory confirmed COVID-19 within the past 7 days, as determined by a positive RT-PCR test or a positive antigen test.
4. Under resting conditions, oxygen saturation ≤93% when breathing air, or P/F value ≤ 300 mmHg (1 mmHg = 0.133 kPa).
5. No birth plan and must agree to take effective contraceptive methods.

Exclusion Criteria:

1. Received a vaccine within 4 weeks prior to the study, or plan to receive a vaccine during the study period, or received treatment with tetrandrine tables prior to enrolling in the study.
2. Patient must be on invasive mechanical ventilation/ECMO at baseline.
3. Any clinically important serious diseases unstable or uncontrolled.
4. Allergy history to any biological or other agent.
5. Patient has severe mental or psychological abnormalities, cognitive impairment or intellectual disability before being diagnosed with COVID-19.
6. Subjects who are pregnant or breastfeeding, or plan to become pregnant during the study.
7. Investigator think the subject should not participate in the study.

Primary outcomes:
measure: Diagnosed with critical COVID-19 pneumonia
timeFrame: 84 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University 3rd Hospital
name: Yongchang Sun, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01833429: Autonomic Dysfunction in Resistant Hypertension
Official title: Circadian Autonomic Disturbances in Resistant Hypertension With and Without White-coat Phenomenon
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension, Resistant to Conventional Therapy
Keywords: Resistant hypertension
White-coat phenomenon
Heart rate variability
autonomic activity
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2013-04-16
Enrollment: 44
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: Forty-four resistant hypertension subjects, regularly followed up at the cardiovascular clinical pharmacology out-patients' clinic, and who complied with pharmacological prescription for hypertension, were recruited to participate in this transversal and observational study.

Brief summary: The contribution of this study is the unedited evaluation of the circadian autonomic profiles of resistant hypertension with and without white-coat response.

Detailed description: All patients were submitted to office blood pressure measurement, Ambulatory blood pressure monitoring and 24-hour Holter monitoring.

Baseline blood samples for the measurement of glycemia (mg/dL), total cholesterol (mg/dL), LDL cholesterol (mg/dL), triglycerides (mg/dL), creatinine (mg/dL), serum uric acid, serum sodium, serum potassium, plasma aldosterone concentration (PAC) and plasma renin activity (PRA) were collected at 08:00 after overnight fasting.

Eligibility criteria: Inclusion Criteria:

* resistant hypertensive patients

Exclusion Criteria:

* White-coat hypertension
* obstructive sleep apnea

Primary outcomes:
measure: evaluation of the autonomic function in resistant hypertensive patients
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Cardiovascular Pharmacology Laboratory
state: Sao Paulo
Study officials:
References:
citation: Calhoun DA, Jones D, Textor S, Goff DC, Murphy TP, Toto RD, White A, Cushman WC, White W, Sica D, Ferdinand K, Giles TD, Falkner B, Carey RM; American Heart Association Professional Education Committee. Resistant hypertension: diagnosis, evaluation, and treatment: a scientific statement from the American Heart Association Professional Education Committee of the Council for High Blood Pressure Research. Circulation. 2008 Jun 24;117(25):e510-26. doi: 10.1161/CIRCULATIONAHA.108.189141.
citation: Muxfeldt ES, Fiszman R, de Souza F, Viegas B, Oliveira FC, Salles GF. Appropriate time interval to repeat ambulatory blood pressure monitoring in patients with white-coat resistant hypertension. Hypertension. 2012 Feb;59(2):384-9. doi: 10.1161/HYPERTENSIONAHA.111.185405. Epub 2012 Jan 3.
Clinical trial NCT04593329: Efficacy and Safety of Tiradentes Association in the Treatment of Acute Pain
Official title: National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Tiradentes Association in the Treatment of Acute Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Acute Pain
Keywords: Acute Pain
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2020-10-20
Enrollment: 0
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of Tiradentes association in adolescents and adults with acute pain.


Eligibility criteria: Inclusion Criteria:

* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
* Participants of both sexes, aged 15 years or more;
* Participants who require extraction of impacted mandibular third molar;
* Third molar with bone impactions observed in panoramic radiography, with classification of Winter (1926) mesioangular or vertical, and classification according to Pell \& Gregory (1933) class II position B or class III position A or B;
* Participants with acute pain of moderate or severe intensity after completion of surgery.

Exclusion Criteria:

* Known hypersensitivity to the formula components used during the clinical trial;
* History of alcohol and/or substance abuse within 2 years;
* Participants whose surgery for molar extraction lasted more than 50 minutes;
* Participants with known gastroduodenal ulcers or diagnosis of persistent gastritis;
* Participants who used sedatives or hypnotic agents before surgery;
* Anesthesia technical failure or need for more than three anesthetic tubes;
* Participants with temporomandibular joint dysfunction or limited mouth opening;
* Surgical accident that, in the investigator's opinion, may interfere with the procedures or evaluations of the trial;
* Postoperative complications such as, but not restricted to: neuropraxia and paresthesia;
* Participants who used any medication that acts on the pain mechanism in the 3 days prior to the start of the trial;
* Participants under chronic opioid treatment.

Primary outcomes:
measure: Time-weighted Sum of Pain Intensity Difference Over 6 Hours (SPID0-6)
timeFrame: 0-6 hours
Secondary outcomes:
measure: Incidence and severity of adverse events recorded during the study.
timeFrame: 26 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00924729: Study of Ocular Penetration of Topically Administered Fluoroquinolones
Official title: Parallel-group Study of Ocular Penetration of Peri-operative Topically Administered Fluoroquinolones With Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract Extraction
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2009-06-19
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is being conducted to evaluate the intraocular penetration of Moxifloxacin 0.5% ophthalmic solution (Vigamox) and Besifloxacin 0.6% ophthalmic suspension (Besivance) after pre-operative topical administration in subjects undergoing cataract surgery.


Eligibility criteria: Inclusion Criteria:

* Subjects who have a visually significant cataract and are planning to have cataract surgery.
* Subjects who are willing/able and have signed informed consent approved by the Institutional Review Board.

Exclusion Criteria:

* Subjects who have a known hypersensitivity, allergy, or contraindication to any fluoroquinolone medication, in any form.
* Subjects who signs of ocular infection or active inflammation in the study eye.
* Subjects who have corneal pathology, including epithelial defect, corneal scarring, or severe dry eye syndrome.
* Subjects who have used any disallowed medication (including antibiotics) during the time period designated as described in the protocol.
* Subjects who have any active or chronic/recurrent ocular or systemic disease that is uncontrolled and is likely to increase the risk of infection to the patient or confound the results of the study.
* Subjects who are pregnant (or suspect to be pregnant) or nursing/lactating.
* Subjects who have participated in any study of an investigational drug or device within 30 days prior to enrollment.

Primary outcomes:
measure: Aqueous Humor Concentration of Study Drug
timeFrame: approximately 3 to 4 months
Secondary outcomes:
measure: Disk Diffusion Assay of Collected Aqueous Humor
timeFrame: Approximately 3-4 months.
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Wilmer Eye Institute at Johns Hopkins University
state: Maryland
Study officials:
affiliation: The Wilmer Eye Institute
name: Walter J. Stark, M.D.
role: PRINCIPAL_INVESTIGATOR
References: