louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01651871: Combination Study Of S-555739/Cetirizine HCl In Adult Patients With Seasonal Allergic Rhinitis
Official title: A Phase 2, Multicenter, Parallel-Group, Randomized, Double-Blind, Placebo- And Active Comparator-Controlled, Combination Study Of S-555739 And Cetirizine HCl In Adult Patients With Seasonal Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Seasonal Allergic Rhinitis
Keywords: Agents, anti allergic
Nasal congestion
Sneezing
Nasal discharge
D prostanoid (DP) receptor antagonist
Lead sponsor: Shionogi Inc.
Sponsor class: INDUSTRY
First posted: 2012-07-27
Enrollment: 779
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study was to examine the efficacy and safety of S-555739/cetirizine HCl compared with the individual components and placebo.


Eligibility criteria: Inclusion Criteria:

* History and diagnosis of seasonal allergic rhinitis by skin prick test
* Have nasal symptom scores as defined by the study protocol
* Able to comply with study procedures

Exclusion Criteria:

* Any nasal disease or abnormality, active respiratory tract infections within the past 2 weeks, or recent nasal surgery or sinus surgery at Screening
* Use of any prohibited concomitant drugs or therapies

Primary outcomes:
measure: Change in average morning/evening (AM/PM) reflective Total Nasal Symptom Score (rTNSS)
timeFrame: Change from baseline through the 2-week treatment period (Day 2 through Day 15)
measure: Incidence of adverse events (AEs)
timeFrame: From Screening period to Week 6 (Follow-up)
Secondary outcomes:
measure: Change in average AM/PM instantaneous Total Nasal Symptom Score (iTNSS)
timeFrame: Change from baseline through the 2-week treatment period (Day 2 through Day 15)
measure: Change in average AM/PM Total Ocular Symptom Score
timeFrame: Change from baseline through the 2-week treatment period (Day 2 through Day 15)
measure: Assessment of Quality of Life
timeFrame: Change from Week 3 to Week 5
measure: Assessment of vital signs
timeFrame: At Week 1 (Screening), Week 2, Week 3, Week 4, and Week 5
measure: Assessment of clinical laboratory parameters
timeFrame: At Week 1 (Screening), Week 4, Week 5, and Week 6 (Follow-up)
measure: Assessment of electrocardiogram (ECG) findings
timeFrame: At Week 1 (Screening) and Week 5
Other outcomes:
Locations:
Study officials:
affiliation: Shionogi
name: Shionogi Clinical Trials Administrator Clinical Support Help Line
role: STUDY_DIRECTOR
References:
Clinical trial NCT05892471: Safety and Effectiveness of Ciprofol in Cardiac Surgery Anesthesia
Official title: Safety and Effectiveness of Ciprofol in Cardiac Surgery Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Lead sponsor: Shanghai East Hospital of Tongji University
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 80
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Ciprofol, a novel intravenous general anesthetic with a chemical structure akin to propofol, boasts significantly enhanced potency. It offers a rapid onset, reduced incidence of injection pain, and minor impact on the cardiovascular system. However, clinical research regarding ciprofol's use for anesthesia induction in cardiac surgery remains limited. The investigators want to assesse the safety and effectiveness of ciprofol in cardiac surgery anesthesia


Eligibility criteria: Inclusion Criteria:

1. Elective surgery patients
2. Aged 55 to 75
3. New York Heart Association class II or III cardiac functions
4. Median sternotomy approach for coronary artery bypass grafting or heart valve replacement procedures.

Exclusion Criteria:

1. With a history of benzodiazepine allergy
2. Significant liver or kidney insufficiency
3. Coagulation dysfunction
4. Neurological or psychiatric disorders
5. Undergone major surgery within the past three months.

Primary outcomes:
measure: Mean arterial pressure
timeFrame: 1 second before induction of anesthesia (T1)
measure: Mean arterial pressure
timeFrame: 1 second before tracheal intubation (T2)
measure: Mean arterial pressure
timeFrame: 1 minute after tracheal intubation (T3)
measure: Mean arterial pressure
timeFrame: 5 minutes after tracheal intubation (T4)
measure: Heart beats
timeFrame: 1 second before induction of anesthesia (T1)
measure: Heart beats
timeFrame: 1 second before tracheal intubation (T2)
measure: Heart beats
timeFrame: 1 minute after tracheal intubation (T3)
measure: Heart beats
timeFrame: 5 minutes after tracheal intubation (T4).
Secondary outcomes:
measure: Oxygenation index
timeFrame: 1 second before induction of anesthesia (T1)
measure: Oxygenation index
timeFrame: 10 minutes after tracheal intubation (T5).
measure: Injection pain
timeFrame: During procedure (When injecting the drug, ask the subject if the injection site is painful)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai East Hospital of Tongji University
state: Shanghai
Study officials:
affiliation: Shanghai East Hospital of Tongji University
name: Handong Sun
role: STUDY_DIRECTOR
References:
Clinical trial NCT04960371: Effects of Anxiety on Coronary Microcirculatory Function in Hypertensive Patients
Official title: Effects of Anxiety on Coronary Microcirculatory Function in Hypertensive Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Microvascular Disease
Anxiety State
Keywords: anxiety
coronary microcirculatory function
hypertension
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The hypertensive patients with chest pain for suspicious coronary heart disease (CHD) in Peking University Third Hospital were seriesly enrolled. All the patients underwent coronary angiography or coronary CT angiography to exclude the diagnosis of OCAD.

Brief summary: This study assessed anxiety status and coronary flow reserve in hypertensive patients to investigate the effects of anxiety on coronary microcirculatory function.

Detailed description: This study assessed anxiety status and coronary flow reserve in hypertensive patients to investigate the effects of anxiety on coronary microcirculatory function.The hypertensive patients with chest pain for suspicious coronary heart disease were seriesly enrolled. All the patients underwent coronary angiography or coronary CT angiography to exclude the diagnosis of obstructive coronary artery disease . Coronary flow reserve (CFR) is an integrated measure of flow through both the large epicardial arteries and the coronary microcirculation. In the absence of obstructive stenosis of the epicardial arteries, CFR is an indicator of coronary microcirculatory function，which can be assayed by Transthoracic Doppler echocardiography. The symptoms of anxiety were measured with Self-rating Anxiety Scale (SAS) . According to the SAS score,the patients were divided into anxiety group and non-anxiety group.We assessed the association of anxiety with coronary microcirculatory function.

Eligibility criteria: Inclusion Criteria:

1. Patients with clear diagnosis of hypertension (≥1 year, drug control within 140/90mmHg); (2) Significant coronary artery stenosis was excluded by imaging within 1 year (≤50%); (3) Age between 18 and 80.

Exclusion Criteria:

1. CHD, heart valve disease, congenital heart disease, cardiomyopathy and pericardial disease; (2) Left ventricular ejection fraction (LVEF) \<50%; (3) Increased markers of myocardial injury; (4) Diabetes mellitus, connective tissue disease, chronic obstructive pulmonary disease and malignant tumor; 5) Severe hepatic and renal impairment (Cr ≥120 umol/L, ALT ≥120 umol/L); 6) Pregnant women.

Primary outcomes:
measure: Coronary flow reserve
timeFrame: baseline
Secondary outcomes:
measure: Inflammatory mediators
timeFrame: baseline
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Lijun Guo
role: STUDY_DIRECTOR
References:
Clinical trial NCT01931371: Anal Fistula Plug Versus Endorectal Advancement Flap
Official title: An Outcome and Cost Analysis of Anal Fistula Plug Versus Endorectal Advancement Flap in Complex Anal Fistulae
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anal Fistula
Keywords: fistula in ano
anal fistula
recurrence
costs
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2013-08-29
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether anal fistula plug or endorectal advancement flap is more successful in the treatment of anal fistulas and compared both procedures with regards to cost.

Detailed description: A detailed analysis will be performed to determine independent predicting factors of recurrence and of higher costs.

Eligibility criteria: Inclusion Criteria:

* Adults (18 years of age or more)
* Single anal fistula
* Surgically treated with anal fistula plug or endorectal advancement flap

Exclusion Criteria:

* Children or adolescents
* Pregnancy
* Patients treated with setons alone

Primary outcomes:
measure: Anal fistula recurrence rate
timeFrame: One year
Secondary outcomes:
measure: Cost
timeFrame: 3 days
measure: Complication rate
timeFrame: 3 days
measure: Length of hospital stay
timeFrame: 3 days
measure: Independent factors predicting fistula recurrence
timeFrame: One year
measure: Independent factors predicting higher costs
timeFrame: One year
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University of Zurich
name: Oliver M Fisher, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Zurich
name: Antonio Nocito, MD
role: STUDY_CHAIR
References:
citation: Adamina M, Hoch JS, Burnstein MJ. To plug or not to plug: a cost-effectiveness analysis for complex anal fistula. Surgery. 2010 Jan;147(1):72-8. doi: 10.1016/j.surg.2009.05.018. Epub 2009 Sep 6.
citation: Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.
Clinical trial NCT00302471: MK0429 Study in Prostate Cancer Patients With Metastatic Bone Disease (0429-011)
Official title: A Phase I, Randomized, Multicenter, Double-Blind Study of MK0429 in the Treatment of Men With Hormone Refractory Prostate Cancer and Metastatic Bone Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostatic Neoplasms
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-03-14
Enrollment: 29
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This two part study will evaluate the safety and tolerability of MK0429 in addition to assessing it's pharmacokinetic profile and pharmacodynamic response.


Eligibility criteria: Inclusion Criteria:

* Eligible patients must have:

  * Prostate cancer
  * Bone metastases without symptoms
  * Lack of response to hormone therapy as evidenced by a rising PSA or clinical progression

Exclusion Criteria:

* Prostate cancer-related bone pain
* Previously received bisphosphonate therapy (e.g. zoledronate)
* Received any investigational treatment within the last 30 days

Primary outcomes:
measure: Safety and tolerability of 4 weeks of MK0429 therapy.
timeFrame: up to 14 days following last dose of medication
Secondary outcomes:
measure: Part 1: Pharmacokinetic profile of MK0429 and pharmacodynamic responses to treatment of MK0429
timeFrame: 4 weeks
measure: Part 2: Pharmacokinetic profile of MK0429 [Time frame 4 weeks] and pharmacodynamic responses to treatment of MK0429 [Time frame 8 weeks]
timeFrame: 4 weeks and 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Rosenthal MA, Davidson P, Rolland F, Campone M, Xue L, Han TH, Mehta A, Berd Y, He W, Lombardi A. Evaluation of the safety, pharmacokinetics and treatment effects of an alpha(nu)beta(3) integrin inhibitor on bone turnover and disease activity in men with hormone-refractory prostate cancer and bone metastases. Asia Pac J Clin Oncol. 2010 Mar;6(1):42-8. doi: 10.1111/j.1743-7563.2009.01266.x.
Clinical trial NCT04361071: Clinical Study of Stent Versus Direct Atherectomy to Treat Iliac Artery Occlusive Diseases
Official title: Clinical Study of Stent Versus Direct Atherectomy to Treat Iliac Artery Occlusive Diseases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Iliac Artery Occlusion
Keywords: stent
atherectomy
iliac Artery
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized study comparing stent and plaque excision systems in treatment of Iliac artery occlusive disease.

Detailed description: This is a randomized study comparing stent and plaque excision systems in treatment of Iliac artery occlusive disease

Eligibility criteria: Inclusion Criteria:

1. The patients have non thrombotic arteriosclerosis obliterans of the common iliac or external iliac arteries
2. Clinical diagnosis of stenosis or occlusive disease
3. The patients have unobstructed distal outflow tract
4. Receiving surgical treatment at the same time

Exclusion Criteria:

1. The patients who have previously implanted stent(s) or stent graft(s) in target leg
2. Life expectancy less than 12 months
3. Has any planned surgical or endovascular intervention of target vessel 30 days before or after index procedure
4. Thrombophlebitis, uremia, or deep venous thrombus, within past 30 days
5. Receiving dialysis or immunosuppressant therapy
6. Recent stroke within past 90 days
7. Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix®) or ticlopidine (Ticlid®), heparin, Nitinol (nickel titanium), contrast agent, that cannot be medically managed
8. Tissue loss due to ischemic disease (Rutherford/Becker category 5 or 6)
9. Serum creatinine level \>/= 2.5 mg/dl at time of screening visit
10. Known or suspected active infection at the time of the procedure
11. Bleeding diathesis
12. Patient is unwilling or unable to comply with procedures specified in the protocol or has difficulty or inability to return for follow-up visits as specified by the protocol.
13. Patients are known to be pregnant, incarcerated, mentally incompetent, and/or alcohol or drug abuser.
14. Patients are currently participating in any other investigational drug or medical device study that has not completed primary endpoint(s) evaluation or clinically interferes with the endpoints from this study or future participation in such studies prior to the completion of this study.

Primary outcomes:
measure: 12-month Primary Patency Rate
timeFrame: 12 months
measure: 12-month Limb Salvage Rate
timeFrame: 12 months
Secondary outcomes:
measure: Index Limb Ischemia at 6-month Follow up
timeFrame: 6 months
measure: Index Limb Ischemia at 12-month Follow up
timeFrame: 12 months
measure: Major Adverse Events at 12-month Post Procedure
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Yongquan Gu
state: Beijing
Study officials:
References:
Clinical trial NCT02370771: Proteomic Analysis in Sera From Patients With Erosive Hand Osteoarthritis
Official title: Proteomic Analysis in Sera From Patients With Erosive Hand Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erosive Hand Osteoarthritis
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2015-02-25
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Hand osteoarthritis is a common phenotype of osteoarthritis which affects about 70 % of the elderly population. Usually considered as a minor illness, it nevertheless leads to an important functional impairment. The mechanism of this disease is still poorly known. Furthermore there are 2 different subtypes : erosive and non erosive hand osteoarthritis from which mechanisms may differ.

Methods:

This is a cross-sectional study recruiting patients with hand osteoarthritis addressed in consultation of rheumatology and plastic surgery in Rouen University Hospital.

Two groups of patients will be studied: 20 patients with non erosive subtype of hand osteoarthritis and 20 patients with erosive subtype of hand osteoarthritis.

A clinical evaluation of hand osteoarthritis will be performed. Blood sample for proteomic analysis will be taken. Hand MRI and Bone Mineral Analyser will be performed.


Eligibility criteria: Inclusion Criteria:

* Female gender
* Less than 70 years old
* Diagnosis of hand osteoarthritis according to ACR criteria ACR after exclusion of thumb base osteoarthritis:

  1. Hand pain, aching or stiffness most of the days during the preceding month
  2. Hard tissue enlargement of at least two of 8 selected joints \*
  3. Hard tissue enlargement of at least two distal interphalangeal joint
  4. Swelling of fewer than three metacarpophalangeal joint
  5. Deformity of at least one of 10 selected joints \* Patients have to fulfil criteria 1, 2 AND 3 + 4 OR 5 \* the 8 selected joints are the second and third distal interphalangeal joint and the second and third proximal interphalangeal of both hands Then confirm by experts' committee
* Exclusively symptomatic treatment
* For women of child-bearing age, use of an effective contraceptive method
* French spoken and read

Exclusion Criteria:

* Male gender
* More than 70 years old
* Hemochromatosis
* Inflammatory arthritis
* Cristal induced arthritis
* Active diseases such as infection or cancer
* Use of DMARDs
* Pregnant or breast-feeding woman

Primary outcomes:
measure: Quantification by label-free proteomic analysis of the serum of patients affected by hand osteoarthritis
timeFrame: day 1
Secondary outcomes:
measure: Number of Erosion in patients affected by hand osteoarthritis
timeFrame: Day 1
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: UH Rouen
name: Gilles AVENEL, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01677871: Efficacy and Safety of Modified Anti-tubercular Regimens in Treatment of Tuberculosis in Patients With Underlying Compensated and Decompensated Chronic Liver Disease
Official title: Study of Efficacy and Safety of Modified Anti-tubercular Regimens in Treatment of Tuberculosis in Patients With Underlying Compensated and Decompensated Chronic Liver Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Liver Disease With Tuberclosis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2012-09-03
Enrollment: 120
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: During the Study:

* Subject is required to visit every week for the first 2 months and then every month till completion of study or as and when required
* The usual symptomatic and supportive treatment of Chronic Liver Disease, including use of antiviral, will be given to all patients.
* Effort will be made to avoid use of other hepatotoxic drug(s) during Anti-Tubercular Treatment.
* Liver function tests (LFT) will be done weekly during first 2 months then at one month interval or as when required.
* The treatment efficacy of Anti-Tubercular Treatment (ATT) will be made on the basis of clinical, biochemical, microbiological and imaging parameters at months 2, 4, 7 and 9. Patients not improving at 4 weeks after initiation of treatment will be shifted to alternative regimens and will be excluded from the study.


Eligibility criteria: Inclusion Criteria:

* Males or Females subjects aged 18-75 years.
* Subjects with chronic liver disease (cirrhosis)
* Pulmonary or extra-pulmonary tuberculosis.
* Serum ALT≤5times upper limit and serum bilirubin ≤3 mg/dl.
* consent and willingness to follow-up

Exclusion Criteria:

* Serum ALT\>5times upper limit and serum bilirubin \>3 mg/dl.
* Renal failure (serum creatinine\>2mg/dl).
* Presence of hepatocellular carcinoma
* Alcoholic cirrhotic who continue to drink alcohol.
* Prior history of ATT (ANTI TUBERCULAR TREATMENT) with documented hepatotoxicity.
* Known hypersensitivity to levofloxacin, other quinolones

Primary outcomes:
measure: Successful completion of modified ATT (ANTI TUBERCULAR TREATMENT) regimen.
timeFrame: 6 and 9 months
Secondary outcomes:
measure: Worsening of CTP (CHILD TURCOTTE PUGH) score to ≥10 for patients with compensated cirrhosis,
timeFrame: 6 and 9 months
measure: Failure to re-institute the assigned ATT (ANTI TUBERCULAR TREATMENT) regimen after development of an episode of hepatotoxicity. (I.e. second episode of hepatotoxicity.
measure: Survival
timeFrame: 6 and 9 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
state: Delhi
Study officials:
affiliation: Institute of Liver and Biliary Sciences
name: Dr Naveen Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References: