louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05591430: Pulsed Radiofrequency of S2-4 Versus Ganglion Impar Neurolysis for Severe Perianal and Perineal Pain in Cancer Patients
Official title: Bilateral Pulsed Radiofrequency of Dorsal Root Ganglia of S2-4 Versus Ganglion Impar Neurolysis for Severe Perianal and Perineal Pain in Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2022-10-24
Enrollment: 40
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: Perineal pain resulting from malignancy is usually severe. Pain can be related to the malignancy or as a complication related to the treatment. several modalities are adopted to control such pain starting from medical management to interventional pain procedures.

Detailed description: Perineal pain resulting from malignancy is usually severe. Pain can be related to the malignancy or as a complication related to the treatment. several modalities are adopted to control such pain starting from medical management to interventional pain procedures. Ganglion impar block has been traditionally used for treatment of such perineal pain. Radiofrequency of sacral dorsal root ganglia can be used as an alternative for pain control.

Eligibility criteria: Inclusion Criteria:

* patients aged 18-75 years
* ASA II-III with perianal and perineal pain related to cancer

Exclusion Criteria:

* patient refusal
* coagulation defects
* abnormal kidney or liver functions
* local infection at site of injection

Primary outcomes:
measure: Visual analogue scale
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Walaa Y Elsabeeny
Study officials:
affiliation: Assistant professor of Anesthesia and Pain Management, National Cancer Institute, Cairo University
name: Walaa Y Elsabeeny, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01448330: A Bioequivalence Study Comparing Clopidogrel/Aspirin Combination Tablet With Coadministration of Clopidogrel and Aspirin
Official title: A Sequence-randomized, Open-label, Single Dose, Crossover Study to Evaluate Pharmacokinetics and Safety After Oral Administration of Clopidogrel and Aspirin in Free Combination and Fixed-dose Combination as HCP0911 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: clopidogrel
aspinin
combination
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2011-10-07
Enrollment: 64
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of clopidogrel and aspirin in free combination as HCP0911.


Eligibility criteria: Inclusion Criteria:

* Age between 20 and 55
* Signed informed consent

Exclusion Criteria:

* Has a history of hypersensitivity to IP ingredients
* Hypotension or hypertension
* Has a history of acute infection within 14days of screening

Primary outcomes:
measure: Cmax
timeFrame: 0-24 hrs
measure: AUC
timeFrame: 0-24 hrs
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung medical center
Study officials:
affiliation: Samsung Medical Center
name: Jae-wook Ko, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jung JA, Kim TE, Kim JR, Kim MJ, Huh W, Park KM, Lee SY, Ko JW. The pharmacokinetics and safety of a fixed-dose combination of acetylsalicylic acid and clopidogrel compared with the concurrent administration of acetylsalicylic acid and clopidogrel in healthy subjects: a randomized, open-label, 2-sequence, 2-period, single-dose crossover study. Clin Ther. 2013 Jul;35(7):985-94. doi: 10.1016/j.clinthera.2013.05.015.
Clinical trial NCT01716130: Acceptability of Fluzone Intradermal Vaccine to Patients and Vaccine Administrators
Official title: Acceptability of Fluzone Intradermal Vaccine to Patients and Vaccine Administrators
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Response to Fluzone ID Vaccine
Keywords: Fluzone Intradermal vaccine
Lead sponsor: Touro University, California
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2012-10-29
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

Brief summary: To assess the acceptance of the Fluzone Intradermal (ID)vaccine in adults and vaccine administrators in the United States. Patients completed 2 surveys, one immediately post-vaccination and one seven days later, that documented demographics and assessed their injection pain, injection anxiety, speed of injection, overall satisfaction, and preference for next year's vaccine. Vaccine administrators completed one survey assessing ease of vaccine preparation and administration, time required to administer, and safety/risk of needle stick injury for patient and administrator.

Detailed description: Patients were divided into two groups: 1) those that reported receiving the intramuscular (IM) influenza vaccine in the past 3 years; and 2) those that reported not receiving the IM influenza vaccine in the past 3 years. The survey responses were compared between the two groups. In addition, the subjects that reported receiving the IM vaccine in the past 3 years were asked to compare their experience with the IM vaccine versus the ID vaccine.

Eligibility criteria: Inclusion Criteria:Age 18 -64 years of age Desire to receive the Fluzone Intradermal vaccine to protect against influenza. -

Exclusion Criteria:Less than 18 years of age, or 65 years of age and older. Desire to receive the Fluzone Intramuscular vaccine to protect against influenza.

problems of the immune system, current illness, severe allergy to eggs, severe (life threatening) allergies, history of having Guillain-Barre Syndrome (a severe paralytic illness) or having received a flu vaccine in the past three months.

-

Primary outcomes:
measure: Overall patient satisfaction with intradermal vaccine
timeFrame: 7 days
Secondary outcomes:
measure: Overall satisfaction with the Fluzone ID vaccine by vaccine administrators
timeFrame: seven days
Other outcomes:
measure: Overall satisfaction with the Fluzone ID vaccine in two cohort groups
timeFrame: 7 days
Locations:
city: Vallejo
country: United States
facility: Touro University California
state: California
Study officials:
affiliation: Touro University, California
name: James E Foy, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02605330: Kinetics of Plasma Fibrinogen in Cardiac Surgery
Official title: Kinetics of Plasma Fibrinogen During Cardiac and Thoracic Aortic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibrinogens, Abnormal
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2015-11-16
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing cardiac surgery with extracorporeal bypass

Brief summary: The study intends to measure fibrinogen plasma levels during the first 24 hrs in cardiac and thoracic surgical patients who undergo surgical procedures using extracorporeal circulation.


Eligibility criteria: Inclusion Criteria:

* Elective patients undergoing coronary artery bypass grafting, aortic valve replacement or thoracic aortic surgery
* Signed written informed consent

Exclusion Criteria:

* Participation in another study
* Language barrier to understand study purposes (e.g. french as a native language)
* Preoperative low level of plasma fibrinogen (\< 1.75 g/l)
* Preoperative anemia (Hb \< 10g/dl)
* Emergency treatment
* Intake of anticoagulants other than aspirin within 14 days preceding surgery.
* Known coagulation disorder.
* Jehovah's witnesses

Primary outcomes:
measure: Plasma fibrinogen concentration
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Periprocedural thromboembolic complications
timeFrame: through study completion, an average of 1 year
measure: Thoracic drain loss
timeFrame: through study completion, an average of 1 year
measure: In-hospital mortality
timeFrame: through study completion, an average of 1 year
measure: Intensive Care Unit (ICU) length of stay
timeFrame: through study completion, an average of 1 year
measure: Platelet count
timeFrame: through study completion, an average of 1 year
measure: Prothrombin time (Quick)
timeFrame: through study completion, an average of 1 year
measure: Activated partial thromboplastin time (aPTT)
timeFrame: through study completion, an average of 1 year
measure: Thromboelastometric (ROTEM) parameters (e.g., INTEM, EXTEM, HEPTEM)
timeFrame: through study completion, an average of 1 year
measure: Thrombin concentration
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University Hospital Bern
Study officials:
affiliation: University of Bern
name: Gabor Erdoes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00777530: Study Evaluating Ascending Single-Dose Of Bosutinib Administered With Multiple Doses Of Ketoconazole To Healthy Subjects
Official title: Ascending Single-Dose Of The Safety, Tolerability, And Pharmacokinetics Of Bosutinib Administered Orally With Multiple Doses Of Ketoconazole To Healthy Adult Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Tumors
Leukemia
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2008-10-22
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to assess the safety and tolerability of ascending single oral doses of bosutinib administered with multiple doses of ketoconazole and to provide the pharmacokinetic profile of bosutinib when administered with multiple doses of ketoconazole and with food in healthy adult subjects.


Eligibility criteria: Inclusion criteria:

1. Men or women of nonchildbearing potential (WONCBP) aged 18 to 50 years inclusive on study day 1. WONCBP may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for ≥ 1 year (with follicle-stimulating hormone \[FSH\] ≥ 38 mIU/mL) and must have a negative serum pregnancy test result before administration of test article.
2. Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight ≥ 50 kg.
3. Healthy as determined by the investigator on the basis of screening evaluations.

Exclusion criteria:

1. Family history QT prolongation, syncope, seizure, or unexplained cardiac related death.
2. Presence or history of any disorder that may prevent the successful completion of the study.
3. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.

Primary outcomes:
measure: Safety based on adverse events monitoring, physical examinations, vital sign evaluations, 12-lead ECGs and routine laboratory tests.
timeFrame: 5 weeks
Secondary outcomes:
measure: Blood samples
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Abbas R, Leister C, El Gaaloul M, Chalon S, Sonnichsen D. Ascending single-dose study of the safety profile, tolerability, and pharmacokinetics of bosutinib coadministered with ketoconazole to healthy adult subjects. Clin Ther. 2012 Sep;34(9):2011-9.e1. doi: 10.1016/j.clinthera.2012.07.006. Epub 2012 Aug 9.
Clinical trial NCT04422730: Evolution of Body Connection After Surgery
Official title: Evolution of Body Connection and Identity Post-surgery: The Pancreas Cancer Case
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreas Cancer
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult people males and females

Brief summary: Evaluation of psychological impact of patients after pancreatectomy because of cancer diagnosis. Patients will be evaluated with questionnaires after and before intervention. 3 control groups will be used to compare de psychological impact.


Eligibility criteria: Inclusion Criteria:

* Patient is older than 18 years old
* With a good understanding and practice of the French language
* And depending on the group, experimental or control, presenting:

  * pancreatic cancer expected to be treated with pancreatectomy or planned to be treated with pancreatectomy excluding cancer or breast cancer scheduled to be treated with mastectomy or acute leukaemia at a recent diagnosis (21 days).
* No patient's opposition to the information provided
* Affiliated to the social security plan or beneficiary

Exclusion Criteria:

* Other medical or psychiatric condition,
* Level of cognitive efficiency incompatible with response to questions about himself,
* A person in an emergency situation, a person under legal protection or unable to express the non opposition to their participation to research.

Primary outcomes:
measure: comparaison of Scale of Body Connection score between 4 groups
timeFrame: 12 months
measure: comparaison of psychological interview between 4 groups
timeFrame: 12 months
measure: comparaison of Hospital Anxiety and Dépression score between 4 groups
timeFrame: 12 months
measure: comparaison of Test IES-R score between 4 groups
timeFrame: 12 months
measure: comparaison of quality of life score between 4 groups
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli-Calmettes
Study officials:
affiliation: Institut Paoli-Calmettes
name: Thérèse AURRAN, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00395330: Airways Dysfunction Following WTC Dust Exposure
Official title: Airways Dysfunction Following WTC Dust Exposure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Diseases
Keywords: Respiratory Function Tests
Oscillometry
World Trade Center Disaster
Environmental Exposure
Distal Airways
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2006-11-02
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: study will retrospectively review the charts of all patients referred to the pulmonary function laboratory for evaluation of symptoms following exposure to WTC dust.

Brief summary: In the weeks following the terrorist attacks of September 11, 2001, many patients presented to their physicians with complaints related to exposure to the debris. These included nose and throat complaints (drip, congestion, sore throat), increased GE reflux (heartburn, regurgitation, retrosternal chest burning) and respiratory symptoms (worsening cough, wheezing, shortness of breath, chest tightness, sleep disturbance). In addition, there was a disproportionate rate of self-reported worsening asthma symptoms in patients living in Lower New York 5-9 weeks after the attack; those with exposure to the dust cloud fared worse. The functional abnormalities of firefighters with exposures to dust at the WTC site has been recently described. However, the effects of WTC dust exposure on pulmonary function in residents and workers near the WTC site remain unclear. This study will retrospectively review the charts of all patients referred to the pulmonary function laboratory for evaluation of symptoms following exposure to WTC dust. The main objectives for this study will be to characterize the functional abnormalities in these subjects.


Eligibility criteria: Inclusion Criteria:

* age 18-80
* referral for pulmonary function evaluation of respiratory symptoms following exposure to WTC dust

Exclusion Criteria:

* inability to perform testing

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: NYU Langone Health
name: Kenneth I Berger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oppenheimer BW, Goldring RM, Herberg ME, Hofer IS, Reyfman PA, Liautaud S, Rom WN, Reibman J, Berger KI. Distal airway function in symptomatic subjects with normal spirometry following World Trade Center dust exposure. Chest. 2007 Oct;132(4):1275-82. doi: 10.1378/chest.07-0913. Epub 2007 Sep 21.
Clinical trial NCT05399030: A Phase I Randomized, Double-Blind, Placebo-Controlled, Parallel Group Clinical Study of ICP-332 in Healthy Subjects
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Single and Multiple Ascending Dose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ICP-332 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-06-01
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: This is a randomized, double-blind, placebo-controlled, parallel group, single and multiple ascending dose phase I study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ICP-332 in Healthy Subjects


Eligibility criteria: Inclusion Criteria:

1. Body mass index (BMI) between 18-26 kg/m2, the weight of male subject should not be less than 50 kg, and the weight of female subject should not be less than 45 kg.
2. Age and fertility status

   1. Male or infertile female subjects who are between 18-45 years old (inclusive).
   2. Female subjects who are infertile.
   3. Male subjects and their partners must agree to use effective contraception.

Exclusion Criteria:

1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic and other diseases, or allergic diseases.
2. Subjects with clinically significant gastrointestinal dysfunction that may affect drug intake, transport or absorption.
3. Acute disease state (such as nausea, vomiting, pyrexia or diarrhea, etc.) within 14 days before administration.
4. Other situations judged by the investigator to be unsuitable to join this trial.

Primary outcomes:
measure: Number of participants with Treatment-Emergent Adverse Events (AEs).
timeFrame: Baseline up to 28 days after last dose.
Secondary outcomes:
measure: Change from baseline in Maximum concentration (Cmax)
timeFrame: Single ascending dose: baseline up to 72 hours; post-dose multiple ascending dose: baseline to Day 14.
measure: Change from baseline in blood cells.
timeFrame: Multiple ascending dose: Baseline to 28 days.
Other outcomes:
Locations:
city: Jinan
country: China
facility: Jinan Central Hospital
Study officials:
affiliation: Jinan Central Hospital
name: Qing Wen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01423630: Supplementation of Probiotics and Fruit Fibre to Patients With Fatty Liver
Official title: Supplementation of Probiotics and Fruit Fibre to Patients With Fatty Liver
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fatty Liver
Keywords: fatty liver
probiotics
Lactobacillus
fruit
fibre
dietary intervention
obesity
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
First posted: 2011-08-26
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Probiotics and fruit fibre are given for 12 weeks to patients with fatty liver disease.

The hypothesis is that probiotic bacteria and fruit fibre affect the gut microbial composition in a positive manner. The improved ecological system is believed to contribute to improved liver health and thereby counteract fatty liver disease.


Eligibility criteria: Inclusion Criteria:

* be able to participate in magnetic resonance imaging

Exclusion Criteria:

* unable to understand oral and written information

Primary outcomes:
measure: Improved and normalized liver status
timeFrame: after 12 weeks intervention
Secondary outcomes:
measure: Changes in the gut bacterial flora
timeFrame: after 12 weeks intervention
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Skåne University Hospital
Study officials:
References: