louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00486369: SMC021A - Absorption, Efficacy and Tolerance in Patients With Osteoarthritis. A Placebo-Controlled 14-Days Study
Official title: SMC021A - Absorption, Efficacy and Tolerance in Patients With Osteoarthritis. A Placebo-Controlled 14-Days Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoarthritis
Keywords: Osteoarthritis, oral salmon calcitonin, tolerability, biomarkers
Lead sponsor: Nordic Bioscience A/S
Sponsor class: INDUSTRY
Collaborators: name: Novartis
First posted: 2007-06-14
Sex: ALL
Minimum age (years): 52
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to expose patients with OA to calcitonin and to determine plasma calcitonin levels after administration of 0.6 mg and 0.8 mg oral calcitonin. Also the purpose is to assess the effect of different doses of oral calcitonin (0.6 mg and 0.8 mg oral) compared to placebo on serum CTX-I and CTX-II. Finally to assess the tolerance profile of different doses/formulations of oral calcitonin compared to placebo.


Eligibility criteria: Inclusion Criteria:

* Medical history and symptoms of knee osteoarthritis

Exclusion Criteria:

* Any other disease or medication affecting the bone or cartilage.
* Any clinical signs or laboratory evidence diseases, which in the Investigator's opinion would preclude the participant from adhering to the Protocol or completing the trial.

Primary outcomes:
Secondary outcomes:
measure: Changes in Urine CTX-I and CTX-II
measure: Changes in serum osteocalcin and serum CTX-I
measure: Number of adverse events
Other outcomes:
Locations:
city: Ballerup
country: Denmark
facility: CCBR A/S
Study officials:
affiliation: Nordic Bioscience A/S
name: Bente J Riis, M.D.
role: STUDY_CHAIR
References:
citation: Karsdal MA, Byrjalsen I, Bay-Jensen AC, Henriksen K, Riis BJ, Christiansen C. Biochemical markers identify influences on bone and cartilage degradation in osteoarthritis--the effect of sex, Kellgren-Lawrence (KL) score, body mass index (BMI), oral salmon calcitonin (sCT) treatment and diurnal variation. BMC Musculoskelet Disord. 2010 Jun 17;11:125. doi: 10.1186/1471-2474-11-125.
citation: Karsdal MA, Byrjalsen I, Henriksen K, Riis BJ, Lau EM, Arnold M, Christiansen C. The effect of oral salmon calcitonin delivered with 5-CNAC on bone and cartilage degradation in osteoarthritic patients: a 14-day randomized study. Osteoarthritis Cartilage. 2010 Feb;18(2):150-9. doi: 10.1016/j.joca.2009.08.004. Epub 2009 Sep 1.
Clinical trial NCT02290769: Time of Cannulation During Primary ERCP With Short Guide Wire Rapid Exchange or With Long Guide Wire
Official title: Evaluation of the Cannulation Time During Primary ERCP With Short Guide Wire Rapid Exchange or With Long Guide Wire. Multicentre Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Pancreatitis
Keywords: Guide wire cannulation ERCP
Time of cannulation
Rapid exchange guide wire
Guide wire
Lead sponsor: Niguarda Hospital
Sponsor class: OTHER
First posted: 2014-11-14
Enrollment: 292
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 aim of this study is to compare the cannulation time during primary wire guided ERCP (Endoscopic Retrograde Cholangio-Pancreatography) according to two different length of guide wire: long wire or short wire rapid exchange, artery by a prospective randomized trial.

Detailed description: In primary Endoscopic Retrograde Cholangio-Pancreatography (ERCP) cannulation is wire guided. Up to now there is no doubt about the efficacy of such a procedure. The use of long wire requires the help of another person behind primary operator. The use of short wire rapid exchange allows the primary operator to perform all the steps by himself. Time of cannulation is known to be directly associated to post ERCP pancreatitis.

Aim of the study is to assess which length of guide wire allows the shorter cannulation time during primary ERCP. Post ERCP pancreatitis onset will be assessed for all patients

Eligibility criteria: Inclusion Criteria:

* indication to primary ERCP
* ASA (American Society of Anesthesiologists) 1, 2, 3

Exclusion Criteria:

* pancreas neoplasia
* pancreatitis
* ampulloma
* duodenum stenosis
* under mucous membrane haematoma

Primary outcomes:
measure: Time of cannulation
timeFrame: 8 hours from intervention
Secondary outcomes:
measure: Incidence of post ERCP pancreatitis
timeFrame: 8 hours post ERCP
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Niguarda Hospital
Study officials:
affiliation: Niguarda Ca' Granda Hospital
name: Francesco Pugliese, MD
role: STUDY_CHAIR
affiliation: Niguarda Ca' Granda Hospital
name: Edoardo Forti, MD
role: STUDY_CHAIR
affiliation: Niguarda Ca' Granda Hospital
name: Raffaele Manta, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01124669: Biomarkers in Blood Samples From Patients With Refractory Non-Small Cell Lung Cancer Previously Treated With Sorafenib Tosylate
Official title: BRAF, KRAS and EGFR Mutation Detection in Non-Small Cell Lung Cancer Patients Treated With Sorafenib Monotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-05-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples submitted for research from patients enrolled on E2501

Brief summary: RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in blood samples from patients with refractory non-small cell lung cancer previously treated with sorafenib tosylate.

Detailed description: OBJECTIVES:

* To determine the mutation rates of BRAF, KRAS, and EGFR in patients with non-small cell lung cancer treated with sorafenib tosylate on protocol ECOG-2501.
* To determine the association between BRAF, KRAS, or EGFR mutation status and clinical benefits in patients treated with this regimen.

OUTLINE: This is a multicenter study.

DNA is isolated from archived plasma samples and analyzed for BRAF, KRAS, and EGFR mutations.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of refractory non-small cell lung cancer
* Received sorafenib tosylate on protocol ECOG-E2501
* Available blood specimens

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Mutation rate of sorafenib tosylate-target gene BRAF, and its upstream proteins KRAS and EGFR
timeFrame: 1 mont
measure: Association between BRAF, KRAS, and EGFR mutation status and clinical benefits (stable disease or partial response)
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Christine Chung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03742869: HPV Integration and Tumorigenesis of Uterine Cervical Adenocarcinoma
Official title: A Multi-omics Study on the Human Papillomavirus Integration and Tumorigenesis of Uterine Cervical Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Adenocarcinoma
Human Papillomavirus
Genome-wide Association Study
Whole Exome Sequencing
Transcriptome
Metabolome
Tumorigenesis
Prognosis
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2018-11-15
Enrollment: 40
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients confirmed primary adenocarcinoma of the uterine cervix

Brief summary: This study aims to analyze the multi-omics results between uterine cervical adenocarcinoma patients with and without human papillomavirus (HPV) infections. The multi-omics profiles include genome wide association study (GWAS), whole exome sequencing, analysis of transcriptomics and metabolomics. The HPV integration status is interpreted by GWAS. A comprehensive multi-omics will reveal the role of HPV integration in the molecular mechanism of tumorigenesis and prognosis of uterine cervical adenocarcinoma.


Eligibility criteria: Inclusion Criteria:

* Confirmed primary adenocarcinoma of the uterine cervix
* Signed an approved informed consents
* Feasible for biopsy

Exclusion Criteria:

* Not meeting all of the inclusion criteria

Primary outcomes:
measure: Frequencies of somatic driving mutations
timeFrame: Two years
Secondary outcomes:
measure: Frequencies of alteration of RNA expression
timeFrame: Two years
measure: Frequencies of alteration of protein expression and signal pathway
timeFrame: Two years
measure: Progression-free survival
timeFrame: Five years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03105869: Repeatability of Positron Emission Tomography (TEP) With fluorométhyl-(18F)-diméthyl-2-hydroxyéthyl-ammonium
Official title: Repeatability of Positron Emission Tomography (TEP) With fluorométhyl-(18F)-diméthyl-2-hydroxyéthyl-ammonium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: repeatability
positron emission tomography (PET)
fluorocholine
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2017-04-10
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: test and retest in a single group of patient
Primary purpose: DIAGNOSTIC

Brief summary: Monocentric study. Objective : Determination of the repeatability of fluorocholine PET/CT in prostate cancer

Detailed description: A second PET/CT with fluorocholine is performed within 2 weeks after a first examination performed in patient referred for an initial prostate cancer or a biological suspicion of relapse.

Eligibility criteria: Inclusion criteria :

* biological suspicion of relapse of prostate cancer or initial staging of prostate cancer
* positive PET/CT with fluororocholine

Exclusion criteria :

-none

Primary outcomes:
measure: reproducibility of the results
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CHU Poitiers
name: Catherine CHEZE LE REST
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06190769: Prevalence Of Musculoskeletal Disorders Among Monks And Nuns In Egypt
Official title: Prevalence Of Musculoskeletal Disorders Among Monks And Nuns In Egypt
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Musculoskeletal Disorders
Prevalence
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 400
Sex: ALL
Minimum age (years): 24
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: both genders (monks and nuns) randomly selected from different monasteries

Brief summary: 1. Sample size will be 400.
2. Age starts from 24 years old and more.
3. Body mass index ( BMI ) between 18.5 to 24.9 kg/m2
4. Years of ordination

   * (1-3) years novice or probationary
   * (4-10) years of monasticism.
   * more than 10 years of monasticism.
5. Samples will be selected from several monasteries in Egypt.
6. All data collected by Arabic version of Nordic questionnaire.

Detailed description: Study design: Observation study - cross-sectional survey.

Participants: sample size of monks will be 400 subjects of both genders (monks and nuns) randomly selected from different monasteries, Participants aged from 24 years old and above thought monastic years. As:

* (1-3) years novice or probationary
* (4-10) years of monasticism
* more than 10 years of monasticism

Eligibility criteria: Inclusion Criteria:

1. Both genders will include in study.
2. Monks and nuns work in different works administration.
3. Age starts from 24 years old and more.
4. Body mass index (BMI) between 18.5 to 24.9 kg/m2

Exclusion Criteria:

1. Monk or nun had musculoskeletal abnormalities due to causes (congenital or traumatic).
2. Monk or nun with previous operation involving locomotor system.
3. Outside body mass index range.

Primary outcomes:
measure: correlation between the daily life of monks and musculoskeletal disorders by Nordic Musculoskeletal Questionnaire
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: supervisor of research
name: Mohamed H EL Gendy, professor
role: STUDY_DIRECTOR
References:
citation: Vieira ER, Schneider P, Guidera C, Gadotti IC, Brunt D. Work-related musculoskeletal disorders among physical therapists: A systematic review. J Back Musculoskelet Rehabil. 2016 Aug 10;29(3):417-28. doi: 10.3233/BMR-150649.
Clinical trial NCT04537169: Clinical Significance of Whitnall Ligament Structure
Official title: Clinical Significance of Whitnall Ligament Structure in Patients With Congenital Ptosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congenital Ptosis
Keywords: Whitnall ligament
congenital ptosis
levator resection
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2020-09-03
Enrollment: 45
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with congenital ptosis

Brief summary: Prospective clincal study to relate the structure of Whitnall ligament in cases of congenital ptosis to the severety of ptosis and the postoperative results.

Detailed description: The study will be a prospective obsevational study. It will include patients (2-16 years old) who will undergo levator resection for simple congenital ptosis correction in Ophthalmology Department of Menoufia University Hospital.

Patients will be divided into 3 groups, 15 patients in each. Group I for mild ptosis, Group II for moderate ptosis Group 3 for severe ptosis.

Exclusion criteria included any patients with previous ptosis or any eyelid surgery and patients with a non congenital ptosis.

Patients included in the study well be informed about the research and the surgical maneuver which will be used with full discussion of all details regarding the postoperative follow up and the potential complications. A written consent in Arabic will then be taken from the parents of the patients

Preoperative assessment will include Complete ophthalmological examination including; Margin to Reflex Distance 1 (MRD1), Vertical Fissure Height (VFH), Levator function (LF), and eyelid crease shape and position.

Intraoperative assessment will include Whitnall ligament structure assessment including:

* The level (the length from the insertion of the levator aponeurosis to Whitnall's ligament)
* Shape (definite band-like, weak string, undifferentiated)
* Tightness.

Postoperative assessment will be on scheduled visits at first week, one month, 3 months and 6 months postoperatively and will include MRD1, VFH, LF, and lagophthalmos measurements

Results will be documented and tabulated and statistically managed.

Eligibility criteria: Inclusion Criteria:

* Congenital ptosis

Exclusion Criteria:

* Previous ptosis surgery
* Non congenital ptosis

Primary outcomes:
measure: Success of levator resection in relation to structure of Whitnall ligament
timeFrame: An average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Ophthalmology Department, Menoufia University Hospital
state: Menoufia
Study officials:
affiliation: Department of Ophthalmology, Cullen Eye Institute,
name: Richard C Allen
role: STUDY_CHAIR
References:
Clinical trial NCT00802269: Pain Using Reduced Fluence Parameters in Photocoagulation for Diabetic Retinopathy.
Official title: Pain Using Reduced Fluence Parameters in Photocoagulation for Diabetic Retinopathy.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Proliferative Diabetic Retinopathy
Keywords: Proliferative diabetic retinopathy
Laser photocoagulation
Pain
Lead sponsor: Asociación para Evitar la Ceguera en México
Sponsor class: OTHER
First posted: 2008-12-04
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The used of reduced fluence parameters for panretinal photocoagulation decreases pain as perceived by the patient, compared to traditional parameters.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years or older, that signed informed consent
* Proliferative diabetic retinopathy with indication for panretinal photocoagulation

Exclusion Criteria:

* Previous retinal photocoagulation
* Previous ocular surgical procedures
* Ocular media opacities
* History of trigeminal neuralgia
* Chronic ocular pain
* Depression under conductual or medical treatment

Primary outcomes:
measure: Pain (NRS-11 scale)
timeFrame: Immediately post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Asociacion para Evitar la Ceguera en Mexico
state: DF
Study officials:
affiliation: Asociación para Evitar la Ceguera en México
name: Oscar Alvarez-Verduzco, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01203969: Safety and Efficacy of Single Port Laparoscopic Surgery in Colon Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Colon Cancer
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
First posted: 2010-09-17
Enrollment: 62
Sex: ALL
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized trial is designed to identify the safety and efficacy of single port laparoscopic surgery in colon cancer compared with conventional laparoscopic surgery.


Eligibility criteria: Inclusion Criteria:

* pathologic proven colon cancer

Exclusion Criteria:

* Tumor located in distal transverse colon, splenic flexure, and descending colon
* distant metastasis
* acute obstruction and/or perforation
* associated with FAP or HNPCC
* synchronous malignancy
* ASA score 3 or 4
* pregnancy
* no consent

Primary outcomes:
measure: rate of intraoperative complication
timeFrame: 1 day
measure: rate of 30 day morbidity and mortality
timeFrame: 1 month
Secondary outcomes:
measure: operation time
timeFrame: 1 day
measure: degree of postoperative pain
timeFrame: 5 days
measure: amount of postoperative analgesics usage
timeFrame: 5 days
measure: postoperative functional recovery
timeFrame: 7 days
measure: Duration of postoperative hospital stay
timeFrame: 7 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University School of Medicine, Neo Medical Center
Study officials:
affiliation: Kyung Hee University School of Medicine
name: Suk Hwan Lee, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kang BM, Park SJ, Lee KY, Lee SH. Single-Port Laparoscopic Surgery Can Be Performed Safely and Appropriately for Colon Cancer: Short-Term Results of a Pilot Randomized Controlled Trial. J Laparoendosc Adv Surg Tech A. 2017 May;27(5):501-509. doi: 10.1089/lap.2016.0467. Epub 2017 Jan 6.
Clinical trial NCT06526169: Assessment of Human Exposure to Chemical Hazards
Official title: Assessment of Human Exposure to Chemical Hazards and Their Association with Food Consumption in the Singapore Population
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Dietary Exposure
Lead sponsor: National University of Singapore
Sponsor class: OTHER
Collaborators: name: Singapore Food Agency
First posted: 2024-07-29
Enrollment: 300
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy adults in the Singapore population

Brief summary: The aim of this study is to evaluate the occurrence of chemical hazards exposure in the Singapore population and assess their association with food consumption.

Detailed description: Human biomonitoring is an exposure assessment approach with the potential value-add supplementation to existing sources of information for regulatory risk assessments and for supporting food safety policies. The collaboration involving academic partners from the sciences and public health disciplines to quantify the in vivo chemical exposure of chemicals will take reference from the findings in the Singapore's total diet study on the prioritised chemical hazards of interest for a more precise assessment of the distribution of risk in the population. Direct measurement of chemicals and/or metabolites in biological specimens obtained from study subjects will be conducted to provide a more comprehensive understanding on the baseline dietary chemical exposure in the local population. Dietary assessment using food frequency questionnaire will be administered to the same group of study subjects to associate human exposure to chemical hazards with food consumption across the different population groups in Singapore.

Eligibility criteria: Inclusion Criteria:

* Must be English-literate and able to give informed consent in English
* 21 to 60 years of age (inclusive) at screening
* Healthy adults
* Race must be Chinese or Indian or Malay
* Reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Exclusion Criteria:

* Known or ongoing psychiatric disorders within 3 years
* Being diagnosed with cancer, heart disease, stroke, renal failure, serious mental or physical illnesses at the time of recruitment
* Have donated blood of more than 500 mL within 4 weeks of study enrolment

Primary outcomes:
measure: Chemical hazards occurrence
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University of Singapore
city: Singapore
country: Singapore
facility: National University of Singapore, Department of Food Science & Technology
Study officials:
affiliation: National University of Singapore
name: Mei Hui Liu
role: PRINCIPAL_INVESTIGATOR
References: