louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05267210: Turkish Translation, Validity and Reliability of the Back Pain and Body Posture Assessment Questionnaire
Official title: Turkish Translation, Cultural Adaptation, Validity and Reliability Study of the Back Pain and Body Posture Assessment Questionnaire
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Back Pain
Lead sponsor: Karamanoğlu Mehmetbey University
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: According to the power analysis, the number of samples was calculated to be at least 10 times the number of items in the scale. 220 people aged between 18-65 will be included in the study.

Brief summary: The Adult Back Pain and Body Posture Assessment Instrument (BackPDE-Y), whose validity and reliability is planned, will be applied. This assessment scale will be translated into Turkish by two native Turkish speakers, one who is fluent in English.

Detailed description: 220 people aged between 20-65 are planned to be included in the study. The data obtained from the study will be analyzed with appropriate statistical methods.

In addition, a previously valid and reliable Musculoskeletal System Health Inquiry (MIS-SS) questionnaire, which evaluates the musculoskeletal problems of individuals included in the Study, will be applied. It will be evaluated whether the results of the data obtained from the Back Pain and Body Posture Assessment Instrument for Adults (BackPDE-Y), which we have validated in Turkish, and the results of the data obtained from the Musculoskeletal Health Questionnaire (CIS-SS) questionnaire are consistent with each other.

Eligibility criteria: Inclusion Criteria:

18-65 years old Willingness to participate in the study The mother tongue is Turkish, Being able to read and write, - It is between the ages of 18-65.

Exclusion Criteria:

Those with a known or concomitant diagnosis of dementia Not wanting to participate in the study Patients with psychotic disorders, depression with psychotic symptoms, bipolar depression Having a psychiatric illness with a serious psychiatric illness that may prevent the individual from understanding and completing the questionnaire

Primary outcomes:
measure: Back Pain and Body Posture Assessment Instrument for Adults (BackPDE-Y) total score
timeFrame: 6 month
Secondary outcomes:
measure: Musculoskeletal Health Questionnaire (CIS-SS)
timeFrame: 6 month
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Karamanoglu Mehmetbey University
Study officials:
affiliation: Karamanoğlu Mehmetbey University
name: Ayşenur Gökşen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Erdinc O, Hot K, Ozkaya M. Turkish version of the Cornell Musculoskeletal Discomfort Questionnaire: cross-cultural adaptation and validation. Work. 2011;39(3):251-60. doi: 10.3233/WOR-2011-1173.
Clinical trial NCT05117281: Comparison of Postoperative Analgesic Efficacy of Caudal Block Versus Spinal Block With Levobupivacaine for Inguinal Hernia in Children
Official title: Comparison of Postoperative Analgesic Efficacy of Caudal Block Versus Spinal Block With Levobupivacaine for Inguinal Hernia in Children: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Analgesia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-11-11
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Neuraxial analgesia may improve postoperative outcomes for high-risk children who are susceptible to respiratory complications (e.g. post-operative apnea). The use of spinal anesthesia in infants and children requiring surgeries of the sub-umbilical regions is gaining considerable popularity worldwide. Caudal analgesia along with general anesthesia is a very popular regional technique for prolonged postoperative analgesia in different pediatric surgical procedures where the surgical site is sub-umbilical. Bupivacaine has been thoroughly studied, and a large global experience exists.

Detailed description: Neuraxial analgesia may improve postoperative outcomes for high-risk children who are susceptible to respiratory complications (post-operative apnea). In this population, spinal anesthesia has been proposed as a means to reduce post-operative complications, especially apnea and post-operative respiratory dysfunction, although this utility has been questioned.

Spinal anesthesia modifies the neuroendocrine stress response, ensures a more rapid recovery, and may shorten hospital stay with fewer opioid-induced side effects.

Caudal analgesia along with general anesthesia is a very popular regional technique for prolonged postoperative analgesia in different pediatric surgical procedures where the surgical site is sub-umbilical. Caudal anesthetics usually provide an-algesia for approximately 4-6 hours.

Eligibility criteria: Inclusion Criteria:

* Age: 2-10 years.
* Weight: 15-40 kg.
* Sex: both males and females.
* ASA physical status: 1-II.
* Operation: surgery below the umbilicus.

Exclusion Criteria:

* Allergic reaction to local anesthetics (LAs).
* Local or systemic infection (risk of meningitis).
* Intracranial hypertension.
* Hydrocephalus.
* Intracranial hemorrhage.
* Coagulopathy.
* Hypovolemia.
* Parental refusal.
* Spinal deformities, such as spina bifida or myelomeningocele.
* Presence of a ventriculoperitoneal shunt because of a risk of shunt infection or dural leak.

Primary outcomes:
measure: FLACC scale FLACC scores will be recorded. FLACC scores will be recorded. FLACC score will be recorded
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: Total consumption of rescue analgesics
timeFrame: 24 hours
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut governorate
Study officials:
References:
Clinical trial NCT00285181: Effects of Statins on Pro- and Antioxidant Status : Link With Statin-Associated Myopathy.
Official title: Effects of Statins on Pro- and Antioxidant Status : Link With Statin-Associated Myopathy. A Randomized, Placebo-Controlled, Double-Blind Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: persons
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2006-02-01
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effects of a 8-week treatment with 80 mg/day simvastatin on prooxidant and antioxidant status at rest and after exercise, on mitochondrial respiration and calcium release in skeletal muscle, and on aérobic aptitude in 24 healthy male subjects.

Detailed description: Day 1 : baseline oxidative status, lipid profile, exercice test, start of randomized treatment Day 53 : muscular biopsy Day 57 : follow-up oxidative status, lipid profile, exercice test, end of treatment

Eligibility criteria: Inclusion Criteria:

* BMI between 18.0 and 25.00

Exclusion Criteria:

-

Primary outcomes:
measure: Blood antioxidant status before treatment and after treatment.
measure: Lipid and protein peroxidation indexes before treatment and after treatment.
measure: In vitro mitochondrial respiration, enzymatic activities and calcium release parameters before treatment and after treatment.
Secondary outcomes:
measure: Blood lipids before treatment and after treatment
measure: LDL composition before and after treatment
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Centre d'Investigation Clinique
Study officials:
affiliation: Centre d'Investigation Clinique
name: Pierre PETIT, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00959881: Study Evaluating The Coadministration of Begacestat And Donepezil
Official title: Combined Administration Of Begacestat And Donepezil: A Multiple-Dose Study In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: Alzheimer Disease
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2009-08-17
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study examines the cardiac effects (effects on the heart) of administering donepezil and begacestat together to healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy
* Men and women of non-childbearing potential
* Non smoker or smoker of \<10 cigarettes per day and able to refrain from smoking during study
* 18-50 years old

Exclusion Criteria:

* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
* Cardiac rhythm abnormalities
* Family history of cardiac risk factors

Primary outcomes:
measure: Pharmacodynamic interaction of multiple doses of begacestat and donepezil coadministered to healthy subjects as assessed by 12-lead electrocardiogram (ECG).
timeFrame: 5 months
Secondary outcomes:
measure: Pharmacokinetic parameters including Cmax, AUC, and t 1/2
timeFrame: 5 months
measure: Safety and tolerability as assessed by results of 12-lead ECGs, cardiac telemetry, laboratory tests, vital signs, physical examinations and reported adverse events.
timeFrame: 5 months
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05910710: Impact of Immuno-Oncologic Agent on Neoadjuvant Chemotherapy in Triple Negative Breast Cancer
Official title: Impact of Immuno-Oncologic Agent on Neoadjuvant Chemotherapy in Triple Negative Breast Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Triple Negative Breast Cancer
Neoadjuvant Chemotherapy
Pembrolizumab
Tumor Microenvironment
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2023-06-20
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Locally advanced triple negative breast cancer subjects who were administered neoadjuvant chemotherapy with Weekly paclitaxel, Carboplatin followed by Doxorubicin, Cyclophosphamide add Pembrolizumab or not

Brief summary: It analyzes the Tumor microenvironment(TME) changes in non pathologic complete response(pCR) subjects among subjects who were administered neoadjuvant pembrolizumab and those who were not administered neoadjuvant pembrolizumab for triple negative breast cancer.

(Neoadjuvant Weekly paclitaxel, Carboplatin +- Pembrolizumab followed by Doxorubicin, Cyclophosphamide +- Pembrolizumab regimen)


Eligibility criteria: Inclusion Criteria:

* Triple negative breast cancer
* Subjects administered neoadjuvant Weekly paclitaxel, Carboplatin followed by Doxorubicin, Cyclophosphamide add Pembrolizumab or not
* Non pCR patients who are undergoing surgery after neoadjuvant chemotherapy
* Sign to informed consent

Exclusion Criteria:

* Patients with difficulty in obtaining sufficient samples

Primary outcomes:
measure: Genomic profiling will be assessed by tissue and blood samples(analyze the TME changes)
timeFrame: 3year
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT02062710: Antitussive Effect of a Naturally Flavored Syrup Containing Diphenhydramine, Compared With Dextromethorphan and Placebo
Official title: Antitussive Effect of a Naturally Flavored, Multi-Component Syrup Containing Diphenhydramine, Compared With Dextromethorphan and Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cough Reflex Sensitivity
Keywords: cough
cough reflex
capsaicin
diphenhydramine
phenylephrine
dextromethorphan
placebo
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2014-02-14
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the antitussive (cough-suppressing) effects of two liquid medications: a combination of diphenhydramine and phenylephrine in a naturally cocoa flavoring, and, dextromethorphan syrup, compared with placebo.


Eligibility criteria: Inclusion Criteria:

* healthy adult nonsmokers
* onset of acute, viral upper respiratory tract infection (common cold) within 72 hours of enrollment

Exclusion Criteria:

* smokers
* history of asthma or other respiratory disorders

Primary outcomes:
measure: Change in Cough Reflex Sensitivity to Capsaicin
timeFrame: 2 hours after study drug administration
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Einstein Division/Montefiore Medical Center
state: New York
Study officials:
References:
citation: Dicpinigaitis PV, Dhar S, Johnson A, Gayle Y, Brew J, Caparros-Wanderley W. Inhibition of cough reflex sensitivity by diphenhydramine during acute viral respiratory tract infection. Int J Clin Pharm. 2015 Jun;37(3):471-4. doi: 10.1007/s11096-015-0081-8. Epub 2015 Feb 12.
Clinical trial NCT01128010: Role of CCL2 in Alcoholic Liver Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcoholic Liver Disease
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2010-05-21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients undergoing transjugular liver biopsy for alcoholic liver disease will be include in the study to measure plasma levels and hepatic expression of CCL2. We determine also the rs1024611 polymorphism of these patients. All these parameters are correlated to severity of the disease.

The frequency of the presence of this polymorphism was also compared to a population of healthy subjects.

Brief summary: Immune dysregulations, including cytokines and chemokines secretions occurs in alcoholic liver disease. Serum levels and liver expression of CCL2 are increased in patients with alcoholic hepatitis but the role of this chemokine in the pathogenesis of alcoholic liver disease is nevertheless unknown. The aim of the study is to analyze plasma level and liver expression of CCL2 and their relation with liver disease severity and inflammatory infiltrate in our cohort of alcoholic patients. We studied also the association between -2518 CCL2 polymorphism and the severity of alcoholic liver disease.


Eligibility criteria: ALD patients

Inclusion Criteria:

* Excess alcohol intake
* Abnormality of liver biopsy compatible with alcoholic aetiology
* Caucasian ethnicity

Exclusion Criteria:

* Presence of any other chronic liver disease
* co-infection with HIV Controls Inclusion criteria
* Caucasian ethnicity
* presence of a disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02585310: Packed Red Blood Cell Transfusion in Elective Coronary Artery Bypass Graft Surgery in A University Hospital
Official title: Packed Red Blood Cell Transfusion in Elective Coronary Artery Bypass Graft Surgery in A University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PRBC Transfusion
CABGs
Keywords: PRBC transfusion
CABGs
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2015-10-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing CABGs

Brief summary: In Siriraj Hospital, blood consumption in Cardiac surgery is high (units per patient) and frequent (number of patients receiving blood). The incidence of side effects are unknown, as is the exact amount of blood used/provided for patients with elective CABGs.

The primary objective of this study was to demonstrate the incidence of packed red blood cell (PRBC) transfusion in elective CABGs.

Detailed description: Three hundred patients undergoing isolated, first time CABGs during November 2011-September 2013 were prospective enrolled in this observational study. Patients' preoperative variables and postoperative outcomes, as well as perioperative transfusion characteristics were recorded.

Eligibility criteria: Inclusion Criteria:

* patients undergoing first-time isolated elective coronary artery bypass graft surgery

Exclusion Criteria:

* None

Primary outcomes:
measure: incidence of PRBC transfusion in elective CABG surgery
timeFrame: 14 days
Secondary outcomes:
measure: risk factors of PRBC transfusion in elective CABG surgery
timeFrame: 14 days
Other outcomes:
Locations:
Study officials:
affiliation: Mahidol University
name: Sirilak Suksompong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06667310: Effects of Neutrophil/Lymphocyte, Platelet/Lymphocyte, CRP/Albumin and Lactate on Mortality in Trauma Patients Admitted to Intensive Care
Official title: Evaluatıon Of The Effect Of Neutrophıl/Lymphocyte, Platelet/Lymphocyte, Crp/Albumın, Base Defıcıt And Lactate Levels On Mortalıty Durıng The Admıssıon Of Trauma Patıents To Intensıve Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intensive Care
Lead sponsor: Harran University
Sponsor class: OTHER
First posted: 2024-10-31
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 95
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1-95 age intensive care patients

Brief summary: Intensive care units are medical units where patients are closely monitored 24 hours a day due to critical health problems that threaten their lives and where rapid interventions are made when necessary. The clinical conditions of patients in these units can change rapidly. There are many studies in the literature indicating that inflammation indicators such as Neutrophil/Lymphocyte, Platelet/Lymphocyte and C-Reactive Protein/Albumin ratios and blood gas values such as Lactate and Base Deficit are simple, cheap and rapid biomarkers that can provide an early idea about the clinical course of patients.

Detailed description: Intensive care units are medical units where patients are closely monitored 24 hours a day due to critical health problems that threaten their lives and where rapid interventions are made when necessary. The clinical conditions of patients in these units can change rapidly. There are many studies in the literature indicating that inflammation indicators such as Neutrophil/Lymphocyte, Platelet/Lymphocyte and C-Reactive Protein/Albumin ratios and blood gas values such as Lactate and Base Deficit are simple, cheap and rapid biomarkers that can provide an early idea about the clinical course of patients. The researchers aimed to evaluate the relationship between Neutrophil/Lymphocyte, Platelet/Lymphocyte and C-Reactive Protein/Albumin ratios and biomarkers such as Lactate and Base Deficit with the clinical course and survival of trauma patients admitted to the ICU and to see the compatibility of our data with the existing literature.

Eligibility criteria: Inclusion Criteria:

* 1. All trauma patients admitted to our general intensive care unit

Exclusion Criteria:

- 1. Patients whose follow-up and treatment started and completed in the services.

2. Patients whose data is missing or whose data cannot be accessed.

Primary outcomes:
measure: Primary outcome
timeFrame: one day
Secondary outcomes:
measure: seconary outcome
timeFrame: one day
Other outcomes:
Locations:
city: Karaköprü
country: Turkey
facility: Veli Fahri Pehlivan
state: Şanliurfa
Study officials:
References:
Clinical trial NCT03248310: A Study Comparing Quality of Life in Patients With Lymphedema Who Undergo Surgical Treatment Versus Non-Surgical Management
Official title: A Prospective Study Comparing Quality of Life in Patients With Lymphedema Who Undergo Surgical Treatment Versus Non-Surgical Management
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lymphedema
Keywords: Quality of Life (QoL)
17-377
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2017-08-14
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who present for consultation of their lymphedema and who meet eligibility criteria will be offered the option of enrolling in this study at the time of their initial consultation.

Brief summary: This study is being done to see the long-term results for patients who choose to have surgery for lymphedema (with the vascularized lymph node transfer), compared to patients who choose not to have surgery.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18-80 years
* Primary and secondary lymphedema of the upper or lower extremity
* International Society of Lymphology (ISL) Stage 1, 2, or 3 lymphedema
* Proficiency in English language

Exclusion Criteria:

* Patients with clotting disorders, venous insufficiency, end-stage lymphedema unless they are on the non-surgical arm.
* Additionally, if the patient refuses to complete questionnaires, the patient will be excluded from the study and replaced at the discretion of the principal or co-principal investigator.

Primary outcomes:
measure: Quality of Life
timeFrame: up to 40 months
Secondary outcomes:
Other outcomes:
Locations:
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Nassau (Limited Protocol Activites)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Babak Mahrara, MD
role: PRINCIPAL_INVESTIGATOR
References: