louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06675292: Psychometric Properties of the Turkish Version of the HANA in Tension Type Headache
Official title: Psychometric Properties of the Headache Needs Assessment (HANA) Survey in Tension Type Headache: Turkish Version, Reliability, and Validity Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tension Type Headache
Keywords: Headache Needs Assessment Survey
Tension type headache
Turkish
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with tension type headache

Brief summary: Individuals with tension type headache


Eligibility criteria: Inclusion Criteria:

* Having a diagnosis of tension-type headache,
* Being between 18 and 65 years of age.

Exclusion Criteria:

* Having a diagnosis of any headache disorder other than tension-type headache,
* Having a history of any systemic disease, such as malignancy, inflammatory conditions, acute fractures, surgical history, or neurological, psychological, or rheumatological disorders.

Primary outcomes:
measure: Headache Needs Assessment Survey
timeFrame: through study completion, an average of 1 month
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: through study completion, an average of 1 month
measure: Headache Impact Test-6 (HIT-6)
timeFrame: through study completion, an average of 1 month
measure: Henry Ford Hospital Headache Disability Inventory
timeFrame: through study completion, an average of 1 month
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Tokat Gaziosmanpaşa University
Study officials:
affiliation: Tokat Gaziosmanpaşa University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
name: Halime ARIKAN, Doctor of Philosophy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03026192: Near Infrared Spectroscopy to Determine Patent Ductus Arteriosus Closure
Official title: Use of Near Infrared Spectroscopy in Preterm Infants to Determine Patent Ductus Arteriosus Closure Following Medical Treatment
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Patent Ductus Arteriosus
Lead sponsor: Albany Medical College
Sponsor class: OTHER
First posted: 2017-01-20
Enrollment: 4
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm infants both with and without hsPDA. They will have NIRS monitors placed to measure cerebral and renal regional tissue oxygenation. Those without a hsPDA will be monitored solely around the time of initial echocardiogram. Those with a hsPDA will be monitored around initial echocardiogram and the subsequent echocardiogram after treatment completion.

Brief summary: Using cerebral and renal near infrared spectroscopy monitoring to determine PDA closure in preterm infants after completing medical treatment for a hemodynamically significant PDA.


Eligibility criteria: Inclusion Criteria:

* preterm infants less than 32 weeks gestation

Exclusion Criteria:

* infection, congenital heart disease, syndromic anomalies, and perinatal asphyxia.

Primary outcomes:
measure: Change in NIRS readings
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical Center Neonatal Intesive Care Unit
state: New York
Study officials:
References:
Clinical trial NCT01328392: Evaluating Treatment Response in Laryngo-Pharyngeal Reflux
Official title: Evaluating Treatment Response in Laryngo-Pharyngeal Reflux
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Laryngo-pharyngeal Reflux
Keywords: LPR
GERD
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Takeda Pharmaceuticals North America, Inc.
First posted: 2011-04-04
Enrollment: 0
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: Although laryno-pharyngeal reflux (LPR) and gastroesophageal reflux disease (GERD) differ in symptoms and treatment, they are diagnosed by the same standard 24-hour pH monitoring system which measures liquid reflux in the esophagus. The investigators are evaluating a new 24-hour pharyngeal pH monitoring system by Restech which can measure acid exposure in the airway and can be used specifically for LPR diagnosis. The purpose of this study is to determine whether the Restech device is more effective than standard pH monitoring in predicting the response to proton pump inhibitor (PPI) acid suppression therapy using Dexlansoprazole in patients with symptoms and/or manifestations of LPR.


Eligibility criteria: Inclusion Criteria:

* Age 18 years old or above
* Have a clinical diagnosis of LPR
* Able and willing to provide consent

Exclusion Criteria:

* History of any previous anti-reflux operation or procedure
* History of pharyngeal or laryngeal surgery
* History of larngeal or hypolaryngeal neoplasm
* Allergy or significant adverse reaction to PPI
* Patient on PPI therapy within 4 weeks prior to enrollment
* A cumulative history of PPI therapy equal to or greater than 3 months
* History of noncompliance with medication or study protocols
* Enrolled in another clinical trial using investigational medications

Primary outcomes:
measure: Ability of Restech to predict LPR symptom improvement after treatment with Dexlansoprazole.
timeFrame: 3 months
Secondary outcomes:
measure: Comparison between standard pH data and Restech data (normal vs.abnormal acid exposure, using established normative data values) before and after treatment with Dexlansoprazole.
timeFrame: 3 months
measure: Correlation between Restech acid exposure events and standard pH monitoring acid exposure events.
timeFrame: 3 months
measure: Laryngoscopic findings pre and post Dexlansoprazole treatment.
timeFrame: 3 months
measure: Differences between RSI and general GERD symptom questionnaire scores on and off Dexlansoprazole.
timeFrame: 3 months
measure: Correlation of RSI and general GERD symptom questionnaire scores with Restecha dn standard pH values.
timeFrame: 3 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Brant K Oelschlager, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04431492: Effect of Anaesthesia on Basic Aminoacids
Official title: Effect of Anaesthesia and Surgery on Plasma Levels of Nitric Oxide and Basic Aminoacids
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Effect of Anaesthesia on Basic Aminoacids
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 58
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing cardiopulmonary bypass and thoracotomy for lung resection secondary to lung carcinoma, three samples will be taken to evaluate the levels of basic amino acids and NO levels

Brief summary: Basic amino acids are acids that contains amino groups more than carboxylic groups. At least five basic amino acids namely; Arginine, citrulline, ornithine, lysine and hydroxylysine metabolize in our body. Loss of body protein represents a typical feature of the catabolic response to surgery.


Eligibility criteria: Inclusion Criteria:

* elective surgery
* ASA II,III

Exclusion Criteria:

* Emergency surgery
* Associated renal or liver disease
* Chronic disease as D.M

Primary outcomes:
measure: basic aminoacids and NO levels
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References:
Clinical trial NCT00792792: Monitoring of Tissue Transfer Flaps by Modulated Imaging
Official title: Non-contact, Intra-operative & Post-operative Device, Evaluation of Tissue Transfer Flaps After Reconstructive Surgery.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Other Reconstructive Surgery
Keywords: tissue transfer
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2008-11-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population will be selected from Surgical Department as outpatients and in-patient bases that require reconstructive surgery using a pedicle or free tissue transfer flap.

Brief summary: Tissue transfer flaps are a method of moving tissue from a donor location to a recipient location. In the case of a free tissue transfer flaps, the blood vessels to the transferred tissues are detached and then re-attached to different arteries and veins at the recipient site. The process of reconstructive surgery using tissue transfer flaps is not without complications. These complications may include acute arterial or venous occlusion, as well as the development of late complications such as fat necrosis and flap atrophy.

Detailed description: The researchers developed a safe, non-contact, intra-operative and post-operative device called Modulated Imaging, can detect changes in a flap's optical properties and can correlate with arterial or venous occlusion or with the development of fat necrosis or flap atrophy.

Eligibility criteria: Inclusion Criteria:

* Adult 18 years and older planned to undergo reconstructive surgery

Exclusion Criteria:

* All emergency reconstructive surgery

Primary outcomes:
measure: Transfer Skin flap
timeFrame: up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California Medical Center
state: California
Study officials:
affiliation: Aesthetic & Plastic Surgery Institute, UCIMC
name: Evans R Gregory, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02291692: Ultrasound Guided Thoracic Paravertebral Block for Percutaneous Nephrolithotomy Operations in Children
Official title: Ultrasound Guided Thoracic Paravertebral Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2014-11-14
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators aimed to evaluate the effect of ultrasound guided thoracic paravertebral block with bupivacaine on both perioperative anesthetic agent consumption and postoperative analgesia in pediatric patients undergoing percutaneous nephrolithotomy for kidney stone.

Detailed description: This study was performed after approval of Ethics Committee and parents written consent. Between the ages 1-5, planned percutaneous nephrolithotomy due to kidney stones 40 patients were enrolled in this study, and patients were randomly divided into two group. All patients were performed general anaesthesia. The Group I patients was given ultrasound guided thoracic paravertebral block with 0.5 ml/kg bupivacaine %0.5 after giving prone position and the Group II patients was given 15 mg/kg of paracetamol as postoperative analgesia. In the period of postoperative, if the FLACC \> 4; it was planned to dose 1 mg/kg of tramadol. Patients' hemodynamic parameters, oxygen saturation, sevoflurane concentration were recorded 10, 15, 30 and 60 minutes intraoperatively. Patients' hemodynamic parameters, oxygen saturation, pain scores (FLACC), satisfaction of parents, the number of patients who additional analgesic requirements and side effects (nausea,vomiting, hypotension, bradycardia, respiration problems etc) were recorded in the postoperative period. Primary outcome measures was pain scores using FLACC scale.

Eligibility criteria: Inclusion Criteria:

* ASA physical status I-II
* Between the ages of 1-5 years
* Forty children

Exclusion Criteria:

* Refusals by parents
* Children with spine deformities
* Cutaneous infection
* Bleeding diathesis
* Allergy to drugs used
* ASA physical status III-IV

Primary outcomes:
measure: Pain score
timeFrame: 12 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cukurova University
name: Gülşah Akıncı, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berta E, Spanhel J, Smakal O, Smolka V, Gabrhelik T, Lonnqvist PA. Single injection paravertebral block for renal surgery in children. Paediatr Anaesth. 2008 Jul;18(7):593-7. doi: 10.1111/j.1460-9592.2008.02592.x. Epub 2008 May 8.
Clinical trial NCT04729192: Translation and Validation of the Turkish Version of the ObsQoR-10 Questionnaire (ObsQoR-10T)
Official title: Translation and Validation of the Turkish Version of the ObsQoR-10 Questionnaire (ObsQoR-10T)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Recovery
Delivery
Keywords: ObsQoR-10T Questionnaire
Lead sponsor: Konya Meram State Hospital
Sponsor class: OTHER
First posted: 2021-01-28
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted for spontaneous obstetrical labor or scheduled cesarean section.

Brief summary: The quality of recovery scoring tools for the obstetric patient population is limited. In 2019, Ciechanowicz et al. developed and validated a postpartum recovery score; the ObsQoR-11; used following elective and non-elective cesarean delivery. The ObsQoR-11 was modified to the ObsQoR-10 by Sultan et al. and used spontaneous and operative vaginal delivery based on patient feedback. There is currently only a Hebrew version of this recovery score. ObsQoR has not yet been validated for use in Turkish, which is one of the most spoken languages in the World. Therefore the investigators aimed to psychometrically evaluate (assess validity, reliability, and clinical feasibility) the Turkish translated version of the ObsQoR-10 PROM in a Turkish cohort of women.


Eligibility criteria: Inclusion Criteria:

* Turkish-speaking women (in Turkey) greater than 18 years of age who are also able to read and understand written Turkish
* Spontaneous vaginal delivery with or without neuraxial anesthesia for labor analgesia (including repair of vaginal tears and manual removal of the placenta) or elective cesarean delivery
* Women who have singleton births
* Primiparous (first baby) -≥38 weeks gestational age

Exclusion Criteria:

* Psychiatric or neurological pathology compromising cooperation in the questionnaire validation protocol,
* Age \< 18 years
* Women whose infants have died
* Mother or baby requiring ICU after delivery.
* Patient refusal to participate
* Inability to read or understand written Turkish
* Failed neuraxial analgesia: elective cesarean delivery
* General anesthesia
* Intrapartum cesarean
* Assisted/operative (i.e. vacuum, forceps) vaginal delivery

Primary outcomes:
measure: Validity of Obstetric Quality of Recovery-10 Turkish (ObsQoR-10T) questionnaire
timeFrame: on day 1 following delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Betul Kozanhan
Study officials:
References:
Clinical trial NCT05570292: Study of Effects of Preoperative Oral Domperidone on Gastric Residual Volume After Clear Fluid Ingestion in Patients Scheduled for Elective Surgeries
Official title: Study of Effects of Preoperative Oral Domperidone on Gastric Residual Volume After Clear Fluid Ingestion in Patients Scheduled for Elective Surgeries: Prospective , Randomized ,Double Blinded Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Residual Volume
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-10-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: General Anesthesia requires preoperative fasting according to specific instructions. Regarding Fasting Guidelines, The American Society of Anesthesiologists (ASA) recommends patients to fast from fatty food or meat eight hours prior to surgery, non-human milk or light meal for six hours prior, breast milk for four hours prior, and clear liquids including water, pulp-free juice, and tea without milk for two hours prior to the anesthetic. ASA fasting guidelines application represents the primary method to avoid aspiration as it ensures that stomach is empty before induction of anesthesia. These guidelines cannot be applied on all cases as in urgent or emergent situations or in morbidities associated with delayed gastric emptying, like Diabetes mellitus and some neurological disorders (


Eligibility criteria: Inclusion Criteria:

* Patients of both sexes
* aged between 18-65 years
* who are categorized by ASA physical status as I or II
* undergoing elective surgeries under general anesthesia

Exclusion Criteria:

* Patients with known or suspected delayed gastric emptying (e.g. Diabetes mellitus) -psychiatric disorders
* hypersensitivity to the study medications
* peoples undergoing surgeries that associated with high incidence of Post operative nausea and vomiting (PONV) (e.g. Cholecystectomy, gynecological, ophthalmological, otorhinolaryngological, and laparoscopic surgeries).

Primary outcomes:
measure: assess the effect of oral Domperidone preoperatively on gastric residual volume by ultrasound for patients undergoing elective surgeries under general anesthesia
timeFrame: first 2 hours preoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University hospitals
Study officials:
References:
Clinical trial NCT01184092: A Study To Compare The Amount Of Tasocitinib (CP-690,550) That Is Absorbed Into The Blood Of Healthy Subjects Following Oral Administration Of Three Different Tablet Versions Of Tasocitinib (CP-690,550)
Official title: Phase 1, Open-Label, Randomized, Single-Dose, 3-Treatment, 3-Period, Cross-Over, Bioequivalence Study Comparing Phase 2b, Phase 3 And Commercial Image Tablet Formulations Of Tasocitinib (CP-690,550) Under Fasted Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Keywords: Bioequivalence
healthy volunteer study
Rheumatoid Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-08-18
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: In this study, a 10 mg dose of tasocitinib (CP-690,550) will be given to study subjects on three separate occasions using one of three different tablet formulations (tablet versions) each time. The amount of tasocitinib (CP-690,550) available in the blood following administration of each tablet formulation will be measured and compared. The overall aim of the study is to establish that a similar amount of tasocitinib (CP-690,550) is absorbed into the blood following administration of the same dose of each different tablet formulation.

Detailed description: This is a pivotal bioequivalence study for tasocitinib (CP-690,550).

Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female (non-childbearing potential) subjects between the ages of 21 and 55 years, inclusive.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight for males\>50 kg (110 lbs). For females, total body weight \>45 kg (99 lbs).
* No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB).

Exclusion Criteria:

* Evidence of any clinically significant illness, medical condition, or disease.
* Evidence or history of any clinically significant infections within the past 3 months.
* Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.

Primary outcomes:
measure: PK parameters: AUCinf, AUClast and Cmax of tasocitinib (CP-690,550).
timeFrame: PK blood samples out to 24 hours post dose in each period
Secondary outcomes:
measure: PK parameters: Tmax, t½ of tasocitinib (CP-690,550).
timeFrame: Derived from PK blood samples out to 24 hours post dose in each period.
measure: Safety: laboratory tests.
timeFrame: Pre-dose on Day 0 for Period 1 and at 24 hours post last dose in Period 3.
measure: Safety: vital signs
timeFrame: Prior to dosing in each period and at 24 hours post last dose in Period 3.
measure: Safety: adverse event reporting
timeFrame: Throughout study.
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03316092: Monitoring and Preventing Hydroxychloroquine, Plaquenil, Toxicity.
Official title: Update on Monitoring and Preventing Hydroxychloroquine Toxicity.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hydroxychloroquine Toxicity
Lead sponsor: Dr. S.S. Michel Clinic
Sponsor class: OTHER
First posted: 2017-10-20
Enrollment: 1000
Sex: ALL
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients whose doctors decide to treat them with oral Hydroxychloroquine. This medication is very popular in treating patients with rheumatoid arthritis and some other auto-immune diseases.

Brief summary: Oral Hydoxychloroquine is a very popular medication widely used by patients with rheumatoid arthritis, Systemic Lupus Erythematosus and other diseases. Ocular side effects of this medication are very serious and causes loss of central vision. In most patients these side effects are dose related, cumulative. This means that the risk of side effects would increase in all patients with continued use of the medication. In few people use of the medication would not be recommended if they have some bilateral macular problems. This is because the side effects of this medication does cause serious degredation of the macula in both eyes.

Detailed description: The ocular side effects of Hydroxychloroquine has been known for long time. Due to the seriousness of these side effects all possible efforts were done to prevent them. Preventing these side effects would ideally need prior screening of all patients who are to use oral Hydroxychloroquine. If patients are not screened prior to oral Hydroxychloroquine use they should be examined as soon as possible after starting this medication. Advances in technology, specifically the advent of optical coherence tomography, made screening and monitoring for Hydroxychloroquine toxicity much more easier and reliable meantime.

Eligibility criteria: Inclusion Criteria: all patients who need treatment with oral Hydroxychloroquine.

-

Exclusion Criteria: patients who are not using oral Hydroxychloroquine.

-

Primary outcomes:
measure: optical coherence tomography (OCT) is a very reliable, accessible and documented way for monitoring all people who are to use or have been using oral Hydroxychloroquine
timeFrame: Ten years
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Dr. S.S. Michel Clinic
state: Alberta
Study officials:
affiliation: Dr. S.S. Michel Clinic
name: shawkat s michel, FRCS Ed
role: PRINCIPAL_INVESTIGATOR
References: