louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04726605: Turkish Version of the Postoperative QoR-15
Official title: Translation and Validation of the Turkish Version of the Postoperative Quality of Recovery Score QoR-15
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Cross-Cultural Comparison
Postoperative Period
Recovery of Function
Keywords: Questionnaire Quality-of-recovery 15 (QoR-15)
Lead sponsor: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 250
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: All patients admitted for any type of scheduled surgery with general anesthesia except heart and vascular surgery

Brief summary: Patient perceived quality of recovery is an important outcome after surgery and should be measured in clinical trials. The QoR-15 was designed to measure quality of recovery after surgery. It provided an efficient evaluation of the postoperative quality of recovery. The primary objectives of this study is to translate the original QoR-15 questionnaire into Turkish, and do a full psychometric evaluation of the Turkish version. We will test its validity, reliability, responsiveness, and clinical acceptability and feasibility, with patients undergoing abdominal, thoracic, orthopedic, gynecological, urologic, eye and ENT surgery, in the University of Health Sciences, Gülhane Education and Rraining Hospital Ankara, Türkiye.


Eligibility criteria: Inclusion Criteria:

* aged \> 18 years old
* underwent selective or day surgery with general anesthesia (including all surgical categories except heart and vascular surgery)
* able to complete the QoR-15T in Turkish
* agreed to provide written informed consent to participate

Exclusion Criteria:

* aged \< 18 years old
* patients with a neuropsychiatric disturbance
* not agreed to provide written informed consent to participate

Primary outcomes:
measure: Quality of Recovery 15 Score
timeFrame: 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Etlik
country: Turkey
facility: SBÜ Gülhane Education and Training Hospital
state: Ankara
Study officials:
References:
citation: Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.
citation: Lyckner S, Boregard IL, Zetterlund EL, Chew MS. Validation of the Swedish version of Quality of Recovery score -15: a multicentre, cohort study. Acta Anaesthesiol Scand. 2018 Aug;62(7):893-902. doi: 10.1111/aas.13086. Epub 2018 Feb 7.
Clinical trial NCT03842605: Efficacy of Strength Training in Improving Elbow Range of Motion and Function in Adults With Hemophilia
Official title: Efficacy of Strength Training in Improving Elbow Range of Motion and Function in Adults With Hemophilia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemophilia
Elbow Joint Contracture
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 10
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: This is a research study of adults with hemophilia that have limitations in elbow joint motion that is the result of bleeding into the joint.

People with hemophilia who have bleeding into their elbow joint may have limitations in elbow joint movement and pain in the joint. This research is being done to determine the effect a strength training program has on the amount of movement people with hemophilia and elbow joint disease have.


Eligibility criteria: Inclusion Criteria:

* Patients of the Oregon health and Science University Hemophilia treatment Center
* greater or equal to 18 years old
* Loss of elbow range of motion that is greater than or equal to 5 degrees

Exclusion Criteria:

* Present inhibitor

Primary outcomes:
measure: Elbow range of motion
timeFrame: measurements to be taken at 4 and 8 weeks after entering study
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
References:
Clinical trial NCT00384605: An Investigational Drug Study to Assess Weight Loss in Obese and Overweight Patients (0364-037)(TERMINATED)
Official title: A Phase III Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of Taranabant (MK0364) in Obese Patients and in Overweight Patients With Obesity-Related Co-Morbidities, Followed by a 1-Year Extension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Obesity
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-10-06
Enrollment: 1000
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: A 1 year worldwide study in obese and overweight patients to assess the safety and effect on body weight of an investigational weight loss drug.


Eligibility criteria: Inclusion Criteria:

* Male or female, 18 years of age or older, with Body Mass Index (BMI) between 30 kg/m2 and 43 kg/m2, inclusive (BMI between 27 kg/m2 and 43 kg/m2, inclusive, for those with obesity-related comorbidities). Obesity-related comorbidities associated with a BMI of 27 kg/m2 or higher include hypertension, dyslipidemia or sleep apnea
* Stable weight (+/-3 kg) for at least 3 months prior to study start

Exclusion Criteria:

* History of diabetes mellitis, major psychiatric disorder, significant cardiovascular disease, stroke, TIA, neurological disorder, non-febrile seizures
* Screening systolic blood pressure \> 160 mm Hg or diastolic blood pressure \> 100 mm Hg

Primary outcomes:
measure: Body weight after 52 weeks of treatment
timeFrame: 52 weeks
Secondary outcomes:
measure: Waist circumference, percent body fat, biochemical markers, blood pressure, and patient-reported outcomes after 52 weeks of treatment
timeFrame: 52 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02744105: Effect of Spirulina on Liver Fibrosis by Transient Elastography in Beta Thalassemic Children With Hepatitis C
Official title: Effect of Spirulina on Liver Fibrosis by Transient Elastography in Beta Thalassemic Children With Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Beta Thalassemia Major
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2016-04-20
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Thalassemics can develop liver fibrosis because of iron overload and hepatitis C infection. The latter is the main risk factor for liver fibrosis in transfusion dependent thalassemics. Excess liver iron is clearly recognized as a co factor for the development of advanced fibrosis in patients with hepatitis virus C infection. Transient elastography (Fibroscan) is a reliable non invasive method for diagnosing as liver fibrosis in thalassemic patients regardless of the degree of iron overload. There is evidence that suggests Spirulina may help to protect against liver damage, cirrhosis and liver failure in those with chronic liver disease.


Eligibility criteria: Inclusion Criteria:

* multitransfused beta thalassemic children with and without super added hepatitis C virus (HCV) infection diagnosed by serological detection of HCV antibodies and HCV RNA by polymerase chain reaction.

Exclusion Criteria:

* liver decompensation child younger than 3 years patients with hepatitis B infection implantable cardiac device failure to obtain transient elastography (Fibroscan) results

Primary outcomes:
measure: liver stiffness measurement using transient elastography (Fibroscan)
timeFrame: 3 months
Secondary outcomes:
measure: liver function tests
timeFrame: 3 months
measure: aspartate aminotransferase to platelet ratio index (APRI)
timeFrame: 3 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of Medicine- Tanta University
state: Gharbia
Study officials:
References:
Clinical trial NCT04100005: A Pilot Study to Explore the Role of Gut Flora in Crohn's Disease
Official title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Crohn's Disease
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Crohn Disease
Crohn Colitis
Crohn's Ileocolitis
Crohn Ileitis
Crohn Disease of Ileum
Crohn's Disease Relapse
Crohn's Gastritis
Crohns Disease Aggravated
Crohn Disease in Remission
Crohn's Jejunitis
Crohn's Duodenitis
Crohn's Disease of Pylorus
Crohn's Esophagitis
Crohn's
Lead sponsor: ProgenaBiome
Sponsor class: OTHER
First posted: 2019-09-23
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: Patients who have been diagnosed with Crohn's disease

Brief summary: This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Crohn's disease.

Detailed description: The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding Crohn's disease.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
2. Male or female patients age 12 and older. (interest is given to children 12 and older to compare with mothers).
3. Diagnosis of Non-Fistulating Crohn's disease confirmed by at least one of the following

   1. Colonoscopy
   2. Capsule Endoscopy
   3. Computerized Tomography (CT) Scan
   4. Magnetic Resonance Imaging (MRI)
   5. Balloon-assisted enteroscopy

Exclusion Criteria:

1. Refusal to sign informed consent form
2. Presence of Fistulating Crohn's disease
3. Treatment with antibiotics within 2 weeks prior to screening
4. Treatment with probiotics within 6 weeks prior to screening.
5. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
6. Postoperative stoma, ostomy, or ileoanal pouch
7. Participation in any experimental drug protocol within the past 12 weeks
8. Treatment with total parenteral nutrition
9. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
10. Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study

Primary outcomes:
measure: Correlation of Microbiome to Crohn's Disease via Relative Abundance Found in Microbiome Sequencing
timeFrame: 1 year
Secondary outcomes:
measure: Validation of Sequencing Methods
timeFrame: 1 year
Other outcomes:
Locations:
city: Ventura
country: United States
facility: ProgenaBiome
state: California
Study officials:
affiliation: ProgenaBiome
name: Sabine Hazan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00443105: Topical Tacrolimus 0.03% Ointment for Intractable Allergic Conjunctivitis: An Open Label Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Allergic Conjunctivitis
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-03-05
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy, tolerance and safety of tacrolimus 0.03% ointment in the treatment of intractable allergic conjunctivitis.


Eligibility criteria: Inclusion Criteria:

* Subjects included if they were \> 5 years old and suffered from intractable allergic conjunctivitis

Exclusion Criteria:

* pregnancy or breastfeeding,history of herpetic eye disease,transplant patients concomitant administration of drugs inhibiting cytochrome CYP3A4, hypersensitivity to macrolides

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf Harofeh Medical Center, Department of Ophthalmology
Study officials:
affiliation: Assaf Harofeh Medical Center, Tel Aviv University
name: David Zadok, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00120705: Treatment for Anemic Subjects With Non-Myeloid Malignancies Receiving Chemotherapy
Official title: A Randomized, Open-Label, Pilot Study to Evaluate Every Three Week Maintenance Dosing of Darbepoetin Alfa Therapy in Anemic Subjects With Non-Myeloid Malignancies Receiving Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neoplasms
Anemia
Keywords: anemia
darbepoetin alfa
Amgen
Non-myeloid Malignancies
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-07-19
Enrollment: 204
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 purpose of this study is to assess the ability of darbepoetin alfa to maintain hemoglobin concentrations greater than or equal to 10 g/dL when administered every 3 weeks (Q3W).


Eligibility criteria: Inclusion Criteria: - Subjects with non-myeloid malignancies - Anemia (screening hemoglobin concentration greater than or equal to 10.5 g/dL but less than or equal to 12.0 g/dL) related to cancer and chemotherapy - At least 8 additional weeks of cyclic chemotherapy planned regardless of schedule - Karnofsky Performance Status of greater than or equal to 50% - Serum creatinine concentration less than or equal to 2.0 mg/dL Exclusion Criteria: - Iron deficiency - Red blood cell (RBC) transfusion within 4 weeks of screening - Unstable cardiac disease

Primary outcomes:
measure: To assess the ability of darbepoetin alfa to maintain hemoglobin concentrations greater than or equal to 10 g/dL when administered every 3 weeks (Q3W)
Secondary outcomes:
measure: Assess safety profile of subjects treated with darbepoetin alfa
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Charu V, Saidman B, Ben-Jacob A, Justice GR, Maniam AS, Tomita D, Rossi G, Rearden T, Glaspy J. A randomized, open-label, multicenter trial of immediate versus delayed intervention with darbepoetin alfa for chemotherapy-induced anemia. Oncologist. 2007 Oct;12(10):1253-63. doi: 10.1634/theoncologist.12-10-1253.
Clinical trial NCT02576405: Psychiatric Disorder and Postoperative Morbidity in Hip and Knee Artroplasty
Official title: Characterization of Preoperative Psychiatric Disorder in Relation to Postoperative Morbidity in Elective Fast-Track Total Hip and Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Focus is on Preoperative Psychiatric Charactarization of Elective Fast-track Hip and Knee Arthroplasty Patients
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2015-10-15
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Danish population sample (N=2000) of hip and knee arthroplasty patients in an elective fast-track setting.

Brief summary: It has been established that patients with psychiatric disorders tend to do worse in a surgical setting. Some types of surgery with greater impact than others, including orthopedic surgery. In our research group the investigators have shown this to be the case for hip and knee replacements within the mentioned patient category. However, the role of psychiatric disorder and use of different psychopharmacological drugs in relation to perioperative morbidity and mortality have not been thoroughly examined. The objective of this study is to shed light on the issue.

Recent studies have shown that different types of psychiatric disorder influence surgical outcome differently. This emphasizes the need for specific knowledge regarding psychiatric diagnoses preoperatively. In this study around 2000 patients with or without psychiatric disorder of any kind will be studied preoperatively, which according to our previous study will include more than 200 patients receiving psychopharmacological treatment. The specifics that characterize every patient's psychiatric trades will be included in a validated questionnaire constructed for that purpose. The questionnaire is called SCL-92 and has been chosen in collaboration with Professor in Psychiatry, Rigshospitalet Anders Fink-Jensen. Preoperative information regarding their mental condition and medicine will be linked to surgical outcome in order to identify potential hazards in the perioperative period.


Eligibility criteria: Inclusion Criteria:

* All patients planned for elective unilateral fast-track hip or knee arthroplasty.
* Age \> 18.
* Can understand and read danish.

Exclusion Criteria:

-

Primary outcomes:
measure: Psychological characterization of hip and knee arthroplasty patients using the validated SCL-92 questionnaire
timeFrame: 90 days postoperatively
Secondary outcomes:
measure: Length of stay
timeFrame: 90 days postoperatively
measure: Readmissions
timeFrame: 30 and 90 days postoperatively
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04136405: Cross Sectional Survey on the Burden, Impacts and Causes of Hepatitis C Virus (HCV) Outbreak in South West Region in Burkina Faso
Official title: Cross Sectional Survey on the Burden, Impacts and Causes of Hepatitis C Virus (HCV) Outbreak in South West Region in Burkina Faso
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis C Virus Infection, Past or Present
Chronic Hepatitis c
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Centre Muraz
name: Université Montpellier
First posted: 2019-10-23
Enrollment: 3300
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: General population of South West region of Burkina Faso

Brief summary: This study investigates hepatitis C virus (HCV) outbreak in South West general population in Burkina Faso with three specific objectives: estimate HCV prevalence in South West Region general population in 2019; identify factors associated with recent HCV infection (in subjects younger than 20 years); and evaluate the pilot treatment strategy implemented by the national program for diagnosed cases during investigation.

Detailed description: A previous ANRS (French National Agency for Research on AIDS and Viral Hepatitis)12270 study supported by Burkina Faso's Minister of Health, used blood samples from the 2010 Demographic and Health Survey (DHS) to document the country's national and regional prevalences and highlighted a localized HCV epidemic in the Southwest Region with a prevalence of 13.2% which was 4 times higher than the national prevalence. This high prevalence of HCV was found in both adults and youth.

Given the particular epidemiological situation of the South-West region and the limits of the 2010 DHS, we aimed to carry out a thorough investigation of this HCV epidemic in the South-West region of Burkina Faso in order to control it.

A mixed methodology (quantitative and qualitative) will be used including: (i) a cross-sectional survey to estimate the prevalence of HCV infection in the South-West population in Burkina Faso; (ii) a case-control study among individuals less than 20 years of age to identify factors associated with current HCV transmission; (iii) a qualitative survey to provide additional information explaining the high prevalence of HCV infection (historical events, for example); (iv) a cohort study to evaluate a pilot treatment management strategy to be implemented by the national program in the South West Region

Eligibility criteria: Inclusion Criteria:

* To be a usual resident of the Burkina Faso South West region
* Express informed consent

Primary outcomes:
measure: HCV seroprevalence
timeFrame: at inclusion (cross-sectional survey)
Secondary outcomes:
measure: Chronic hepatitis C prevalence
timeFrame: at inclusion (cross-sectional survey)
Other outcomes:
Locations:
city: Gaoua
country: Burkina Faso
facility: Région du Sud-Ouest
Study officials:
References:
Clinical trial NCT06897605: Impact of Dapagliflozin in Anemic Chronic Kidney Disease Patients
Official title: Clinical Study Evaluating the Impact of Dapagliflozin on Erythropoiesis-Stimulating Agent Responsiveness in Anemic Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Kidney Disease(CKD)
Anemia, Kidney Disease, Chronic
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2025-03-27
Enrollment: 80
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: Dapagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor, primarily used in the management of type 2 diabetes mellitus. Emerging research suggests that SGLT2 inhibitors may offer additional benefits, including reducing the risk of cardiovascular events and renal complications. Post hoc analyses of previous clinical trials have shown that patients treated with SGLT2 inhibitors exhibited higher levels of hemoglobin and hematocrit compared to those in the control group. These findings suggest that dapagliflozin's ability to elevate hemoglobin levels could potentially be utilized for the treatment of anemia in patients with chronic kidney disease.


Eligibility criteria: Inclusion criteria

1. Adults aged ≥ 18 years with CKD stage III or IV.
2. Patients with anemia of CKD and a hemoglobin level \< 11.5 g/dL
3. Patients are receiving erythropoiesis-stimulating agent therapy.

Exclusion criteria

1. Anemia due to causes other than chronic kidney disease, such as pernicious anemia, thalassemia, sickle cell anemia, or myelodysplastic syndromes.
2. Patients with severe ketosis, diabetic coma, severe infection, perioperative complications, or severe trauma.
3. Patients with acute heart failure, acute myocardial infarction, or stroke occurring within 6 months before enrollment in the trial.
4. Patients with current malignancies or a history of malignancy within the past 2 years.
5. Diagnosed with pure red cell aplasia.
6. Patients with severe gastrointestinal bleeding.
7. Pregnant or lactating females.

Primary outcomes:
measure: Change in Erythropoiesis stimulating agent therapy dose
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in hemoglobin level
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Urology and Nephrology Center
Study officials:
affiliation: Mansoura University
name: Noha O. Mansour, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: