louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02382237: Comparison of Tumor Glucose Metabolism Before and After Artificial Nutrition
Official title: Comparison of Tumor Glucose Metabolism Before and After Artificial Nutrition Assessed by F-FDG Petscan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Oesophageal Cancer
Keywords: denutrition in Head and Neck cancer or oesophageal cancer
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2015-03-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Evaluate the feasability to determine the difference of tumoral metabolism before and after artificial nutrition.

Detailed description: Evaluation of the feasability to determine the difference of tumoral metabolism before and after artificial nutrition. This activity will be measured with TEP/TDM 18F-FDG

Eligibility criteria: Inclusion Criteria:

* VADS cancer or oesophageal cancer
* Evaluation by 18F-FDG PET
* denutrition with weight loss of 5%
* Artificial nutrition
* ECOG\<2

Exclusion Criteria:

* Treatment by chemotherapy, surgery unless 2 months
* Treatment by radiotherapy unless 4 months
* Capillar glycemia \>12mmol/l during the PET

Primary outcomes:
measure: rate of Standardized Uptake Value (SUV)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: ICM Val d'Aurelle
Study officials:
affiliation: ICM Co. Ltd.
name: DESHAYES Emmanuel
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00029237: Alternative Stress Management Approaches in HIV Disease
Official title: Alternative Stress Management Approaches in HIV Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: Behavioral intervention
Psychoneuroimmunology
Complementary therapy
Stress and coping
complementary therapies
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2002-01-10
Enrollment: 392
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: ECT

Brief summary: The overall purpose of the proposed study is to determine whether three short-term stress management interventions along with booster strategies will improve and sustain improvements in psychosocial functioning, quality of life, and somatic health among persons with varying stages of HIV disease. The 10-week group interventions are designed to reduce perceived stress and increase coping effectiveness and include cognitive-behavioral stress management focused on positively living (+LIVE), focused Tai Chi (TCHI) training, and spiritual growth groups (SPRT). Effects of the interventions will be evaluated immediately upon completion of the group training and at 6 months and 12 months following stress management training.

Detailed description: The overall purpose of the proposed study is to determine whether three short-term stress management interventions along with booster strategies will improve and sustain improvements in the domains of psychosocial functioning, quality of life, and somatic health among persons with varying stages of HIV disease. These three outcome domains, along with neuroendocrine mediation, will be measured by multiple indicators derived from the psychoneuroimmunology (PNI)paradigm. The interventions are designed to reduce perceived stress and increase coping effectiveness and include cognitive-behavioral stress management focused on positively living (+LIVE), focused Tai Chi (TCHI) training, and spiritual growth groups (SPRT). The primary aim of this randomized clinical trial is to compare the +LIVE, TCHI, and SPRT interventions to each other and to standard care received by a control group of wait-listed participants (WAIT) for effects on psychosocial functioning (perceived stress, coping patterns, social support, psychological distress), quality of life (including spiritual well-being), neuroendocrine mediation (cortisol, DHEA levels), and somatic health (disease progression, HIV-specific health status, immune status).

Eligibility criteria: Inclusion Criteria:

* Aware of HIV-infected diagnosis

Exclusion Criteria:

* Current psychoactive drug use
* Severe and unstable psychiatric diagnosis
* Major cognitive dysfunction

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
References:
Clinical trial NCT00394537: Labetalol to Prevent Hypertension and Tachycardia During Fiberoptic Bronchoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bronchoscopy
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2006-11-01
Enrollment: 72
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: Passing a bronchoscope through the airways frequently causes a stress response even though patients are sedated. This stress response is usually an increase in pulse and blood pressure, which may have undesirable effects on the heart and circulation.

We plan to give patients labetalol (a beta blocker which reduces pulse and blood pressure) in addition to normal sedation, to patients undergoing bronchoscopy in our department.


Eligibility criteria: Inclusion Criteria:

* All patients over 18 years old undergo fiberoptic bronchoscopy in our unit

Exclusion Criteria:

* inability or refusal to give informed consent
* bronchoscopy through an artificial airway
* intolerance or allergy to the study drug
* bradycardia (HR\<60/min) or hypotension (systolic BP \<100) at screening
* pregnancy,
* concomitant treatment with diltiazem or verapamil
* intention to use propofol as the sedative agent for bronchoscopy.

Primary outcomes:
measure: Heart Rate
measure: Systolic Blood Pressure
measure: Diastolic Blood Pressure
measure: Rate pressure product (HR*SBP/100)
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Rabin Medical Center
name: Mordechai Kramer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fox BD, Krylov Y, Leon P, Ben-Zvi I, Peled N, Shitrit D, Kramer MR. Benzodiazepine and opioid sedation attenuate the sympathetic response to fiberoptic bronchoscopy. Prophylactic labetalol gave no additional benefit. Results of a randomized double-blind placebo-controlled study. Respir Med. 2008 Jul;102(7):978-83. doi: 10.1016/j.rmed.2008.02.011. Epub 2008 Apr 3.
Clinical trial NCT01948037: Effectiveness Study of Hydrotherapy Against Pain and Other Symptoms in Diabetes-induced LEAD
Official title: Hydrotherapy for the Treatment of Symptomatic Lower Extremity Arterial Disease in Diabetes Type 2 Patients:A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes
Lower Extremity Arterial Disease
Keywords: hydrotherapy
randomized controlled trial
lower extremity arterial disease
diabetes
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2013-09-23
Enrollment: 70
Sex: ALL
Minimum age (years): 48
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate whether the hydrotherapy are effective in against pain and other symptoms in diabetes-induced LEAD.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Type 2 diabetes mellitus
* diagnosis of lower extremity arterial disease

Exclusion Criteria:

* Severe heart disease
* can't hydrotherapy

Primary outcomes:
measure: Change from the intensity of numbness and cold feeling at 4 weeks. Change from the improvement of the pain index at 4 weeks.
timeFrame: 4 weeks
Secondary outcomes:
measure: Change from ankle-brachial index at 4 weeks
timeFrame: 4 weeks
Other outcomes:
measure: Change from flow velocity values at 4 weeks
timeFrame: 4 weeks
Locations:
city: Nanjing
country: China
facility: Nanjing Jinling Hospital
state: Jiangsu
Study officials:
affiliation: Jinling Hospital, China
name: Qiu Y bin
role: STUDY_CHAIR
References:
Clinical trial NCT00256737: Sopran - Omeprazole Treatment Versus Surgery
Official title: Omeprazole Versus Anti-reflux Surgery in the Long-term Management of Peptic Esophagitis - a 10 Year Follow up Study of Patients Previously Studied for 5 Years - A Nordic Multicentre Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: GERD
Keywords: Maintenance of healed erosive esophagitis
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-11-22
Enrollment: 219
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 study gastritis, GI symptoms during long term omeprazole treatment


Eligibility criteria: Inclusion Criteria:

* Previous inclusion into Astra study I-635 and willing to continue for another 10 years,

Exclusion Criteria:

* Pregnancy or lactation; Woman planning pregnancy within 5 years; Suspected or confirmed malignancy; Documented eradication of Helicobacter pylori.

Primary outcomes:
measure: Determine the safety of omeprazole during long term treatment
Secondary outcomes:
measure: To investigate the long term control of reflux symptoms, healing of esophagitis and persistence of post fundoplication symptoms during long term treatment of omeprazole
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Research Site
city: Glostrup
country: Denmark
facility: Research Site
city: Hillerød
country: Denmark
facility: Research Site
city: Kolding
country: Denmark
facility: Research Site
city: Odense
country: Denmark
facility: Research Site
city: Roskilde
country: Denmark
facility: Research Site
city: Kuopio
country: Finland
facility: Research Site
city: Bergen
country: Norway
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Trondheim
country: Norway
facility: Research Site
city: Göteborg
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Örebro
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca GI Medical Science Director, MD
role: STUDY_DIRECTOR
References:
citation: Attwood SE, Ell C, Galmiche JP, Fiocca R, Hatlebakk JG, Hasselgren B, Langstrom G, Jahreskog M, Eklund S, Lind T, Lundell L. Long-term safety of proton pump inhibitor therapy assessed under controlled, randomised clinical trial conditions: data from the SOPRAN and LOTUS studies. Aliment Pharmacol Ther. 2015 Jun;41(11):1162-74. doi: 10.1111/apt.13194. Epub 2015 Apr 10.
Clinical trial NCT06616337: Patients Suffering From Emotional Dysregulation
Official title: Retrospective Study of the Acceptability and Effectiveness of a Dialectical Behavioral Therapy Group in Patients Suffering From Emotional Dysregulation (Borderline Personality Disorder, Bipolar Disorder and Adult ADHD)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Emotional Dysregulation
Keywords: Emotional Dysregulation
Schizophrenia
Bipolar disorder
Borderline personality disorder
Attention deficit hyperactivity disorder (ADHD)
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2024-09-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major subject (≥18 years old) having participated in the first session of a GREMO group, which is a behavioral and dialectical therapy protocol during the period from January 1, 2018 to December 31, 2023.

Brief summary: Emotional dysregulation (ED) is a common syndrome in psychiatric disorders. It is characterized by intense emotions, easily triggered, and with significant psychological impact: explosions of anger, irritability, impulsivity, emotional lability, etc. It is systematic in borderline personality disorder, and observed in a majority of patients with bipolar disorder. (even in the interictal period), adult ADHD, or addictions. ED is a cause of psychological distress, suicidal behavior or non-suicidal self-injury, and impaired quality of life. Pharmacological treatments only very partially improve these symptoms. Psychotherapies aimed at reducing ED are poorly developed in France. Dialectical behavioral therapy is a therapy that has shown its effectiveness in ED of BPD.

This is why the psychiatry and addiction center of the University Hospitals of Strasbourg has set up groups using this psychotherapeutic approach based on this technique for almost 3 years. This technique being very little practiced in France, and even less studied, we want to see if it is adapted to a French population not accustomed to this type of practice.


Eligibility criteria: Inclusion Criteria:

* Major subject (≥18 years old)
* Having participated in the first session of a GREMO group, which is a behavioral and dialectical therapy protocol from January 1, 2018 to December 31, 2023,
* Subject not opposing the reuse of their data for scientific research purposes.

Exclusion Criteria:

* Subject having expressed their opposition to the reuse of their personal data for scientific research purposes.

Primary outcomes:
measure: Evaluate the change of symptoms of emotional dysregulation
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Psychiatrie 2 - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT05529537: Manual Lymphatic Drainage for Rheumatoid Arthritis
Official title: The Effect of Manual Lymphatic Drainage on Upper Extremity Functionality in Rheumatoid Arthritis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effect of Manual Lymphatic Drainage on Upper Extremity Functionality in Rheumatoid Arthritis
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 39
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Rheumatoid arthritis (RA) is a chronic, progressive, autoimmune disease characterized by inflammation of the synovial joints and tendon sheaths. As a result of synovitis, progressive damage occurs in cartilage, bone and joints. This damage leads to severe functional limitations and deterioration in quality of life. Synovial tissues are the main site of involvement. Manual lymph drainage reduces the levels of inflammatory mediators associated with edema and pain in the acute phase. On the basis of this concept; Stimulating the lymph system and increasing circulation, removing biochemical residues, regulating sympathetic and parasympathetic system responses, and thus reducing edema and pain. The increase in cardiac parasympathetic activity measured after MLD also contributes to relaxation. In addition to the transport of lymphatic fluid, manual lymph drainage stimulates free nerve endings in the skin with the touches it contains. Gentle stimulation to the skin increases tactile input and closes the pain pathways. In addition, the superficial relaxation and warming provided by soft stimulation creates an effect on the autonomic nervous system and activates the parasympathetic system. The aim of this study is to evaluate the effect of manual lymphatic drainage on upper extremity functionality in individuals with rheumatoid arthritis.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with RA according to ACR criteria
* Being between the ages of 18-65
* Volunteering to participate in the study

Exclusion Criteria:

* Presence of neuromuscular disease
* Having difficulty walking
* Cognitive impairment
* Having systemic disease such as diabetes mellitus and osteoarthritis
* History of upper extremity sIf you have Hand Deformity

Primary outcomes:
measure: Rheumatoid Arthritis Quality of Life Scale (QOL-RA)
timeFrame: 10 minutes
measure: pressure pain threshold
timeFrame: 5 minutes
measure: hand grip strength
timeFrame: 5 minutes
measure: finger grip strength
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kütahya
country: Turkey
facility: Kutahya Health Science University Hospital
Study officials:
References:
Clinical trial NCT00404937: Tobradex BID Compared to TOBRADEX and TOBREX/Vehicle
Official title: Tobradex BID Compared to TOBRADEX and TOBREX/Vehicle
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Post-surgical Inflammation
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2006-11-29
Enrollment: 0
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 compare the new formulation of Tobradex to the current approved formulation


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for cataract extraction

Exclusion Criteria:

* Under 18 years

Primary outcomes:
measure: Anterior chamber inflammation
Secondary outcomes:
measure: Aqueous cells and flare
measure: ocular pain
measure: physician's impression of infection
measure: frequency of treatment failures
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03539237: Closing the Gap Between Self-reported and Accelerometer-based Physical Activity
Official title: Effect of an Intensity Level Video Demonstration on the Gap Between Self-reported and Accelerometer-measured Physical Activity in Individuals Aged 40 to 75 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: Video demonstration
Intensity levels
Physical activity
Self-report
Accelerometer
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
Collaborators: name: Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
First posted: 2018-05-29
Enrollment: 379
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study examines the effect of a video-based intensity level demonstration on self-reported physical activity in individuals aged between 40 and 75 years. Aim of the video demonstration is to achieve a better concordance of physical activity reports with accelerometer-based measurements.

Detailed description: This study examines whether the demonstration of different intensity levels of physical activity by video in the context of a tablet PC (personal computer)-based survey can achieve a higher degree of concordance between self-reported and accelerometer-measured physical activity compared to an assessment without video demonstration. The recruitment of the study participants in the age range between 40 and 75 years takes place in a shopping center in the city Greifswald in Germany.

Informed consent consists of: (i) activity recording over 7 days using an accelerometer, (ii) completion of standardized questionnaires, (iii) participation in a standardized measurement of weight and height as well as waist and hip circumference.

Participants are asked to wear an accelerometer during the day for a period of 7 days. Subsequently, a questionnaire about the frequency, duration and intensity of physical activity in the last 7 days will be answered in the DZHK (Deutsches Zentrum für Herz-Kreislauf-Forschung)- examination center. Prior to the physical activity assessment the study participants are randomly assigned to the study conditions "Video" or "No Video" (ratio 1:1). Optionally, participants may receive feedback on their physical activity measured by accelerometer upon completion of the study.

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* cognitive impairment
* inadequate language skills

Primary outcomes:
measure: Difference between physical activity measured by self-report and by accelerometry
timeFrame: The accelerometer is worn for 7 days and then the IPAQ-SF is retrospectively answered for these 7 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: Institute of Social Medicine and Prevention, University Medicine Greifswald
Study officials:
References:
Clinical trial NCT03456037: Incidence Of Hepatitis In Intensive Care Unit
Official title: Incidence Of Hepatitis And Its Effect On Prognosis In Patients Who Follow In Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intensive Care Unit
Keywords: HBsAg
Anti-HCV,
seropositivity
Lead sponsor: Sakarya University
Sponsor class: OTHER
First posted: 2018-03-07
Enrollment: 500
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: The study was conducted from 1 january 2015 to 1 january 2016 . Patients who were followed with various diagnoses in intensive care units between 1 january 2015 to 1 january 2016, covering the one year period, retrospectively.

Brief summary: The aim is to investigate incidence of HBsAg, anti-HCV in serum samples and evaluation of biomarkers taken from patients who were followed the intensive care unit of Sakarya University Training and Research Hospital and The intensive care unit attracts attention by making health workers more susceptible to the risk of hepatitis.

Detailed description: This retrospective study included 536 cases who were followed with various diagnoses in intensive care units between 1 Ocak 2015 ile 1 Ocak 2016, covering the six months period, retrospectively. Sakarya University's Faculty of Medicine Review Board (71522473/050.01.04/113) approved the study after approval of the research ethics committee (. Medical record forms and electronic medical record system of the hospital were used in the analysis of medical data with regard to age, sex, HBsAg, anti-HCV, AST, ALT, bilirubin, creatinine levels.

Eligibility criteria: Inclusion Criteria:

All patients who were followed in the intensive care unit

Exclusion Criteria:

None

Primary outcomes:
measure: HBsAg
timeFrame: 1 month
Secondary outcomes:
measure: anti-HCV
timeFrame: 1mounth
Other outcomes:
Locations:
city: Sakarya
country: Turkey
facility: Sakarya University Research and Training Hospital
Study officials:
affiliation: Sakarya University Research and Training Hospital
name: Havva Sayhan,, Assis Prof
role: STUDY_CHAIR
References:
citation: Dayan S, Tekin A, Tekin R, Dal T, Hosoglu S, Yazgan UC, Bekcibasi M, Gul K. HBsAg, anti-HCV, anti-HIV 1/2 and syphilis seroprevalence in healthy volunteer blood donors in southeastern Anatolia. J Infect Dev Ctries. 2013 Sep 16;7(9):665-9. doi: 10.3855/jidc.2835.