louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05240729: Using Ultrasound in Infraclavicular in Upper Limb Surgeries
Official title: Ultrasound Guided Retroclavicular Approach Versus Costoclavicular Approach of Infraclavicular Brachial Plexus Block for Upper Limb Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Limb Surgeries
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Comparison of 3 approach of infraclavicular brachial plexus

Detailed description: Comparison of retroclavicular \& costoclavicular and classic type of infraclavicular brachial plexus block for upper limb surgeries

Eligibility criteria: Inclusion Criteria:

* age: between 18 and 60 years ASA I and II BMI between 18 and 35 surgeries to forearm and hand

Exclusion Criteria:

* patient refusal pregnancy allergy to local anaesthetics local infection neuropathy ,coagulopathy anatomical abnormality in clavicular region

Primary outcomes:
measure: Motor and sensory block success rate
timeFrame: 30 min
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Facutly of Medicine
Study officials:
affiliation: Minia University
name: Jozef zekry, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03462329: Patient's Pretreatment Expectations About Post-Lyme Symptoms
Official title: Impact of Patient's Pretreatment Expectations on Treatment Outcome of Early Lyme Borreliosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Erythema Migrans
Keywords: Post-Lyme symptoms
Pretreatment expectations
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2018-03-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Patients will evaluate their pre-treatment expectations about treatment outcome of erythema migrans.

Nonspecific symptoms will be assessed in patients and control subjects.
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators will focus on pretreatment expectations of patients with early Lyme disease manifested as erythema migrans with the aim of assessing the association between pretreatment expectations quantified with a questionnaire and treatment outcome quantified with the presence of post-Lyme symptoms. Furthermore, the investigators will compare the prevalence of nonspecific symptoms among patients and among age-matched controls without a history of Lyme borreliosis.


Eligibility criteria: Inclusion Criteria:

* erythema migrans

Exclusion Criteria:

* pregnancy or lactation
* immunocompromised
* taking antibiotic with antiborrelial activity within 10 days

Primary outcomes:
measure: Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 14 days postenrollment in patients treated for erythema migrans
timeFrame: Study point: at 14 days post-enrollment.
measure: Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 2 months postenrollment in patients treated for erythema migrans
timeFrame: Study point: at 2 months post-enrollment.
measure: Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 6 months postenrollment in patients treated for erythema migrans
timeFrame: Study point: at 6 months post-enrollment.
measure: Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 12 months postenrollment in patients treated for erythema migrans
timeFrame: Study point: at 12 months post-enrollment.
Secondary outcomes:
measure: Change in occurrence of nonspecific symptoms from baseline to 6 months and to 12 months post-enrollment in patients with erythema migrans and control subjects
timeFrame: Study points will be: at enrollment, at 6, and at 12 months post-enrollment.
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical center Ljubljana
Study officials:
References:
Clinical trial NCT01599429: Study of the Predictive Marker FLT in Patients Suffering From AML
Official title: Use of FLT-TEP Scan as Predictive Marker and Early Prognostic in Patients Suffering From AML Treated by Chemotherapy
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Acute Myeloid Leukemia
Keywords: AML / LMA
Lead sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Sponsor class: OTHER
First posted: 2012-05-16
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 newly diagnosed with acute myeloid, between October 2011 and October 2013, at the Centre Hospitalier Universitaire de Sherbrooke (CHUS).

Brief summary: Positron emission tomography uses various radioactive tracers to measure the metabolic activity in a none-invasive way, and specially to follow the activity of the disease during the treatments.

Among those new tracers, fluorothymidine (18F-FLT) arouses a lot of interest. This new tool would allow to image and follow time wise acute myeloid leukemia (AML). The investigators want, with the (18F-FLT), to characterise the aggressivity of the tumors and the prognostic before and after chemotherapy treatment.

The aim of this study is to be able to identify earlier the responders, because if they are detected sooner, these patients will benefit from more aggressive treatments.


Eligibility criteria: Inclusion Criteria:

1. Patients 18 years or above at the time of inclusion;
2. Patients newly diagnosed with acute myeloid leukemia;
3. No contraindication or intolerance to any of the components of the standard chemotherapy by induction (7+3);
4. Patients able to give written informed consent.

Exclusion Criteria:

1. Patients unable to tolerate decubitus position for at least 45 minutes;
2. Any previous neoplasia or other neoplasia simultaneously;
3. Previously treated buy radiotherapy, with bone marrow in the field of radiation;
4. Other chemotherapy treatment than the standard chemotherapy by induction (7+3), before the second FLT-TEP was done.

Primary outcomes:
measure: To mesure the pronostic value of metabolic activity in the bone marrow with FLT-PET prior to chemotherapy in patients with AML disease.
timeFrame: September 2015
Secondary outcomes:
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Université de Sherbrooke, Centre Hospitalier Universitaire de Sherbrooke, Centre d'imagerie moléculaire de Sherbrooke (CIMS), Centre de recherche Étienne Le-Bel
name: Éric E Turcotte, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Sherbrooke, Centre Hospitalier Universitaire de Sherbrooke
name: Rami Kotb, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03216629: Sorry Not Sorry: Apologizing and Its Effect on Discomfort During Dressing Removal
Official title: Sorry Not Sorry: Apologizing and Its Effect on Discomfort During Dressing Removal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bandages
Pain
Empathy
Keywords: Pain
Empathy
Dressing change
Lead sponsor: London Health Sciences Centre
Sponsor class: OTHER
First posted: 2017-07-13
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Use of dressing is common place following surgery, allowing for wounds to be covered and protected. Dressing material with adhesive contact layers or adhesive tape is integral to sealing off the wound. Mechanical stripping of stratum corneum during dressing removal causes pain and discomfort. During dressing removal, practitioners may at times apologize as a function of empathy. Previous study investigated speed of dressing removal and its effect on discomfort during dressing change. In this study, the investigators aim to investigate how empathy expressed in form of saying "sorry" affect the perception of pain during dressing change?


Eligibility criteria: Inclusion Criteria:

* Healthy adult volunteers, age \>18.

Exclusion Criteria:

* individuals with sensitivity to tape or dressing, anxiety disorders, or pain syndromes.

Primary outcomes:
measure: Pain
timeFrame: Immediate
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Science Centre - Victoria Hospital
state: Ontario
Study officials:
affiliation: London Health Science Centre
name: Danielle MacNeil, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02618629: Mass Balance and Metabolism Study of 14C-Z-215
Official title: A Phase I Mass Balance and Metabolism Study of 14C-Z-215 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Subjects
Lead sponsor: Zeria Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2015-12-01
Enrollment: 6
Sex: MALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this Phase I study is to determine the absorption, metabolism, and excretion of 14C-Z-215 in healthy male subjects following a single oral administration at a therapeutically relevant dose level (20 mg).


Eligibility criteria: Inclusion Criteria:

* Any race/ethnic origin
* Subjects will have a body mass index (BMI) between 18.5 and 30.0 kg/m2
* Subjects will have a body weight between 50 and 110 kg
* Subjects will have given their written informed consent to participate in the study, and to abide by the study restrictions.

Exclusion Criteria:

* Subjects who have a significant history of drug allergy, as determined by the Investigator.
* Subjects who have serum hepatitis or are carriers of the hepatitis B surface antigen (HBsAg) or the hepatitis C antibody.
* Subjects who have a positive result for the test for human immunodeficiency virus (HIV) antibodies.
* Subjects who are exposed to radiation as a result of their occupation.
* Subjects who, in the opinion of the Investigator, should not participate in this study.

Primary outcomes:
measure: Mass balance recovery of total radioactivity concentration in plasma, red blood cells and whole blood
timeFrame: Predose,15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours postdose
measure: Concentration of Z-215 in plasma
timeFrame: Predose,15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours postdose
measure: Mass balance recovery of total radioactivity in urine
timeFrame: Predose, 0 to 6, 6 to 12, 12 to 24, 24 to 36, 36 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, 144 to 168, 168 to 192, 192 to 216, 216 to 240 hours postdose, Day 15 (336 hours postdose), Day 19 (432 hours postdose), Day 23 (528 hours postdose)
measure: Mass balance recovery of total radioactivity in faecal
timeFrame: Predose, 0 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, 144 to 168, 168 to 192, 192 to 216, 216 to 240 hours postdose, Day 15 (336 hours postdose), Day 19 (432 hours postdose), Day 23 (528 hours postdose)
Secondary outcomes:
Other outcomes:
Locations:
city: UK
country: United Kingdom
Study officials:
References:
Clinical trial NCT01331629: Impact of Art Therapy on Fatigue and Quality of Life of Patients Treated With Adjuvant Radiotherapy for Breast Cancer
Official title: Impact of Art Therapy on Fatigue and Quality of Life of Patients Treated With Adjuvant Radiotherapy for Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Breast Cancer
Keywords: breast cancer
fatigue
quality of life
art-therapie
adjuvant radiotherapy
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
Collaborators: name: Ligue contre le cancer, France
First posted: 2011-04-08
Enrollment: 322
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to compare intervention by Art-therapy to standard care in patients treated with adjuvant radiotherapy for breast cancer and evaluate the fatigue.


Eligibility criteria: Inclusion Criteria:

* Breast cancer surgery (invasive or in situ) by conservative surgery
* Age ≥ 18 years
* Indication of adjuvant radiotherapy
* Adjuvant chemotherapy allowed
* Agreeing to participate in a clinical study
* Able to participate in a clinical trial

Exclusion Criteria:

* Metastatic Breast Cancer
* Personal history of breast cancer

Primary outcomes:
measure: evaluate persistent fatigue
timeFrame: up to 12 months after radiotherapy
Secondary outcomes:
measure: Evaluate the quality of life patients.
timeFrame: up to 12 months after radiotherapy
measure: Assess the impact of the condition of patients on the reactions, depression and anxiety of relatives Assess the impact of the condition of patients on the reactions, depression and anxiety of relatives
timeFrame: up to 12 months after radiotherapy
measure: Evaluate the fatigue away from the treatment (at 6 months and 1 year) of patients
timeFrame: 6 months and 12 months after treatment
measure: Evaluate the anxiety of patients
timeFrame: up 12 months after radiotherapy
measure: evaluate the depression of patients
timeFrame: up 12 months after study
measure: Evaluate the quality of life away from the treatment (at 6 months and 1 year) of patients
timeFrame: 6 months and 1 year after treatment
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François BACLESSE
state: Calvados
city: Grenoble
country: France
facility: CHU
state: Isère
city: Lille
country: France
facility: Centre Oscar LAMBRET
state: Nord
city: Rouen
country: France
facility: Centre Henri Becquerel
state: Seine Maritime
city: Nice
country: France
facility: Centre Antoine LACASSAGNE
city: Reims
country: France
facility: Institut Jean Godinot
Study officials:
References:
Clinical trial NCT04543929: Effects of Innovative Aerobic Exercise Training in Cystic Fibrosis
Official title: Effects of Innovative Aerobic Exercise Training in Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2020-09-10
Enrollment: 9
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 main objective of this study is to compare the effectiveness of two different exercise interventions in a patient-centered, home-based exercise program for improving cardiorespiratory-fitness in people with cystic fibrosis (CF). We hypothesize cystic fibrosis patients participating in a high intensity interval training (HIIT) group will experience greater improvements in cardiorespiratory-fitness than those in a moderate continuous training (MCT) group. Further, we plan to investigate the efficacy of the comparators on patient-centered outcomes.

Detailed description: This study is a randomized control trial that compares MCT to HIIT using a patient-centered and home-based delivery model with CF Care Centers in the United States. Participants will be randomly allocated to either an MCT or HIIT arm. Both the MCT and HIIT interventions are accepted forms of prescribed exercise in clinical practice. The interventions will be delivered with a telehealth platform using internet (HIPAA-Compliant video), phone, and email/text support. All study sites will receive initial and on-going training and program facilitation to assure consistency of delivering the intervention. All participants across both arms visit their respective CF clinics on a regular basis for routine CF care. Thus, our research team will be able to coordinate all testing/assessment visits, including long-term (18-month timepoint), with participants throughout the study. The primary and secondary outcomes include important patient-centered outcomes as selected by our study's CF Patient and Stakeholder Advisory Board.

Eligibility criteria: Inclusion Criteria:

* diagnosed with Cystic Fibrosis
* Prescribed and taking for 28 days ivacaftor-tezacaftor-elexacaftor (Trikafta)
* 18 years and older

Exclusion Criteria:

* 17 years of age or less
* not eligible for ivacaftor-tezacaftor-elexacaftor (Trikafta)
* inability to exercise
* pregnancy
* status post lung transplantation
* already participating in more than 150 minutes of aerobic exercise per week

Primary outcomes:
measure: Aerobic Exercise Capacity - V02max
timeFrame: 18 months
Secondary outcomes:
measure: Pulmonary function testing
timeFrame: 18 months
measure: Quality of Life measured by Cystic Fibrosis Questionnaire - Revised (CFQ-R)
timeFrame: 18 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Dave Burnett, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00771329: BIIB023 (Anti-TWEAK) in Subjects With Rheumatoid Arthritis
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB023 (Anti-TWEAK) Administered to Subjects With Rheumatoid Arthritis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2008-10-13
Enrollment: 53
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: Phase I study designed to determine the safety and tolerability of a single dose of BIIB023 administered intravenously versus placebo to subjects with RA.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of adult onset RA (functional class I-III) for at least 6 months
* Must have been treated with and be tolerating Methotrexate (5-25 mg/week) for 3 months, at a stable dose for at least 4 weeks
* Must have at least 4 swollen and tender joints due to rheumatoid arthritis

Exclusion Criteria:

* History of recurrent infections requiring antibiotic treatment within 12 months
* Serious local infection or systemic infection within 3 months
* Suffering from rheumatic or autoimmune disease other than RA
* History of cancer, heart failure, kidney disease, liver disease, HIV infection, tuberculosis or other serious illness

Primary outcomes:
measure: Determine the safety and tolerability of single doses of BIIB023 administered intravenously (IV) to subjects with RA.
timeFrame: Baseline through Day 70
Secondary outcomes:
measure: • Estimate the pharmacokinetic (PK) parameters of single doses of BIIB023 administered IV to subjects with RA • Evaluate potential markers of pharmacodynamic (PD) action of BIIB023 and its biological effects
timeFrame: Day -1, 0 (at several timepoints), 1, 2, 7, 14, 21, 28, 42, 56 and Day 70
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Research Site
state: Alabama
city: Palm Desert
country: United States
facility: Research Centre
state: California
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Duncansville
country: United States
facility: Research Centre
state: Pennsylvania
city: Moscow
country: Russian Federation
facility: Research Centre
city: Yaroslavl
country: Russian Federation
facility: Research Centre
Study officials:
References:
citation: Wisniacki N, Amaravadi L, Galluppi GR, Zheng TS, Zhang R, Kong J, Burkly LC. Safety, tolerability, pharmacokinetics, and pharmacodynamics of anti-TWEAK monoclonal antibody in patients with rheumatoid arthritis. Clin Ther. 2013 Aug;35(8):1137-49. doi: 10.1016/j.clinthera.2013.06.008. Epub 2013 Aug 6.
Clinical trial NCT02034929: EndoCuff-assisted Versus Standard Colonoscopy for Adenoma Detection
Official title: A Randomized Controlled Study to Compare EndoCuff-assisted With Standard Colonoscopy for the Detection of Adenomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polyp
Adenoma
Cancer
Keywords: colon cancer
adenoma
colon polyps
Lead sponsor: Helios Albert-Schweitzer-Klinik Northeim
Sponsor class: OTHER
First posted: 2014-01-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

Brief summary: The EndoCuff is novel flexible cuff that can be attached to the distal tip of the colonoscope and helps to flatten large mucosal folds during withdrawal.

The study hypothesis is that the use of the Endocuff (EC) increases the adenoma detection rate during colonoscopy.

The study purpose is to compare EC-assisted colonoscopy with standard colonoscopy for polyp detection.


Eligibility criteria: Inclusion Criteria:

indication for colonoscopy (screening, surveillance, diagnostic) ager ≥ 18 years ability to give informed consent

Exclusion Criteria:

* pregnancy
* age\<18 years
* known colonic strictures
* chronic inflammatory bowel disease
* active inflammation
* s/p colonic resection

Primary outcomes:
measure: adenoma detection rate
timeFrame: 25 minutes
Secondary outcomes:
measure: polyp detection rate
timeFrame: 1 Week
measure: number of LGIN and HGIN adenomas detected
timeFrame: one week
measure: polyp distribution
timeFrame: 25 minutes
measure: procedure time
timeFrame: 25 Minutes
measure: withdrawal time
timeFrame: 10 Minutes
measure: ileum intubation rate
timeFrame: 10 minutes
measure: total colonoscopy rate
timeFrame: 25 minutes
measure: adverse events
timeFrame: 25 minutes
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: University Medical Center Göttingen
city: Helmstedt
country: Germany
facility: HELIOS St. Marienberg Hospital Helmstedt
city: Northeim
country: Germany
facility: Helios Albert-Schweitzer-Hospital, Academic University Teaching Hospital
city: Siegburg
country: Germany
facility: HELIOS Medical Center Siegburg, Department of Gastroenterology
Study officials:
affiliation: Helios Albert-Schweitzer-Hospital
name: Tobias Meister, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Floer M, Biecker E, Fitzlaff R, Roming H, Ameis D, Heinecke A, Kunsch S, Ellenrieder V, Strobel P, Schepke M, Meister T. Higher adenoma detection rates with endocuff-assisted colonoscopy - a randomized controlled multicenter trial. PLoS One. 2014 Dec 3;9(12):e114267. doi: 10.1371/journal.pone.0114267. eCollection 2014.