louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03008473: Chest CT for the Placement of the Uniblocker
Official title: Placement of the Uniblocker Under the Guidence of Chest Computerized Tomography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Therapeutic Procedural Complication
Lead sponsor: The First Hospital of Qinhuangdao
Sponsor class: OTHER_GOV
First posted: 2017-01-02
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Video laryngoscope and chest CT iminge for the placement of the Uniblocker

Detailed description: Comparing the traditional method of Uniblocker intubation and video laryngoscope combined with chest CT iminge guide the precise localization of Uniblocker

Eligibility criteria: Inclusion Criteria:

BMI less than 35 kg/m2 ASA classifications of I-III, Modified Mallampati classification 1 or 2 Under general anesthesia

Exclusion Criteria:

* Age younger than 18 yr or older than 65 yr
* ASA class IV or V
* Abnormalities of the heart, brain, liver, lung, kidney and coagulation functions

Primary outcomes:
measure: Intubation Time
timeFrame: 5min
Secondary outcomes:
Other outcomes:
Locations:
city: Qinhuangdao
country: China
facility: The first hospital of Qinhuangdao
state: Hebei
Study officials:
affiliation: The First Hospital of Qinhuangdao
name: Ximing Qi, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06054373: The Distribution of Immunoglobulin Isotype in Polyclonal Hypergammaglobulinemia in Systemic and Autoimmune Diseases
Official title: The Distribution of Immunoglobulin Isotype in Polyclonal Hypergammaglobulinemia in Systemic and Autoimmune Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Polyclonal Hypergammaglobulinemia
Autoimmune Diseases
Keywords: Polyclonal Hypergammaglobulinemia
Autoimmune Diseases
immunoglobulin isotypes
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Binding site
First posted: 2023-09-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with diagnosis of various autoimmune diseases and polyclonal hypergammaglobulinaemia. Medical records from 2004 to 2018 were reviewed to identify eligible patients.

Brief summary: Polyclonal hypergammaglobulinaemia is characterized by increased levels of immunoglobulins and is a common feature observed in various diseases such as autoimmune diseases, chronic infectious diseases or lymphoid hemopathy. Some autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis or Sjögren's syndrome are frequently associated with polyclonal hypergammaglobulinaemia. Recent data have suggested that the distribution of immunoglobulin isotypes in polyclonal hypergammaglobulinaemia may be disease-specific. However, isotype repartition in polyclonal hypergammaglobulinaemia remains poorly understood.

The investigators will investigate the distribution of immunoglobulin isotype in patients with autoimmune disease and polyclonal hypergammaglobulinaemia. Moreover, the investigators will evaluate the isotype repartition as predictor of lymphoma or monoclonal gammopathy among patients with autoimmune diseases.


Eligibility criteria: Inclusion Criteria:

* All adult patients \> 18 years old
* patients with one of the following diseases: systemic lupus erythematosus, rheumatoid arthritis, Sjögren's syndrome, autoimmune hepatitis, sarcoidosis or lymphoma.

Exclusion Criteria:

* Age \< 18 years;
* chronic viral hepatitis;
* HIV infection, syphilis,
* tuberculosis

Primary outcomes:
measure: distribution of immunoglobulin isotypes
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT06244173: Clinical and Laboratory Parameters of Myelodysplastic Syndromes at Upper Egypt
Official title: Clinical and Laboratory Parameters of Myelodysplastic Syndromes at Upper Egypt
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myelodysplastic Syndromes
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: cases of Denovo MDS attending to Sohag Univeristy hospital and Assuit University hospitals

Brief summary: The aim of our study is to assess clinical \& laboratory parameters of adult Egyptian myelodysplastic syndrome patients in upper Egypt, its correlation with disease-free survival, overall survival (OS) and acute leukemia transformation.

Detailed description: The aim of this study is to assess clinical \& laboratory parameters of adult Egyptian myelodysplastic syndrome patients in upper Egypt, its correlation with disease-free survival, overall survival (OS) and acute leukemia transformation.

Materials and methods:

This study will be conducted in Sohag University Hospital and Assuit University Hospitals on available number of newly diagnosed patients with MDS according to the diagnostic criteria proposed by the WHO in 2016 .

full history taking, clinical assessment and certain laboratory investigations are conducted to every patient enrolled in this study.

Eligibility criteria: Inclusion Criteria:

* De novo MDS according to WHO criteria diagnosis 2016

Exclusion Criteria:

* MDS on top of AML

Primary outcomes:
measure: overall survival
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag univeristy hospitals
Study officials:
affiliation: faculty of medicine - Sohag university
name: Asmaa abdelbaset, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00069173: Preventing Osteoporosis in Adolescent Girls
Official title: Prevention of Osteoporosis Among Sedentary Adolescent Females
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Osteoporosis
Keywords: Females
Sedentary
School-based
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2003-09-17
Enrollment: 250
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Physical activity in adolescents is an important part of bone health. Good bone health in adolescents can decrease the risk of osteoporosis. This study will evaluate a program designed to increase the level of physical activity in adolescent girls.

Detailed description: Despite the documented health benefits of increased physical activity, there is limited research on behavioral programs designed to increase exercise in adolescents. Psychosocial characteristics, such as self-efficacy for exercise, social support for exercise from family and peers, and perceived benefits of and barriers to exercise, may predispose adolescents toward the adoption and maintenance of physical activity. This study will implement a multifaceted behavioral program specifically designed to increase bone strengthening physical activity by addressing many of the psychosocial factors relating to exercise.

Girls in this study will be enrolled in Project Fitness and Bone (FAB). The Project FAB intervention is delivered during a regular school class period 5 days per week for 10 months. One day per week is devoted to didactic presentations and/or discussion about reasons for being active, ways of overcoming barriers to being active, and strategies for maintaining an active lifestyle. The remaining four days are structured activity sessions, including a range of activities such as modified basketball, aerobic dance, and walking around a track. Primary outcome measures will include bone mass (measured via dual-energy x-ray absorptiometer \[DEXA\]) and serum and urinary measures of bone formation and resorption. Participants will be contacted by telephone 12 months after their final clinic visit to ascertain their activity level at that time.

Eligibility criteria: Inclusion Criteria

* Entering the 10th or 11th grade
* Participating in fewer then three vigorous activity sessions per week lasting 20 minutes or more or fewer than five moderate activity sessions per week lasting 30 minutes or more
* At or below the 75 percentile for age- and gender-specific cardiovascular fitness
* Past the age of first menstrual cycle

Exclusion Criteria

* Health problems that would preclude participation in regular exercise

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California at Irvine
state: California
Study officials:
affiliation: University of California at Irvine
name: Margaret S. Jamner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00395473: Ezetimibe Added to Statin Therapy (EASY) Study (0653-087)(COMPLETED)
Official title: Ezetimibe Added to Statin Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2006-11-03
Enrollment: 141
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: In the context of australian general practice, to determine the efficacy and safety of ezetimibe 10mg/statin 40mg coadministration in patients with uncontrolled cholesterol receiving statin 40mg or more.


Eligibility criteria: Inclusion Criteria:

* Patients who will remain on a stable statin dose of 40mg or more, for the duration of the study
* Patients with coronary heart disease or diabetes mellitus whose cholesterol levels remain above the initial threshold for government subsidy after at least 3 months of treatment at a daily dose of 40mg or greater of a statin

Exclusion Criteria:

* Illnesses such as congestive heart failure nyha class iii or iv
* Uncontrolled hypertension
* Myocardial infarction
* Coronary bypass surgery or angioplasty with or without stent within 3 months of the enrolment visit
* Unstable angina pectoris or unstable or severe peripheral vascular disease
* Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins, ex: type i or type ii diabetes mellitus that is poorly controlled
* Serum creatinine \>0.18mmol/l at enrolment or active renal disease with significant proteinuria
* Disorders of the haematologic, digestive (including malabsorptive disorders)
* Central nervous system including cerebrovascular disease and degenerative diseases that would limit study evaluation or participation
* Active acute or chronic hepatobiliary disease
* Patients taking the following medication: medications known to interact with statin medication including antifungal azoles, macrolide antibiotics, telithromycin; nefazodone; protease inhibitors; amiodarone; danazol and verapamil; fibrates; cyclosporin
* Tg \>4.0mmol/l while using a statin

Primary outcomes:
measure: Percent (%) reduction in plasma low-density lipoprotein cholesterol (ldl-c) concentration after 6 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Simons LA, Symons J. Ezetimibe added to statin therapy (EASY study) - an evaluation by Australian general practitioners. Aust Fam Physician. 2007 Jan-Feb;36(1-2):90-2, 96.
Clinical trial NCT03358173: Operative Plate Fixation Versus Conservative Treatment for Acute, Displaced Fractures of Humeral Shaft
Official title: Operative Plate Fixation Versus Conservative Treatment for Acute, Displaced Fractures of Humeral Shaft
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Humeral Fractures
Keywords: Humeral Fractures
plate
Conservative Treatment
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2017-11-30
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men or women aged 18 to 65 years of age Completely displaced ,closed fracture of humeral shaft confirmed by radiograph Fractures within 1 month post injury

Brief summary: Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle

Detailed description: From Jane 2015 to October 2016, patients with displaced humeral shaft fractures are retrospectively included in this study, they were treated with either operative plate or conservative treatment. All the patients are regularly followed up in clinic. Then we will compare the union rate and clinical functional outcome(DASH score) between the 2 groups at 1 year after surgery.

Eligibility criteria: Inclusion Criteria:

Men or women aged 18 to 65 years of age Completely displaced ,closed fracture of humeral shaft confirmed by radiograph Fractures within 1 month post injury Provision of informed consent

Exclusion Criteria:

Pathological fractures Non-displaced (cortical contact) fractures Open fractures Presence of vascular or nerve injury Fractures more than 1 month post-injury Limited life expectancy due to significant medical co-morbidity Medical contraindication to surgery Inability to comply with rehabilitation or form completion Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, patients not mentally competent to give consent, etc.)

Primary outcomes:
measure: Union rate
timeFrame: 1 year after surgery
Secondary outcomes:
measure: Functional score
timeFrame: 1 year after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Peking University People's Hospital
name: Peng Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00136773: Effects of Amlodipine/Benazepril on Albuminuria in Hypertensive Patients With Type 2 Diabetes Mellitus
Official title: Effects of Amlodipine/Benazepril on Albuminuria in Hypertensive Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Albuminuria
Keywords: Albuminuria
Type 2 diabetes mellitus
Hypertension
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-08-29
Enrollment: 332
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Type 2 diabetes mellitus is usually associated with high blood pressure, which is a risk factor for kidney disease. Aggressive blood pressure reduction is an important strategy to protect the kidney and reduce urinary protein which develops with kidney disease. This study will evaluate the effects of amlodipine/benazepril in reducing blood pressure and urinary protein in hypertensive subjects with type 2 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* Mild to moderate hypertension
* Type 2 diabetes mellitus
* Presence of protein in the urine (albuminuria)

Exclusion Criteria:

* Kidney disease not caused by diabetes or hypertension
* Renal artery stenosis
* Myocardial infarction or stroke within the last 6 months
* Type 1 diabetes mellitus
* Pregnant or lactating females
* Cancer within the last 5 years

Primary outcomes:
measure: Change from baseline in the urine albumin/creatinine ratio after 52 weeks
Secondary outcomes:
measure: Percentage of patients who have progressed to diabetic kidney disease (urine albumin/creatinine ratio ≥ 300 µg/mg creatinine) after 52 weeks
measure: Change from baseline in the ratio of urine albumin/creatinine ratio an estimate of kidney function after 52 weeks
measure: Change from baseline in insulin resistance after 52 weeks
measure: Change from baseline in urine albumin secretion after 52 weeks
measure: Change from baseline in a marker of heart failure after 52 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT03983473: Identification of Fecal Microbiota Biomarkers of Spondyloarthritis in Patients Suffering From Crohn's Disease.
Official title: Identification of Fecal Microbiota Biomarkers of Spondyloarthritis in Patients Suffering From Crohn's Disease. Identification de Biomarqueurs de SPondylArthrite Chez Les Patients Atteints de Maladie de CROhn présents Dans le MICrobiote fécal.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Crohn Disease
Spondyloarthritis
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Régional Metz-Thionville
name: University Hospital, Strasbourg, France
name: Saint Antoine University Hospital
First posted: 2019-06-12
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The MICROSPA project aims to compare gut microbiota, serum cytokines, and PBMC of patients suffering from Crohn's disease (CD) associated or not to spondylarthritis (SpA). 3 groups of patients will be analyzed: patients suffering from CD alone, patients suffering from SpA alone, patients suffering from CD and SpA. One group of healthy controls will be analysed as a comparator. Fecal microbiota will be determined by bacteriome, virome and fungome NGS sequencing


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Patients will be recruited according to 3 groups:
* Patients with Crohn's disease and axial spondyloarthritis according to the criteria below.
* Patients with Crohn's disease (MC patients) with a diagnosis established according to clinical, biological criteria, radiological, endoscopic and / or histological studies for 3 months. With diagnosis of exclusion of a spondyloarthritis on criteria ASAS and / or New York modified.
* Patients with axial spondyloarthritis (SpA patients) with a diagnosis based on modified ASAS and / or New York criteria with exclusion diagnosis of Crohn's disease.
* Patient with the ability to give free and express informed consent.

Exclusion Criteria:

* History of colonic resection
* Taking antibiotics or colon preparation for colonoscopy within 8 weeks before stool collection (Temporary contraindication = removal possible before colic or first bowel preparation after the start of colonic preparation).
* Ostomy at the time of sampling
* BMI\> 30
* extreme diet
* unbalanced diabetes
* Pregnant woman
* Patient under guardianship, under curatorship or under the protection of justice Contacts/Locations Central Contact

Primary outcomes:
measure: Alpha and Beta diversity of Fecal bacteriome
timeFrame: + 6 months
measure: Alpha and Beta diversity of Fecal fungome
timeFrame: + 6 months
measure: Alpha and Beta diversity of Fecal virome
timeFrame: + 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: Central Hospital
state: Lorraine
city: Paris
country: France
facility: Saint Antoine Hospital
Study officials:
References:
Clinical trial NCT04096573: Efficacy and Safety of LC51-0255 in Subjects With Ulcerative Colitis
Official title: A Phase 2, Multi Center, Randomized, Placebo Controlled Parallel Group Study to Evaluate the Clinical Efficacy and Safety of LC51 0255 in Subjects With Moderately to Severely Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Ulcerative Colitis
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2019-09-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 2, multi center, randomized, placebo controlled parallel group study to evaluate the clinical efficacy and safety of LC51 0255 in subjects with moderately to severely active ulcerative colitis


Eligibility criteria: Inclusion Criteria:

* Aged 18 to 80 years
* Active UC confirmed by endoscopy
* Moderately to severely active UC defined as a 3-component Mayo Clinic score

Exclusion Criteria:

* Severe extensive colitis
* Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
* Treatment with cyclosporine, tacrolimus, sirolimus, methotrexate, or mycophenolate mofetil within 16 weeks of screening
* Treatment with a biologic agent (ie, anti TNFs, anti integrins, and anti interleukin 23) within 8 weeks prior to screening endoscopy
* Any prior exposure to S1P receptor modulators, natalizumab, lymphocyte-depleting therapies (ie, alemtuzumab, anti CD4, cladribine, rituximab, ocrelizumab, cyclophosphamide, mitoxantrone, total body irradiation, bone marrow transplantation, alemtuzumab, daclizumab)

Primary outcomes:
measure: Clinical remission
timeFrame: Week 12
Secondary outcomes:
measure: Clinical response
timeFrame: Week 12
measure: Endoscopic improvement and remission
timeFrame: Week 12
Other outcomes:
measure: Clinical response and remission
timeFrame: Week 52
measure: Endoscopic improvement and remission
timeFrame: Week 52
Locations:
Study officials:
References: