louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00629941: Safety and Efficacy Study of AzaSite® in Subjects With Blepharitis
Official title: A Multi-Center, Open-Label Study Evaluating the Cytokine and Eyelid Margin Bacterial Load Levels of Subjects Diagnosed With Chronic Blepharitis Following Dosing With AzaSite® (Azithromycin Ophthalmic Solution) 1%
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Blepharitis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-03-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of AzaSite® ophthalmic solution, 1% on signs \& symptoms of blepharitis and tear cytokine and eyelid bacterial load levels


Eligibility criteria: Inclusion Criteria:

* Diagnosis of moderate to severe chronic blepharitis
* If female of childbearing potential, are non-pregnant and non-lactating

Exclusion Criteria:

* Had ocular surface surgery (LASIK, refractive, etc.) within the past year
* Unwilling to discontinue use of contact lenses during the study
* Have glaucoma
* Unable or unwilling to withhold the use of lid scrubs during the study
* Have a serious systemic disease or uncontrolled medical condition that in the judgment of the investigator could confound study assessments or limit compliance
* Currently using any preserved topical ocular medications (with the exception of unpreserved tear substitutes) at the time of entry into the study or during study participation

Primary outcomes:
measure: Change in clinical signs and symptoms associated with blepharitis
timeFrame: 8 weeks
Secondary outcomes:
measure: Standard ocular safety assessments
timeFrame: 4 weeks
measure: Change in tear cytokine and eyelid bacterial load levels
timeFrame: 4 Weeks
Other outcomes:
Locations:
city: Lewiston
country: United States
facility: Central Maine Eye Care
state: Maine
city: Andover
country: United States
facility: Ophthalmic Research Associates
state: Massachusetts
Study officials:
affiliation: Sponsor GmbH
name: Reza Haque, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06048341: FNB in Meniscal Tear Under SA
Official title: Effects of Sono-guided Femoral Nerve Block in Arthroscopic Surgery for Meniscal Tear Under Spinal Anesthesia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Meniscus Tear
Femoral Nerve Block
Keywords: Meniscus Tear
Femoral Nerve Block
Lead sponsor: Chuncheon Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators will compare the results of sono-guided femoral nerve block in arthroscopic surgery for meniscal tear under spinal anesthesia

Detailed description: This study is a randomized controlled trial of 100 patients, who underwent history taking, physical examinations, x-rays, and MRI or ultrasonography, and were diagnosed with meniscal tear from september 2023 to august 2028. The 100 patients will be assigned to Group I (with femoral nerve block) or Group II (without femoral nerve block) under double-blinded randomization. The randomization will be performed by an independent nurse using a computerized random sequence generator. The operators who participated in the procedure will be blinded to the participant's information. Both group will undergo spinal anesthesia for arthroscopic meniscal surgery. After anesthesia, sono-guided femoral nerve block will be performed. The injection for group1 is 20 mL ropivacaine and for groupII is 20 mL 0.9% saline. A visual analog scale (VAS) for pain will be recorded 1, 3, 6, 12, 18, 24, 36, 48 hours after the operation. VAS scores range from 0 to 10, with 0 being no pain and 10 being the most severe pain ever experienced. Injection with ultrasonography will be performed by a single anesthesiologist. 3 orthopedic surgeons will perform the surgery.

Eligibility criteria: Inclsuion Criteria:

* individuals who are scheduled to undergo meniscal surgery and must be received sufficient explanation about the research prior to surgery and have provided their informed consent to participate.

Exclusion Criteria:

* who require simultaneous surgery for concomitant cartilage injury, collateral ligament tear.
* who have previously undergone surgical treatment within the knee joint.
* who have declined to participate in the research.
* where medical, surgical, or anesthetic complications occurred during surgery.
* other cases deemed necessary by the researchers.

Primary outcomes:
measure: postoperative pain after 24hours
timeFrame: 24hours
Secondary outcomes:
measure: postoperative pain after 1, 3, 6, 12, 18, 48 hours
timeFrame: 1, 3, 6, 12, 18, 48 hours
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Chuncheon Sacred Heart Hospital
state: Gangwon-do
Study officials:
References:
Clinical trial NCT05360641: Risk Factors for Recurrence of Thrombosis or Thrombotic Extension, in the Event of Acute Non-cirrhotic Portal Vein Thrombosis Secondary to a Local Cause.
Official title: Risk Factors for Recurrence of Thrombosis or Thrombotic Extension, in the Event of Acute Non-cirrhotic Portal Vein Thrombosis Secondary to a Local Cause.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Portal Vein Thrombosis
Local Cause
Keywords: liver vascular disease
portal vein thrombosis
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients 18 years of age or older with acute portal thrombosis segmental or truncal diagnosed in the context of a local cause inflammatory, infectious, trauma or abdominal surgery dating from less than 3 months.

Brief summary: In case of acute portal vein thrombosis (PVT) prothrombotic factors are identified in about 60% of cases, while a local condition is present in 30% of cases. Prothrombotic factors may indicate a long term anticoagulant therapy whereas the risk of recurrence seems low when a local condition is isolated (cholecystitis, angiocholitis, liver abces, diverticulitis, appendicitis, acute/chronic pancreatitis, chronic bowel inflammatory disease, acute hepatitis due to cytomegalovirus, bacteroïdes pylephlebitis, abdominal neoplasia such as adenocarcinoma of the colon, abdominal traumatism or surgery such as cholecystectomy, bariatric surgery or splenectomy). To date the impact of prothrombotic factors associated with local conditions responsible for acute PVT has not been well studied except for acute or chronic pancreatitis. No significant association has been pointed out in this pathology. The aim is to determine what are the risk factors of thrombotic recurrence or extension associated with local conditions responsible for acute non cirrhotic PVT, and to evaluate the rate of secondary long term anticoagulant therapy.


Eligibility criteria: Inclusion Criteria:

* acute portal thrombosis segmental or truncal, diagnosed in the context of a local inflammatory, infectious, trauma or abdominal surgery cause, dating from less than 3 months.
* patients already included in european cohort ENVIE-VALDIG

Exclusion Criteria:

* liver cirrhosis
* liver, biliary or pancreatic neoplasia
* thrombosis limited to mesenteric vein, splenic vein or splenomesaraic confluence
* cavernoma or Budd-Chiari syndrom

Primary outcomes:
measure: Recurrence of thrombosis at 5 years
timeFrame: 5 years
Secondary outcomes:
measure: Prevalence of thrombotic factors
timeFrame: 5 years
measure: Prothrombotic factors
timeFrame: 5 years
measure: Long-term anticoagulation
timeFrame: 5 years
Other outcomes:
Locations:
city: Caen
country: France
facility: Chu de Caen
state: Calvados
Study officials:
References:
Clinical trial NCT01612741: Diabetes Treatment With Glucobay in Combination With Metformin
Official title: Prospecitve, Non Interventional, Non Controlled, Post Marketing Survelliance Study to Evaluate Efficacy, Safety, Tolerability of Glucobay on Top of Metformin Under Daily Life Treatment Conditions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus, Type-2
Acarbose
Drug Therapy
Combination
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2012-06-06
Enrollment: 19509
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Type 2 diabetes

Brief summary: In this prospective, non interventional, observational Post Marketing Survelliance study data are obtained on the efficacy, safety and tolerability of Glucobay treatment on top of metformin under daily life treatment conditions.Specifically investigated is the influence of Glucobay on Post Prandial Blood Glucose and HbA1c as well as on pateint's weight when added to an already existing metformin therapy.The study is planned to carried out in 25000 - 30000 patients from 200 trial sites in India.The PMS study will be performed with commercially available medication prescribed within regular practice of the physician. No other examination will be performed than would be done without Post Marketing Survelliance study.


Eligibility criteria: Inclusion Criteria:

* All patient with type 2 diabetes with one of the following treatment ongoing : 1) Metformin 2) Metformin + OHA.
* In such patients, if investigator feels that addition of acarbose would be benficial for the patients

Exclusion Criteria:

* According to local product information

Primary outcomes:
measure: Data collection on body weight
timeFrame: 16 weeks
measure: Data collection on blood glucose
timeFrame: 16 weeks
measure: Data collection on Hba1c
timeFrame: 16 weeks
measure: Data collection on pre treatment concomitant diseases
timeFrame: 16 weeks
Secondary outcomes:
measure: Safety variables will be summarized using descriptive statistics based on adverse events collection
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Many Locations
country: India
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01771341: Evaluation of Synchrony in the Post-operative Patient
Official title: Evaluation of Synchrony in the Post-operative Patient (NAVA vs Pressure Support)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient-ventilator Asynchronism
Keywords: NAVA
post operative
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2013-01-18
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Neurally adjusted ventilatory support improved synchronization in the medical patient. However no data are available in the postoperative patient.

This way the investigators designed a prospective randomized cross over trial to evaluate this issue in the abdominal post-operative patient.


Eligibility criteria: Inclusion Criteria:

* adult \> 18 yr-old
* abdominal post-operative patient
* able to trigger the ventilator

Exclusion Criteria:

* infant
* pregnancy
* esophageal surgery
* recent esophageal variceal bleeding

Primary outcomes:
measure: Asynchrony index (AI)
timeFrame: 8 hours
Secondary outcomes:
measure: PaO2/FiO2 ratio
timeFrame: 8 hours
Other outcomes:
Locations:
city: Pierre Bénite
country: France
facility: Hospices Civils de Lyon- Centre Hospitalier Lyon Sud
Study officials:
affiliation: Hospices Civils de Lyon
name: Florent WALLET, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04825041: Efficacy of Hysteroscopic Bubble Test, Flow Test and Peristalsis Test.
Official title: Efficacy of Hysteroscopic Bubble Test, Flow Test, and Peristalsis Test.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tubal Patency
Keywords: hysteroscopy
bubble flow test
Flow test
Peristalsis
Darwishscope
Lead sponsor: Woman's Health University Hospital, Egypt
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 155
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infertility women

Brief summary: Fallopian tube (FT) function is complex. One of the main functions is transport of sperms for fertilization and transport of the embry for implantation. Hysteroscopic access to "Darwish Hysteroscopic Triad" allows excellent way to assess FT patency. This study compares three ways of assessing FT patency separably or in combination: flow test, bubble flow test and peristalsis test. Combined bubble flow test and peristalsis test is recently published and coined (Darwishscope)1.

Detailed description: This study includes infertile women subjected to combined hysteroscopy and laparoscopy UGA. During hysteroscopy, on each side, three patency test are done successively: flow test, bubble flow test and peristalsis test. Gold standard diagnosis of tubal patency and status is concomitant laparoscopy.

Eligibility criteria: Inclusion Criteria:

* infertile women
* Probably patent FT as proved by a previous hysterosalpingography or laparoscopy.
* Office setting.
* Postmenstrual
* Non use of hormones or hormonal contraceptives.

Exclusion Criteria:

Premenstrual period. Pathologic FT.

Primary outcomes:
measure: FT patency
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Woman's Health University Hospital
Study officials:
References:
Clinical trial NCT00453141: Betamethasone Dosing Interval - 12 or 24 Hours?
Official title: Betamethasone Dosing Interval - 12 or 24 Hours?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Delivery
Keywords: Betamethasone for preterm labor
Preterm delivery
Infant Respiratory Distress Syndrome
Lead sponsor: The Cooper Health System
Sponsor class: OTHER
First posted: 2007-03-28
Enrollment: 200
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if there may be a benefit to the newborn if betamethasone is given 12 hours apart instead of 24 hours apart.

Detailed description: Betamethasone is a medicine given to women expected to deliver after 24 but before 34 weeks of pregnancy. It is very advantageous in preventing or decreasing the many problems these small babies may face if born early. Betamethasone makes breathing easier for them, also decreases the chance of them bleeding in the head and makes their chances of survival better. This medicine is used routinely in pregnancy but the best timing between doses in not well established. The 'standard' dosing schedule involves giving 2 injections of 12mg of the medicine 24 hours apart. However, many women deliver before reaching the 24-hour mark, despite the doctors best efforts to try and delay delivery, and therefore miss the opportunity for the 2nd dose.

Eligibility criteria: Inclusion Criteria:

* Pregnant women expected to deliver preterm (either induced or spontaneously) for any obstetrical or medical indication.
* Gestational age between 23 and 34 weeks gestational age.
* Dating must either be by LMP which is consistent with ultrasound performed at any gestational age, or calculated by a sonogram less than or equal to 23 weeks.

Exclusion Criteria:

* Patients at \<23 or \>34 weeks gestational age.
* Known drug allergy to betamethasone.
* Given steroid other than betamethasone for lung maturation.
* Any contraindication to steroid therapy.

Primary outcomes:
measure: The diagnosis of RDS is defined as: PaO2 < 50 mm Hg in room air, central cyanosis in room air, or a requirement for supplemental O2 to maintain PaO2 > 50 mm Hg, along with chest xray findings consistent with RDS (per the Vermont Oxford Network)
timeFrame: Until neonatal discharge
Secondary outcomes:
measure: Incidence of INH, NEC, BPD, Blindness
timeFrame: until neonatal discharge
Other outcomes:
Locations:
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Pomona
country: United States
facility: Atlanticare Regional Medical Center
state: New Jersey
Study officials:
affiliation: The Cooper Health System
name: Meena Khandelwal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liggins GC, Howie RN. A controlled trial of antepartum glucocorticoid treatment for prevention of the respiratory distress syndrome in premature infants. Pediatrics. 1972 Oct;50(4):515-25. No abstract available.
Clinical trial NCT00775541: Hyperglycemia and Oxidative Stress in the Human Brain With Diabetes
Official title: Hyperglycemia and Oxidative Stress in the Human Brain With Diabetes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Diabetes
Type 2 Diabetes
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2008-10-20
Enrollment: 5
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to use an MRI exam to measure the concentrations of glutathione (GSH) and Vitamin C (Asc) in the brains of normal healthy persons and type 2 diabetic persons. The study will look at the relationship between chronic hyperglycemia and the levels of these naturally occurring chemicals in the brain.

Detailed description: Cerebral GSH and Asc concentrations are modulated by increased oxidative stress induced by hyperglycemia in diabetes and reflect changes in the cerebral antioxidant defense system. Inhibition of cellular uptake of Asc by hyperglycemia further hampers maintaining adequate antioxidant capacities. Reduced concentrations of these antioxidants might serve as good indicators of increased susceptibility to oxidative damage, impaired cellular uptake or the antioxidant, and further, as sensitive in vivo biomarkers to assess early manifestations or progression of diabetic complications and the efficacy of the antioxidant therapy in the human brain. Specific aims (1) to determine cerebral concentrations of GSH and Asc in the living brain of healthy controls and type 2 diabetic patients; (2) to quantify the effect of chronic hyperglycemia on cellular uptake of Asc across the blood-brain barrier.

Eligibility criteria: Inclusion Criteria:

* Good health except for having type 2 diabetes
* Being treated with diet, insulin, or oral hyperglycemic agents
* Male or non pregnant female
* Non-smoker
* HbA1c 8 or above
* Able to provide informed consent

Exclusion Criteria:

* Presence of mental illness
* Co-existing chronic inflammatory condition or neurological disease or diseases associated with abnormal glutathione metabolism
* BMI over 35
* Smoker

Primary outcomes:
measure: MRI, mRS, urine and blood samples
timeFrame: before and after IV infusion, 6 hours
Secondary outcomes:
measure: 7 day food and DHQ food questionnaire
timeFrame: 7 days prior to MRI and vitamin C infusion
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: In-Young Choi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00757341: Study Evaluating The Mass Balance And Metabolic Disposition Of SKI-606
Official title: An Open-Label, Single-Dose Study of the Mass Balance and Metabolic Disposition of Orally Administered [14C]-Labeled Bosutinib in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2008-09-23
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess the mass balance, metabolic disposition, and identification of metabolites following single oral administration of \[14C\]-SKI-606 in healthy male subjects.


Eligibility criteria: Healthy men, aged 18 to 50 years.

Primary outcomes:
measure: Mass Balance and Metabolic Disposition
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tacoma
country: United States
state: Washington
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01499641: Epidural Steroid Following Discectomy for Herniated Disc Reduces Morbidity
Official title: Epidural Steroid Following Discectomy for Herniated Lumbar Disc Reduces Neurological Impairment and Enhances Recovery. A Randomized Study With Two-year Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disc Disease
Keywords: discectomy
methylprednisolone
randomized control trial
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
First posted: 2011-12-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Focus of this study is evaluation of the outcome, neurologic impairment and safety of epidural steroide following lumbar discectomy for herniated disc disease.

Detailed description: Methylprednisolone might enhance recovery after discectomy for herniated disc disease without apparent side effect.

Convalescence after discectomy for herniated disc disease is dependent on pain and the inflammatory response. In arthroscopic and abdominal surgery steroids reduce the inflammatory response and enhance recovery.

200 patients with herniated disc disease are randomly allocated to receive epidural methylprednisolone 40 mg or none.

Eligibility criteria: Inclusion Criteria:

* Patients with primary lumbar herniated disc disease who had received and performed standardized conservative treatment program with intensive exercises
* Patients more than 18 years old

Exclusion Criteria:

* Patients with central or lateral spinal stenosis due to spondylosis or disc degeneration who needed bilateral decompression, laminectomy or fusion
* Patients with cauda equina syndrome who needed acute operative treatment
* Lack of informed consent and inability to read and understand Danish

Primary outcomes:
measure: Symptoms and signs of neurologic impairment and rate of operation during a 2-year follow-up.
timeFrame: 2 years
Secondary outcomes:
measure: Hospital stay, back and leg pain and reflex deficit.
timeFrame: 2 years
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Orthopaedic Surgery Research Unit, Aalborg University Hospital
city: Copenhagen
country: Denmark
facility: Section for Surgical Pathophysiology, Juliane Marie Centre, Rigshospitalet
city: Vejle
country: Denmark
facility: Department of Orthopaedic Surgery, Vejle and Give Hospital
Study officials:
affiliation: Orthopaedic Research Unit, Aalborg University Hospital
name: Sten Rasmussen, M.D.Sci.
role: STUDY_CHAIR
References: