louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00670852: Followup of Glenoid Fix Utilizing Auto Bone Graft in Shoulder Replacement
Official title: Computed Tomographic and Functional Follow-up of Glenoid Anchor Peg Component Fixation Utilizing Autologous Bone Graft in Total Shoulder Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis
Keywords: Glenoid component
radiolucent lines
Glenoid loosening
glenohumeral arthritis
autologous bone graft
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2008-05-02
Enrollment: 29
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Maximum number will be 70. Patients who received a total shoulder replacement with an anchor peg glenoid and autologous bone grafting from the investigator of this study will be recruited for this study.

Brief summary: This is a case study to evaluate the adequacy of fixation and functional outcome of the glenoid anchor peg following autologous bone grafting around the prosthesis at the time of implant.

Detailed description: To investigate if the use of autologous bone graft around the anchor-peg glenoid prosthesis correlates with bony apposition on computed tomography scans, decreased radiolucent lines and component loosening, and functional outcomes. We hypothesize that by utilizing autologous bone graft from the resected humeral head, placed around the anchor peg glenoid prosthesis at implantation, there is a low incidence of glenoid loosening. We suggest that the absence of radiolucent lines correlated with excellent shoulder function.

Eligibility criteria: Inclusion Criteria:

* Patients who received a total shoulder replacement with an anchor peg glenoid and autologous bone grafting from the investigator of this study will be recruited for this study.

Exclusion Criteria:

* Patients will be excluded if they are unable to comprehend the consent information.
* Pregnant women will be excluded from this study.

Primary outcomes:
measure: Autologous bone graft, anchor-peg glenoid prosthesis and functional outcomes
timeFrame: case study over approximate 3 months time.
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center, Dept Orthopaedic Surgery
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Edward Fehringer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03343652: A Study of Safety and Efficacy of Nivolumab and Bendamustine (NB) in Patients With Relapsed/Refractory Hodgkin's Lymphoma
Official title: A Phase I/II Clinical Trial to Evaluate the Safety and Efficacy of Nivolumab and Bendamustine Combination (NB) in Patients With Relapsed or Refractory Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hodgkin's Lymphoma
Keywords: Hodgkin's Lymphoma
Nivolumab
Bendamustine Hydrochloride
Lead sponsor: St. Petersburg State Pavlov Medical University
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A clinical study of safety and efficacy of treatment with Nivolumab and Bendamustine (NB) in patients with relapsed/refractory Hodgkin's lymphoma.


Eligibility criteria: Inclusion Criteria:

* Diagnosis: Histologically confirmed Hodgkin's lymphoma
* Relapsed or refractory to at least two prior treatment lines
* Relapsed after nivolumab treatment or refractory to nivolumab treatment
* Age 18-70 years old
* Signed informed consent
* No severe concurrent illness

Exclusion Criteria:

* Uncontrolled bacterial or fungal infection at the time of enrollment
* Requirement for vasopressor support at the time of enrollment
* Karnofsky index \<30%
* Pregnancy
* Somatic or psychiatric disorder making the patient unable to sign informed consent
* Active or prior documented autoimmune disease requiring systemic treatment.

Primary outcomes:
measure: Overall Response Rate (ORR) of Nivolumab in combination with Bendamustine Hydrochloride in patients with Hodgkin's lymphoma
timeFrame: up to 3 months
Secondary outcomes:
measure: Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03
timeFrame: up to 12 months
measure: Duration of Response (DOR)
timeFrame: up to 12 months
measure: Time to Progression (TTP)
timeFrame: up to 12 months
measure: Progression-Free Survival (PFS)
timeFrame: up to 12 months
measure: Overall Survival (OS)
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Saint-Petersburg
country: Russian Federation
facility: First Pavlov State Medical University of St. Petersburg
Study officials:
affiliation: First Pavlov State Medical University of St. Petersburg
name: Boris V Afanasyev, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01791452: Novel Association of Cholesterol Ester Storage Disease Due to Lysosomal Acid Lipase Deficiency and Non-Alcoholic Fatty Liver Disease: A Prospective Clinical Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-alcoholic Fatty Liver Disease
Cholesterol Ester Storage Disease
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2013-02-15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 400 subjects will be enrolled and informed consent obtained. After clinical evaluation, subjects will undergo liver ultrasound, non-invasive liver elastography (Fibroscan) and standard biochemical evaluation including glucose, insulin, TG, HDL, LDL, leptin, adiponectin and TNF-alpha. They will then be divided into 2 groups: NAFLD, and NAFLD with fibrosis (NASH). In addition a cohort of healthy volunteers will also be studied. LAL activity in dry blood spots (DBS) will be measured using the substrate 4-methylumbelliferyl palmitate. LAL activity will be measured by measuring total lipase activity and lipase activity in the presence of Lalistat2.

Brief summary: Non-alcoholic fatty liver disease (NAFLD) is a world-wide problem with a global prevalence estimated at 1.5 billion people. It is characterised by significant diversity and phenotypic heterogeneity. Morbidity rates are estimated at 20% to 30% in Western adults, increasing to 90% in patients who are morbidly obese or diabetic. Risk factors in non-obese NAFLD patients are of especial practical and theoretical importance. Cholesterol Ester Storage Disease (CESD) is an autosomal recessive chronic disease of variable phenotype, caused by a deficiency in lysosomal acid lipase (LAL) and characterized by accumulation of fat in tissues and organs. Hepatic accumulation of fat in this disorder can cause hepatomegaly with varying degrees of damage varying from steatosis to fibrosis, elevated aminotransaminases, and isolated splenomegaly. Since the contribution of LAL deficiency to non-obese NAFLD is poorly understood, the investigators propose to evaluating the association between NAFLD and LAL deficiency in a prospective study in our population.


Eligibility criteria: Inclusion Criteria:

* Age between 18-80 years;
* BMI 25-40;
* Fatty liver disease (bright liver, hepatomegaly by ultrasound (Liver span \> 15 cm mid clavicle line), splenomegaly (\>13 cm) or both.

Exclusion Criteria:

* Alcohol abuse\>30 gm/day, or \> 70 gram per week;
* Soft drink abuse;
* Drugs known to cause fatty liver;
* Chronic hepatitis (B and C);
* Biliary liver disease;
* Autoimmune hepatitis;
* HIV;
* Genetic/Metabolic liver disease (Wilson, alpha-1 antitrypsin, CF);
* Failure to give informed consent

Primary outcomes:
measure: liver ultrasound, ultrasound Doppler of the common carotid artery, hepatic Fibroscan evaluation (transient elastography) for assessment of steatosis and fibrosis
timeFrame: year
Secondary outcomes:
Other outcomes:
Locations:
city: Safed
country: Israel
facility: Assy Nimer
Study officials:
References:
Clinical trial NCT03010852: Focused Incentive Spirometry Monitoring to Reduce Postoperative Oxygen Therapy and Respiratory Complications After Bariatric Surgery
Official title: Focused Incentive Spirometry Monitoring to Reduce Postoperative Oxygen Therapy and Respiratory Complications After Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Complication
Keywords: Bariatric Surgery
Spirometry Monitoring
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2017-01-05
Enrollment: 60
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: PREVENTION

Brief summary: Postoperative (PO) hypoventilation, atelectasis and hypoxemia after bariatric surgery are common and multifactorial, contributing to prolonged oxygen (O2) therapy after surgery and even at hospital discharge. Incentive spirometry (IS) is recommended postoperatively but its success in preventing postoperative atelectasis and hypoxemia (POH) heavily depends on patient compliance with IS effort and frequency. The investigators hypothesize that a focused education preoperatively on IS for POH and intensive monitoring of patient compliance with IS therapy in the early postoperative period shortens postoperative oxygen therapy, decreases POH episodes, and improves respiratory outcomes after bariatric surgery, compared to patients receiving standard of care.


Eligibility criteria: Inclusion Criteria:

* Patients having planned elective bariatric surgery at University of Colorado Hospital

Exclusion Criteria:

* Emergency procedure
* Oxygen therapy within the previous 30 days
* Smoking within the previous 30 days
* Inability or refusal to provide consent

Primary outcomes:
measure: Frequency of at least one episode of moderate/severe hypoxemic event
timeFrame: During first post operative day
Secondary outcomes:
measure: Duration of postoperative oxygen therapy
timeFrame: Up to 7 days after surgery
measure: Presence of postoperative oxygen therapy and postoperative hypoxemic events
timeFrame: Up to 7 days after surgery
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, School of Medicine - Department of Anesthesology
name: Ana Fernandez-Bustamante, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02902952: Physical Exercise to Reduce Anxiety in Underserved Children With ASD
Official title: Physical Exercise to Reduce Anxiety in Underserved Children With Autism Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Exercise Condition
Control Condition
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: University of Missouri-Columbia
First posted: 2016-09-16
Enrollment: 148
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anxiety is one of the most frequent comorbidities in children with ASD leading to poor clinical outcomes. Physical exercise has been shown to be a promising and easy to implement intervention for reducing anxiety. However, little is known about the feasibility and efficacy of physical exercise to reduce anxiety in children with ASD from underserved, low-income families. Children with ASD, ages 6 - 12 years old from low-income and Latino families will be recruited for the study and assigned to an exercise intervention group and a sedentary control group. The physical exercise program is an eight-week program, administered three times per week in small groups. Compliance, parent-rated anxiety, and salivary cortisol will be measured before and after completion of the exercise and control group interventions.


Eligibility criteria: Inclusion Criteria:

* Autism Spectrum Disorder (ASD) Diagnosis 6-12 years old
* ≥ 93rd percentile on CBCL or total score of ≥ 25 on SCARED
* Able to attend 3x/week for 8 consecutive weeks
* Able to follow instructions
* CalOptima Insurance or Medicaid and ability to participate in moderate physical exercise

Exclusion Criteria:

* Danger to themselves or others
* Medical conditions that may pose a risk during exercise
* Unable to participate in moderate physical exercise
* Joining a regular physical exercise program in the last 4 weeks or planning to start or discontinue a regular physical exercise program in the next 8 weeks
* Unable to attend 3x/week for 8 consecutive weeks
* Visual, auditory or motor impairments, which would preclude participation in study activities

Primary outcomes:
measure: Anxiety rating
timeFrame: Change from baseline at Week 8
Secondary outcomes:
measure: Salivary Cortisol
timeFrame: Change from baseline at Week 8
Other outcomes:
Locations:
city: Santa Ana
country: United States
facility: 2500 Red Hill Avenue
state: California
city: Columbia
country: United States
facility: Thompson Center for Autism
state: Missouri
Study officials:
affiliation: University of California, Irvine
name: Jean Gehricke, Ph.D.
role: STUDY_CHAIR
affiliation: University of Missouri-Columbia
name: Lea Ann Lowery, OTD/OTR-L
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01617252: High Flow Nasal Oxygen Therapy for Hypoxemy After Cardiac Surgery
Official title: High Flow Nasal Oxygen Therapy for Hypoxemy After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxemic Acute Respiratory Failure
Keywords: Cardiac surgery
Acute respiratory failure
High flow oxygen therapy
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2012-06-12
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The main objective of this study is to evaluate the gas exchange (ventilation-perfusion ratio) with the system Optiflow® compared to facial mask among patients having an acute respiratory failure after cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* Patient with indication of coronary artery bypass
* Absence of preoperative respiratory failure
* Hypoxia after extubation defined as SpO2 \< 96% with Venturi mask 50% 8L/min
* Age \> 18 years
* Signed informed consent

Exclusion Criteria:

* Patients requiring an imminent intubation, in coma or respiratory exhaustion, in a state of shock or severe rhythm disorders
* Hemodynamic instability, low flow rate
* Pneumothorax or hemothorax
* Bleeding major, ischemic signs
* Ventricular arrhythmia
* Respiratory failure
* Non controlled hyperalgia
* Alteration of mental status
* Cardiac surgery patients in post-operative valve surgery associated with coronary artery bypass surgery or isolated valve surgery
* Pregnancy
* Major under guardianship

Primary outcomes:
measure: Measure of PaO2/FiO2 ratio
timeFrame: One hour and 24 hours
Secondary outcomes:
measure: Scale of satisfaction completed by the patient
timeFrame: at withdrawal of oxygen system
measure: Measure of pH, SatO2, PaO2, FiO2
timeFrame: 2 days
measure: Number of days of hospitalization
timeFrame: at day 28
measure: Measure of PCO2 and respiratory frequency
timeFrame: One day
measure: Possibility of patient transfer in conventional service
timeFrame: at day 5
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
References:
Clinical trial NCT02776852: 18519 - Sun Protection Factor Assay
Official title: Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay on Minimal Persistent Pigment - Darkening Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agent
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-05-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF
* Signed and dated Informed Consent Form
* Signed and dated HIPAA Form
* An unambiguous MED or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.

Primary outcomes:
measure: Minimal Erythema Dose (MED)
timeFrame: Up to 15 minutes
measure: Minimal Persistent Pigment Darkening Dose (MPPD)
timeFrame: Up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02438852: Continuous Infusion of Ropivacaine Hydrochloride in Reducing Pain After Surgery in Patients With Bladder Cancer
Official title: Efficacy of Continuous Infusion of Local Anesthesia After Radical Cystectomy: A Randomized, Double Blind, Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Bladder Carcinoma
Post-operative Pain
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-05-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized phase IV trial studies how well the continuous infusion of ropivacaine hydrochloride works in reducing pain after surgery in patients with bladder cancer. Ropivacaine hydrochloride is an anesthetic drug used to decrease pain by numbing an area of the body without putting the patient to sleep. Continuous infusion of ropivacaine hydrochloride may reduce pain and improve the quality of life for patients after bladder surgery.

Detailed description: PRIMARY OBJECTIVES:

I. To determine if continuous infusion of local anesthesia (CILA) decreases post-operative pain after radical cystectomy (RC).

II. To determine if CILA reduces narcotic requirements after RC.

SECONDARY OBJECTIVES:

I. To determine if CILA decreases length-of-stay after RC. II. To determine if CILA improves patients satisfaction with post-operative pain control after RC.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive ropivacaine hydrochloride intravenously (IV) continuously over 72 hours after radical cystectomy.

ARM II: Patients receive normal saline (placebo) IV continuously over 72 hours after radical cystectomy.

After completion of study, patients are followed up within 30 days.

Eligibility criteria: Inclusion Criteria:

* Undergoing elective open radical cystectomy
* Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

* Allergy or adverse reaction to ropivacaine (ropivacaine hydrochloride) or any amide type of local anesthesia
* Allergy or adverse reaction to local anesthesia catheter
* Additional surgery at the same time as RC (e.g. nephroureterectomy)
* Coagulopathy
* Thrombocytopenia
* Local or systemic infection
* Pregnancy
* Chronic hepatic disease
* Use of type III antiarrhythmics (e.g. amiodarone)
* History of chronic pain and/or daily opioid use

Primary outcomes:
measure: Narcotic requirement
timeFrame: Up to 72 hours after surgery
Secondary outcomes:
measure: Length of hospitalization
timeFrame: Up to 30 days after surgery
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Siamak Daneshmand
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01765452: Phase IV Study to Compare Efficacy and Safety of Plavix 75mg With Astrix 100mg and Closone
Official title: Multi-center, Randomized, Open Study for Comparison of Efficacy and Safety of Plavix With Astrix and Closone in Patients With Post-Percutaneous Coronary Artery Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2013-01-10
Enrollment: 285
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Aim of this study is to prove non-inferiority of Closone to the Combination treatment of Plavix with Astrix.


Eligibility criteria: Inclusion Criteria:

* Subjects under a stable condition after Post-Percutaneous Coronary Artery Intervention over three months
* 20\~86 years old
* Willing to adhere to protocol requirements and sign a informed consent form

Exclusion Criteria:

* Subject who did not undergo or failed Drug-Stent Implantation
* Subjects who took an anti-coagulant, anti-thrombotic regularlly( ≥ 2weeks in a month) before the study, or plan to have continuous treatment during the study(Except Aspirin alone or combination of Aspirin and Clopidogrel)
* Subjects with a history of substance or alchol abuse
* Subjects with a history of hypersensitivity to Clopidogrel, Aspirin or other NSAIDS
* Subjects having Aspirin or other NSAIDs-induced Asthma or history
* Subjects with Severe hepatopathy(AST and ALT \> 5 times the upper limit of normal)
* Subjects with Severe nephropathy(Cr \> 3 times the upper limit of normal)
* Subjects with hemorrhage like gastric ulcer, intracranial hemorrhage etc.
* Subjects with high risk of hemorrhage like blood coagulation disorders, uncontrolled severe hypertension, active bleeding, history of severe bleeding
* subjects who are pregnant, breastfeeding
* Subjects not using medically acceptable birth control
* Subjects who are unsuitable to take the Investigational product due to a medical/mental condition
* Subjects inherently having Galactose malobsorption, Lactase deficiency or Glucose-Galactose malobsorption

Primary outcomes:
measure: Change from baselinine in P2Y12% inhibition at week 8
timeFrame: Baseline, week 8
Secondary outcomes:
measure: Change from baseline in PRU, ARU at week 8
timeFrame: Baseline, week 8
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje university haeundae paik hospital
city: Busan
country: Korea, Republic of
facility: Kosin university gospel hospital
city: Busan
country: Korea, Republic of
facility: Pusan national university hospital
city: Chungbuk
country: Korea, Republic of
facility: Chungbuk national university hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Dongguk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: SNU Boramae Medical Center
Study officials:
References: