louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02021552: Genetic Polymorphisms & The Risk for Sepsis After Trauma
Official title: Genetic Polymorphisms & The Risk for Sepsis After Trauma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma
Keywords: Trauma
Sepsis
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2013-12-27
Enrollment: 357
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective cohort in which patients with severe injury, defined by combined anatomic injuries sufficient to require admission to the intensive care unit for treatment (blood transfusions, mechanical support of respiration) and intensive monitoring that is expected to be required for more than 24 hours, will be enrolled

Brief summary: The specific aim of this is to establish a cohort of severely injured patients admitted to our trauma center. Investigators will collect DNA, utilizing discarded blood samples, from 3000 injury victims in an effort to identify perhaps 50 - 100 single-nucleotide polymorphisms (SNP) (out of 1000s) that can be used, when taken together, to identify patients at highest risk for developing complicated sepsis and death.

Detailed description: The specific aim of this is to establish a cohort of severely injured patients admitted to our trauma center. Investigators will collect DNA, utilizing discarded blood samples, from 3000 injury victims in an effort to identify perhaps 50 - 100 single-nucleotide polymorphisms (SNP) (out of 1000s) that can be used, when taken together, to identify patients at highest risk for developing complicated sepsis and death

Eligibility criteria: Inclusion Criteria:

Admitted to the Intensive Care Unit (ICU) at Harborview Medical Center after suffering a traumatic injury

* ability to obtain a 5 ml blood sample
* Expected to be in the ICU for more than 24 hours

Exclusion Criteria:

* We will exclude subjects with chronic medical conditions for the reasons stated above as well as vulnerable populations (children, pregnant females, and prisoners)

Primary outcomes:
measure: Investigators aim to identify up to 100 single-nucleotide polymorphisms (out of 1000s) that can be used, when taken together, to identify patients at highest risk for developing complicated sepsis and death.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: Professor; Dept of Surgery
name: Grant O'Keefe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00709059: Efficacy of PegIntron and Rebetol in Previously Untreated Patients With Chronic Hepatitis C Infected With HCV Genotype 1/4/5/6 (Study P04243)
Official title: A Non-interventional Phase IV Survey to Assess the Antiviral Effectiveness of PegIntron® and Rebetol® Treatment According to the Stage of Liver Fibrosis in Previously Untreated Patients With Genotype 1/4/5/6 Chronic Hepatitis C (CHC) (PRACTICE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Keywords: hepatitis C
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-07-03
Enrollment: 538
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: Previously untreated patients with chronic hepatitis C, infected with HCV genotype 1, 4, 5, or 6, receiving treatment with PegIntron and Rebetol.

Brief summary: The objective of the study is to evaluate the effectiveness of PegIntron plus Rebetol combination in treating patients with chronic hepatitis C in a primary care setting. Patients received no antiviral therapy prior to the current study. Only patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6 will be enrolled in the study. The study will also explore the influence of liver fibrosis stage on the chances of achieving a sustained virologic response.


Eligibility criteria: Inclusion Criteria:

* Previously untreated ('treatment naïve') adults (18 year or more) for whom the treating physician has decided to start treatment with PegIntron and Rebetol
* Detectable Hepatitis C Virus - Ribonucleic Acid (HCV-RNA) in serum by Polymerase Chain Reaction (PCR)
* Repeated (with at least a 1 month interval) serum transaminase (alanine aminotransferase \[ALT\]) levels above the upper normal limit for gender
* Documented chronic hepatitis C (CHC) of genotype 1/4/5/6
* A representative liver biopsy within 1 year prior to inclusion, allowing fibrosis grading into METAVIR score F0, F1, F2, F3 or F4

Exclusion Criteria:

* Known hypersensitivity for any active ingredient or constituent
* Pregnancy or lactation
* Medically documented history of severe psychiatric disturbance, including severe depression, suicidal ideation or suicide attempt
* Medically documented history of severe heart disease, including unstable or uncontrolled cardiac disease, within the last 6 months
* Severely weakening medical condition, including chronic renal insufficiency or creatinine clearance \<50 mL/minute
* Hepatitis of immunologic origin or medically documented history of auto-immune disease
* Severe hepatic disorder or decompensated cirrhosis
* Pre-existing thyroid disorder, except if under control with classical treatment
* Epilepsy or central nervous system disorder
* Hemoglobin pathology, eg, thalassaemia, sickle cell anemia

Primary outcomes:
measure: Number of Study Participants Who Had a Virological Response (VR) at Week-72
timeFrame: Treatment Week 72
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02287259: Olanzapine Versus Lithium in the Treatment of Acute Depression in Patients With Bipolar II or Bipolar Not Otherwise Specified(OL Study)
Official title: A Randomized, Open Label Trial of Olanzapine Versus Lithium in the Treatment of Acute Depression in Patients With Bipolar II or Bipolar Not Otherwise Specified.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar Disorder
Lead sponsor: Chiba University
Sponsor class: OTHER
First posted: 2014-11-10
Enrollment: 50
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: Determine the efficacy and tolerability of olanzapine for treatment of acute depression in patients with bipolar II or bipolar disorder NOS compared with lithium.


Eligibility criteria: Inclusion Criteria:

* major depressive episode in type2 bipolar disorder or bipolar disorder NOS.(MADRS more than 20 point)
* 18years to 65years
* subjects who sign the informed consent document

Exclusion Criteria:

* don't have Diabetes and abnormal metabolism of sugar
* not noticed as bipolar disorder
* have an organic brain disease
* pregnant or breastfeeding women
* don't have heart disease
* have actively suicidal thought(Suicidal ideation score of MADRS is 6)
* who are judged by the investigator to should be excluded from the study

Primary outcomes:
measure: Change in Montgomery- Åsberg Depression Rating(MADRS)
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Change in Young Mania Rating Scale(YMARS)
timeFrame: Baseline and 8 weeks
measure: Quick Inventory of Depressive Symptomatology Japanese version(QIDS-J)
timeFrame: Baseline and 8 weeks
measure: State Trait Anxiety Inventory Form JYZ(STAI)
timeFrame: Baseline and 8 weeks
measure: Clinical Global Impression for Bipolar Disorder(CGI-BP)
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Chiba-shi
country: Japan
facility: Chiba University Hospital
Study officials:
References:
Clinical trial NCT05577559: Ultrasound-Guided Intermediate Cervical Plexus or Cervical Erector Spinae Block for Anterior Cervical Spine Surgery
Official title: Regional Analgesia Using Ultrasound-Guided Intermediate Cervical Plexus Block or Cervical Erector Spinae Block for Anterior Cervical Spine Surgery: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2022-10-13
Enrollment: 58
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: • Neck pain and stiffness or sore throat, are common after anterior cervical spine surgery. Complications are rare but can be serious and even potentially life-threatening if they do occur. Rapid recovery and emergence from general anesthesia are important in cases of anterior cervical spine surgery.

Detailed description: * Null hypothesis (H0): No difference between the regional analgesia effects of bilateral ultrasound-guided superficial cervical plexus block and bilateral cervical erector spinae block in patients undergoing anterior cervical spine surgery under general anesthesia.
* Alternative hypothesis (H1): There are differences between the regional analgesia effects of bilateral ultrasound-guided superficial cervical plexus block and bilateral cervical erector spinae block in

Eligibility criteria: Inclusion Criteria:

* Patient acceptance.
* Age (21-60) years old.
* Both sex
* American Society of Anesthesiologist physical status I / II
* Elective anterior cervical spine surgery under general anesthesia.
* patient With Body Mass Index (BMI) (25-35kg/m²)

Exclusion Criteria:

* Local infection at site of puncture.
* Altered mental status.
* History of allergy to study drugs ( bupivacaine, fentanyl).
* Patients with chronic pain.
* Patients with severe hepatic or kidney impairment.
* Patients having a history of hematological disorders, including coagulation abnormality.

Primary outcomes:
measure: The time to first call to rescue analgesia
timeFrame: 24 hour postoperative
Secondary outcomes:
measure: The total amount of nalbuphine
timeFrame: 24 hour postoperative
measure: Pain intensity
timeFrame: up to 24hs postoperative
measure: Total intra-operative fentanyl consumption
timeFrame: intra-operative
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Faculty of Human Medicine, Zagazig University
Study officials:
affiliation: Zagazig University, Faculty of Human Medicine
name: Alshaimaa Kamel, MD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02626559: Serum Bupivacaine Concentration Levels After Injection of Liposomal Bupivacaine Into the Knee
Official title: Serum Bupivacaine Concentration Levels After Injection of the Knee Joint With a Mixture of Liposomal Bupivacaine and Free Bupivacaine During Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia, Local
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2015-12-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults of at least 18 years of age having a primary, unilateral total knee arthroplasty with a surgical plan to have an intra-articular injection of a mixture of 266 mg of Exparel, 125 mg of bupivacaine, 1:300,000 epinephrine, and 0.9% saline to make a total volume of 100 ml.

Brief summary: Serum levels of bupivacaine over time after peri-articular injection of a mixture of liposomal bupivacaine and plain bupivacaine during total knee arthroplasty.


Eligibility criteria: Inclusion Criteria:

* Adults of at least 18 years of age having a primary, unilateral total knee arthroplasty with a surgical plan to have an intra-articular injection of a mixture of 266 mg of Exparel, 125 mg of bupivacaine, 1:300,000 epinephrine, and 0.9% saline to make a total volume of 100 ml.

Exclusion Criteria:

* Known hepatic dysfunction or renal insufficiency (creatinine \> 1.5 mg/dL);
* allergy to the study medications;
* pregnancy;
* incarceration;
* inability to communicate with the investigators;
* morbid obesity (body mass index \> 40 kg/m2).

Primary outcomes:
measure: Serum Bupivacaine levels
timeFrame: 5 minutes to 24 hours after injection
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Uutah
state: Utah
Study officials:
References:
citation: Buys MJ, Murphy MF, Warrick CM, Pace NL, Gililland JM, Pelt CE, Bankhead BR, Patzkowsky JL, Johnson KB. Serum Bupivacaine Concentration After Periarticular Injection With a Mixture of Liposomal Bupivacaine and Bupivacaine HCl During Total Knee Arthroplasty. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):582-587. doi: 10.1097/AAP.0000000000000636.
Clinical trial NCT01461759: Efficacy Study of Chemotherapy to Treat Advanced or Recurrent Endometrial Cancer
Official title: A Phase II Trial of Docetaxel / Cisplatin in Patients With Recurrent or Stage IVb Endometrial Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Advanced or Recurrent Endometrial Cancer
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Boryung Pharmaceutical Co., Ltd
First posted: 2011-10-28
Enrollment: 59
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 75
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 treat advanced or recurrent endometrial cancer, paclitaxel-containing regimen is the preferred chemotherapeutic regimen which is selected by most physicians. Docetaxel may have similar efficacy and more favorable treatment related toxicity profile as tested in epithelial ovarian cancer trials. Therefore, the investigators aimed to evaluate the efficacy and safety of docetaxel plus cisplatin in patients with advanced or recurrent endometrial cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed chemotherapy naïve endometrial cancer
* One of following histology Endometrioid, UPSC, CCCa, squamous, adenosquamous, mixed
* FIGO stage IVb or recurrent endometrial cancer (incurable by surgery and/or RT)
* At least one measurable lesion by RECIST on CT
* ECOG PS: 0-2
* Age: 20-75
* Adequate organ function BM: ANC≥1,000/mm3, Plt≥100X103/mm3 Kidney: Creatinine\<1.25 × UNL이고, GFR ≥ 60 Liver: AST, ALT\< 3×UNL, T- bil\<1.5 mg/ mm3
* Informed Consent
* Contraception during study period

Exclusion Criteria:

* Previous chemotherapy
* RT, hormone therapy, or immunotherapy within 1 month
* Other malignant disease
* Uncontrolled medical disease
* Infection requiring antibiotics
* Symptomatic CHF, RF, Angina, Arrhythmia, etc.
* Neurosis or psychosis
* Pregnancy, breast-feeding
* Etc.

Primary outcomes:
measure: Response rate
timeFrame: 3 months after completion of study treatment
Secondary outcomes:
measure: Progression-free survival
timeFrame: 2 years after completion of study treatment
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Before each chemotherapy, an expected average of 3 weeks
measure: Quality of life
timeFrame: 3 months after completion of study treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
Clinical trial NCT03523559: Genetic and Histopathologic Characteristics of Interstitial Cystitis
Official title: Genetic and Histopathologic Characteristics of Interstitial Cystitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Interstitial Cystitis
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2018-05-14
Enrollment: 14
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Patients diagnosed with Hunner lesion in Interstitial cystitis and who is scheduled to undergo transurethral resection
* Patients diagnosed with Bladder cancer and who is scheduled to undergo cystectomy

Brief summary: Genetic and Histopathologic Characteristics of Interstitial Cystitis


Eligibility criteria: Inclusion Criteria:

* Male and female aged 19 yrs or greater
* Patients diagnosed with Hunner lesion in Interstitial cystitis and who is scheduled to undergo transurethral resection
* Patients diagnosed with Bladder cancer and who is scheduled to undergo cystectomy

Exclusion Criteria:

* Male and female under aged 20 yrs
* A person whose area of bladder cancer is larger than that of the normal area
* A person who is going to have a cystectomy after chemotherapy on bladder cancer

Primary outcomes:
measure: Genetic differences between ulcer and non-ulcer of bladder in Interstitial Cystitis
timeFrame: 30days
measure: Genetic differences between bladder tissue of Interstitial Cystitis and normal bladder tissue
timeFrame: 30days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center, Sungkyunkwan University School of Medicine
Study officials:
References:
Clinical trial NCT00797459: Safety & Tolerability Study That Compares Restylane to Restylane With Lidocaine While Correcting Wrinkles in the Nasolabial Folds
Official title: A Randomized, Double-Blind Study Comparing Safety and Tolerability of Restylane® With and Without Addition of 0.3% Lidocaine HCL During Correction of Nasolabial Folds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasolabial Folds
Keywords: Correction of Nasolabial Folds
Lead sponsor: Medicis Global Service Corporation
Sponsor class: INDUSTRY
Collaborators: name: Q-Med Scandinavia, Inc.
First posted: 2008-11-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Safety \& tolerability study that compares Restylane to Restylane with Lidocaine (Restylane-L) while correcting wrinkles in the area around your nose.

Detailed description: A Randomized, Double-Blind Study Comparing Safety and Tolerability of Restylane® With and Without Addition of 0.3% Lidocaine HCL During Correction of Nasolabial Folds

Eligibility criteria: Inclusion Criteria:

* Subjects seeking augmentation therapy for correction of bilateral NLFs
* Same WSRS score at both NLFs (either both Moderate \[3\] or both Severe \[4\])
* Subjects willing to give written informed consent to participate in the study
* Women of childbearing potential willing to use an acceptable form of birth control during the study period

Exclusion Criteria:

* Active or chronic skin disease, inflammation or related conditions, near or on the NLFs
* Subjects who had undergone procedures based on active dermal response e.g., laser or chemical peeling procedures) within 6 months prior to study entry
* Use of any facial tissue augmenting therapy with non-permanent filler or aesthetic facial surgical therapy within 9 months prior to study entry
* Permanent implant placed in the NLF area

Primary outcomes:
measure: Treatment Difference in Pain as Measured by a Visual Analogue Scale
timeFrame: After Injection on Day of Treatment
Secondary outcomes:
measure: Wrinkle Improvement at Day 14
timeFrame: 14 days after treatment when compared to baseline
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: Dermatology Research Institute LLC
state: Florida
city: Hunt Valley
country: United States
facility: Maryland Laser Skin and Vein Institute
state: Maryland
city: Mount Kisco
country: United States
facility: The Center for Dermatology, Cosmetic and Laser Surgery
state: New York
Study officials:
affiliation: The Center for Dermatology, Cosmetic and Laser Surgery
name: David Bank, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatology Research Institute LLC
name: Fredric Brandt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maryland Laser Skin and Vein Institute
name: Robert Weiss, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medicis Pharmaceutical
name: Ron Staugaard
role: STUDY_DIRECTOR
References:
Clinical trial NCT00806559: Space and Interaction Trial: Room Design and Patient-physician Interaction
Official title: SIT Trial: The Effect of Clinical Room Design on the Quality of the Clinical Encounter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Internal Medicine Patients
Participating Staff
Keywords: effects clinical space
follow-up appointments
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Steelcase
First posted: 2008-12-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to improve the clinical encounter through the design of the clinical environment. We will conduct a randomized controlled trial to measure the extent to which a newly designed clinical room, compared to a traditional room, affects the patient-physician interaction. We will judge this outcome by (a) videotaping encounters; and (b) conducting post-visit surveys with patients and an interview with physicians. We will use both qualitative and quantitative tools, including a validated and widely used interaction coding system on the videotapes, to draw inferences from these data.


Eligibility criteria: Eligible Clinicians:

1. In the Department of GIM or Preventive Medicine
2. Able and Willing to participate in research study.

Eligible patients:

1. Patient of a clinician participating in the study
2. 18 years or older
3. Seeing clinician for return/summary visit.

Exclusion Criteria:

1.) Not able to give informed consent.

Primary outcomes:
measure: Patient and Clinician Interaction variables (duration of the encounter, patient sense of control in encounter, patient's ability to access information from the computer monitor and the quality of the verbal and non-verbal interaction).
timeFrame: Immediately post clinical visit (survey)
measure: Patient experience of the clinical encounter. The following variables will be measured: patient satisfaction with the room, patient satisfaction with the encounter and the quality of the relationship.
timeFrame: Immediately post visit
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Victor M. Montori, M.D., MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Almquist JR, Kelly C, Bromberg J, Bryant SC, Christianson TH, Montori VM. Consultation room design and the clinical encounter: the space and interaction randomized trial. HERD. 2009 Fall;3(1):41-78. doi: 10.1177/193758670900300106.