louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06020781: Efficacy and Safety of Dexmedetomidine to Bupivacaine in Supraclavicular Brachial Plexus Block
Official title: Efficacy and Safety of Dexmedetomidine to 20ml Bupivacaine in Supraclavicular Brachial Plexus Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dexmedetomidine
Bupivacaine
Supraclavicular Brachial Plexus Block
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2023-09-01
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to evaluate the analgesic efficacy and safety of addition of 1µg/kg dexmedetomidine to 20ml bupivacaine compared to 20ml and 30ml bupivacaine without additives in ultrasound-guided supraclavicular brachial plexus block for anesthesia.

Detailed description: Dexmedetomidine, a highly selective α2 adrenergic agonist, has been used as an adjuvant to local anesthetics. Various clinical trials performed have shown dexmedetomidine to be safe when used as an adjuvant to local anesthetic in subarachnoid, caudal, and epidural Different doses of dexmedetomidine are commonly used as an additive in Ultrasound-guided supraclavicular brachial plexus block, 1 μg/kg and 2 μg/kg in which a high dose of dexmedetomidine does not prolong the duration of analgesia, but it is associated with lower heart rate and blood pressure. Incidence of hypotension and bradycardia is also more. Hence, a lower dose of 1 μg/kg dexmedetomidine is a good balance between safety and efficacy

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist (ASA) grade I or II patients
* both sexes
* scheduled for elective upper limb surgery below mid-humerus level under Ultrasound -guided Supraclavicular brachial plexus block .

Exclusion Criteria:

* with pre-existing peripheral neuropathy of upper limb.
* Bleeding disorders.
* Infection at injection site.
* Untreated pneumothorax.
* Patients on adrenoreceptor agonist or antagonist therapy.
* History of severe cardiac,.respiratory, hepatic, or renal disease.
* pregnancy and known hypersensitivity to the study drugs.

Primary outcomes:
measure: Success rate.
timeFrame: 30 minutes after block performance
Secondary outcomes:
measure: Total pethidine consumption.
timeFrame: 24 hours postoperative.
measure: Pain score.
timeFrame: 24 hours postoperative.
measure: Mean arterial blood pressure
timeFrame: From preoperatively till the end of surgery
measure: Heart rate
timeFrame: From preoperatively till the end of surgery
measure: Postoperative side effects.
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafrelsheikh University
state: Kafrelsheikh
Study officials:
References:
Clinical trial NCT00014781: Study of Hepatic Glucose Production and De Novo Lipogenesis in Patients With Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Keywords: cardiovascular and respiratory diseases
cystic fibrosis
genetic diseases and dysmorphic syndromes
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
First posted: 2001-04-11
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes

Brief summary: OBJECTIVES:

I. Determine the amount of hepatic glucose production derived from gluconeogenesis and glycogenolysis in the post-absorptive state in patients with cystic fibrosis.

II. Determine de novo lipogenesis in relationship to resting energy expenditure in this patient population.

Detailed description: PROTOCOL OUTLINE:

Patients undergo an oral glucose tolerance test (OGTT) in which blood is drawn from an IV in the arm 6 times over 3 hours. After the first blood draw, patients receive a beverage containing sugar and write down everything they ate and drank during the 24 hours before study entry. Patients also undergo a dual energy x-ray absorptiometry (DEXA) scan over 15 minutes.

Within 2 weeks after the OGTT, patients keep a journal of everything they ate and drank over 3 days. Patients are fed a selected meal the following evening and receive saline fluids IV overnight. During the night, patients receive 2 doses of oral doubly labeled water. The next morning, patients receive \[1,2-13C\]acetate IV. A liquid mixed meal (Ensure Plus) is ingested hourly throughout the day. Patients also undergo hood indirect calorimetry over 30 minutes twice to measure resting energy expenditure. All urine is collected.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of cystic fibrosis OR Normal healthy volunteer; not an endurance-trained athlete No colonization with Burkholderia cepacia

--Prior/Concurrent Therapy--

Endocrine therapy: At least 2 months since prior oral or IV corticosteroids; low-dose inhaled corticosteroids allowed

Other: Short-acting insulin therapy allowed; at least 24 hours since prior long-acting insulin (i.e., neutral protamine Hagedorn, or ultalente); at least 4 weeks since prior oral or IV antibiotics; no hospital admissions within the past 6 weeks

--Patient Characteristics--

Hepatic: No elevation of SGOT or SGPT within the past 3 months

Other: Must be medically stable; diabetes mellitus allowed; weight stable within the past 3 months; not pregnant; no prisoners

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Southwest Medical Center at Dallas
state: Texas
Study officials:
affiliation: Southwest Medical Center at Dallas
name: Dana S. Hardin
role: STUDY_CHAIR
References:
Clinical trial NCT00780481: Characterization of Brachial Arterial t-PA Release, Endothelial Function, Obesity and Inflammation
Official title: Characterization of Brachial Arterial t-PA Release, Vasodilator Function, and Vascular Compliance and Correlation With Fibrinolytic Balance, Oxidative Stress, and Inflammation Measures (SCCOR Project 1 Aim 3B)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Endothelial Function
Fibrinolytic Balance
Baseline
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2008-10-27
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: T-PA release is impaired in obese subjects. In order to have a better mechanistic understanding of t-PA release, we will compare t-PA release to Flow Mediated Vasodilation, Radial Artery Tonometry, and other markers of endothelial function and oxidative stress.


Eligibility criteria: Inclusion criteria:

1. Adults 18 years and greater
2. Healthy

Exclusion criteria:

1. PVC \< 30
2. Hypertensive subjects on ACE inhibitors
3. Pregnant or nursing mothers
4. Diabetic with HbA1C \> 7.5 or stigmata of end organ damage (neuropathy, retinopathy, nephropathy, cardiomyopathy)
5. Cholesterol \> 30 mg/dL above NCEP accepted level based on cardiac risk.
6. Triglycerides \> 200
7. Previously diagnosed obstructive coronary artery disease, myocardial infarction or left ventricular dysfunction (with or without a history of congestive heart failure)
8. Renal insufficiency (Creatinine ≥ 1.5 mg/dl)
9. History of cerebrovascular disease
10. Any chronic inflammatory disease (rheumatologic, inflammatory bowel disease, etc)
11. Uncontrolled Stage 2 Hypertension (160/100 mmHg), or end organ damage due to hypertension (left ventricular hypertrophy, atrial fibrillation, hematuria, renal insufficiency, prior cerebrovascular disease).
12. Angiotensin converting enzyme inhibitor use
13. Coagulopathy (INR ≥ 1.5, PTT ≥ 1.5 x control)
14. Other chronic medical illnesses at the discretion of the investigators

Primary outcomes:
measure: Peak t-PA Release
timeFrame: Single Study day
Secondary outcomes:
measure: Peak FMD
timeFrame: Single Study Day
measure: Radial Artery Elasticity
timeFrame: Single Study Visit
measure: Lipid Levels, PAI-1 Levels, CRP Levels, F2 Isoprostanes and Other Biomarkers of Inflammation and Obesity.
timeFrame: Single Study Day
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: James AS Muldowney, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00329381: Safety and Efficacy Study of Omalizumab Given Prior to Immunotherapy
Official title: A26-wk,Randomized,Dble-Blinded,Parallel-Grp,Placebo-Controlled,Multi-Centered Study to Eval.the Effect of Xolair(Omalizumab)on Improving the Tolerability of Spec.Immunotherapy in Patients With at Least Mod. Persistent Allergic Asthma Inadequately Controlled w/Inhaled Corticosteroids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Allergic
Asthma
Immunotherapy
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2006-05-24
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In patients with at least moderate persistent allergic asthma controlled with inhaled steroids, omalizumab(administered per US product label), when compared to placebo, will provide the participants with significantly improved tolerability of specific allergen immunotherapy (allergy shots) administered per a cluster schedule(rapid build up method).

Detailed description: Omalizumab is an FDA approved anti-IgE drug used to treat allergic asthma. This study is designed to give omalizumab 13 weeks prior to administering rapid build up of specific allergy shot, with an overlap of omalizumab and cluster therapy for 3 weeks. The cluster therapy will take 4 week to complete with maintenance dosage lasting an additional 6 weeks.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis and history of moderate persistent allergic asthma
* body weight \>/= 20kg and \</= 150kg
* Total serum IgE \>/= 30 and \</= 700IU/mL
* on a stable asthma treatment including corticosteroids for the preceding 4 weeks
* non smoker for at least 1 year prior to visit 1

Exclusion Criteria:

* patients with severe asthma
* history of immunotherapy to any allergen within the past 3 years
* history of anaphylactic allergic reaction
* upper respiratory tract infection

Primary outcomes:
measure: Evaluate the effect of omalizumab on systemic allergic reactions to specific immunotherapy (SIT) in patients with persistent allergic asthma who require treatment with inhaled steroids
timeFrame: 2005-2007
Secondary outcomes:
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Gailen D. Marshall, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04303481: The Effect of Consuming Enzymes and Prebiotics on Body Composition and Blood Biochemical Index
Official title: The Effect of Consuming Enzymes and Prebiotics on Body Composition and Blood Biochemical Index
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gut Microbiota
Keywords: Anthropometric index
Biochemical items
Lead sponsor: TCI Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-03-11
Enrollment: 88
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To assess the effects of consuming enzymes and prebiotics on improvement of weight loss and biochemical parameters


Eligibility criteria: Inclusion Criteria:

* Male or female aged between 20 and 50 years old
* Body mass index (BMI) ≥ 22 (kg/m\^2) or body fat mass: male \> 25%, female \> 30%
* Prohibitions on other nutritional supplements (probiotics and prebiotics) before two weeks of the study
* Abidance by the similar diet and exercise habits over the study.

Exclusion Criteria:

* Pregnant or breastfeeding woman
* Menopausal woman
* Diabetes mellitus
* Implementation in weight loss programs before a half year of this study
* Metabolic disorders
* Kidney diseases
* Liver diseases
* Cardiovascular diseases
* Nervous system diseases
* Gastrointestinal diseases
* Heavy drinking or constant drug use.

Primary outcomes:
measure: The change of body fat mass
timeFrame: Months 0, 1 and 2
measure: The change of Triglyceride
timeFrame: Months 0, 1 and 2
measure: The change of Total cholestrol
timeFrame: Months 0, 1 and 2
measure: The change of HDL-cholestrol
timeFrame: Months 0, 1 and 2
measure: The change of LDL-cholestrol
timeFrame: Months 0, 1 and 2
measure: Fecal microbiome analysis
timeFrame: Months 0, 1 and 2
measure: The change of body mass index (BMI)
timeFrame: Months 0, 1 and 2
measure: The change of body fat percentage
timeFrame: Months 0, 1 and 2
measure: The change of visceral fat
timeFrame: Months 0, 1 and 2
Secondary outcomes:
measure: The change of fasting glycemia
timeFrame: Months 0, 1 and 2
measure: The change of aspartate aminotransferase
timeFrame: Months 0, 1 and 2
measure: The change of alanine aminotransferase
timeFrame: Months 0, 1 and 2
measure: The change of albumin
timeFrame: Months 0, 1 and 2
measure: The change of creatine
timeFrame: Months 0, 1 and 2
measure: The change of uric acid
timeFrame: Months 0, 1 and 2
measure: The change of white blood cell
timeFrame: Months 0, 1 and 2
Other outcomes:
Locations:
city: Pingtung
country: Taiwan
facility: National Pingtung University of Science and Technology
state: Neipu Township
Study officials:
affiliation: Study Principal Investigator
name: Bo-Han Wu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00094081: Concomitant Radiation and Cisplatin With and Without Tirapazamine in Treatment of Advanced Head and Neck Cancer
Official title: Phase III Randomized Trial of Concomitant Radiation, Cisplatin, and Tirapazamine Versus Concomitant Radiation and Cisplatin in Patients With Advanced Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Head and Neck Neoplasms
Keywords: squamous cell carcinoma
oropharynx
oral cavity
larynx
hypopharynx
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2004-10-14
Enrollment: 861
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The trial will compare the efficacy and safety of concomitant chemoradiation with tirapazamine, cisplatin and radiation versus cisplatin and radiation.


Eligibility criteria: Inclusion Criteria:

* Previously untreated squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx.
* Stage III or IV disease (excluding T1N1, and T2N1).
* ECOG performance status less than or equal to 2.
* Absolute neutrophil count at least 1.5 X 10\^9/L, platelet count at least 100 X 10\^9/L, and hemoglobin \> 9g/dL.
* Serum bilirubin \< 1.25 times ULN and AST/ALT \< 2.5 times ULN.
* Calculated creatinine clearance (Cockcroft-Gault) \> 55 mL/min.

Exclusion Criteria:

* Metastatic Disease

Primary outcomes:
measure: Overall survival.
Secondary outcomes:
measure: Time to locoregional failure.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Foundation for Cancer Research and Education
state: Arizona
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
city: Tampa
country: United States
facility: H-Lee Moffitt Cancer Center and Research
state: Florida
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Detroit
country: United States
facility: Harper Hospital
state: Michigan
city: East Orange
country: United States
facility: VA New Jersey Health Care Medical Center
state: New Jersey
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References:
citation: Ringash J, Fisher R, Peters L, Trotti A, O'Sullivan B, Corry J, Kenny L, Nuyts S, Wratten C, Rischin D. Effect of p16 Status on the Quality-of-Life Experience During Chemoradiation for Locally Advanced Oropharyngeal Cancer: A Substudy of Randomized Trial Trans-Tasman Radiation Oncology Group (TROG) 02.02 (HeadSTART). Int J Radiat Oncol Biol Phys. 2017 Mar 15;97(4):678-686. doi: 10.1016/j.ijrobp.2016.03.017. Epub 2016 Mar 23.
Clinical trial NCT00069381: Treatment for Women With Post-Traumatic Stress Disorder Related to Childhood Abuse
Official title: Skills Training, Exposure, and Their Combination in Childhood Abuse PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-09-25
Enrollment: 144
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare one- and two-component treatments in women with post-traumatic stress disorder (PTSD).

Detailed description: PTSD is a debilitating and often chronic anxiety disorder with serious psychiatric comorbidity. The most common trauma associated with PTSD among women is childhood abuse. PTSD related to childhood abuse may cause problems with emotion regulation and interpersonal functioning. This study will address three domains of PTSD related to childhood abuse: emotion management problems, interpersonal problems, and PTSD symptoms.

Participants in this study will be randomly assigned to 16 sessions of one of three treatments: Skills Training for Affective and Interpersonal Regulation (STAIR), which focuses on helping individuals strengthen and build skills in managing feelings and improving interpersonal relationships; Modified Prolonged Exposure (MPE), which focuses on developing narratives of abuse history and completing an "emotional processing" of the trauma in a safe environment; and a combination of STAIR and MPE. Dropout rates and adverse effects will be measured.

Eligibility criteria: Inclusion Criteria:

* DSM-IV criteria for Post-Traumatic Stress Disorder related to childhood physical and/or sexual abuse by a care-giver
* At least one clear memory of the abuse
* Willing to have all assessments tape recorded and sessions video taped
* Willing to maintain any concurrent treatments for the duration of the study

Exclusion Criteria:

* Bipolar Disorder
* Eating Disorder
* Borderline Personality Disorder
* Active substance abuse or dependence
* Living with the abuser
* Self mutilation
* Pregnancy

Primary outcomes:
measure: outcome
timeFrame: within study timeframe
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Child Study Center Institute for Trauma and Stress
state: New York
Study officials:
References:
citation: Cloitre M, Stovall-McClough KC, Nooner K, Zorbas P, Cherry S, Jackson CL, Gan W, Petkova E. Treatment for PTSD related to childhood abuse: a randomized controlled trial. Am J Psychiatry. 2010 Aug;167(8):915-24. doi: 10.1176/appi.ajp.2010.09081247. Epub 2010 Jul 1.
Clinical trial NCT06482281: COVID-19 and Childhood Cancer
Official title: COVID-19 and Childhood Cancer - Diagnostic Delay, Survival, and COVID-19 Susceptibility
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: COVID-19
Childhood Cancer
Childhood Leukemia, Acute Lymphoblastic
Keywords: Childhood Cancer
Childhood Cancer Incidence
Childhood Cancer Survival
Childhood Leukemia, Acute Lymphoblastic
Cohort Study
Register Study
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
name: The Swedish Childhood Cancer Fund
First posted: 2024-07-01
Enrollment: 100000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Childhood cancer cases (age 0-19) diagnosed from 1971 in Sweden and Denmark who were alive five years after diagnosis + their matched comparisons AND all siblings of the childhood cancer survivors
* All children (age 0-19) diagnosed with cancer from 2015 in Sweden and Denmark

Brief summary: The investigators will first examine the impact of the COVID-19 pandemic on childhood cancer patients in Sweden and Denmark, both regarding susceptibility to severe COVID-19 among long-term childhood cancer survivors, and, for those diagnosed with childhood cancer during the pandemic, whether the path through primary care to cancer diagnosis as well as short-term survival has changed. Second, the investigators will study childhood cancer incidence before, during and after the pandemic with the particular aim to test the hypothesis regarding an infectious disease etiology for acute lymphoblastic leukemia.


Eligibility criteria: Inclusion Criteria for studying severe COVID-19 among childhood cancer survivors:

* Childhood cancer cases (age 0-19) diagnosed from 1971 in Sweden and Denmark who were alive five years after diagnosis
* Two different comparisons groups: five age- and sex-matched comparisons for each childhood cancer survivor as well as all siblings of the childhood cancer survivors.
* All childhood cancer survivors, matched comparisons, and siblings of the survivors should be 20+ at the start of 2020.

Inclusion Criteria for studying childhood cancer incidence and survival and number of contacts with healthcare before the childhood cancer diagnosis:

- All children (age 0-19) diagnosed with cancer from 2015 in Sweden and Denmark

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: Severe COVID-19
timeFrame: Up to 3 years
measure: Childhood cancer survival
timeFrame: After three and twelve months after the cancer diagnosis and three years after cancer diagnosis
measure: Number of contacts before childhood cancer diagnosis
timeFrame: One year before cancer diagnosis
measure: Childhood cancer incidence
timeFrame: From 2015
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Giorgio Tettamanti, PhD
role: PRINCIPAL_INVESTIGATOR
References: