louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04938414: Investigate the Relationship Between Inflammatory and Coagulation in SAH CSF
Official title: Inhibition of Caspase-1 Reduces Pyroptotic Neuroinflammation and Tissue Factor-Induced Cerebrospinal Fluid Circulation Impairment After Subarachnoid Hemorrhage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subarachnoid Hemorrhage, Aneurysmal
Keywords: subarachnoid hemorrhage
coagulation
inflammation
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-24
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with SAH

Brief summary: Investigate the role of inflammasome and blood coagulation response in human cerebrospinal fluid after subarachnoid hemorrhage.

Detailed description: Investigate the role of inflammasome and blood coagulation response in human cerebrospinal fluid after subarachnoid hemorrhage (SAH).

1.40 patients with SAH will be included. The CSF will used for ELISA test for inflammatory factors and cogulation factors.

2.CSF obtained from 4 patients with non-neuroloogical disease with 4 addittional SAH patients will be used for Mass Spectrometry

Eligibility criteria: Inclusion Criteria:

* SAH patients with modified Fisher Scale 3-4.

Exclusion Criteria:

* Patients with history of CNS disease (e.g., stroke, traumatic brain injury, CNS infection) or accompanied by serious comorbidities before SAH onset (e.g., severe coagulation disorders, malignant tumor, uncontrollable heart disease, and hypertension) or other organ dysfunctions within 6 months were excluded from the study

Primary outcomes:
measure: Length of hospital stay
timeFrame: evaluated 1day after discharge
measure: modified Rankin Scale
timeFrame: evaluated 1day after discharge
measure: Glasgow Outcome Scale
timeFrame: evaluated 1day after discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second affiliated hosipital of zhejiang univerisity school of medicine
state: Zhejiang
Study officials:
affiliation: Zhejiang Univerisity
name: Yuanjian Fang, M.D
role: STUDY_CHAIR
References:
Clinical trial NCT02984514: Brown Adipose Tissue in Type 1 Diabetes
Official title: Studies of Activity of Brown Adipose Tissue With Positron Emission Tomography Using the Tracer 18F-deoxy Glucose in Patients With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type1diabetes
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
First posted: 2016-12-07
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Brown adipose tissue has the capacity to consume large amounts of energy and has insulin-independent glucose uptake. The investigators have recently observed an inverse correlation between irisin levels and insulin needs of type 1 diabetes patients. Transplantation of brown adipose tissue to insulin-deficient rats normalized their blood glucose levels.

In this study 12 patients with long-standing type 1 diabetes (\>10 years) and with variable exogenous insulin needs will be investigated for amount of brown adipose tissue with positron emission tomography using the tracer 18F-deoxy glucose.


Eligibility criteria: Inclusion Criteria:

1. Adult patients (18 years of age or more)
2. Type 1 diabetes diagnose for more than 10 years

Exclusion Criteria:

1. Ongoing pregnancy
2. Ongoing breast-feeding
3. BMI\<19
4. BMI \>30
5. P-creatinine \<110 µmol/l

Primary outcomes:
measure: Activity of brown adipose tissue in correlation to exogenous insulin needs using the tracer 18F-deoxy glucose in positron emission tomography measurements
timeFrame: Assessment performed after more than 10 years of diagnosed type 1 diabetes
Secondary outcomes:
measure: Glucose uptake in muscle in correlation to exogenous insulin needs; assessment using the tracer 18F deoxy glucose in positron emission tomography measurements.
timeFrame: Assessment performed after more than 10 years of diagnosed type 1 diabetes
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
References:
Clinical trial NCT03685214: Comparison of Balanced Crystalloids and Normal Saline in Septic Patients
Official title: Comparison of Balanced Crystalloids and Normal Saline in Septic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sepsis
Acute Kidney Injury
Septic Shock
Sepsis, Severe
Keywords: sepsis
intensive care unit
acetated Ringer's solution
AKI
normal saline
prognosis
continuous renal replacement therapy
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
Collaborators: name: Wu Jieping Medical Foundation
First posted: 2018-09-26
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: One model using normal saline for resuscitation fluid,the other using acetated Ringer's solution
Primary purpose: TREATMENT

Brief summary: In this prospective randomized controlled trial, investigators attempt to study the effects of acetated Ringer's solution on the prognosis and renal function of patients with sepsis in intensive care unit compared with normal saline, and provide evidence for current fluid resuscitation strategies for sepsis.

Detailed description: During the study period，either normal saline or acetated Ringer's solution will be assigned as resuscitation fluid to the septic patients meeting the inclusion criteria.It is anticipated that about 500 patients will be enrolled during the study period.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed sepsis aged 18\~75 and accepted therapy in ICU

Exclusion Criteria:

* Need of Renal replacement treatment
* End-stage renal failure
* pregnant woman

Primary outcomes:
measure: Development of kidney injury as defined by the KDIGO criteria.
timeFrame: 5 days after the admission
measure: Need of renal replacement treatment
timeFrame: After the admission and before the discharge from ICU,average 15 days
Secondary outcomes:
measure: ICU stay
timeFrame: After the admission and before the discharge from ICU,average 15 days
measure: 28 days mortality
timeFrame: 28 days after the admission in ICU
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital
state: Hubei
Study officials:
affiliation: Zhongnan Hospital
name: ZhiYong Peng, professor
role: STUDY_DIRECTOR
References:
citation: Liu F, Zhang J, Zhu Y, Su L, Li Y, He L, Yu L, Peng Z. Acetate Ringer's solution versus 0.9% saline for septic patients: study protocol for a multi-center parallel controlled trial. Trials. 2021 Jan 25;22(1):89. doi: 10.1186/s13063-020-05007-5.
Clinical trial NCT00825214: Evaluation of Zapperclick Device for Relief From Mosquito Bites
Official title: Evaluation of a Piezoelectric Device (Zapperclick) for Relief From Mosquito Bites
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Insect Bites
Stings
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
First posted: 2009-01-19
Enrollment: 120
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Mosquito bites commonly result in redness, swelling and itching. This study will determine if a device that emits a small piezo-electrical impulse can provide relief from these symptoms. Volunteers entering the study will have a mosquito bite on one forearm. Redness and irritation will be recorded periodically for 24 hours. Comparing data from subjects randomised to the treatment or a placebo device will be analysed to determine effectiveness of the product. We will also ask the subjects their view on how easy the product is to use and clarity of instructions provided.


Eligibility criteria: Inclusion Criteria:

* known rection to mosquito bites
* willing to attend clinic for 2 hours during measurements
* informed written consent

Exclusion Criteria:

* hypersensitivity to bites or stings
* atopic allergy
* pacemaker
* pregnant / breast feeding
* use of other medication including pain killers

Primary outcomes:
measure: reduction in itching
timeFrame: 24 hours
Secondary outcomes:
measure: reduction in erythema / oedema
timeFrame: 24 hours
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: London School of Hygiene & Tropical Medicine
Study officials:
References:
Clinical trial NCT02069314: Diet and Muscle Function In Older Adults
Official title: Diet and Muscle Function In Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2014-02-24
Enrollment: 12
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This research study was conducted to investigate the effects of a high protein diet on the efficiency of energy use at rest and at low-levels of physical activity. The hypothesis was that a high intake of dietary protein would result in a less efficient use of energy in skeletal muscle in older adults.

Detailed description: This research study was conducted to investigate the effects of a high protein diet on the efficiency of energy use at rest and at low-levels of physical activity. The hypothesis was that a high intake of dietary protein would result in a less efficient use of energy in skeletal muscle in older adult

Eligibility criteria: Inclusion Criteria:

* 65 years and older

Exclusion Criteria:

* Diabetic
* Acute symptoms of cardiovascular disease or congestive heart failure
* uncontrolled hypertension
* supplemental oxygen consumption at rest or during exercise
* lactose intolerance
* inability to ride a stationary cycle

Primary outcomes:
measure: Dietary protein effects on muscle energy use
timeFrame: participants will be measured over an average of 26 days
Secondary outcomes:
measure: Effect of protein supplements on food intake
timeFrame: participants will be measured over an average of 26 days
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: Purdue University Dept of Nutrition Science
name: Wayne W Campbell, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03347214: dbGaP Protocol: The Pediatric Cardiac Genetics Consortium (PCGC)
Official title: dbGaP Protocol: The Pediatric Cardiac Genetics Consortium (PCGC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Keywords: dbGaP
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2017-11-20
Enrollment: 6260
Sex: ALL
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People who already participated in the Pediatric Cardiac Genomics Study

Brief summary: Background:

Researchers do not know much about the causes of congenital heart disease (CHD). They do know that many factors play a role. Some factors are environmental. Some are genetic. But few specific factors have been identified. And researchers do not know how many involve genes. They want to study data that has already been collected from people with CHD and their families.

Objectives:

To identify genetic variations related to CHD. To study molecules related to vascular disease in order to learn new ways to treat it.

Eligibility:

People who already participated in the Pediatric Cardiac Genomics Consortium (PCGC) study

Design:

Researchers will study data that was already collected in the PCGC. There will be no active participants.

Researchers will get access to the data through the coordinating center. They will not download data to local storage devices.

The data will have no personally identifying information....

Detailed description: Current understanding of the causes of congenital heart disease (CHD) is limited, but CHD is known to be multifactorial and affected by a combination of environmental, teratogenic, and genetic causes. Furthermore, both genetic and environmental factors have been proposed to act as disease modifiers, accounting for a wide variation in phenotypic expression and clinical outcomes of these disorders. To date however, few specific genetic or environmental causative factors have been identified, nor is it even known what proportion of cases involve genetic factors.

Eligibility criteria: * Retrospective Analysis Study. Data will be analyzed from subjects from cardiovascular disease databases.

Primary outcomes:
measure: Identification of novel genetic variants associated with a CHD phenotype
timeFrame: Ongoing
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Heart, Lung and Blood Institute (NHLBI)
state: Maryland
Study officials:
affiliation: National Heart, Lung, and Blood Institute (NHLBI)
name: Jonathan R Kaltman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02116114: Effects of Aquatic Physical Training Program on Cardiorespiratory Variables in Patients With COPD
Official title: Effects of Aquatic Physical Training Program on Cardiorespiratory Variables in Patients With COPD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adverse Effects in the Aquatic Exercises
Keywords: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Universidade Metodista de Piracicaba
Sponsor class: OTHER
First posted: 2014-04-16
Enrollment: 24
Sex: MALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We have as hypothesis that the aquatic aerobic physical training program can help promote beneficial adaptations on the cardiovascular, respiratory and systemic inflammation variables, functional capacity and quality of life in patients with chronic obstructive pulmonary disease (pulmonary emphysema).

Detailed description: First paragraph

* aquatic aerobic physical training program
* beneficial adaptations

Next paragraph

* cardiovascular
* respiratory
* systemic inflammation
* functional capacity
* quality of life

Eligibility criteria: Inclusion Criteria:

* Diagnosis of COPD ( GOLD I / II / III / IV rating )
* Clinically stable
* Low level of physical activity , according to the IPAQ ( International Physical Activity Questionnaire )
* Absence of exacerbation in the last three months
* Do not participate in a regular exercise program in the past six months

Exclusion Criteria:

* Diabetes Mellitus
* Endocrine Disorders
* Chronic renal failure
* Liver Diseases
* Other lung diseases or inflammatory diseases associated
* Cardiac
* Use of drugs that prevented physical performance
* Musculoskeletal and neuromuscular changes that make it impossible to run experimental protocols
* Dermatological disorders ( cutaneous fistulas , infected wounds , ringworm skin , varicose ulcers )
* Hypersensitivity to the product used for the treatment of pool water
* Rabies

Primary outcomes:
measure: Change from baseline in cardiac autonomic modulation by heart rate variability at week 8
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Change from baseline in quality of life by the Saint George Respiratory Questionnaire at week 8
timeFrame: Baseline, Week 8
Other outcomes:
measure: Change from baseline in systemic inflammation by C-reactive protein at week 8
timeFrame: Baseline, Week 8
Locations:
Study officials:
affiliation: Universidade Metodista de Piracicaba
name: Bruna G Silva, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00596414: Sedation and Analgesia for Transjugular Liver Biopsy: A Randomized Double Blind Placebo Controlled Trial
Official title: Sedation and Analgesia for Transjugular Liver Biopsy: A Randomized Double Blind Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cirrhosis
Chronic Hepatitis
Anxiety
Keywords: liver
biopsy
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2008-01-17
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Transjugular liver catheterisation allows the measurement of hepatic venous pressure gradient (HVPG) and the sampling of liver tissue but patient's tolerance to the procedure is unknown. The aim of this study was to assess tolerance to transjugular hepatic liver biopsy with or without conscious sedation/analgesia.

Detailed description: Consecutive patients undergoing transjugular liver biopsy will be randomly assigned to receive either placebo or midazolam (0.02 mg/kg) or 0.02 mg/kg midazolam combined with 1 mg/kg pethidine before the procedure.

Eligibility criteria: Inclusion Criteria:

* suspected liver disease
* known liver disease

Exclusion Criteria:

* liver transplants
* hepatocellular carcinoma
* hypersensitivity or allergy to benzodiazepines or morphinic derivatives

Primary outcomes:
measure: Patient tolerance to the procedure
timeFrame: 1 hour after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Hopital Erasme - Dpt of Gastroenterology
Study officials:
References:
Clinical trial NCT03960814: A Study of All-Cause and Cardiovascular Mortality in Type 2 Diabetes Patients Using Basal Insulin Detemir and Glargine
Official title: Retrospective Cohort Study of All-Cause and Cardiovascular Mortality in Type 2 Diabetes Patients Using Basal Insulin Detemir and Glargine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2019-05-23
Enrollment: 12847
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: New users of basal insulins glargine and detemir

Brief summary: This study will examine the influence of the basal insulins detemir and glargine on risk of cardiovascular death and death from all causes in patients treated by their general practitioner in United Kingdom (UK). The data for this study will be drawn from the Clinical Practice Research Datalink (CPRD) Register.


Eligibility criteria: Inclusion Criteria:

* Diagnosis (ever) of type 2 diabetes
* Prescription (ever) of basal insulins glargine or detemir
* Insulin-naïve until initiation of basal insulins glargine or detemir
* Aged 40 years or older at start of observation period

Exclusion Criteria:

* Diagnosis of type 1 diabetes

Primary outcomes:
measure: Age at all cause death or censoring
timeFrame: Observation period 2004 - 2018
measure: Age at death of cardiovascular disease
timeFrame: Observation period 2004 - 2018
Secondary outcomes:
Other outcomes:
Locations:
city: Bagsværd
country: Denmark
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02762214: Role of Uterine Manipulator in Hysterectomy - Ro.Man.HY
Official title: Role Of Uterine Manipulator in Hysterectomy for Early Stage Endometrial Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Endometrial Cancer
Keywords: Uterin manipulator
Endometrial Cancer
Laparoscopy
Robotic
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2016-05-04
Enrollment: 154
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective multicentric randomized trial to evaluate the role of uterine manipulator on laparoscopic/robotic total hysterectomy for the treatment of early stage G1 - G2 endometrial cancer (International Federation of Gynecology and Obstetrics - FIGO stages IA-IB).

Detailed description: This multicentric prospective randomized Phase III trial is aimed to verify if the use of uterine manipulator for laparoscopic/robotic treatment of early stage endometrial cancer can influence the impact of peritoneal cytology and lymph vascular space invasion (LVSI) and the outcomes in terms of perioperative and oncological (disease free survival - DFS, overall survival - OS) outcomes.

Eligibility criteria: Inclusion Criteria:

For patients

* Age \> 18 \< 80 years
* Patient's informed consent
* American Society of Anesthesiologists: \< class III or IV
* No actual pregnancies
* Body Mass Index (BMI) ≤ 35

For diseases

* Early stage endometrial cancer (IA-IB)
* Endometrioid histotype (G1-G2)

Exclusion Criteria:

For patients

* Age \> 18 \< 80
* Actual pregnancies
* Previous gynecological cancer

For disease

* Type II endometrial cancer histotype
* Grade 3 endometrial cancer
* Advanced stage endometrial cancer (II - IV)
* Previous radiotherapy on the pelvic field
* Uterine size larger than conform 12 weeks gestation or 9 cm in horizontal
* Necessity of laparotomic procedures

Primary outcomes:
measure: Upstaging rate
timeFrame: 30 days
Secondary outcomes:
measure: Complications
timeFrame: within 30 days from surgery
measure: Blood Loss
timeFrame: Intraoperative
measure: Impact of surgical procedure
timeFrame: Perioperative
measure: Role of uterine manipulator in Obesity
timeFrame: Intraoperative
measure: Impact on postoperative pain
timeFrame: Postoperative
measure: Oncological Outcomes: Rate of local relapses
timeFrame: 1 years - 5 years
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Division of Oncologic Gynecology, Fondazione Policlinico Gemelli
Study officials:
References:
Clinical trial NCT00426114: Acute Haemodynamic Impact of an IV Glucose-injection
Official title: Acute Haemodynamic Impact of an IV Glucose-injection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Peritoneal Dialysis
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2007-01-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Patients with peritoneal dialysis will be administered an IV glucose-injection to evaluate the haemodynamic impact of this injection. The patients will be matched with healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* \> 18 years old
* Stable clinical condition
* Either peritoneal dialysis (at least one month) either matched healthy subject

Exclusion Criteria:

* Heart Failure
* Diabetes requiring insulin treatment

Primary outcomes:
measure: Haemodynamic parameters
measure: Glycemia
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Ghent
name: Wim Van Biesen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: