louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01236339: Early TIPS for Ascites Study
Official title: The GORE® VIATORR® TIPS Endoprosthesis Versus Large-Volume Paracentesis for the Treatment of Ascites in Patients With Portal Hypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Liver Cirrhosis
Portal Hypertension
Ascites
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2010-11-08
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate that TIPS with the GORE® VIATORR® TIPS Endoprosthesis improves transplant-free survival compared to LVP alone in patients who have cirrhosis of the liver with portal hypertension and difficult to treat ascites.


Eligibility criteria: Inclusion Criteria:

\> Patient has cirrhosis of the liver with portal hypertension

\> Patient has difficult to treat ascites

\> Patient is 18 years or older and \<70 years old at randomization

\> Patient is willing and able to comply with all study protocol requirements, including specified follow-up and testing.

\> Patient, or legal authorized representative, is willing to provide written informed consent prior to enrollment in the study.

Exclusion Criteria:

\> Patient has more than 6 large volume paracenteses within 90 days prior to randomization

\> Patient is contraindicated for TIPS placement

\> Patient has had previous TIPS placement

Primary outcomes:
measure: Transplant-free Survival
timeFrame: Through 24 months
Secondary outcomes:
measure: Overall Survival
timeFrame: Through 24 months
measure: Time to Transplant
timeFrame: Through 24 months
measure: Frequency of Paracentesis
timeFrame: Through 24 months
measure: Frequency of Hepatic Encephalopathy
timeFrame: Through 24 months
measure: Procedural Success
timeFrame: Time of TIPS Procedure (within 2 weeks of enrollment for TIPS arm, at least 6 months after enrollment for Control arm crossover participants)
measure: Liver Disease Complications (Adverse Events)
timeFrame: Through 24 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Baltimore
country: United States
facility: University of Maryland-Baltimore
state: Maryland
Study officials:
affiliation: University of Arizona College of Medicine
name: Thomas Boyer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland
name: Ziv Haskal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00438139: Ph1 Marinol Interaction Study - Part 1 - 1
Official title: Phase 1, Pilot Study to Examine the Cardiovascular Effects of Smoked Marijuana, Interactions With Oral Dronabinol, and Effects of Dronabinol on Withdrawal in Marijuana Dependent Volunteers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Marijuana Dependence
Keywords: marijuana dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2007-02-21
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effects of oral dronabinol tetrahydrocannabinol (THC) on withdrawal symptoms in marijuana dependent volunteers, and evaluate the safety, pharmacokinetics (PK), and cardiovascular effects of the combination of oral dronabinol and smoked marijuana to determine if there are potential significant interactions before conducting outpatient studies.


Eligibility criteria: Inclusion Criteria:

* Must be between the ages of 18 to 45 years of age
* Must be in good general health
* Must meet DSM-IV criteria for marijuana dependence and are non- treatment seekers at the time of study
* Must be able to provide written informed consent
* Must be able to provide 1 marijuana positive urine specimen (\> 50 ng/mL) within the 28-day screening period
* If female and of child bearing potential, must agree to use birth control.

Exclusion

Criteria:

* Please contact site for more information.

Primary outcomes:
measure: Cardiovascular responses
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Uniformed Services University of Health Science
state: Maryland
Study officials:
affiliation: Uniformed Services University of Health Science
name: Louis Cantilena, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04084639: Mycoprotein Consumption and Glucose Absorption
Official title: To Determine the Effects of Mycoprotein Consumption on Glucose Absorption in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Exeter
Sponsor class: OTHER
Collaborators: name: Quorn
First posted: 2019-09-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Previous research has demonstrated that the food found in Quorn 'Mycoprotein' can lower the blood glucose response to a meal, which may be an important finding for the management of type 2 diabetes. However, it has never been investigated how this lower response occurs, and whether there is dose-dependent response with mycoprotein. The present study will include 12 healthy young adults, who will visit the laboratory for 3 test days, with each day lasting 9 hours. On each visit, separated by a washout period of at least 2 weeks, participants will ingest either a control drink with no mycoprotein, a drink containing 20g mycoprotein or a drink containing 40g mycoprotein. By intravenously infusing labelled glucose during each visit in combination with repeated blood sampling, investigators will determine if the lower blood glucose after mycoprotein ingestion is due to reduced glucose absorption from the gut or increased uptake into body tissues.


Eligibility criteria: Inclusion Criteria:

* Male and female
* 18-35 years of age
* Consumption of sufficient amounts of carbohydrate in the diet
* Body mass index between 18.5 and 30

Exclusion Criteria:

* Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes), or other form of abnormal glucose metabolism (as this will affect outcome of the study).
* Any diagnosed cardiovascular disease
* Insufficient consumption of carbohydrate in the diet
* A personal or family history of epilepsy, seizures or schizophrenia
* Known pre-existing liver disease/condition
* Allergy or intolerance to milk

Primary outcomes:
measure: Glucose absorption
timeFrame: 6 hours following ingestion of drink
Secondary outcomes:
measure: Incretin Hormones
timeFrame: 6 hours following ingestion of drink
measure: Insulinaemic Response
timeFrame: 6 hours following ingestion of drink
measure: Production of Short-Chain Fatty Acids
timeFrame: 6 hours following ingestion of drink
measure: Glucose Kinetics
timeFrame: 6 hours following ingestion of drink
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: University of Exeter
Study officials:
References:
Clinical trial NCT01445639: Dexmedetomidine in Patients After Intracranial Surgery
Official title: Use of Dexmedetomidine for Prophylactic Analgesia and Sedation in Patients After Intracranial Surgery (Prophylactic Analgesia and Sedation Trial, PASTrial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Central Nervous System Diseases
Keywords: dexmedetomidine
sedation
neurosurgery
postoperative care
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2011-10-04
Enrollment: 192
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: Dexmedetomidine is a highly selective a2-adrenoreceptor agonist that produces dose-dependent sedation and analgesia without respiratory depression. Dexmedetomidine has been used in critically ill medical, surgical, and pediatric patients. No study has been designed specifically to evaluate dexmedetomidine uses in the neurocritical care population. The primary objective is to evaluate the safety and efficacy of dexmedetomidine for prophylactic analgesia and sedation in patients after intracranial surgery.

Detailed description: The PASTrial is a non-commercial, multi-center, randomized, placebo-controlled, double blinded clinical trial. The study compares dexmedetomidine versus normal saline (placebo) in patients after intracranial surgery with delayed extubation. In dexmedetomidine group, infusion (0.4μg/kg/h) is started when patients are admitted to neuro-intensive care unit for postoperative recovery. In control group, patients receive normal saline infusion at the same rate and volume in dexmedetomidine group. The patient's level of sedation is assessed by Sedation-Agitation Scale (SAS) per hour. Midazolam is administered in 0.3-0.5 mg bolus or continuous infusion as SAS above 4. The study is designed primarily to compare the percentage of patients with agitation and requiring midazolam infusion in the 2 study arms.

Eligibility criteria: Inclusion Criteria:

* Adult patients after intracranial surgery with delayed extubation

Exclusion Criteria:

* emergency operation
* brain stem operation
* preoperative consciousness disorders or epilepsy
* bradycardia, hypotension, acute myocardial infarction, second- or third degree heart block, or need continuous infusions of vasopressor before the start of study drug infusion
* patients enrolled in another trial

Primary outcomes:
measure: Mean percentage of hours of optimal sedation.
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: Percentage of patients with agitation and receiving additional sedatives.
timeFrame: During the first 24 hours postoperatively
Other outcomes:
measure: Percentage of patients with adverse events.
timeFrame: During the first 24 hours postoperatively
Locations:
city: Beijing
country: China
facility: Neuro-ICU, Beijing Tiantan Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Neuro-ICU, Beijing Tiantan Hospital, Capital Medical University
name: Jian-Xin Zhou, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03494439: Prevalence of Anterior Open Bite in a Group of Egyptian Children Aged Eight Years and Above
Official title: Prevalence of Anterior Open Bite in a Group of Egyptian Children Aged Eight Years and Above: A Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anterior Open Bite
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-04-11
Enrollment: 113
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Egyptian children aged 8 years and above, from the Out Patients' clinic of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University.

Brief summary: This study aims to determine the prevalence of anterior open bite and its etiological factors in a group of Egyptian children aged 8 years and above. patients who met the eligibility criteria will be given a questionnaire to fill followed by obtaining casts stabilized into occlusion to obtain the vertical and horizontal relationships.


Eligibility criteria: Inclusion Criteria:

* Medically free children aged 8 years and above, both genders and cooperative parents and children

Exclusion Criteria:

* Presence of orthodontic appliance and parents refuse to participate

Primary outcomes:
measure: Anterior Open bite
timeFrame: 1 year
Secondary outcomes:
measure: Its different etiological factors
timeFrame: 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT04793139: Efficacy and Safety of Camrelizumab in Real-World Prospective Study
Official title: Efficacy and Safety of Camrelizumab for Chinese NSCLC Patients: a Prospective, Observational, Multicenter Real-World Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Guangdong Association of Clinical Trials
Sponsor class: OTHER
First posted: 2021-03-11
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Total 1000 patients who should accept camrelizumab with NSCLC will be enrolled. The patients should be registered consecutively in each site.

Brief summary: This observational real-world study is designed to evaluate the efficacy and safety of camrelizumab for the treatment of Chinese NSCLC patients.

Detailed description: Camrelizumab is a humanized antibody for cancer immunotherapy. The National Medical Products Administration (NMPA, China) approved camrelizumab as a first-line treatment of certain patients with NSCLC. This is a multicenter non-interventional study, NSCLC patients who have been treated with camrelizumab will be included. The main objective of this study is to evaluate the efficacy and safety of camrelizumab in the clinical practice.

Eligibility criteria: Inclusion Criteria:

1. Sign the informed consent and volunteer to participate in the study;
2. Non-small cell lung cancer confirmed by histological/cytopathological tests;
3. Age ≥18;
4. The investigators determined that patients should receive camrelizumab alone or in combination.

Exclusion Criteria:

1. Patients who are also receiving other immunomedications or therapies;
2. Patients participating in other interventional studies;
3. Patients complicated with other malignant tumors;
4. Women who have been confirmed to be pregnant or lactating;
5. The Investigator considers the patient unsuitable for participation in any other condition of the study.

Primary outcomes:
measure: AE,Grade 3-5
timeFrame: From April 1, 2021 to Septeember 30, 2024
Secondary outcomes:
measure: pCR
timeFrame: From April 1, 2021 to December 30, 2024
measure: MPR
timeFrame: From April 1, 2021 to December 30, 2024
measure: R0 resection rate
timeFrame: From April 1, 2021 to December 30, 2022
measure: ORR
timeFrame: From April 1, 2021 to December 30, 2022
measure: PFS
timeFrame: From April 1, 2021 to December 30, 2022
measure: OS
timeFrame: From April 1, 2021 to December 30, 2022
Other outcomes:
Locations:
Study officials:
affiliation: Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences
name: Yilong Wu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04687839: Assessment of the Wound Healing Efficacy and Tolerance of a Medical Device on Wounds in Healthy Subjects.
Official title: Assessment of the Wound Healing Efficacy and Tolerance of the Medical Device RL3010A DP0378 on a Blister Suction Model in Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Heaklthy adult subject
Wound
Lead sponsor: Pierre Fabre Dermo Cosmetique
Sponsor class: INDUSTRY
First posted: 2020-12-29
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The tested medical device is indicated for the treatment of wounds and small skin injuries. The intention of this study is to evaluate the tolerance and efficacy of the test product by measuring the recovery of the skin barrier after wound produced by suction blister. But also, by validating the accompanying physiological effect of the study product during this recovery.


Eligibility criteria: Inclusion Criteria:

* Subject with a phototype I, II or III according to the Fitzpatrick scale
* Subject aged between 18 and 45 years included at selection visit
* Subject with absence of infectious diseases (HIV and Hepatitis), confirmed by negative blood test results

Exclusion Criteria:

* History of keloids and hypertrophic scars
* Subject with removal of axillary lymph nodes
* Pathology, active skin disease or dermatological condition in progress (psoriasis and/or lichen ruber and/or eczema ...) or presence of dermatological lesions on the inner side of the forearm (solar erythema or dermatosis ...) that may affect the performance of the research or judged incompatible with the realization of the study
* Subject with severe illness (severe infectious disease (e.g. severe flu)), chronic disease or acute evolutionary pathology likely to influence the study results or considered by the investigator hazardous for the subject or incompatible with the study
* Knowledge of Acquired Immunodeficiency Syndrome or Infectious (acute) Hepatitis
* Subject presenting a healing pathology or a pathology with consequences on the healing like the diabetes mellitus (type I and type II)
* Subject with congenital methemoglobinemia or porphyria

Primary outcomes:
measure: Effect of the tested product on the wound healing at D6
timeFrame: Day6
Secondary outcomes:
measure: Effect of the tested product on the cutaneous barrier restoration
timeFrame: Day1, Day2, Day4, Day6, Day8(+/-1), Day10(+/-1) and Day13(+/-1)
measure: Effect of the tested product on healing
timeFrame: Day1, Day2, Day4, Day6, Day8(+/-1), Day10(+/-1) and Day13(+/-1)
measure: Tolerance of the tested product
timeFrame: Day1, Day2, Day4, Day6, Day8(+/-1), Day10(+/-1) and Day13(+/-1)
Other outcomes:
Locations:
city: Schenefeld
country: Germany
facility: Dr. Kirstin Deuble-Bente
Study officials:
affiliation: Kiebitzweg 2, 22869 Schenefeld/Hamburg, Germany
name: Kirstin Deuble-Bente, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03749239: Effects of Collagen Protein on the Amino Acid Profile of the Blood
Official title: Effect of Intake of Enzymatically Hydrolyzed and Non-enzymatically Hydrolyzed Collagen Protein on the Amino Acid Profile of the Blood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Collagen Protein
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2018-11-21
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This project aims to investigate the absorption of enzymatically hydrolysed and non-enzymatically hydrolysed collagen on the Amino acid profile of the blood


Eligibility criteria: Inclusion Criteria:

* Healthy

Exclusion Criteria:

* Medicine influencing protein turnover
* Diabetes
* Smoking

Primary outcomes:
measure: Amino acid profile of the blood
timeFrame: Blood samples is collected at pre, 0 min, 20 min, 40 min, 60 min, 90 min, 120 min, 180 min and 240 min.
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University, Department for Public Health, Section for Sport Science
Study officials:
References:
Clinical trial NCT01485939: Lidocaine Patch for Postoperative Analgesia After Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative, Pain
Keywords: lidocaine patch
laparoscopic cholecystectomy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-12-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators hypothesized that application of a 5% lidocaine patch would be associated with reduced pain scores after operation compared with placebo patch in patients undergoing laparoscopic cholecystectomy.

Detailed description: * The 5% lidocaine patch have been approved for the treatment of postherpetic neuralgia.
* The investigators hypothesized that application of a 5% lidocaine patch would be associated with reduced pain scores, pain controlled drug(opioids, NSAID) in post operative period.

Eligibility criteria: Inclusion Criteria:

* patients of ASA Ⅰ-Ⅱ
* aged 18\~65
* scheduled to undergo elective laparoscopic cholecystectomy under general anesthesia.

Exclusion Criteria:

* patients with chronic pain
* patients with taking regular analgesics
* patients with allergy to ketorolac or lidocaine

Primary outcomes:
measure: post operative pain after laparoscopic cholecystectomy
timeFrame: post operative periods
Secondary outcomes:
measure: pain controlled drug doses in postoperative periods.
timeFrame: postoperative periods
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul national university Bundang hospital
state: Kyoung-ki-do
Study officials:
References:
Clinical trial NCT05643339: The Reproducibility of Microvascular Flow Imaging in Fibroids and Its Correlation With 2D and 3D Power Doppler Outcomes
Official title: The Reproducibility of Microvascular Flow in Fibroids and Its Correlation With 2D and 3D Power Doppler Outcomes: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibroid Uterus
Keywords: fibroid
microvascular flow
power doppler
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2022-12-08
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients were women with one or more uterine fibroids, with a diameter between 1,5 and 12 cm, of which one was easily recognizable on ultrasound to assure the quality of the Doppler images.

Brief summary: The investigators hypothesized that Macrovascular Flow imaging could contribute to 2D power Doppler and 3D power Doppler in depicting fibroid vascularity. However, data concerning the feasibility and reproducibility of Macrovascular Flow imaging is lacking. Therefore the purpose of our study was to determine 1) the reproducibility of Macrovascular Flow imaging, 2) its correlation with 2D and 3D power Doppler, and 3) penetration depth, in order to investigate the added value for daily clinical practice.


Eligibility criteria: Inclusion Criteria:

* one or more uterine fibroids
* diameter between 1,5 and 12 cm
* fibroid easily recognizable on ultrasound

Exclusion Criteria:

* younger than 18 years
* pregnancy
* uterine or cervical malignancy
* adenomyosis.

Primary outcomes:
measure: reproducibility by inter- and intraobserver agreement
timeFrame: Day 1
Secondary outcomes:
measure: penetration in centimeters
timeFrame: Day 1
measure: architecture
timeFrame: Day 1
measure: presence doppler signal
timeFrame: Day 1
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
state: Noord-Holland
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Judith Huirne, Prof.
role: PRINCIPAL_INVESTIGATOR
References: