louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00446420: Cognitive Impairment Following Sedation for Colonoscopy With Propofol, Midazolam and Fentanyl Combinations
Official title: Cognitive Impairment Following Sedation for Colonoscopy With Propofol, Midazolam and Fentanyl Combinations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cognitive Impairment
Lead sponsor: Melbourne Health
Sponsor class: OTHER
First posted: 2007-03-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Our hypothesis is that adding midazolam and/or fentanyl to propofol sedation for elective outpatient colonoscopy increases cognitive impairment at hospital discharge without improving intraoperative conditions or reducing intraoperative side-effects.

200 healthy patients aged 18 years or older will be randomised to receive propofol or propofol plus midazolam and/or fentanyl. Cognitive impairment will be tested at hospital discharge using Cogstate computerised testing software.

Detailed description: A great variety of drug combinations are administered to patients having elective outpatient colonoscopy. In addition, as patients are going home, some may have residual cognitive deficits that making leaving the hospital unsafe. This study aims to find drugs combinations that are associated with the least cognitive impairment.

Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older presenting for elective outpatient colonoscopy following full bowel preparation

Exclusion Criteria:

* No cognitive impairment
* Adequate English language comprehension
* Not combined with other procedures

Primary outcomes:
measure: Cognitive impairment at hospital discharge after elective outpatient colonoscopy
timeFrame: Before discharge from daycare facility
Secondary outcomes:
measure: Dreaming during sedation, intraoperative operating conditions and complications, satisfaction with care
timeFrame: Before discharge from daycare facility
Other outcomes:
Locations:
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
Study officials:
affiliation: Melbourne Health
name: Kate Leslie, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Padmanabhan U, Leslie K, Eer AS, Maruff P, Silbert BS. Early cognitive impairment after sedation for colonoscopy: the effect of adding midazolam and/or fentanyl to propofol. Anesth Analg. 2009 Nov;109(5):1448-55. doi: 10.1213/ane.0b013e3181a6ad31. Epub 2009 Jul 17.
Clinical trial NCT03812120: L-PRF in Cranial Surgery
Official title: L-PRF in Cranial Surgery: a Prospective, Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cranial Sutures; Closure
Keywords: L-PRF
CSF leakage
fibrin sealants
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2019-01-22
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled clinical trial
Primary purpose: PREVENTION

Brief summary: The investigators want to demonstrate in a prospective, randomized trial including 350 patients undergoing cranial surgery that the use of L-PRF is non-inferior to classical fibrin sealants.

Detailed description: The investigators want to demonstrate in a prospective, randomized trial including 350 patients undergoing cranial surgery that the use of L-PRF is non-inferior to classical fibrin sealants.

Approximately 350 patients undergoing cranial surgery will be enrolled in this randomized, controlled, single-blinded monocenter study to evaluate the safety and effectiveness of autologous blood-derived products (L-PRF and fibrinogen) compared to the fibrin sealants as an adjunct for dural repair (= primary objective).

The investigators will also evaluate if the use of L-PRF obviates the need for the use of other autologous grafts (e.g. muscle/fat), commercial collagen-based products (e.g. Tachosil) or articifial dura (=secondary objective).

Eligibility criteria: Inclusion Criteria:

* Patients undergoing cranial neurosurgery whereby the dura is intentionally opened (supratentorial and infratentorial approach)
* Age ≥ 18 years
* Written informed consent
* Willing to comply with the study schedule

Exclusion Criteria:

* Participation in another clinical trial with study drugs or devices
* Pregnancy

Primary outcomes:
measure: Success rate
timeFrame: 4 years
Secondary outcomes:
measure: Cost effectiveness evaluation
timeFrame: 4 years
measure: Complications
timeFrame: 4 years
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Tom Theys
Study officials:
affiliation: UZ Leuven
name: Tom Theys, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01882920: Goal Directed Therapy (GDT) in Cytoreductive Surgery (CRS) and Hyperthermic Intra Peritoneal Chemotherapy (Hipec)
Official title: Cytoreductive Surgery With Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) - Goal Directed Therapy vs. Standard Fluid Therapy. Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Peritoneal Neoplasm
Secondary Peritoneal Neoplasm
Keywords: Cytoreductive surgery
hyperthermic intraperitoneal chemotherapy
Goal directed fluid therapy
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
First posted: 2013-06-21
Enrollment: 80
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 aim of the study is to assess whether in cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) the use of a protocol of intravenous fluid therapy combined with goal directed fluid therapy (GDT) is associated with a significant change in morbidity, length of hospital stay and mortality compared to a standard fluid therapy. Patients undergoing CRS and hipec are randomly divided into two treatment groups. The GDT group receive fluid intravenous therapy according to a specific treatment protocol guided by monitored hemodynamic parameters assessed using the arterial pressure signal monitoring to assess stroke volume and cardiac output via an automated pulse contour analysis (Flotrac/Vigileo®); the control group receive the standard fluid therapy (crystalloid and colloid). Fluid therapy regimen is free in the control group and targeted in the GDT group. In both groups, the investigators evaluate the incidence of major abdominal and systemic complications, the total duration of hospital stay, mortality, the total amount of fluids administered, their breakdown (crystalloid/colloid) and the total number of colloid boluses administered.


Eligibility criteria: Inclusion Criteria:

* Patients selected for Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy

Exclusion Criteria:

* Patients under the age of 18, patients with hemodynamically significant aortic regurgitation and heart rhythm disorders

Primary outcomes:
measure: rate of abdominal complications
timeFrame: 90 day postoperative complication
Secondary outcomes:
measure: Overall Survival
timeFrame: 90 day overall survival
Other outcomes:
measure: length of hospital stay
timeFrame: 4 weeks
Locations:
city: Rome
country: Italy
facility: Regina Elena CI
Study officials:
affiliation: Regina Elena CI
name: Ester Forastiere, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05347420: Diagnostic Accuracy of Quantitative Neuropad Test for Diabetic Peripheral Neuropathy
Official title: Diagnostic Accuracy of Quantitative Neuropad Test for Diabetic Peripheral Neuropathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Peripheral Neuropathy
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with type 2 diabetes in the inpatient ward of the Department of Endocrinology, The First Affiliated Hospital of Chongqing Medical University.

Brief summary: This study aimed to evaluate the diagnostic vaule of quantitative Neuropad for diabetic peripheral neuropathy

Detailed description: This is a diagnostic study. Every patient will undertake Neuropad test, inculding the visual and quantitative screening tests. The visual screening test includes whether the Neuropad test paper changes completely from blue to pink within 10 minutes (visual screening test a) and the time to complete color change (visual screening test b). the quantitative screening test using a handheld color scanner to scan the rate of color change, which estimated by the slope of the Neuropad color change per minute. The visual and quantitative screening tests were compared when the Neuropathy Disability Score (NDS) and the Neurological Symptom Score (NSS) combined score as diagnostic criteria.

Eligibility criteria: Inclusion Criteria:

1) diagnosed type 2 diabetic patients; 2) age between 18 and 80 years.

Exclusion Criteria:

1) patients with type 1 diabetes, secondary diabetes, and patients with pre-existing diabetic foot; 2) exclusion of the following clinical conditions: foot skin lesions (scarring, rash, flaking skin, infection, etc. on the skin of the test site), peripheral arterial occlusive disease, long-term heavy smoking, chronic alcohol abuse, thyroid disease, liver insufficiency (more than 3-fold increase in liver enzymes), renal insufficiency (eGFR ≤ 30 mL /min/1.73m2), acute and chronic infections, cervical and lumbar spine diseases, bone and joint system diseases, other neurological diseases, autoimmune diseases, malignant tumors, psychiatric or psychological diseases, taking drugs that affect autonomic function, and combined with other diseases that can cause peripheral neuropathy; 3) those who cannot complete the experiment as required.

Primary outcomes:
measure: The quantitative Neuropad test
timeFrame: 1 day
Secondary outcomes:
measure: The visual Neuropad test
timeFrame: 1 day
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Rong Li, PHD
role: STUDY_CHAIR
References:
Clinical trial NCT00035620: Pegfilgrastim as Support to Pediatric Sarcoma Patients Receiving Chemotherapy
Official title: A Study of Single Dose Per Cycle Filgrastim-SD/01 as an Adjunct to VAdriaC/IE Chemotherapy in Pediatric Sarcoma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sarcoma
Neutropenia
Keywords: Bone cancer
Sarcoma
Neutropenia
Chemotherapy
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2002-05-06
Enrollment: 44
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Physicians are conducting a clinical trial for patients with pediatric sarcoma. Sarcoma is a type of bone cancer that can be treated with chemotherapy which can affect the bone marrow, where blood cells are produced. Neutrophils are a type of white blood cells that fight infection and are produced in the bone marrow. If the neutrophil count becomes too low due to chemotherapy, a potentially serious condition called neutropenia occurs. Neutropenia is serious because it can affect the body's ability to protect against many types of infections. Pegfilgrastim is an investigational drug being evaluated for its potential ability to increase the number of neutrophils. The purpose of this study is to determine the safety and effectiveness of pegfilgrastim in preventing neutropenia following chemotherapy in pediatric patients up through the age of 21 with sarcoma.


Eligibility criteria: * Sarcoma \* No previous chemotherapy or radiotherapy \* Patients who will be receiving chemotherapy consisting of Vincristine, Doxorubicin, Cyclophosphamide, Etoposide, Ifosfamide, and Mesna

Primary outcomes:
measure: Duration of severe neutropenia in chemotherapy in cycles 1 and 3
timeFrame: cycles 1 and 3
measure: Time to ANC recovery to greater than or equal to 0.5 x 10^9/L in cycles 1 and 3
timeFrame: cycles 1 and 3
Secondary outcomes:
measure: Pharmacokinetic profile in chemotherapy cycles 1 and 3
timeFrame: cycles 1 and 3
measure: Incidence of adverse events across all cycles of chemotherapy
timeFrame: all cycles
measure: Overall rates of febrile neutropenia
timeFrame: all cycles
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05208320: Effectiveness of Community Health Workers in Hypertension Adherence
Official title: Effectiveness of Community Health Workers in Hypertension Adherence: a Community Intervention in Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Pham Ngoc Thach University of Medicine
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 537
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A community intervention in elderly hypertension patients by Community Health Workers in order to improve patients adherence to treatment


Eligibility criteria: Inclusion Criteria:

* All patients aged 60 years and older who had been diagnosed with hypertension for more than 3 months at the time of the study were eligible for inclusion.

Exclusion Criteria:

* People who are not able to answer interviews or have mental illnesses.
* Those who, after being interviewed, re-confirmed that they did not have a diagnosis of hypertension from a medical facility.

Primary outcomes:
measure: Change Medication adherence
timeFrame: Patients were assessed Medication adherence at 3 time points: baseline (at the start of the study), 7 months after baseline, and 13 months after baseline
Secondary outcomes:
measure: Change Follow-up compliance
timeFrame: Patients were assessed Follow-up compliance at 3 time points: baseline (at the start of the study), 7 months after baseline, and 13 months after baseline
measure: Change Compliance with reducing salt intake
timeFrame: Patients were assessed Compliance with reducing salt intake at 3 time points: baseline (at the start of the study), 7 months after baseline, and 13 months after baseline
measure: Change Physical activity compliance
timeFrame: Patients were assessed Physical activity compliance at 3 time points: baseline (at the start of the study), 7 months after baseline, and 13 months after baseline
measure: Change Smoking compliance
timeFrame: Patients were assessed Smoking compliance at 3 time points: baseline (at the start of the study), 7 months after baseline, and 13 months after baseline
measure: Change Compliance with alcohol consumption
timeFrame: Patients were assessed Compliance with alcohol consumption at 3 time points: baseline (at the start of the study), 7 months after baseline, and 13 months after baseline
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Pham Ngoc Thach University of Medicine
Study officials:
References:
Clinical trial NCT03312920: Investigating Memory Retrieval Improvement in Healthy Subjects
Official title: Investigating Memory Retrieval Improvement in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Healthy Adults
Keywords: tDCS, accelerated learning, memory
Lead sponsor: The University of Texas at Dallas
Sponsor class: OTHER
First posted: 2017-10-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate whether learning can be accelerated and associative memory performance improved in healthy subjects by applying transcranial Direct Current Stimulation (tDCS) during a Face Name memory task.

Detailed description: Associative memory refers to remembering the association between two items, such as a face and a name or a word in English and the same word in another language. It is not only important for learning, but it is also one of the first aspects of memory performance that is impacted by aging and by Alzheimer׳s disease. For decades, neuroscientists have investigated associative learning and memory and ways to accelerate and enhance associative learning and memory.

Transcranial Direct Current stimulation (tDCS) is a non-invasive and painless electrical stimulation technique that has demonstrated to accelerate learning and improve memory in some studies. To investigate whether learning can be accelerated and associative memory improved by using tDCS, this study will compare the performance in a Face Name Associate memory task from 3 groups. The first group will get active aodal tDCS during the study phase of the Face Name Memory task, whereas the second group will get sham tDCS during the study phase of the task and the third group will get active cathodal tDCS.

Eligibility criteria: Inclusion Criteria:

* Age: 18-35 years Native English Speaker

Exclusion Criteria:

* History of severe head injuries, epileptic insults, or heart disease. Severe psychiatric disorders and severe untreated medical problems. Contraindications for tDCS (pregnant women, implanted devices)

Primary outcomes:
measure: Associative Memory assessed by a Face Name Associate Memory experiment
timeFrame: Associate Memory is assessed after a 10 minutes break following the study phase
Secondary outcomes:
Other outcomes:
Locations:
city: Richardson
country: United States
facility: University of Texas at Dallas
state: Texas
Study officials:
affiliation: The University of Texas at Dallas
name: Sven Vanneste, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06122220: Optic Nerve Sheath Measurement and Angiogenic Factors in Patients With Pre-eclampsia.
Official title: Optic Nerve Sheath Measurement and Angiogenic Factors for the Diagnosis of Pre-eclampsia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pre-Eclampsia
Keywords: Angiogenic factors
Optic nerve sheath diameter
Pre-eclampsia
Lead sponsor: Saint Thomas Hospital, Panama
Sponsor class: OTHER
First posted: 2023-11-08
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Hypertensive disorders of pregnancy (HPT) are an important cause of maternal-feto-neonatal morbidity and mortality, being one of the three leading causes of maternal death in our country and in developing countries. The only cure for THE is termination of pregnancy, which ends up being a decision in which gestational age and maternal risks must be balanced. Angiogenic factors have come to occupy an indispensable place in the arsenal of tools that can be used to separate the patient with a high likelihood of complications from those in whom prolongation of pregnancy could represent an important neonatal benefit. Refining the diagnostic capability of this test would further improve maternal-fetal outcomes and the use of optic nerve sheath diameter (ONSD) measurement could make the difference.

The purpose of the present study is to correlate the measurement of ONSD with serum angiogenic factor (AF) values in patients with pre-eclampsia and to determine its predictive ability for adverse perinatal outcomes.


Eligibility criteria: Inclusion Criteria:

* Pregnant women between 24 and 40 weeks of gestation.

Exclusion Criteria:

* Multiple gestation
* Maternal vasculitis
* Previous cesarean section (3 or more)
* Brain or eye tumors
* Neurological conditions
* Chronic renal disease
* Purpura
* Heart disease

Primary outcomes:
measure: Optic nerve sheath diameter cut off value
timeFrame: Up to discharge. On average, 7 days.
measure: sFLT-1/PiGF index
timeFrame: Up until discharge. On average, 7 days
Secondary outcomes:
measure: Maternal/fetal morbidity
timeFrame: Up until discharge. On average, 7 days
measure: Neonatal morbidity
timeFrame: Up until discharge. On average, 3 days
Other outcomes:
Locations:
city: Panama
country: Panama
facility: Saint Thomas H
Study officials:
References:
Clinical trial NCT03778320: A Study to Compare the Safety, Tolerability, and Pharmacokinetics of CTP-692 Versus D-serine in Healthy Volunteers
Official title: A Randomized Single Dose Crossover Comparison of the Safety, Tolerability, and Pharmacokinetic Profile of CTP-692 Versus D-Serine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Concert Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2018-12-19
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will assess the safety, tolerability and pharmacokinetic (PK) profile of CTP-692 vs D serine.


Eligibility criteria: Inclusion Criteria:

* Must give written and informed consent and any authorizations required by local law.
* Must have a body mass index (BMI) between 18 kg/m2 and 32 kg/m2, inclusive

Exclusion Criteria:

* Screening laboratory measurements outside the normal range associated with potential risk for the treatment under investigation at screening and/or prior to the first dose of study drug
* Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen or hepatitis C virus antibody
* History of clinically significant central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal (GI) conditions
* Positive drug or alcohol test at screening or prior to the first dose of study drug

Primary outcomes:
measure: The number of AEs in participants as a measure of safety and tolerability.
timeFrame: 7 days
measure: Measurement of CTP-692 exposure in plasma
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: CMAX Clinical Research
state: South Australia
Study officials:
affiliation: Concert Pharmaceuticals, Inc.
name: Emily McIntyre
role: STUDY_DIRECTOR
References: