louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01758172: Comparison of Hemodynamic Effects of Two Colloid Therapies in Post-operative Patients Undergoing Pancreaticoduodenectomy
Official title: Comparison of Hemodynamic and Clinical Effects of Two Colloid Therapies in Post-operative Patients Undergoing Pancreaticoduodenectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pancreaticoduodenectomy
Keywords: pancreaticoduodenectomy
postoperative patient
colloid
albumin
hetastarch
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2013-01-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: From postoperative patients having undergone pancreaticoduodenectomy;

1. To compare the hemodynamic parameters from the patient administrated 5% HA and 6% Voluven
2. To assess the efficacy of the treatment as regards the clinical outcomes and laboratory parameters of the patient
3. To compare the safety of the 2 intravenous colloids in the patient population


Eligibility criteria: Inclusion Criteria:

* Subjects should be meet inclusion criteria to participated into the study

  1. Age-from 18-75 years adult
  2. In the immediate post-operative period of pancreaticoduodenectomy
  3. Written informed consent and admitted ICU immediate post-operative patient

Exclusion Criteria:

* Any patient meeting one or more of the following exclusion criteria may not be entered into the study.

  1. Refusal to participate in the study
  2. Evidence of pre-operative oliguria (Serum creatinine\>1.5mmol/dL)
  3. Known Severe congestive heart failure (NYHAIII,IV)
  4. Known severe respiratory diseases (PaO2/FiO2 \<200)
  5. Known coagulopathy (Platelet\<100k/mm3, aPTT\>70s, PT(INR)\>2.5)
  6. Known allergy to hydroxyethyl starch
  7. Known pregnancy or lactation
  8. Has participated in any other clinical trial within 3months
  9. Any contraindication to Voluven® or albumin according to their package inserts.

Primary outcomes:
measure: Mean arterial pressure
timeFrame: post-op 24hr
Secondary outcomes:
measure: Volume(ml) of colloid
timeFrame: post-op 24hrs
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Song-cheol Kim, MD., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04512872: A Phase I Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy Male Subjects
Official title: A Pilot Phase 1, Double-Blind, Randomized, Two-arm, Parallel Group, Single-dose Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Subjects
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
First posted: 2020-08-14
Enrollment: 30
Sex: MALE
Minimum age (years): 28
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is a Pilot Phase 1, Double-Blind, Randomized, Two-arm, Parallel group, Single-dose Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy Male Subjects

Detailed description: This study is a pilot phase 1, randomized, double-blind, two-arm, parallel group, single-dose study, which is designed to evaluate the safety, immunogenicity, PK and PD of CT-P41 and EU-approved Prolia in healthy male subjects. Approximately 30 male subjects will be enrolled and randomly assigned to one of the two treatment arms in a 1:1 ratio. In each treatment group, all subjects will receive a single 60 mg dose of either CT P41 or EU-approved Prolia by subcutaneous injection via a PFS on Day 1, followed by 134 days of safety, immunogenicity, PK, and PD measurements.

Eligibility criteria: Inclusion Criteria:

* Healthy male subjects, between the ages of 28 and 55 years.
* Subject with a BMI between 18.5 and 29.9 kg/m2.
* Subject with albumin-adjusted total serum calcium ≥8.5 mg/dL (≥2.125 mol/L) and serum 25-OH vitamin D ≥20 ng/ml.
* Male subject and their female partner of childbearing potential must agree to use a highly effective method of contraception throughout the study and for 5 months after the study drug administration.

Exclusion Criteria:

* Subject with a hypersensitivity to any component of denosumab.
* Subject has a history of and/or current known risk factors for hypocalcemia and osteonecrosis of jaw, and any clinically significant illness at investigator's discretion.
* Subject has a history of and/or concurrent use of medications such as an investigational drug, monoclonal antibody, fusion protein, and biologics.
* Subject has a history of and/or concurrent use of any therapy that might significantly affect bone metabolism.
* Subject is vulnerable.
* Subject is not likely to complete the study for whatever reason in the opinion of the Investigator.

Primary outcomes:
measure: Evaluate safety
timeFrame: through study completion, up to day 134
Secondary outcomes:
Other outcomes:
Locations:
city: Herston
country: Australia
facility: Q-Pharm Pty Ltd
state: Queensland
Study officials:
References:
Clinical trial NCT01352572: Effects of Antidepressant on Postsynaptic Signal Transduction in Serotonergic System of Depressed Patients
Official title: Effects of Antidepressant on Postsynaptic Signal Transduction in Serotonergic System of Depressed Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: Antidepressant Response
Signal Transduction
Lymphocyte
Biomarkers
Depressed Patients
Antidepressant Drug Adverse Reaction
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-05-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether alteration of signal transduction components after antidepressant targeting, predict antidepressant responsiveness in advance before the appearance of the drug effects until 4\~6 weeks after drug administration, or represent the clinical status of depressed patients.

Detailed description: The purpose of this study is to determine whether antidepressants effect on signal transduction in peripheral lymphocyte and to determine whether the signaling differences between drug responders and nonresponders predict the antidepressant response or represent the clinical status of depressed patients.

Eligibility criteria: Inclusion Criteria:

1. met the Diagnostic and Statistical Manual of the American Psychiatric Association (DSM-IV) criteria for MDD from the Department of Psychiatry, Sungkyunkwan University, Seoul, South Korea.
2. were 18 years of age or older, the existence of a unipolar major depressive episode as verified by DSM-III/IV criteria, at least 2 years after first episode onset, and agreement to informed consents

Exclusion Criteria:

* pregnancy
* significant medical conditions
* abnormal laboratory baseline values
* unstable psychiatric features (e.g, suicidal attempt)
* history of alcohol or drug dependence, seizure, neurological illness, or concomitant Axis I psychiatric disorder

Primary outcomes:
measure: Antidepressant Response at 6 weeks
timeFrame: 6 weeks
Secondary outcomes:
measure: Biological value at 0 and 6 weeks
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Kangnam
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul
Study officials:
affiliation: Samsung Medical Center
name: Doh Kwan Kim, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02366572: PERFECT Project - Part 1 - Study 2
Official title: Pulse EnRiched Food and Exercise Clinical Trials (PERFECT Project): Part 1 - Acute Effects of Pulse Ingredients in Snack Products on Appetite, Blood Glucose, and Food Intake in Adults - Study 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Prevention
Obesity Prevention
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Saskatchewan Pulse Growers
name: Alberta Pulse Growers
First posted: 2015-02-19
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The objectives are to test the acute effects of different cereals containing pulse ingredients on: 1) post-prandial blood glucose, insulin and appetite for two hours, and 2) food intake two hours following consumption of pulse products.

We hypothesize that cereals containing pulse ingredients will lead to lower blood glucose, insulin, appetite and food intake responses compared to non-pulse cereals.


Eligibility criteria: Inclusion Criteria:

* Normoglycemic (\<5.6 mmol/L) and normotensive (systolic blood pressure \<140 mm Hg and diastolic blood pressure below \< 90 mm Hg)
* BMI of 18.5-29.9 kg/m2

Exclusion Criteria:

* Restrained eaters
* Regularly skip breakfast
* Smokers
* Competitive sports or athletic training at a high intensity
* Those on medications that may influence study outcomes or have experienced any gastrointestinal related health conditions/surgeries over the past year.
* Those unable to walk for an hour continuously

Primary outcomes:
measure: Plasma Glucose and Insulin Concentrations
timeFrame: 0 - 200 min
measure: Food Intake
timeFrame: at 120 min
measure: Subjective Appetite
timeFrame: 0-200 min
Secondary outcomes:
measure: Palatability of treaments and meal
timeFrame: 5 and 140 minutes
measure: Physical comfort
timeFrame: 0 - 200 min
measure: Energy/fatigue
timeFrame: 0-200 min
Other outcomes:
Locations:
Study officials:
affiliation: University of Manitoba, Richardson Centre for Functional Foods and Nutraceuticals
name: Peter JH Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Johnston AJ, Mollard RC, Dandeneau D, MacKay DS, Ames N, Curran J, Bouchard DR, Jones PJ. Acute effects of extruded pea fractions on glycemic response, insulin, appetite, and food intake in healthy young adults, results of a double-blind, randomized crossover trial. Appl Physiol Nutr Metab. 2021 Sep;46(9):1126-1132. doi: 10.1139/apnm-2020-0571. Epub 2021 Mar 4.
Clinical trial NCT00664872: Effect of Psychosocial Treatment by the Case Manager in Patients After a Suicide Attempt
Official title: Effect of Proactive Psychosocial Treatment by the Case Manager in Patients After a Suicide Attempt: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide, Attempted
Keywords: case manager
suicide
attempt
effectiveness
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2008-04-23
Enrollment: 147
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 purpose of this study is to determine the case manager are effective in the treatment of suicide attempters.

Detailed description: Compared with usual care, interventional group will (1) improve treatment attendance, (2) have less repeated suicide attempts in adults after a suicide attempts, and (3)have better patients' satisfaction with care.

Eligibility criteria: Inclusion Criteria:

Participants recruit adults who:

1. Discharge from an emergency department of a teaching hospital after attempt suicide
2. Aged above 18 years old
3. Agree to provide written inform consent.

Exclusion Criteria:

1. Patients were too ill to be interviewed
2. Patients have immediate and severe suicide risk.

Primary outcomes:
measure: treatment adherence, defined as outpatient mental health clinic attendance
timeFrame: 6-month, and 12-month
Secondary outcomes:
measure: During follow-up periods (6-month, and 12-month), interventional group will have (1) less repeated suicide attempts (behavior) (2) less suicidal ideation, (3) lower depression score, (4) better patients' satisfaction with care
timeFrame: 6-month, and 12-month
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
Study officials:
affiliation: Department of Psychiatry, Mackay Memorial Hospital
name: Shen-Ing Liu, MD.PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
Clinical trial NCT05143372: Influence of Vibroacoustic Therapy Modes on the Course of Coronavirus Infection
Official title: The Effect of Various Modes of Vibroacoustic Therapy on the Course of Coronavirus Infection Complicated by Acute Respiratory Failure.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Acute Respiratory Failure
Vibration; Exposure
Keywords: Acute Respiratory Failure
Vibration; Exposure
COVID-19
Lead sponsor: Astana Medical University
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 60
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: Assessment of the dynamics of changes in physical, instrumental and laboratory parameters in patients with identified coronavirus infection complicated by acute respiratory failure included in the study in accordance with the inclusion criteria, and comparison of the results with the control group, study of the effect of modes when using vibroacoustic lung therapy.


Eligibility criteria: Inclusion Criteria:

* adults
* P/F less 300 torr
* COVID-19 Virus Infection

Exclusion Criteria:

* children
* acute stroke
* acute coronary syndrome
* DVT
* implanted pacemaker
* rib fracture
* infection on chest

Primary outcomes:
measure: Change of time spent on ventilation
timeFrame: 1-2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Astana
country: Kazakhstan
facility: NATIONAL CENTER Scientific Center of Traumatology and Orthopedics named after Academician Batpenov N.D.
city: Astana
country: Kazakhstan
facility: Multidisciplinary city hospital No. 3 of Nursultan
city: Astana
country: Kazakhstan
facility: Multidisciplinary Infectious Diseases Hospital of Nursultan
Study officials:
References:
Clinical trial NCT04992572: Study Comparing Local/ MAC Anesthesia in Lumbar Decompression
Official title: Randomized Study Comparing Local/ MAC Anesthesia to General for 1-3 Level Lumbar Decompressions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Lumbar Spinal Stenosis
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Explore efficacy, complications, and other factors associated with anaesthetic choice- To evaluate the efficacy of local + MAC as an alternative anesthetic to general anesthesia and to analyze patients' outcomes and experiences.

Detailed description: 100 Patients ages 40-95 with lumbar stenosis to be decompressed are randomized to undergo the procedure with either general anesthesia or local anesthetic with MAC.

Participants will be randomized to either group 1 General anesthesia or group 2 Local + MAC anesthetic group.

Group 1: General Anesthesia: Medically induced unconsciousness that suppresses reflexes and requires intubation (a tube inserted through the mouth and into the airway) to assist in breathing.

Group 2: Local + MAC: Local anesthetic (lidocaine) injected into the site of the incision/dissection with additional IV medication (Propofol) to achieve a state in which the patient is generally aware, but relaxed

Eligibility criteria: Inclusion Criteria:

Patients with lumbar stenosis to be decompressed over 1-3 segments

* Ages 40-95
* Appropriate for general anesthesia

Exclusion Criteria:

* Planned significant nerve root retraction
* Previous fusion operation
* Unable to comply with follow up
* Patients with daily morphine equivalents or more 100mg
* Patients with a known hypersensitivity to propofol or any of DIPRIVAN Injectable Emulsion components.
* Patients with allergies to eggs, egg products, soybeans or soy products.

Primary outcomes:
measure: Change in Oswestry Disability Index (ODI) score
timeFrame: Basline through year 2
measure: Change in patient reported pain
timeFrame: Basline through year 2
Secondary outcomes:
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Outpatient Surgery Center/Stanford Spine Clinic
state: California
city: Redwood City
country: United States
facility: Stanford Outpatient surgery center
state: California
Study officials:
affiliation: Stanford University
name: Todd Alamin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04966572: Short Term Efficiency of Presurgical Vacuum Formed Nasoalveolar Molding Aligners in Infants With Bilateral Cleft Lip and Palate Compared With Grayson Acrylic Formed Nasoalveolar Molding Appliances.
Official title: Short Term Efficiency of Presurgical Vacuum Formed Nasoalveolar Molding Aligners in Infants With Bilateral Cleft Lip and Palate Compared With Conventional Grayson Acrylic Formed Nasoalveolar Molding Appliances: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cleft Lip and Palate
Bilateral Cleft Lip/Palate
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-07-19
Enrollment: 24
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Newborns with bilateral cleft lip/ palate will be treated pre-surgically by either presurgical vacuum-formed nasoalveolar molding aligners VF (NAM) or conventional Grayson acrylic formed nasoalveolar molding appliances in order to evaluate their effect on the maxillary arch.

Detailed description: The aim of this trial is to evaluate and compare the short-term effect of VF (NAM) aligners with conventional Grayson appliances at 2 stages T1 (Before NAM therapy), and T2 (After NAM therapy) as regards maxillary arch changes.

Newborns with Bilateral cleft lip/ palate will be allocated randomly into two groups: the first group will receive presurgical vacuum-formed nasoalveolar molding aligners while the second group will receive conventional Grayson acrylic formed nasoalveolar molding appliances. The follow-up period will be 4-6 months till surgical lip closure. The changes in the maxillary arch will be assessed by digital maxillary models.

Eligibility criteria: Inclusion Criteria:

* Non-syndromic Infants with complete BCLP infants
* Infants less than 1 month of age
* Males and females.
* Infants with displaced premaxilla
* Patients whose parents provided written consent for the study.

Exclusion Criteria:

* Patients above 1 month of age
* Syndromic and systemically ill infants.
* Patients with unilateral cleft lip and palate.
* Incomplete Cleft lip.
* Medically compromised patients
* Patient's/guardians who will be unwilling to go through the PNAM therapy

Primary outcomes:
measure: Changes in the maxillary arch
timeFrame: T1 and T2 (4- 6 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Fatma Abdu Abdelsayed, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01533272: Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1:FOVIR+EMTRICITABINA + LOPINAVIR/RITONAVIR VS TENOFOVIR+EMTRICITABINA + MARAVIROC (MARAVI-PEP)
Official title: Open Randomized Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1: TENOFOVIR+EMTRICITABINA + LOPINAVIR/RITONAVIR VS TENOFOVIR+EMTRICITABINA + MARAVIROC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infection
Keywords: HIV infection
Postexposure prophylaxis
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2012-02-15
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: As a measure of secondary prophylaxis, and with the final objective of avoiding the infection, it has been suggested to use antiretroviral therapy. This is known as post-exposure prophylaxis (PEP).

Although there are different recommendations, almost every guideline recommend using 3 drugs as PEP both in USA and Europe.

Toxicity is one of the main limitations of PEP. Side effects during PEP are very usual, are attributed mainly to PI and are the main reasons for poor adherence or lost of follow-up.

A current standard regimen is AZT+3TC (Combivir®) or tenofovir+emtricitabine (Truvada®) plus the PI lopinavir/r. Toxicity associated with this regimens are high (31-85% of cases), with a 10-35% interruption of PEP Maraviroc, a CCR5 receptor antagonist, very well tolerated, coul be an adequate drug for PEP.


Eligibility criteria: Inclusion Criteria:

* Both sexes
* Older than 18 years old
* A potentially sexual exposition to HIV
* Accept to participate

Exclusion Criteria:

* Pregnant women
* The source case a person with HIV antiretroviral resistances
* Persons with a treatment that is contraindicated with the drugs in the study

Primary outcomes:
measure: Proportion of patients reaching 28 days of postexposure prophylaxis.
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
Study officials:
affiliation: Consultant
name: Felipe Garcia, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leal L, Leon A, Torres B, Inciarte A, Lucero C, Mallolas J, Laguno M, Martinez-Rebollar M, Gonzalez-Cordon A, Manzardo C, Rojas J, Pich J, Arnaiz JA, Gatell JM, Garcia F; MARAVIPEP Study Group. A randomized clinical trial comparing ritonavir-boosted lopinavir versus maraviroc each with tenofovir plus emtricitabine for post-exposure prophylaxis for HIV infection. J Antimicrob Chemother. 2016 Jul;71(7):1982-6. doi: 10.1093/jac/dkw048. Epub 2016 Mar 18.