louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04601025: The Effect of Different Types of Plant-Based Fiber in a Protein-Containing Meal During Satiety and Hunger States
Official title: The Effect of Different Types of Plant-Based Fiber in a Protein-Containing Meal During Satiety and Hunger States
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appetitive Behavior
Satiety
Keywords: appetite
fiber
protein
satiety
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
Collaborators: name: Medipol University
First posted: 2020-10-23
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study was carried out once a week on the same day and for three-week duration, with total of 17 randomly selected participants with ages between 18 and 24 years. The test foods containing different vegetable fiber sources (chickpeas and oats) were given to the participants every week as isocaloric, which have been the control food for a week. The satiety status was evaluated by visual analog scale (VAS) for total of five times as immediately before the test food consumption and at 30, 60, 90 and 120 minutes after consumption. Fasting and postprandial blood glucose levels were measured. A 24-hour retrospective food consumption record was obtained the next day.


Eligibility criteria: Inclusion Criteria:

* Age range of 18-24 years,
* Studying at the university,
* Not smoking,
* Having normal BMI according to the World Health Organization (18.5-24.9 kg / m2),
* Satisfy blood donation criteria,
* Along with not suffering from diabetes,
* Abnormal thyroid problem,
* Gastrointestinal disorder,
* Food allergy or intolerance

Exclusion Criteria:

* Individuals who smoke,
* Follow a special diet program,
* Having eating disorder,
* Vegan or vegetarian,
* Do not consume legumes,
* Having gluten or lactose intolerance,
* Suffering from a chronic disease,
* Pregnant or breastfeeding

Primary outcomes:
measure: Change of Satiety
timeFrame: 0, 30, 60, 90 and 120 minutes after test food consumption
measure: Baseline and postprandial blood glucose concentration
timeFrame: Up to 120. minutes
measure: Ad libitum lunch intake
timeFrame: End of the 120.minutes
Secondary outcomes:
measure: Quantification of food intake during the rest of the day
timeFrame: During the 24-hours of experimental day.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Medipol University
Study officials:
References:
Clinical trial NCT02596425: Pulmonary Recruitment Maneuver for Postlaparoscopic Shoulder Pain
Official title: Pulmonary Recruitment Maneuver to Reduce Postlaparoscopic Shoulder Pain: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gynecologic Diseases
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2015-11-04
Enrollment: 90
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this clinical trial is to evaluate the efficacy and safety of different recruitment maneuvers for reducing postlaparoscopic shoulder pain.

Detailed description: Shoulder pain after laparoscopy is common and its probable mechanism is residual CO2 gas after surgery. The pulmonary recruitment maneuver can mechanically remove residual CO2 and reduce pain. In literature, there are two different recruitment maneuvers, which was manual inflation of the lungs with positive pressure ventilation of either 40cmH2O or 60cmH2O at the end of surgery. However, the higher positive pressure may be associated with more chance of barotrauma. Therefore, it is important to determine the lowest effective pressure for reducing postlaparoscopic shoulder pain. The aim of this clinical trial is to evaluate the efficacy and safety of different recruitment maneuvers (40cmH2O or 60cmH2O) for reducing postlaparoscopic shoulder pain.

Eligibility criteria: Inclusion Criteria:

* patients undergoing laparoscopy for benign gynecologic diseases
* patients aged 19-65 years
* patients with american society of anesthesiology physical status I-II
* patients obtaining written informed consent

Exclusion Criteria:

* patients with chronic shoulder pain, chronic epigastric pain or chronic pain syndrome
* patients with past history of pneumothorax or any pulmonary surgical history
* patients with any shoulder surgery histories
* patients who required to conversion to open surgery from laparoscopic surgery
* patients who required to receive incidental upper abdominal surgeries due to adhesion and injury at upper abdominal cavity
* patients with inability to understand or express 10 point visual analogue scale
* intrauterine pregnant women

Primary outcomes:
measure: Shoulder pain
timeFrame: after two day of procedure
Secondary outcomes:
measure: Wound pain
timeFrame: after two day of procedure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
Study officials:
affiliation: Kangbuk Samsung Hospital
name: Taejong Song, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01533025: Single Bundle Anterior Cruciate Ligament Reconstruction in Active Young Men
Official title: Single Bundle Anterior Cruciate Ligament Reconstruction in Active Young Men: Free Tendon Achilles Allograft vs. Bone-tendon Achilles Allograft
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Rupture
Keywords: anterior cruciate ligament
Achilles
free tendon
bone-tendon
free tendon Achilles allograft
Achilles allograft with calcaneal bone block on its end
Lead sponsor: National Police Hospital
Sponsor class: OTHER_GOV
First posted: 2012-02-15
Enrollment: 72
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The clinical outcomes of anterior cruciate ligament reconstruction using free tendon Achilles allograft are comparable to those using Achilles allograft with bone block on its end.


Eligibility criteria: Inclusion Criteria:

* male subjects
* subjects who had concomitant medial collateral ligament injury which was managed conservatively
* subjects who had meniscus tear which was managed by partial meniscectomy

Exclusion Criteria:

* subjects who underwent a subtotal or total meniscectomy, meniscal repair, or meniscal transplantation due to meniscus injury
* subjects who underwent an operation due to any concomitant ipsilateral ligament injuries
* subjects who underwent microfracture or cartilage transplantation due to full thickness cartilage injury
* female
* subjects who were older than 45
* subjects who had histories of injuries on either knee

Primary outcomes:
measure: Lysholm score
timeFrame: 2 years
Secondary outcomes:
measure: side-to-side differences
timeFrame: 2 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: National Police Hospital
Study officials:
affiliation: National Police Hospital
name: Jung Ho Noh, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00837525: Validity Study of a Nasal Valve Implant
Official title: Validity of Biodegradable Injectable Implant for the Treatment of External Nasal Valve Collapse.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nasal Valve Collapse
Lead sponsor: Nasoform, LLC
Sponsor class: INDUSTRY
First posted: 2009-02-05
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if an implant material can be injected to repair nasal valve collapse.


Eligibility criteria: Inclusion Criteria:

* Has nasal valve collapse

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Nasal obstruction symptom scale
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: United States
facility: Metropolitan ENT and Facial Plastic Surgery
state: Virginia
Study officials:
affiliation: Metropolitan ENT and Facial Plastic Surgery
name: Iyad S Saidi, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03486925: Oxytocin Effect on Attention Inhibition
Official title: An Eye-tracking Study to Investigate Oxytocin Effect on Attention Inhibition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: oxytocin, eye-tracking, attention inhibition
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2018-04-03
Enrollment: 71
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Effects of intranasal oxytocin (24IU) on cognitive control of attention

Detailed description: The cognitive control of attention towards neutral and emotional stimuli represents a key functional domain and disruptions in this domain have been associated with a range of psychiatric disorders. Saccadic eye movement tasks have been used to assess individual differences in the cognitive control of attention and alterations in psychiatric disorders. Recent evidence suggests that the hypothalamic neuropeptide Oxytocin (OXT) may modulate attention allocation and regulation. To this end the present randomized between-subject placebo-controlled experiment examined whether intranasal OXT modulates behavior in an eye-tracking saccade / anti-saccade paradigm in healthy male subjects. The paradigm used non-social (neutral shape) as well as social (happy, sad, angry, fear, and neutral faces) stimuli to explore emotion-specific effects of OXT.

Eligibility criteria: Inclusion Criteria:

* Male, healthy participants
* Non smokers

Exclusion Criteria:

* Previous or current medical, psychiatric, neurological disorder
* Regular medication
* Use of any psychoactive substances in the 24 hours before experiment
* Contra-indications for oxytocin
* Contra-indications for eye-tracking data acquisition

Primary outcomes:
measure: emotion-specific saccade latencies
timeFrame: 45 minutes - 100 minutes after treatment
measure: emotion-specific error rates
timeFrame: 45 minutes - 100 minutes after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: School of Life Science and Technology, University of Electronic Science and Technology of China
state: Sichuan
Study officials:
References:
Clinical trial NCT05314725: Treatment With SGLT-2 Inhibitor for Postoperative Hyperglycemia in Acute Abdominal Surgery - a Randomized Trial
Official title: Treatment With SGLT-2 Inhibitor for Postoperative Hyperglycemia in Acute Abdominal Surgery - a Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Postoperative Hyperglycemia
Stress Hyperglycemia
Keywords: acute abdominal surgery
SGLT-2 inhibitor
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2022-04-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
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 investigate the effect of an SGLT-2 inhibitor on postoperative hyperglycemia after acute abdominal surgery in patients without diabetes


Eligibility criteria: Inclusion Criteria:

* - Admitted to the ward after acute abdominal surgery (ASAP patient at Slagelse Hospital, OMEGA patient at Zealand University Hospital)
* At least two independent measurements of blood glucose above 7.7mmol/l within the first 48 hours after surgery
* Age of 18 to 85
* Must be able to understand and sign informed content

Exclusion Criteria:

* Patients diagnosed with diabetes mellitus

  * Impaired kidney function (eGFR \< 45mL/min)
  * Severe liver disease (defined as transaminases above X 3 normal levels)
  * Acute pancreatitis within the last two months or a history of chronic pancreatitis
  * Participation in another pharmacological intervention trial
  * Predictable poor compliance (for instance mentally impaired)
  * Pregnancy or lactation (fertile women must have a negative serum or urine pregnancy test to participate)
  * Allergy to study medication

Primary outcomes:
measure: time in range
timeFrame: from inclusion until 10 days after (or when the patient leaves the hospital)
Secondary outcomes:
measure: mean glucose
timeFrame: from inclusion until 10 days after (or when the patient leaves the hospital)
measure: glucose variability
timeFrame: from inclusion until 10 days after (or when the patient leaves the hospital)
measure: time with level 1 hypoglycemia
timeFrame: from inclusion until 10 days after (or when the patient leaves the hospital)
measure: time with level 2 hypoglycemia
timeFrame: from inclusion until 10 days after (or when the patient leaves the hospital)
measure: time with hyperglycemia
timeFrame: from inclusion until 10 days after (or when the patient leaves the hospital)
measure: Quality of recovery-15
timeFrame: every day while taking the study medication and on postoperative day 30
measure: Nanostring
timeFrame: at inclusion, on day 4 of treatment and at end of treatment
Other outcomes:
Locations:
Study officials:
affiliation: Zealand University Hospital
name: Emilie P Palmgren Colov
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02084225: Ultrasound Guided Regional Anesthesia for Acute Injury in Low Resource Settings
Official title: Feasibility, Perceived Utility and Sustainability of Using Ultrasound-guided Regional Anesthesia by Local Providers in a Limited Resource Conflict Setting
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain Management
Acute Injuries
Keywords: low resource
conflict setting
ultrasound guided regional anesthesia
acute injuries
pain management
education
ultrasound
trauma
emergency department
Lead sponsor: Salmon, Margaret, M.D.
Sponsor class: INDIV
Collaborators: name: Sonosite/Fuji Film - (in kind)
name: The ultrasound for the study was given to the sites by Sonosite/Fuji but the company
name: had no other role in the study.
name: MedShare - (in kind)
name: The needles and syringes and kit contents were given to the sites by MedShare but the
name: company had no role in the study.
First posted: 2014-03-11
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants include medical doctors and orthopedic or trauma nurses (officers) who staff the emergency department and/or orthopedic procedure area where acute injuries are treated.

Brief summary: The purpose of this study is to determine feasibility, perceived utility and sustainability of training local providers in ultrasound guided regional anesthesia for acute pain management in a limited-resource conflict setting.

Detailed description: To the investigators knowledge, this is the first study of feasibility, perceived utility and sustainability of USRA as a pain management tool in a low-resource conflict setting and is one of the only large studies to date to assess USRA by local providers for emergent pain relief due to injury in patients presenting to an acute care center.

Eligibility criteria: Inclusion Criteria:

* participants were chosen by hospital administration

Exclusion Criteria:

* only chosen participants were included

Primary outcomes:
measure: Participant perceived utility of ultrasound guided nerve block
timeFrame: study start - ongoing (24 months)
Secondary outcomes:
measure: Participant course satisfaction
timeFrame: at course end (5 days)
Other outcomes:
measure: Patient pain reduction (VAS)
timeFrame: up to 18 months
measure: Post procedure serious and non serious adverse event
timeFrame: before and up to 48 hours after every block performed
measure: Indication for use of USRA by participant
timeFrame: up to 18 months of study period
Locations:
city: Goma
country: Congo
facility: HEAL Hospital
city: Kindu
country: Congo
facility: John Maurice Kikuni Salmu
city: Addis Ababa
country: Ethiopia
facility: Black Lion Hospital
Study officials:
affiliation: HEAL Hospital
name: Margaret Salmon, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04406025: Regional Anesthesia Practice in Greece
Official title: Regional Anesthesia Practice in Greece and Depiction of the Effect of Educational Activities in This Respect
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Questionnaire
Survey
Keywords: seminar
regional anesthesia practice
Lead sponsor: Aretaieion University Hospital
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 425
Sex: ALL
Minimum age (years): 24
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the polulation will be anesthesiologists practicing in Greece

Brief summary: The purpose of this structured questionnaire is to provide useful insight on the practice of regional anesthesia in Greece and depict the result of educational efforts taking place in the country to expand the knowledge and practice of regional anesthesia in the country


Eligibility criteria: Inclusion Criteria:

* greek anesthesia practitioners

Exclusion Criteria:

* nurses
* operating department assistants
* surgeons

Primary outcomes:
measure: knowledge and practice of regional anesthesia techniques
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Aretaieion University Hospital
Study officials:
affiliation: Aretaieion University Hospital
name: Kassiani Theodoraki, PhD, DESA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huang J, Gao H. Regional anesthesia practice in China: a survey. J Clin Anesth. 2016 Nov;34:115-23. doi: 10.1016/j.jclinane.2016.03.071. Epub 2016 May 3.
citation: Smith MP, Sprung J, Zura A, Mascha E, Tetzlaff JE. A survey of exposure to regional anesthesia techniques in American anesthesia residency training programs. Reg Anesth Pain Med. 1999 Jan-Feb;24(1):11-6. doi: 10.1016/s1098-7339(99)90159-1.
Clinical trial NCT04614025: Open-label Multicenter Study to Evaluate the Efficacy of PLX-PAD for the Treatment of COVID-19
Official title: A Randomized, Controlled, Multicenter, Parallel-Group Phase IIa Study to Evaluate the Efficacy and Safety of Intramuscular Injections of PLX-PAD for the Treatment of Severe COVID-19
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: COVID
ARDS
Lead sponsor: Pluristem Ltd.
Sponsor class: INDUSTRY
First posted: 2020-11-03
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial will examine if a new treatment of Mesenchymal-like Adherent stromal Cells (called PLX-PAD) can help patients intubated and mechanically ventilated due to COVID-19 to recover more quickly with less complications.


Eligibility criteria: Key Inclusion Criteria:

* Willing and able to provide written informed consent, or with a legal representative who can provide informed consent.
* Male or non-pregnant female adult 18-85 years of age at time of enrollment.
* Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, in any specimen up to 21 days prior to randomization.
* Meets definition of ARDS according to Berlin criteria.

Key Exclusion Criteria:

* Body weight under 55 kg (121 lbs)
* Serum creatinine level of over 1.5 mg/dL at time of randomization.
* Total Bilirubin ≥2 mg/dL at time of randomization.
* Known allergy to any of the following: dimethyl sulfoxide (DMSO), human serum albumin, bovine serum albumin.
* Stroke or acute myocardial infarction/unstable angina within 3 months prior to randomization.
* Chronic Obstructive Pulmonary disease GOLD stage above II.

Primary outcomes:
measure: Number of ventilator-free days
timeFrame: 28 days
Secondary outcomes:
measure: All-cause mortality
timeFrame: 28 and 60 days
measure: Duration of mechanical ventilation
timeFrame: 28 and 60 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite Campus Virchow
city: Berlin
country: Germany
facility: Campus Benjamin Franklin - CBF Charité - Universitätsmedizin
city: Bonn
country: Germany
facility: University of hospital Bonn
city: Köln
country: Germany
facility: Hospital Cologne-Merheim
city: Afula
country: Israel
facility: Emek Medical Center
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Nahariya
country: Israel
facility: Galilee Medical Center
city: Tiberias
country: Israel
facility: Baruch Padeh Medical Center, Poriya
Study officials:
References:
Clinical trial NCT04074525: Evaluating Decisional Regret Among Mothers
Official title: Delivery Decisions in Extreme Prematurity: Evaluating Decisional Regret
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Extreme Prematurity
Birth, Preterm
Pregnancy Preterm
Keywords: Decisional regret
Comfort care
Palliative care
Infant resuscitation
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
Collaborators: name: Providence Health & Services
First posted: 2019-08-30
Enrollment: 211
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of mothers who delivered infants between 22 and 25 completed weeks gestation during the study timeframe at one of two US perinatal centers.

Brief summary: The anticipated birth of an extremely low gestational age infant presents many complex and ethically challenging questions, including whether to initiate resuscitation or comfort care after delivery. Failure to identify and align decision-making to parents' values during periviabilty counseling may result in greater opportunity for decisional regret. The goal of the proposed research is to assess decisional regret in mothers of extremely premature births and to compare decisional regret in mothers who chose resuscitation at time of delivery to those who chose comfort care. Approximately 1000 mothers of infants born extremely premature at 2 perinatal centers in the US will be surveyed.


Eligibility criteria: Inclusion Criteria:

* Mothers of infants born between 22 and 25 completed weeks gestation during the study timeframe.
* Mothers who had a documented perinatal consult
* Greater than 18 years old

Exclusion Criteria:

* Potential life limiting fetal diagnoses aside from prematurity and non-English primary language

Primary outcomes:
measure: Decisional regret
timeFrame: Within the last 14 years
measure: Comparison of decisional regret
timeFrame: Within the last 14 years
Secondary outcomes:
measure: Define characteristics associated with decisional regret
timeFrame: Within the last 14 years
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care Health Services, Inc.
state: Delaware
Study officials:
affiliation: Christiana Care Health Services, Inc.
name: Laura Belden, DO
role: PRINCIPAL_INVESTIGATOR
References: