louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01087359: Antiinflammatoric and Antioxidative Effect of Melatonin in Human Endotoxaemia
Official title: Antiinflammatoric and Antioxidative Effect of Melatonin in Human Endotoxaemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Human Endotoxaemia
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2010-03-16
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This is a double blinded, randomised, crossover study with 12 healthy men between 18 and 40 year. The design is based on 6 days:

* day 1: On day time administration of LPS.
* day 2: On night time administration of LPS.
* day 3: On day time administration of LPS + Placebo.
* day 4: On day time administration of LPS + melatonin.
* day 5: On night time administration of LPS + placebo.
* day 6: On night time administration og LPS + melatonin.

Measuring the inflammatoric and oxidative response of LPS and the effect of melatonin compared to placebo on the endotoxaemia.


Eligibility criteria: Inclusion Criteria:

* Men
* Age 18-49 year.
* Healthy
* No sleepiness disorders.
* No medication
* ASA I

Exclusion Criteria:

* Allergia to melatonin
* Women
* Smoking.
* Alcohol abuse.

Primary outcomes:
measure: Inflammatoric markers
timeFrame: measured before and after the administration of LPS endotoxin.
measure: Oxidative markers
timeFrame: measured before and after the administration of LPS endotoxin.
Secondary outcomes:
measure: Secondary outcome
timeFrame: constant measurment
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
Study officials:
References:
Clinical trial NCT04732559: General Attitudes Towards Surrogacy in Poland
Official title: General Attitudes Towards Surrogacy in Poland
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surrogate Mothers
Keywords: traditional surrogacy
gestational surrogacy
attitudes
surrogate parenthood
Lead sponsor: University of Gdansk
Sponsor class: OTHER
Collaborators: name: Principal Investigator: Karolina Lutkiewicz, PhD
name: Sub-Investigator: Łucja Bieleninik, PhD
name: Sub-Investigator: Mariola Bidzan, Prof
First posted: 2021-02-01
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General population in Poland with the divison to subgroups to examine differences between attitudes towards surrogacy among men and women, medical staff/personnel, students of medical and health studies with students of other disciplines and people with diagnosed infertility.

Brief summary: The primary aim of the study is to:

- investigate the general attitudes towards surrogacy among Polish population.

The secondary aims of the study are as follows:

* assess the differences in attitudes towards traditional vs. gestational surrogacy among Polish population,
* assess the cognitive concerns about issues related to surrogacy,
* assess the acceptance of surrogate parenthood,
* assess the attitude towards the surrogate mother,
* identify factors that influence the attitudes towards surrogacy,
* examine if there are differences in attitudes among members of the general public, health care professionals, students (health/medical studies vs. non-medical studies) and people with infertility diagnosis.


Eligibility criteria: Inclusion Criteria:

* signed informed consent
* no restrictions to gender
* age ≥ 18
* able to understand and complete the questionnaire in Polish
* country of residence: Poland

Exclusion Criteria:

• if at least one of the inclusion criteria is not met

Primary outcomes:
measure: General attitudes towards surrogacy.
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Attitudes towards traditional vs. gestational surrogacy
timeFrame: Through study completion, an average of 1 year
measure: The Cognitive Concerns About Issues Related to Surrogacy Scale (CCAIRSS)
timeFrame: Through study completion, an average of 1 year
measure: Attitudes towards the acceptance of surrogate parenthood
timeFrame: Through study completion, an average of 1 year
measure: Attitudes towards the surrogate mother
timeFrame: Through study completion, an average of 1 year
measure: Socio-demographic factors
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Univeristy of Gdansk
Study officials:
References:
citation: Constantinidis D, Cook R. Australian perspectives on surrogacy: the influence of cognitions, psychological and demographic characteristics. Hum Reprod. 2012 Apr;27(4):1080-7. doi: 10.1093/humrep/der470. Epub 2012 Jan 30.
Clinical trial NCT01648959: Intra Cranial EEG Activity During Dexmedetomidine Sedation
Official title: Intra Cranial EEG Activity During Dexmedetomidine Sedation.Comparing the Effects of Dexmedetomidine on the Cortical and the Sub Cortical(Hippocampus) Structures.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Complex Partial Seizures
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2012-07-25
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults between 18 to 80 years of age, who are scheduled for elective removal of intracranial (surface and depth) electrodes under conscious sedation

Brief summary: Various parts of the brain are sensitive to various anesthetics.We like to study the effect of dexmedetomidine on the different parts of the brain in patients who are coming for DBS electrode removal under sedation.

Detailed description: Cortical and sub cortical structures will have different sensitivities to various anesthetics.The objective of this study is to look at the changes in the intracranial electroencephalographic (EEG) characteristics during dexmedetomidine sedation and to determine the differences in the EEG characteristics between cortical and subcortical structures.

Eligibility criteria: Inclusion Criteria:

* Adults between 18 to 80 years of age, who are scheduled for elective removal of intracranial (surface and depth) electrodes under conscious sedation

Exclusion Criteria:

* Lack of informed consent
* Hypersensitivity to dexmedetomidine
* Language barrier
* Emergency surgery

Primary outcomes:
measure: iEEG Recording
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital,UHN.
state: Ontario
Study officials:
affiliation: Assistant professor,Toronto western hospital,university health network (UHN)
name: lashmikumar venkatraghavan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05455359: Gastrointestinal Dysmotility on Aspiration Risk
Official title: The Impact of Upper Gastrointestinal Dysmotility on Aspiration-associated Symptoms
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Esophageal Motility Disorders
Gastric Motor Dysfunction
Aspiration Pneumonia
Gastro Esophageal Reflux
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 120
Sex: ALL
Minimum age (years): 5
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The hypothesis of this study is that esophageal and gastric dysmotility increase the risk of developing aspiration-associated symptoms in children with neurologic impairment. The investigators are conducting a ten week cross over study comparing prucalopride to famotidine for the treatment of aspiration-associated symptoms.


Eligibility criteria: Inclusion Criteria:

1. are 5-21 years of age;
2. receive \>90% of their calories by enteral tube (i.e., patients take no food or drink by mouth);
3. are determined to be at high risk for aspiration pneumonia based on evidence of impaired airway protective mechanisms, documented by aspiration on video fluoroscopic swallow study;
4. have static neurologic impairment, defined as functional and/or intellectual impairment that results from a chronic neurologic or related diagnosis (e.g., cerebral palsy) with no prospect of progression for at least one year;
5. have chronic respiratory symptoms, defined as coughing, choking, or need for oral suctioning a minimum of three times per week during the prior four weeks.

   -

Exclusion Criteria:

1. have progressive neurologic impairment;
2. have a history of prior intact Nissen fundoplication;
3. are currently taking oral or inhaled antibiotics, including prophylactic antibiotics;
4. are currently taking or have taken in the last four weeks acid suppression (H2 antagonist or PPI); or
5. are fed by gastrojejunostomy rather than by gastrostomy. -

Primary outcomes:
measure: Pediatric Cough Quality of Life Questionnaire
timeFrame: 4 weeks
Secondary outcomes:
measure: Gastric emptying outcomes
timeFrame: 4 weeks
measure: Total Peds-GI QL score
timeFrame: 8 weeks
measure: Aspiration symptoms
timeFrame: 4 weeks
measure: Microbiome
timeFrame: 8 weeks
measure: Pneumonias
timeFrame: 10 weeks
measure: Esophageal reflux events
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02977559: A Study Between the Laryngeal Tube Suction-Disposable and the Ambu AuraGain in Pediatric Patients
Official title: A Comparative Randomized Prospective Study Between the New Laryngeal Tube Suction-Disposable and the Ambu AuraGain in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adverse Anesthesia Outcome
Keywords: Laryngeal Tube Suction Ambu AuraGain Leak Pressure
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-11-30
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study compared the Laryngeal Tube Suction Disposable (LTS-D) with the Disposable Laryngeal Mask Ambu® AuraGain™ (DLMA AG) during general anesthesia in pediatric patients.

The investigators hypothesized that the LTS-D and the DLMA AG performed similarly during mechanical ventilation despite differences in their structural design.

Detailed description: The Laryngeal Tube Suction-Disposable (LTS-D, (VBM Medizintechnik GmbH, Sulz, Germany), is a second generation single-use supraglottic airway devices (SADs) with gastric access, for airway management in spontaneously and mechanically ventilated patients undergoing general anesthesia.

The AuraGain is a second generation laryngeal mask, satisfying airway management needs by integrating gastric access and ventilation capability in an anatomically curved single-use device that facilitates rapid establishment of a safe airway.

The two devices have now pediatric sizes.

To date, there is no published data comparing the LTS-D and the DLMA AG during mechanical ventilation in pediatric patients. The investigators hypothesized that the LTS-D and the DLMA AG perform similarly during mechanical ventilation despite differences in their structural design.

The chief aim of this prospective randomized study was to compare the LTS-D and the DLMA AG with respect to:

1. time to achieve an effective airway,
2. ease of insertion,
3. need for interventions to achieve an effective airway,
4. cuff seal (leak) pressure at an intracuff pressure of 60 cm H2O,
5. ventilatory variables during mechanical ventilation,
6. fiberoptic score,
7. gastric tube insertion and
8. adverse perioperative events.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients, American Society of Anesthesiologist (ASA) physical status I and II weighing 30 to 10 kg, posted for abdominal surgery under general anesthesia.

Exclusion Criteria:

* Infants with active respiratory tract infection anticipated and known difficult airway, lung disease requiring high positive end expiratory pressure, and active gastrointestinal reflux will be excluded.

Primary outcomes:
measure: Leak pressure measure in cm H2O
timeFrame: 60 seconds
Secondary outcomes:
measure: Time to insertion a device in seconds
timeFrame: 60 seconds
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03397459: Cervicobrachial Neuralgia and Sagital Balance of the Cervical Spine
Official title: Cervicobrachial Neuralgia and Sagital Balance of the Cervical Spine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervicobrachial Neuralgia
Lordosis
Keywords: cervicobrachial neuralgia
sagittal balance
lordosis
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2018-01-12
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering of cervicobrachial neuralgia in the hospital of BESANCON, FRANCE followed by a neurosurgeon.

Brief summary: The aim of this observational study is to establish estimation of global lordosis of the cervical spine (from C3 to C7) in patients with cervicobrachial neuralgia.

Detailed description: The main judgement critearia is the estimation in degree of this lordosis measured on EOS radiographies, The study includes adults patients with non traumatic cervicobrachial neuralgia caused by discal hernia free from any previous spine surgery.

Eligibility criteria: Inclusion Criteria:

* Adults (\>18 years old)
* Suffering of cervicobrachial neuralgia caused by cervical hernia on MRI diagnosed by a neurosurgeon
* with social care rights

Exclusion Criteria:

* Post traumatic cervicobrachial neuralgia in the past 12 months
* Anteriority of spine surgery
* Pregnant patients

Primary outcomes:
measure: Low Cervical spine lordosis
timeFrame: Day 1
Secondary outcomes:
measure: NDI
timeFrame: Day 1
Other outcomes:
Locations:
city: Besancon
country: France
facility: HAMDAN
Study officials:
References:
Clinical trial NCT00034359: Safety and Antiviral Activity Study of ACH-126,443 (Beta-L-Fd4C) in Treatment-naive Adults With Chronic Hepatitis B Virus Infection
Official title: A Double-Blind, Randomized Trial of Antiviral Activity and Safety of 12 Weeks Oral Treatment With ACH-126,443 (Beta-L-Fd4C) in Treatment-Naive HBV-Infected Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis B, Chronic
Keywords: E-antigen Positive
Treatment-naive Chronic Hepatitis B
Achillion
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Achillion, a wholly owned subsidiary of Alexion
First posted: 2002-04-29
Enrollment: 79
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 was to determine the safety and anti-hepatitis B virus (-HBV) activity of ACH-126,443 in comparison to lamivudine or placebo in treatment-naive adults with chronic hepatitis B infection.

Detailed description: Evaluation of the safety and antiviral activity of 3 dose levels of ACH-126,443 versus lamivudine and placebo over 12 weeks of treatment in the population is described.

Eligibility criteria: Inclusion Criteria:

* Chronic hepatitis B virus (HBV) infection, known to be hepatitis B surface antigen positive ≥ 6 months.
* Plasma HBV deoxyribonucleic acid level ≥ 100,000 copies/milliliter.
* Hepatitis B e-antigen positive.
* Human immunodeficiency virus negative.
* Basic hematologic and chemistry parameters within acceptable limits (defined in protocol).
* No need for excluded medications.
* Participants of reproductive capability must have utilized 2 approved forms of birth control, one of which must have been barrier protection.

Exclusion Criteria:

* Human immunodeficiency virus infection.
* Hepatitis C co-infection.
* Concurrent systemic antiviral treatment.
* Previous antiviral treatment for HBV infection within 6 months prior to randomization or treatment with lamivudine for more than 6 months at any time in the past.
* Previous therapy with agents with significant systemic myelosuppressive or cytotoxic potential within 3 months of study start or the expected need for such therapy at study start.
* Alcohol abuse.
* Pregnancy or breast-feeding.
* Inability to tolerate oral medication.
* Aspartate aminotransferase \> 7.0 times the upper limit of normal.
* Alanine aminotransferase \> 7.0 times the upper limit of normal.
* Any clinical condition or prior therapy that, in the Investigators opinion, would make the participant unsuitable for the study or unable to comply with the dosing requirements.
* Use of any investigational drug.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Clinical Trial Site
city: Belgrade
country: Former Yugoslavia
facility: Clinical Trial Site
city: Novi Sad
country: Former Yugoslavia
facility: Clinical Trial Site
Study officials:
References:
Clinical trial NCT04969159: The Degree, Duration and Frequency of Insulin Resistance in Non-operated Patients With Sepsis
Official title: Insulin Resistance in Septic Patients in the Acute Phase and After Discharge From Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: septicaemia
insulin resitance
continous blood glucose
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2021-07-20
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive adults acutely admnitted to hospital with diagnosed sepsis on bacterial basis or on basis of covid-19

Brief summary: Surgery induces insulin resistance lasting for 2-3 weeks. We wanted to elucidate if stress-metabolic, medical conditions carry the same effect.

Detailed description: Background: Insulin resistance is well documented after surgery in a severity positively correlated to the degree of trauma (Thorell et al. 1999; Chambrier et al. 2000). Similar phenomena have been described in severely ill patients in ICU with consequences for the survival (Van den Berghe et al. 2001; The NICE-SUGAR Study Investigators 2009). The documentation, however, is scarce and the extent is unknown in acutely ill patients with sepsis.

Method: Adult, consecutive, non-diabetic patients with elevated CRP, leukocyte counts, SOFA-score of ≥ 2 were monitored with fasting p-C-peptide, blood glucose, CRP, leukocyte count and HOMA-IR at admittance, discharge and at two follow-up visits 2 weeks and 4 weeks after admission. Blood glucose levels were measured continuously during the whole study period with a flash glucose monitor mounted on the patients' upper arm. The diagnosis was sepsis, urosepsis, pneumonia, erysipecosis, bacteremia, infection with unknow focus and covid-19.

Eligibility criteria: Inclusion Criteria:

* elevated CRP on acute asdmission
* elevated leukocyte count on admission
* SOFA-score ≥ 2
* diagnosis: bacterial sepsis
* full age and authority

Exclusion Criteria:

* not able to understand the protocol
* not able to co-operate
* diabetes mellitus of any kind

Primary outcomes:
measure: continous blood glucose
timeFrame: 4 weeks
Secondary outcomes:
measure: C-peptide
timeFrame: 4 weeks
measure: HOMA-IR
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Slagelse
country: Denmark
facility: Department of endocrinology, Slagelse Hospiatl
Study officials:
affiliation: University of Copenhagen
name: Jens R Andersen, MD,MPA
role: STUDY_DIRECTOR
References:
Clinical trial NCT03000959: Stroke Unit in the Philippines: Is it Effective
Official title: Stroke Unit in the Philippines: Is it Effective?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Stroke
Lead sponsor: Jose R. Reyes Memorial Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-12-22
Enrollment: 922
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all consecutive patients diagnosed with stroke (ischemic and hemorrhagic) starting on June 2016.

Brief summary: This study aims to assess the effectiveness of Stroke Unit in the Philippines by comparing the functional outcome between those patient admitted in the general neurology wards and stroke units using modified Rankin Scale

Detailed description: This study aims to look into functionality of patient admitted in the stroke unit in the Philippines

Eligibility criteria: Inclusion Criteria:

* All consecutive patients admitted in participating SUs starting June 2016 during acute stroke (within 7 days from onset), either hemorrhagic or ischemic stroke confirmed by CT-Scan or MRI, will be included

Exclusion Criteria:

* Patient who had previous of stroke and secondary cause of intracerebral hemorrhage such as trauma, arteriovenous malformation and aneurysm are not included in the study. Those who transferred from other institutions will be excluded. And also, patients who are below 18 years old are excluded in the study

Primary outcomes:
measure: Mortality Rate
timeFrame: 3 Months
Secondary outcomes:
measure: Functional outcome in modified rankin scale
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Mano
country: Philippines
facility: Jose R. Reyes Memorial Medical Center
Study officials:
affiliation: Jose R. Reyes Memorial Medical Center
name: Jose C Navarro, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Langhorne P, de Villiers L, Pandian JD. Applicability of stroke-unit care to low-income and middle-income countries. Lancet Neurol. 2012 Apr;11(4):341-8. doi: 10.1016/S1474-4422(12)70024-8. Epub 2012 Mar 19.
citation: Werner Hacke. The stroke care revolution. Lancet 2014; 383: 176-85
citation: Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.
citation: Devuyst G, Bogousslavsky J. Clinical trial update: neuroprotection against acute ischaemic stroke. Curr Opin Neurol. 1999 Feb;12(1):73-9. doi: 10.1097/00019052-199902000-00012.
citation: Peter Langhorne,Martin Dennis. Stroke Units: An evidence based approach. BMJ Books. 1998
citation: Counsell C, Warlow C, Sandercock P, Fraser H, van Gijn J. The Cochrane Collaboration Stroke Review Group. Meeting the need for systematic reviews in stroke care. Stroke. 1995 Mar;26(3):498-502.
citation: Dennis MS, Langhorne P. Stroke Units: An evidence based approach. London, BMJ Publishing, 1998: Chapter 4, 33-40.
citation: The Stroke Society of the Philippines (SSP) Handbook of Stroke. 6th edition. 2014, 220-227.