louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03585894: The Role of Inflammation and Vasodilatation in PACAP38-induced Headache Using MRI on Healthy Subjects
Official title: The Role of Inflammation and Vasodilatation in PACAP38-induced Headache Using MRI on Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2018-07-13
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each participant will receive PACAP28 intravenous infusion over 20 min in both experiment days but treated in randomized order with sumatriptan or ketorolac.
Primary purpose: OTHER

Brief summary: Studying Pituitary adenylate cyclase-activating peptide 38 (PACAP38) induced headache effects on extra- and intracerebral arteries and pre-posttreated by sumatriptan and ketorolac assessed by magnetic resonance imaging (MRI) on healthy volunteers.

Detailed description: The purpose of this research project is to investigate the importance of blood vessel (vasodilatation), vessel wall inflammation and blood flow in arteries of headaches triggered by PACAP38 and for headache treated with sumatriptan (migraine medicine) and ketorolac (NSAID). In addition, we will investigate headache-related changes in the brain's network connectivity.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Aged 18-50
* 50-100 kg

Exclusion Criteria:

* Tension type headache more than 5 dag /month
* Other primary headaches
* Daily medication except contraceptives
* Drug taken within 4 times the half-life for the specific drug except contraceptives
* Pregnant or lactating women
* Exposure to radiation within the last year
* Headache within the last 24 hours before start of trial
* Hypertension
* Hypotension
* Respiratory or cardiac disease
* Primary relatives with current or previous migraine

Primary outcomes:
measure: Intra-extra cerebral arteries vasodilatation
timeFrame: 120 minutes
measure: Headache score
timeFrame: 6 hours
Secondary outcomes:
measure: Blood pressure
timeFrame: 2 hours
measure: Headache characteristics
timeFrame: 24 hours
measure: Heart rate
timeFrame: 2 hours
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish Headache Center
Study officials:
References:
citation: Ghanizada H, Al-Karagholi MA, Arngrim N, Morch-Rasmussen M, Metcalf-Clausen M, Larsson HBW, Amin FM, Ashina M. Investigation of sumatriptan and ketorolac trometamol in the human experimental model of headache. J Headache Pain. 2020 Feb 24;21(1):19. doi: 10.1186/s10194-020-01089-3.
Clinical trial NCT00937794: Screening Study to Identify Pediatric Patients With Hunter Syndrome Who Demonstrate Evidence of Central Nervous System (CNS) Involvement and Who Are Currently Receiving Treatment With Elaprase®
Official title: A Screening Study to Identify Pediatric Patients With Hunter Syndrome Who Demonstrate Evidence of Central Nervous System Involvement and Who Are Currently Receiving Treatment With Elaprase®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hunter Syndrome
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2009-07-13
Enrollment: 33
Sex: MALE
Minimum age (years): 32
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Initial patient eligibility will be based on patient age and gender. Patients must be receiving weekly IV Elaprase infusions to be eligible for enrollment.

Brief summary: This study is being conducted to identify pediatric patients with Hunter syndrome who have neurodevelopmental disease characteristics, who are currently receiving treatment with Elaprase, and who may be suitable to participate in a clinical study with an investigational agent.


Eligibility criteria: Inclusion Criteria:

1. The patient is male and is ≥3 and \<18 years of age
2. The patient is currently receiving weekly IV infusions of Elaprase.
3. The patient, patient's parent(s), or legally authorized guardian(s) has voluntarily signed an Institutional Review Board / Independent Ethics Committee-approved informed consent form after all relevant aspects of the study have been explained and discussed with the patient. The guardians' consent and subject's assent, as relevant, must be obtained.

Exclusion Criteria:

1. The patient has a CNS shunt.
2. The patient has received a hematopoietic stem cell transplant.
3. The patient is currently enrolled in a clinical trial.
4. The patient has a significant medical or psychiatric comorbidity(ies) that might affect study data or confound the integrity of study results.

Primary outcomes:
measure: Number of Participants Who Were Screened For The Follow-On Study With an Investigational Agent
timeFrame: 1 month
measure: Number of Participants With a Score of at Least 90 on The General Conceptual Ability (GCA) Sub-Scale of The Differential Ability Scale (DAS)
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Birmingham
country: United Kingdom
facility: Birmingham Children's Hospital
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00799994: Does Lowering Eye Pressure Affect the Results Obtained From Objective Visual Field Testing?
Official title: Effect of Acutely Lowering Intraocular Pressure on Multifocal Visual Evoked Potential Testing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Keywords: glaucoma
intraocular pressure
multifocal visually evoked potentials
Lead sponsor: Wills Eye
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2008-12-01
Enrollment: 23
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: glaucoma service

Brief summary: A study to determine whether a patient's range of vision test results improve after their eye pressure is lowered by 30% or more by testing on a new machine called the Accumap and how to learn how much the Accumap's results change from one test to another within the same person.

The investigators believe that Multifocal VEP readings (Accumap)(and therefore visual function and ganglion cell function) improve after acutely lowering intraocular pressure.

Detailed description: Accumap testing will be performed before and two to three hours after treatment is initiated to lower IOP. In eye that have bilateral treatment, one eye will be assigned randomly to the study. The mean multifocal objective perimetry amplitude will be compared before and after IOP reduction. Also, the mean amplitudes of five circumferential zones will be compared before and after IOP lowering. Visual field testing and HRT testing will be performed before and after treatment as well if possible. Paired t-tests will be performed no pre-and post-treatment mean MOP amplitude values and circumferential zones to determine statistical significance. A second group of patients whose pressures will not be lowered will also be tested with Accumap at baseline and two hours afterwards, in order to examine reproducibility of mean MOP amplitude and mean circumferential amplitude. HVF and HRT testing will also be obtained on thes patients when possible.

Eligibility criteria: Inclusion Criteria:

* Consecutive patients seen that have their intraocular pressures lowered by at least 30% over the course of two hours.

Exclusion Criteria:

* Recent (within 6 weeks) intraocular surgery
* Visual acuity worse than 20/40
* Pathology unrelated to glaucoma (retinal disease, stroke, brain tumor, etc) associated with visual field defect
* Prior corneal transplant, corneal edema, or corneal diseases such as keratoconus or dense scarring

Primary outcomes:
measure: lowering of intraocular pressure will cause an acute improvement in MfVEP (multifocal visually evoked potential) amplitude readings
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Wills Eye
state: Pennsylvania
Study officials:
affiliation: Wills Eye Institute
name: L. Jay Katz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05430594: This Study Investigate the Impact of Maternal COVID-19 Infection During Birth on the Childrens' Physical and Mental Development.
Official title: Long-term Followup of Children Was Born From COVID Positive Mother During Birth
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Keywords: followup
longterm outcome
child development
maternal COVID-19
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 130
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Firstly we examine the infants at 1 year old. We do control examination if it is necessary or give advice. We did a next examination at 2 years old in every cases.

Brief summary: This study investigates the impact of the maternal COVID infection during birth on the children's development: physical and mental outcomes. We would like to differentiate the effect from the viral infection and effect of the pandemic period, too.


Eligibility criteria: Inclusion Criteria:

* postitive maternal COVID test during the birth
* the newborn was cared at the Semmelweis University after birth

Primary outcomes:
measure: Neurodevelopmental outcome
timeFrame: 2 years old
Secondary outcomes:
measure: Neurodevelopmental outcome
timeFrame: 1 year old
measure: Phsycosomatic outcome
timeFrame: 1 and 2 years old
measure: Regulation disorders
timeFrame: 1 and 2 years old
measure: Feeding
timeFrame: 1 and 2 years old
measure: Maternal mental status
timeFrame: 1 and 2 years old
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University, Department of Obstetrics and Gynecology
Study officials:
References:
Clinical trial NCT01980394: Esophageal Stump Washout
Official title: Esophageal Stump Washout Reduces Free Intraluminal Tumor Cells During Resection of Carcinomas of the Esophagus and Cardia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Cancer
Gastrooesophageal Cancer
Keywords: esophagus
gastro-esophegeal junction
cancer
tumor seeding
free viable tumor cells
surgery
intraluminal tumor cells
stump washout
Lead sponsor: Kantonsspital Liestal
Sponsor class: OTHER
Collaborators: name: University of Bern
First posted: 2013-11-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Intraluminally shed viable tumor cells might contribute to local recurrence in cancer of the esophagus and the cardia. The aim of the the study was to establish a method of mechanical lavage of the remaining part of the esophagus and, hence, to reduce the intraluminal cancer cells before doing the esophageal anastomosis.

Detailed description: See study protocol!

Eligibility criteria: Inclusion Criteria:

* histologically confirmed cancer of gastro-esophageal junction with indication for surgery

Exclusion Criteria:

* missing informed consent

Primary outcomes:
measure: Presence of intraluminal tumor cells in the remaining oesophageal stump
timeFrame: during the operation
Secondary outcomes:
Other outcomes:
Locations:
city: Liestal
country: Switzerland
facility: Kantonsspital Baselland, Liestal
state: Basel-Land
Study officials:
affiliation: Hospital of Liestal, Liestal, Switzerland
name: Christoph A. Maurer, Professor, Chairman of Surgery
role: STUDY_CHAIR
References:
Clinical trial NCT03630094: Plasma and Intrapulmonary Concentrations Study of WCK 5222
Official title: A Phase 1, Multiple-Dose, Open-Label Study to Determine and Compare Plasma and Intrapulmonary Concentrations of WCK 5222 (Cefepime and Zidebactam) in Healthy Adult Human Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: PHA1A
Lead sponsor: Wockhardt
Sponsor class: INDUSTRY
First posted: 2018-08-14
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a Phase 1, multiple dose, open-label pharmacokinetic study in healthy adult male and female subjects.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) greater than or equal to18.5 and less than or equal to 30 (kg per m2) and weight between 55.0 and 100.0 kg (both inclusive).
* Medical history without any major pathology as judged by the Investigator.
* Forced expiratory volume in 1 second (FEV1) of at least 70% of predicted value at screening.

Exclusion Criteria:

* History or presence of significant oncologic, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal,endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
* Positive alcohol breath test or urine drug screen test at screening or confinement.
* Current use or has used tobacco or nicotine containing products 6 month prior to screening.
* Positive testing for HIV, Hepatitis B or Hepatitis C.
* History or presence of alcohol or drug abuse within the 2 years prior to screening.

Primary outcomes:
measure: concentrations of cefepime (FEP) and zidebactam in epithelial lining fluid (ELF)
timeFrame: Day 3
measure: concentrations of cefepime (FEP) and zidebactam in alveolar macrophage (AM)
timeFrame: Day 3
Secondary outcomes:
measure: Number of adverse event reported
timeFrame: Day 3
measure: number variation noted in 12-lead electrocardiogram
timeFrame: Day 3
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pulmonary Associates
state: Arizona
Study officials:
References:
Clinical trial NCT00525694: Zero Calorie Drink Products
Official title: Determination of Clinically Significant Carbohydrates Added to Zero Calorie Drink Products
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
First posted: 2007-09-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: This will be a clinical test to determine if any carbohydrate or a gluconeogenic precursor added to a zero calorie product might be important to consider in the management of obesity, metabolic syndrome and diabetes mellitus. This research trial will evaluate the effect of three different solutions on blood glucose level. One solution is plain water, the second a standard high glucose (sugar) solution used typically in diabetes testing, and the third a low calorie drink (Zero Coke). Based on a prior study evaluating a diet for effective weight loss, we observed that patients who drank large volumes of diet soda did not lose weight as readily as those who did not drink diet soda. Therefore, we propose to examine the actual effect of one diet soda (Zero Coke) on the body's glucose level and compare it to water and a high glucose solution. All participants in this study must have 3 Glucose tolerance evaluations - one with each solution: water, high glucose, and Zero Coke.


Eligibility criteria: Inclusion Criteria:

* healthy,
* asymptomatic individuals for diabetes and pre-diabetes,
* especially for people at high risk of developing diabetes,
* such as those with a family history of diabetes,
* those who are overweight,
* and those who are more than 40 to 45 years old

Exclusion Criteria:

* Patients with chronic illnesses, especially diabetes

Primary outcomes:
measure: to determine if any carbohydrate or a gluconeogenic precursor added to a zero calorie product might be important to consider in the management of obesity, metabolic syndrome and diabetes mellitus.
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care Health System
state: Delaware
Study officials:
affiliation: Christiana Care Health Services
name: James Hays, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01985594: Utrogestan Versus Nifedipine as Tocolysis for Preterm Labor: a Randomised Controlled Trial
Official title: STUDY ON EFFICACY OF UTROGESTAN AS TOCOLYSIS FOR PRETERM LABOR
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Preterm Labor
Keywords: preterm labor
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2013-11-15
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: RESEARCH HYPOTHESIS

-Incidence of preterm delivery is lower in women treated with oral micronized progesterone (Utrogestan) as acute tocolysis agent compare to Nifedipine group with fewer maternal side effect


Eligibility criteria: Inclusion Criteria:

• Singleton pregnancy women between 22 and 34 weeks of gestation who presented with threatened preterm labor.

Exclusion Criteria:

* Multiple pregnancies
* Women with Preterm Prelabour Rupture of Membrane
* Fetal death
* Women with bad obstetric history
* Women with history of cervical incompetence
* Contraindication to Nifedipine such as cardiovascular disease, hyperthyroidism, severe pre eclampsia or to Utrogestan
* Maternal or fetal indication for immediate delivery, such as fetal distress, bleeding placenta previa, abruption placenta
* Contraindication for tocolysis, for example severe pre eclampsia, intrauterine growth restriction, fetal anomaly, chorioamnionitis, significant antepartum haemorrhage
* Cervical dilatation of 3cm or more
* Patients with previous tocolytic treatment during this pregnancy
* Women who refuse to participate in this study

Primary outcomes:
measure: latency period interval between time of tocolysis and delivery
timeFrame: 24 hours up to 7 days
Secondary outcomes:
measure: Pregnancy outcomes
timeFrame: 34 weeks of gestational age
measure: Neonatal outcome
timeFrame: 24 hours
measure: Maternal side effect
timeFrame: 30 minutes up to 48 hours
Other outcomes:
Locations:
city: Cheras
country: Malaysia
facility: Obstetric and Gynaecology Department, National University of Malaysia Medical Centre
state: Kuala Lumpur
Study officials:
affiliation: National University of Malaysia
name: nor azlin mohamed ismail
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.
Clinical trial NCT00740194: Reciprocal Influence of Sex Steroid Environment and Adipocyte Function in Men
Official title: Reciprocal Influence of Sex Steroid Environment and Adipocyte Function in Men.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy
Keywords: Physiology
males
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2008-08-22
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aromatase inhibition versus estradiol during 1 week


Eligibility criteria: Inclusion Criteria:

* Informed consent obtained.
* Male subjects
* Age 18 - 40
* weight \< 120 kg

Exclusion Criteria:

* Primary hypogonadism or secondary hypogonadism due to genetic causes (Kallman syndrome etc.), tumors, infiltrative diseases, infections, pituitary apoplexy, trauma, critical illness, chronic systemic illness or intentional.
* Treatment with insulin, corticoids, opiates (on a daily basis), androgen- or estrogen analogs or CYP2A6 substrates (Dexmedetomidine, Ifosfamide, Methoxsalen, Miconazole, Tranylcypromine).
* Impaired renal function defined as serum-creatine \> 1.5 mg/dL
* Impaired liver function, defined as ALAT \> 2.5 times upper limit of normal
* Clinically significant active cardiovascular disease including history of myocardial infarction within the past 6 months and/or heart failure (NYHA class III or IV) at the discretion of the investigator
* Cancer or any clinically significant disease or disorder, which in the investigator's opinion could interfere with the results of the trial
* Palpable prostate nodule or induration, PSA \> 3 ng/mL, prostatism, untreated sleep apnee syndrome, erythrocytosis (hematocrit \> 50%) or hyperviscosity.
* Known or suspected abuse of alcohol or narcotics
* Mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation.

Primary outcomes:
measure: Effects of sex steroids on adipocytes
timeFrame: 1 week
Secondary outcomes:
measure: Effects of sex steroids on lipid metabolism
timeFrame: 1 week
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Johannes Ruige, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00677794: Small Bowel Cleansing Prior to Video Capsule Endoscopy Examination
Official title: Small Bowel Cleansing Prior to Video Capsule Endoscopy Examination: a Randomized, Blinded, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Endoscopy
Keywords: Video Capsule Endoscopy
Small Bowel
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: American Society for Gastrointestinal Endoscopy
First posted: 2008-05-15
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: There remains debate regarding whether small bowel cleansing is required prior to video capsule endoscopy, and if so, which method is best. This study prospectively tests cleansing with no preparation, preparation with picosalax, and preparation with polyethylene glycol.


Eligibility criteria: Inclusion Criteria:

* patients undergoing VCE.

Exclusion Criteria:

* bowel obstruction or ileus;
* known stricture or fistula;
* previous small bowel surgery;
* severe gastroparesis or motility disorder
* renal impairment (serum creatinine over normal range within three months of study);
* congestive heart failure;
* cirrhosis;
* implanted cardiac pacemaker or defibrillator or other electromedical device;
* pregnancy.

Primary outcomes:
measure: small bowel cleansing
timeFrame: during exam
Secondary outcomes:
measure: yield of Video Capsule Endoscopy (VCE) in iron deficiency
timeFrame: during study
measure: tolerance of preparation
timeFrame: during preparation
measure: effect of preparation on blood chemistry
timeFrame: 24 hours after ingestion
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Hotel Dieu Hospital
state: Ontario
Study officials:
affiliation: Queen's University
name: Lawrence Hookey, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hookey L, Louw J, Wiepjes M, Rubinger N, Van Weyenberg S, Day AG, Paterson W. Lack of benefit of active preparation compared with a clear fluid-only diet in small-bowel visualization for video capsule endoscopy: results of a randomized, blinded, controlled trial. Gastrointest Endosc. 2017 Jan;85(1):187-193. doi: 10.1016/j.gie.2016.07.028. Epub 2016 Jul 21.