louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02158221: PACAP Induced Migraine Attacks in Patients With High and Low Genetic Load
Official title: PACAP Induced Migraine Attacks in Patients With High and Low Genetic Load
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine Without Aura
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2014-06-06
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The investigators hypothesized that migraine without patients with many genetic loci associated with migraine (high genetic load) would be more sensitive and get provoked more migraine attacks by PACAP compared to patients with few genetic loci associated with migraine (low genetic load).

Detailed description: Migraine is a very prevalent neurological disorder with a strong genetic factor. The common forms of migraine have a multifactorial and polygenic pattern of inheritance and genetics research is crucial for a deeper understanding of migraine mechanisms. Recently, 12 genetic loci have been identified to be associated with migraine with (MA) and without aura (MA) in four large genome-wide association studies (GWAS). The functional consequences of this genetic variant in humans are yet unknown.

PACAP is a neuropeptide which plays a crucial role in the pathophysiology of migraine and is present in migraine relevant structures. PACAP can induce migraine attacks in MO patients via an adenosine monophosphate (cAMP) dependent pathway. Also, a recent study has showed that intracellular accumulation of cAMP is crucial for the induction of migraine attacks.

The phenotype of the migraine inducing effects of PACAP might therefore be linked to some of the 12 genetic susceptibility loci that have been identified.

Eligibility criteria: Inclusion Criteria:

* Migraine without aura patients genotyped for the 12 newly idetified gene variants associated with migraine.

Exclusion Criteria:

* Other primary headache
* A history of cerebrovascular disease and other CNS- disease
* A history suggesting ischaemic heart disease
* Serious somatic and mental disease
* Hypo- or hypertension
* Abuse of alcohol or medicine (opioid analgesics).
* Pregnant or breastfeeding women.

Primary outcomes:
measure: Incidence of migraine attacks induced by PACAP in patients with high and low genetic load.
timeFrame: Change from baseline in headache intensity at 12 hours after the start of infusion of PACAP
Secondary outcomes:
measure: Incidence of headache induced by PACAP in patients with high and low genetic load.
timeFrame: Change from baseline in headache intensity at 12 hours after the start of infusion of PACAP
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Danish Headache Center & Department of Neurology
state: Glostrup
Study officials:
References:
Clinical trial NCT01296321: Tailored Internet-administrated Treatment of Panic Symptoms - A Randomised Controlled Trial
Official title: Tailored Internet-administrated Treatment of Panic Symptoms - A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety Disorders
Depression
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2011-02-15
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether tailored internet-administrated CBT is a feasible approach in the treatment of panic symptoms and comorbid anxiety and depressive symptoms.


Eligibility criteria: Inclusion Criteria:

* Be between the ages of 18-30 years old or 31-46 years old
* Have reoccurring panic attacks

Exclusion Criteria:

* Suicide prone
* Alcohol addiction
* PTSD
* OCD
* Ongoing psychological treatment

Primary outcomes:
measure: Panic Disorder Severity Scale (PDSS)
timeFrame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Secondary outcomes:
measure: Clinical Outcome in Routine Evaluation - Outcome Measure (CORE-OM)
timeFrame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
measure: Beck Anxiety Inventory (BAI)
timeFrame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
measure: Montgomery Åsberg Depression Rating Scale-Self Rated (MADRS-S)
timeFrame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
measure: Quality of Life Inventory (QOLI)
timeFrame: Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment
Other outcomes:
Locations:
Study officials:
affiliation: Department of Behavioral Sciences and Learning, Linköping University
name: Gerhard Andersson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Silfvernagel K, Carlbring P, Kabo J, Edstrom S, Eriksson J, Manson L, Andersson G. Individually tailored internet-based treatment for young adults and adults with panic attacks: randomized controlled trial. J Med Internet Res. 2012 Jun 26;14(3):e65. doi: 10.2196/jmir.1853.
Clinical trial NCT01517321: MK-0431/ONO-5435 Phase III Clinical Trial-Rapid-acting Insulin Secretagogue Add-on Study in Patients With Type 2 Diabetes
Official title: MK-0431/ONO-5435 Phase III Clinical Trial-Rapid-acting Insulin Secretagogue Add-on Study in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
Collaborators: name: MSD K.K.
First posted: 2012-01-25
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Phase III clinical trial will examine the safety, tolerability, and efficacy of the addition of MK-0431/ONO-5435 to Japanese patients with Type 2 Diabetes mellitus who have inadequate glycemic control on diet/exercise therapy and rapid-acting insulin secretagogue monotherapy.


Eligibility criteria: Inclusion Criteria:

* Japanese patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on diet/exercise therapy and rapid-acting insulin secretagogue monotherapy

Exclusion Criteria:

* Patients with Type 1 Diabetes Mellitus

Primary outcomes:
measure: Incidences of adverse experiences and change in vital sign, safety lab etc. as parameters of safety and tolerability
timeFrame: 12 weeks and 52 weeks
Secondary outcomes:
measure: HbA1c
timeFrame: 12 weeks
measure: 2-hour postmeal glucose
timeFrame: 12 weeks
measure: Fasting plasma glucose
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chubu
country: Japan
facility: Chubu Region Clinical Site
city: Chugoku
country: Japan
facility: Chugoku Region Clinical Site
city: Kanto
country: Japan
facility: Kanto Region Clinical Site
city: Kinki
country: Japan
facility: Kinki Region Clinical Site
city: Kyusyu
country: Japan
facility: Kyusyu Region Clinical Site
city: Tohoku
country: Japan
facility: Tohoku Region Clinical Site
Study officials:
affiliation: First Division Clinical Development Planning 1
name: Akiteru Seki
role: STUDY_CHAIR
References:
Clinical trial NCT01457521: Pain Control In First Trimester Medical Abortion: A Randomized Trial
Official title: PAIN CONTROL IN FIRST TRIMESTER MEDICAL ABORTION: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: pain
medical abortion
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
name: Family Planning Associates Medical Group, LTD
name: Planned Parenthood of Greater New York
First posted: 2011-10-24
Enrollment: 250
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial will compare two oral analgesic regimens in women undergoing first trimester medical abortion with mifepristone and misoprostol. The primary study outcome is pain.

Detailed description: This trial will compare two oral analgesic regimens in women undergoing first trimester medical abortion with mifepristone and misoprostol. The primary study outcome is pain. Secondary objectives include comparing the regimens for the total amount of ibuprofen taken, use of other analgesics, vaginal bleeding, adverse events, successful completion of abortion, overall satisfaction with the abortion procedure.

Eligibility criteria: Inclusion Criteria:

* Pregnant women with a gestational age of 63 days or less
* Desire a medical abortion with mifepristone and misoprostol

Exclusion Criteria:

- Have contraindications to ibuprofen

Primary outcomes:
measure: 11-point Visual Analog Scale for Pain
timeFrame: 1-2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Family Planning Associates Medical Group
state: Illinois
city: New York
country: United States
facility: Planned Parenthood of New York City, Inc.
state: New York
Study officials:
affiliation: Gynuity Health Projects
name: Elizabeth Raymond, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reynolds-Wright JJ, Woldetsadik MA, Morroni C, Cameron S. Pain management for medical abortion before 14 weeks' gestation. Cochrane Database Syst Rev. 2022 May 13;5(5):CD013525. doi: 10.1002/14651858.CD013525.pub2.
citation: Raymond EG, Weaver MA, Louie KS, Dean G, Porsch L, Lichtenberg ES, Ali R, Arnesen M. Prophylactic compared with therapeutic ibuprofen analgesia in first-trimester medical abortion: a randomized controlled trial. Obstet Gynecol. 2013 Sep;122(3):558-64. doi: 10.1097/AOG.0b013e31829d5a33.
Clinical trial NCT01341821: Influences of Leadership Style on Team Climate for Quality
Official title: Influences of Leadership Style on Team Climate for Quality
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leadership Style
Keywords: Leadership Style
Team Climate
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2011-04-26
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: employees in the hospitals

Brief summary: This study is to discuss how different personalities of leaders and employees result in the effect of quality and efficiency in different organizational climate and also how the leadership style of different leaders affect the organizational climate. The investigators hope that this study will improve the key factor of quality and efficiency among leaders. Besides, the investigators want to provide the reference of quality control for the groups of healthcare quality in order to avoid unnecessary time and costs and achieve the goal of improvement quality.

Detailed description: The specific purpose of this study is the following:

1. to discuss the relationship of organizational climate due to different leadership styles.
2. to discuss the relationship of quality efficiency due to different organizational climates.
3. to discuss the relationship of quality efficiency due to different leadership styles.

Eligibility criteria: Inclusion Criteria:

* employees in the hospitals

Exclusion Criteria:

* none employees in the hospitals

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University - WanFang Hospital
Study officials:
affiliation: Taipei Medical University WanFang Hospital
name: Liang-Ming Lee
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01590121: Hereditary Haemorrhagic Telangiectasia Flight Safety Study
Official title: A Questionnaire Based Study to Evaluate the Safety of Flying in Hereditary Haemorrhagic Telangiectasia (HHT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hereditary Haemorrhagic Telangiectasia
Keywords: Previous flight by aeroplane
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2012-05-02
Enrollment: 156
Sex: ALL
Minimum age (years): 16
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HHT patients previously assesses at Hammersmith Hospital, England

Brief summary: Hereditary Haemorrhagic Telangiectasia (HHT) is a condition in which sufferers have abnormal blood vessels which makes them more likely to bleed than other people, particularly in the lungs, which results in low blood oxygen levels. Flying may make this worse and cause problems. The investigators want to know if there are an increased number of problems on flights compared to on land.

The investigators currently do not have any evidence based guidelines on air travel to best advice people who suffer with HHT. The investigators would therefore like to ask individuals who have HHT about their experience on a flight, using a postal questionnaire.

Detailed description: Individuals with Hereditary Haemorrhagic Telangiectasia (HHT) previously reviewed at HHTIC London will be sent an invitation to participate in a short questionnaire study.

Quantitative variables from the questionnaires for statistical analysis will be the number of individuals responding (and number of questionnaires sent out); number of flights taken and number of complications, subgrouped by type, and flight duration in hours. Complication rates will be expressed as proportion of person flight hours.

The quantitative data from the questionnaire will then be compared with quantitative data from patients' medical records using non parametric methods such as Mann Whitney for univariate analyses.

Eligibility criteria: Inclusion Criteria:

HHT

Exclusion Criteria:

Unable to provide informed consent

Primary outcomes:
measure: HHT Patients Who by the Questionnaire Did or Did Not Self Report a Medical Complication During Flight
timeFrame: Patient were asked to report all flights taken up until questionnaire completion aged 18-90 (mean 55)ys. 145 HHT-affected respondents had flown for 18,943 hours over 3,950 flights.
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: HammersmithHospital, Imperial College Healthcare NHS Trust
Study officials:
affiliation: Imperial College London
name: Claire L Shovlin, PhD MA MB BChir FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mason CG, Shovlin CL. Flight-related complications are infrequent in patients with hereditary haemorrhagic telangiectasia/pulmonary arteriovenous malformations, despite low oxygen saturations and anaemia. Thorax. 2012 Jan;67(1):80-1. doi: 10.1136/thoraxjnl-2011-201027. Epub 2011 Sep 26.
Clinical trial NCT02604121: Cytological Screening for Early Diagnosis of Precancerous or Cancerous Lesions of Oral Cavity
Official title: Interest of Cytological Screening for Early Diagnosis of Precancerous or Cancerous Lesions of Oral Cavity by Transepithelial Brushing in Liquid-based
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mouth Neoplasms
Keywords: oral cavity
cancerous and precancerous lesions
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2015-11-13
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Prospective study of diagnosis validation of a cytological technique. 200 patients with oral cavity cancerous and precancerous lesions will be enrolled.

A cytological sample of the lesion will be performed by transepithelial brushing ( Orcellex® Rovers brush) in cytology liquid-based technology (methode ThinPrep 2000 (Hologic®)). A microscopic double blind reading will be performed. A biopsy sampling will be carried out in accordance with current strategy of screening. The brushing diagnosis quality will be compared to the biopsy which is the gold standard.


Eligibility criteria: Inclusion Criteria:

* one or several cancerous or pre-cancerous lesions of oral cavity newly diagnosed or detected during a follow-up visit

Exclusion Criteria:

* pregnant or lactating women
* patients under juridical protection

Primary outcomes:
measure: Diagnostic validity of lesion (Bethesda system, 2001)
timeFrame: baseline
Secondary outcomes:
measure: Diagnostic validity - predictive value (positive and negative)
timeFrame: baseline
measure: Feasibility of cytology
timeFrame: Baseline
measure: Feasibility of cytology
timeFrame: Baseline
measure: Reproducibility intra and inter observers (coefficient of kappa de cohen)
timeFrame: Baseline
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Laetitia COLIN-LACOSTE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04199221: Use of Stress Inoculation Training in Medical Education
Official title: Use of Stress Inoculation Training in Medical Education
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stress
Keywords: Stress Inoculation
Medical Education
Simulation Training
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 12
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: The purpose of this research study is to test the feasibility and effectiveness of SIT in teaching medical students to perform in high-fidelity simulation settings similar to those they may experience in their practice.

Detailed description: This is a study examining stress inoculation training and its potential role in medical education. The medical field exposes students and providers to various stressful situations each and every day. Various organizations including military organizations have introduced concepts of stress inoculation training (SIT) to help learners manage these situations to produce optimal performance.

Eligibility criteria: Inclusion Criteria:

* 1st and 2nd year medical students who are at least 18 years old

Exclusion Criteria:

* Prior airway management experience (including but not limited to former medics, respiratory technicians, CRNAs)
* Pregnant women

Primary outcomes:
measure: Change in anxiety - visual analog
timeFrame: Baseline to up to 3 weeks
measure: Change in state-trait anxiety
timeFrame: Baseline to up to 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Nathan J Lewis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06209021: Effects of Hyperbaric Oxygen Therapy on Middle and Inner Ear Functions
Official title: Effects of Hyperbaric Oxygen Therapy on Middle and Inner Ear Functions
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Middle Ear Barotrauma
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of both sexes already recommended to be treated by hyperbaric oxygen therapy for various medical conditions in hyperbaric oxygen therapy center.

Brief summary: The goal of this observational study is to measure the effect of hyperbaric oxygen therapy on middle ear pressure in order to predict the risk factors for middle ear barotrauma also, to assess its effects on hearing functions of the inner ear in participant population. The main questions aim to answer are:

* Is there a change in middle ear pressure before and after exposure to hyperbaric oxygen therapy ?
* Is there a change in hearing threshold level before and after exposure to hyperbaric oxygen therapy ? The middle ear pressure, eustachian tube functions and the hearing threshold of the participants will be assessed immediately before the fist session and within one hour after the first and tenth sessions.

Detailed description: Fifty four patients already treated by hyperbaric oxygen therapy recruited from hyperbaric oxygen therapy center of Assiut university hospitals. Otoscopic examination for all patients must be done before and after the session , assessment of middle ear pressure and the state of the eustachian tube through doing eustachian tube function tests (Valsalva and Toynbee tests for ears with intact tympanic membrane and modified inflation - deflation tests for ears with perforated tympanic membrane) by tympanometry for all patients before and after the first session of hjyperbaric oxygen therapy and after completion of the tenth session. Assessment of the hearing threshold level of the patients immediately before the first session and after the tenth session of hyperbaric oxygen therapy through doing pure tone audiometry ( air conduction and bone conduction audiometry) and speech audiometry to assess the speech discrimination score for the patients

Eligibility criteria: Inclusion Criteria:

* Patients of at least 18 years old.
* Patients accept participation in the research.
* Patients with out history of middle ear diseases.

Exclusion Criteria:

* Patients under age of 18 years old.
* Patients have middle ear effusion.
* Patients refuse to participate in the research.

Primary outcomes:
measure: Measuring the changes of the middle ear pressure after exposure to hyperbaric oxygen therapy
timeFrame: Immediately before exposure to the first session of hyperbaric oxygen therapy and within one hour after exposure to the first and tenth session of hyperbaric oxygen therapy.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: