louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00301665: Efficacy and Safety Study of Dysport® Used for Migraine Prophylaxis
Official title: A Phase II, Multicentre, Randomised, Double-blind, Parallel Groups, Placebo Controlled Clinical Study of Efficacy and Safety of Dysport® for Migraine Prophylaxis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Migraine
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2006-03-13
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the efficacy of botulinum toxin type A (Dysport®) injections into pericranial muscles compared to placebo to prevent migraine attacks.


Eligibility criteria: Inclusion Criteria:

* Patients having migraine without aura or with typical aura as defined by International Headache Society criteria
* Migraine attacks have been persisting for more than 1 year
* 2 to 6 migraine attacks per month of at least moderate severity over the 3 months preceding the pre-inclusion visit
* 2 to 6 migraine attacks of at least moderate severity during the screening period

Exclusion Criteria:

* Non-migraine headaches such as tension-type headaches
* Migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, migraine aura without headache, migraine with acute onset aura, ophthalmoplegic migraine, retinal migraine, complications of migraine
* Onset of migraine is after age of 50
* Overuse of acute migraine medications (individuals who take medications for acute migraine more than 10 days per month) or have a history of drug or alcohol abuse

Primary outcomes:
measure: Significant decrease of the number of migraine attacks with Dysport® compared to placebo.
timeFrame: 3 months
Secondary outcomes:
measure: Reduction of the intensity of the migraine attacks.
timeFrame: 3 months
measure: Reduction of duration of the migraine attacks.
timeFrame: 3 months
measure: Reduction of migraine medication consumption.
timeFrame: 3 months
measure: Improvement of quality of life.
timeFrame: 3 months
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: St. Anne's Faculty Hospital
city: Hradec Kralove
country: Czechia
facility: University Hospital Hradec Kralove
city: Prague 2
country: Czechia
facility: General Faculty Hospital
city: Poznan
country: Poland
facility: Medical Academy of Poznan
city: Warsaw
country: Poland
facility: Air Force Institute of Aviation Medicine
city: Wolomin
country: Poland
facility: City Hospital of Wolomin
city: Zgierz
country: Poland
facility: Voivodeship (Provincial) Specialist Hospital
city: Bratislava
country: Slovakia
facility: Faculty Hospital Bratislava
city: Martin
country: Slovakia
facility: Faculty Hospital
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01186965: Ehealth: Second Life Impacts Diabetes Education & Self-Management
Official title: Ehealth: Second Life Impacts Diabetes Education & Self-Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Diabetes
Second Life
virtual community
diabetes education
diabetes support group
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2010-08-23
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to to develop and evaluate the feasibility, usability, and effect of participation in SLIDES (a virtual diabetes community in Second Life) for providing interactive diabetes education, support, and resources.


Eligibility criteria: Inclusion Criteria:

* current Duke Endocrinology patient
* are between 21 and 75 years old
* are able to speak and read English
* are computer literate (have used a computer for at least 6 months)
* understand how to use the Internet (have accessed the Internet on at least 6 occasions)
* have access to a computer with a non-dial-up Internet connection in a private location (home)
* are mentally capable of informed consent
* are reachable by telephone
* have no pre-existing medical condition(s) or severe diabetes related complications that would interfere with study participation (i.e., physical activity) or measures (e.g., renal failure, Stage III hypertension, severe orthopedic conditions or joint replacement scheduled within 6 months, paralysis, bleeding disorders, cancer, or receipt of pharmacologic doses of anti-coagulant medications \[warfarin\])
* are able to travel to Duke University Medical Center (DUMC) for follow-up appointments.

Exclusion Criteria:

-

Primary outcomes:
measure: Perceived Usefulness
timeFrame: 3 and 6 months
measure: Perceived Ease of Use
timeFrame: 3 and 6 months
measure: Process data
timeFrame: January 2011 through May 2012
Secondary outcomes:
measure: Demographics
timeFrame: baseline
measure: Metabolic Indicators
timeFrame: baseline, 3 months, 6 months
measure: Diabetes knowledge
timeFrame: baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University School of Nursing
name: Constance M Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01559480: Postoperative Desogestrel for Endometriosis Related Pain
Official title: A Prospective Double Blind Randomized Controlled Trial to Study the Effectiveness of a Desogestrel for the Treatment of Pelvic Pain or Dysmenorrhea in the Patients Undergone Conservative Surgery for Pelvic Endometriosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis
Keywords: Endometriosis
Desogestrel
Placebo
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2012-03-21
Enrollment: 40
Sex: FEMALE
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: Endometriosis is one of the most common disease in reproductive aged women.Surgical intervention has a significant symptoms relief. However, symptom recurrence is often after surgery. This study aims to determine the efficacy of Desogestrel compared with placebo in pain symptom of symptomatic endometriosis patient undergo conservative surgery . The primary outcome measurement is pain score at 6 months after surgery.

Detailed description: After conservative surgery, the patients are randomized to Desogestrel and placebo groups. VAS pain score are compared after complete 6 months

Eligibility criteria: Inclusion Criteria:

* diagnoses endometriosis
* Plan conservative surgery
* initial pain score at least 5
* voluntary to be the participant of this study with inform consent
* No desired child bearing in 6 months

Exclusion Criteria:

* residual lesion after surgery which required further treatment
* cannot participate complete 6 months after surgery
* contraindication for Desogestrel, Paracetamol or Ponstan
* Pregnant

Primary outcomes:
measure: Pain score
timeFrame: 6 months
Secondary outcomes:
measure: Side effect compared between both group
timeFrame: 6 month
measure: Patients satisfaction compare between both groups
timeFrame: 6 months
Other outcomes:
Locations:
city: Bangkok noi
country: Thailand
facility: Faculty of medicine Siriraj hospital, Mahidol university
state: Bangkok
city: Bangkok noi
country: Thailand
facility: Siriraj hospital Mahidol university
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Prasong Tanmahasamut, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05477680: Intraoperative Brain Shift Calculation Study
Official title: Intraoperative Brain Shift Calculation Study: a Prospective, Single Arm Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tumor, Brain
Cavernoma
Arteriovenous Malformations
Intracerebral Hematoma
Keywords: brain shift
tumor
cavernoma
arteriovenous malformation
intracerebral hematoma
Lead sponsor: Sklifosovsky Institute of Emergency Care
Sponsor class: OTHER_GOV
First posted: 2022-07-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to calculate magnitude, type of intraoperative brain shift and assess possibility of it's prediction.

Detailed description: Brain shift is the main natural cause of major navigation imprecision. Despite numerous attempts no trials showed a possibility to calculate and predict it's value although some patterns were found. Some modern navigational features allow to partially resolve this problem. Manual shift correction allows to displace brain structures but can only be used if brain shift is linear. Intraoperative computed tomography (CT) and magnetic resonance imaging (MRI) allow to update navigational data but violate surgical workflow and cannot display brain tissue in real time. Intraoperative sonography has poorer quality, limited observe volume and lengthy learning curve.

The purpose of the study is to calculate magnitude, type of intraoperative brain shift and assess possibility of it's prediction.

For each patient a surgeon intraoperatively will assess location of brain surface, various intracranial structures and lesion margins during surgery. Postoperatively these data will be compared to lesion's characteristics, patient's state and intraoperative features.

Eligibility criteria: Inclusion Criteria:

* all intracranial tumors
* cavernomas
* arteriovenous malformations
* spontaneous (non-traumatic) intracerebral hemorrhages
* traumatic intracerebral hemorrhages
* supratentorial localization
* newly diagnosed
* age 18-100 years
* stable hemodynamics
* error of patient registration in neuronavigation no more than 2 mm

Exclusion Criteria:

* rapid cerebral dislocation

Primary outcomes:
measure: Brain shift (in millimeters)
timeFrame: Intraoperatively
Secondary outcomes:
measure: Karnofsky Performance status in percents
timeFrame: within 10 days after surgery
measure: Cerebral complications
timeFrame: From admission to intensive care unit after surgery till hospital discharge, up to 365 days
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Sklifosovsky Institute of Emergency Care
Study officials:
affiliation: Sklifosovsky Institute of Emergency Care
name: Alexander Dmitriev, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01799265: Transcend Auto vs Commercially Available Device Clinical Evaluation for Treatment of Obstructive Sleep Apnea (OSA)
Official title: Transcend Auto vs Commercially Available Device Clinical Evaluation for Treatment of Obstructive Sleep Apnea (OSA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: obstructive sleep apnea
OSA
AutoPAP
PAP
sleep disordered breathing
CPAP
Apnea hypopnea index
AHI
Lead sponsor: Somnetics International, Inc.
Sponsor class: INDUSTRY
First posted: 2013-02-26
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the Transcend Auto is as effective in treating obstructive sleep apnea as another device that is already on the market.

Detailed description: This is a prospective, randomized, crossover trial. Patients will be randomized 1:1 to undergo two full night sleep studies with the Transcend Auto and a commercially available device.

Eligibility criteria: Inclusion Criteria:

* Adult 18 years of age or older
* Diagnosis of obstructive sleep apnea
* Presently using CPAP or APAP therapy

Exclusion Criteria:

* Central or mixed apnea

Primary outcomes:
measure: Mean Apnea Hypopnea Index (AHI) During Treatment
timeFrame: first and second night sleep study
Secondary outcomes:
measure: Unanticipated Adverse Device Effects
timeFrame: first and second night sleep study
measure: Mean Differences Between Polysomnography (PSG) and Device Measures of Apnea Index (AI) and Hypopnea Index (HI)
timeFrame: first and second night sleep study
Other outcomes:
Locations:
city: Coon Rapids
country: United States
facility: Northwind Lung Specialists and Sleep Center
state: Minnesota
city: Plymouth
country: United States
facility: Whitney Sleep Center
state: Minnesota
city: San Antonio
country: United States
facility: Sleep Therapy and Research Center
state: Texas
Study officials:
affiliation: Sleep Therapy and Research Center
name: Eric Powell, PhD RPSGT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02827565: Technical Optimization of Detection of KRAS, BRAF and NRAS Mutations on Tumor DNA Circulating in Metastatic Colorectal Cancer
Official title: Prospective Study of Technical Optimization of the Detection of KRAS Mutations, BRAF and NRAS by Next Generation Sequencing on Tumor DNA Circulating in Metastatic Colorectal Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Colorectal Cancer
Keywords: colorectal cancer
Kras mutation
Nras mutation
Braf mutation
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The objective of this study is to optimize the search by next-generation sequencing (NGS) mutations in the KRAS, BRAF and NRAS on circulating tumor DNA and compare the genetic profiles obtained with those from tumors embedded in paraffin


Eligibility criteria: Inclusion Criteria:

* Patients with metastatic or locally advanced colorectal carcinoma with a KRAS, BRAF or NRAS mutation
* Age ≥ 18 years
* Patient information and written informed consent form signed
* Patient must be affiliated to a social security system

Exclusion Criteria:

* Patients whose health-cons indicates a blood sample 10mL
* Age \< 18 years
* Pregnant or breast feeding females
* Persons deprived of liberty or under supervision

Primary outcomes:
measure: Technical Optimization of KRAS, BRAF and NRAS mutations detection
timeFrame: 1 day
Secondary outcomes:
measure: KRAS, NRAS et BRAF mutational status
timeFrame: 1 day
Other outcomes:
Locations:
city: Vandoeuvre-lès-Nancy
country: France
facility: Institut de Cancerologie de Lorraine
Study officials:
affiliation: Institut de Cancérologie de Lorraine
name: GAVOILLE CELINE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut de Cancérologie de Lorraine
name: HARLE ALEXANDRE
role: STUDY_CHAIR
References:
Clinical trial NCT05218486: Effect of Oral Isotretinoin on The Level of SerumYKL40 in Acne Vulgaris Patients
Official title: Evaluation of The Effect of Oral Isotretinoin on The Level of Serum YKL40 in Acne Vulgaris Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acne Vulgaris
Lead sponsor: Aswan University
Sponsor class: OTHER
First posted: 2022-02-01
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to evaluate the effect of oral isotretinoin on SerumYKL40 in acne vulgaris patients.

Detailed description: Acne vulgaris is a common chronic inflammatory disease of the skin. It is found in about 80% of young adults and adolescents. It is a disease that affects the pilosebaceous units of the skin and may result in inflammatory or non-inflammatory lesions,Oral isotretinoin (13-cis-retinoic acid) is the only drug that counteracts all the pathogenetic mechanisms that contribute to the development of acne .The standard dose of isotretinoin is 0.5 to 1 mg/kg per day for 4 months to a cumulative dose of 120-140 mg/kg is effective in the management of acne vulgaris The scope of our study is to detect serum YKL-40 level in acne patient before and after oral isotretinoin treatment

Eligibility criteria: Inclusion Criteria:

1. Healthy persons of both sexes with moderate and severe acne.
2. Age above 14 years.

Exclusion Criteria:

1. Pregnant and lactating women, immunocompromised patients.
2. History of chronic liver disease, hyperlipidemia, non-inflammatory acne conditions, , history of neurologic disorders, history of neoplastic disorders, and history of cardiac disease.
3. History of systemic acne treatment for at least 4 weeks prior to inclusion and no topical treatments for at least 2 weeks.
4. Cases with known hypersensitivity reaction to isotretinoin.

Primary outcomes:
measure: Evaluation of the effect of oral isotretinoin on SerumYKL40 in acne vulgaris patients.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan university
Study officials:
References:
Clinical trial NCT01612286: Endostar Combination With Chemotherapy for the Metastatic Nasopharyngeal Carcinoma
Official title: A Phase II Clinical Study of Endostar Combination With Chemotherapy in the Metastatic Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Keywords: Recombinant human endostatin
nasopharyngeal carcinoma
chemotherapy
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2012-06-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators designed this study to evaluate the efficiency and the acute toxicities of recombinant human endostatin (endostar) combined with chemotherapy in the metastatic nasopharyngeal carcinoma (NPC).

Detailed description: To evaluate the progression free survival (PFS), overall survival (OS), Acute adverse reaction of recombinant human endostatin (endostar) combined with chemotherapy to the metastatic nasopharyngeal carcinoma (NPC).

Eligibility criteria: Inclusion Criteria:

* Diagnosed metastatic NPC patient who have received radiotherapy or chemoradiotherapy with an at least 6 months interval
* Have measurable lesions
* No dysfunction of the major organs
* Can understand this study and give a signed informed consent certificates
* without a history of allergic reaction to the biological agents

Exclusion Criteria:

* Pregnant or lactating women; Women of child-bearing age without contraception
* with a Serious infection or dysfunction of the major organs
* have taken other antitumor drugs during the period of 30 days ahead of this clinical trial
* allergic to the Escherichia coli preparations
* Cann't understand this study and give a signed informed consent certificates

Primary outcomes:
measure: progress free survival(PFS)
timeFrame: 1 year and 2years
Secondary outcomes:
measure: overall survival(OS)
timeFrame: baseline to date of death from any cause
measure: Adverse events
timeFrame: participants will be followed for the duration of hospital stay,an expected average of 100 days and every 3 months thereafter for 1 year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang cancer hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Bin Li
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jin T, Li B, Chen XZ. A phase II trial of Endostar combined with gemcitabine and cisplatin chemotherapy in patients with metastatic nasopharyngeal carcinoma (NCT01612286). Oncol Res. 2013;21(6):317-23. doi: 10.3727/096504014X13983417587401.
Clinical trial NCT01201486: Use of Color Doppler in Routine Examination of Fetal Heart in Second Trimester
Official title: Use of Color Doppler in Routine Examination of Fetal Heart in Second Trimester.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Defects
Keywords: Ultrasound
Pregnancy
Fetal heart defects
Color doppler
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
First posted: 2010-09-14
Enrollment: 6781
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women for routine examination in the 2nd trimester.

Brief summary: To evaluate the percentage of severe heart defect diagnosed with the use of color Doppler at a routine fetal scan in the second trimester of pregnancy

Detailed description: Almost all women in Norway have a routine ultrasound examination in the second trimester, however, the detection rate of heart defect are only around 50%. In this study we use color Doppler at three different levels in the fetal heart; the four chamber view, the outlet of the aorta on on the level of the great arteries.

All heart defects at delivery are recorded and compared with the ultrasound findings.

Eligibility criteria: Inclusion Criteria:

* Pregnant
* 2nd trimester

Exclusion Criteria:

* Unwilling

Primary outcomes:
measure: Sensitivity of Color Doppler Examination to Detect Major Heart Defects During the Second Trimester of Pregnancy
timeFrame: 2nd trimester
Secondary outcomes:
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: Stavanger University Hospital
Study officials:
affiliation: Helse Stavanger HF
name: Claudia Heien, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Helse Stavanger HF
name: Torbjørn M. Eggebø, MD
role: STUDY_DIRECTOR
References:
citation: Tegnander E, Eik-Nes SH, Johansen OJ, Linker DT. Prenatal detection of heart defects at the routine fetal examination at 18 weeks in a non-selected population. Ultrasound Obstet Gynecol. 1995 Jun;5(6):372-80. doi: 10.1046/j.1469-0705.1995.05060372.x.
citation: Chaoui R, McEwing R. Three cross-sectional planes for fetal color Doppler echocardiography. Ultrasound Obstet Gynecol. 2003 Jan;21(1):81-93. doi: 10.1002/uog.5.
citation: Eggebo TM, Heien C, Berget M, Ellingsen CL. Routine use of color Doppler in fetal heart scanning in a low-risk population. ISRN Obstet Gynecol. 2012;2012:496935. doi: 10.5402/2012/496935. Epub 2012 May 20.