louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01202123: Post Marketing Surveillance of MENOPUR
Official title: Post Marketing Surveillance of MENOPUR
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-09-15
Enrollment: 2501
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infertile women

Brief summary: The purpose of this study is to evaluate the safety and efficacy of highly purified (HP) menotrophine to Korean women.


Eligibility criteria: Inclusion Criteria:

* Anovulation in women (WHO group II)
* Controlled ovarian hyperstimulation cases for ART

Exclusion Criteria:

* Hypersensitivity to MENOPUR
* Pregnancy, lactation or contraindication to pregnancy
* Ovarian cysts not related to polycystic ovarian syndrome
* Abnormal uterine bleeding
* Tumors in uterus, ovaries and breasts
* Ovarian hyperstimulation syndrome
* Thromboembolism or history of it
* Infertile due to other reason than anovulation
* High FSH level indication primary ovarian failure

Primary outcomes:
measure: Number of follicles per cycle
timeFrame: Up to 6 weeks
Secondary outcomes:
measure: Number of adverse events
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Miz Women's Hospital
state: Daejeon Metropolitan City
city: Bucheon
country: Korea, Republic of
facility: Seoul´s Women´s Hospital
state: Gyeonggi Province
city: Ilsan
country: Korea, Republic of
facility: Ilsan Maria Hospital
state: Gyeonggi Province
city: Kwangju
country: Korea, Republic of
facility: Premedi Women's Clinic
state: Kwangju Metropolitan City
city: Gumi
country: Korea, Republic of
facility: Gumi CHA University Medical Center
state: Kyoungbuk Province
city: Ulsan
country: Korea, Republic of
facility: Mama Papa & Baby Hospital
state: Kyoungnam Province
city: Busan
country: Korea, Republic of
facility: Busan Maria hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Maria
city: Daejeon
country: Korea, Republic of
facility: Daejeon Maria
city: Daejeon
country: Korea, Republic of
facility: Daejeon Seoul Women Hospital
city: Daejeon
country: Korea, Republic of
facility: Ellemedi Women Clinic
city: Incheon
country: Korea, Republic of
facility: Incheon Seoul women Hospital
city: Seoul
country: Korea, Republic of
facility: Cheil General Hospital & Women's Healthcare Center
city: Seoul
country: Korea, Republic of
facility: Gangseo Mizmedi Hospital
city: Seoul
country: Korea, Republic of
facility: Hamchoon women clinic
city: Seoul
country: Korea, Republic of
facility: Maria Plus Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Songnae Maria Hospital
city: Seoul
country: Korea, Republic of
facility: Maria Hospital
state: ´Shinseoul-dong, Dongdaemun-gu
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
Clinical trial NCT01085123: Determine Central 5-HT1B Receptor Occupancy of ZOMIG® Rapimelt (Zolmitriptan) in Healthy Male Volunteers
Official title: An Open Label, Positron Emission Tomography (PET) Study With [11C]AZ10419369 to Determine Central 5-HT1B Receptor Occupancy of ZOMIG® Rapimelt (Zolmitriptan) in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Migraine
Keywords: Migraine
ZOMIG® Rapimelt
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-03-11
Enrollment: 10
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the central 5-HT1B receptor occupancy of ZOMIG® Rapimelt (zolmitriptan) in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Body mass index between ≥19 and ≤30 kg/m2.

Exclusion Criteria:

* A history or presence of neurological, haematological, psychiatric, gastrointestinal, hepatic, pulmonary, renal disease
* Use of drugs that induce the liver drug metabolising enzymes within 4 weeks before first PET

Primary outcomes:
measure: To determine zolmitriptan and/or its active metabolite 183C91 occupancy at 5-HT1B receptors in the living human brain
timeFrame: The first PET measurement will serve as a baseline assessment. The second, third and fourth PET measurements will be performed after oral administration of ZOMIG® Rapimelt (10 mg, 5 mg and 2.5 mg, respectively).
Secondary outcomes:
measure: To describe the relation between Zomig® Rapimelt dose and 5-HT1B receptor occupancy
timeFrame: The second, third and fourth PET measurements will be performed after oral administration of ZOMIG® Rapimelt (10 mg, 5 mg and 2.5 mg, respectively). Imaging data analysis will be performed after each PET measurement
measure: To describe the relation between plasma concentrations of zolmitriptan and 183C91 and 5-HT1B receptor occupancy
timeFrame: For each of 3 visits venous blood for zolmitriptan and 183C91 PK analyses taken before drug administration and at 3 time points during PET examination: start, middle and end, ie, at 0, +30 and + 63 minutes relative to injection of the radioli
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Stephen Kanes
role: STUDY_DIRECTOR
affiliation: Quintiles AB Phase I Services
name: Wolfgang Kühn
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Brendan Smyth
role: STUDY_CHAIR
References:
Clinical trial NCT01428323: Study of the Aerosol Deposition With Vented and Unvented Jet Nebulizer in Healthy Subjets
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aerosol Drug Therapy
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
Collaborators: name: Fonds National de la Recherche Scientifique
First posted: 2011-09-02
Enrollment: 7
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Open-vent jet nebulizers are frequently used to promote drug lung deposition but their clinical efficacy and indications are not clear.

Our study aimed to compare inhaled mass, and lung deposition of amikacin by using a jet nebulizer (Sidestream) under two different configurations: vented and unvented coupled to a 110 ml corrugated piece of tubing.


Eligibility criteria: Inclusion Criteria:

* Healthy Volunteers between 18 and 60 years old

Exclusion Criteria:

* Smokers
* Pathological spirometry
* History of treatment with aminoglygosides 1 month prior the study
* Known allergy to aminoglycosydes
* Any lung pathology or history of lung surgery

Primary outcomes:
measure: Amikacin Urinatory excretion
timeFrame: Each miction during 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
Study officials:
References:
Clinical trial NCT01104623: ADHD - Voice Analysis, Vocal Acoustic Biomarkers in Attention Deficit Hyperactivity Disorder
Official title: Phase 1 Study of Vocal Acoustic Biomarkers in Attention Deficit Hyperactivity Disorder (ADHD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Attention-Deficit/Hyperactivity Disorder
Keywords: ADHD
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: MediTECH Electronic GmbH
name: AudioProfiling, Dr. Joerg Langner
First posted: 2010-04-15
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: German speaking: Adults, age 18-50 years.

Brief summary: The purpose of this study is to detect specific vocal acoustic patterns in the voice of attention deficit hyperactivity disorder (ADHD) patients.

Detailed description: This project aims to develop an objective diagnostic instrument for ADHD through an automatic voice-analysis system, which uses as input the natural speech of the participants. The underlying voice-analysis procedure was developed by J. Langner at Humboldt University of Berlin (Langner 2003). It ignores the semantic content of spoken words and extracts prosodic and sound features from the speech.

Aims of the study:

* deliver optimized multivariate logistic regression models of prosodic and sound properties of speech for ADHD.
* observe sensitivity and specificity of the voice-analysis procedure.

Eligibility criteria: Inclusion Criteria:

1. Age 18-50.
2. Written informed consent.
3. Adult ADHD / Non-ADHD according to the fourth version of the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV)
4. Normal vocal functioning, negative history for voice or laryngeal disorders.
5. Currently euthyroid condition; in case of past history of thyroid disease and need for current pharmacological treatment, patient needs to be on stable medication for at least 4 weeks.

Exclusion Criteria:

1. Exclusion of borderline and antisocial personality disorder, assessed by the German version of the SCID-II (Fydrich et al., 1997).
2. Exclusion of schizophrenia and psychotic disorders not otherwise specified.
3. Exclusion of Epilepsia.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Center for ADHD Research, Department of Psychiatry, Charite - University Medicine
Study officials:
affiliation: Center for ADHD Research, Department of Psychiatry, Charite - University Medicine Berlin
name: Michael Colla, PhD
role: STUDY_CHAIR
References:
citation: Hamdan AL, Deeb R, Sibai A, Rameh C, Rifai H, Fayyad J. Vocal characteristics in children with attention deficit hyperactivity disorder. J Voice. 2009 Mar;23(2):190-4. doi: 10.1016/j.jvoice.2007.09.004. Epub 2007 Dec 21.
citation: Banse R, Scherer KR. Acoustic profiles in vocal emotion expression. J Pers Soc Psychol. 1996 Mar;70(3):614-36. doi: 10.1037//0022-3514.70.3.614.
Clinical trial NCT01761123: Immunogenicity of Seasonal Influenza by Delivery Directly to Ileum
Official title: An Open Label Phase I Substudy to Evaluate the Safety and Ability to Enhance Immunogenicity of VXA-A1.1 by Delivery Directly to the Ileum Using the InteliSite Companion Capsule in Healthy Adult Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Seasonal Influenza
Keywords: Prevention of Influenza
Lead sponsor: Vaxart
Sponsor class: INDUSTRY
First posted: 2013-01-04
Enrollment: 37
Sex: MALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: the purpose of the study is to determine the safety and tolerability of VXA-A1.1, an adjuvanted adenoviral based influenza vaccine, when delivery is targeted to the ileum, using a radio controlled capsule. The secondary objective is to evaluate the immune response (cellular and humoral) of two doses of VXA-A1.1 oral vaccine.


Eligibility criteria: Inclusion Criteria:

* Able and willing to complete informed consent
* Healthy, as established by medical history, physical exam, and laboratory assessments
* Has normal bowel movements
* Willing to abstain from caffeine and xanthine containing substances for 24 hours before procedure until after discharge

Exclusion Criteria:

* Not able to donate up to 550 ml of blood over several months
* Exposure to an investigational drug or vaccine 8 weeks prior to study
* Abnormal ECG findings
* History of irritable bowl or any other inflammatory gastrointestinal disorder
* Any individual with increased risk for bowl obstruction
* Radiation exposure above target values 50 mSv within the past 30 days or a cumulative dose above 150 mSV in the past 12 months
* History of substance abuse
* Subject unwilling to use an approved method of contraception during study and for 2 months after study
* Positive for HCV, HIV, or HBV
* Presence of implantable device that is sensitive to radio frequencies ( e.g. pacemakers)
* History of autoimmune disorder, or an immunosuppressive disorder
* Stool sample with occult blood at baseline
* Any other medical, psychiatric, social condition, or occupation, in the judgement of the investigator is a contraindication to the compliance of the protocol or informed consent

Primary outcomes:
measure: Safety
timeFrame: 1 year
Secondary outcomes:
measure: Immunogenicity
timeFrame: 1 year
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Scintipharma
state: Kentucky
Study officials:
affiliation: Scintipharma
name: Walter Doll, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vaxart, Inc.
name: David Liebowitz, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01102023: Effect of Solar Salt Diet in Elderly Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Sponsor class: OTHER
Collaborators: name: Mokpo National University
name: the ministry of knowledge economy
First posted: 2010-04-12
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT

Brief summary: High sodium intake causes hypertension. Various efforts for reducing salt consumption are proceeding all over the world. Solar salt contains reduced sodium and abundant mineral, such as calcium, potassium, and magnesium, comparing to ordinary salt. Use of solar salt, instead of ordinary salt, may have beneficial effects to blood pressure.

The investigators are going to conduct a preliminary study that can support antihypertensive effect of solar salt intake.


Eligibility criteria: Inclusion Criteria:

* above 50 years elderly hypertensive patients
* possible oral intake

Exclusion Criteria:

* dementia, GDS\>6
* terminal cancer patient

Primary outcomes:
measure: Blood pressure
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Lohas-clover silver hospital
Study officials:
References:
Clinical trial NCT00316823: Genetic Analysis in Diagnosing Thyroid Cancer in Patients With Thyroid Nodules
Official title: Gene Expression Analysis in Thyroid Nodule FNA Samples
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Keywords: thyroid cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-04-21
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: DIAGNOSTIC

Brief summary: RATIONALE: Finding genetic markers for thyroid cancer in a biopsy specimen may help doctors diagnose thyroid cancer.

PURPOSE: This clinical trial is studying how well genetic analysis works in diagnosing thyroid cancer in patients with thyroid nodules.

Detailed description: OBJECTIVES:

* Evaluate the diagnostic accuracy of biomarkers and mRNA expression analysis using fine-needle aspiration (FNA) biopsy samples from patients with thyroid nodules.
* Correlate the level of gene expression with the aggressiveness of differentiated thyroid cancer in FNA biopsy samples.

OUTLINE: Patients undergo fine-needle aspiration (FNA) biopsy as part of routine care. Additional thyroid tissue is collected during the biopsy for gene expression analysis. Patients who have already had a biopsy undergo FNA biopsy during thyroidectomy.

Tissue samples will be examined for gene expression by reverse transcriptase-polymerase chain reaction (PCR), real-time quantitative PCR, and immunohistochemistry.

PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of a thyroid nodule that requires fine-needle aspiration biopsy or thyroidectomy to exclude a diagnosis of thyroid cancer

PATIENT CHARACTERISTICS:

* Platelet count ≥ 70,000/mm\^3
* PT (INR) ≤ 14.5
* PTT ≤ 35.2
* Not pregnant

PRIOR CONCURRENT THERAPY:

* No aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) 7 days before sample procurement

Primary outcomes:
measure: Diagnostic accuracy of biomarkers by mRNA expression analysis
measure: Correlate levels of gene expression with the aggressiveness of differentiated thyroid cancer in FNA biopsy samples
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Helen Diller Family Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Electron Kebebew, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00886223: Laparoscopic Sacropexy With Robot-Assisted Surgical System
Official title: Laparoscopic Sacropexy: Clinical Prospective Study With Robot-Assisted Technique(da Vinci®-System)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vaginal Vault Prolapse
Keywords: vaginal vault prolapse repair
robot-assisted laparoscopic sacropexy
robot-assisted laparoscopic sacrocolpopexy
robotic laparoscopic sacropexy
Lead sponsor: Kantonsspital Aarau
Sponsor class: OTHER
First posted: 2009-04-22
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate safety and outcome of robot-assisted laparoscopic sacropexy regarding perioperative data, objective anatomical results and postoperative quality of life.

Detailed description: Vaginal vault prolapse is a common finding in Gynecology. Many different approaches for vaginal vault prolapse repair are available. During the last few years robot-assisted surgery has been introduced in many surgical specialties and experiences in gynecologic surgery are very limited.

Several aspects like the wider range of motion of robot-instruments leading to more precision in surgery, the 3 dimensional optical system and the ergonomically designed console may offer some advantages. For better judgment these possible benefits as well as safety and outcome need to be evaluated and compared with conventional laparoscopic sacropexy techniques.

This prospective clinical study evaluates robot-assisted laparoscopic sacropexy (da Vinci®-System) focusing on peri-operative data, objective anatomical results and postoperative quality of life and compares the results with conventional laparoscopic sacropexy. Pre- peri- and post-operative data are collected using the prolapse quantification system (POP-Q) and the German Pelvic Floor questionnaire. The objective of the study will be to investigate if the robot assisted procedure shows significant advantages for the patient considering duration of surgery, complications, hospitalization, quality of life and costs.

Eligibility criteria: Inclusion Criteria:

* vaginal vault prolapse
* recurrence after vaginal prolapse repair
* signed consent

Exclusion Criteria:

* rectocele
* BMI \> 40

Primary outcomes:
measure: Duration of surgery
timeFrame: during hospitalisation
Secondary outcomes:
measure: Complications
timeFrame: 6 months after hospitalisation
measure: Anatomical results
timeFrame: 6 months after hospitalisation
measure: Quality of life
timeFrame: 6 months after hospitalisation
measure: Costs
timeFrame: 6 months after hospitalisation
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
Study officials:
affiliation: Kantonsspital Aarau, Department of Obsterics and Gynecology
name: Dimitri Sarlos, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01146223: Biomarkers in Bone Marrow Samples From Patients With Acute Promyelocytic Leukemia
Official title: Observational - WT-1's Role in Leukemogenesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adult Acute Myeloid Leukemia
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Adult Acute Promyelocytic Leukemia (M3)
Childhood Acute Promyelocytic Leukemia (M3)
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-06-17
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: acute promyelocytic leukemia

Brief summary: This research study is studying biomarkers in patients with acute promyelocytic leukemia. Studying samples of bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and about biomarkers related to cancer.

Detailed description: OBSERVATIONAL STUDY MODEL: Case-only TIME PERSPECTIVE: Retrospective BIOSPECIMEN RETENTION: Samples With DNA BIOSCPECIMEN DESCRIPTION: Bone marrow STUDY POPULATION DESCRIPTION: Primary Care Clinic SAMPLING METHOD: Non-Probability Sample

PRIMARY OBJECTIVES:

I. To measure WT1 and VEGF-1 expression in patients with acute promyelocytic leukemia.

OUTLINE: This is a multicenter study.

Patient mRNA samples from diagnosis are analyzed via quantitative PCR to measure WT1 and VEGF-1 expression.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of acute promyelocytic leukemia \[t(15;17) translocation\]
* Not specified
* Not specified

Primary outcomes:
measure: WT1 and VEGF-1 expression
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Monrovia
country: United States
facility: Children's Oncology Group
state: California
Study officials:
affiliation: Children's Oncology Group
name: Mustafa Moazam, MD
role: PRINCIPAL_INVESTIGATOR
References: