louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01535586: A Randomized Cross Over Trial of Two Treatments for Obstructive Sleep Apnea in Veterans With Post Traumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Obstructive Sleep Apnea
Keywords: CPAP
MAD
sleep apnea
PTSD
Lead sponsor: The VA Western New York Healthcare System
Sponsor class: FED
First posted: 2012-02-17
Enrollment: 42
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: Sleep disturbances are cardinal features of Veterans with post traumatic stress disorder (PTSD). In particular, obstructive sleep apnea is reported to occur more frequently in patients with PTSD compared to those without PTSD and contribute to worsening cognitive and behavioral functions. Continuous positive airway pressure (CPAP) is considered the treatment of choice for OSA but adherence to CPAP in Veterans with PTSD is poor compared to the general population. The proposed study aims at comparing the efficacy, tolerability, and adherence of mandibular advancing devices-an alternative therapy to OSA- to CPAP. The study is instrumental in identifying the optimal OSA therapy for Veterans with PTSD and the OSA phenotype that would predict MAD response.


Eligibility criteria: Inclusion Criteria:

* • Consecutive patients aged 18-70 years of age

  * Documented obstructive sleep apnea by polysomnography (AHI≥5 or more/hr)
  * Established diagnosis of PTSD related to any past lifetime traumatic event and have a diagnosis of current, chronic PTSD

Exclusion Criteria:

* • Central sleep apnea defined as central apnea/hypopnea \>50% of the total respiratory events

  * Prior treatment for sleep apnea
  * Veterans with fewer than 4 teeth remaining in either arch
  * Coexisting narcolepsy
  * Tempo-mandibular joint disease
  * Epilepsy
  * Prominent suicidal or homicidal ideation
  * Diagnosis of dementia

Primary outcomes:
measure: Efficacy
timeFrame: 12 weeks
Secondary outcomes:
measure: Adherence
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04398186: The Effect of Polycystic Ovary Syndrome on Pelvic Floor Structure and Function
Official title: The Effect of Polycystic Ovary Syndrome on Pelvic Floor Structure and Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Reproductive System Disorder
Urinary Incontinence
Urogenital Disease
Polycystic Ovary Syndrome
Keywords: polycystic ovary syndrome
urinary incontinence
anogenital distance
Lead sponsor: Giresun University
Sponsor class: OTHER
First posted: 2020-05-21
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Reproductive aged females, age between 18-40 yrs.

Brief summary: Polycystic Ovarian Syndrome (PCOS) is the most common endocrinological disorder in women of reproductive age, and its prevalence is reported to be 6-21% in women aged 15-49 (1). Although its etiopathogenesis is still not clear, it is known that it is due to the disregulation of ovarian steroidogenesis under the influence of some environmental and genetic factors. Diagnosis of ESHRE / ASRM has set Rotterdam criteria in 2003; one of these criteria is the presence of hyperandrogenism (2). Hyperandrogenism leads to an increase in general muscle mass in the body (1, 3, 4).

Pelvic floor muscles are associated with urethra in the anterior compartment, rectum and anus in the posterior compartment, and uterine support in the apex; major urinary and fecal continence ensuring its functions in order to stop in the appropriate position of the pelvic organs (5). The well-being of the pelvic floor muscle strength has a protective effect from urinary and fecal incontinence.

It has been emphasized that the "anogenital distance" determined by the measurement of the anal region anterior to the clitoris anterior may also be a criteria in the diagnosis of Polycystic Ovary Syndrome (7,8,9).

In this study, patients in the reproductive age between 18-40 years, who applied to our gynecology outpatient clinic and were diagnosed as PCOS according to Rotterdam criteria wil be study gorup and the women without PCOS will be control group. We aimed to evaluate the pelvic muscle strength with perineometry, to measure anogenital distance and to determine possible relationships with each other. In addition to demographic information, ICIQ-SF (Urinary incontinence inquiry short form) will also be taken to evaluate pelvic floor function (10).


Eligibility criteria: Inclusion Criteria:

* Nulliparity

Exclusion Criteria:

* Endocrine disorders
* Anabolic drug usage Multiparity

Primary outcomes:
measure: Anogenital distance measurement in PCOS
timeFrame: 01.06.2020- 01.11.2020
Secondary outcomes:
Other outcomes:
Locations:
city: Giresun
country: Turkey
facility: Sebnem Alanya Tosun
Study officials:
References:
Clinical trial NCT00637286: ZAP, US. Zomig for Appropriate for Primary Care
Official title: A Multicenter, Open-Label Study Using the MIDAS Questionnaire to Assess the Effect of Using the HCPC Guidelines for Migraine Management in Primary Care, Including the Use of Zomig-ZMT (Zolmitriptan) Orally Disintegrating Tablets 5.0mg and Zomig Nasal Spray 5.0mg as Indicated.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine
Keywords: Zolmitriptan
ZOMIG
migraine
headache response
headache
headache pain
MIDAS
HCPC
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine how useful and effective the use of ZOMIG-ZMT™ (zolmitriptan) 5.0 mg and ZOMIG® Nasal Spray (zolmitriptan) 5.0 mg is for patients, in treating migraine over a period of 6 months


Eligibility criteria: Inclusion Criteria:

* Have an established diagnose of migraine as with an age at onset of less than 50 years
* Have experienced an average of at least 1 migraine headache per month in the previous three months
* Be able to differentiate between migraine and non-migraine headaches

Exclusion Criteria:

* Use of any triptan within the last 12 months or use of MAO-A inhibitors, methysergide or methylergonovine in the 2 weeks before entering the study.
* History of basilar, ophthalmoplegic or hemiplegic migraine headache or any potentially serious neurological condition that is associated with headache
* History, symptoms, or significant risk factors for ischaemic heart or other cardiovascular disease, including coronary vasospasm, cardiac accessory conduction pathways or arrhythmias or uncontrolled hypertension.

Primary outcomes:
measure: Change in Migraine Disability Assessment questionnaire (MIDAS) score
timeFrame: Twice within 28 weeks
Secondary outcomes:
measure: Explore patients assessment of value of zolmitriptan
timeFrame: Maximum of 3 times between 1 - 28 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00399386: Electrocardiogram (ECG) Recordings in Paediatric Population
Official title: ECG Recordings From EP Study, Defibrillator Implantation or Ablation Procedure in Paediatric Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arrhythmia
Keywords: S ICD
ICD
Ablation
EP study
Paediatric
ECG
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2006-11-14
Enrollment: 62
Sex: ALL
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: Pediatric patients at the Bristol Royal Hospital for Children

Brief summary: The primary goal of this protocol is to collect ECG signals from paediatric patients using 4 surface electrodes placed in the configurations proposed for the Cameron Health, Inc. subcutaneous implantable defibrillator (S-ICD) system. These signals will then be used to test the S-ICD system for future use in paediatric patients.

Detailed description: The surface ECGs collected from pediatric patients in normal sinus rhythm and a variety of ventricular and atrial arrhythmias will be used as test signals for the development of the S-ICD system. These signals will be collected from patients undergoing electrophysiology (EP) study, transvenous defibrillator implantation or ablation procedures

Eligibility criteria: Inclusion Criteria:

* Patients \< 18 years of age
* Patient scheduled for an EP study, implantation of an ICD or for an ablation procedure

Exclusion Criteria:

* Patients whose parents/guardians do not sign an informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: Bristol Childrens' Hospital
state: Avon
Study officials:
affiliation: Bristol Childrens' Hospital
name: Graham Stuart, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00982163: A Single-Center Evaluation of the Pattern of Allergic Signs and Symptoms During 4 Weeks in Ragweed Season
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergic Conjunctivitis
Lead sponsor: ORA, Inc.
Sponsor class: INDUSTRY
First posted: 2009-09-23
Enrollment: 34
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: A community sample of subjects with allergic conjunctivitis and at least 18 years of age were enrolled into the study.

Brief summary: The study was designed to evaluate the pattern of seasonal allergic signs and symptoms consistent with ongoing ocular allergic inflammation during ragweed season. It was hypothesized that a pattern of ongoing ocular allergic inflammation existed in certain subjects.

Detailed description: Subjects who had a positive skin test to ragweed within 24 months of Visit 1 were instructed to complete a diary, which assessed their allergic signs and symptoms 3 times a day for 4 weeks. During the in-office visits, subjects were asked to completed a quality of life questionnaire, as well as a retrospective and/or prospective eye allergy questionnaire.

Eligibility criteria: Inclusion Criteria:

* Subjects must:

  1. be willing and able to read, sign, and date the informed consent and HIPAA documents prior to initiation of Visit 1 procedures or exams;
  2. be at least 18 years of age;
  3. be willing to avoid disallowed medication, such as anti-allergy therapies
  4. have a positive history of ocular allergies and a positive skin test reaction to ragweed within the past 24 months;
  5. have a calculated logMAR visual acuity score using the ETDRS Chart of 0.60 or better in each eye at Visit 1;

Exclusion Criteria:

* Subjects may not:

  1. have preauricular lymphadenopathy or any ocular condition that could affect study parameters (particularly, clinically significant blepharitis, follicular conjunctivitis and iritis);
  2. have had any ocular infection within the last 30 days;
  3. have a positive diagnosis of moderate to severe dry eye syndrome (i.e., requiring daily use of artificial tears);
  4. wear contact lenses to each office visit; Note: Subjects will be allowed to use cold compresses.

Primary outcomes:
measure: Diary Data
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: North Andover
country: United States
facility: ORA, Inc.
state: Massachusetts
Study officials:
affiliation: ORA, Inc.
name: H. Jerome Crampton, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01026363: hCAP18 Levels and Vitamin D Deficiency in Chronic Kidney Disease
Official title: hCAP18 Levels and Vitamin D Deficiency in Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Kidney Disease
Vitamin D Deficiency
Keywords: Vitamin D
Chronic Kidney Disease
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: National Kidney Foundation, United States
First posted: 2009-12-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The human immune system produces a protein called hCAP18 (also known as LL-37 or cathelicidin). This protein is believed to help the body to fight infections. Studies suggest that vitamin D may important in the production of hCAP18. This study is designed to test the ability of two different forms of vitamin D to affect levels of hCAP18. Vitamin D and hCAP18 levels will be measured during an initial visit. Individuals who are vitamin D deficient will be randomly assigned to receive one of two forms of vitamin D for two weeks. After this, follow-up levels will be measured.


Eligibility criteria: Inclusion Criteria:

* Age 18-80
* Chronic Kidney Disease stage 3-4 (estimated glomerular filtration rate 15-60 ml/min)

Exclusion Criteria:

* 6 month history of hypercalcemia, hyperphosphatemia, or nephrolithiasis
* use of active vitamin D analog within 30 days
* functioning renal transplant
* Symptoms of active infection
* Granulomatous disorders

Primary outcomes:
measure: hCAP18 levels
timeFrame: 2 weeks
Secondary outcomes:
measure: 1,25-dihydroxyvitamin D
timeFrame: 2 weeks
measure: 25-hydroxyvitamin D
timeFrame: 2 weeks
measure: calcium
timeFrame: 2 weeks
measure: phosphorus
timeFrame: 2 weeks
measure: Parathyroid hormone
timeFrame: 2 weeks
measure: T-cell subsets
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Massachusetts Institute of Technology
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital, Massachusetts Institute of Technology
name: Ishir Bhan, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gombart AF, Bhan I, Borregaard N, Tamez H, Camargo CA Jr, Koeffler HP, Thadhani R. Low plasma level of cathelicidin antimicrobial peptide (hCAP18) predicts increased infectious disease mortality in patients undergoing hemodialysis. Clin Infect Dis. 2009 Feb 15;48(4):418-24. doi: 10.1086/596314.
Clinical trial NCT06698263: 13-cis Retinoic Acid (Isotretinoin) and Sperm Production
Official title: 13-cis Retinoic Acid (Isotretinoin) and Sperm Production
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Men with Infertility
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 100
Sex: MALE
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the effectiveness of weekly administration of isotretinoin (40 mg) in increasing sperm production in men with oligozoospermia, a condition characterized by a low sperm count. Participants will be randomized into two groups: one receiving isotretinoin and the other a placebo. The primary outcome will be the change in sperm production over 20 weeks of treatment.


Eligibility criteria: Inclusion Criteria:

* Subjects will be infertile men (no pregnancy with partner with normal cycles and normal hysterosalpingogram despite \>1 year of unprotected intercourse).
* Abnormal sperm analyses with a total, motile sperm count of less than 10 million sperm as assessed by semen analysis on two occasions separated by one week.
* Male patients aged 21-55 years
* Affiliation with a social security system
* Ability to provide informed consent

Exclusion Criteria:

* -Men participating in another clinical trial
* Clinically significant abnormal findings at screening
* Known genetic infertility (e.g. Klinefelter syndrome or Y-chromosome microdeletions),
* Hypogonadotropic hypogonadism (that might respond to gonadotropin injections),
* Severe mental health problems requiring medications
* Current therapy with retinoic acid (e.g. Accutane) or vitamin A.
* History of psychiatric disorders (e.g., depression, suicidal tendencies).
* Abnormal serum chemistry values according to local laboratory normal values which indicate liver or kidney dysfunction.
* Men currently receiving tetracycline containing medications
* Men who have used isotretinoin within eight weeks of the start of dosing
* Men with elevated serum triglycerides

Primary outcomes:
measure: Millions of Sperm Per Ejaculate
timeFrame: Day 0
measure: Millions of Sperm Per Ejaculate
timeFrame: Months 2
measure: Millions of Sperm Per Ejaculate
timeFrame: Months 5
measure: Millions of Sperm Per Ejaculate
timeFrame: Months 12
measure: Millions of Sperm Per Ejaculate
timeFrame: Months 24
Secondary outcomes:
Other outcomes:
Locations:
city: Schiltigheim
country: France
facility: CECOS Alsace Strasbourg
Study officials:
References:
Clinical trial NCT02425163: Shear Wave Elastography of Prostate Cancer
Official title: Shear Wave Elastography of Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Shear Wave Elastography
Prostate
Prostate Biopsy
Lead sponsor: University of Magdeburg
Sponsor class: OTHER
First posted: 2015-04-23
Enrollment: 73
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Evaluation of significant Shear Wave Elastography Parameters for Prostate Biopsy and Prostate Cancer detection.

Detailed description: This Study will evaluate the Shear Wave Elastography (SWE) Parameters for Prostate Biopsy and Prostate Cancer detection.

Eligibility criteria: Inclusion Criteria:

* Suspicious for prostate cancer with no pretreatment and Prostata specific Antigen (PSA) \>4ng/ml or PSA velocity \> 0.75 ng/ml per year or suspicious transrectal digital examination
* Status after external beam radiotherapy of the prostate in localized prostate cancer and suspicious for local prostate cancer recurrence

Exclusion Criteria:

* None.

Primary outcomes:
measure: Shear wave elastography
timeFrame: 12 Months
Secondary outcomes:
measure: Differentiation of Entity by Elastography
timeFrame: 12 Months
measure: Differentiation of benign tissue elasticity depending on prostate Location (Basis, Mid, Apex)
timeFrame: 12 Months
measure: Differentiation of Prostate cancer malignity by Elastography
timeFrame: 12 Months
measure: Histopathological Analysis
timeFrame: 12 Months
Other outcomes:
Locations:
city: Magdeburg
country: Germany
facility: Department of Urology University Hospital Otto-von-Guericke-University Magdeburg
state: Sachsen-Anhalt
Study officials:
affiliation: Urologische Klinik, Otto-von-Guericke University Magdeburg
name: Martin Schostak, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Correas JM, Tissier AM, Khairoune A, Vassiliu V, Mejean A, Helenon O, Memo R, Barr RG. Prostate cancer: diagnostic performance of real-time shear-wave elastography. Radiology. 2015 Apr;275(1):280-9. doi: 10.1148/radiol.14140567. Epub 2014 Nov 19.
Clinical trial NCT01021163: Effects of N-acetylcysteine on Pulmonary Function in High-risk Patients Undergoing Off-pump Coronary Bypass Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Occlusion
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2009-11-26
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to study the effects of N-acetylcysteine on pulmonary function in high-risk patients undergoing off-pump coronary bypass surgery.


Eligibility criteria: Inclusion Criteria:

* Adult patients with Euroscore ≥ 5

Exclusion Criteria:

* Patients in need of emergency surgery,acute renal failure patients, kidney transplanted patients, patients injected with NAC 5days before planned surgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT02741063: Oxytocin Effect on Attentional Bias Towards Emotional Expression Faces in Individuals With High and Low Autistic Traits: A Functional Magnetic Resonance Imaging (fMRI) Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Healthy
Keywords: oxytocin
attentional bias
Autism
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2016-04-18
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: to investigate whether oxytocin alter attentional bias towards emotional expression faces in individuals with high and low autistic traits, and the brain mechanism of this effect

Detailed description: In the present study, investigator plan to use a double-blind, between-subject placebo controlled design.Firstly, all healthy male subjects' autistic trait levels will be assessed by the Autism Spectrum Quotient (ASQ) and only subjects with higher or lower ASQ score will be recruited in the next experiment and divided into high and low subgroup. Then, subjects are randomly assigned to receive either intranasal administration of oxytocin (24 IU) or placebo. 45 min later, subject need to complete an attentional bias task named rapid serial visual presentation (RSVP) task in fMRI scanner.

Eligibility criteria: Inclusion Criteria:

* healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

* history of head injury;
* claustrophobia;
* medical or psychiatric illness.

Primary outcomes:
measure: attentional bias toward emotional expression faces
timeFrame: 1 hour
Secondary outcomes:
measure: brain activity during RSVP task
timeFrame: 1 hour
Other outcomes:
Locations:
city: Chengdu
country: China
facility: China, Sichuan
state: Sichuan
Study officials:
affiliation: University of Electronic Science and Technology of China
name: Keith Kendrick, Dr.
role: PRINCIPAL_INVESTIGATOR
References: