louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02338219: Effects of Pregnancy and Childbirth on Pelvic Floor Morphology and Sexual Function in Egyptian Women
Official title: Effects of Pregnancy and Childbirth on Pelvic Floor Morphology and Sexual Function in Egyptian Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Pregnancy, Childbirth and Puerperal Disorders
Keywords: postpartum pelvic floor
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2015-01-14
Enrollment: 120
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is t o evaluate levator ani morphology following normal vaginal delivery and cesarean section (elective and emergent), using three-dimensional (3D) ultrasound, and to study the effect of mode of delivery on female sexual function.

Detailed description: 1. transperineal pelvic floor ultrasound applied for the submitted 120 women "primiparae" (40 women after normal vaginal delivery), (40 women after urgent cesarean section), (40 women after elective cesarean section), in early postpartum period (48 to 72) hours postpartum, to evaluate levator ani morphology.
2. answering of the validated female sexual function index (F.S.F.I) three months postpartum period for same cases submitted to ultrasound.

Eligibility criteria: Inclusion Criteria:

* primiparae in early postpartum period (48 hours to72 hours). written consent was taken. easy communicable, reachable women for further requirements.

Exclusion Criteria:

* Refused consent. 2. Previous vaginal or cesarean delivery. 3. Severe mental illness. 4. Severe physical handicap or difficulties in communication. 5. Women without postpartum active sexual life or separate from their spouse. 6. Past history of sexual dysfunction.

Primary outcomes:
measure: Pelvic floor muscle strength as assessed by three/four dimensional translabial pelvic floor ultrasound had worst morbidity after normal vaginal delivery
timeFrame: early postpartum period (48 to 72) hours postpartum
Secondary outcomes:
measure: Sexual function of pelvic floor as assessed by the validated female sexual function index questionnaire was impaired in all women after delivery
timeFrame: at 3 months after delivery
Other outcomes:
Locations:
Study officials:
affiliation: Al-Azhar University
name: Mahmoud Edessy, prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Al-Azhar University
name: Muhamed Osman Osman
role: STUDY_CHAIR
References:
Clinical trial NCT00601419: Drug Use Investigation of Somatropin for GHD-ADULTS.
Official title: Drug Use Investigation of GENOTROPIN for GHD-ADULTS.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dwarfism, Growth Hormone Deficiency
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-01-28
Enrollment: 230
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients whom an investigator involving A6281286 prescribes the Somatropin.

Brief summary: Post marketing drug use investigation of Genotropin for GHD-ADULTS.

Detailed description: All the patients whom an investigator prescribes the first Somatropin should be registered consecutively until the number of subjects reaches target number.

Eligibility criteria: Inclusion Criteria:

The patients who were administered Somatropin to treat "Adult growth hormone deficiency (limited to severe type)".

Exclusion Criteria:

Patients not administered Somatropin.

Primary outcomes:
measure: Number of Participants With Treatment Related Adverse Events.
timeFrame: 6 month
measure: Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.
timeFrame: 6 month
measure: Number of Participants With Treatment Related Adverse Events of Somatropin: <65 Years of Age vs. >=65 Years of Age.
timeFrame: 6 month
measure: Number of Participants With Treatment Related Adverse Events of Somatropin by Gender.
timeFrame: 6 month
measure: Number of Participants With Treatment Related Adverse Events of Somatropin: With Thyroid Stimulating Hormone (TSH) Deficiency vs. Without TSH Deficiency.
timeFrame: 6 month
measure: Number of Participants With Treatment Related Adverse Events of Somatropin: With Past History of Any Disease vs. Without Past History of Any Disease.
timeFrame: 6 month
measure: Number of Participants With Treatment Related Adverse Events of Somatropin by Initial Dose of Somatropin.
timeFrame: 6 month
measure: Proportion of Participants Achieving Clinical Efficacy.
timeFrame: 6 month
measure: Proportion of Participants Achieving Clinical Efficacy: <65 Years of Age vs. >=65 Years of Age.
timeFrame: 6 month
measure: Proportion of Participants Achieving Clinical Efficacy by Gender.
timeFrame: 6 month
measure: Proportion of Participants Achieving Clinical Efficacy: With ACTH Deficiency vs. Without ACTH Deficiency.
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Morrhaye G, Kermani H, Legros JJ, Baron F, Beguin Y, Moutschen M, Cheynier R, Martens HJ, Geenen V. Impact of growth hormone (GH) deficiency and GH replacement upon thymus function in adult patients. PLoS One. 2009 May 22;4(5):e5668. doi: 10.1371/journal.pone.0005668.
Clinical trial NCT02486419: Human Neck Brown Adipose Tissue mRNA Profile, a Seasonal Variation Study.
Official title: Human Neck Brown Adipose Tissue mRNA Profile, a Seasonal Variation Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nonshivering Thermogenisis
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
First posted: 2015-07-01
Enrollment: 95
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted for neck surgery at Aarhus University Hospital.

Brief summary: The primary objective in this study is to examine the seasonal variation in genetic markers in the deep neck adipose tissue in humans.

Human adipose tissue biopsies are taken from patients admitted for elective surgery in the neck. During the surgical procedure a subcutaneous adipose tissue biopsy is taken for reference.

Detailed description: The knowledge of brown adipose tissue (BAT) is derived mainly from studies in rodents where cold is an important regulator of BAT development and function. Yet, little is known about the regulation of BAT in humans.

With this study the investigators aim to investigate the effects of seasonal changes in outdoor temperature on genetic markers of BAT in human deep neck adipose tissue.

Project participants are patients who are admitted to Aarhus University Hospital for elective neck surgery. Operations are primarily due to suspected malignancy in the thyroid gland or hyperparathyroidism.No additional surgery is necessary to obtain the biopsies.

Eligibility criteria: Inclusion Criteria:

* written concent

Exclusion Criteria:

-

Primary outcomes:
measure: Differences in gene expression in BAT associated genes (PGC1a, UCP1, CIDEA, PRDM16)
timeFrame: 1 day (The biopsies will be taken as a "point in time" value. Differences between seasons will be assesed. And so will correlations between genes at one point in time.)
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
state: Region Midtjylland
Study officials:
affiliation: Aarhus University Hospital
name: Bjørn Richelsen, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01562119: Long Term Evaluation of Human Acellular Dermal Matrix Allograft For Coverage of the Wound After Extensive Deep Burn
Official title: Long Term Evaluation of Human Acellular Dermal Matrix Allograft For Coverage of the Wound After Extensive Deep Burn
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Burn
Traumatic Implants
Keywords: Burns
Wound repair
Skin substitutes
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2012-03-23
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 52
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Thirty burn patients, treated by composite graft of ADM with autologous split-thickness skin from January 2007 to December 2009, were enrolled in this study.

Brief summary: The present study was to retrospectively evaluate the long-term outcomes of the cograft acellular dermal matrix (ADM) with autologous thin split-thickness skin for coverage of functional regional wounds in burned patients.

Detailed description: The potential of acellular dermal matrix (ADM) had been proved to improve cosmetic and functional outcomes, nevertheless, there had been few reports about the long term results of the morphological, histological and functional changes after placement. The present study was to retrospectively evaluate the long-term outcomes of the cograft acellular dermal matrix (ADM) with autologous thin split-thickness skin for coverage of functional regional wounds in burned patients.

Eligibility criteria: Inclusion Criteria:

* the patient's skin with ADM implant

Exclusion Criteria:

Primary outcomes:
measure: Function of the region covered by human acellular dermal matrix allograft
timeFrame: March, 2012 to May, 2013
Secondary outcomes:
measure: Physical characteristics of the transplanted human acellular dermal matrix allograft
timeFrame: March, 2012 to May, 2013
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department of Burn and Plastic Sugery, Tangdu Hospital
state: Shaanxi
Study officials:
affiliation: Department of Burn and Plastic Sugery
name: Xueyong Li, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04288219: Non-Invasive Positive Pressure Ventilation Management of High Altitude Pulmonary Edema
Official title: Non-Invasive Positive Pressure Ventilation Management of High Altitude Pulmonary Edema
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: High Altitude Pulmonary Edema
Non-Invasive Positive Pressure Ventilation
Hypoxia
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Himalayan Rescue Association
First posted: 2020-02-28
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Trial of Non-Invasive Positive Pressure Ventilation Management of High Altitude Pulmonary Edema

Detailed description: Patients in the Everest area will assessed for evidence of acute HAPE. Subjects will be randomized and assigned to standard care options or treatment with Non-Invasive Positive Pressure Ventilation.

Eligibility criteria: Inclusion Criteria:

* Healthy adults (age 18-80)
* Travel through Pheriche, Nepal
* Diagnosis of HAPE by symptoms, vital signs, and lung ultrasound

Exclusion Criteria:

* History of chronic respiratory conditions (asthma, COPD, ILD)
* Concomitant pneumonia or aspiration, cardiomyopathy, congestive heart failure
* Kidney disease
* Neurologic disorder
* Cognitive disorder
* Temporary altered mental status
* Use of phosphodiesterase inhibitors or nifedipine prior to diagnosis of HAPE
* Age under 18 or over 80
* Pregnancy

Primary outcomes:
measure: Oxygen saturation
timeFrame: Up to 4 hours
Secondary outcomes:
measure: Ultrasonographic assessment of pulmonary edema
timeFrame: Up to 4 hours
measure: Subjective rating of dyspnea
timeFrame: Up to 4 hours
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Himalayan Rescue Association
Study officials:
References:
Clinical trial NCT00947219: Treatment of Androgenic Alopecia in Males
Official title: A Randomized, Double-Blind, Control Device Clinical Trial to Evaluate the Safety and Efficacy of the HairMax LaserComb 2009, 9 & 12 Beam Models: For the Treatment of Androgenetic Alopecia in Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Androgenetic Alopecia
Hair Loss
Male Pattern Baldness
Keywords: Androgenetic Alopecia
Hair Loss
Male Pattern Baldness
Lead sponsor: Lexington International, LLC
Sponsor class: INDUSTRY
First posted: 2009-07-28
Enrollment: 79
Sex: MALE
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the change in terminal hair count at 16 and 26 weeks compared to baseline measurements.

Detailed description: This is randomized, double-blind, control device clinical study across 3 sites, evaluating changes in terminal hair-count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair).

The trial will involve approximately 75 male subjects who have been diagnosed with androgenetic alopecia, who are between 25 and 60 years of age, have Fitzpatrick Skin Types I-IV, with classifications of Norwood-Hamilton IIa to V, have active hair loss within the last 12 months.

Subjects will use the device on three non-consecutive days a week as directed per device for 26 weeks treatment duration.

Safety analysis will be assessed based on the reports of adverse events during study.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of androgenetic alopecia
* Fitzpatrick Skin Types I-IV
* Norwood-Hamilton IIa to V
* Active hair loss within last 12 months

Exclusion Criteria:

* Photosensitivity to laser light
* Malignancy in the target area

Primary outcomes:
measure: Changes in Terminal Hair Count at 16 and 26 Weeks Compared to Baseline in Men Diagnosed With Androgenetic Alopecia
timeFrame: baseline, 16 and 26 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: West Palm Beach
country: United States
facility: Abe Marcadis, M.D.
state: Florida
city: Hackensack
country: United States
facility: David Goldberg, M.D.
state: New Jersey
city: High Point
country: United States
facility: Zoe Draelos, M.D.
state: North Carolina
Study officials:
affiliation: High Point, NC
name: Zoe Draelos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Skin & Laser
name: David Goldberg, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Palm Beach Research
name: Abe Marcadis, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leavitt M, Charles G, Heyman E, Michaels D. HairMax LaserComb laser phototherapy device in the treatment of male androgenetic alopecia: A randomized, double-blind, sham device-controlled, multicentre trial. Clin Drug Investig. 2009;29(5):283-92. doi: 10.2165/00044011-200929050-00001.
Clinical trial NCT02578719: Greater Occipital Nerve (GON) Block Effectivity in the Treatment of Chronic Migraine: 6 Months Follow up
Official title: Placebo-Controlled Randomized Double Blind Trial of Blocking Greater Occipital Nerve Block With Bupivacaine Versus Saline in the Treatment of Chronic Migraine
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Migraine Disorders
Lead sponsor: Bozok University
Sponsor class: OTHER
First posted: 2015-10-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates effectiveness of greater occipital nerve blocks with bupivacaine compared to placebo in chronic migraine patients.

Detailed description: The greater occipital nerve (GON), which derives most of its fibers from the C2 dorsal root, is the primary sensory nerve of the occipital region. The response to GON blockade was not simply dependent on the direct local anesthetic effect of the injection . The mechanism of action might have been via changes in brain nociceptive pathways. Another possible explanation for these findings is, therefore, that GON injections initiated diffuse noxious inhibitory controls, independent of anesthetic effect . Neurophysiological and clinical data suggest there is a functional connection between the sensory occipital segments and the trigeminal nociceptive system in humans.

Eligibility criteria: Inclusion Criteria:

* Chronic migraine headache according to International Headache Society Classification Criteria
* Patients who are not using any prophylacting agent

Exclusion Criteria:

* patients given similar treatments before
* pregnant women
* hereditary diseases causing bleeding
* patients who have intracranial tumor or operation in posterior fossa
* allergic reactions to local anesthetics.

Primary outcomes:
measure: 50% decrease in migraine severity
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bozok University Neurology Department
name: Levent E Inan, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Inan LE, Inan N, Karadas O, Gul HL, Erdemoglu AK, Turkel Y, Akyol A. Greater occipital nerve blockade for the treatment of chronic migraine: a randomized, multicenter, double-blind, and placebo-controlled study. Acta Neurol Scand. 2015 Oct;132(4):270-7. doi: 10.1111/ane.12393. Epub 2015 Mar 13.
Clinical trial NCT02028819: Compassionate Use of Ibalizumab for the Treatment of HIV Infection
Official title: Compassionate Use of Ibalizumab for the Treatment of HIV Infection
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Human Immunodeficiency Virus (HIV)
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2014-01-07
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Ibalizumab is a humanized immunoglobulin G monoclonal antibody directed against a human T-cell receptor (CD4) and thus suppresses HIV replication by blocking entry of HIV into CD4+ lymphocytes. Ibalizumab has completed phase I and II clinical studies in HIV-negative and HIV-infected individuals showing safety and efficacy for suppressing HIV replication.

Detailed description: 1. Ibalizumab is a humanized immunoglobulin G monoclonal antibody directed against a human T-cell receptor (CD4) and thus suppresses HIV replication by blocking entry of HIV into CD4+ lymphocytes. Ibalizumab is in the pipeline for FDA approval to treat HIV infection. Phase I and II clinical studies have been completed in HIV-negative and HIV-infected individuals showing safety and efficacy for suppressing HIV replication.
2. Use of this medication requires that a single patient IND be obtained from the FDA for each patient requiring ibalizumab. An individual use IND has been approved by the FDA for one patient on treatment through this protocol; The IND number is 114515. The manufacturer of ibalizumab (TaiMed Biologics, Inc) will ship the drug directly to the Denver Health pharmacy.

Eligibility criteria: Inclusion Criteria:

* Adult patients with a diagnosis of HIV-infection with resistance or intolerance to currently available antiretroviral medications available in the United States or in whom additional drugs need to be added to their regimen because of inadequate response to existing therapy
* Patients with HIV infection that is expected to be sensitive to dolutegravir and ibalizumab
* Patients who do not qualify for or who are otherwise ineligible for clinical trials of medications not currently approved for treatment of HIV infection in the U.S.

Exclusion Criteria:

* Patients who are allergic to or have had a severe adverse reaction to dolutegravir or ibalizumab in the past.
* Age \<18 years or \>89 years
* Women may not be pregnant
* Prisoners and decisionally challenged patients will be excluded

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Edward M Gardner, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01677819: Inhibition Control of Children and Adolescents With ADHD
Official title: Inhibition Control of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2012-09-03
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will recruit 60 children and adolescents, aged 10 to 18, who are diagnosed with ADHD at the Department of Psychiatry, National Taiwan University Hospital.

Brief summary: The objectives of this study are to investigate:

1. the effect of methylphenidate on attention;
2. the relations between methylphenidate and inhibition control and working memory;
3. the relations between inhibition control and verbal attention and working memory;
4. the effect of methylphenidate on the changes of neuropsychological functioning and blood pressure.

Detailed description: Attention deficit hyperactivity disorder (ADHD), characterized by inattention, hyperactivity and impulsivity, is an early onset, highly heritable, clinically heterogeneous, long-term impairing disorder with tremendous impact on individuals, families, and societies. It affects 5-10% of school-aged children worldwide (7.5% in Taiwan). Methylphenidate, a stimulant, is effective in treating these patients. Studies in Taiwan show no effect of methylphenidate on blood pressure. There are evidences show that the change of blood pressure was associated with inhibition of impulsive behaviors. Stop Signal Task(SST) is used to assess the improve of inhibition control after methylphenidate response. By using repeated outcome measurements, we anticipate that this study will evaluate the improvement of neuropsychological performances after medication and determinie the association between medication response and neuropsychological functions and vital signs in a Taiwanese sample.

Eligibility criteria: Inclusion Criteria:

The inclusion criteria for the subjects are (1)that subjects have a clinical diagnosis of ADHD defined by the DSM-IV which was made by a full-time board-certificated child psychiatrist; (2)their ages range from 10 to 18 when we conduct the study; (3)their IQ greater than 80; and (4)they are under treatment of methylphenidate.

Exclusion Criteria:

The subjects will be excluded from the study if they currently meet criteria or have a history of the following condition as defined by DSM-IV: Schizophrenia, Schizoaffective Disorder, Organic Psychosis, or Pervasive Developmental Disorder.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan Univeristy Hospital
Study officials:
affiliation: National Taiwan University Hospital & College of Medicine
name: Susan Shur-Fen Gau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: