louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02212418: Effect of an Abdominal Hypopressive Technique Program on Pelvic Floor Muscles and Urinary Incontinence in Women
Official title: Effect of an Abdominal Hypopressive Technique Program on Pelvic Floor Muscles and Urinary Incontinence in Women: A Randomized Cross-over Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Pelvic Floor Dysfunction
Lead sponsor: University of Valladolid
Sponsor class: OTHER
First posted: 2014-08-08
Enrollment: 42
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Abdominal hypopressive technique (AHT) is a therapy created for the treatment of the pelvic floor dysfunctions in the postpartum. In the last years it has been extended out of such medical context but there is a lack of scientific evidence, and the endurability of the effects of this technique are unknown. The investigator´s aim was to evaluate the effect of a 12 weeks AHT program on 1) the tone of the pelvic floor muscles and 2) on urinary incontinence, in women out of the postpartum phase. In addition the investigators looked for the endurability of its effect.

Methods: The investigators performed a cross-over blinded intervention study of 4 month duration, in which women, stratified by age, were randomly assigned to a sequence of AHT-no AHT or no AHT-AHT. The AHT program consisted of 30 minute sessions, 3 days per week during 2 months. The investigators compared the effect of AHT versus no AHT, and of no AHT after 2 months versus AHT.

The endpoints were the differences in perineal tonometry, and urinary incontinence symptoms, as measured by the ICIQ_SF. Comparisons were tested with student t tests, paired or unpaired as adequate.


Eligibility criteria: Inclusion Criteria:

* no systematic participation in sports or physical activities (≤ 3 sessions per week, ≤ 2 weeks per month)
* between 20 and 65 years old
* with availability for three afternoons per week.

Exclusion Criteria:

* hypertension
* serious diseases
* pregnancy
* postpartum phase up to 2 months after delivery.

Primary outcomes:
measure: change of pelvic floor tone at 2 months and after 4 months
timeFrame: at baseline, after 2 months, and after 4 months
Secondary outcomes:
measure: change of urinary incontinence at 2 months and after 4 months
timeFrame: perfomed at baseline, after 2 months, and after 4 months
Other outcomes:
Locations:
Study officials:
affiliation: Alfonso X El Sabio University
name: Lidon Soriano, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Valladolid
name: Rafael J Curbelo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto de Salud Músculo Esquelética
name: Loreto Carmona, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02995018: Sun Protection Factor Assay (317/2016)
Official title: Sun Protection Factor (SPF) Assay : UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-12-16
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female.
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form).
* Signed and dated Informed Consent Form
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose).

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnosed by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma, diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.

Primary outcomes:
measure: Minimal Erythema Dose (MED)
timeFrame: Up to 15 minutes
measure: Minimal Persistent Pigment Darkening Dose (MPPD)
timeFrame: Up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
References:
Clinical trial NCT01320618: Prospective Cohort Study of Robotic Assisted Laparoscopic Sacrocolpopexy Using MPATHY Restorelle Mesh
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Urinary Incontinence
Mesh Erosion
Keywords: uterine prolapse
vaginal prolapse
mesh erosion
urinary incontinence
bowel symptoms
Lead sponsor: Atlantic Health System
Sponsor class: OTHER
First posted: 2011-03-22
Enrollment: 120
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Our study population will be woman who underwent Robotic assisted laparoscopic sacral colpopexy at the Morristown Memorial Hospital for correction of pelvic organ prolapseusing synthetic polypropelene mesh.

Brief summary: Robotic approach to sacral colpopexy is a relatively new procedure. The literature is scarce in regard to long term outcome. This advanced procedure is offered at Morristown Memorial. This protocol will review the one year outcome of patients who underwent this procedure using a polypropylene mesh. These outcomes will include anatomical and quality of life measures.


Eligibility criteria: Inclusion Criteria:

* Any patient receiving Robotic assisted laparoscopic sacral colpopexy with polypropylene mesh

Exclusion Criteria:

* Other graft material than polypropylene mesh
* Enrollment in another study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01544218: Validating NIAAA Screen Guide in YCMC
Official title: Validating NIAAA's Brief Screening Guide in Youth With Chronic Medical Conditions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcohol Related Disorders
Keywords: Alcohol related disorders
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2012-03-05
Enrollment: 521
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 9-18 year old youth with one of four chronic conditions - asthma, diabetes, rheumatic or gastroenterologic conditions

Brief summary: Alcohol use is a serious health threat to the 26% youth in the US with chronic medical conditions. While alcohol use can significantly impact an underlying illness and its safe/effective management, medical specialists rarely screen their adolescent patients for alcohol use. The investigators will validate a new, brief alcohol- screening tool with 9-18 year old youth with chronic medical conditions. Comprehensive assessment information will be collected and analyzed to describe relationships between youth alcohol use, other substance use, and chronic disease outcomes and findings integrated into the validated screen as actionable clinician guidance and health advice.


Eligibility criteria: Inclusion Criteria:

* 9-18 years of age
* duration of chronic illness of at least one year
* ability to speak/read English and use a computer keyboard and/or complete an interviewer-assisted questionnaire

Exclusion Criteria:

* medically or emotionally unstable
* unable to assent/consent

Primary outcomes:
measure: eGuide diagnosis of alcohol use disorder
timeFrame: Baseline
Secondary outcomes:
measure: Correlation of HgbA1c level with level of alcohol use
timeFrame: Baseline
measure: Correlation between score on the Asthma Control Test (ACT)and level of alcohol use
timeFrame: Baseline
measure: Correlation of score on The Childhood Health Assessment Questionnaire (CHAQ) with level of alcohol use
timeFrame: baseline
measure: Correlation between The Pediatric Ulcerative Colitis Activity Index (PUCAI)score and level of alcohol use
timeFrame: Baseline
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Sharon Levy, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Children's Hospital
name: Elissa Weitzman, ScD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03127618: Lorlatinib - PF-06463922
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2017-04-25
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Lorlatinib expanded access program


Eligibility criteria: Inclusion Criteria:

* Adult, Senior

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00731718: Control of Head Lice Infestations in Children and Adults
Official title: Control of Head Lice in Children and Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediculosis
Keywords: Head Lice
Lead sponsor: Larada Sciences, Inc.
Sponsor class: INDUSTRY
First posted: 2008-08-11
Enrollment: 543
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to see if heated air will kill head lice and their eggs. The treatment visit is approximately 1 hour long with a follow up phone call.

Detailed description: Head lice strikes fear into the hearts of parents of school age children. Ridding a child of head lice is one of the most frustrating experiences a parent can face.

The objective of this project is to test whether louse desiccation using our prototype is an effective means of controlling head louse infestations in children.

Children age 6 and over are included in this study.

Eligibility criteria: Inclusion Criteria:

* Must be at least 6 years old, male or female Parent to attend treatment Able to comb the hair with no problems

Exclusion Criteria:

* Chemical shampoos used within 14 days Open sores or wounds on the scalp Recent head radiation

Primary outcomes:
measure: Efficacy of using heated air to kill head lice and their eggs
timeFrame: Through out
Secondary outcomes:
measure: Safety of device
timeFrame: Through out
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Larada Sciences,Inc.
state: Utah
Study officials:
affiliation: Larada Sciences Inc., University of Utah
name: Dale Clayton, PhD/Biology
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goates BM, Atkin JS, Wilding KG, Birch KG, Cottam MR, Bush SE, Clayton DH. An effective nonchemical treatment for head lice: a lot of hot air. Pediatrics. 2006 Nov;118(5):1962-70. doi: 10.1542/peds.2005-1847.
citation: Bush SE, Rock AN, Jones SL, Malenke JR, Clayton DH. Efficacy of the LouseBuster, a new medical device for treating head lice (Anoplura:Pediculidae). J Med Entomol. 2011 Jan;48(1):67-72. doi: 10.1603/me10122.
Clinical trial NCT04909918: Impact of Steroids on Inflammatory Response in Covid-19
Official title: The Impact of Dexamethasone Versus Methylprednisolone Upon Neutrophil/Lymphocyte Ratio (NLR) in COVID-19 Diseased Patients Admitted in ICU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Covid19
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-06-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: we designed this study to observe the efficacy and safety of dexamethasone versus methylprednisolone in covid-19 diseased patients upon monitoring the inflammatory response and to compare the outcome when these steroids will be given in covid-19 diseased patients in our ICU.

Detailed description: A written informed consent will be taken from the patients or their relatives. The study will involve adults (age 18-no limit years) who will be diagnosed covid-19 with destructive inflammatory immune response needing ICU admission to be run on steroid therapy.

Patients will be assigned randomly to two groups (30 subjects each). The study drug will be delivered in opaque bags labeled "study drug" and in (Group D) intravenous dexamethasone 8 mg/day given for 7 days, in (Group M) intravenous methylprednisolone 1 mg/kg/day in 2 divided doses per day given for 7 days.

Eligibility criteria: Inclusion Criteria:

* Adults (age 18-no limit years) who will be diagnosed covid-19
* With destructive inflammatory immune response needing ICU admission to be run on steroid therapy.

Exclusion Criteria:

* Severe immunosuppression like HIV (Human immunodeficiency Virus)
* Long term use of immunosuppressant for any other chronic illness
* Pregnant or lactating females
* Patients who are on chronic use of corticosteroids like asthma, rheumatoid arthritis.

Primary outcomes:
measure: Neutrophil/lymphocyte ratio (NLR)
timeFrame: 7 days
Secondary outcomes:
measure: Interleukin-6 (IL-6) level
timeFrame: 7days
measure: C-reactive protein (CRP) test
timeFrame: 3 days
measure: Arterial oxygen tension/ inspired oxygen fraction (P/F ratio)
timeFrame: 3 days
measure: ICU stay
timeFrame: 7 days
measure: ICU mortality
timeFrame: 7days
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospital
state: Assuit
Study officials:
affiliation: Assiut University
name: Omar Soliman
role: PRINCIPAL_INVESTIGATOR
References:
citation: Polidoro RB, Hagan RS, de Santis Santiago R, Schmidt NW. Overview: Systemic Inflammatory Response Derived From Lung Injury Caused by SARS-CoV-2 Infection Explains Severe Outcomes in COVID-19. Front Immunol. 2020 Jun 26;11:1626. doi: 10.3389/fimmu.2020.01626. eCollection 2020.
Clinical trial NCT02285218: Role of New Adipokines and Hepatokines in Prediction of Patients With Metabolic Syndrome or NAFLD
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-alcoholic Fatty Liver Disease
Type 2 Diabetes
Metabolic Syndrome
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-11-06
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects are recruited from either patients who visit out-patient clinics (Diabetes center in Severance hospital) or healthy volunteers.

Brief summary: To investigate the predictive roles of adipokines and hepatokines to detect non-alcoholic fatty liver disease (NAFLD), diabetes, or dyslipidmia.

To examine the association or effects of clinical and biochemical factors (lab results and medication, etc.) on serum levels of adipokines and hepatokines in certain subjects with non-alcoholic fatty liver disease (NAFLD), diabetes, or dyslipidmia.


Eligibility criteria: Inclusion Criteria:

1. dyslipidemia 1. serum triglyceride≥150mg/dl, or taking medication to lower triglyceride levels (e.g. fibrates, niacin, omega-3, etc.) or 2. serum LDL-C≥100mg/dl, or taking medication to lower LDL-C levels (e.g. statin, ezetimibe, etc.)
2. type 2 diabetes 1. defined according to the ADA guideline (DM definition) or 2. taking any anti-diabetic medications
3. non-alcoholic fatty liver disease (NAFLD) 1. diagnosed as having fatty liver by ultrasonogram or 2. diagnosed as having fatty liver by transient elastogram (Fibroscan) or 3. diagnosed as having fatty liver by abdomina CT scan
4. Normal control 1. should not be included in other groups as above and 2. not taking any medication related to diabetes and dyslipidemia and 3. BMI \<25kg/m2

Exclusion Criteria:

1. subjects who refused to agree with informed consents
2. subjects with organ-transplantation
3. serum creatinine ≥1.5mg/dl
4. pregnant women
5. liver cancer or pancreatic cancer
6. subjects with chronic hepatitis B or C virus infection
7. for NAFLD group, subjects with excessive alcohol consumption (men: ≥210g of alcohol per week, women: ≥140g of alcohol per week)

Primary outcomes:
measure: new adipokines
timeFrame: To 8h fasting blood sample
measure: new hepatokines
timeFrame: To 8h fasting blood sample
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
References:
citation: Lee YH, Lee SG, Lee CJ, Kim SH, Song YM, Yoon MR, Jeon BH, Lee JH, Lee BW, Kang ES, Lee HC, Cha BS. Association between betatrophin/ANGPTL8 and non-alcoholic fatty liver disease: animal and human studies. Sci Rep. 2016 Apr 5;6:24013. doi: 10.1038/srep24013.
Clinical trial NCT01771718: Pilot Study on In-vivo Non-invasive Skin Imaging Using Multiphoton Microscopy
Official title: Non-invasive Skin Imaging Using Multiphoton Microscopy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Skin Lesion
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
First posted: 2013-01-18
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will be selected from University of California Irvine Medical Clinic

Brief summary: The purpose of this pilot study is to employ multiphoton microscopy to non-invasively image in-vivo pigmented and non-pigmented human skin lesions for characterization of their morphologic and functional features. .

Detailed description: This study is performed using a multiphoton microscopy-based tomograph (MPTflex) developed by JenLab, GmbH (Germany) to image non-invasively normal and lesional skin. Skin lesions are imaged by multiphoton microscopy and images are compared to those obtained from histopathology through standard of care processed skin biopsies.

Any biopsies will be performed by the health care provider as a standard of care procedure.

Eligibility criteria: Inclusion Criteria:

* Male or Female all age groups
* Ability to understand and carry out subject instructions

Exclusion Criteria:

* Pregnant women

Primary outcomes:
measure: high-resolution images of skin
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute Medical Clinic
state: California
Study officials:
affiliation: Beckman Laser Institute, UCI
name: Kristen Kelly, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03262818: Transvaginal Ultrasound and Photoacoustic Imaging of the Ovary
Official title: Transvaginal Ultrasound and Photoacoustic Imaging of the Ovary
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Oophorectomy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-08-25
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators have developed co-registered photoacoustic and ultrasound (US) imaging technique that allows the investigators to visualize tumor structure and functional changes simultaneously, which may potentially reveal early tumor angiogenesis development that is not available by US alone. The ability to detect early angiogenesis changes, as well as tumor morphology changes in the ovary, using a non-invasive imaging modality will greatly enhance the care for women.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Referred to Washington University School of Medicine for conditions necessitating surgery to include at least a unilateral oophorectomy
* Willingness to participate in the study
* Able to provide informed consent

Exclusion Criteria

* Younger than 18 years of age
* Not able to provide informed consent

Primary outcomes:
measure: Measure PAI/ultrasound signatures from ovaries prior to surgery
timeFrame: Prior to surgery (no more than 30 days prior to surgery)
Secondary outcomes:
measure: Characterize the tissue images with pathologic diagnosis
timeFrame: At the time of surgery (no more than 30 days after PAI/US)
measure: Refine the system and imaging algorithms based on the characteristic features of in vivo imaging
timeFrame: At the time of surgery (no more than 30 days after PAI/US)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Cary L Siegel, M.D.
role: PRINCIPAL_INVESTIGATOR
References: