louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02766803: Effects of Simvastatin and Micronized Trans-resveratrol Treatment on Polycystic Ovary Syndrome (PCOS) Patients
Official title: Prospective, Randomized, Double - Blind Placebo Controlled Trial of Simvastatin and Resveratrol Therapy on Clinical, Endocrinological, Biochemical and Endothelial Dysfunction Parameters in Women With Polycystic Ovary Syndrome.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: PCOS, Insulin Resistance
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: University of California, San Diego
First posted: 2016-05-10
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Polycystic ovary syndrome (PCOS) is the most common endocrinopathy affecting women of reproductive age. Hyperandrogenism is the central feature of PCOS. Studies on isolated ovarian theca-interstitial cells indicate that resveratrol, a natural polyphenol, reduces androgen production.

This study is designed to evaluate the endocrine and metabolic effects of simvastatin and resveratrol on PCOS.

Methods: A randomized (1:1) double-blind, placebo-controlled trial will evaluate the effects of administering 20 mg of simvastatin daily and 500 mg of resveratrol daily, or administering 20 mg simvastatin and the placebo to women with PCOS at an academic hospital. PCOS is defined according to the Rotterdam criteria. Evaluations are performed at baseline and repeated after 3 and 6 months of treatment. The main outcome is a change of the serum total testosterone and the fasting insulin level.


Eligibility criteria: Inclusion Criteria:

* PCOs
* insulin resistance
* normal prolactin, TSH, 17 OH progesterone No evidence of androgen producing malignancy, Cushing's syndrome or acromegaly

Exclusion Criteria:

* use of oral contraceptives and/or other steroid hormones 3 months prior to the study

Primary outcomes:
measure: testosterone serum concentration
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obsterics
Study officials:
References:
Clinical trial NCT04213703: A Pilot Study to Explore the Role of Gut Flora in Epidermolysis Bullosa
Official title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Epidermolysis Bullosa
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Epidermolysis Bullosa
Epidermolysis Bullosa Simplex
Epidermolysis Bullosa Dystrophica
Lead sponsor: ProgenaBiome
Sponsor class: OTHER
First posted: 2019-12-30
Enrollment: 0
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: Patients who have been diagnosed with Epidermolysis Bullosa

Brief summary: This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

Detailed description: The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to Epidermolysis Bullosa

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study i. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent
2. Male or female of all ages. (interest is given to children who present with autism or Crohn's and whose parents wish to analyze their children's gut flora. Also of interest analysis of development of the child's microbiome. In the case of autism, the younger the child, the better to correct the neurological problems if an association is found between autism and the microbiome)
3. Diagnosis of Epidermolysis by at least one of the following i. Biopsy ii. Genetic testing

Exclusion Criteria:

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Participation in any experimental drug protocol within the past 12 weeks
5. Treatment with total parenteral nutrition

Primary outcomes:
measure: Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing
timeFrame: Three years
Secondary outcomes:
Other outcomes:
Locations:
city: Ventura
country: United States
facility: ProgenaBiome
state: California
Study officials:
affiliation: ProgenaBiome
name: Sabine Hazan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04490603: The Effect of Virtual Reality Experience on Infusion-related Pain
Official title: The Effect of Virtual Reality Experience on Infusion-related Pain With Lumbar Epidural Catheterization: A Prospective, Randomized Comparative Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Virtual Reality
Lead sponsor: Seoul National University
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized open-label clinical trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: This clinical trial aims to analyze the effect of virtual reality experience on infusion-related pain with lumbar epidural catheterization.

Detailed description: Patients with chronic pain are to suffer from acute pain during their chronic pain-relieving interventions. However, there is no active countermeasure against pain during these procedures. This prospective randomized clinical study seeks to find an appropriate solution to the procedure related acute pain of these patients by actively utilizing virtual reality experiences.

Eligibility criteria: Inclusion Criteria: If all of the following conditions are met

* A person with chronic low back pain that lasts more than 3 months due to spinal stenosis or lumbar disc disease.
* Adults over 20
* Those who decided to participate out of his/her own free will and signed in written consent

Exclusion Criteria: If the patient meets one or more of the following criteria, He or She cannot participate this clinical trial.

* In case of contraindication to general lumbar catheterization (e.g. coatulopathy, infection, etc)
* Hearing and vision impairments
* Affective disorder
* History of epilepsy or seizure
* If communication is not possible due to impaired cognitive ability
* Those who have been deemed inappropriate by the researchers

Primary outcomes:
measure: Procedure-related pain
timeFrame: Right after the produre for 50 minutes ended.
Secondary outcomes:
measure: Patient satisfaction with virtual reality experience
timeFrame: Right after the produre for 50 minutes ended.
measure: Intervention-related wellness index-1 (IWI-1)
timeFrame: Right after the produre for 50 minutes ended.
measure: Intervention-related wellness index-2 (IWI-2)
timeFrame: Right after the produre for 50 minutes ended.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Associate Professor
name: Jee Youn Moon, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03476603: Bariatric Surgery and Pharmacokinetics of Irbesartan
Official title: Bariatric Surgery and Pharmacokinetics Irbesartan: BAR-MEDS Irbesartan
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity, Morbid
Keywords: Bariatric surgery
Gastrointestinal tract
Biological availability
Pharmacokinetics
Irbesartan
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Volvat Medisinsk Senter Stokkan
name: Namsos Hospital
name: Alesund Hospital
First posted: 2018-03-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for bariatric surgery (gastric bypass or sleeve gastrectomy)

Brief summary: Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on irbesartan are investigated.


Eligibility criteria: Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract

Primary outcomes:
measure: Irbesartan concentration in blood serum (area under curve (AUC))
timeFrame: From baseline to 1 year postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs University Hospital
Study officials:
affiliation: St. Olavs University Hospital
name: Magnus Strømmen, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03994003: BIO-PREDISC-TIA SWISS Cohort Study
Official title: BIOmarkers and PREDISC Diagnostic Evaluation for Patients With Suspected Transient Ischemic Attacks: the BIOPREDISC- TIA SWISS Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebrovascular Disease, Ischemic Stroke
Lead sponsor: Ospedale Civico, Lugano
Sponsor class: OTHER_GOV
Collaborators: name: Ente Ospedaliero Cantonale, Bellinzona
First posted: 2019-06-21
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with suspected TIA (defined as the acute onset of focal neurological symptoms lasting \<24 h and presumed to be caused by brain ischemia at the time of referral) within 48 h of symptoms onset.

Brief summary: This research project aims at contributing to improve TIA diagnosis and management by using PREDISC scores and specific biomarkers thought to have elevated levels in TIA patients. A swift and accurate TIA diagnosis allows starting treatment of the patient adequately and shortly after the event. The shorter the time between the event and treatment onset, the better the outcome. This approach will be an important step forward in TIA diagnosis and management, similarly to acute coronary syndrome as discussed above.


Eligibility criteria: Inclusion Criteria:

* Patients with suspected TIA (defined as the acute onset of focal neurological symptoms lasting \<24 h and presumed to be caused by brain ischemia at the time of referral) within 48 h of symptoms onset.

  * At least 18 years old.
  * Having given their Informed Consent.

Exclusion Criteria:

* · Patients with ocular TIA (Amaurosis fugax).

  * Patients that still have neurological deficits at the moment of inclusion.
  * Contraindication to perform MRI.
  * For women: pregnancy.

Primary outcomes:
measure: Levels of specific biomarkers (Platelet Basic Protein (PBP), ceruloplasmin, microRNAs, exosomal particles) in patients with suspected TIA.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Ospedale Regionale di Lugano
state: Ticino
city: Lausanne
country: Switzerland
facility: Centre hospitalier Vaudois
state: Vaud
Study officials:
affiliation: Neurocentro della Svizzera Italiana Ospedale Regionale di Lugano
name: Carlo Cereda, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02709603: Hyoscine Butyl Bromide in Reducing Pain During HSG
Official title: Randomized Clinical Trial of Oral Hyoscine Butyl Bromide in Reducing Pain During HSG
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain Relief With HSG
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-03-16
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Many oral analgesic drugs such as nonsteroidal anti-inflammatory drug(NSAID) are used to relieve pain from gynecological procedure and dysmenorrhea. Hyoscine-N-butyl bromide, an antispasmodic drug are commonly used for relief of smooth muscle spasms and can use to relieve genito-urinary spasm. Some studies reported hyoscine can't relieve pain in minor gynecological procedures. So the efficacy of hyoscine use are still controversial and no previous studies investigated its efficacy for pain relief in HSG procedure.


Eligibility criteria: Inclusion Criteria:

The infertile women who indicated for HSG.

Exclusion Criteria:

* contraindications to Hyoscine or NSAID - known sensitivity to these drugs
* known sensitivity to contrast media
* abnormal uterine bleeding
* genital tract infection
* suspected pregnancy

Primary outcomes:
measure: Mean pain score during. hysterosalpingography by visual analog scale
timeFrame: intraoperative
Secondary outcomes:
measure: Mean pain score after hysterosalpingography
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Please Select
Study officials:
affiliation: Woman health hospital Assiut
name: ahmed abbas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01371903: The Effects of Patient Features on Opioid Induced End-Tidal CO2
Official title: The Effect of Patient Features on Opioid Induced End-Tidal CO2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid Use During Medical Care
Keywords: morphine
fentanyl
dilaudid
opioid
capnography
Lead sponsor: Albany Medical College
Sponsor class: OTHER
First posted: 2011-06-13
Enrollment: 278
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: Patients receiving opioid such as morphine, fentanyl, or dilaudid during their emergency department visit.

Brief summary: Emergency department patients receiving opioid pain medicine such as morphine, fentanyl or Dilaudid are eligible. After medication exhaled carbon dioxide is measured. and recorded.

Detailed description: Emergency department patients receiving opioid pain medicine such as morphine, fentanyl, or Dilaudid are eligible. After receiving the pain medication, a small soft plastic tube will be placed between the upper lip and nose. This tube is used to measure the amount of carbon dioxide the patient is breathing out. It can also be used to deliver oxygen if the provider feels the patient needs it. The carbon dioxide breathed out is measured and collected. Other information collected are height, weight, and vital signs. Patient participation time is approximately 2 hours during the emergency department visit.

Eligibility criteria: Inclusion Criteria:

* non intubated patients receiving intravenous opioid medications

Exclusion Criteria:

* mechanically ventilated patients
* patients with physiologic shock

Primary outcomes:
measure: end tidal carbon dioxide
timeFrame: study start, 30 minutes, 60 minutes, 90 minutes, 120 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical Center Emergency Department
state: New York
Study officials:
References:
Clinical trial NCT02058303: Study of A Long Lasting Local Anesthestic for Hand, Wrist or Finger Surgery
Official title: Exparel (Bupivacaine Liposome Injectable Suspension) for Distal Upper Extremity Blocks in Orthopedic Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hand Injuries
Wrist Injuries
Finger Injuries
Keywords: hand surgery
wrist surgery
finger surgery
anesthesia
regional anesthesia
postoperative pain
Lead sponsor: Ochsner Health System
Sponsor class: OTHER
Collaborators: name: Pacira Pharmaceuticals, Inc
First posted: 2014-02-10
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare Exparel, a new, long-lasting numbing medication and a shorter-acting nerve block to a traditional single-shot nerve block in patients having hand, wrist or finger surgery.


Eligibility criteria: Inclusion Criteria:

* patients 18 years or older having hand, wrist, or finger surgery
* ability to understand and provide informed consent
* American Society of Anesthesiologists status I-III
* presence of a responsible adult caregiver for 48-72 hours after surgery

Exclusion Criteria:

* patient refusal or inability to provide informed consent
* true allergy, not sensitivity to local anesthetics, midazolam, fentanyl, hydromorphone, propofol
* pregnancy
* hepatic or renal failure
* evidence of infection at or near the proposed needle insertion site
* any sensorimotor deficit of the upper extremity
* BMI greater than or equal to 35
* uncontrolled or severe pulmonary disease
* anticoagulant use (not aspirin or non-steroidal anti-inflammatories)
* chronic pain patients

Primary outcomes:
measure: Onset of Sensorimotor Block
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
Study officials:
affiliation: Ochsner Health System
name: Jose Soberon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02695303: 18790 - Sun Protection Factor Assay
Official title: Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay (UVAPF) Minimal Persistent Pigment-Darkening Dose (MPPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agent
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-03-01
Enrollment: 10
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: TREATMENT

Brief summary: To evaluate the Sun Protection Factor (SPF) 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
* Signed and dated Informed Consent Form
* Signed and dated HIPAA (Health Insurnace Portability and Accountability Act) Form
* An unbmbiguous 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 dianoses 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:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05552703: Traumatic Extradural Hematoma in Paediatric Age Group
Official title: Traumatic Extradural Hematoma in Paediatric Age Group
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Extradural Hematoma
Keywords: paediatrics
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 111
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 with traumatic extradural hematoma presenting at our institute and managed surgically.

Brief summary: The aim of this study is to assess the clinical and radiological characteristics of children with traumatic extradural hematoma and factors affecting the initial neurological status and outcome.

Detailed description: Extradural hematoma (EDH) represents 2.7-4% of traumatic brain injury .EDH is a potentially lethal condition which is easily cured if diagnosed early .EDH is less frequent in pediatric age group than in adults. The mean age of pediatric patients harboring EDH is between 6 and 10 years and it is rare among infants under the age of 12 months. EDH in children differs significantly from adults in terms of mode of injury, prognostic factors, and outcome. EDH in children may follow a trivial trauma and the course is more insidious and associated skull fractures is less frequent and these factors make it difficult to diagnose and often challenging to manage. The reported rate of mortality from EDH in children is varying from 0% and 17%, The criteria for choosing the surgical evacuation Vs. conservative management in pediatric age group still ill-defined this is what encouraged the investigators to carry this study to present our experience in the management of EDH in children aged less than 18 years.

Eligibility criteria: Inclusion Criteria:

* All pediatric patients with traumatic extradural hematoma presenting at our institute and managed surgically.

Exclusion Criteria:

* Patients aged more than 18 years old.
* patients with other traumatic brain injuries like: acute subdural hematoma, intra-cerebral hematoma and subarachnoid hemorrhage.

Primary outcomes:
measure: glascow outcome scale
timeFrame: immediately after the intervention/procedure/surgery
Secondary outcomes:
measure: mortality
timeFrame: immediately after the intervention/procedure/surgery, through study completion, an average of 1 year
measure: morbidity
timeFrame: immediately after the intervention/procedure/surgery, through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
References: