louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04776863: Effect of Smokeless Tobacco on Anterior Segment
Official title: Evaluation of the Effect of Smokeless Tobacco on Anterior Segment Parameters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eye Manifestations
Tobacco; Use, Harmful
Tobacco Chewing Toxicity
Keywords: Optical biometry
pupillar diameter
smokeless tobacco
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2021-03-02
Enrollment: 107
Sex: ALL
Minimum age (years): 26
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All the study subjects underwent a full ophthalmological examination.The anterior segment parameter measurements were taken with optical biometry.

Each subject was questioned in respect of how many years and how many times a day they used ST. Before taking the optical biometry measurements, the subjects were questioned as to whether they had used ST, drunk anything containing caffeine or smoked cigarettes in the previous 12 hours, and those who had were excluded from the study.

Each subject was given 1mg ST and the optical biometry measurements were repeated after 5, 30 and 60 mins. A single measurement was performed with optical biometry in the control group. To avoid diurnal variations, the measurements were taken in the morning between 09.00 and 12.00 hours.

Brief summary: Observational, comparative, cross-sectional study

Detailed description: To evaluate the acute and chronic effects of smokeless tobacco (ST) on the anterior segment parameters using optical biometry. Observational, comparative, cross-sectional study Place and Duration of Study: Department of Ophthalmology, Kahramanmaras Sutcu Imam University.

The study included 53 right eyes of 53 subjects (study group), who used ST and 54 right eyes of 54 healthy subjects without ST (control group). Following a full ophthalmological examination, baseline measurements were taken with optical biometry and these measurements were repeated at 5, 30 and 60 mins after using ST.

Eligibility criteria: Inclusion Criteria:

* A subject who use ST
* A subject who was not using ST

Exclusion Criteria:

* Refractive disorder
* Systemic chronic disease (diabetes, hypertension, neurological, etc.)
* Ocular trauma
* Ocular surgery
* Glaucoma
* Optic disc abnormalities
* Congenital anomaly

Primary outcomes:
measure: Central Corneal Thickness (CCT)
timeFrame: Baseline to 60 minutes after intervention
measure: Axial Length (AL)
timeFrame: Baseline to 60 minutes after intervention
measure: Anterior chamber deep (ACD)
timeFrame: Baseline to 60 minutes after intervention
measure: Lens thickness (LT)
timeFrame: Baseline to 60 minutes after intervention
measure: Pupillary diameter (PD)
timeFrame: Baseline to 60 minutes after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Kahramanmaras
country: Turkey
facility: Abdullah Beyoğlu
state: None Selected
Study officials:
affiliation: Kahramanmaras Sutcu Imam University
name: Abdullah Beyoğlu
role: STUDY_CHAIR
References:
Clinical trial NCT03879863: The RENEW Trial: A Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Adaptive Phase 3 Clinical Trial to Assess the Safety and Efficacy of Subjects With Dry Eye Disease
Official title: The RENEW Trial: A Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Adaptive Phase 3 Clinical Trial to Assess the Safety and Efficacy of Reproxalap 0.25% Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye
Lead sponsor: Aldeyra Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-03-19
Enrollment: 422
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: The RENEW Trial is a Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Adaptive Phase 3 Clinical Trial to Assess the Safety and Efficacy of Reproxalap 0.25% Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age of either gender and any race;
* Have a reported history of dry eye for at least 6 months prior to Visit 1;
* Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1

Exclusion Criteria:

* Have any clinically significant slit-lamp findings at Visit 1, including active blepharitis; meibomian gland dysfunction (MGD); lid margin inflammation; or active ocular allergies that require therapeutic treatment, or, in the opinion of the investigator may interfere with the assessment of the safety or efficacy of reproxalap or vehicle;
* Have or be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal) or active ocular inflammation at Visit 1;
* Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
* Have used any eye drops within 2 hours of Visit 1;
* Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
* Have used ophthalmic cyclosporine or lifitegrast 5.0% ophthalmic solution within 90 days of Visit 1;
* Have any planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1;
* Have used temporary or permanent punctal plugs within 30 days prior to Visit 1 or anticipate their use during the study period

Primary outcomes:
measure: Subject-reported Ocular Dryness Score (0 - 100 Visual Analogue Scale (VAS))
timeFrame: The efficacy assessment period (Day 1 through 85) was assessed at Weeks 1, 2, 4, 6, 8, 10, and 12; baseline was Day 1.
measure: Fluorescein Nasal Region Score (0 = None - 4 = Severe)
timeFrame: The efficacy assessment period (Day 15 through 85) was assessed at Weeks 2, 4, 6, 8, 10, and 12; baseline was Day 1.
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
Study officials:
References:
Clinical trial NCT01996163: The Effect of Gender on the Consumption of Pain Medication in Infants Undergoing Craniosynostosis Repair or Untethering of Cord in ITU
Official title: The Effect of Gender on the Consumption of Pain Medication in Infants Undergoing Craniosynostosis Repair or Untethering of Cord in ITU
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Craniosynostosis Repair
Untethering of Cord
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-11-27
Enrollment: 40
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All infants 0-1 year old, admitted to PICU after craniosynostosis repair or untethering of cord.

Brief summary: Postoperative pain is a major concern in routine management of children admitted to pediatric intensive care treatment. There are significant negative physiological and psychological ramifications of postoperative pain such as impairment of cardiac function due to tachycardia, restlessness in an intubated patient requiring increase dosage of sedative and paralytic drugs and reduced patient cooperation in the healing process.

The main body of evidence dealing with gender differences in pain perception and treatment stems from studies in the adult and adolescent population as the gonadal hormones have a central role in the way one experiences pain The hypothesis of this study is that there is a difference in the perception of pain, the amount of analgesia used and the response to pain medication between male and female infants undergoing craniosynostosis repair or untethering of cord.


Eligibility criteria: Inclusion Criteria:

All infants 0-1 year old, admitted to PICU after craniosynostosis repair or untethering of cord.

Exclusion Criteria:

1. Contraindication to analgesic medication
2. Infants with neurologic deficits that may hinder the assessment of pain severity such as facial nerve palsy and limb paralysis.
3. Ventilated infants.

Primary outcomes:
measure: The average amount per kg of analgesic medications in male and female infants 0-1 year old.
timeFrame: The first 24h after surgery
measure: The average reduction in pain severity score after receiving analgesics in male and female infants.
timeFrame: 24h after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03861663: Venue Ultrasound Evaluation - Israel
Official title: Clinical Evaluation of the Next Generation Venue Ultrasound System, Components, and Accessories - Israel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ultrasound Exam in Emergency/Medical Care
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Rambam Health Care Campus
First posted: 2019-03-04
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Device evaluation - feasibility
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The study purpose is to collect images and user feedback from the Next Generation Venue Ultrasound system, components, and accessories under clinical conditions, as required for device development and optimization.

Detailed description: Adult patients (aged \>18 years) will be enrolled that present for emergency or immediate medical care, in facilities such as the intensive care unit (ICU), US unit, and/or other departments. Subjects may or may not have a clinical indication for ultrasound scanning as part of their regular medical care and will be required to meet the inclusion criteria and none of the exclusion criteria. If a subject has a clinical indication for ultrasound exam, the routine exam will be performed with the standard equipment, and an additional exam will be performed using the investigational ultrasound device.

Eligibility criteria: Inclusion Criteria:

1. Adults (aged 18 years of age or older) at the time of consent;
2. Eligible to undergo ultrasound scanning per the site standard of care (with or without a clinical indication for scanning);
3. Able and willing to provide written informed consent for participation

Exclusion Criteria:

1. Are pregnant subjects
2. Require procedures that cannot be readily completed using available investigational devices;
3. Require or are anticipated to require medical care where study participation could reasonably be expected to adversely impact patient care.

Primary outcomes:
measure: Obtain Image sets using Ultrasound Venue System
timeFrame: Two months
measure: Periodic user feedback
timeFrame: Two months
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Center
Study officials:
References:
Clinical trial NCT01647763: Hemorrhoidal Artery Ligation and Rectoanal Repair Versus Stapled Hemorrhoidopexy
Official title: Hemorrhoidal Artery Ligation and Rectoanal Repair Versus Stapled Hemorrhoidopexy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hemorrhoids
Keywords: Hemorrhoids
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2012-07-24
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background:

Hemorrhoids of grade 3 and 4 can be treated either by conventional, rather invasive procedures, like Milligan-Morgan or Ferguson or by modern, less invasive procedures with less postoperative pain. Doppler guided hemorrhoidal artery ligation and stapled hemorrhoidopexy are examples for such modern procedures. Hemorrhoidal artery ligation causes less post operative pain than stapled hemorrhoidopexy, however the former has a higher recurrence rate. Combining hemorrhoidal artery ligation with rectoanal repair should reduce the recurrence rate without increasing the post operative pain.

Hypothesis and aim:

The study tries to prove the assumption that combined hemorrhoidal artery ligation and rectoanal repair cause less pain and have less post operative complications than stapled hemorrhoidopexy.


Eligibility criteria: Inclusion Criteria:

* hemorrhoids grade 3
* no active anti-coagulation treatment
* no hemorrhoidal recurrence
* no previous surgery on rectum or anus
* no previous local radiotherapy
* no mental incapacities, good study compliance can be expected
* no severe incontinence (Wexner score \> 12)
* no severe comorbidities
* no inflammatory anal diseases (abscesses, fistulas)
* informed consent

Exclusion Criteria:

* patient wish
* inoperability with the assigned intervention, switching to other treatment method

Primary outcomes:
measure: Pain POD1
timeFrame: between 6:00 am and 8:00 am the day after surgery
Secondary outcomes:
measure: Pain after 8h
timeFrame: 8 hours after surgery
measure: Pain 30d
timeFrame: 30 days after surgery
measure: Pain 1y
timeFrame: 1 year after surgery
measure: Pain 2y
timeFrame: 2 years after surgery
measure: post operative surgical complications
timeFrame: within 30 post operative days
measure: duration of medical leave
timeFrame: up to 3 months after surgery
measure: Continence 30d
timeFrame: 30 days after surgery
measure: Continence 1y
timeFrame: 1 year after surgery
measure: Continence 2y
timeFrame: 2 years after surgery
Other outcomes:
Locations:
city: _Rorschach
country: Switzerland
facility: Kantonsspital Rorschach
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
Study officials:
affiliation: Cantonal Hospital St. Gallen, Department of Surgery
name: Lukas Marti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01860963: Anal Dysplasia in Patients With Inflammatory Bowel Disease and Healthy Controls
Official title: Prevalence of Anal Dysplasia in Patients With Inflammatory Bowel Disease and Healthy Controls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anal Squamous Intraepithelial Lesion (ASIL)
HPV DNA
Keywords: ASIL
Anal dysplasia
IBD
HPV DNA
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2013-05-23
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study is designed to establish the prevalence of anal squamous intraepithelial lesion (ASIL) in patients with inflammatory bowel disease (IBD) and healthy controls.

Detailed description: IBD patients attending the Stanford Inflammatory Bowel Disease (IBD) clinic and age-matched healthy controls are screened for eligibility. Informed consent is obtained for eligible subjects. An anonymous self-administered questionnaire is administered to assess risk factors for HPV. For IBD patients, information regarding IBD diagnosis and treatment is obtained.

An anal pap smear is performed at the time of a clinic visit or at the time of an already scheduled colonoscopy. Samples are collected and processed at Stanford pathology where a blinded pathologist reads all specimens. Human Papillomavirus (HPV) DNA testing is performed on all specimens. All patients with anal squamous intraepithelial lesion (ASIL) are referred to a colorectal surgeon for further recommendations or treatment, which includes a high-resolution anoscopy.

Eligibility criteria: Inclusion Criteria:

* All IBD patients followed in the IBD clinic and healthy controls who are greater than 18 years old

Exclusion Criteria:

* History of HPV vaccination
* Pregnancy
* Other immunosuppressed states (i.e. systemic lupus erythematosus, rheumatoid arthritis, cancer, Human Immunodeficiency Virus (HIV), transplant)
* IBD patients who don't meet immunosuppression/non-immunosuppression criteria
* Inability to obtain informed consent from patient
* Previous diagnosis of ASIL or anal/rectal cancer

Primary outcomes:
measure: Presence of high risk HPV and/or abnormal cytology
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Digestive Health Center
state: California
Study officials:
affiliation: Stanford Hosptial and Clinics
name: Mark Welton, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford Hospital and Clinics
name: Shamita Shah, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shah SB, Pickham D, Araya H, Kamal A, Pineda CE, Ghole S, Shih L, Kong C, Pai R, Welton M. Prevalence of Anal Dysplasia in Patients With Inflammatory Bowel Disease. Clin Gastroenterol Hepatol. 2015 Nov;13(11):1955-61.e1. doi: 10.1016/j.cgh.2015.05.031. Epub 2015 Jun 2.
Clinical trial NCT03062163: Efficacy and Safety of Resveratrol and Lipoic Acid Transdermal Patch for Lipolysis in Overweight Volunteers
Official title: Efficacy and Safety of Resveratrol and Lipoic Acid Transdermal Patch for Lipolysis in Overweight Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lipolysis
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the lipolysis effect of resveratrol and lipoic acid transdermal patch in overweight volunteers

Detailed description: 66 participants with overweight received a resveratrol and lipoic acid transdermal patch treatment. The treatment areas have been treated including left and right arms. Subjects were evaluated using standardized measurements of body weight and circumference of arms at baseline and 2 weeks follow-up visits. Evaluation of physician were also measured.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers with BMI \> 23

Exclusion Criteria:

* resveratrol or lipoic acid allergies

Primary outcomes:
measure: fat thickness measured
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Chulalongkorn University
Study officials:
affiliation: Chulalongkorn University
name: Amornpun Sereemaspun, MD., Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT04368663: The Beneficial Effect of TJ-134 for Patients With Symptomatic Pneumatosis Cystoides Intestinalis
Official title: The Beneficial Effect of the Traditional Japanese Medicine, Keishi-ka-shakuyaku-daio-to（TJ-134）for Patients With Symptomatic Pneumatosis Cystoides
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pneumatosis Cystoides Intestinalis
Keywords: Pneumatosis Cystoides Intestinalis
Lead sponsor: Showa Inan General Hospital
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The traditional Japanese medicine, Keishi-ka-shakuyaku-daio-to is administered to patients with symptomatic pneumatosis cystoides intestinalis (PCI) as compared with lactomin for 8 weeks.

Detailed description: 1. Based on endoscopic finding, patients with symptomatic PCI are recruited.
2. After enrollment, abdominal symptoms are evaluated and abdominal CT is performed.
3. Patients were randomized in a 1:1 ratio in blocks of 4 to undergo either the traditional Japanese medicine or lactomin (control). Randomization was carried out by computer-generated random sequences.
4. The traditional Japanese medicine, Keishi-ka-shakuyaku-daio-to（TJ-134, 7.5g/day), which consists of a mixture of a compound of peony root (6 g), cinnamon bark (4 g), jujube (4 g), glycyrrhiza (2 g), rhubarb (2 g), and ginger (1 g) or lactomin (3g/day) is administered to enrolled patients for 8 weeks.
5. After the administration of each drug for 8 weeks, abdominal symptoms are evaluated and abdominal CT is performed again.

Eligibility criteria: Inclusion Criteria:

* typical findings of PCI on colonoscopy; Line or pebble like sessile cysts are distributed around the colon with normal overlying mucosa

Exclusion Criteria:

* patients can not take Keishi-ka-shakuyaku-daio-to（TJ-134）

Primary outcomes:
measure: Change of computed tomography (CT) findings
timeFrame: at enrollment and 8 weeks after the administration of TJ134
Secondary outcomes:
measure: Bloating and abdominal pain
timeFrame: at enrollment and 8 weeks after the administration of TJ134
measure: Abdominal symptoms
timeFrame: at enrollment and 8 weeks after the administration of TJ134
Other outcomes:
Locations:
city: Komagane
country: Japan
facility: Showa Inan General hospital
state: Nagano
Study officials:
References:
Clinical trial NCT02477163: Ayurvedic Management of Chronic Kidney Disease
Official title: An Observational Clinical Study to Determine the Effect of Multi-modal Ayurvedic Treatment in the Patients of Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Nephropathy
Hypertensive Nephropathy
Keywords: Nephropathy
Chronic Renal Failure
Chronic Kidney Disease
Chronic Renal Disease
Ayurveda
Herbal treatment
Lead sponsor: J.S. Ayurveda College
Sponsor class: OTHER
First posted: 2015-06-22
Enrollment: 521
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre-post design
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of multi-dimentional ayurvedic treatment in the patients of various types of chronic kidney disease.

Detailed description: Ayurvedic treatment includes some complex classical herbal formulations and Niruha basti (procto-colonic administration of ayurvedic medicines mainly contained decoction of punarnavadi compound, rocksalt, sesame oil and mixture of some herbal poweders) will be given to the patients of chronic kedney disease who are not on dialysis. Patients of CKD of various etiology will be grouped accordingly and will get the same treatment.

Eligibility criteria: Inclusion Criteria:

* Patients having a confirm diagnosis of chronic kidney disease with GFR level \< 60mL/min and persistent (present for \> 3 months) indicates substantial reduction in kidney function. Confirmation of diagnosis with ultrasound of KUB, indicating reduction of kidney size and / or cortico-medullary difference.

Exclusion Criteria:

* Female patients having pregnancy, breast feeding or post-delivery period.
* Patients who are on dialysis treatment from more than 6 months period. Patients who are already operated for renal transplantation and then having nephropathy.
* Patients with some serious illness like cardio-vascular diseases, acute mental disorders, serious acute organic diseases, serious chronic co-morbidity, hypo or hyper thyroidism, other kidney, liver or metabolic disorders etc.

Primary outcomes:
measure: Improvement in the signs and symptoms
timeFrame: 4 weeks
measure: Changes in the value of laboratory investigations
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nadiad
country: India
facility: P D Patel Ayurveda Hospital
state: Gujarat
Study officials:
affiliation: J S Ayurveda College,College Road, Nadiad
name: Manishkumar V Patel, MD(Ayurveda)
role: PRINCIPAL_INVESTIGATOR
References: