louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01544777: Visual Quality Following Aspheric Intraocular Lens (IOL) Implantation - a Comparative Clinical Study
Official title: Visual Quality Following Aspheric and Monovision Lens Implantation - a Comparative Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphakia
Cataract
Keywords: Aphakia
Cataract
Lead sponsor: Hoya Surgical Optics, Inc.
Sponsor class: INDUSTRY
First posted: 2012-03-06
Enrollment: 42
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: To evaluate visual acuity and quality of vision in participants undergoing cataract surgery with a Hoya model 751 intra-ocular lens and to compare the visual results to the common monofocal lens in use.


Eligibility criteria: Inclusion Criteria:

* Senile cataract
* Patient identified as a candidate for cataract surgery and IOL implantation
* Willing to sign informed consent document approved by the Ethical Committee
* Willing to complete all required tests and exams per this protocol

Exclusion Criteria:

* Amblyopia
* History or evidence of any ocular disease that may affect visual acuity
* Previous ocular surgery, including refraction surgery
* Ocular anomalies (e.g. microphthalmos, kerataconous)
* Subjects with greater than 1.0 D of corneal astigmatism
* Subjects who experience intraoperative complications that could affect postoperative IOL centration or tilt

Primary outcomes:
measure: Uncorrected Visual Acuity (UCVA) (ETDRS)for distance, intermediate and near
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
Study officials:
affiliation: Sir Charles Gairdner Hospital, Nedlans WA
name: Graham Barrett, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04636177: Pain Rehabilitation Virtual Reality (PRVR): Innovations to Enhance Mobility in the Presence of Pain
Official title: Pain Rehabilitation Virtual Reality (PRVR): Innovations to Enhance Mobility in the Presence of Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Musculoskeletal Pain
Fibromyalgia
Virtual Reality
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2020-11-19
Enrollment: 34
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The proposed research is a single arm feasibility trial of pain rehabilitation virtual reality (PRVR) aimed at measuring feasibility, acceptability and utility of VR as well as changes in physical function and fear for adolescents with chronic musculoskeletal pain. The intervention includes standard physiotherapy treatment including functional goal setting and progressive exercise.


Eligibility criteria: Inclusion Criteria:

* 10 to 17 years old
* Musculoskeletal pain (e.g. localized \[back, limb\], diffuse) not due to acute trauma (e.g. active sprain or fracture)
* English Language Proficiency

Exclusion Criteria:

* Significant cognitive impairment (e.g., brain injury)
* Significant medical or psychiatric problem that would interfere (e.g. psychosis, suicidality)
* Presents with a condition that interferes with virtual reality usage (e.g., history of seizure, facial injury precluding safe placement of headset, visual impairment, significant hearing impairment impact ability to follow audio instructions).

Primary outcomes:
measure: Feasibility, Acceptability, and Utility of VR
timeFrame: Baseline to end of treatment at 6-8 weeks, on average
Secondary outcomes:
measure: Pain-related Fear and Avoidance
timeFrame: Baseline to end of treatment at 6-8 weeks, on average
measure: Physical Function: Lower Extremity
timeFrame: Baseline to end of treatment at 6-8 weeks, on average
measure: Physical Function: Upper Extremity
timeFrame: Baseline to end of treatment at 6-8 weeks, on average
Other outcomes:
Locations:
city: Menlo Park
country: United States
facility: Pediatric Pain Management Clinic - Stanford Children's Health
state: California
city: Palo Alto
country: United States
facility: California Rehabilitation and Sports Therapy
state: California
Study officials:
affiliation: Stanford School of Medicine
name: Laura Simons, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04305977: Writing to Alleviate Violence Exposure for Transgender Women (WAVE-TW)
Official title: Writing to Alleviate Violence Exposure for Transgender Women
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: PTSD
Depression
Virus, Human Immunodeficiency
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Empower U Community Health Center
name: Miami Center for AIDS Research at the University of Miami Miller School of Medicine
First posted: 2020-03-12
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: WAVE - TW (Writing to Alleviate Violence Exposure for Transgender women living with HIV) is an intervention development study which aims to assess the feasibility and acceptability of a proposed trauma writing and adherence intervention that addresses Post-Traumatic Stress Disorder (PTSD) and depressive symptoms, antiretroviral therapy (ART) adherence and viral suppression among transgender women.


Eligibility criteria: Inclusion Criteria:

* Living with HIV
* Age 18 or older
* Detectable viral load within the past year
* Transgender female
* English speaking
* Capable of completing and fully understanding the informed consent process and the study procedures
* History of trauma/abuse

Exclusion Criteria:

* Unable to completely and fully understand the consent process and the study procedures.
* Significant interfering mental health symptoms (e.g., untreated active psychosis, active suicidality with a plan).
* Engaged in an intervention to address trauma symptoms and adherence within the past year

Primary outcomes:
measure: Percentage of participant satisfaction
timeFrame: Up to 11 months
measure: Number of Completed visits
timeFrame: Up to 11 months
Secondary outcomes:
measure: Change in PTSD symptoms as assessed by the PTSD Checklist for DSM-5
timeFrame: Baseline, 9 months
measure: Change in Depressive symptoms as assessed by the CES-D Scale
timeFrame: Baseline, 9 months
measure: Change in HIV viral load levels
timeFrame: Baseline, Up to 6 months
measure: Number of Participants with Viral load suppression
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: UHealth Don Soffer Clinical Research Building
state: Florida
Study officials:
affiliation: University of Miami
name: Sannisha Dale, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01205477: Safety and Efficacy of Methylprednisolone Infiltration in Anserine Bursitis Treatment
Official title: Phase 2 Double-blinded, Placebo-controlled, Clinical Trial for Safety and Efficacy of Methylprednisolone Infiltration in Anserine Bursitis Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bursitis
Keywords: Anserine bursitis
Lead sponsor: Universidad Autonoma de Nuevo Leon
Sponsor class: OTHER
First posted: 2010-09-20
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the safety and efficacy of methylprednisolone infiltration in anserine bursitis treatment


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of anserine bursitis

Exclusion Criteria:

* Intraarticular pathology that reflects pain in the medial part of the knee

Primary outcomes:
measure: WOMAC score
timeFrame: 4 weeks
Secondary outcomes:
measure: VAS satisfaction
timeFrame: 4 weeks
measure: Improvement
timeFrame: 4 weeks
measure: SAFETY
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Hospital Universitario "José Eleuterio González"
state: Nuevo León
Study officials:
affiliation: Universidad Autónoma de Nuevo León
name: Mario Alberto Garza Elizondo, MD
role: STUDY_DIRECTOR
References:
citation: Alvarez-Nemegyei J, Canoso JJ. Evidence-Based Soft Tissue Rheumatology IV: Anserine Bursitis. J Clin Rheumatol. 2004 Aug;10(4):205-6. doi: 10.1097/01.rhu.0000135561.41660.b0.
citation: Calvo-Alén J, Rua-Figueroa I, Erausquin C. Anserine bursitis treatment: local corticoesteroid injction against NSAID: a prospective study [Spanish]. Rev Esp Reumatol. 1993;20:13-15.
Clinical trial NCT05945745: Molecular Analysis and Treatment Options of SCLC
Official title: Molecular Landscape Analysis and Clinical Implications for SCLC
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Small-cell Lung Cancer
Small Cell Lung Cancer, Combined Type
Small Cell Lung Carcinoma
Small Cell Lung Cancer Extensive Stage
Small Cell Lung Cancer Limited Stage
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with SCLC are with the standard treatment and/or are enrolled in the clinical trials.

Brief summary: Small cell lung cancer (SCLC) is an aggressive disease that is characterized by rapid growth and the early development of metastases. Patients typically respond to initial chemotherapy but quickly experience relapse, resulting in a poor long-term outcome. Therapeutic innovations that substantially improve survival have historically been limited, and reliable, predictive biomarkers are lacking.

Ongoing research has advanced the understanding of molecular categories and the immunologic microenvironment of SCLC, which in turn has helped improve disease classification and staging. Considering the role of molecular alterations has not yet fully to be defined in the treatment of SCLC, there is an urgent recognition that molecular alterations in the SCLC are important to predict response and survival for novel therapies and ongoing clinical trials. Advances in research have revealed critical information regarding biologic characteristics of the disease, which may lead to the identification of vulnerabilities and the development of new therapies. Further research focused on identifying biomarkers and evaluating innovative therapies will be paramount to improving treatment outcomes for patients with SCLC.

In summary, identification of (genetic) biomarkers in SCLC is increasingly essential to perform molecular diagnostics and individualized treatments. This project aims to create a registry of patients with SCCL to further the characterization of molecular alterations and develop (novel) treatments based on the detection.


Eligibility criteria: Inclusion Criteria:

* Histologically proven diagnosis of SCLC
* 18 years of age or older
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Histologically proven diagnosis of non-SCLC

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: 20 years
measure: Disease control rate (DCR)
timeFrame: 20 years
measure: Progression-free survival (PFS)
timeFrame: 20 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 20 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
Study officials:
References:
Clinical trial NCT00925145: Single Incision Laparoscopic Appendectomy in the Community Utilizing Conventional Instruments
Official title: Single Incision Laparoscopic Appendectomy in the Community Utilizing Conventional Instruments
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Appendicitis
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2009-06-19
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients presenting to a community hospital (RGH) with a working diagnosis of acute appendicitis when the investigator (myself) and co-investigator (Dr. Bloom) are on call for general surgery emergencies.

Brief summary: There is a move to "scarless surgery" and this achieved by doing laparoscopic abdominal surgery though a single small umbilical incision. A technique for laparoscopic appendectomy done through a single incision utilizing conventional instruments has been developed. The operative risk of the single incision approach is no different that the standard three incision laparoscopic appendectomy. The goal is to study the operative time, length of hospital stay, and complications from this operation.


Eligibility criteria: Inclusion Criteria:

* all patients undergoing appendectomy for acute appendicitis

Exclusion Criteria:

* pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: Canada
facility: The Richmond Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Nam Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Scott Bloom
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Connie Chiu
role: STUDY_DIRECTOR
References:
Clinical trial NCT03984045: SPG Block for Acute Pediatric Migraine
Official title: Sphenopalatine Ganglion Block for Treating Acute Frontal Migraine Headache in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Migraine in Children
Sphenopalatine Neuralgia
Migraine in Adolescence
Lead sponsor: Newark Beth Israel Medical Center
Sponsor class: OTHER
First posted: 2019-06-12
Enrollment: 72
Sex: ALL
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized double blind trial comparing an intranasal sphenopalatine block with 2% lidocaine to intravenous (0.15 mg/kg, max 10mg) prochlorperazine in patients greater than 10 years of age presenting to a pediatric emergency department with an acute frontal migraine headache.

Detailed description: This is a randomized double blind trial comparing an intranasal sphenopalatine block with 2% lidocaine to intravenous (0.15 mg/kg, max 10mg) prochlorperazine in patients greater than 10 years of age presenting to a pediatric emergency department with an acute frontal migraine headache. Excluded populations include those with sickle cell, concern for CNS infection

Eligibility criteria: Inclusion Criteria:

- Frontal migraine headache

Exclusion Criteria:

* Non-english speaking
* Known pregnancy
* Sickle cell hemaglobinopathy
* Concern for CNS infection
* Acute febrile illness
* non-frontal headaches
* Concern for increased intracranial pressure

Primary outcomes:
measure: Time to headache resolution
timeFrame: treatment start to patient reported resolution, up to 6 hours
measure: ED Length of stay
timeFrame: Registration to discharge up to 6 hours
Secondary outcomes:
measure: Patient satisfaction: Rated on a Likert 100 millimeter scale
timeFrame: Within 6 hours from ED registration
measure: 24 hr follow up
timeFrame: 1 day
measure: Number of participants with treatment induced side effects
timeFrame: 1 day
measure: Determine adequacy of blinding
timeFrame: Asked at time of patient discharge from the emergency department or at 1 hr.
Other outcomes:
Locations:
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
Study officials:
affiliation: Newark Beth Israel Medical Center
name: Adam Sivitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05447845: Rapid Computerized Visual Acuity Test
Official title: A Novel Rapid, Reproducible and Accurate Computerized Visual Acuity Test
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vision Disorders
Refractive Errors
Retinal Disease
Cataract
Corneal Disease
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * healthy volunteers with no known ocular condition or past ocular surgery for the healthy group.
* patients with ocular conditions who presented for treatment at the Department of Ophthalmology at the Outpatient Clinic at Rambam Health Care Campus

Brief summary: A novel computerized visual acuity test was developed and tested on both healthy persons and patients with ocular conditions. Visual acuity outcomes of the computerized test will be compared to the Early Treatment Diabetic Retinopathy Study (ETDRS) in measures of reproducibility, accuracy and numbers of questions.


Eligibility criteria: Inclusion Criteria:

- age 18 years old and older

Exclusion Criteria:

* visual acuity \<0.2 decimal for the patient group
* visual acuity \<0.5 decimal for the healthy group

Primary outcomes:
measure: Visual acuity
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Department of Ophthalmology at Rambam Health Care Campus
Study officials:
affiliation: Head of the Department of Ophthalmology
name: Eytan Z Blumenthal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mimouni M, Shamir RR, Cohen AD, El-Yaniv R, Cohen MJ, Joskowicz L, Blumenthal EZ. A Comparison of different scoring terminations rules for visual acuity testing: from a computer simulation to a clinical study. Curr Eye Res. 2019 Jul;44(7):790-795. doi: 10.1080/02713683.2019.1589524. Epub 2019 Apr 8.
citation: Cohen ADN, Mimouni M, El-Yaniv R, Blumenthal EZ. Shortening the Early Treatment Diabetic Retinopathy Study visual acuity test utilizing a novel computer software: reproducibility in control and patient eyes. Acta Ophthalmol. 2021 Dec;99(8):e1281-e1288. doi: 10.1111/aos.14807. Epub 2021 Mar 19.
Clinical trial NCT06067945: Comparison of Marginal Fit and Internal Adaptation in All-Metal Crowns: an in Vitro Experimental Trial
Official title: Comparison of Marginal Fit and Internal Adaptation in All-Metal Crowns: an in Vitro Experimental Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Evaluation of Marginal and Internal Fit of Metal Crowns
Lead sponsor: Altamash Institute of Dental Medicine
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The phantom teeth (Nissin dental products Inc. Kyoto 601-8469,Japan) will be fixed in the model plaster block type II (Super national, Karachi Pakistan) with full crown and only 2mm of root portion

Brief summary: The goal of this in vitro study is to compare the marginal fit and internal adaptation of all-metal crowns in polished crown preparations and non-polished crown preparations The main question it aims to answer is: are the non polished tooth preparations comparable to polished preparations? We will compare polish and non polish groups and see their effects on marginal fit and internal adaptation of all metal crown


Eligibility criteria: Inclusion Criteria:

1. Phantom teeth
2. Maxillary molars
3. Metal crowns with conventional lost-wax technique for crown fabrication

Exclusion Criteria:

1. Over prepared or underprepared crowns
2. Defective metal crowns
3. Ruptured silicone films upon removal
4. Defective die stone casts

Primary outcomes:
measure: marginal fit
timeFrame: six months
Secondary outcomes:
measure: Internal fit
timeFrame: six months
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Altamash Institute Of Dental Medicine
state: Sindh
Study officials:
affiliation: Altamash Institute of Dental Medicine
name: Naseer Ahmad, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT00887445: First in Man Study With SLV341
Official title: A Double-blind, Randomized, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SLV341 in Young Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Diabetes
Keywords: First in Man
SLV341
diabetes
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
First posted: 2009-04-24
Enrollment: 87
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: First in man study with single and multiple rising doses with SLV341


Eligibility criteria: Inclusion Criteria healthy Exclusion Criteria not healthy

Primary outcomes:
measure: Safety and tolerability parameters: adverse event, vital signs, 12-Lead ECG, continuous lead II ECG monitoring, laboratory safety variables and physical examination.
timeFrame: 7 days
Secondary outcomes:
measure: Pharmacokinetic parameters: Plasma: Cmax, tmax, AUC, t½, λz, CL/F, and Vz/F. Urine: Aeurine, fe, and CLR
timeFrame: 1 - 28 days
measure: Pharmacodynamic parameters: biochemistry and 24 h Holter monitoring.
timeFrame: 28 days
measure: Interaction with Midazolam
timeFrame: 24 hours
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: S341.1.001 Site #
Study officials:
affiliation: Solvay Pharmaceuticals
name: Ingrid Meuwsen
role: STUDY_DIRECTOR
References: