louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00317850: Gabapentin for the Treatment of Tinnitus
Official title: Gabapentin for the Relief of Idiopathic Subjective Tinnitus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Tinnitus
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2006-04-25
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The specific aim of the Gabapentin for the Relief of Idiopathic Subjective Tinnitus Trial is to assess the therapeutic benefit of Gabapentin (Neurontin®) for subjective idiopathic troublesome tinnitus. We employed a double-blind placebo-controlled randomized clinical trial design to assess the efficacy of Gabapentin. Adults, between the ages of 18 and 70 with idiopathic, subjective, troublesome, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or greater and score of 38 or greater on the Tinnitus Handicap Inventory were enrolled.


Eligibility criteria: Inclusion Criteria:

* Adults, between the ages of 18 and 70
* Idiopathic, subjective, troublesome, unilateral or bilateral, non-pulsatile tinnitus (ICD-9 --388.31) of 6 month's duration or greater
* Tinnitus handicap score of 38 or greater on the Tinnitus Handicap Inventory.

Exclusion Criteria:

* The symptoms of tinnitus can be affected by the concomitant use of tricyclic antidepressants, carbamazepine, phenytoin, valproate sodium, or benzodiazepines. Patients who have used these drugs within 30 days of screening will not be enrolled.
* Impaired renal function as determined from serum creatinine levels, using the following formulas35: adult male Ccr = (140 -age) X weight in kilograms/(72 X serum creatinine in milligrams per deciliter); and adult female Ccr = \[(140 - age) X weight in kilograms/(72 X serum creatinine in milligrams per deciliter)\] X 0.85,whereCcr indicates creatinine clearance.
* Patients with tinnitus related to cochlear implantation, retrocochlear lesion, or other known anatomic/structural lesions of the ear and temporal bone
* Patients with any serious or unstable medical or psychiatric condition.
* Patients whose ability to give informed consent is in question.

Primary outcomes:
measure: Tinnitus Handicap Inventory Score from Baseline to Week 8
Secondary outcomes:
measure: Beck Depression Inventory Score from Baseline to Week 8
measure: Brief Symptom Inventory Score from Baseline to Week 8
measure: Epworth Sleepiness Scale Score from Baseline to Week 8
Other outcomes:
Locations:
Study officials:
affiliation: Washington University School of Medicine
name: Jay F Piccirillo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Piccirillo JF, Finnell J, Vlahiotis A, Chole RA, Spitznagel E Jr. Relief of idiopathic subjective tinnitus: is gabapentin effective? Arch Otolaryngol Head Neck Surg. 2007 Apr;133(4):390-7. doi: 10.1001/archotol.133.4.390.
Clinical trial NCT03543150: BOTOX® Drug Use Investigation (Spasmodic Dysphonia)
Official title: Botox Drug Use Investigation (Spasmodic Dysphonia)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dysphonia
Keywords: Spasmodic Dysphonia
VHI-10 scores
BOTOX
Drug use investigation
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2018-06-01
Enrollment: 400
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: Subjects receiving BOTOX for spasmodic dysphonia after obtaining approval for the indication of BOTOX for spasmodic dysphonia will be included in this study.

Brief summary: This study is a drug use investigation program of BOTOX. The objective of this investigation is to collect and assess information on the safety and efficacy of BOTOX injections in subjects with a diagnosis of spasmodic dysphonia in daily clinical practice. All subjects treated with BOTOX for spasmodic dysphonia after obtaining approval for the indication of BOTOX for spasmodic dysphonia will be included in this study. Approximately 400 subjects will be included in the study. The observation period per subject will be up to 12 months from the date of the first administration of BOTOX. The total study duration will be will be approximately 3 years from the date of approval for the indication of BOTOX for spasmodic dysphonia. BOTOX is a registered trademark of Allergan, Inc.


Eligibility criteria: Inclusion Criteria:

* All subjects treated with Botox for spasmodic dysphonia after obtaining approval for the indication of BOTOX for spasmodic dysphonia are included in this study.

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: Number of subjects with adverse drug reactions
timeFrame: Up to 1 year
measure: Change from Baseline in voice handicap index (VHI)-10 scores
timeFrame: Baseline and up to 1 year
measure: Efficacy rate based on global assessment of efficacy
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06022250: The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of JS207 in Patients With Advanced Malignant Tumor
Official title: A Phase I Study to Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of JS207 in Patients With Advanced Malignant Tumor
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Malignant Tumor
Lead sponsor: Shanghai Junshi Bioscience Co., Ltd.
Sponsor class: OTHER
Collaborators: name: Sponsor GmbH
First posted: 2023-09-01
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a Phase I open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK),Pharmacodynamic characteristics, immunogenicity and antitumor activity of JS207 in patients with advanced malignant tumor. The Recommended dose for phase II trial （RP2D） will be determined based on the safety, tolerability, pharmacokinetics.


Eligibility criteria: Inclusion Criteria:

1. Patients with advanced malignant tumor confirmed by histology or pathology, failed by standard treatment, no standard treatment or no standard treatment is applicable;
2. Eastern Cooperative Oncology Group (ECOG) 0 or 1;
3. Life expectancy ≥ 12 weeks;
4. At least one measurable lesion according to RECIST 1.1;
5. Adequate organ function;

Exclusion Criteria:

1. central nervous system metastasis；
2. There is a pleural, abdominal or pericardial effusion that is clinically symptomatic or requires repeated management (puncture or drainage, etc.)；
3. Images in screening showed that the tumor surrounded important blood vessels or had obvious necrosis and voids, and the investigators believed that it might cause bleeding risk；
4. The presence of severe, unhealed or open wounds, active ulcers, or untreated fractures；
5. A history of significant bleeding tendency or severe coagulopathy；
6. The presence of poorly controlled hypertension；

Primary outcomes:
measure: Dose-limiting toxicity （DLT）、adverse event（AE）
timeFrame: 2 Years
measure: Maximum tolerated dose (MTD),RP2D
timeFrame: 2 Years
Secondary outcomes:
measure: Peak concentration（Cmax）
timeFrame: 2 years
measure: Time to peak（Tmax）
timeFrame: 2 years
measure: Elimination half life（t1/2）
timeFrame: 2 years
measure: Progression free survival(PFS)
timeFrame: 2 years
measure: Overall survival (OS)
timeFrame: 2 years
measure: Immunogenicity
timeFrame: 2 years
measure: Objective response rate (ORR) based on Response Evaluation Criteria In Solid Tumors 1.1 (RECIST1.1)
timeFrame: 2 years
Other outcomes:
Locations:
city: Jinan
country: China
facility: Affiliated Cancer Hospital of Shandong First Medical University
state: Shandong
Study officials:
References:
Clinical trial NCT04376255: Augmented Reality Medical Simulation
Official title: Augmented Reality Medical Simulation: A Multi-Collaborative Study of Acceptance and Usability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Educational Problems
Keywords: Augmented Reality
Simulation
Education
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In order to improve the quality of care we provide to patients, medical trainees need to experience low incident, high mortality events in a safe learning environment. There is a selection bias for predisposing characteristics of health care providers, as most people who have pursued a career in medicine are motivated to learn how to manage medical emergencies. Resources have been traditionally enabled with conventional simulation centers or mobile simulation units. However, these are costly and difficult to access. The purpose of this study is to evaluate a mixed reality alternative to conventional simulation. The need for this is inherent in becoming a medical provider and use of these resources will improve health practices and health services.


Eligibility criteria: Inclusion Criteria:

* Trainees or personnel working and/or volunteering at Lucile Packard Children's Hospital Stanford / Stanford Health Care facilities
* 18 years and older

Exclusion Criteria:

* Have a history of severe motion sickness
* Currently have nausea
* History of seizures
* Are clinically unstable
* Currently using corrective glasses (not compatible with AR headset)

Primary outcomes:
measure: Qualitative Interview Assessment of Remote Simulations
timeFrame: Post-Simulation, Approximate time duration (3-5 minutes)
Secondary outcomes:
measure: System Usability Scale (SUS) Questionnaire
timeFrame: Post-Simulation, Approximate time duration (3-5 minutes)
measure: Ergonomic Survey
timeFrame: Post-Simulation, Approximate time duration (3-5 minutes)
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital Stanford
state: California
Study officials:
References:
Clinical trial NCT06393855: Base Curves of Bandage Contact Lenses and Their Effects on Post Trans-PRK Vision and Pain
Official title: Base Curves of Bandage Contact Lenses and Their Effects on Post Transepithelial Photorefractive Keratectomy (Trans-PRK) Vision and Pain： A Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopia
Keywords: Transepithelial photorefractive keratectomy
High Myopia
bandage contact lenses
Lead sponsor: Dongyang People's Hospital
Sponsor class: OTHER_GOV
First posted: 2024-05-01
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study was to investigate the impact of employing bandage contact lenses with a base curve of 8.4 mm versus 8.8 mm on visual recovery following Trans-PRK in patients characterized by steep corneas and high myopia.

Detailed description: Comparing two kind of bandage lenses in the contralateral eyes of the same individual following Trans-PRK may enable the derivation of reliable conclusions regarding the optimal choice for bandage lenses after Trans-PRK.

Eligibility criteria: Inclusion Criteria:

Spherical equivalent refractive error between -6.00 and -8.00 D in either eye.

Astigmatism of no more than 2.0 D in either eye.

Best spectacle-corrected visual acuity (BCVA) according to the logarithm of the Minimum angle of resolution (logMAR) scale of 0 or better in both eyes.

Willing and able to participate in all required activities of the study.

Exclusion Criteria:

Diabetes mellitus.

Systemic connective tissue disease.

Cardiovascular disease, epilepsy.

Eyelid abnormalities.

Corneal disease.

Glaucoma.

A history of ocular disease.

Noncompliance with measurement at enrollment.

Primary outcomes:
measure: Early postoperative uncorrected visual acuity
timeFrame: 14 days
Secondary outcomes:
measure: re-epithelialization after Trans-PRK
timeFrame: 1 week
measure: postoperative pain score after Trans-PRK
timeFrame: 2 weeks
measure: spherical equivalent after Trans-PRK
timeFrame: 1 week
Other outcomes:
Locations:
city: Dongyang
country: China
facility: Dongyang People's Hospital
state: Zhejiang
Study officials:
affiliation: Dongyang People's Hospital
name: Guangjin Zhao
role: STUDY_DIRECTOR
References:
Clinical trial NCT02448550: Comparison of Anticoagulation for All-comers Undergoing Percutaneous Coronary Revascularization Trial
Official title: Comparison of Unfractionated Heparin and Bivalirudin for Percutaneous Coronary Intervention for Stable Angina, Unstable Angina, and Non-ST Segment Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Percutaneous Coronary Intervention
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2015-05-19
Enrollment: 250
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 purpose of this trial is to determine whether bivalirudin is non-inferior to unfractionated heparin in patients with stable angina, unstable angina, or non-ST segment elevation myocardial infarction undergoing percutaneous coronary intervention.


Eligibility criteria: Inclusion Criteria:

1. Undergoing PCI for stable angina, unstable angina, or non-ST segment elevation myocardial infarction.
2. Age 18 years or older.

Exclusion Criteria:

1. Inability to obtain consent
2. Emergency cardiac catheterization for ST-segment elevation myocardial infarction.

Primary outcomes:
measure: Net adverse clinical events (composite of efficacy and safety [bleeding] endpoints)
timeFrame: 30-days
Secondary outcomes:
measure: all cause mortality, myocardial infarction, or unplanned revascularization for ischemia
timeFrame: 30-days
measure: Bleeding Academic Research Consortium grade III or V bleeding events
timeFrame: 30-days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles Medical Center
state: California
Study officials:
References:
Clinical trial NCT01122550: Reproducibility Study of Overactive Bladder Symptom Score [OABSS]
Official title: Reproducibility Study of OABSS and Its Response to Treatment in Indonesia - Part 1: Reproducibility -
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overactive Bladder
Keywords: OABSS
IPSS
PPBC
3-day micturition diary
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Indonesia Inc.
First posted: 2010-05-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Symptomatic OAB patients having urgency episodes

Brief summary: The purpose of this study is to evaluate its reproducibility of overactive bladder symptom score (OABSS) and to evaluate its correlation to other measures of OAB symptoms.


Eligibility criteria: Inclusion Criteria:

* Symptoms OAB for 3 months or longer
* At least 1 urgency episode in last 3 days
* Symptoms of OAB as verified by 3-day micturition diary prior to Visit 1, defined by:

  * Number of micturition per day ≥8
  * Number of urgency episodes in 3 days ≥1

Exclusion Criteria:

* Significant stress incontinence or mixed stress/urge incontinence
* Subjects with indwelling catheters or practicing intermittent self-catheterization
* Symptomatic urinary tract infection, chronic inflammation
* Diabetic neuropathy
* Drug or non-drug treatment for OAB was started, quitted or changed in 4 weeks
* Participation in any clinical trial in 30 days

Primary outcomes:
measure: OABSS
timeFrame: Weeks 0 and 2
Secondary outcomes:
measure: International Prostate Symptom Score (IPSS)
timeFrame: Weeks 0 and 2
measure: Quality of Life (QOL) score
timeFrame: Weeks 0 and 2
measure: Patient Perception of Bladder Condition (PPBC)
timeFrame: Weeks 0 and 2
Other outcomes:
Locations:
city: Bandung
country: Indonesia
city: Jakarta
country: Indonesia
city: Surabaya
country: Indonesia
Study officials:
affiliation: Astellas Pharma Indonesia
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT02923050: Simple Suppers Scale-up (S3)
Official title: Simple Suppers Scale-up (S3): an Expanded Pilot Study to Determine the Effectiveness of a Family Meals Intervention Aimed at Eliciting Positive Changes in Child Diet and Weight Status
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Cardinal Health
First posted: 2016-10-04
Enrollment: 223
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine effectiveness of a family meals intervention, Simple Suppers, aimed at eliciting positive changes in child dietary intake and weight status.


Eligibility criteria: Inclusion Criteria:

* Caregivers: Primary food preparer in the home; responsible for at least one child 4-10 years of age; speak English as the primary language in the home; lived in the U.S. for at least one year.

Exclusion Criteria:

* Family member: Following a restrictive or therapeutic diet.

Primary outcomes:
measure: Child standardized body mass index (BMI)
timeFrame: Change from baseline child BMI at 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Gunther C, Rogers C, Holloman C, Hopkins LC, Anderson SE, Miller CK, Copeland KA, Dollahite JS, Pratt KJ, Webster A, Labyk AN, Penicka C. Child diet and health outcomes of the simple suppers program: a 10-week, 2-group quasi-experimental family meals trial. BMC Public Health. 2019 Dec 10;19(1):1657. doi: 10.1186/s12889-019-7930-7.
citation: Rogers C, Anderson SE, Dollahite JS, Hill TF, Holloman C, Miller CK, Pratt KJ, Gunther C. Methods and design of a 10-week multi-component family meals intervention: a two group quasi-experimental effectiveness trial. BMC Public Health. 2017 Jan 9;17(1):50. doi: 10.1186/s12889-016-3908-x.
Clinical trial NCT00447850: Endometrial Gene Expression Profile in Controlled Ovarian Stimulation Cycles With Premature Luteinization
Official title: Endometrial Gene Expression Profile in Controlled Ovarian Stimulation Cycles With Premature Luteinization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Luteinization
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor class: OTHER
First posted: 2007-03-15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes

Brief summary: Previous studies have suggested that premature luteinization (PL)during controlled ovarian stimulation (COS) decreases the implantation rate due to a negative effect on the endometrium receptivity. This study aims to describe the impact on endometrial gene expression of PL in GnRH antagonist and GnRH agonist cycles.


Eligibility criteria: Inclusion Criteria:

* Oocyte donors
* Age between 18-35 years old
* BMI 18-29
* NORMOGONADOTROPHICS
* PROGESTERONE ≥ 1.2 ng/ml on hCG day

Exclusion Criteria:

* PolyCystic Ovarian Syndrome (PCOS)
* Endometriosis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Ivi Valencia
Study officials:
affiliation: Instituto Valenciano de la Infertilidad
name: Elena Labarta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05716750: Serum Prolidase Activity and the Role of Leptin in Osteomalacia
Official title: Serum Prolidase Activity and the Role of Leptin in Osteomalacia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteomalacia
Lead sponsor: University of Beykent
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 38
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
Primary purpose: TREATMENT

Brief summary: Evaluation of the change of serum Prolidase and Leptin values in the diagnosis and follow-up of osteomalacia and its clinical usability

Detailed description: Osteomalacia describes a bone disorder in adults that is usually caused by long-term vitamin D deficiency. Osteomalacia, a metabolic bone disease characterized by impaired mineralization of the bone matrix.Not a single laboratory finding is specific to osteomalacia.The relationship between collagen and prolidase activity has been observed during fibrotic processes, where an increase in prolidase activity is accompanied by an increase in tissue collagen deposition. It has also been suggested that serum activity is increased in metabolic bone diseases.Leptin is a 16 kDa peptide hormone. It is a member of the long chain helical cytokine family, which is mainly produced by fat cells and proportional to the size of the stored fat. Leptin affects bone remodeling by reducing the activity of osteoclasts and thus participates in the pathogenesis of osteoporosis. In the light of these studies, the investigators planned our study according to the clinical significance of serum prolidase activity in osteomalacia and the place of leptin in osteomalacia.

Eligibility criteria: Inclusion Criteria:

* Among the patients who applied to the outpatient clinic, those with clinical complaints of osteomalacia (diffuse pain, fatigue, rapid fatigue, proximal extremity weakness, etc.)
* 25 0H vit. D level of 10ng/ml and below

Exclusion Criteria:

* Other metabolic and endocrine bone diseases (secondary osteoporosis, paget hast, osteogenesis imperfecta, osteomyelitis etc.)
* Patients who have previously received treatment for low vitamin d
* Those with low vitamin D levels due to liver or kidney failure
* Those who receive treatment for tumor

Primary outcomes:
measure: Serum Prolidase activity
timeFrame: 8 weeks
measure: Serum Leptin
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: