louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01811043: Improving Biopsy Experiences Study for Women
Official title: Improving Biopsy Experiences Study for Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Imaging Guided Breast Biopsy
Keywords: breast biopsy
anxiety
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-03-14
Enrollment: 243
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this study is to examine whether a guided meditation intervention will reduce anxiety and distress as compared to a music intervention or radiologist supportive dialogue in women undergoing imaging-guided core needle breast biopsies. Both the guided meditation and music interventions are administered through use of headphones during routine outpatient imaging-guided core needle breast biopsies. Women in the guided meditation and music conditions will be given a CD with instructions for home practice. Women complete follow-up questionnaires in the 12 months after biopsy. Receipt of recommended follow-up care is examined for 60 months.


Eligibility criteria: Inclusion Criteria:

* 21 years old or older
* Undergoing imaging guided core needle biopsy
* Mammography or ultrasound Breast Imaging - Reporting and Data System(BI-RADS) final assessment category 3,4a-c, or 5
* Able to speak and read English
* Able to provide meaningful consent

Exclusion Criteria:

* significant hearing impairment

Primary outcomes:
measure: Change in Anxiety
timeFrame: Change in anxiety from baseline (i.e., pre biopsy) assessment to post biopsy assessment will be examined. Participants will be followed for the duration of the biopsy, with an expected average of 1.5 hours between assessments.
Secondary outcomes:
measure: Rates of adherence to recommended follow-up care
timeFrame: 60 months following biopsy
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Cancer Institute
state: North Carolina
Study officials:
affiliation: Duke University
name: Mary Scott Soo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00708643: Clinical Performance of a New Daily Disposable Contact Lens Worn in an Established Contact Lens Wearing Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Myopia
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Manchester
First posted: 2008-07-02
Enrollment: 80
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study seeks to evaluate the clinical and subjective performance of a new daily disposable soft contact lens.


Eligibility criteria: Inclusion Criteria:

1. They are of legal age (17 years) and capacity to volunteer.
2. They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
3. They are willing and able to follow the protocol.
4. They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.
5. They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.
6. They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC).
7. They have successfully worn contact lenses within six months of starting the study.

Exclusion Criteria:

1. They have an ocular disorder which would normally contra-indicate contact lens wear.
2. They have a systemic disorder which would normally contra-indicate contact lens wear.
3. They are using any topical medication such as eye drops or ointment.
4. They are aphakic.
5. They have had corneal refractive surgery.
6. They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.
7. They are pregnant or lactating.
8. They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
9. They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV).
10. They have diabetes.
11. They have taken part in any other clinical trial or research, within two weeks prior to starting this study.

Primary outcomes:
measure: Limbal Hyperemia
timeFrame: At 2 weeks and 4 weeks
measure: Lens Comfort
timeFrame: At 3,7,10,13,17,21,24, and 27 days
measure: Upper Lid Margin Staining
timeFrame: At 2 weeks and 4 weeks.
Secondary outcomes:
measure: Tarsal Roughness
timeFrame: At 2 weeks and 4 weeks
measure: Tarsal Hyperemia
timeFrame: At 2 weeks and 4 weeks.
measure: Corneal Staining
timeFrame: At 2 weeks and 4 weeks.
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Centre for Contact Lens Research
state: Ontario
Study officials:
References:
Clinical trial NCT06329843: Intermountain Inpatient Bilirubin Decision Accuracy Study Using Smartphone-based Measurements by Picterus Jaundice Pro
Official title: Intermountain Inpatient Bilirubin Decision Accuracy Study Using Smartphone-based Measurements by Picterus Jaundice Pro
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neonatal Jaundice
Keywords: jaundice
neonate
phototherapy
Lead sponsor: Picterus AS
Sponsor class: INDUSTRY
Collaborators: name: Intermountain Medical Center
First posted: 2024-03-26
Enrollment: 500
Sex: ALL
Minimum age (years): 12
Maximum age (years): 192
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: newborns

Brief summary: The goal of this project is to evaluate the performance of Picterus Jaundice Pro in an American population, including preterm and term newborns and pre- and post- phototherapy.

Detailed description: The purpose of this study is to compare serum bilirubin levels with non-invasive bilirubin measurements in neonates during the first 12 to 192 hours of life using the "Picterus Jaundice Pro" smartphone application with a proprietary calibration card placed over the neonate's sternum. We will also validate the accuracy of Picterus Jaundice Pro bilirubin measurements before and after phototherapy treatment.

Eligibility criteria: Inclusion Criteria:

* the patient is free of skin rash, bruising, or other medical conditions that can interfere with transcutaneous measurement
* (preterm) \< = 35 weeks gestational age
* (term) \> 35 weeks gestational age
* the patient has not been excluded by PI discretion.

Exclusion Criteria:

* Neonates will be excluded from participation if all four inclusion criteria listed above are not met.

Primary outcomes:
measure: Enable high qualitative estimation of bilirubin levels in the blood of term and preterm newborns undergoing phototherapy using Picterus JP.
timeFrame: 2 months
Secondary outcomes:
measure: Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from term-born babies without phototherapy.
timeFrame: 2 hours
measure: Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from preterm-born babies without phototherapy.
timeFrame: 2 hours
measure: Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from term-born babies who have received phototherapy.
timeFrame: 2 hours
measure: Correlate the bilirubin measurement from Picterus JP with serum bilirubin levels from preterm-born babies who have received phototherapy.
timeFrame: 2 hours
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Intermountain Health
state: Utah
Study officials:
affiliation: Intermountain Health Care, Inc.
name: Timothy M Bahr, MS MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02253043: The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Alzheimer's Disease
Official title: The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease
Lead sponsor: Beijing Pins Medical Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Beijing Tiantan Hospital
First posted: 2014-10-01
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Purpose: The purpose of this clinical study is to verify the long term effectiveness and safety of a bilateral deep brain stimulation (DBS) produced by Beijing PINS Medical Co., Ltd. as a treatment option for patients with cognitive, behavioral, and functional disability of Alzheimer's disease.

Detailed description: Other: Deep Brain Stimulation Implanted device Subjects will then be instructed to apply PINS Deep Brain Stimulation Device for 12 month.

Eligibility criteria: Inclusion Criteria:

1. Subject is aged 40 to 80 years old;
2. Subject with AD diagnosed according to the criteria for probable AD as defined by the National Institute of Neurological Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA);
3. Subject have received the diagnosis of AD within the past 2 years;
4. Subject have a CDR of 0.5 or 1.0;
5. Score between 20 and 28 on the Mini Mental State Examination
6. have been taking a stable dose of cholinesterase inhibitors for a minimum of 6 months.

Exclusion Criteria:

1. Patients with hearing impairment;
2. Failures of important organs and in severe conditions
3. Be reluctant or disabled to receive neuropsychological assessments;
4. Participate in other clinical trial;
5. Has a life expectancy of \< 1 year.
6. The investigator and/or enrollment review committee, would preclude participation in the study.

Primary outcomes:
measure: Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog)
timeFrame: 12 month
Secondary outcomes:
measure: Clinical Dementia Rating Scale
timeFrame: 12 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
city: Beijing
country: China
facility: 301 Hospatl
state: Beijing
Study officials:
affiliation: Tsinghua University
name: Li Luming, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02835443: Electrical Stimulation of the Dentate Nucleus for Upper Extremity Hemiparesis Due to Ischemic Stroke
Official title: Electrical Stimulation of the Dentate Nucleus Area (EDEN) for Improvement of Upper Extremity Hemiparesis Due to Ischemic Stroke: A Safety and Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Ischemic Stroke
Deep Brain Stimulation
DBS
Physical Therapy
Rehab
Brain Stimulation
Lead sponsor: Enspire DBS Therapy, Inc.
Sponsor class: INDUSTRY
First posted: 2016-07-18
Enrollment: 12
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical trial will evaluate if Deep Brain Stimulation (DBS) is safe for the treatment of stroke and will help understand if DBS improves motor recovery for patients who continue to have significant impairment.

Detailed description: The proposed study is a safety and feasibility study intended to provide preliminary data to design a future pilot study. The objective of this study is to document the safety and patient outcomes of electrical stimulation of the dentate nucleus area for the management of chronic, moderate to severe upper extremity hemiparesis due to ischemic stroke.

Eligibility criteria: Key Inclusion Criteria:

* One-time stroke that occurred 1-3 years ago (i.e. index stroke 12-36 months)
* Stroke due to a blocked blood vessel (i.e. unilateral MCA stroke)
* Moderate to severe weakness in one arm (i.e. unilateral upper-extremity hemiparesis)

Key Exclusion Criteria:

* Seizures since time of stroke (i.e. seizures or seizure disorder)
* Unable to have an MRI (i.e. contraindicated for MRI)

Primary outcomes:
measure: Adverse Events
timeFrame: 18 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Andre Machado, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00334243: Protocols for Improved in Vitro Fertilization (IVF) Outcomes
Official title: Protocol Evaluation for Improved In Vitro Fertilization Outcomes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Infertility
Keywords: in vitro fertilization
infertile
infertility
pregnancy
pregnancy rates
microflare protocol
antagonist protocol
demi-halt protocol
poor responders
low antral follicle count
Infertile Patients undergoing in vitro fertilization (IVF)
Patients with a previous poor response to ovarian stimulation
Patients with an antral follicle count of less than 10
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2006-06-07
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Many infertile patients have a decreased chance of becoming pregnant when using in vitro fertilization (IVF). For these patients, many different treatments are available, but none of them have been shown to be better than the others. We are testing which of three different treatments are better than the others. Patients who are expected to have a decreased response to ovarian stimulation will be randomized to either a microflare protocol, an antagonist protocol, or a demi-halt protocol.

Detailed description: Infertile patients with an anticipated poor response to ovarian stimulation will be randomized to one of three different protocols in their upcoming IVF cycle. Each of the protocols will be performed as is the standard of care with the addition of serum evaluation during the course of the stimulation as well as follicular fluid analysis which is obtained as a byproduct of the oocyte retrieval. Chart review will be performed to collect background characteristics (including age, ethnicity, previous fertility treatment), treatment response (such as oocyte number, embryo grade, embryo quality), and pregnancy outcome (such as miscarriage, singleton pregnancy, or higher-order multiple pregnancy). Statistical analysis will be performed to determine if one protocol leads to higher pregnancy rates and multivariate analysis will be performed to determine potential etiologic variables.

Eligibility criteria: Inclusion Criteria:

* Infertile patients
* Undergoing IVF
* Antral Follicle Count Less than 10
* Prior history of less than 5 oocytes generated during an IVF cycle

Primary outcomes:
measure: Pregnancy Rate
Secondary outcomes:
measure: Cycle Cancellation Rates
measure: Number of Oocytes Generated
measure: Number of Embryos Generated
measure: Serum hormonal evaluation
measure: Follicular fluid evaluation
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Marcelle I Cedars, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02132143: Comparative Study of Chemoradiation and Sequential Chemoradiation About Lung Adenocarcinoma Patients With Postoperative in pN2
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Adenocarcinoma Patients With Postoperative in pN2
Keywords: Lung adenocarcinoma
Concurrent chemoradiotherapy
Sequential chemoradiotherapy
Progression-free survival
Lead sponsor: People's Hospital of Guangxi Zhuang Autonomous Region
Sponsor class: OTHER
First posted: 2014-05-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study compares chemoradiation and sequential chemoradiation about Lung adenocarcinoma patients with postoperative in pN2 and then determines which therapeutic method is better for the patients.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Lung adenocarcinoma
* Postoperative staging pN2 period
* Voluntary participation and informed consent
* Age ≥ 18 years old, male or female, within six months of weight loss of less than 10%, can tolerate radiotherapy
* performance status( PS) score 0-2.
* Hemoglobin ≥ 80 g / L, white blood cell ≥ 4 × 109 / L, platelets ≥ 100 × 109 / L.
* Liver function: alanine aminotransferase (ALAT), aspartate transaminase (ASAT) \<upper limit of normal (ULN) of 1.5 times, bilirubin \<1.5 × ULN.
* Renal function: serum creatinine \<1.5 × ULN.
* Compliance, and can be regular follow-up, voluntary compliance with study requirements

Exclusion Criteria:

* Do not meet the inclusion criteria
* There is evidence of distant metastases
* Suffered from other malignancies in five years
* Within the past January subjects received other drug trials
* Having serious allergies or idiosyncratic persons, such as you can not use folic acid, dexamethasone, vitamin B12 patients
* Severe lung or heart disease, a history
* Refuses or is unable to sign informed consent to participate in trials
* The abuse of drugs or alcohol addicts.
* Patients with difficult to control bacterial, viral, fungal infections
* Having a personality or mental disorders, without civil capacity or restricted civil capacity.
* Being pregnant or lactating women.

Primary outcomes:
measure: progression-free survival
timeFrame: two and a half years
Secondary outcomes:
measure: Overall survival
timeFrame: two and a half years
Other outcomes:
measure: side-effect
timeFrame: one year
Locations:
city: Nanning Shi
country: China
facility: The People's Hospital of Guangxi Zhuang Autonomous Region
Study officials:
References:
Clinical trial NCT03991143: Efficacy, Safety and Tolerability of ATH3G10 in Patients With ST-elevation Myocardial Infarction
Official title: A Phase IIa, Placebo-controlled, Double Blind, Randomised Multicentre Pilot Study to Investigate the Efficacy, Safety and Tolerability of the Monoclonal Antibody ATH3G10 in Patients With ST-elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: ST Elevation Myocardial Infarction
Lead sponsor: Athera Biotechnologies AB
Sponsor class: INDUSTRY
First posted: 2019-06-19
Enrollment: 82
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with ST-segment elevation myocardial infarction (STEMI) that have suffered a major anterior wall infarction or where coronary blood flow is less than normal in spite of successful percutaneous coronary intervention (PCI) have a poor prognosis. There are today no medical treatments that specifically reduce risk in these patients. The acute inflammatory reaction in conjunction with a STEMI and reperfusion by PCI determines the final size of the infarction and the signals leading to left ventricular remodelling.

This study is designed to assess the efficacy and safety of single intravenous injection with ATH3G10, a fully human IgG1 antibody against phosphorylcholine, in high-risk subjects with STEMI. ATH3G10 aims to reduce inflammation and thereby infarction size and remodeling.


Eligibility criteria: Inclusion Criteria:

* Acute myocardial infarction with ST elevation at the J-point in two contiguous leads
* Start of PCI less than 4 hours after symptom onset.

Exclusion Criteria:

* Cardiogenic chock, non-compensated acute heart failure and/or pulmonary edema.
* Previous major vascular intervention within the last 4 weeks.
* History of an infarct in the same artery that is currently affected.
* Conditions contraindicating MRI

Primary outcomes:
measure: Left ventricular remodelling
timeFrame: From Visit2 (day 3) to visit 3 (day 90)
Secondary outcomes:
measure: Myocardial Salvage index (MSi)
timeFrame: Visit 2 (day 3)
Other outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and tolerability]
timeFrame: From baseline (Visit 1, day 1) to visit 3 (day 90)
Locations:
city: Uppsala
country: Sweden
facility: Department of Cardiology, Uppsala University Hospital
Study officials:
References:
Clinical trial NCT00002443: The Safety and Effectiveness of MK-639 and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
Official title: Twelve-Month Study in HIV-1 Seropositive Retroviral-Naive Patients to Compare the Safety and Efficacy of MK-639 and Zidovudine (AZT) Administered Concomitantly to MK-639 Alone and Zidovudine (AZT) Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 780
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To compare the effects on CD4 counts and safety of MK-639 (indinavir, IDV) and AZT administered concomitantly to MK-639 alone and AZT alone in HIV-1 seropositive patients.

Detailed description: Patients are randomized to 1 of 3 groups for 12 months of treatment. Group 1 receives MK-639 plus AZT. Group 2 receives MK-639 alone. Group 3 receives AZT alone. Safety and tolerability are assessed by the incidence of clinical and laboratory adverse experiences. Blood and urine samples are collected for safety assessment and to determine CD4 cell counts and serum viral RNA levels. If therapy with MK-639 alone or with AZT is found to be generally safe and clinically efficacious, patients who have completed the study will have the opportunity to continue in an extension study protocol on a treatment regimen including MK-639.

Eligibility criteria: Inclusion Criteria

Patients must have:

* HIV seropositivity.
* Average CD4 count between 50 and 500 cells/mm3 based on 2 separate pre-study determinations at least 1 week apart.

Note:

* Patients with known hemophilia may be enrolled at the discretion of the investigator.

Prior Medication:

Excluded:

* Any protease inhibitor.
* Significant prior use (greater than 2 weeks) of nucleoside analogues.
* Chronic therapy for an active opportunistic infection. (Allowed:
* Prophylaxis with aerosolized pentamidine, trimethoprim/sulfamethoxazole, dapsone, topical antifungals, and isoniazid).
* Investigational agents or immunomodulators within 30 days prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Acute hepatitis.
* Lymphoma.
* Visceral Kaposi's sarcoma.
* Invasive cervical cancer.
* Active infection.

Concurrent Medication:

Excluded:

Anticipated immunosuppressive therapy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: