louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01724385: Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy
Official title: Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy With New Dense Vitreous Hemorrhage After Full Panretinal Photocoagulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vitreous Hemorrhage
Proliferative Diabetic Retinopathy
Keywords: bevacizumab,
proliferative diabetic retinopathy,
vitreous hemorrhage,
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2012-11-09
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of intravitreal bevacizumab injections for treatment of proliferative diabetic retinopathy (PDR) with new dense vitreous hemorrhage (VH) after previous full panretinal photocoagulation (PRP).

Detailed description: The investigators will carry out a prospective study in patients with PDR and prior complete laser treatment who presented with new dense VH. All eyes will be treated with intravitreal injection of bevacizumab (1.25 mg). Complete ophthalmic examination and/or ocular ultrasonography will be performed at baseline and 1, 6, 12 weeks and 6, 9, 12 months after first injection. Re-injection will be done in non-clearing and recurrent VH.

Eligibility criteria: Inclusion Criteria:

* patients with diabetes mellitus
* proliferative diabetic retinopathy
* prior complete panretinal photocoagulation
* presented with new dense vitreous hemorrhage

Exclusion Criteria:

* one-eyed patient
* previous intraocular surgery
* severe lens opacity precluding fundus examination
* advance glaucoma
* history of thromboembolic events such as myocardial infarction and cerebrovascular accident
* uncontrolled systemic hypertension, systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg
* known coagulation abnormalities or current use of anticoagulant medications other than aspirin
* known allergies to any relevant drugs in this study
* evidence of external ocular infection such as conjunctivitis and significant blepharitis.

Primary outcomes:
measure: The percentage of eyes that vitreous hemorrhage has been completely resolved
timeFrame: 12 months
Secondary outcomes:
measure: The change in best corrected visual acuity (BCVA) from baseline
timeFrame: 12 months
Other outcomes:
measure: Numbers of injection
timeFrame: 12 months
Locations:
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital, Khon Kaen University
Study officials:
affiliation: Department of Ophthalmology, Faculty of Medicine, Khon Kaen University
name: Suthasinee Sinawat, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00601185: Confocal Reflectance Microscopy of Shave-Biopsy Sites on Skin in Vivo.
Official title: Confocal Reflectance Microscopy of Shave-Biopsy Sites on Skin in Vivo
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Basal Cell Carcinoma
Melanoma
Squamous Cell Carcinoma
Non-Malignant Skin Disorders
Keywords: 06-009
Confocal reflectance microscopy
shave-biopsy
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2008-01-25
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Dermatology clinic

Brief summary: The purpose of this study is to evaluate a new instrument that shines light and takes digital pictures of skin. The goal is to develop a technique that may enable fast and accurate detection of skin disorders and cancers for future clinical diagnosis and surgical use.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing shave-biopsy on an anatomical site that is readily accessible to the VivaScope 1500 (for example, chest, back, legs, arms, cheek, forehead).
* The additional 110 patients for this amendment will be imaged with the newly developed Vivascope 3000 handheld confocal microscope.
* Ability to sign informed consent.
* Age ≥ 18 years.

Exclusion Criteria:

* Shave-biopsy located on a site that is not amenable to confocal imaging (for example, adjacent to the nose, ears or eyes, fingers, toes).
* Inability to give informed consent.
* Known hypersensitivity to adhesive rings.
* Inability to tolerate imaging procedure (i. e., remain relatively still for multiple short durations of 3-4 minutes).

Primary outcomes:
measure: is to evaluate and quantify the technical feasibility of reflectance CSLM imaging of shave-biopsy sites on skin in vivo.
timeFrame: conclusion of study
Secondary outcomes:
measure: To assess the quality of the CSLM images of the biopsy sites to determine a point estimate of the proportion of images that will be of acceptable quality for formal analysis in the planned study of intraoperative margin detection.
timeFrame: conclusion of study
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering at Basking Ridge
state: New Jersey
city: Harrison
country: United States
facility: Memorial Sloan Kettering West Harrison
state: New York
city: Hauppauge
country: United States
facility: Memorial Sloan Kettering Cancer Center Hauppauge
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Kishwer Nehal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02053285: Pilot Study of a Novel Type of CT Scan to Assess Treatment Response During Chemoradiotherapy for Stage III Non-Small Cell Lung Cancer
Official title: Pilot Study of Dual-Energy Computed Tomography in Stage III Non-Small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer Stage III
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2014-02-03
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stage III lung cancer treated with chemoradiotherapy or chemoradiotherapy followed by surgery

Brief summary: Dual-energy CT (DECT) provides information on the blood volume in tumors and lymph nodes. As tumors respond to treatment, preliminary data suggests that the blood volumes changes as well. Investigators are therefore using DECT to test whether it can be used on radiation treatment to rapidly assess response to treatment.


Eligibility criteria: Inclusion Criteria:

* Patients aged greater than 18 years with a diagnosis of stage III non-small cell lung cancer.
* Planned treatment with either definitive chemoradiotherapy or preoperative chemoradiotherapy followed by surgical resection.
* PET-CT study within 4 weeks of next available DECT study.
* Patients must have measurable primary and nodal disease, defined by at least one lesion (primary and lymph node) greater than 1 cm.
* Kidney function sufficient to tolerate iodine-based CT contrast.
* No allergy to iodine-based contrast.
* Ability to understand and the willingness to sign informed consent.

Exclusion Criteria:

* Participants with a prior history of thoracic radiotherapy.
* Participants may not be receiving any other study agents.
* Inability to tolerate CT contrast
* Pregnant women are excluded from this study because radiotherapy has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with radiotherapy, breastfeeding should be discontinued if the mother is treated with radiotherapy. These potential risks may also apply to other agents used in this study.

Primary outcomes:
measure: Change in the tumor's maximum iodine related attenuation (IRA) from baseline to on-treatment DECT.
timeFrame: 0, 1, 3, 5
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
References:
Clinical trial NCT02315885: Biomarkers to Measure Treatment Response for Alcohol Dependence
Official title: Biomarkers to Measure Treatment Response for Alcohol Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Dependence
Keywords: healthy volunteers
social drinkers
alcohol
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2014-12-12
Enrollment: 29
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of the research study of the K23 award is to develop a blood test that can check how much alcohol a person has consumed in the past few days. We will enroll heavy social drinkers who do not have alcohol-related problems but used to drinking 5 or more beers on a single occasion. Both men and women between ages 21 and 65 years can join the study. All participants must be of European decent.


Eligibility criteria: Inclusion Criteria:

* Experienced binge drinking episode(s) (5 or more standard drinks for men and 4 or more standard drinks for women consumed in about 2 hours according to NIAAA definition) in the past 30 days

Exclusion Criteria:

* DSM-IV diagnosed alcohol dependence, other drug dependencies including nicotine dependence

Primary outcomes:
measure: Validity of using serotonin transporter mRNA expression levels
timeFrame: Within 24 hours of blood sample collection and in archived blood samples from the same participant stores at -80 degrees celsius for a duration of 6 months or more from the collection date
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Clinical Neurobehavioral Center
state: Maryland
Study officials:
affiliation: csenevi@som.umaryland.edu
name: Chamindi Seneviratne
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03572985: Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #3
Official title: Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #3: Alcohol Calibration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Participants
Lead sponsor: Taisho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Nagoya University
First posted: 2018-06-28
Enrollment: 25
Sex: MALE
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to collect alcohol calibration data for the driving simulator.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) ≥18.5 and \<25.0 kg/m\^2 at screening inspection
* No visual impairment (enable to correct the vision with eyeglasses or contact lens)
* Receive a prior explanation on the study, able to accept its content, and capable to provide voluntary written consent for participation in this study

Exclusion Criteria:

* History of drug and food allergy
* Alcohol dependence, drug dependence or abnormal drunken (including past history)
* Inappropriate for enrollment in this study was judged by principal investigator or subinvestigator

Primary outcomes:
measure: Standard Deviation of Lateral Position (SDLP)
timeFrame: 60 min
Secondary outcomes:
measure: Distance Coefficient of Variation (DCV)
timeFrame: 5 min
measure: Brake Reaction Time (BRT)
timeFrame: 5 min
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Taisho Pharmaceutical Co., Ltd selected site
Study officials:
affiliation: Taisho Pharmaceutical Co., Ltd.
name: Shigeru Okuyama
role: STUDY_DIRECTOR
References:
citation: Iwata M, Iwamoto K, Omura T, Ando M, Ozaki N. Protocol for the development and validation of a driving simulator for evaluating the influence of drugs on driving performance. Medicine (Baltimore). 2019 Feb;98(8):e14613. doi: 10.1097/MD.0000000000014613.
Clinical trial NCT01738685: Intervention to Improve Self-Care of Symptoms in Breast Cancer Survivors on Adjuvant Endocrine Therapy
Official title: Intervention to Improve Self-Care of Symptoms in Breast Cancer Survivors on Adjuvant Endocrine Therapy.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer Female
Keywords: Breast Cancer.
Adjuvant Endocrine therapy.
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2012-11-30
Enrollment: 0
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Hormone responsive breast cancer is common and costly. Long-term adjuvant endocrine therapy (AET) improves breast cancer outcomes greatly, but, unfortunately, is commonly associated with physical and emotional concerns. I propose to evaluate the feasibility and preliminary effectiveness of a behavioral intervention to facilitate problem identification, provide education, coaching for breast cancer survivors with symptoms while on AET. Therefore, the intervention intends to empower women to engage in better self-care and seek out resources they need, which, in turn, will lead to better symptom management.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 50.
* Nonmetastatic bread cancer survivors reporting being bothered by 1 or more symptoms related to their treatment with AET (for \> 0 months and \< 6 months).
* Possess a household or cell telephone.
* Ability to provide informed consent.

Exclusion Criteria:

* Clinically significant cognitive impairment.
* Communication barrier limiting ability to participate in telephone assessments.

Primary outcomes:
measure: Satisfaction determined by the Client Satisfaction Survey
timeFrame: Up to 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: G van Londen, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04447885: Weighted Blankets and Chronic Pain
Official title: Weighted Blankets and Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Chronic Pain Syndrome
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2020-06-25
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to test whether the use of weighted blankets can change the experience of chronic pain and to examine if social, psychological, or health factors influence the perception of the blanket. Multiple blanket weights will be tested.


Eligibility criteria: Inclusion Criteria:

1. 18 years or older
2. Fluent in English
3. Diagnosis of chronic pain (self-report; those already indicating this diagnosis on researchmatch.org)
4. Willing to sleep with a weighted blanket and fitness watch for 1 week
5. Able to safely lift up to 15lb
6. Willing and able to use their personal smartphone for fitness tracker app and EMA app to submit ratings using personal data plan

Exclusion Criteria:

1. Pregnancy
2. Major medical conditions such as kidney, liver, cardiovascular (hypertension, preexisting cardiac arrhythmia), autonomic, pulmonary, or neurological problems (e.g., seizure disorder)
3. Current or previous use of a weighted blanket
4. Claustrophobia

Primary outcomes:
measure: Change in pain ratings from before to after brief blanket use
timeFrame: 0 and 15 minutes
measure: Change in pain ratings from before to after nightly blanket use
timeFrame: at baseline (3 nights) and over 7 nights of use
Secondary outcomes:
measure: Change in anxiety ratings from before to after brief blanket use
timeFrame: 0 and 15 minutes; also at baseline (3 nights) and over 7 nights of use
measure: Change in ratings of sleep quality from before to after brief blanket use
timeFrame: baseline (3 nights) and over 7 nights of use
measure: Change in sleep quality measured by fitness watch from before to during week of blanket use
timeFrame: baseline (3 nights) and over 7 nights of use
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego
state: California
Study officials:
References:
citation: Baumgartner JN, Quintana D, Leija L, Schuster NM, Bruno KA, Castellanos JP, Case LK. Widespread Pressure Delivered by a Weighted Blanket Reduces Chronic Pain: A Randomized Controlled Trial. J Pain. 2022 Jan;23(1):156-174. doi: 10.1016/j.jpain.2021.07.009. Epub 2021 Aug 20.
Clinical trial NCT02324985: Phase II Study of AP0302 5% Versus a Vehicle Comparator
Official title: Phase II Study of the Effects of AP0302 5% (S-Ibuprofen Topical Gel 5%) Versus the Vehicle Control on Delayed Onset Muscle Soreness of the Elbow Flexors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Delayed Onset Muscle Soreness
Keywords: muscle soreness
Lead sponsor: Aponia Laboratories, Inc.
Sponsor class: INDUSTRY
First posted: 2014-12-24
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the analgesic safety and efficacy of study drug (AP0302) applied topically every 6 hours as compared to a vehicle, in subjects experiencing delayed onset muscle soreness.

Detailed description: The purpose of this study is to evaluate the efficacy and safety of S-Ibuprofen Topical Gel 5% in reducing pain/soreness associated with delayed onset muscle soreness (DOMS).

Eligibility criteria: Inclusion Criteria:

* no clinically significant medical conditions
* BMI between 18-30
* negative drug, alcohol, pregnancy screens
* other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* no upper extremity workout in last 6 months
* no job requiring heavy lifting
* history of muscle disorders
* allergy or intolerance to study drug
* history of recent pain medication use
* other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Sum of pain intensity differences over 24 hours from baseline (SPID24) with movement
timeFrame: 0-24 hours
Secondary outcomes:
measure: Sum of pain intensity differences over 48 hours from baseline (SPID48) with movement
timeFrame: 0-48 hours
measure: Sum of pain intensity differences over 48 hours from baseline (SPID48) at rest
timeFrame: 0-48 hours
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Lotus Clinical Research, LLC
state: California
Study officials:
affiliation: Lotus Clinical Research
name: Sonia Singla, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02275585: Portal Vein Thrombosis in Cirrhosis
Official title: Portal Vein Thrombosis in Cirrhosis: A Cohort Sudy
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hepatic Vein Thrombosis
Cirrhosis
Keywords: Portal vein
Thrombosis
Cirrhosis
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2014-10-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital care clinic

Brief summary: This study evaluates the supervivence of cirrhotic patients that develop portal vein thrombosis in comparison to cirrhotic patients that do not develop portal vein thrombosis.

Detailed description: Patients newly diagnosed with portal vein thrombosis by imaging tests, that evaluate the extent and exclude tumoral origin, will be included (informed consent previously signed).

Anticoagulant treatment will be initiated according to clinical guidelines (if there is no contraindication) first with LMWH (low molecular weight heparin) and later with dicoumarin.

An abdominal CT will be performed to evaluate the extent and exclude tumoral origin; a gastroscopy to evaluate portal hypertension (and do prophylaxis if required) and thrombophilia study.

Patients will be followed by imaging and laboratory tests every 6 months; to evaluate the response to the treatment and detect any cirrhosis complication.

Eligibility criteria: Inclusion Criteria:

* Cirrhosis diagnosed by liver biopsy or non-invasive methods/clinical, analytics or ultrasound usual criteria
* Portal vein thrombosis of newly diagnosed (defined as partial or complete obstruction of splenoportal vessels objectified by imaging with/without symptomatology) ≤ 6 months.
* Over 18 years old
* Want to participate (informed consent)

Exclusion Criteria:

* Pregnant or lactating
* Patients with tumoral vein thrombosis or elevated alpha-fetoprotein or high suspicion of underlying neoplastic disease.
* Thrombocytopenia \< 25.000 .
* Patients with cavernomatosis or portal vein thrombosis already known.
* Patient refusal to participate
* Patients already treated with anticoagulants for other diseases (atrial fibrillation, pulmonary thrombosis...)

Primary outcomes:
measure: Survival of patients with cirrhosis
timeFrame: 12 months
Secondary outcomes:
measure: Complications related with cirrhosis
timeFrame: 12 months
measure: Complications related with anticoagulation treatment
timeFrame: 12 months
measure: Prevalence of thrombophilic disorders in patients with Portal Vein Thrombosis
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02930785: Sun Protection Factor Assay (SPF Assay 202/2016)
Official title: Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-10-12
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female.
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form).
* Signed and dated Informed Consent Form.
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose).

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma, diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.

Primary outcomes:
measure: Minimal Erythema Dose (MED)
timeFrame: Up to 15 minutes
measure: 2 Minimal Persistent Pigment Darkening Dose (MPPD)
timeFrame: Up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
References: