louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01319773: Study of Two Formulations of Cyclosporine Ophthalmic Emulsion in Healthy Volunteers and in Patients With Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dry Eye Syndromes
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2011-03-22
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study will evaluate the safety, tolerability and pharmacokinetics of two formulations of cyclosporine ophthalmic emulsion in healthy adults (parallel-group phase). The parallel-group phase will be followed by a paired-eye phase which will evaluate the safety and tolerability of two formulations of cyclosporine ophthalmic emulsion compared with cyclosporine ophthalmic emulsion (RESTASIS®) in patients with dry eye.


Eligibility criteria: Inclusion Criteria:

Parallel-Group Phase:

* Weigh at least 110 lbs
* 18 to 45 years old

Paired-Eye Phase:

* Dry eye disease in both eyes

Exclusion Criteria:

Parallel-Group Phase:

* Use of nicotine products, any medications, supplements or herbal products or consumption of grapefruit juice within 14 days or anticipated use during the study
* Has donated blood within 90 days
* Significant weight change (over 10 lbs) within 60 days
* Previous use of RESTASIS®

Parallel-Group and Paired-Eye Phases:

* Anticipated wearing of contact lenses during the study or wearing of contact lenses within 14 days
* Consumption of alcohol products within 72 hours

Paired-Eye Phase:

* Previous ocular surgery
* Use of RESTASIS® within 30 days

Primary outcomes:
measure: Concentration of Cyclosporine Measured in Blood at Day 1 in the Parallel-Group Phase (PGP)
timeFrame: Day 1
Secondary outcomes:
measure: Number of Subjects Who Reported Ocular Symptoms During the Parallel-Group Phase (PGP)
timeFrame: 3 Days
measure: Number of Eyes With Ocular Symptoms Post-Dose During the Paired-Eye Phase (PEP) at Day 1
timeFrame: Day 1
Other outcomes:
Locations:
city: Newport Beach
country: United States
state: California
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01415973: Nutrient Synergy in Beef and Stimulation of Protein Synthesis in Elderly
Official title: Nutrient Synergy in Beef and Stimulation of Protein Synthesis in Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: beef
protein
synergy
intact beef constituents
protein constituent
Nutrient Synergy
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2011-08-12
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will compare the effects of cooked, ground beef to those of beef protein isolate on blood and muscle proteins.

Detailed description: STUDY OBJECTIVES Primary: To compare the effects of consumption of a 3-ounce serving of beef to that of a 20g serving of BPI on skeletal muscle synthetic and breakdown rate in healthy elderly subjects.

Secondary: To investigate the effect the study products on plasma levels of amino acids, insulin, and glucose in healthy elderly subjects.

Eligibility criteria: Inclusion Criteria:

* Healthy male or female.
* Age 60 years or older.

Exclusion Criteria:

* Any (history of) gastrointestinal disease that interferes with GI function
* Diagnosed and active treatment of Diabetes Mellitus type I or II
* History of congestive heart failure
* Recent (6 months) hospitalization for heart disease treatment or management (e.g. PTCA, stent, surgery)
* Myocardial infarction in the past year
* Infection or fever in the 7 days prior to enrollment
* Current use of corticosteroids, growth hormone, or testosterone
* Adherence to a weight loss diet
* Use of protein-containing or amino acid-containing nutritional supplements within one week of enrollment
* Current alcohol (\>7 ETOH per week) or drug abuse
* Platelet count (PLT) \< 100,000
* History of hypo- or hyper-coagulation disorders including use of a coumadin derivative
* Currently taking anti-thrombotics and cannot stop for 7 days (i.e. medical indication)
* Allergy to local anesthetic
* Blood hemoglobin \< 9.0 g/dL
* Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements

Primary outcomes:
measure: skeletal muscle synthetic and breakdown rate
timeFrame: day one
Secondary outcomes:
measure: concentrations of plasma amino acids, insulin and glucose
timeFrame: day one
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: UAMS Center on Aging
state: Arkansas
Study officials:
affiliation: UAMS
name: Robert R Wolfe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02760173: Verticality Perception - Effects of Prolonged Roll-tilt in Healthy Human Subjects
Official title: Verticality Perception - Effects of Prolonged Roll-tilt in Healthy Human Subjects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Vestibular
Perception
Keywords: verticality perception
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2016-05-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The long-term goal of this research is to advance our knowledge of how the brain combines the information of multiple sensory systems coding for spatial orientation and how adaptation to vestibular imbalance influences spatial orientation. In healthy human subjects verticality perception is accurate while upright. After prolonged roll-tilt, humans show a systematic bias in perceived direction towards the previous roll-tilted position (so-called "post-tilt bias"). Here we evaluate different potential explanations for this bias using both vision-dependent and vision-independent paradigms of verticality perception.


Eligibility criteria: Inclusion Criteria:

1. ages 18-65 years
2. informed consent
3. absence of exclusion criteria

Exclusion Criteria:

1. peripheral-vestibular deficit
2. disturbed consciousness
3. history of sensory deficits
4. visual field deficits
5. other neurological or systemic disorder which can cause dementia or cognitive dysfunction
6. intake of antidepressants, sedatives, or neuroleptics
7. pregnancy, unless excluded by a negative pregnancy test
8. known neck pain or status post neck trauma

Primary outcomes:
measure: Adjustment errors and trial-to-trial variability as assessed by line adjustments (subjective visual vertical (SVV)), adjustments of a rod (subjective haptic vertical (SHV)) or self-adjustments (subjective postural vertical (SPV)) after prolonged roll
timeFrame: measurements will be obtained over periods of 5min in a single session and day
Secondary outcomes:
measure: Impact of a rotating optokinetic stimulus (velocity 60°/s) on adjustment errors as assessed by the SVV, the SHV or the SPV after 5min of static roll-tilt at +/- 90° roll.
timeFrame: measurements will be obtained over periods of 5min in a single session and day
Other outcomes:
Locations:
Study officials:
affiliation: University of Zurich, Switzerland
name: Dominik Straumann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01709773: Focal Ablation of Cervical Precancer
Official title: Focal Ablation of High-grade Cervical Intraepithelial Neoplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High-grade Cervical Intraepithelial Neoplasia
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2012-10-18
Enrollment: 20
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot cohort study of women undergoing focal ablation for high-grade cervical intraepithelial neoplasia (HGCIN). The cohort was recruited from the UCSF Dysplasia Clinics. The standard treatment involves treatment of the entire cervix. Women with HGCIN meeting inclusion criteria were recruited for enrollment into the pilot study of focal treatment. Upon enrollment, they underwent focal ablational treatment rather than standard ablational treatment of the cervix. Follow-up visits were conducted at 2 weeks and 6 months to assess safety, feasibility, and acceptability. The 6-month recurrence rate of HGCIN will be calculated.


Eligibility criteria: Inclusion Criteria:

* Age 21-45 yo
* Biopsy-confirmed high grade cervical intraepithelial neoplasia grade 2, 3, or 2/3
* Satisfactory colposcopy, i.e., the entire transformation zone is visible
* Lesion occupying \<= 2 quadrants of the cervix.

Exclusion Criteria:

* Unsatisfactory colposcopy.
* Colposcopic lesion extending into the endocervical canal beyond colposcopic visualization.
* Endocervical curettage positive for high-grade cervical intraepithelial neoplasia.
* Suspicion for invasive cancer on colposcopic exam.
* Glandular dysplasia or atypical glandular cells on cytology.
* Unreliable for follow-up.
* Immunosuppression (HIV, transplant recipient, etc.)

Primary outcomes:
measure: Six-month recurrence rate of high-grade cervical intraepithelial neoplasia
timeFrame: six months
Secondary outcomes:
measure: Safety of focal treatment
timeFrame: six months
measure: Acceptability of focal treatment
timeFrame: six months
measure: Feasibility of focal treatment
timeFrame: enrollment
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: Karen Smith-McCune, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05911373: Serratus Plane Block Versus Serratus Plane Block Plus Parasternal Block Combination for Breast Surgery
Official title: Serratus Plane Block Versus Serratus Plane Block Plus Parasternal Block on Postoperative Opioid Consumption and Dermatomal Analyses for Breast Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Cancer, Breast
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Mastectomy is a technique often used in breast cancer surgery. Patients experience moderate to severe pain postoperatively after this procedure. Various plane blocks, NSAIDs, and opioid analgesics can be administered to these patients as components of multimodal analgesia. In the the study, the investigators aimed to evaluate the analgesic effects of the serratus plane block, the parasternal block added to the serratus plane block, and the dermatomal differences.


Eligibility criteria: Inclusion Criteria:

1. American Society of Anesthesiologist's physiologic state I-III patients
2. To undergo Mastectomy Surgery
3. Being between the ages of 18-65 years

Exclusion Criteria:

* Having a known heart, kidney, liver or hematological disease
* Having a history of peptic ulcer, gastrointestinal bleeding, allergy, chronic pain
* Routine analgesic use and history of analgesic use in the last 24 hours
* Not willing to participate in the study
* Uncooperative patients who have coagulopathy or use anticoagulant drugs
* To be allergic to one of the drugs to be used

Primary outcomes:
measure: Postoperative opioid consumption
timeFrame: first 24 hours
Secondary outcomes:
measure: Visual analog pain score
timeFrame: First 24 hours
measure: Sensory Assessment
timeFrame: 24 hours
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ali Ahiskalioglu
Study officials:
affiliation: Ataturk University
name: Hüsnü Kürşad
role: STUDY_DIRECTOR
References:
citation: Hu NQ, He QQ, Qian L, Zhu JH. Efficacy of Ultrasound-Guided Serratus Anterior Plane Block for Postoperative Analgesia in Patients Undergoing Breast Surgery: A Systematic Review and Meta-Analysis of Randomised Controlled Trials. Pain Res Manag. 2021 Oct 25;2021:7849623. doi: 10.1155/2021/7849623. eCollection 2021.
citation: Piraccini E, Biondi G, Corso RM, Maitan S. The use of rhomboid intercostal block, parasternal block and erector spinae plane block for breast surgery. J Clin Anesth. 2020 Feb;59:10. doi: 10.1016/j.jclinane.2019.06.004. Epub 2019 Jun 6. No abstract available.
Clinical trial NCT05449873: No-touch Radiofrequency Ablation for Recurrent Hepatocellular Carcinoma Using Triple Cooled-Wet Electrodes
Official title: No-touch Radiofrequency Ablation for Recurrent Hepatocellular Carcinoma After Locoregional Treatment Using Combined Energy Delivery Mode and Triple Cooled-Wet Electrodes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Recurrent Hepatocellular Cancer
Chronic Liver Disease and Cirrhosis
Keywords: No-touch radiofrequency ablation
Combined energy delivery mode
Triple cooled-wet electrodes
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: RF medical
First posted: 2022-07-08
Enrollment: 73
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate local tumor progression rate at 12 months after no-touch percutaneous radiofrequency ablation using combined energy delivery mode and triple cooled electrodes


Eligibility criteria: Inclusion Criteria:

* Child-Pugh Class A or B
* chronic hepatitis B or chronic hepatitis C or liver cirrhosis
* presence of recurrent hepatocellular carcinoma (HCC) after locoregional treatment confirmed by pathology or imaging studies including contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) according to Liver Imaging Reporting and Data System (LI-RADS) v2018
* single lesion less than or equal to 5 cm, or up to 3 lesions, each greater than less than or equal to 3 cm at the time of locoregional treatment

Exclusion Criteria:

* number of recurrent HCCs, equal or more than 3
* largest recurrent HCC size over 3 cm
* presence of vascular invasion by HCC
* platelet count less than 40,000 per mm3 or International Normalized Ratio (INR) prolongation over 50%
* presence of extrahepatic metastasis

Primary outcomes:
measure: Local tumor progression rate
timeFrame: 12 months after radiofrequency ablation
Secondary outcomes:
measure: Disease-free survival
timeFrame: 12 moths after radiofrequency ablation
measure: Technical success rate
timeFrame: 1 month after radiofrequency ablation
measure: Overall survival
timeFrame: 12 moths after radiofrequency ablation
measure: Complication rate
timeFrame: 1, 3, 6, 9, 12 months after radiofrequency ablation.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT00853476: The Standard Concentration of Morphine as a Positive Control for Intradermal Skin Test
Official title: The Standard Concentration of Morphine as a Positive Control for Intradermal Skin Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intradermal Test
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2009-03-02
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Healthy Volunteers

Brief summary: This study aims to compare skin reactivity results between morphine and histamine as a positive control agents in intradermal skin test.

Detailed description: Histamine hydrochloride and different concentrations of morphine sulfate will be intradermally injected and wheal diameter size will be comparatively measured between 15-30 minutes' time points after the test.

Eligibility criteria: Inclusion Criteria:

* age 18-60 years old

Exclusion Criteria:

* immunodeficiency state
* cancer
* severe skin diseases
* severe medical illnesses
* malnutrition
* uncontrolled asthma
* pregnancy
* received oral or systemic corticosteroid within 1 month before this study
* receiving immunosuppressive agents
* taken antihistamine within 3 days before this study
* taking beta-blocker
* previous history of immunotherapy
* have hypersensitivity reaction to morphine/opiates

Primary outcomes:
measure: Wheal diameter from morphine skin test at different concentrations compared to standard histamine between 15-30 minutes after skin test
timeFrame: 30 minutes
Secondary outcomes:
measure: Side effects
timeFrame: 24 hours
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Chulalongkorn University
Study officials:
affiliation: Chulalongkorn University
name: Jettanong Klaewsongkram, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03406676: Pre-treatment With Methylene Blue Prevent Peri-operative Reduced Systemic Vascular Resistance
Official title: The Preventive Effects of Pre-treatment With Methylene Blue for Vascular Paralysis of the Patients With Obstructive Jaundice During Operation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Jaundice
Keywords: Methylene blue; Peripheral vascular resistance
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To explore the effects of pre-treatment with methylene blue on reduced perioperative vascular resistance in patients with obstructive jaundice.

Detailed description: Hemodynamic characteristics of patients with obstructive jaundice are high cardiac output, low peripheral vascular resistance. The molecular basis for this feature is the increased production of NO. Methylene blue can increase peripheral resistance, the mechanism is: methylene blue is an oxidoreductase inhibitor, can inhibit the increased production of NO in the vascular endothelium, thereby increasing peripheral vascular resistance.

Eligibility criteria: Inclusion Criteria:

1. Aged between 18-60 years;
2. American Society of Anesthesiologists（ASA） grade I\~III;
3. TBIL\>ULN and TBA\>ULN; The patients with obstructive jaundice.

Exclusion Criteria:

1. Organs dysfunction(heart,lungs and etc);
2. Mental disorders;
3. in other clinical trial.

Primary outcomes:
measure: Peripheral vascular resistance
timeFrame: through operation completion, an average of 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Southwest Hospital
state: Chongqing
city: Chongqing
country: China
facility: Southwest Hospital
state: Chongqing
Study officials:
affiliation: MD Study Director Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University
name: Zheng ShuGuo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04886076: Sleep Profiles in REM Sleep Behavior Disorder
Official title: Circadian Rhythms Regulation in Pre-Manifest Synucleinopathies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rapid Eye Movement Sleep Behavior Disorder
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2021-05-13
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will involve men and women of all ethnic groups. We will recruit adults ≥ 40 years of age.

Control participants will be age- (±5 years) and gender-matched to participants with RBD, have no diagnosis of RBD, and meet all other inclusion/inclusion criteria as the RBD group.

Brief summary: Rapid eye movement (REM) sleep behavior disorder (RBD) is a sleep disorder in which you act out dreams during REM sleep. Sleep disturbances are very common in RBD, where they negatively impact patients' quality of life and safety. One of the known causes of sleep disturbance is the impairment of the "circadian rhythm", or the human sleep/wake cycle. The purpose of this study is to examine the role of disruption of the circadian rhythm in the development of RBD.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of RBD as assessed by the International Classification of Sleep Disorders (ICDS) diagnostic criteria within 3 years
2. 40 yrs of age

Exclusion Criteria:

1. Other significant neurological disorder
2. Untreated significant sleep apnea and/or current sleep apnea symptoms as assessed by the clinical investigator
3. Co-existent restless legs syndrome (RLS), as assessed by the ICDS diagnostic criteria for RLS
4. Cognitive impairment as determined by the Montreal Cognitive Assessment (MoCA) score of ≤ 23
5. Presence of depression defined as the Beck Depression Inventory (BDI) score \>20
6. Use of tricyclic antidepressants, MAO inhibitors or selective serotonin reuptake inhibitors since they may induce/worsen RBD, unless on a stable dose of medication for at least 8 weeks
7. Use of medications known to affect melatonin secretion, such as lithium, α- and β-adrenergic antagonists
8. Shift work, currently or within the prior 3 months
9. Travel through ≥ 2 time zones within 60 days prior to the screening

Primary outcomes:
measure: Circadian Amplitude
timeFrame: Study Day 17-18
measure: REM Sleep Phenomena
timeFrame: Study Day 16-17
measure: Objective Daytime Sleepiness
timeFrame: Study Day 17
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: