cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Efficacy and Safety of Fospropofol Disodium

The aim of this study was to evaluate the pharmacodynamics, safety, and tolerability of Fospropofol disodium up to a dose producing maximal hypnotic effect as defined by electroencephalogramderived assessment (Bispectral Index \[BIS\]) and to compare the dynamic properties of PropofolF to those of Propofol.

After local ethics committee (West China Hospital, Sichuan University, Chengdu, China) approval and written informed consent were obtained, 80 healthy volunteers (40 males and 40 females) aged between 18 and 45 yr were included. For 1 week before the study, subjects were to follow a diet with limited amounts of alcohol and caffeine. Ingestion of caffeine, alcohol, products containing aspartame (aspartame may increase formate concentrations), or use of paracetamol within 24 h before study drug administration resulted in ineligibility. Exclusion criteria included hypersensitivity to any anesthetic; known or suspected serious disorders and/or significant dysfunction; an abnormal, clinically significant ECG finding; participation in an investigational drug study within the previous month; known or suspected pregnancy; anatomical malformations expected to produce a difficult intubation and known or suspected history or family history of malignant hyperthermia.

Eligibility Criteria:
Inclusion Criteria:

* After local ethics committee (West China Hospital, Sichuan University, Chengdu, China) approval and written informed consent were obtained, 80 healthy volunteers (40 males and 40 females) aged between 18 and 45 yr were included. For 1 week before the study, subjects were to follow a diet with limited amounts of alcohol and caffeine.

Exclusion Criteria:

* Exclusion criteria included hypersensitivity to any anesthetic; known or suspected serious disorders and/or significant dysfunction; an abnormal, clinically significant ECG finding; participation in an investigational drug study within the previous month; known or suspected pregnancy; anatomical malformations expected to produce a difficult intubation and known or suspected history or family history of malignant hyperthermia.
Laparoscopic Versus Open Liver Resection in the Treatment of Hepatocellular Carcinoma

The purpose of this study is to investigate the clinical value of laparoscopic liver resection in the treatment of hepatocellular carcinoma by assessing its Surgical and oncologic outcomes comparing with open liver resection.


Eligibility Criteria:
Inclusion Criteria:

* Liver solid tumor, with clinical diagnosis of hepatocellular carcinoma
* Located at segment Ⅱ、Ⅲ、Ⅳb、Ⅴ or Ⅵ
* The tumor location and size do not affect the dissection of hepatic hilar region
* Tumor size less than 10cm
* Without portal vein tumor thrombus
* Without intrahepatic or distant metastasis
* Willingness to participate in the study
* Able to understand the nature of the study and what will be required of them
* Body mass index of between 18 and 35
* Child-Pugh classification of A to B
* American Society of Anesthesiologists (ASA) grading of I to III

Exclusion Criteria:

* Pregnant or lactating women
* Unwillingness to participate
* Inability to give written informed consent
* Child-Pugh classification of C
* ASA grading of IV to V
* Tumor invasion of the inferior vena cava or confluence part of hepatic vein
* Decompensated liver cirrhosis
EF5 and Motexafin Lutetium in Detecting Tumor Cells in Patients With Abdominal or Non-Small Cell Lung Cancer

This clinical trial is studying the amount of EF5 and motexafin lutetium present in tumor cells and/or normal tissues of patients with abdominal (such as ovarian, colon, or stomach cancer) or non-small cell lung cancer. EF5 may be effective in measuring oxygen in tumor tissue. Photosensitizing drugs such as motexafin lutetium are absorbed by tumor cells and, when exposed to light, become active and kill the tumor cells. Knowing the level of oxygen in tumor tissue and the level of motexafin lutetium absorbed by tumors and normal tissue may help predict the effectiveness of anticancer therapy

OBJECTIVES:

I. Determine the uptake of motexafin lutetium in tumors and normal tissue of patients with intra-abdominal malignancies or non-small cell lung cancer.

II. Determine the ratio of tumor to normal tissue by measuring the level of motexafin lutetium uptake in tumor and normal tissue removed from these patients.

III. Determine the pattern, presence, and level of EF5 binding (as a surrogate marker for hypoxia) in tumors of these patients.

IV. Determine the feasibility of measuring optical properties, tissue oxygenation, motexafin lutetium concentration, fluorescence, and blood flow by non-invasive means in these patients.

OUTLINE: This is a multicenter, diagnostic study. Patients are stratified according to diagnosis (intra-abdominal malignancy vs non-small cell lung cancer).

Patients receive EF5 IV over 1-2.5 hours on day 1 and motexafin lutetium IV over 10-15 minutes on day 2. Patients undergo definitive surgical resection approximately 3 hours after motexafin lutetium administration. Hypoxia and motexafin lutetium levels in the resected tumors are evaluated. Tumor to normal tissue ratios are also determined.

After completion of study treatment, patients are followed at approximately 1-8 weeks.

PROJECTED ACCRUAL: A total of 30 patients (20 with intra-abdominal malignancies and 10 with non-small cell lung cancer) will be accrued for this study within 10-15 months.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed or suspected diagnosis of 1 of the following:

  * Intra-abdominal malignancy of 1 of the following types:

    * Sarcoma
    * Ovarian cancer
    * Gastrointestinal malignancies, including, but not limited to, appendiceal cancer, colon cancer, or gastric cancer
  * Non-small cell lung cancer
* Planning to undergo surgical resection of disease
* Disease has the propensity to spread to the peritoneal cavity (intra-abdominal malignancy patients)
* Performance status - ECOG 0-2
* WBC ≥ 2,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Bilirubin \< 1.5 mg/dL
* Creatinine normal
* Creatinine clearance ≥ 60 mL/min
* Body weight ≤ 130 kg
* No G6PD deficiency
* No porphyria
* No history of peripheral neuropathy ≥ grade 3
* Able to tolerate anesthesia and major surgery
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 1 month after study participation
SYL040012, Treatment for Open Angle Glaucoma

The purpose of this double-masked, randomized, controlled study is to assess the safety and ocular hypotensive efficacy of four different doses of SYL040012 (bamosiran) eye drops compared to Timolol maleate 0.5% after 28 treatment days in patients with elevated intraocular pressure.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years of either sex
* Good or fair general health as assessed by the investigator.
* Signed informed consent prior to any clinical trial-related procedures
* Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT)
* Post-washout mean IOP above target range
* BCVA 1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200)
* Stable visual field
* Central corneal thickness 480-620 μm
* Shaffer gonioscopic grade of ≥ 3 (in at least 3 quadrants) in both eyes

Exclusion Criteria:

* Pregnant or breastfeeding females
* Females of childbearing potential not willing to use a medically acceptable contraceptive method
* Clinically significant systemic disease
* Changes of systemic medication that could have a substantial effect on IOP
* Known hypersensitivity to any component of the formulations
* Unable to comply with the clinical trial requirements
* Clinically significant abnormalities in laboratory tests
* Severe visual field defect
* Any secondary glaucoma
* Pseudoexfoliation or pigment dispersion component, history of angle closure or narrow angles.
* IOP ≥ 35 mm Hg in any eye
* Previous non-laser glaucoma surgery or glaucoma laser procedures (e.g., laser trabeculoplasty) and refractive surgery
* Any ocular surgery or laser treatment, cataract extraction or ocular trauma within 6 months prior to Baseline
* Evidence of ocular infection, inflammation, clinically significant blepharitis or conjunctivitis at baseline (Visit 0), or a history of herpes simplex keratitis
* Clinically significant ocular disease
Decipher Genomics Resource for Intelligent Discovery

To prospectively evaluate the utility of genomic expression data as a tool to better characterize the tumors of individual patients, and to understand how genomic information from individual patients undergoing routine clinical testing can be used in population-level analysis to improve treatment and outcomes.

Observational study involving the release of tumor genome-wide expression data generated by the Decipher assay which will be linked to clinical treatment and outcome data for patients in whom Decipher clinical testing was performed. The GRID database population will be used to characterize the genomics of cancer and discover or validate gene expression signatures that may be useful for understanding of the biology of the disease and implementing precision medicine approaches for cancer patients.

Eligibility Criteria:
Inclusion Criteria:

Subjects that have had a Decipher clinical test
QUICKly Eradicate Hepatitis C in Patients Undergoing REnal Transplant With 4 Weeks of Glecaprevir/Pibrentasvir

This is a single center study characterizing the experience of administration of 4 weeks of pan-genotypic DAA therapy in kidney transplantation to prevent the transmission of hepatitis C virus infection from an HCV-positive donor kidney to an HCV-negative recipient.

The goal of this study is to determine if the administration of glecaprevir and pibrentasvir (G/P) for 4 weeks beginning in the immediate peri-transplant period prevents establishment of HCV infection in HCV negative recipients receiving transplanted kidneys from HCV RNA positive donors.

Eligibility Criteria:
Inclusion Criteria (Recipient)

1. Met MGH Transplant Center criteria and already listed for kidney transplant with stage 5 CKD / ESRD (eGFR \<15 ml/min/1.73m2 or on renal replacement therapy)
2. Must agree to birth control. Women must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Strategy and at least one barrier method
3. No evidence of clinically significant liver disease at the time of transplant readiness as determined by the clinical team
4. Able to sign informed consent

Inclusion Criteria (Deceased Donor)

1. Detectable HCV NAT test
2. KDPI score is less than ≤ 0.850
3. Traditional Donor Selection Criteria Met - acceptable for transplantation per usual evaluation

Exclusion Criteria (Recipient)

1. Pregnant or nursing (lactating) women
2. HBV positivity (Ag or DNA)
3. Any contra-indication to kidney transplantation per MGH transplant center protocol
4. Any signs or symptoms of clinically significant chronic liver disease per transplant center physician
5. Inability to discontinue any medication with a known drug-drug interaction as listed in the G/P package insert

Exclusion Criteria (Deceased Donor)

1. Confirmed HIV
2. Confirmed HBV positive (surface antigen or HBV DNA positive)
3. Any standard contra-indication to donation noted in donor (significant malignancy, unusual infection, kidney anatomical damage or significant pathology)
The Effect of Platelet-rich Fibrin Matrix on Skin Rejuvenation

Platelet-rich fibrin matrix (PRFM) is made from platelets that are extracted from a patient's blood, and many plastic surgeons and dermatologists have used it to fill in wrinkles and lines on the face. Both patients and doctors have observed that it gives extra volume in these areas and improves overall appearance. However, there is no research that shows how PRFM affects skin quality, such as pores, spots, red areas, and texture. The aim of this study is to determine whether PRFM has a role in rejuvenating facial skin.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years of age and older who had a dermatological concern, specifically, conspicuous spots, pores, rhytids, uneven texture, or red or brown discoloration, and a VISIA complexion analysis score greater than 10
* Agreed to continue any contraceptive hormonal therapy for duration of the study
* Agreed to not initiate the use of hormonal therapy during the study
* Agreed to not undergo any facial procedures or treatments, including injections and fillers, lasers, peels, and topical therapies, during the duration of the study
* Agreed to adhere to a standardized skin care regimen throughout the duration of the study consisting of the use of a single cleanser and moisturizer twice a day
* Agreed to refrain from excessive sun exposure/tanning

Exclusion Criteria:

* History of skin/connective tissue disorders
* History of immunosuppressive therapy or radiotherapy
* Participation in facial procedures, such as injections, lasers, peels, and dermabrasion, in the last six months
* Use of topical/prescription acne medications in the last three months
* Current smokers or prior smokers who quit fewer than 10 years ago
Comparison of a Water-soluble Topical Antimicrobial to Silver Sulfadiazine in Partial Thickness Burns

Partial thickness burns are a common, painful injury requiring a great deal of resources in their care. Silver sulfadizine is a commonly-used topical antimicrobial, but is difficult to remove due to its lipid base. We are comparing a water-based topical antimicrobial therapy to silver sulfadiazine and hypothesize that the water-based therapy is superior in terms of pain control and resources required to deliver care.


Eligibility Criteria:
Inclusion Criteria:

* adult inpatients with partial thickness burns

Exclusion Criteria:

* superficial or full thickness burns, facial burns, intubated or sedated, pediatric
Comparison of Three Different Treatment Regimes in Early Rheumatoid Arthritis: A Randomized Open-labelled Trial

Many studies have been conducted to evaluate the role of pulse steroids in early rheumatoid arthritis (RA) but no consensus exists. The aim of this study is to study the efficacy of various treatment regimens in early RA. Methods: This is a randomized open-labeled trial. Patients were randomised into three groups. In group A, patients were treated with single drug (methotrexate 15 mg/wk). The patients in Group B were treated with a combination of DMARDS (Methotrexate, sulfasalazine and hydroxychloroquine). The patients in Group C received combination therapy as in group B and 3 pulses of methylprednisolone intravenously.

Many studies have been conducted to evaluate the role of pulse steroids in early rheumatoid arthritis (RA) but no consensus exists. The aim of this study is to study the efficacy of various treatment regimens in early RA. Patients were divided into three groups. In group A, patients were treated with single drug (methotrexate 15 mg/wk). The patients in Group B were treated with a combination of DMARDS (Methotrexate, sulfasalazine and hydroxychloroquine). The patients in Group C received combination therapy as in group B and 3 pulses of methylprednisolone intravenously.

Eligibility Criteria:
Inclusion Criteria:

1. Rheumatoid Arthritis diagnosed on the basis of revised American college of rheumatology criteria,1987
2. Age \>18 years
3. Early Rheumatoid Arthritis i.e. less than 2 years duration
4. Patient giving consent to participate in study
5. Disease Modifying Anti-Rheumatic Drugs naive -

Exclusion Criteria:

1. Pregnant and lactating patient or planning to conceive in next year
2. Patient who had joint surgery in last 6 months
3. Co morbidities such as liver disease, kidney disease, hematological malignancies
4. Uncontrolled hypertension, diabetes mellitus
5. Coronary artery disease -
Testing Alcohol Only Samples for Drugs and Drugs Only Samples for Alcohol

This study intends to supply information about the prevalence of psychoactive drugs and alcohol in suspected DUI samples which are suspected of only one of these rather than both drugs and alcohol.

Police samples for suspected DUI samples that have been sent for alcohol analysis or drug analysis only will be screened for drugs and alcohol respectively.

There are 3 different possibilities for forensic analysis of suspected driving under the influence samples. Testing for alcohol or drugs only or testing for both alcohol and drugs.

Often if the primary suspicion of the apprehending police officer is of driving under the influence of drugs or alcohol then only laboratory analysis concerning that primary suspicion is requested.

The study aims to provide information about those 'missed cases' where only analysis for drugs or alcohol is carried out. Traffic police samples from a 2 week period are to be screened for both drugs and alcohol, even if the primary suspicion is only one of these.

The study is part of the EU-project DRUID. Altogether 13 European countries are participating in DRUID.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* driver of a motorised vehicle

Exclusion Criteria:

* 17 years or younger
* not the driver of a motorised vehicle
Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05529)

This study seeks to prospectively demonstrate that Nasonex is better than placebo in relieving nasal congestion in patients with seasonal allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* A subject must be 12 years of age or older, of either sex, and of any race.
* A subject must have at least a 2-year history of SAR which exacerbates during the study season.
* A subject must have a positive skin prick test response to an appropriate seasonal allergen at Visit 1.
* A subject must be clinically symptomatic at the Screening and Baseline Visits.

Exclusion Criteria:

* A subject with a history of severe local reaction(s) or anaphylaxis to skin testing.
* A subject who has had an upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or who has had a viral upper respiratory infection within 7 days prior to the Screening Visit.
* A subject who has used any drug in an investigational protocol in the 30 days prior to the Screening Visit.
* A subject who is participating in any other clinical study.
* A subject who is part of the staff personnel directly involved with this study.
* A subject who is a family member (parent, spouse, or sibling) of the investigational study staff.
* A female subject who is breast-feeding, pregnant, or intends to become pregnant.
* A subject previously randomized into this study.
* A subject who has a family member (parent, spouse, or sibling) currently enrolled in this study.
AWARE Registry: Wearable ECG in Structural Heart Interventions

This study is a multi-center (Sinchon Severance hospital / Gangnam Severance hospital), prospective cohort observational study to patients who had undergone structural heart intervention including device closure for secundum type atrial septal defect or Patent foramen ovale. Transthoracic echocardiography will be performed before the procedure, immediately after, and at 6, 18, 30 months after the procedure. Wearable ECG monitoring (\> 3 days) will be performed before the procedure or immediately after procedure. Demographic, laboratory, hemodynamic data during procedure, and non-invasive imaging dat are obtained.


Eligibility Criteria:
Inclusion Criteria:

* Adult ≥ 19 year-old
* Patients who scheduled to perform percutaneous device closure for atrial septal defect or patent foramen ovale
* Patients provided with the written, informed consent to participate in this study

Exclusion Criteria:

* Patients who had paroxysmal, persistent, or chronic AF
* Life expectancy \< 12 months
* Subject who the investigator deems inappropriate to participate in this study
Video Intervention to Enhance the Safety Of Cognitively Impaired Older Drivers

This pilot study was done to assess the feasibility and possible efficacy of a video feedback intervention to improve the safety of cognitively impaired older drivers.

The goals of this pilot study were to demonstrate that 1) g-force technology can effectively detect unsafe driving events by older adults, and 2) cognitively impaired older adults can improve their driving safety with an in-car video feedback intervention. Unsafe driving events were triggered by g-forces leading to capture of a video record that was then transmitted wirelessly to a remote office where the events were analyzed and scored. During the baseline phase (3 months), there was no feedback. During the intervention phase (4-6 months), participants received a weekly progress report in the mail along with DVD of recorded unsafe driving events with recommendations. The research team then contacted the participant and informant weekly to provide additional coaching, and verify that participants reviewed the information and videos. During the post-intervention monitoring phase (7-9 months), there was no further feedback. The primary quantitative outcomes were total number of unsafe driving events/1,000 miles and total safety driving score/1,000 miles. Secondary qualitative outcomes included the types and severity of unsafe driving events that were recorded.

Eligibility Criteria:
Inclusion Criteria:

* age 60-90
* English speaking
* currently driving adults with a valid driving license and at least 10 years of driving experience
* neurological examinations judged to be normal for age or consistent with AD
* questionable to mild dementia (CDR 0.5 to 1)
* MMSE \< 28
* have an adult family member or other caregiver, age \>21 to participate in counseling feedback

Exclusion Criteria:

* ophthalmologic, physical, or neurologic disorders other than dementia that impair their driving abilities
* visual acuity worse than 20/40 in best eye using distance vision measured by wall chart
* homonymous hemianopia or bitemporal hemianopia on confrontation testing
* musculoskeletal disorders causing major physical handicaps such as frozen joints, inadequately healed fractures, and amputations
* history of alcohol or substance abuse by DSM V diagnostic criteria within the past year
* sedating medications that impair level of consciousness or attention
* language impairment that would interfere with the ability to participate in the educational intervention
* previous road test evaluation or opinion of caregiver or health professional that subject is unsafe to drive.