cyrilzakka/clinical-trials huggingface dataset:
Paravertebral Block (PVC) Versus Pectoral Nerve Block (PEC)

The purpose of this study is to compare two standard methods of pain control management used at Spectrum Health for patients undergoing breast surgery. The two methods being compared are the paravertebral block (PVB) and the pectoral nerve block (PEC). Postoperative pain control is essential following any major operative procedure. A variety of methods have been used to ensure adequate pain control, each with its own advantages and risks. Increasingly, attention has focused on regional methods of analgesia, which may allow for reduction in systemic narcotic use and their associated complications. Proposed benefits of regional analgesia and a resultant reduction in narcotic use include decreased risk of cancer progression, decreased length of stay, and decreased risk of ileus.

The purpose of this study is to compare the clinical profiles of two currently acceptable analgesia techniques. The most common regional block used to achieve postoperative analgesia following mastectomy is the paravertebral block, during which local anesthetic is injected into the paravertebral space which contains the thoracic spinal nerves, between the costotransverse ligament and the pleura. At our institution there has been recent interest in an alternative regional block. The pectoral nerve block is performed by injecting anesthetic between the pectoralis major and the pectoralis minor (PECs I) or between the pectoralis minor and the serratus anterior (PEC II).

The proposed advantage of the pectoral nerve block for regional anesthesia during breast surgery is equal analgesic efficacy with fewer potential complications.

Eligibility Criteria:
Inclusion Criteria:

* Female patients ≥ 18 years of age
* Total mastectomy or partial mastectomy with or without reconstruction OR planned lumpectomy.
* Patient determined by their surgeon as medically able to receive a regional block for post-operative analgesia
* Patient agrees to participate in the study and signs informed consent

Exclusion Criteria:

* Neoadjuvant radiation therapy
* Stage IV cancer
* Previous breast surgery (excluding percutaneous biopsies of all types)
* History of either PVB or PEC procedures
* Planned general anesthesia use during surgery
* Allergies to ropivacaine, midazolam, fentanyl, or propofol
* Pregnant women
* Prisoners
* Adults unable to consent
* Non-English-speaking patients
Long Term Follow-Up of KNEE PAIN Patients Accompanying Meniscus Tear

The purpose of this study is to reveal the effectiveness and satisfaction of integrative Korean medicine for Meniscus Tear by observation patients treated with integrative Korean medicine.

This study is a prospective observational study. The subjects for study are patients diagnosed with Meniscus Tear and who have been admitted to Gangnam Jaseng Hospital of Korean medicine, Bucheon Jaseng Hospital of Korean medicine, Daejeon Jaseng Hospital of Korean medicine and Haeundae Jaseng Hospital of Korean medicine for 2015.06-2020.06.

Medical records of selected patients will be analyzed, and telephone surveys will be conducted for each patient. The survey questions are Numeric rating scale (NRS), Western Ontario and McMasters Universities(WOMAC) Osteoarthritis Index, quality of life, and Patient Global Impression of Change (PGIC), etc.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who have been diagnosed with "Meniscus Tear" in the EMR imaging (X-ray or MRI or CT) of hospitalization
2. Patients who have been hospitalized by Knee Pain
3. A person who voluntarily orally agrees to participate in a clinical trial

Exclusion Criteria:

1. If the hospitalization period is less than 3 days,
2. If there are other chronic diseases that may interfere with the treatment effect or interpretation of the results: cardiovascular disease, kidney disease, diabetic neuropathy, dementia, epilepsy, etc.
3. If the cause of pain is caused by a soft tissue disease other than Knee joint: tumor, fibromyalgia, rheumatoid arthritis, gout, etc.
4. Patients within 3 months of surgery on the hip joint
5. If there is a fracture of the joint in the image finding
6. If researchers judge that it is inappropriate to participate in the study;
7. If you do not agree to participate in the study;
8. Minors
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of ID120040002 in Healthy Volunteers

A Randomized, Double-blinded, Partial-open, Placebo and Active-controlled, Single and Multiple Dose-escalation Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of ID120040002 in Healthy Volunteers

To evaluate the safety, tolerability, and pharmacokinetic characteristics and to explore pharmacodynamic characteristics and food effects after single and multiple doses of ID120040002 in healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have a body weight of ≥50.0 kg to ≤90.0 kg, and Body Mass Index (BMI) of ≥18.0 kg/m2 to ≤27.0 kg/m2
* Subjects who have decided to voluntarily participate and consented in writing to comply with the precautions after listening to a detailed explanation of this clinical study
* Subjects who consent to use contraceptive methods\* accepted in this trial with their partners and not to donate sperm until 90 days and eggs until 28 days after the administration of the last dose of the IP from the time of written consent.

Exclusion Criteria:

* Subjects with a history of clinically significant cardiovascular, respiratory, renal, endocrine, hematological, gastrointestinal, central nervous system, urinary, musculoskeletal and psychological disorders or malignant tumor, or current active diseases (however, subjects may be enrolled if the disease is completely recovered and does not affect the current health status)
* Subjects with a history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis, hypochlorhydria, achlorhydria, etc.) or gastrointestinal surgery (excluding simple appendectomy and herniotomy) that can affect the absorption of the investigational product
* Subjects who have received the therapy for peptic ulcer, esophageal disease or Zollinger-Ellison syndrome within 90 days prior to the administration of the IP, or have clinically suspected symptoms of such diseases
* Subjects who have received H. pylori eradication therapy within 6 months, or have positive result for H. pylori test at screening
Online Mind/Body Program for Fertility

This pilot-study assesses the feasibility and acceptability of an Online Mind/Body Fertility Program, designed to help individuals and/or couples cope with the physical and emotional impact of infertility by learning special relaxation strategies and improving lifestyle habits. Participants included women experiencing infertility who had not given birth to a child. Half of participants received access to the 10-week Online Mind-Body Program and the other half were placed on a waiting-list.

Infertility is defined as the inability to conceive a child. A couple may be acknowledged as infertile if conception has not occurred after 12 months of having regular, unprotected intercourse. Over six million couples in the United States are affected by infertility. Research suggests that there is a relationship between psychological distress and infertility, but the relationship is complex. The information from this study will be used to better understand the relationship between psychological distress and infertility among couples. Furthermore, the investigators are interested in testing Dr. Alice Domar's Mind/Body Fertility Program that was designed to help individuals regain control of their life and learn new lifestyle habits that can increase their chances of conceiving. There is evidence that individuals that participated in the group format of this treatment protocol showed statistically significant decreases in physical and psychological symptoms of stress and increases in conception rates. Our primary goals are to evaluate patients willingness to be recruited and randomized as well as their adherence and attrition to the program. Our secondary goals are to evaluate reductions in emotional distress (i.e., anxiety, depression, and stress) and enhance emotion regulation skills as well as pregnancy rates.

Eligibility Criteria:
Inclusion Criteria:

* Women and Men
* Infertility diagnosis
* Trying to get pregnant
* 18 years or older
* Read and write English

Exclusion Criteria:

* No current diagnosis for an active psychotic disorder, eating disorder, substance abuse or dependence
* Not reporting current suicidal ideation/intent
* No psychotropic medication changes in the last four weeks
* Has not completed a formal mind/body program focused on infertility that included relaxation, yoga, mindfulness, cognitive restructuring, stress reduction strategies, listening and communication skills, goal setting and assertiveness training.
Contingency Management for Meth in South Africa Methamphetamine Abuse in South Africa

This study will link findings from neuroscience with clinical outcomes using contingency management (CM) to identify changes in brain structure and function that emerge during purely behavioral therapy for methamphetamine (MA) use.

This study will correlate MA-abstinence outcomes from an 8-week program of voucher-based incentives using an escalating schedule for 30 treatment-seeking, MA-dependent individuals with scores on tasks of working memory and assessments of neuropsychological and demographic status. At the beginning and end of the CM program, participants will participate in MRI scans while performing a working memory task and will complete a battery of select neurocognitive and psychological assays to address two specific aims: (1) to determine whether changes in neural function within frontostriatal circuitry from baseline to end of the 8-week CM program are associated with parallel changes in measures of cognitive control and impulsivity and with MA abstinence outcomes and (2) to determine whether structural changes in frontostriatal circuitry over the 8-week CM intervention correspond with neurocognitive, psychological and MA abstinence measures.

Eligibility Criteria:
Inclusion Criteria:

* provide voluntary informed consent
* meet DSM-5 criteria for MA or amphetamine use disorder
* provide at least one urine sample positive for MA/amphetamine metabolites during screening (i.e. prior to the commencement of the study).
* aged 18-45
* right-handed
* English-speaking

Exclusion Criteria:

* currently receiving treatment for stimulant addiction or needing more intensive treatment than outpatient care
* meet DSM-5 criteria for substance use disorder other than nicotine
* unable to attend 4+ visits during the 2-week screening period or to complete measures
* Physical or mental illness that would require intervention that would alter imaging or that would interfere with safe study participation
* pregnant, claustrophobic, or have metal prostheses, cardiac pacemakers, or metal clips that are incompatible with the scanner
* HIV positive status
* unable to comprehend written or spoken English
* currently taking psychiatric medication
Treatment of Vasospasm of Aneurysmal Subarachnoid Hemorrhage With Intrathecal Nicardipine - FAST-IT Trial

To investigate whether patients with cerebral vasospasm associated with aneurysmal subarachnoid hemorrhage have a better prognosis with intrathecal nicardipine injection via extraventricular drainage or lumbar drainage.

Objective:

To investigate whether patients with cerebral vasospasm associated with aneurysmal subarachnoid hemorrhage have a better prognosis with intrathecal nicardipine injection via extraventricular drainage or lumbar drainage.

Design:

This study is a multi-center, prospective, double-blinded, randomized controlled trial.

Interventions:

First, 6 ml of cerebrospinal fluid is withdrawn from the EVD or LD catheter, and then 4 ml of nicardipine hydrochloride is injected into the EVD or LD drain tube, followed by 2 ml of 0.9 % sodium chloride solution (NaCl), and then the EVD or LD tube was clamped for 2 hours after the injection was completed, then kept open as clinically necessary until the next dose (twice a day).

Eligibility Criteria:
Inclusion criteria:

1. Age 18-80.
2. Spontaneous SAH confirmed by head CT.
3. Saccular brain aneurysm is identified and treated, either surgically or endovascularly.
4. SAH Fisher grade \>1 or modified Fisher grade \>0.
5. EVD placed for acute hydrocephalus, or LD placed for draining bloody CSF as deemed necessary by the treating physician.
6. Any clinical scenario leading to the diagnosis of possible vasospasm, which includes:

   1. Mean flow velocity of MCA \>120, or Lindegaard Ratio ( LR ) \> 3.
   2. Any intracranial artery including MCA, ACA, PCA, and BA, TCD showed an upward trend of mean flow velocity for 2 consecutive days (\>25cm/s/day).
   3. Clinical deterioration including mental status change (GCS score decrease \> 2) and focal neurological deficit unable to be attributed to other known neurological reasons.
   4. Evidence of vasospasm on CTA or DSA, or ischemic change by CTP, MRI.
7. Within 14 days of onset of SAH.
8. Informed consent obtained from the patient or family member.

Exclusion criteria:

1. Hunt Hess grade 5 or WFNS grade 5 (evaluation after EVD placement for acute hydrocephalus).
2. Need antiplatelet treatment for the embolization of the aneurysm
3. Mycotic or very distal aneurysm with no basal cistern SAH.
4. Culprit aneurysm is deemed as not secured with a very high chance of re-bleeding by the treating physician.
5. Recent head trauma within 3 months.
6. Any recent cerebral disease, such as a brain tumor, stroke, seizure, vasculitis, AVM, or hydrocephalus within 3 months.
7. History of psychological disease, or seizure.
8. Severe other medical morbidities.
9. Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test.
10. Female in the breast-feeding.
11. Life expectancy less than 1 year before SAH onset.
12. Before SAH onset mRS \>1.
13. Participation in another randomized clinical trial that could confound the evaluation of the study.
14. Contraindication of using nicardipine
Albumin Bilirubin Index as a Predictor of Outcome of Variceal Bleeding

Albumin bilirubin index as a predictor of outcome of variceal bleeding

This study is to clarify the predictive value of albumin bilirubin index for recurrent bleeding within 3 month after endoscopic treatment in patients with cirrhosis and EGVB

Eligibility Criteria:
Inclusion Criteria:

* age between 18-80 years old

Exclusion Criteria:

* Hcc Hematological disease
Weight Loss With Risedronate for Bone Health

This is a pilot project to determine the feasibility of recruiting, enrolling, treating, and following 24 older sleeve gastrectomy patients into a randomized controlled trial (RCT) examining the efficacy of bisphosphonate use versus placebo in the prevention of surgical weight loss associated loss of bone mass and quality.

This pilot study is a RCT, involving 24 participants randomized to Risedronate or placebo capsules for 24 weeks. All subjects planning a sleeve gastrectomy (SG) procedure will be approached during their pre-surgical evaluation for possible participation in the study. Eligible participants will be referred onto the study coordinator to read/sign an IRB-approved informed consent prior to enrollment.

Two in-person baseline assessment visits \[baseline visit 1 (BV1), baseline visit 2 (BV2)\] occurring 1-6 weeks prior to surgery, and two in-person follow up assessment visits \[follow up visit 1 (FV1) and follow up visit 2 (FV2)\] occurring ±2 weeks from their 23-week post-surgery date will be conducted, as well as monthly medication compliance reminders and adverse event reporting via phone. Optional additional exploratory assessments include CT-derive bone health and blood-based biomarkers, as well as 12-month DXA, CT, and blood assessments. The Wake Forest WMC, under the direction of Drs. Ard and Fernandez, will serve as a source of recruitment for potential study participants.

Eligibility Criteria:
Inclusion Criteria

* Subjects planning a sleeve gastrectomy procedure
* 40-79 yrs of age
* Willingness to provide informed consent
* Agreement to all study procedures and assessments

Exclusion Criteria

* Age \<40 years
* Baseline weight \>450 pounds
* Chronic anti-reflux treatment
* History of medical disorders known to affect bone metabolism
* Use of bone-active medications
* Known allergy to Risedronate
Partnership Programs to Reduce Cardiovascular Disparities- Morehouse- Emory Partnership

The theme of this Morehouse-Emory Partnership Program focuses on elucidating the etiologic basis of ethnic differences in obesity-related CVD and discovering new intervention strategies to ameliorate CV health in all communities. The proposed Program uses a multi-disciplinary strategy to systematically characterize ethnic differences in obesity-related CVD by drawing upon the fields of physiology, psychology, biochemistry, vascular biology, public health, nursing and clinical medicine.

Emerging evidence indicates that there are ethnicity-specific differences in the profile of biochemical, metabolic and physiological perturbations associated with obesity. The implications of these ethnic differences remain to be further defined. Several epidemiologic studies have shown that vascular disease and its cardiovascular complications, carry significantly higher morbidity and mortality in African Americans compared with Caucasians.1-3 These observations may be partly explained by a higher prevalence of cardiovascular disease risk factors, such as essential hypertension, diabetes mellitus, and tobacco use among African Americans.4-6 However, the pathophysiological processes underlying this racial predisposition have not been fully elucidated.7 It is likely that the etiologic basis of ethnic disparities in cardiovascular disease is multi-factorial and involves dynamic gene-environment interactions in which variances in behavior and the social context are critical determinants.

The proposed Program recognizes the importance of incorporating both biological factors and social determinants in the analysis of cardiovascular disparities

Eligibility Criteria:
Inclusion Criteria:

Our methodological approach will involve a random digit-dialing cross-sectional survey of 4000 Metro Atlanta area AA and white residents (ages 30-65 years). This aim will focus on using well-validated survey instruments to examine self-reported perceptions of psychosocial stress, neighborhood segregation factors and health beliefs related to weight/weight control. These parameters will be assessed in relation to the differential prevalence of three major outcomes: (1) self-reported maladaptive cardiovascular behaviors that predispose to obesity-related CVD (ie high fat/sodium and low fruit/vegetables dietary intake and physical inactivity); (2) obesity; and (3) hypertension.

This study will address the following research questions: Are the observed racial differences in maladaptive health behaviors (diet/inactivity) and MetS components (obesity, hypertension) associated with: a) perceived psychosocial stress, and if so, does depression, neighborhood factors or health beliefs around weight and weight control modify this relationship?

-

Exclusion Criteria:

-
Safety, Tolerability, and Distribution of Laquinimod Eye Drops : The LION Study

The LION Study is a prospective, single-center phase 1 clinical trial to evaluate the safety, tolerability, and distribution of Laquinimod administered as topical eye drops for two weeks in human participants.

Participants who fulfill the study eligibility criteria and who are planned to undergo a pars plana vitrectomy will be enrolled in the study. Eligible participants scheduled for a diagnostic vitrectomy may also be enrolled.

The study will consist of two stages:

Stage One - Open label dose escalation:

Up to three subsequent dose-escalation groups will receive Laquinimod eye drops for 2 weeks and samples will be assayed for Laquinimod concentration in aqueous humor, vitreous and plasma.

Stage Two- Randomized, Controlled Comparison of 2 Laquinimod doses:

After the dose escalation cohorts are analysed, 2 Laquinimod doses will be selected for a randomized comparison. The doses in stage 2 will not exceed those studied in stage 1.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. Participants who are capable and willing to provide informed consent and follow study instructions.
3. Participants who are scheduled to undergo pars plana vitrectomy (PPV).
4. Participants with intraocular pressure (IOP) ≥ 5 mmHg and ≤22 mmHg in study eye
5. Women who are not pregnant or lactating, are post-menopausal or have undergone a sterilization procedure.

Exclusion Criteria:

1. Participants with active periocular or ocular infectious disease (e.g., blepharitis, scleritis, or conjunctivitis, keratitis or endophthalmitis).
2. Participants with active infectious uveitis
3. Participants with a history of prior intraocular or extraocular surgery within 90 days of study enrollment
4. Participant with a history of intravitreal steroids administered to the study eye within 90 days of enrollment.
5. Participants with a history of intravitreal injection of VEGF inhibitors within 30 days of enrollment
6. Use of any topical cyclosporine or corticosteroid or other specified (i.e. calcineurin inhibitors) ophthalmic medication in the study eye for any reason within 14 days of enrollment and before the surgery
7. Use of medication consisting of a strong or moderate inhibitor of CYP3A4 within 2 weeks of Baseline visit (and during the study).
8. Use of medication consisting of a strong inducer of CYP3A4 within 2 weeks of Baseline visit (and during the study)
9. Mild, moderate, or severe hepatic impairment (any of Child-Pugh Score A, B, and C)
10. Moderate or severe renal impairment (GFR ≤60 mL/min)
11. History of HIV disease or other immunodeficiency disorder
12. History of acute hepatitis A (IgM positive), hepatitis B, or hepatitis C
13. History of organ or bone marrow transplant
14. Presence of malignancy under active treatment
15. Any other acute or chronic medical condition that would, in the judgment of the study investigators, reasonably preclude participation in the clinical study
16. Already enrolled in a clinical trial.
17. Any condition that would prevent the investigator from acquiring images of the eye as required per protocol
Assessing Safety and Efficacy of DE-089 Ophthalmic Solution in Patients With Dry Eye Disease

The objective of this study is to assess safety and efficacy of DE-089 ophthalmic solution in patients with dry eye disease in Taiwan.


Eligibility Criteria:
Inclusion Criteria:

* At least 6-month dry eye history

Exclusion Criteria:

* Diagnosed with Stevens-Johnson Syndrome or ocular pemphigoid
* Diagnosed with keratoconjunctival chemical burns or thermal burn
* Eye disease other than dry eye disease which needs treatment
* Allergic conjunctivitis that may possibly be aggravated during the clinical study and inappropriate for efficacy evaluation
* Those who need to wear contact lenses during the clinical study
* Those who are considered inappropriate for this study by the investigator or subinvestigators