cyrilzakka/clinical-trials huggingface dataset:
Single Center Pilot Study of Corticosteroid Discontinuation in Liver Transplant Recipients

To determine the safety and efficacy of early corticosteroid discontinuation in liver transplant recipients more than 90 days post transplant, utilizing a combination of two drugs (tacrolimus and mycophenolate mofetil) for maintenance immunosuppressant therapy.

To determine the safety and efficacy of early corticosteroid discontinuation in liver transplant recipients more than 90 days post transplant, utilizing a combination of two drugs (tacrolimus and mycophenolate mofetil) for maintenance immunosuppression therapy.

Eligibility Criteria:
Inclusion Criteria:

* Greater than 90 days post transplant.
* Free from rejection within the last 30 days.
* Patient with primary diagnosis of AIH will be evaluated on an individual basis.
* Negative pregnancy test.
* Practicing an acceptable method of birth control.
* Capable of providing written informed consent.

Exclusion Criteria:

* Rejection within the last 30 days.
* Patients with AIH unable to discontinue corticosteroids.
* Patients currently receiving systemic corticosteroids for other medical diseases in which the physician feels discontinuation is contraindicated.
* Known sensitivity or contraindication to tacrolimus or MMF.
* Kidney, pancreas, islet, heart, lung, or small bowel transplant recipient.
* Pregnant or lactating.
Comparison of Diagnostic Performance of Medical Monitor and Medical Augmented Reality Glasses in Endoscopy: Observation Study

The purpose of this study was to compare the outcomes of medical augmented reality glasses and general monitors when distinguishing mucosal lesions from submucosal lesions in endoscopic diagnosis for early gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients with early gastric cancer who are scheduled for endoscopic submucosal dissection
* Age 19 or more
* Patients who voluntarily participated in this clinical study and signed a written informed consent

Exclusion Criteria:

* Patients with poor general medical condition which does not allow them to understand and submit a informed consent
* Patients who do not agree with this study
Evaluate Analgesic / Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental Pain

The objective of the study is to evaluate the efficacy and safety of a single oral dose of naproxen sodium 440 mg in combination with DPH (diphenhydramine) 25 mg in subjects with postsurgical dental pain and phase advanced sleep.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, ambulatory, male and female volunteers ages 12 and older
* Scheduled to undergo surgical removal of a minimum of two third molars of which at least one has to be a mandibular third molar. The mandibular extraction(s) required by each subject must meet one of the following scenarios:

  * one full bony impaction
  * two partial bony impactions
  * one full bony impaction and one partial bony impaction
  * one full bony impaction and one soft tissue impaction
  * one full bony impaction and one erupted third molar. Two full bony mandibular impactions are not allowed. Maxillary third molars may be removed regardless of impaction level.
* Have moderate to severe postoperative pain on the Categorical Pain Rating Scale and a score of \>/= 50 mm on the 100-mm visual analog Pain Severity Rating Scale between 1600 hour and 1830 hour on the day of surgery
* Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-Provera, or double-barrier and have a negative pregnancy test at Screening and prior to surgery. Female subjects of non-childbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy.

Exclusion Criteria:

* History of hypersensitivity to naproxen, diphenhydramine, nonsteroidal anti-inflammatory drug (NSAIDS), tramadol, aspirin or any other antihistamine and similar pharmacological agents or components of the products
* Evidence or history of clinically significant (in the judgment of the investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies within the last 5 years
* Relevant concomitant disease such as asthma (exercise induced asthma is permitted), chronic sinusitis or nasal structural abnormalities causing greater than 50 percent obstruction (polyposis nasi, marked septal deviation) that can interfere with the conduct of the study in the judgment of the investigator
* Current or past history of bleeding disorder(s)
* Acute illness or local infection prior to surgery that can interfere with the conduct of the study in the judgment of the investigator
* Chronic use of antihistamines defined as using 5 or more times a week for 2 or more consecutive weeks during the past 3 months
* Positive alcohol breathalyzer test and positive urine drug test prior to surgery
* Females who are pregnant or lactating
* Chronic or severe sleep problems that do not respond to Over the Counter (OTC) medication and requires a prescription hypnotic or sedative
* Habitually spends less than 6.5 hours in bed
Comparison of Standard Epidural and Dural Puncture Epidural Analgesia in Open Gynecological Surgery Techniques

The aim of this study is to compare the effectiveness of standard epidural and dural puncture epidural analgesia techniques used under NOL guidance.

The primary aim of this study was to evaluate the effect of NOL-guided antinociception on intraoperative total local anesthetic consumption during anesthesia.

The secondary aim is to compare onset time, analgesia duration time, hemodynamic parameters, time to first postoperative analgesic requirement, and postoperative side effects.

This prospective randomized double-blind study was planned in 36 adult female patients aged 18-75 years, with ASA I-III, who underwent elective open gynecological surgery under general anesthesia with lower midline or Pfannenstiel incision after Ataturk University Medical Faculty Hospital ethics committee approval and written consent of the patients.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-III physical condition
* patients aged between 18-75 years
* elective surgeries under general anesthesia for gynecological procedures
* lower midline or Pfannenstiel incision

Exclusion Criteria:

* patients with classical contraindications to neuraxial procedures,
* morbidly obese (body mass index \> 40 kg / m2),
* pregnant and lactating women
* hypersensitive or allergic to local anesthetic agents,
* abuse of drugs or alcohol in the past 6 months.
* chronic opioid use before surgery,
* using chronic psychoactive drugs in the 90 days before surgery,
* patients with peripheral and central nervous system disease,
* preoperative hemodynamic compromise (patients with irregular sinus heart rhythm and pacemaker)
* patients using antimuscarinic, α2-adrenergic agonists, β1-adrenergic antagonists, antiarrhythmic agents,
* patients with diabetes, severe lung and significant liver disease with increased bilirubin,
* operations that will take less than 2 hours
* MAP \>160 mmHg or \<60 mmHg, heart rate \>90 beats/min or \<45 beats/min on the day of surgery
* patients who do not want to participate in the study will be excluded from the study
Potential Causes of Retained Items During Surgery

to understand and analyze the potential causes of retained items (sponge and instruments) during surgery, which include room preparations, initial count, adding sponges, removing sponges, first closing count, final closing count.


Eligibility Criteria:
Inclusion Criteria:

• operating room staff of hail hospital cluster

Exclusion Criteria:

• none
The Safety and Scientific Validity of Low-dose Whole Brain Radiotherapy in Alzheimer's Disease.

Alzheimer's disease is the most frequent neurocognitive disorder associated with dementia, with a constantly increasing prevalence associated with an aging population. Amyloid deposition is considered as the first molecular event on the onset of Alzheimer's disease. It has already been demonstrated that low-dose radiotherapy is capable of reducing Alzheimer's disease-associated amyloid-β plaques and improving cognitive function in an animal model. In human, low-dose radiotherapy has demonstrated effectiveness in reducing bronchial amyloidosis.

The present study aims to conduct research by including 10 patients with a diagnosis of mild or moderately severe Alzheimer's disease and with evidence of amyloid pathology. Furthermore, the aim is to demonstrate the effectiveness of low-dose radiotherapy in reducing amyloid deposits in the human brain using molecular imaging (Flutemetamol(18F) PET) along with treatment of the specific target.

The investigators decided to use fractionated whole brain radiation doses of 1.8 Gy x 5 and 1.8 Gy x 3. Subjects will be followed with neurocognitive testing at 6 months post radiotherapy.

subjects 1-5 - 9Gy in 5 daily fractions

subjects 6-10 - 5.4Gy in 3 daily fractions

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of mild or moderate Alzheimer's disease.
* Amyloid PET scan positivity.
* Korean Mini-Mental State Examination score ≥10 and ≤24.
* Clinical dementia rating scale 0.5, 1 or 2.
* Ability to undergo neurocognitive assessment at baseline visit, alone or accomparined by a caregiver.
* Ability to understand the clinical trial and give an informed consent

Exclusion Criteria:

* previous therapeutic whole brain irradiation
* Evidence of seizure activity
* Evidence of active dermatological skin disease of the scalp.
* History of malignant tumors.
* Pregnant or breastfeeding.
* If the researcher determines that participation in this study is inadequate because of other findings that are considered clinically important.
Trial of Pancreatic Enzyme Supplements (Pancrelipase) for Treating Pain in Patients With Chronic Pancreatitis

The study purpose is to characterize the effect of pancreatic enzyme supplementation on chronic pancreatitis type pain.

Study Type: Interventional, randomized, double-blind, placebo-controlled, crossover design, efficacy study Intervention arm: Pancreatic enzyme replacement (Pancrelipase) with meals and snacks daily, for 4 weeks.

Placebo arm: Lactose placebo tablets with meals and snacks, for 4 weeks. Washout Phase: Weeks 4 to 6, there will be cessation of placebo or Pancrelipase use.

Crossover Phase: Weeks 6 to 10, initial placebo arm receives Pancrelipase, Pancrelipase arm receives placebo

Surveys - Izbicki score and PANQOLI assessment occur at Week 0, 4, 6, and 10. Narcotic and non-narcotic usage will also be noted at these intervals. Patient will also report the tobacco and alcohol use.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic pancreatitis based on chronic pancreatitis-type pain \> 6 months leading to impaired quality of life AND at least 1 of the following (27):
* Confirmed diagnosis of hereditary pancreatitis (PRSS1 gene mutation)
* History of recurrent acute pancreatitis (\>1 documented episode of characteristic abdominal pain associated with diagnostic imaging and/or elevated serum amylase or lipase \> 3 times upper limit of normal).
* Pancreatic calcifications on CT scan
* At least 2 of the following:
* Endoscopic Ultrasound (EUS) with = or \> 4 criteria for chronic pancreatitis (hyperechoic foci, strands, or ducts, lobulation, irregular duct margin, visible side - branches, calcifications, cysts, ductal dilatation) (28)
* Ductal (changes in side branch morphology) or parenchymal (loss of T1 signal intensity) abnormalities on secretin enhanced Magnetic resonance cholangiopancreatography (MRCP)
* Abnormal endoscopic pancreatic secretory function tests (HCO3 \<= 75mmol/L at 30 or 45 minutes or \<= 80mmol/L at 1 hour
* Subjects are capable of informed consent

Exclusion Criteria:

* Pregnancy
* Lactation
* Active acute pancreatitis or an episode of acute pancreatitis within 2 months of presentation for evaluation
* Pancreatic cancer
Sleep and Circadian Contributions to Nighttime Blood Pressure

Broadly, this study (SCN-BP) seeks to examine sleep and circadian factors that contribute to blood pressure levels at night.

SCN-BP is imbedded in a parent grant titled "Improving the Detection of Hypertension (IDH-MEGA)" and examines a variety of sleep (e.g., sleep duration, timing, and the presence of sleep disorder) and circadian factors in Aims 1 and 2. In Aim 3, the investigators will conduct a 30-hour constant routine protocol to directly examine endogenous circadian and blood pressure rhythms.

Eligibility Criteria:
Inclusion Criteria:

* Participant in the parent grant (IDH-MEGA)

Exclusion Criteria:

-
Phase III Randomized Study of the Effect of Postmenopausal Estrogen Replacement Therapy on Alveolar Bone Loss

OBJECTIVES: I. Quantify periodontal alveolar bone loss rates in postmenopausal women.

II. Evaluate the effects of estrogen on alveolar bone loss rates in these patients.

III. Determine whether changes in periodontal bone mass relate to bone mass changes in other skeletal sites in these patients.

PROTOCOL OUTLINE: This is a randomized, double-blind, placebo controlled study. Patients are randomly assigned to receive placebo or conjugated estrogens and, if no prior hysterectomy, medroxyprogesterone. Patients also receive calcium supplementation therapy daily for 3 years.

Participants in the placebo group may be removed from study if bone loss exceeds 5% per year.

A study duration of 3 years is anticipated.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

* Women postmenopausal for at least 2 years
* At least 10 teeth for which radiographic measurements can be obtained, i.e.: Not severely tilted Not so closely spaced that interproximal bone is thin Not in positions of restricted access
Obesity and Mindful Eating in Patients With Anxiety

Background: Obesity is chronic disease with high prevalence rates, functional disability and difficult long-term management. Anxiety is one of the most common psychological disorders in obesity, and when associated with other factors such as emotional eating and emotional dysregulation, it impairs treatment and interferes with lifestyle changes. Finding an intervention that improves the eating behavior of these patients and facilitates adherence to obesity treatment, associated with less emotional distress, is of great clinical interest. Objective: The aim of this study is to evaluate the effectiveness of the Mindful Eating (ME) intervention on neurocognitive and behavioral outcomes in patients with obesity and anxiety compared to the control group with exposure to videos promoting quality of life. Methods: A five-weeks randomized clinical trial will be performed with 52 patients in adulthood. The Mindful Eating intervention group will receive an online protocol with one meeting per week. This is a protocol that has been adapted for five weeks and consists of a group intervention with 10-15 participants. Mindfulness, Mindful Eating and Self-Compassion training will be based on the Eat for Life protocol. The control group will receive five videos of psychoeducation, one topic per week. After, all participants will receive lifestyle advices, a first-line "treatment-as-usual" to obesity. There will be a face-to-face assessment with anthropometric, behavioral and biological measurements pre and post-intervention. The outcomes may help in understanding the mechanisms underlying the change in eating behavior, in order to direct new therapeutic strategies for the treatment of anxiety and obesity comorbidities.

This study is the second phase of a cross-sectional study.

Eligibility Criteria:
Inclusion Criteria:

* Be between 18 and 50 years old;
* Inclusion for Generalized Anxiety Disorder (GAD):

Primary GAD diagnosed by the M.I.N.I.;

✔Inclusion for Obesity: Obesity BMI grade I (between 30.0 and 34.9); Obesity BMI grade II (between 35.0 and 39.9)

Exclusion Criteria:

* In individuals with obesity or control only, not having any psychiatric disorder;
* In individuals with only GAD or control, do not have a BMI above 25.
* In individuals with GAD, not having a diagnosis of primary or severe depression;
* Being under psychopharmacological, psychotherapeutic or nutritional treatment;
* Bipolar Disorder, Psychotic Disorder, Substance Use Disorder (except Tobacco) in the last 6 months or Suicidal Ideation in the last 6 months (M.I.N.I);
* Have a clinical instability or immobility;
* Being in Pregnancy or Lactation;
* Antisocial Personality Disorder;
* Eating Disorder.
Clinical Evaluation of Two Cosmetic Contact Lenses

This is a single visit, single-masked, non-dispensing, randomized, controlled, 2×2 bilateral crossover study to evaluate visual acuity.


Eligibility Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:

1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. Be between 18 and 39 (inclusive) years of age at the time of screening.
4. Be a current soft contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week over the last 30 days by self-report.
5. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 D to -6.00 D (inclusive) in each eye.
6. The subject's refractive cylinder must be less than or equal to 0.75 D (inclusive) in each eye.
7. Have spherical best corrected visual acuity of 20/25 or better in each eye.

Potential subjects who meet any of the following criteria will be excluded from participating in the study:

1. Be currently pregnant or lactating.
2. Have any systemic disease (eg, Sjögren's Syndrome), allergies, infectious disease (eg, hepatitis, tuberculosis), contagious immunosuppressive diseases (eg, HIV), autoimmune disease (eg rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study (at the investigator's discretion).
3. Use of systemic medications (eg, chronic steroid use) that are known to interfere with contact lens wear (at the investigator's discretion).
4. Have any previous, or planned (during the study), ocular surgery (eg, radial keratotomy, PRK, LASIK, etc.).
5. Have any previous history or signs of a contact lens-related corneal inflammatory event (eg, past peripheral ulcer or round peripheral scar), or any other ocular abnormality that would contraindicate contact lens wear (at the investigator's discretion).
6. Have participated in any contact lens or lens care product clinical trial within seven (7) days prior to study enrollment.
7. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site.
8. Have any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion (at the investigator's discretion).
9. Have any clinically significant (Grade 3 or 4 on FDA scale) tarsal abnormalities, bulbar injection, corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
Study of Aripiprazole to Reduce Medical Risks in Bipolar Disorder

The proposed study is a non-randomized, open label trial that will examine the potential to reduce metabolic risk factors in patients with bipolar I disorder and improve psychiatric and functional outcomes. To accomplish our objective, we plan to conduct a 5-month intervention of 50 obese or overweight adults diagnosed with bipolar disorder. The study will be divided in three steps: Screening, Baseline Period (cross taper to aripiprazole, up to 2 months in duration), Months 1-3 (continued aripiprazole treatment). Subjects will be assessed and meet with their study psychiatrist at least bi-monthly throughout their participation, more frequently when clinically necessary (e.g. during medication tapering or if manic/depressive symptoms emerge). Brief clinical assessments will be conducted at each visit. More thorough assessments will be conducted at Baseline, Week 2, and Month 3.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 65 years
2. Body mass index (BMI) \>=25;
3. Currently taking a regimen of medications for bipolar disorder likely to cause, sedation, weight gain or undesirable metabolic effects;
4. Able to give basic informed consent
5. Meets DSM-IV criteria for lifetime bipolar I or II disorder and are presently in sustained remission (CGI BP\<3 in the previous 8-week period measured through a complete psychiatric history at screening and patient report.)
6. Epworth Scale Score \> 7
7. Women of childbearing potential must agree to use a doctor-approved birth control throughout participation in the study

Exclusion Criteria:

1. Unwilling or unable to comply with study requirements (i.e., complete forms, attend scheduled evaluations)
2. Not competent to provide informed consent in the opinion of the investigator
3. Ultra-rapid cycling (\>4 episodes per month) bipolar I disorder
4. Unstable and severe medical illness that requires immediate and intensive medical attention, When appropriate, the patients can be reconsidered for inclusion in the study if/when their medical condition becomes compatible with participation in a protocol-driven research study
5. Women who are planning to become pregnant, currently pregnant, or breast-feeding;
6. Current substance dependence; however, if a subject only has substance abuse/use, after the first positive drug screen, another drug screen will be repeated. If that drug screen is positive, the subject will be excluded. If the second drug screen is negative, the subject will be considered for the study;
7. Subjects who have previously failed an adequate trial of aripiprazole.
8. Subjects with a suicide attempt in the past 2 years;
9. Subjects with a history of inpatient admission in the past 1 year;
10. Subjects with a history of homicidal ideation;
11. Any subject for whom the PI deems that the potential risks in participating in the study outweigh the potential benefits.