cyrilzakka/clinical-trials huggingface dataset:
Study of ARO-APOC3 in Adults With Mixed Dyslipidemia

Participants who have met all protocol eligibility criteria will be randomly assigned to treatment (ARO-APOC3 or placebo) in a double-blind fashion and will be evaluted for safety and efficacy over 48 weeks. Participants will be counseled to remain on a specified diet throughout the study, as recommended by the Investigator in accordance with local standard of care. After week 48, participants will be eligible and invited to consent and continue in an open-label extension study. All placebo participants who opt to continue will switch to active drug (ARO-APOC3) during the extension study.


Eligibility Criteria:
Inclusion Criteria:

Based on medical history, evidence of TG ≥ 150 mg/dL but ≤ 499 mg/dL on more than one occasion

* Fasting levels at Screening of non-HDL-C ≥ 100 mg/dL OR LDL-C ≥ 70 mg/dL after at least 4 weeks of stable diet and stable optimal statin therapy
* Mean fasting TG ≥ 150 mg/dL and ≤ 499 mg/dL during Screening collected at two separate and consecutive visits and at least 7 days apart and not more than 14 days apart
* Willing to follow diet counseling as per Investigator judgment based on local standard of care
* Participants of childbearing potential (males \& females) must use highly-effective contraception during the study and for at least 24 weeks following the last dose of study medication. Males must not donate sperm and females must ot donate eggs during the study and for at least 24 weeks following the last dose of study medication.
* Women of childbearing potential must have a negative pregnancy test at Screening and cannot be breastfeeding
* Women of childbearing potential on hormonal contraceptives must be stable on the medication for ≥ 2 menstrual cycles prior to Day 1
* Willing to provide written informed consent and to comply with study requirements

Exclusion Criteria:

* Current use or use within 365 days from Day 1 of any hepatocyte targeted siRNA or antisense oligonucleotide molecule
* Active pancreatitis within 12 weeks prior to Day 1
* Any planned bariatric surgery or similar procedures to induce weight loss from consent through end of study
* Acute coronary syndrome event within 24 weeks of Day 1
* Major surgery within 12 weeks of Day 1
* Planned coronary intervention (e.g., stent placement or heart bypass) during the study
* New York Heart Association Class II, III or IV heart failure or last known ejection fraction of \<30%
* Uncontrolled hypertension
* Known history of human immunodeficiency virus (HIV) infection, seropositive for Hepatitis B (HBV), seropositive for Hepatitis C (HCV)
* Uncontrolled hypothyroidism or hyperthyroidism
* Hemorrhagic stroke within 24 weeks of Day 1
* History of bleeding diathesis or coagulopathy
* Current diagnosis of nephrotic syndrome
* Systemic use of corticosteroids or anabolic steroids within 4 weeks prior to Day 1 or planned use during the study
* Malignancy within the last 2 years prior to date of consent requiring systemic treatment (some exceptions apply)

Note: additional inclusion/exclusion criteria may apply per protocol
Urine Biomarker for Kidney Transplant Rejection

An adaptive sample collection to support biomarker evaluation for kidney transplant rejection.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide informed consent
* Kidney Transplant

Exclusion Criteria:

* Pediatric patients, under 18 years of age
Effect of Nutrition on Muscle Protein Synthesis

The present proposal is designed to examine the effect of carbohydrate and protein co-ingestion on muscle protein synthesis during endurance type exercise activities. We hypothesize that muscle protein synthesis is higher when protein is co-ingested during exercise.


Eligibility Criteria:
Inclusion Criteria:

* recreationally endurance trained

Exclusion Criteria:

* BMI \> 25 kg/m2
* Not physically active
A Study to Evaluate Next Day Effects of TS-142 on Driving Performance in Healthy Subjects

A clinical study to evaluate the residual effects of TS-142 on driving performance in healthy and elderly subjects.


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 21 years or older but less than 80 years at the time of informed consent
* Those with a BMI of 18.5 or more and less than 25.0 and a body weight of 40.0 kg or more at screening tests
* Have an ordinary driving license and have driven on a daily basis for more than 3 years
* Have a constant sleep pattern (waking up from 5:00 to 9:00, falling asleep from 21:00 to 1:00 and time in bed is from 6 to 8 hours)
* No visual impairment (those who have \>=0.7 vision in both eyes and \>=0.3 in each eye at vision test of screening tests, enable to correct the vision with eyeglasses or contact lens)
* Those who have cognitive and physical function (adequate dexterity of fingers, vision and hearing etc.) to operate Driving Simulator (DS) certainly, understand and carry out the direction on the task of the DS evaluation
* Those with no abnormal findings in medical examinations, vital signs, or 12-lead electrocardiogram and whose laboratory test results were within the reference values of the study site based on the results of screening tests and tests obtained before hospitalization of Visit 1
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Those who have any disease and are not regarded as healthy subjects based on the medical judgment of the principal investigator or sub-investigator
* Those who have a medical history that makes them ineligible for participation in this study such as respiratory disease, cardiovascular disease, gastrointestinal disease, liver disorder, renal disorder, urological disease, endocrine disease, metabolic disease, hematological disease, immune disease, skin disease, neurological disease, mental disorder etc.
* Those who have had symptoms of parasomnia (parasomnia, sleepwalking, abnormal dreams, nightmares), narcolepsy-like symptoms (cataplexy, hypnagogic hallucinations, sleep paralysis), or suicide attempt
* Those who have hypersensitivity to zopiclone or s-zopiclone
* Those who have experienced a time difference of 6 hours or more within 1 week prior to Visit 1, or who will be exposed to such time difference during the study period
* Those who have performed irregular shift work or night shift work within 4 weeks prior to Visit 1, or need to do so during the study period
* Those who have performed the DS evaluation used in this clinical trial in the past
* Those who received TS-142 (active drug) in the past
* Those who go of course even once at the DS evaluation in Visit1
* Those whose total SDLP in 60 minutes at the DS evaluation in Visit1 is more than 60 cm
* Other protocol defined exclusion criteria could apply
Patient-Informed Educational Intervention for the Improvement of Cervical Cancer Literacy

This study investigates the health literacy, cervical cancer knowledge, and radiation knowledge of patients with cervical cancer. The goal of this study is to develop a video that can improve patients 'understanding of cervical cancer and its treatment.

PRIMARY OBJECTIVES:

I. To assess the baseline health literacy, cervical cancer knowledge and radiation knowledge in a diverse sample of patients from two hospitals in Houston, Texas. (Phase 1) II. To test improvement in comprehension of cervical cancer and radiation terminology in a diverse sample of cervical cancer patients after viewing the video-based educational tool developed in this study. (Phase 2)

SECONDARY OBJECTIVES:

I. To assess barriers to care and assess baseline radiation adherence, defined as missing no treatments and time to radiation completion, in a diverse sample of patients from two hospitals in Houston, Texas.

II. To describe the impact of the video on radiation treatment adherence in terms of radiation completion, defined as missing no treatments) and time to radiation completion.

III. To describe the relationships between time to radiation completion, health literacy, sociodemographics, reported barriers to care, and baseline cervical cancer knowledge and misconceptions.

OUTLINE:

PHASE I: Patients complete surveys over 10 minutes on their background, health literacy level, barriers to cancer care, and knowledge of cervical cancer and its treatment.

PHASE II: Patients watch educational video on cervical cancer. Patients also complete surveys over 5-10 minutes at baseline and after watching educational video.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven carcinoma of the cervix
* Federation of Gynecology and Obstetrics (FIGO) stage IB-IVA
* N0 and N1 nodal status according to TNM staging
* Planned for definitive chemoradiation with curative intent
* Able to speak and read English or Spanish
* Age 18 or older
* Able to give informed consent

Exclusion Criteria:

* Physicians or nurses
Testing the Effectiveness of WW Clinic GLP1

The study objective is to evaluate the efficacy of the WeightWatchers (WW) GLP-1 behavioral program + WW Clinic (formerly known as Sequence medical weight management program) on weight loss and related outcomes. Participants will be invited to take part and answer surveys at 0, 12 and 24 weeks.

This is a 24 week prospective single-arm efficacy outcomes study. Up to 180 adult participants who are currently enrolled in WW GLP-1 behavioral program program + WW Clinic (formerly known as Sequence medical weight management program) and already prescribed semaglutide or tirzepatide. The application of a comprehensive lifestyle-based intervention focused on dietary intake, physical activity, support and behavioral principles in conjunction with anti-obesity medication (AOM) is novel and may increase AOM efficacy while minimizing maintenance concerns. As obesity care can now be delivered virtually, it will also include an innovative strategy of virtual/remotely delivered medical care via Sequence and WW. Further, this study will examine multiple psychosocial domains associated with weight loss and weight loss related outcomes including physical activity, dietary behavior, disordered eating, depression symptoms, internalized weight bias and community, that have not been examined in AOM trials.

Eligibility Criteria:
Inclusion criteria:

1. 18 years or older
2. BMI of \>30 or BMI of \>27 with one or more weight related medically qualifying condition (hypertension, dyslipidemia, sleep apnea, cardiovascular disease)
3. Access to a smartphone or tablet that runs iOS/iPadOS 15.0 or later, or Android 7.0 or later
4. A prescription for Wegovy, Mounjaro, or Zepbound

Exclusion criteria:

1. Diabetes
2. Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia type 2
3. History of pancreatitis within 180 days
4. Previous surgical obesity treatment
5. Use of other anti-obesity medication in last 90 days
6. Use of GLP-1 within the last 180 days
7. Lost weight \>11 lbs in the last 90 days
8. Pregnant, breastfeeding, intends to become pregnant, of child-bearing potential and not using a highly effective contraceptive method
Abdominal Wall Nerve Blockade: A Comparison With Local Port Site Injection as Well as Between the Use of Ultrasound and Laparoscopy to Guide Placement

The investigators will perform a prospective randomized study to compare the effectiveness of laparoscopic-guided abdominal wall nerve blocks with local wound site infiltration and with ultrasounded guided abdominal wall blocks.

Pain control after abdominal surgery in children is often a complex, multifaceted problem that requires a multimodal approach to treatment. Infiltration of wounds with long-acting local anesthetic, either into the surgical field or through locoregional nerve blockade, has been known to decrease narcotic requirements. Nerve blocks of the abdominal wall can occur through several modalities, among them the transverse abdominis plane block and the rectus sheath block. The transversus abdominis plane (TAP) block places local anesthetic in a plane between the internal oblique and transversus abdominis muscles, directly blocking innervation of spinal nerves T9-L3, the ilioinguinal, iliohypogastric and lateral cutaneous branches of L1-3, reducing pain sensation to the anterior abdominal wall. The rectus sheath block places local anesthetic between the internal oblique and transversus abdominis at the level of the terminal branches of intercostal nerves 9-11.

The investigators will perform a prospective randomized study to compare the effectiveness of laparoscopic-guided abdominal wall nerve blocks with local wound site infiltration and with ultrasounded guided abdominal wall blocks.

The goal of this study is to determine whether patients who receive a nerve block have significantly less pain compared to patients who receive local infiltration of anesthetic. Secondly, the investigators believe that laparoscopic-guided abdominal wall nerve blocks should be as effective as abdominal wall blocks performed under ultrasound-guidance, and may in fact allow for more consistent infiltration of local anesthetic to desired nerve bundles. Thirdly, the investigators believe that laparoscopic-guided abdominal wall nerve blocks are significantly less time intensive than ultrasound-guided abdominal wall nerve blocks, allowing a cost savings and decreased time under general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

1. Patients 5 - 17 years old.
2. Patients undergoing laparoscopic procedures
3. Patients that weigh greater than or equal to 34 kg and less than 100 kg.

Exclusion Criteria:

1. Patients who underwent open surgical procedures will be excluded from this study.
2. Patients that weigh less than 34kg.
3. Patients that weigh more than 100 kg.
4. Perforated appendicitis.
5. Bowel obstruction
Continuous Supraglottic pH Monitoring in Prolonged Intubated Intensive Care Patients and High Risk Aspiration Intraoperative Patients

This is a pilot prospective cohort study of the incidence of supraglottic pH readings.

Aspiration is a serious morbidity that leads to an increase in both patient mortality and duration of hospital stays. Many practices exist within the hospital setting whose goal is to help prevent clinically significant aspiration including preoperative starvation, pharmaceutically reducing gastric acidity, facilitating gastric drainage, postural changes, cricoid pressure, endotracheal cuff pressure modification, and maintenance of a competent lower esophageal sphincter. However, to date, no monitoring system exists to help a clinician identify active aspiration. At present, video fluoroscopy, is the gold standard for detecting aspiration. This pilot prospective cohort study will examine the incidence of supraglottic pH readings.

A continuous pH/impedence sensor will be placed immediately above the glottic opening in four high risk populations: burn patients who are intubated, intubated post-stroke patients, patients undergoing robotic prostectomy, and in patients undergoing peritoneal tumor debulking and chemotherapy. The presence of acidic fluid above the glottic opening will be measured using a supraglottic impendence/pH probe attached to an endotracheal tube.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled to undergo robotic prostatectomy.
* Patients undergoing peritoneal tumor debulking and chemotherapy
* Mechanically ventilated Burn Intensive Care Unit (BICU) Patients
* Mechanically ventilated Neuro Care Unit (NCU) Patients who have suffered a stroke

Exclusion Criteria:

* ICU patients who are not receiving enteral feeds
* Patients who present for tumor debulking or robotic prostatectomy who receive preoperative H2 blockers, proton pump inhibitors, antacids or metoclopramide.
Effects of Infrared Laser Moxibustion on Cancer-related Fatigue in Breast Cancer Patients

Cancer-related fatigue (CRF) is the most common and distressing symptom associated with tumor or cancer treatment that breast cancer survivors (BCS) experience.The investigators previously found the laser moxibustion was potentially efficacious for CRF; however, more rigorously designed study is needed to confirm its benefit. The primary aim of this study is to determine the efficacy of 10.6µm infrared laser moxibustion and its long-term effects on CRF. Secondary aims are to evaluate the effect of infrared laser moxibustion on co-existing symptoms such as among BCS experiencing CRF.

The randomized, placebo-controlled, three-arm trial will be conducted to evaluate the efficacy of infrared laser moxibustion (ILM) and sham ILM (SILM) compared to waitlist control (WLC) for moderately to severely fatigued BCS. The two intervention groups will receive real/sham infrared laser moxibustion on four acupoints (e.g. ST36 (bilateral), CV4, and CV6) for 20 minutes each session for six weeks (two times per week). The primary endpoint is the change in fatigue scores from Baseline to Week 6 as measured by the Chinese version of the Brief Fatigue Inventory (BFI-C). Our secondary aims are to compare the severity of comorbidities (e.g. depression, insomnia, and pain) and biological outcomes (e.g. telomere length) among the three groups.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 years and 75 years
* Breast cancer survivors with a diagnosis of stage I-IIIa
* Cessation of cancer-related treatments (e.g. surgery, chemotherapy, radiotherapy) at least 12 weeks before the trial, with the exception of hormonal and trastuzumab therapy
* Complaint of fatigue starting on or after their cancer diagnosis,Brief Fatigue Inventory score of ≥ 4

Exclusion Criteria:

* Severe anemia (platelet count \<60,000/μL,hemoglobin \<8 g/dL, or leukocyte count\<3000/μL)
* Abnormal findings in a thyroid function test (abnormal level of free thyroxine and thyroid stimulating hormone \<0.1 μIU/ml or TSH\> 5.1 μIU/ml)
* Having received acupuncture for any indication in the previous 4 weeks or having received acupuncture test within the past 6 months.
* Untreated major depressive disorder and suicidal ideations.
* Pregnant or planning to become pregnant
Carbonic Anhydrase Inhibitors and Carbonation: A Novel Approach to Reduce Soda Consumption

Acetazolamide is a drug that is approved by the FDA for treating various conditions like epilepsy, altitude sickness, and glaucoma. Acetazolamide works by inhibiting an enzyme called carbonic anhydrase, which is important for many essential processes in our body. For example, carbonic anhydrase is needed to transport carbon dioxide in our blood which is essential for respiration.

One of the interesting effects of acetazolamide is that it reduces the taste of carbonation, making carbonated drinks like soda taste flat and or like soapy water. This effect has been noticed by hikers using the drug for mountain sickness treatment. It's believed that carbonic anhydrase inhibitors decrease the levels of carbonic acid in our mouths, which in turn reduces and changes the perception of carbonation taste.

It was hypothesized that this side effect of acetazolamide could be used to help people cut down on soda consumption. Since soda has been linked to health issues like obesity and type 2 diabetes, reducing its intake could be beneficial. In a case study, a person who took low-dose acetazolamide for six weeks experienced weight loss and found it easier to avoid carbonated drinks.

We are proposing a study to explore the effects of using acetazolamide as an oral rinse to decrease soda intake. The use of acetazolamide as an oral rinse has yet to be tested and is a possible way to decrease the taste of carbonation while also decreasing the side effects of the drug. Our plan is to use different doses of the rinse on participants and monitor their soda consumption and body mass index changes.

In summary, acetazolamide, a drug with various medical uses, could potentially help people reduce soda consumption by altering the taste of carbonation.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. Consumes on average ≥ 7 sodas per week
3. Healthy and without a history of significant neurological, liver, renal, cardiac or pulmonary disease.
4. No allergy to sulfa drugs or aspirin (contained in Alka Seltzer).
5. Ability to provide informed consent.

Exclusion Criteria:

Healthy adults, UA students, UA faculty and staff Exclusion Criteria:

1. Pregnant or lactating women.
2. Prisoners.
3. Refugees.
4. Cognitive impairment.
5. Chronic illness.
6. Allergy to sulfa drugs or aspirin.
The Oral Microbiome and Upper Aerodigestive Squamous Cell Cancer

The human oral cavity is a diverse habitat that contains approximately 700 prokaryotic species. The oral microbiome is comprised of 44% named species, 12% isolates representing unnamed species, and 44% phylotypes known only from 16S rRNA based cloning studies (http://www.homd.org/). Species from 11 phyla have been identified: Firmicutes, Bacteroidetes, Proteobacteria, Actinobacteria, Spirochaetes, Fusobacteria, TM7, Synergistetes, Chlamydiae, Chloroflexi and SR1 (http://www.homd.org/). Because these observations have been mainly based on data generated from traditional Sanger sequencing, the diversity of oral microbiome is highly likely underestimated. Application of high throughput sequencing to the oral microbiome similar to the scale of the microbiome studies of other body sites (GI tract, skin, and vagina) under the Human Microbiome Project is necessary to obtain data essential for understanding the diversity and community structure of the oral microbiome in health and disease.

The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial and The American Cancer Society Cancer Prevention Study II (CPS-II) investigators have identified 140 UADSCC cases that have been frequency matched 3:1 (420 controls) by incidence density sampling for study (ACS. PLCO), gender, ethnic background, and age, within 10 years.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Upper Aerodigestive Squamous Cell Cancer and registered in:
* The American Cancer Society Cancer Prevention Study II (CPS-II)
* The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial.
A Comparative Study of ZG-801 and Placebo in Patients With Hyperkalemia

The purpose of this study is to evaluate the superiority of ZG-801 to placebo in Japanese hyperkalemia patients whose serum potassium value becomes normal in the Run-in period by comparing the change in the value at the Double-blind period week 4, and to further evaluate the efficacy and safety of ZG-801 in Japanese hyperkalemia patients administrated ZG-801 for maximum 9 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Patients whose serum potassium value (local) at the Run-in period baseline is ≥5.5mEq/L, \< 6.5 mEq/L
* Age 20 - 80 years old at informed consent
* Patients who understand an overview of the study and voluntarily consented to participate in the study by documents.

Main Exclusion Criteria:

* Patients determined to require emergency treatment for hyperkalemia at the Run-in period baseline
* Patients with poorly controlled blood pressure
* Patients with heart failure in New York Heart Association Class IV
* Patients who have experienced heart transplant, liver transplant or kidney transplant or who are predicted that the need for them will occur during the study
* Patients who have taken any of the following medication within 7 days prior to the Run-in period baseline or currently administrated.

  1. Sodium polystyrene sulfonate
  2. Calcium polystyrene sulfonate
  3. Sodium zirconium cyclosilicate hydrate
  4. Potassium supplement
* Patients with or who have experienced a severe swallowing disorder, moderate to severe gastroparesis, severe constipation, bowel obstruction, incarceration, abnormal post-operative bowel motility disorders or severe gastrointestinal disorders. In addition, patients who have experienced bariatric surgery or major gastrointestinal surgery (e.g., bowel resection).
* Patients suspected to be with transient high potassium value.(ex. caused by dietary effects only)