cyrilzakka/clinical-trials huggingface dataset:
A Master Protocol for Orforglipron in Participants With Obstructive Sleep Apnea and Obesity or Overweight

Study GZRA is a master protocol that will support 2 independent studies, GZ01 and GZ02. Participants will be assigned to the appropriate study prior to randomization. The purpose of the studies is to evaluate the efficacy and safety of orforglipron in participants who have moderate-to-severe OSA and obesity or overweight. Study GZ01 will include participants who are unable or are unwilling to use PAP therapy. Study GZ02 will include participants who are on PAP therapy for at least 3 months at time of screening and plan to continue PAP therapy during the study.


Eligibility Criteria:
Inclusion Criteria:

Master GZRA inclusion criteria

* have AHI ≥15 on PSG as part of the trial at screening (V1).
* have body mass index (BMI) ≥27 kg/m²

Study 1 GZ01 inclusion criteria

* Participants who are unable or unwilling to use PAP therapy.
* Participants must not have used PAP for at least 4 weeks prior to screening.

Study 2 GZ02 inclusion criteria

* Participants who have been on PAP therapy for at least 3 consecutive months prior to study start and plan to continue PAP therapy during the study.

Exclusion Criteria:

Master GZRA exclusion criteria

* Have Type 1 diabetes (T1D) or Type 2 diabetes (T2D), history of ketoacidosis, or hyperosmolar state/coma
* Have HbA1c ≥6.5% (≥ 48 mmol/mol), as determined by the central laboratory at Visit 1.
* Had any previous or planned upper airway surgery for sleep apnea or major ear, nose or throat surgery
* Have diagnosis of Central or Mixed Sleep Apnea with % of mixed or central apneas/hypopneas ≥50%, or diagnosis of Cheyne Stokes Respiration
* Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia.
* Active device treatment of OSA other than PAP therapy
* Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator.
* Have a self-reported change in body weight \>5 kg within 3 months prior to screening
* Have a prior or planned surgical treatment for obesity (excluding liposuction, abdominoplasty or cryolipolysis if performed more than 1 year prior to screening)
* Have a prior or planned endoscopic and/or present device-based therapy for obesity.
* Have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity.

Study 2 GZ02 exclusion criteria

* Have personal or job-related responsibilities, or in the opinion of the investigator have any situation that would make it unsafe to stop PAP therapy for 7 days prior to PSG testing during the study.
* Are unwilling to temporary discontinue PAP therapy for 7 days prior to PSG testing during the study.
A 12 Week Safety And Efficacy Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients

The safety and efficacy at 100 mg once daily for oral dose of sitaxentan sodium were demonstrated in the STRIDE clinical trial program. Sitaxentan sodium was approved in the EU, Canada and Australia. In this study, the safety and efficacy after administrations of sitaxentan sodium at a dose of 100 mg alone or in combination with another medication will be investigated in Japanese PAH patients.


Eligibility Criteria:
Inclusion Criteria:

* Has a current diagnosis of symptomatic PAH
* Has 6MWT distances from 150 to 450 meters and distance

Exclusion Criteria:

* Previous exposure to an endothelin receptor antagonist
* Has uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure \>160 mm Hg or sitting diastolic blood pressure \>100 mm Hg at Screening.
* Has hypotension defined as systolic arterial pressure \<90 mm Hg after sitting for 5 minutes at Screening.
Spine Procedures Assisted with RoboTics and Navigation

Creation of a pediatric robotic spine surgery registry will allow for data collection and analysis on the coupled use of robotics and navigation, as well as patient-specific rods in pediatric spine deformity surgery across participating study institutions. Eventually, an educational and informative framework for this technology will be established.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a spine deformity
* Scheduled for surgery using robotics and navigation and/or patient-specific rods
* Up to and including 21 years of age
* Speak and read English or Spanish

Exclusion Criteria:

• None
Effect of Mouthwash Containing Camellia Sinensis Extracts on Oral Malodor

The purpose of this study is to determine effect of Mouthwash containing Camellia sinensis extracts on oral malodor and gingival inflammation in gingivitis subjects.

At baseline, level of volatile sulfur compounds (VSC) in mouth air, Plaque Index and Papillary Bleeding Index will be recorded. Gingivitis subjects will be asked to rinse with Camellia sinensis mouthwash or placebo mouthwash. VSC level will be measured at 30 minutes and 3 hours post-rinsing. For the following 4 weeks, subjects will be rinsed with the assigned mouthwash twice daily after toothbrushing. All parameter will be recorded again at Day 28.

Eligibility Criteria:
Inclusion Criteria:

* at least 20 teeth
* clinical diagnosis as plaque induced gingivitis
* having over 80 ppb of volatile sulfur compounds in mouth air

Exclusion Criteria:

* smoker
* denture wearer
* having systemic diseases or oral pathology
* taking antibiotics 1 month prior to study
Optimalization of Nephroprotection Using Atorvastatin (Sortis)

The main purpose of the study is find whether the addition of statin (Atorvastatin) to dual renin-angiotensin-aldosterone system blockade involving angiotensin converting enzyme inhibitor and AT-1 angiotensin II receptor blocker leads to the reduction of proteinuria, main prognostic marker of chronic kidney disease progression.

The renin-angiotensin-aldosterone system (RAAS) plays an important role in the progression of chronic kidney diseases (CKD), and inhibition of the RAAS with angiotensin-converting enzyme inhibitors (ACEI) and angiotensin II type 1 receptor blockers (ARB) may retard CKD progression. Dual pharmacological blockade of the RAAS with ACEI and ARB is recommended as a standard renoprotective management at least in patients with nondiabetic proteinuric CKD. However, neither ACEI nor ARB, even in high doses or in concomitant usage, abrogate the progression of CKD completely. Innovative approaches are needed to keep patients with CKD off dialysis. Additional statin (Atorvastatin) pathway may prove to be such beneficial therapeutic concept.Given these facts additional administration of statin to combination treatment with ACEI and ARB, may provide additional renal protection. To shed more light on this issue, we performed a randomised open controlled study to evaluate the influence of triple therapy with ACEI and/orARB and statin on surrogate markers of kidney injury, i.e. proteinuria, markers of tubular involvement and kidney fibrosis.

Eligibility Criteria:
Inclusion Criteria:

* Chronic kidney disease
* Stable proteinuria above 300 mg/24 hours (no variations above 25% in the last 6 months)
* Normal or slightly impaired stable renal function defined as serum creatinine level below 1.7 mg/dl (eGFR \> 45 ml/min)

Exclusion Criteria:

* Nephrotic syndrome
* Steroids or other immunosuppressive treatment minimum during six months before the study
* Diabetes mellitus
* Potassium serum level \> 5.1 mEq/L
* Albumin serum level \< 2.0mg/dL
* Creatinine serum level \>2 mg/dl
* Current diagnosis of heart failure New York Heart Association (NYHA) Class II-IV
* Clinically significant valvular heart disease or second or third degree heart block without a pacemaker
* History of hypertensive encephalopathy, cerebrovascular accident or transient ischemic cerebral attack
* History of myocardial infarction, unstable angina pectoris, coronary bypass surgery, or any percutaneous coronary intervention
* History of malignancy including leukemia and lymphoma (but not basal cell skin carcinoma) within the past five years
* Pregnant or nursing women
* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs.
* History of alcohol abuse
* NSAID abuse (more than 2 doses per week)
* Known or suspected contraindications to the study medications, including history of allergy to ACE inhibitors, AT-1 receptor blockers and atorvastatin
Study of Afimoxifene Gel to Treat Cyclic Mastalgia in Premenopausal Women

The purpose of this study is to evaluate the efficacy of two doses of 4-hydroxy tamoxifen (4-OHT) compared with placebo on the intensity of cyclic mastalgia in pre-menopausal women with regular menstrual cycles who are not taking oral contraceptives.

This study is a Phase II, randomised, double-blind, placebo-controlled, two-dose, multicentre trial of 4-OHT gel in approximately 130 otherwise healthy pre-menopausal women with a history of cyclical mastalgia, peaking during the second half of the menstrual cycle and decreasing significantly with the onset of menstruation, during the four months prior to study entry.

The primary efficacy endpoint in this study is change in change in average pain Visual Analog Scale (VAS) scores for the seven worst pain scores within a cycle, from baseline to the fourth cycle after start of treatment.

Eligibility Criteria:
Inclusion Criteria:

* A woman is eligible for this study if she:

  * is pre-menopausal and at least 18 years of age.
  * has a history of cyclical mastalgia for each of the four months prior to study entry.
  * moderate or severe mastalgia as determined by \>40 mm on the VAS for ≥7 days per cycle in the second part of the cycle, i.e. 13 days prior to menses and the first two days of the next cycle with a substantial decrease during the two weeks following the onset of menses, assessed during the two month run-in period.
  * has a history of regular menstrual cycles of 28 plus/minus 3 days.

Exclusion Criteria:

-
Postoperative Pain After Intravenous Vitamin C Injection for Arthroscopic Rotator Cuff Repair

1. Treatment of rotator cuff tear The rotator cuff tear is the most demanding part of the shoulder surgery. Rotator cuff degeneration is thought to be the largest cause of rotator cuff tear.

   As the field of shoulder surgery evolves, the diagnosis and surgical treatment of the rotator cuff tear was increased. Repair and reconstruction of the rotator cuff tear annually more than 300,000 have been performed according to US statistics.

   Rotator cuff repair is a successful procedure, both objectively and subjectively, with regard to pain relief and functional outcome.
2. postoperative pain management after rotator cuff repair Shoulder surgeries are associated with a level of postoperative pain requiring opioid use for several days. The opioid requirements after shoulder surgery have been reported to be similar to those required after gastrectomy or thoracotomy, which might cause several opioid-related side effects, such as nausea and vomiting, pruritus, urinary distention, and constipation. Although the introduction of arthroscopy has reduced postoperative pain, a considerable proportion of patients suffer from moderate to severe acute postoperative pain, as its benefit is typically apparent after a few days. Consequently, proactive pain control is also required during the first 24-48 h after arthroscopic shoulder surgeries, just like in open surgeries. Adequate pain management during the immediate postoperative period is not only important for patient satisfaction and well-being, but also for facilitating postoperative rehabilitation and preventing persistent postsurgical pain.

Recently preoperative intravenous vitamin C has shown to increase the analgesic effect after otorhinolaryngologic surgery and thoracic surgery. Vitamin C is a water-soluble and known to have anti oxidant action, and fewer side effects.

However, there is no report about the analgesic effect of vitamin C after arthroscopic rotator cuff repair.

The purpose of this trial was to compare the effects of a intravenous vitamin C injection on postoperative pain and opioid consumption versus non-treated group after arthroscopic rotator cuff repair.


Eligibility Criteria:
Inclusion Criteria:

* Rotator cuff tear patients undergoing arthroscopic rotator cuff tear

Exclusion Criteria:

* age \<45 or \>80
* allergies to medications used in the study
* history of renal diseases, a coagulation abnormality, a hepatic disease, or drug abuse
* definite radiographic evidence of osteoarthritis of the glenohumeral joint
* inflammatory arthritis including rheumatoid arthritis
* a history of acute trauma
* systemic conditions associated with chronic pain
* a history of infection
* an inability to understand the questionnaires
Exercise and Therapeutic Learning Among Women With PTSD

This study aims to test whether aerobic exercise performed after fear extinction learning improves the consolidation and subsequent recall of the learned safety memories (i.e., fear extinction memories) among adult women with PTSD related to interpersonal violence exposure, and whether this effect is mediated by the ability of exercise to increase acute levels of Brain-Derived Neurotrophic Factor (BDNF) and endocannabinoids (eCB). Participants can expect to be on study for up to 90 days, participating in 4 study stages: Day 1 of Assessments, Day 2 of Fear Learning, Day 3 of Fear Extinction (and activity), and Day 4 of Recall of Fear Extinction.


Eligibility Criteria:
Inclusion Criteria:

* Current diagnosis of PTSD where the index traumatic event includes physical or sexual assault
* English speaking
* Medically healthy

Exclusion Criteria:

* Any endorsed medical concerns related to physical activity (as probed in the phone screening questions regarding cardiovascular, pulmonary, or metabolic disease and as assessed via the Physical Activity Readiness Questionnaire (PAR-Q), which probes into participants' history of heart conditions, chest pain, dizziness, loss of consciousness, bone/joint problems, and medication history). Participants would not be excluded if they report this condition being "controlled" or "addressed" through medication or lifestyle change, such as regular exercise.
* Major medical disorders (such as cancer, AIDS)
* Physical discomfort or difficulty with blood draws
* Psychotic disorders
* Intellectual disabilities
* Developmental disorders
* Active substance use disorders
* Pregnancy
* Due to safety concerns, participants with these conditions will be ineligible to participate:

  * Major medical disorders (e.g., HIV, cancer)
  * Daily cannabis use
  * History of light headedness or fainting during blood draws or physical activity
  * History of chest pain during physical activity
  * Abnormal EKG finding at intake visit screening, without follow-up clearance from their physician
  * Bone, joint, cardiac, pulmonary, metabolic, or other medical conditions that may be worsened by physical activity (e.g., Chronic Obstructive Pulmonary Disease (COPD), diabetes, hypertension) that is not currently addressed via medication or lifestyle change.
  * A positive pregnancy test
  * A self-reported history of loss of consciousness (greater than 30 minutes)
  * Physical disabilities that prohibit task performance (such as blindness or deafness)
  * Psychotic disorders (e.g., schizophrenia)
  * Any other condition that the investigator believes might put the participant at risk
The Comparison of Two Crosslinked Hyaluronate for the Treatment of Osteoarthritis Pain

The aim of this study is to compare the safety and effectiveness between two BDDE-crosslinked hyaluronate, HYAJOINT Plus and Durolane, for the Treatment of Knee Osteoarthritis Pain.


Eligibility Criteria:
Inclusion Criteria:

1. age from 35 to 85 years;
2. radiographic Kellgren-Lawrence grade II to III;
3. symptoms ≧6 months despite conservative treatments such as analgesics, NSAID and/or physical therapy;
4. average knee pain score ≧30mm on 100-mm visual analog scale (VAS) in recent one week;
5. radiographic evidence of bilateral knee OA not reason for exclusion if VAS pain in contralateral knee \<30mm.

Exclusion Criteria:

1. previous orthopedic surgery in the lower extremity;
2. disabling osteoarthritis of hip or ankle;
3. previous IAHA within 6 months;
4. IA steroid or joint puncture within 3 months;
5. characters of severe acute synovitis under ultrasound (US) examination, such as Grade 3 in suprapatellar synovitis (SPS), suprapatellar effusion (SPE), medial compartment synovitis (MCS) or lateral compartment synovitis (LCS);
6. Any specific medical condition, such as rheumatoid arthritis, Lupus erythematous, hemiparesis, infection, neoplasm, and etc., that would interfere with assessments;
7. confirmed or suspected pregnancy or lactating;
8. known allergy history to any avian protein or HA product.
Using the Xbox Kinect for Chronic TBI

This study will evaluate the potential for improving balance for a single individual with a history of traumatic brain injury (TBI). The participant will engage in supervised therapy using commercial games on the Xbox Kinect. This study will also evaluate the viability of improving cardiovascular fitness using this intervention as well. The investigators hypothesize that balance improvements will occur and that using the Xbox Kinect is a viable way of improving cardiovascular fitness.

Various forms of virtual reality (VR) training have been recently used for rehabilitation of neurological impairments including postural stability and coordination. Virtual reality training has also been shown to increase motivation and attention through its use of novel goal-directed challenges. The Xbox Kinect gaming system allows the Veteran to perform challenging full-body and goal-oriented activities. Balance improvements using laboratory developed games have been demonstrated in those with a history of TBI. However, the investigators are specifically interested if improvements can be made using commercial games which can be utilized in physical therapy clinics more readily. Exercise gaming has been shown to provide adequate intensity exercise to improve heart health in the healthy population. However, such benefits have not yet been investigated using the Xbox Kinect for individuals with a history of TBI.

Eligibility Criteria:
Inclusion Criteria:

* A male or female Veteran participant must have sustained traumatic brain injury greater than 1 year prior to baseline assessments
* Veteran will be between the ages of 18 and 65 years old

Exclusion Criteria:

* Veterans with any cardiac condition that may cause sudden decompensation during cardiovascular testing and training (e.g., severe congestive heart failure and uncontrolled hypertension)
* If Veteran has a significant cardiac history (as defined by American College of Sports Medicine), physician approval will be acquired prior to cardiac stress tests
* Veterans with a previous history of behavioral impairments (e.g., aggression or inappropriate actions) that would preclude participation in standard physical therapy
* Veterans with lower extremity amputation
* Veterans that exhibit greater than mild cognitive impairments as shown by a score 17/30 or less on the Montreal Cognitive Assessment (MoCA).
* Veterans that are unable to stand unsupported for at least 2 minutes
* Veterans that are unable to ambulate on treadmill with bilateral hand support
Effect of Oral Magnesium Supplementation on Type II Diabetes Mellitus Guided by Serum Ionized Magnesium Level

Studies have shown that type 2 diabetic patients (T2DM) may have low serum magnesium levels leading to poor control and outcome of the disease. Supplementation with Mg might improve overall diabetic control and disease outcome. However, there is yet no consensus on whether the ionized (iMg) or the total Mg (tMg) level should be used as a basis to determine the status of Mg in the blood. Recently it was shown that iMg may correlate better with diabetes control than tMg. Therefore, Mg supplements to diabetic patients may improve their disease status. Unfortunately, and to the best of our knowledge all of the available trials on Mg supplementation guided by iMg levels were conducted on healthy volunteers rather than T2DM patients, and they were all for a short period of time (10 days to 10 weeks). Here we hypothesize that supplementations of T2DM patients with Mg based on serum iMg levels correlate better with diabetes control and prognosis. Such hypothesis is supported by a retrospective study that concluded that iMg correlate better with BP control than tMg. In addition, another trial that investigated the effects of three Mg dietary supplements; Mg oxide, Mg citrate and Mg carbonate on healthy female young adults, showed that only Mg oxide led to an increase in the levels of iMg and tMg concentrations when compared to baseline. Furthermore, a case-control study on older diabetic patients revealed a significant association between iMg and HbA1c. This study aims to investigate the effect of supplementing Mg oxide tablets versus placebo tablets guided by serum iMg levels in T2DM patients with or without hypomagnesemia on diabetic control and prognosis.


Eligibility Criteria:
Inclusion Criteria:

* Adults (≥18 years old).
* Treated with oral hypoglycemic agents (OHA) ± insulin regimen.
* Had HbA1c ≥ 7% in the last 3 months

Exclusion Criteria:

* HbA1c of \< 7%.
* Fully dependent patients as per clinical frailty score
* End stage renal disease (creatinine clearances (CrCl) at \< 10ml/min)
* With neuromuscular disease
* With active solid or hematological malignancies.
* With cognitive disorders.
* With the following regular medications (baloxavir marboxil, calcium/sodium polystyrene sulfate, raltegravir, or unithiol) due to X category drug-drug interaction (contraindicated combinations) when given concurrently Mg oxide
New Magnetic Resonance Imaging and Spectroscopy Software in the Improvement of Image Quality

This trial studies how well new magnetic resonance imaging (MRI) and magnetic resonance spectroscopic imaging (MRSI) software works in improving the image quality of scans in both patients and healthy volunteers. Improving the image quality of MRI and MRSI through new software may lead to implementation of these techniques and better clinical care for patients.

PRIMARY OBJECTIVE:

I. To help develop and/or optimize new magnetic resonance (MR) imaging and spectroscopy applications and analysis software in order to provide the best MR services for our patients.

OUTLINE:

Patients undergo an additional investigational MRI or MRSI sequence along with the standard MRI or MRSI. Healthy volunteers undergo an investigational MRI or MRSI sequence. Healthy volunteers may also undergo an additional standard sequence if there is one that can be compared to the investigational sequence. All MRI or MRSI procedures, including the standard MRI or MRSI, are no longer than 60 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled for routine MR imaging or spectroscopy examinations at MD Anderson Cancer Center (MDACC).
* Written informed consent will be obtained from each subject scanned who enrolled to individual sub-project under this protocol.
* HEALTHY VOLUNTEERS: Written informed consent will be obtained from each subject scanned who enrolled to individual sub-project under this protocol

Exclusion Criteria:

* No pregnant subjects will be enrolled
* No one under 18 years of age will be enrolled
* No investigational devices or drugs will be used.
* No contraindications to MR exam(s)
* HEALTHY VOLUNTEERS: No pregnant subjects will be enrolled
* HEALTHY VOLUNTEERS: No one under 18 years of age will be enrolled
* HEALTHY VOLUNTEERS: No investigational devices or drugs will be used
* HEALTHY VOLUNTEERS: No contraindications to MR exam(s) - healthy volunteers will use the same screening process utilized for MDACC patients (DI Patient Record - Part I, MR Screening Section)
* HEALTHY VOLUNTEERS: Healthy volunteers (including healthy MD Anderson employee volunteers) under the direct report of a sub-project principal investigator (PI) will be excluded for that specific sub-project.