cyrilzakka/clinical-trials huggingface dataset:
A Phase I Study of MK-2206 in Combination With Standard Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors (MK-2206-003)

The purpose of this study is to compare the safety and tolerability of several dose levels of MK-2206 in combination with chemotherapy and targeted therapy agents in participants with locally advanced or metastatic solid tumors.

The primary hypotheses are that administration of MK-2206 in combination with either carboplatin + paclitaxel, docetaxel, or erlotinib in participants with locally advanced or metastatic solid tumors will have acceptable tolerability, a dose limiting toxicity (DLT) rate of ≤30%, plasma exposure and pharmacodynamics that exceed target thresholds, and allow for definition of a maximum tolerated dose (MTD) in each of the 3 combinations.


Eligibility Criteria:
Inclusion Criteria :

* Participants must have locally advanced or metastatic solid tumors.
* Participant is male or female greater than or equal to 18 years of age.
* Participant must have a performance status less than or equal to 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
* Female participants of childbearing potential has a negative serum or urine pregnancy test within 72 hours prior to receiving the first dose of study medication.
* Participants in the MK-2206 + carboplatin/paclitaxel and MK-2206 + docetaxel treatment arms will be limited to no more than 3 prior cytotoxic therapies for metastatic or recurrent diseases.
* Participant is able to swallow capsules and has no surgical or anatomical condition that will prevent the Participant from swallowing.

Exclusion Criteria:

* Participant has had chemotherapy, radiotherapy or biological therapy within 4 weeks.
* Participants must be least 4 weeks post-surgery and do not expect major surgery in the study duration.
* Participant is currently participating or has participated in a study with an investigational compound or device within 30 days.
* Participant has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Participant with a primary central nervous system tumor.
* Participant has known hypersensitivity to the components of study drug.
* Participant has a history or current evidence of heart disease.
* Participant has evidence of clinically significant bradycardia (slow heart rate).
* Participant has uncontrolled high blood pressure.
* Participant at significant risk for hypokalemia (low potassium levels).
* Participant is a known diabetic
* Participant has known psychiatric or substance abuse disorders.
* Participant is a user of illicit drugs.
* Participant is pregnant or breastfeeding.
* Participant is Human Immunodeficiency Virus (HIV) positive.
* Participant has known history of Hepatitis B or C or active Hepatitis A.
* Participant has symptomatic ascites or pleural effusion.
* Participant is receiving treatment with oral corticosteroids.
* Participant is using a potent cytochrome P(450) 3A4 (CYP3A4) inhibitor or inducer.
Glucose Metabolism, Muscle Mass/Function and Inflammation in the Elderly

A thorough characterization of glucose metabolism and "inflammaging" in elderly subjects will help determine to what extent each of these factors affects muscle mass/function and contributes to age-related muscle wasting. The investigators will correlate patterns of insulin secretion/sensitivity with "muscle "quality/quantity" in diabetic and non-diabetic elderlies (≥70 years old). By comparing different groups (healthy, sarcopenic, diabetic, diabetic/sarcopenic), the investigators expect to identify an "oxidative/inflammatory signature" (e.g., circulating interleukins/myokines, plasma antioxidant capacity) specific for the sarcopenic phenotype and related to muscle insulin resistance.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus: patients taking drugs for diabetes will be diagnosed as having diabetes. In all other patients, a diagnosis will be established according to the criteria of the American Diabetes Association
* Sarcopenia (non-severe): individuals with low muscle mass and either low muscle strength or low physical performance will be diagnosed with sarcopenia, according to the criteria of the European Working Group on Sarcopenia in Older People (EWGSOP)
* Healthy volunteers: no diabetes, no sarcopenia and none of the exclusion criteria

Exclusion Criteria (overall population):

* acute diseases,
* chronic obstructive pulmonary disease (COPD)
* conditions associated with sarcopenia/altered body composition (e.g. disability, altered endocrine function, chronic diseases, nutritional deficiencies, cancer),
* obesity (body mass index ≥30 kg/m2)
* moderate-severe hepatic disease,
* chronic kidney disease (estimated glomerular filtration rate \<30 ml/min per 1.73m2),
* metal prostheses,
* recent or ongoing infection,
* inability or unwillingness to provide informed consent

Exclusion Criteria (diabetic population):

* type 1 diabetes,
* hemoglobin A1c \>8.5% (69 mmol/mol),
* basal-bolus insulin therapy,
* insulin pump therapy,
* proliferative diabetic retinopathy,
* diabetic foot.
Central Obesity and Hepatocellular Carcinoma

Recurrence and metastases after microwave ablation(MWA) of hepatocellular carcinoma(HCC) are the major factors that influence the survival. Obesity has been reported was significantly correlated with increased risk of developing HCC.

In this study, we will analysis the association of multiple obesity index(waist circumference,waist-hip ratio and body mass index) with the prognosis of HCC treated by MWA.


Eligibility Criteria:
Inclusion Criteria:

* absence of ascites or the depth of ascites on US detection less than 4 cm;
* a normal serum total bilirubin level or less than 60 µmol/L;
* a normal albumin level or not less than 30 g/L;
* for radical treatment, single lesion of 8 cm or smaller, three or fewer multiple lesions with a maximum diameter of 4 cm or less, absence of portal vein cancerous thrombus or extrahepatic metastases;
* for palliative treatment, those with large or multiple lesions, suffering multiple metastases and unsuitable for other modalities can be considered to undergo the MWA on the condition of good hepatic function and blood coagulation function to tolerate the procedure.

Exclusion Criteria:

1. clinical evident liver failure, such as massive ascites or hepatic encephalopathy or with a trance-like state
2. severe blood coagulation dysfunction (prothrombin time of more than 30 seconds, prothrombin activity less than 40%, and platelet count less than 30 cells×109/L)
3. high intrahepatic tumor burden (tumor volume \>70% of the target liver volume or multiple tumor nodules) or high extrahepatic tumor burden
4. acute or active inflammatory and infectious lesions at any organ
5. acute or severe chronic renal failure, pulmonary insufficiency or heart dysfunction
6. relative contraindication concerns medical risk for the tumor proximity to diaphragm, gastrointestinal tract, gallbladder, pancreas, hepatic hilum and major bile duct or vessels, which may require adjunctive techniques to prevent off-target heating of adjacent structures during the ablation procedure.
Spinal Cord Stimulation Versus Instrumentation for FBSS

Low back pain affects people of all ages and has become the leading cause of living with disability worldwide. Patients, suffering from persistent pain after spinal surgery in the absence of any clear spinal pathology are defined of having a "failed back surgery syndrome (FBSS)" and treatment of FBSS remains a great controversy in the spinal community. Apart from conservative treatment, spinal fusion remains as therapeutic option. Furthermore, minimal invasive Neuromodulation techniques might be a promising alternative. Aim of this randomized interventional multi center study is to compare treatment success in FBSS patients with either spinal cord stimulation (SCS) or fusion surgery, 12 months after intervention according to the Oswestry Disability Index (ODI) and other scales and scores. Radiological and health economic outcome also will be analysed for thorough comparison of techniques. Additionally, the safety of the interventions needs to be compared.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Symptomatic degenerative disc disease with LBP as a predominant symptom for at least 6 months following pervious surgery for disc herniation
* ODI score at least 21
* Correctly signed informed consent form

Exclusion Criteria:

* Spinal stenosis resulting in spinal claudication or neurological deficits
* Spinal Instability (\> 3 mm Motion on dynamic Lumbar X-rays)
* Major psychiatric disorder
A Study of the Efficacy and Safety of Omalizumab Through 48 Weeks in Participants With Chronic Idiopathic Urticaria

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of subcutaneous (SC) omalizumab (Xolair) as an add-on therapy through 48 weeks for treatment of H1 antihistamine refractory chronic idiopathic urticaria (CIU). After completing an initial 24-week open-label treatment period with omalizumab 300 milligrams (mg) every 4 weeks (Q4W), participants responding to omalizumab will be randomized at a 3:2 ratio (omalizumab:placebo) to either continue omalizumab or be transitioned to placebo for a further 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CIU refractory to H1 antihistamines at baseline
* Presence of itch and hives for at least 8 consecutive weeks at any time prior to enrollment despite current use of H1 antihistamine treatment (up to four times the approved dose) during this time period
* UAS7 score (range 0-42) ≥ 16 and itch component of UAS7 (range 0-21) ≥ 8 during 7 days prior to baseline
* Participants must have been on a non-sedating H1 antihistamine treatment (up to four times the approved dose) for CIU for at least 3 consecutive days immediately prior to screening visit with continued current use on the day of the initial screening visit
* CIU diagnosis for ≥ 6 months
* Willing and able to complete a daily symptom eDiary for the duration of the study

Exclusion Criteria:

* Treatment with an investigational agent within 30 days of the initial screening visit
* Body weight less than 20 kilograms
* Clearly defined underlying etiology for chronic urticarias other than CIU
* Evidence of a parasitic infection
* Atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or other skin disease associated with itch
* Previous treatment with omalizumab within 1 year prior to the initial screening visit
* Participants may not have taken during treatment period or have been taking within 30 days before the initial screening visit any of the following medications or treatments:

regular (daily/every other day during 5 or more consecutive days) systemic corticosteroids, hydroxychloroquine, methotrexate, mycophenolate, cyclosporine, cyclophosphamide, intravenous immunoglobulin G or plasmapheresis

* Regular (daily/every other day) oral doxepin use within 14 days prior to the initial screening visit
* Pregnant or lactating women, or women intending to become pregnant during the study
Slotted Hole Versus Fixed Hole C-Tek

The purpose of this study is to compare the fusion rates between the EBI, LLC C-Tek™ Anterior Cervical Plate, Slotted Hole Design versus the Fixed Hole Design.

This study's purpose is to compare the fusion rates between the EBI, LLC C-Tek™ Anterior Cervical Plate, Slotted Hole Design versus the Fixed Hole Design

Eligibility Criteria:
Inclusion Criteria:

1. Radiographic evidence of compressed cervical roots or cord by either ossified bony elements or herniated nucleus pulposus.
2. Symptomatic radiculopathy appropriate to compressed nerve root.
3. Cervical spondylosis as evidenced by reactive changes in the vertebral bodies about the interspace, and may be associated with chronic discopathy.
4. Primary anterior cervical spinal fusion (ACDF) performed using an anterior cervical plate and either a discectomy (Smith-Robinson technique) or a Corpectomy.
5. Adult male or female, 18 to 75 years of age.
6. The subject or his/her legal guardian is willing to consent to participate in this study.
7. The subject will be available for follow-up for a minimum of 24 months.

Exclusion Criteria:

1. Traumatic cervical injury.
2. Posterior augmentation or revision fusion.
3. Cervical fusion involving C1 and C2 vertebrae.
4. Cervical fusion involving more than three levels.
5. Previous spine surgery at the same levels as those that will be fixed with the C-Tek plate.
6. Systemic conditions: Spondylitis, Paget's disease, Rheumatoid arthritis, Infection within two weeks before surgery, Cancer, Renal disease or insufficiency with creatinine level above 2, Chronic use of steroids or other conditions that may affect bone metabolism
7. Subjects who are pregnant, nursing or plan to be pregnant within the next 24 months.
8. Mental or physical conditions that may preclude compliance with physician instruction or the study protocol.
9. Subjects who require non-steroidal medications chronically for other conditions.
10. Subject declines to cooperate with the follow-up schedule.
11. Subject or legal guardian refuses or is unable to sign the informed consent.
Compare Two Dosing Algorithms in Insulin-Naive Patients With Type 2 Diabetes Mellitus

This randomized, multicenter, open-label, active-comparator, 2-arm, parallel-group, 6 month study with approximately 360 patients will compare the efficacy of two treatment regimens (Algorithm A versus Algorithm B) in insulin-naive patients with type 2 diabetes not optimally controlled by one or more oral antihyperglycemic medications. Patients will be assigned randomly to receive one of the following treatment groups:

Algorithm A is defined as a simplified diabetes management regimen starting with a fixed dose of HIIP (also known as AIR® Inhaled Insulin)(AIR® is a registered trademark of Alkermes,Inc.), titrating 2 times per week based on 2 times per week 4 point blood glucose values for the first month and titrating 1 time per week based on once weekly 4-point blood glucose values for the remainder of the study, increasing total daily dose by a maximum of 6 U per day.

Algorithm B is defined as an intensive diabetes management regimen, starting with an adjusted dose of AIR® Inhaled Insulin, titrating 2 times per week based on daily 4 point blood glucose values, with sustained monitoring of dose and blood glucose throughout the study, increasing total daily dose by a maximum of 8 U per day.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus for at least 6 months
* Have a HbA1c greater than 7.0% and less than or equal to 10.5% at screening.
* Patients who have been treated with the following regimen:

One or more oral antihyperglycemic medications on a stable dose for at least 6 weeks (12 weeks for thiazolidinediones \[TZDs\]),

AND

have been on insulin for 14 days or less throughout life and have not taken insulin within 6 months,

AND

are candidates for insulin therapy, in the opinion of the investigator.

Exclusion Criteria:

* Pregnancy
* Smoker
* History of more than two episodes of severe hypoglycemia during the 6 months prior to study entry
* Diagnosed with pneumonia in the 3 months prior to screening
* Patients who have received systemic glucocorticoid therapy within 3 months prior to study entry
* History of renal transplantation
* History of lung transplantation
* Active or untreated malignancy
* Treated with Incretin mimetics
Clinical Evaluation of Direct Manufactured Prosthetic Sockets

The purpose of this study is to evaluate a new prosthetic socket construction technique in order to improve the quality of care to lower extremity amputees.

Many members of the Armed Forces and civilians are in need of prosthetic devices due to amputations resulting from gunshots, bombings, vehicular accidents, and other traumas. As the number of amputees increase at a high rate, the limited number of certified prosthetists is finding it harder to satisfy the patient demand. Therefore, the overall goal is to provide the Orthopedic \& Prosthetic (O\&P) industry with a tool that accommodates the increasing prosthetist to patient ratio and still provide acceptable product quality.

The practice of creating prosthetic sockets by the plaster-casting of amputees' residual limbs has been around for decades but continues to be the most commonly used method for the shape capture, modification and fabrication of prosthetic sockets. Using this traditional plaster-casting approach has many limitations that can now be overcome through the use of technology.

With the advancing developments in Computer Aided Design (CAD) and Computer Aided Manufacturing (CAM) technologies over the past ten years, it is now possible to completely replace the plaster-casting approach with handheld, portable scanners.

While this current CAD/CAM approach certainly creates substantial efficiencies in the clinical aspects of creating the prosthetic socket, the actual manufacturing of the prosthetic device continues to rely on the use of a positive model and a lengthy manual fabrication process.

The continuing development of direct manufacturing technologies may serve as the final piece in the effective utilization of CAD/CAM in the care of prosthetic and orthotic patients. Direct manufacturing provides a means to quantify alterations and accurately reproduce prosthetic sockets. Additionally, direct manufacturing has the potential to reduce time, cost, and waste, as a result improve the quality and care ability to patients.

This study will compare two fabrication techniques for diagnostic and definitive sockets: manually fabricated (positive model technique) and direct manufactured (experimental).

Eligibility Criteria:
Inclusion Criteria:

* Be a lower extremity amputee longer than one year
* Be a consenting adult (at least 18 years or age or older)
* Albe to ambulate in current prosthesis without an aid (can, crutches or walker) for 30 minutes without rest
* Currently using a liner with prosthesis
* Be available during regular business hours for appointments

Exclusion Criteria:

* An inability to give informed consent
* Presence of any sores, lacerations or rashes on the residual limb
* Impaired contra lateral foot
* Poor distal sensation
Pilot Study of Liposomal Bupivacaine Redosing in Patients Undergoing Major Gynecologic Procedures

The purpose of this research study is to find out which type of transversus abdomens plane (TAP) and block (bupivacaine, liposomal bupivacaine or liposomal bupivacaine with re-dosing at 48-60 hours) improves your pain control and lowers your risk of post-operative common side effects of surgery and narcotic pain medications.

The purpose of this research study is to find out which type of TAP block (bupivacaine, liposomal bupivacaine or liposomal bupivacaine with re-dosing at 48-60 hours) improves your pain control and lowers your risk of post-operative common side effects of surgery and narcotic pain medications.

An anesthesiologist participating on this study will describe the TAP block to you during your preoperative interview and will obtain your consent for the block procedure with your anesthesia consent prior to the procedure. TAP blocks are one of the various methods of controlling your pain after surgery. They are typically placed with an anesthetic agent, such as bupivacaine. The U.S. Food and Drug Administration (FDA) has recently approved a longer-acting form of the anesthetic used in this study, liposomal bupivacaine. Although both medications, bupivacaine and liposomal bupivacaine are approved by the FDA, there are only a few trials such as this one, in the United States, comparing the various types of TAP blocks. No studies exist comparing the re-dosing of a TAP block, as we will be doing in this study.

Currently, the standard of care after a gynecologic procedure may or may not include receiving a TAP block. This was a decision typically made, with your consent, at the discretion of an anesthesiologist and your surgeon. As per the standard of care, after surgery, you would be given oral pain medications to control your pain and intravenous pain medications for severe breakthrough pain. Our study will not change your post-operative pain medication schedule or timing. It will only study the effectiveness of the TAP block you get in controlling your pain.

Even though the medicines (bupivacaine or liposomal bupivacaine) used in this study are FDA-approved, the use of these drugs in this study is investigational.

Eligibility Criteria:
Inclusion Criteria

* Age ≥ 18 years old
* Must be undergoing an open gynecologic procedure through a midline vertical incision with a gynecologic oncologist

Exclusion Criteria

* History of chronic pain
* History of opioid dependence
* Suspected or confirmed history of endometriosis
* History of fibromyalgia
* Suspected or confirmed interstitial cystitis or painful bladder syndrome
* History of or current opioid use prior to surgery
* Hypersensitivity to bupivacaine
* Severe hepatic or renal disease
The Effect of Religious Practices on Mental and Spiritual Health

The goal of this clinical trial is to test the effects of using a religious mobile app (i.e., Pray.com) in participants who have high levels of stress. The main question it aims to answer is:

•What are the effects of using Pray.com on stress in individuals who report high levels of stress?

Participants will complete measures at baseline (i.e., Time 1), four-weeks (i.e., Time 2), and eight weeks (i.e., Time 3). Participants will be randomly assigned one of three conditions: (1) autonomous use (directed to use the app daily), (2) meditative prayer condition (directed to use this feature of the app daily), or (3) wait-list control condition.

Participants (N = 300) will be adults recruited through social media and faith-based organizations. Participants will first complete a brief screener to determine eligibility for the study.

Eligible participants will be invited to participate in the study. Participants will read an informed consent document that will give information about the study and their rights as participants. Participants will be given the opportunity to contact the research team and ask questions. If they agree to participate, participants will be randomly assigned to one of three conditions. Condition 1 is the control condition (i.e., no intervention condition). In Condition 2, participants will be given a free subscription to the Pray.com app and will be directed to use the app five days per week (i.e., autonomous use condition). In Condition 3, participants will be given a free subscription to the Pray.com app and will be directed to listen to a meditation prayer five days per week (i.e., meditative prayer condition). Participants will receive periodic reminders on their phone if they have not used the app.

All participants will fill out a series of online questionnaires monthly for a two-month time-period (i.e., Baseline / Time 1, Time 2, and Time 3). Participants will receive a link from the research team when it is time for them to fill out their questionnaire via a secure online data collection portal. After finishing the study, participants will be debriefed and given the opportunity to ask questions about their participation.

Eligibility Criteria:
Inclusion Criteria:

* over the age of 18
* own a smart phone and be willing to download a mobile app
* willing to engage in a Christian practice on a mobile app
* score of 14 or greater on the Perceived Stress Scale (indicating at least a moderate level of stress)

Exclusion Criteria:

* n/a