cyrilzakka/clinical-trials huggingface dataset:
A Phase 1, SAD Study to Evaluate the Safety and Tolerability of LY03017

This is a phase 1，randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability and pharmacokinetics of oral LPM526000133 Fumarate Capsules (LY03017) in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subject who voluntarily participate and sign the informed consent form.
* Healthy male/female volunteers aged ≥18 and ≤ 45 years.
* Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) ≥18.5 and \< 26.0 kg/m2.
* Able to comply with the lifestyle restrictions.

Exclusion Criteria:

* Subject has a history of allergy to any component of the investigational drug or similar drugs, or allergic constitution.
* Subject has a current or past medical history that may affect the clinical trial or dysfunction, including but not limited to the past or current respiratory system, circulatory system, digestive system, urinary system, reproductive system, nervous system, endocrine system, immune system, motor system, blood system, psychiatry/ psychology, dermatology and other clinically serious diseases or chronic diseases; or any other diseases that may interfere with the test results.
* Any surgical condition or condition may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the subjects.
* Subject has a history of surgery within 3 months prior to administration, or failure to recover from surgery, or having an expected surgical plan during the trial.
* Subject has abnormal vital signs, laboratory abnormalities, and ECGs.
* Subject has used any of over-the-counter products within 7 days or prescription medications within 28 days prior to dosing.
* Subject positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab), or syphilis seroreactivity (Trust).
* Subject has a history of alcohol abuse within 1 year or positive alcohol breath test results.
* Subject has a history of substance abuse within 1 year or a positive urine drug screen.
* Subject who has daily smoking of ≥ 5 cigarettes within 3 months.
* Subject who has special requirements for food, cannot comply with the unified diet or have dysphagia.
* Subject who has consumption of special diet (such as grapefruit, chocolate, coffee, xanthine-rich foods/drinks) within 48 hours prior to dosing and/or subject who has excessive daily consumption of tea, coffee, grapefruit juice, caffeinated beverages for nearly 3 months.
* Subject who has participated in other clinical trials within 3 months before administration.
* Subject has used blood products or being blood donor or blood loss within 3 months.
* Pregnant, lactating women, or positive pregnancy test.
* Subject who refusal to contraception, or plan to donate sperm or ovums.
* Subject who has a history of needle or blood faintness.
* Subject directly involved in this clinical trial.
* Poor compliance or other conditions which would make participation in the study unsuitable.
Pharmacokinetics (PK) Drug Interaction Study of Milademetan and Itraconazole or Posaconazole in Healthy Participants

This will be an open-label, randomized, 3-treatment, 2-period, 2-sequence study in healthy subjects to evaluate the single-dose PK of milademetan when given as monotherapy and when administered with steady-state levels of the strong CYP3A4 inhibitors itraconazole or posaconazole.

The duration of the study for each individual subject will be approximately 49 days from the start of Screening through Study Discharge. Subjects will remain in-house for up to 23 days, including 22 overnight stays.


Eligibility Criteria:
Healthy participants with no clinically significant medical history or physical examination findings and who also meet all protocol-defined inclusion and exclusion criteria summarized as follows:

Inclusion Criteria:

* Has negative urine test for drugs of abuse, alcohol and tobacco
* If female, is surgically sterile or postmenopausal
* If male, agrees to protocol-defined contraceptive methods
* Has adequate hematologic, hepatic, and renal function as defined by the protocol
* Is able and willing to follow all study procedures
* Has provided a signed informed consent

Exclusion Criteria:

* Is female who is pregnant or breastfeeding
* Is unable to swallow oral medication
* Is unable to follow study procedures
* Has creatinine clearance \< 90 mL/min at screening
* Is taking or has taken any medications or therapies outside of protocol-defined parameters
* Has history of or a known allergic reaction to azole antifungal agents
* Has any disease or condition that, per protocol or in the opinion of the investigator, might affect:

  1. safety and well-being of the participant or offspring
  2. safety of study staff
Clinical and Radiological Outcomes: Two-level Cervical ProDisc-C Vivo Versus Hybrid Construct.

The objective of this study is to investigate the clinical and radiological results of two-level cervical ProDisc-C vivo versus hybrid construct.

This is a prospective, randomized, multicenter trial at 7 years of follow-up comparing two level ProDisc-C vivo artificial cervical disc replacement and hybrid construct, i.e., combining ACDF (Anterior cervical discectomy fusion) and ProDisc-C vivo to treat degenerative disc disease (DDD). 542 DDD patients (age from 20 to 70) from several hospitals matching the inclusion criteria will be randomly assigned to two groups (271 patients in each group). One group will be treated with two level ProDisc-C vivo disc replacement. The other group will be treated with hybrid construct. Clinical outcomes and radiological analysis will be done at 1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of degenerative disc disease with radiculopathy or myeloradiculopathy at 2 contiguous levels from C-3 to C-7.
* The symptom is unresponsive to nonoperative treatment for at least 6 weeks.
* The patient demonstrates progressive symptoms calling for immediate surgery.

Exclusion Criteria:

* Any prior cervical spine surgery.
Registry in Patients With Thoracoabdominal Aneurysms

In this study patients will be observed, who receive a multi-branch stent graft tailored to the patients anatomy for the endovascular treatment of a thoracoabdominal aortic aneurysm Crawford type I, II, III, IV or V.

The objective of this study is to evaluate clinical and technical success as well as safety and feasibility of the multi-branch stent graft Systems used in endovascular treatment of thoracoabdominal aortic aneurysms that cannot be treated with commercially available devices. Primary endpoint of this study is the rate of patients with stable or decreasing aneurysm size at 12 months follow-up.

In this study patients will be observed, who receive a multi-branch stent graft tailored to the patient´s anatomy for the endovascular treatment of a thoracoabdominal aortic aneurysm Crawford type I, II, III, IV or V. Participating physicians will be asked to provide their observations collected during routine care for patients he/she had decided to treat with a multi-branch stent graft produced by JOTEC GmbH. Informed consent of the patients to allow the use of their clinical records for the purpose of this observational study will be obtained before data are being collected.

The period of data collection will be 36 months from the intervention for each patient. A risk based source data verification will be performed. CT angiograms will be evaluated by a CoreLab.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients must have a thoracoabdominal aneurysm type Crawford type I, II, III, IV, or V
* Patients must have a suitable proximal landing area
* Patients must have a suitable distal landing area in the abdominal aorta or the iliac arteries
* Patients must have suitable access vessels
* Patients must be available for the appropriate follow-up times for the duration of the study
* Patients have signed the informed consent before intervention

Exclusion Criteria:

* Patients with infectious aneurysm
* Patients with inflammatory aneurysm
* Patients with ruptured or symptomatic aneurysm
* Patients with traumatic aneurysm
* Patients with aortic dissection
* Patients who have a congenital degenerative collagen disease or connective tissue disorder
* Patients with thrombocytopenia
* Patients with an eGFR \< 45ml/min/1.73m2 before the intervention
* Patients with untreated hyperthyroidism
* Patients with malignancy needing chemotherapy or radiation
* Patients that will be treated or are treated with iliac branch devices
* Patients pre-treated with Nellix (Endologix) or Ovation (Endologix) or Altura (Lombard Medical) stent grafts
* Patients who are enrolled in another clinical study
* Patients with life expectancy of less than 36 months
A Feasibility Trial and Protocol for Remote Cognitive Training Developed for Use in a Cognitively Healthy Adult Population During the COVID-19 Pandemic

The COVID-19 pandemic has created a shift in the use of at-home spaces for work, play and research. In the current study, the feasibility of implementing an at-home cognitive training tool called NeuroTrackerX, an anaglyph version of the three-dimensional multiple object tracking (3D-MOT) software NeuroTracker was examined, and with the intent of developing an effective protocol and determining the suitability of this tool for research purposes .

The work looks at the feasibility of using a newly developed anaglyph 3D cognitive training tool called NeuroTrackerX in research with adult participants. The work looks to validate an at-home program by comparing participants who complete an online version of Neurotracker (NeurotrackerX) with a group of individuals who completed the classically used in-lab version (Neurotracker). Due to COVID-19, many laboratories forced to transition to remote-based studies, and the purpose of the work is to validate the remote-based protocol. Twenty cognitively healthy adults (10 Male; 10 female) were recruited to engage in this at-home program. The results of these individuals will be compared with results from a group of cognitively healthy adults who had previously engaged in the in-lab version of the program prior to the pandemic.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for both groups included being aged 50 years and older and to have either normal or corrected vision.

Exclusion Criteria:

* Exclusion criteria included the presence of any major neurocognitive disorder or the presence of visual deficits that impeded one's ability to complete the 3D task.
Kelee® Meditation: A Distinctive and Effective Therapeutic Intervention for Stress, Anxiety, and Depression

The purpose of this study is to determine how effective Kelee meditation is in improving stress, anxiety, and depression.

The Kelee and Kelee meditation (KM) were developed and founded by Ron W. Rathbun. KM is a unique and distinctive form of meditation that is easy to learn and requires only about 10 minutes twice a day to perform. The goal and discipline of KM is the development of one-pointed stillness of mind. To better comprehend how KM is effective in reducing stress, anxiety, and depression, one must understand the difference between concentration and meditation, and the basic principles of the Kelee. Experiencing and understanding the distinction between brain function and mind function are of vital importance in KM. Brain function is associated with the tension-based, intellectual, thinking process and the five physical senses whereas mind function is associated with the relaxation-based, experiential, mental feeling process, self-awareness, and clear perception. Performing KM leads to the calming of brain function and opening to the experience of mind function. With continued practice, persistence, and patience, the practitioner can begin to learn on his own how to examine and understand (ie, troubleshoot) his own thoughts and feelings from a calm, clear internal space that is free from the negative chatter and preconception associated with the brain. This increases self-awareness of the presence of internalized compartments (misperceptions of life that exist as negative thoughts and/or feelings) and the practitioner begins to develop clarity of perception. Clear perception allows one to begin the process of detachment from internalized compartments, which occurs through the cessation of looping followed by the processing of compartments. As each negative compartment dissipates, the practitioner experiences a subtle, but cumulative, corresponding improvement in stress, anxiety, and depression. When the flow of the Kelee is allowed to be, there is balance between the thinking and the feeling process leading to overall well-being, which leads to improved self-efficacy and reinforces the repetition of KM.

Eligibility Criteria:
Inclusion Criteria:

* Documented HIV-1 infection
* Ages 18 to 65
* Experiencing some level of stress, anxiety, or depression
* No current use of other meditation practices or holistic modalities

Exclusion Criteria:

* Non-English readers or speakers
* Hearing-impaired
* Low literacy below 5th grade reading and comprehension level
Effect of CPAP on Biomarkers in Patients With OSA

CPAP, the standard treatment for Obstructive sleep apnea syndrome (OSAS) that reduces sleep fragmentations and neurocognitive deficit in OSAS may also have a key role in reduction of cardiovascular, mortality risks in the same patients.

Obstructive sleep apnea (OSA) is a condition in which there is collapse of the upper airway during sleep, as a result of which there is a decrease or complete cessation of airflow. This leads to repeated episodes of hypoxia during sleep and sleep fragmentation. It is a highly prevalent though under-recognized clinical problem.There is increasing evidence that inflammation plays important role in development of cardiovascular complications in patients with OSA.

Continuous positive airway pressure (CPAP) is the standard treatment for OSA with significant symptoms.However, it is a costly treatment option and poor compliance is an important limiting factor. CPAP treatment has been shown to improve the daytime somnolence and neurocognitive function in people with OSAS. However, its effect on cardiovascular biomarkers in people with OSAS has not been satisfactorily assessed.

This study aims to assess the effect of CPAP treatment on cardiovascular biomarkers in OSA.

Eligibility Criteria:
Inclusion Criteria:

The 1st part of the study will include

1. males and females, aged 30-65 years,
2. with AHI \>5 and excessive daytime sleepiness
3. naïve to CPAP treatment.
4. Subjects from first part of the study who have moderately severe OSAS and have never received treatment for OSA,diabetes mellitus and hypertension

Exclusion Criteria:

1. Hypothyroidism
2. Chronic renal failure
3. Chronic liver disease
4. Chronic lung disease
5. Known systemic inflammatory diseases (lupus , sarcoidosis and other connective tissue disorders),
6. Use of drugs that influence urinary protein excretion (eg. steroids, lithium, NSAIDS, ACE inhibitors/Angiotensin Receptor Blockers etc.)
7. Immune deficiency conditions
8. Pregnancy
9. Active menstruation at time of sampling
10. Macroalbuminuria (aACR\>300mg/g),
11. Patients of coronary artery disease and left ventricular dysfunction
12. Not on treatment for hypertension, diabetes mellitus or dyslipidemia
13. Long lasting hypertension or diabetes mellitus (more than 5 years after diagnosis)
Internal Unicompartmental Arthroplasty After Tibial Valgization Osteotomy

This retrospective, monocentric study is about outcomes concerning patients who benefit from medial unicompartmental knee arthroplasty after previous high tibial osteotomy. This previous high tibial osteotomy was performed because of genu varum.

Clinical, funtionnal and radiological outcomes were examined.


Eligibility Criteria:
Inclusion Criteria:

* operated between January 2005 and June 2019
* HTO followed by implantation of medial UKA (Oxford Partial Knee, Zimmer Biomet, Bridgend, UK) in the same knee
* medial knee osteoarthritis with healthy lateral compartment
* patellofemoral pain
* coronal plane deformity of less than 15°

Exclusion Criteria:

* death
* lost to follow-up
* medial UKA implant other than the Oxford Partial Knee
Effect of Tadalafil, Sildenafil and Pentoxyfylline on Frozen Embryo Transfer Outcomes

The aim of this study is to investigate the Effect of different vasodilators as Tadalafil, Sildenafil and pentoxyfylline in In vitro Fertilization. In addition, the thickness of endometrium and pregnancies rates of these women will also be examined. All adverse effects of all drugs will be estimated

A prospective randomized clinical study will be conducted in the IVF clinic of the gynecology department of Beni Suef University Hospital, Beni-Suef, Egypt. The study will These patients will be randomized into four groups.

The participants will take drugs starting from the end of menstruation cycle till endometrium reach optimal and then will start progesterone 800 mg daily.

Eligibility Criteria:
Inclusion Criteria:

* women having thawed embryos

Exclusion Criteria:

* hypotension
* cardiovascular, hepatic, and renal diseases;
* uncontrolled diabetes mellitus;
* ovarian cysts;
* hyperprolactinemia;
* abnormal thyroid functions;
* uterine fibroids;
* patients taking nitrates;
* endometriosis and adenomyosis
Comparison of Empagliflozin and Dapagliflozin in Patients With Heart Failure Taking Standard Treatment

Participants were enrolled and randomly divided in two groups. In group A, participants were prescribed Dapagliflozin 10 mg daily. In group B, participants were prescribed Empagliflozin 10 mg daily. All participants were followed-up in OPD after 12 weeks for assessment of ejection fraction.

This study's rationale is to examine the effects of dapagliflozin and empagliflozin on heart failure in patients receiving ARNI and SGLT2. Research revealed that the two medications results are identical. Although the cardiac functioning improved better with empagliflozin. But limited data has been available in this regard, while no local trial conducted before. Thus, in routine SGLT2 and ARNI are given to control glycemic level and maintain cardiac functioning. However, addition of Empagliflozin and Dapagliflozin can be more beneficial in improving cardiac functioning and reducing adverse events. Therefore the investigators planned to conduct this study to get evidence in local population. This will help to improve practice.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 40-60 years of either gender diagnosed with heart failure ( Heart failure was defined as presence of ejection fraction \<50% on echocardiography, with pedal edema, water in lungs, paroxysmal nocturnal dyspnea or exertional limitation due to failure of ventricular fillings)
* Diabetic patients, with HBA1c\>6.5% for \>1 year already taking SGLT-2 and ARNI inhibitor.

Exclusion Criteria:

* Patients already had valvular device, mitral or aortic valve regurgitation or stenosis detected on echocardiography, heart transplantation, chronic renal failure or dialysis patients, cardiomyopathy, liver failure or malignancy.
* Patients already taking trial drugs or other anti-glycemic or cardiac medication.
The Impact of Co-Dispensing Naloxone to Patients Prescribed Chronic Opioid Therapy

In the setting of naloxone standing orders, this study will assess if co-dispensing naloxone with opioids to patients prescribed chronic opioid therapy changes opioid risk behaviors, increases naloxone uptake, and increases knowledge about overdose and naloxone.

This is a pragmatic, pharmacy-based, cluster randomized controlled trial of a naloxone co-dispensing program for adults prescribed chronic opioid therapy. Pharmacies (target N=6) will be randomized to the order in which they are encouraged to implement a naloxone co-dispensing program for patients prescribed chronic opioid therapy. The intent of this program is to provide patients prescribed chronic opioid therapy naloxone for potential opioid overdose reversal under the terms of a standing order. Participants prescribed chronic opioid therapy who use randomized pharmacies will be recruited to receive knowledge and risk surveys at baseline and over the follow-up. The primary outcome is opioid risk behaviors (target enrollment is 200 patients). Secondary outcomes include knowledge about overdose and naloxone, substance use, and pain intensity. Patients who use randomized pharmacies (anticipated n=550 patients) will also be followed in the electronic health record for secondary outcomes: naloxone dispensings, changes in opioid dose, aberrant urine toxicology results, and overdose events.

Eligibility Criteria:
Study Population:

* Eligible pharmacies
* Patients prescribed chronic opioid therapy

Inclusion Criteria for pharmacies:

* Stock naloxone for outpatient dispensing.
* Pharmacy leadership willing to provide naloxone under a co-dispensing protocol.
* Pharmacy leadership willing to be randomized to order of implementation.
* Have or can implement a naloxone standing order.

Exclusion Criteria for pharmacies:

• None

Inclusion Criteria for patients:

* Prescribed chronic opioid therapy and meet criteria for the pharmacy co-dispensing protocol
* Receive medications at participating pharmacies
* Have a health plan which covers the formulation of naloxone available at the pharmacy they received their opioid prescriptions from.
* (for surveys)18 years of age or greater

Exclusion Criteria:

• (for surveys) Non-English speaking, hospice enrollment, do-not-resuscitate order
Trial of a Novel Fibrinolytic (Alfimeprase) to Clear Thrombosed Vascular Access Devices

This trial is for patients with a central venous catheter (a vascular access device) that is not functioning properly (unable to withdraw blood). The trial compares a new blood clot dissolving agent (alfimeprase) against the currently used treatment.


Eligibility Criteria:
Subjects must:

* have a dysfunctional Central Venous Access Device (CVAD) defined as unable to withdraw 3 mL blood
* have had the device in place for \> 48 hours
* be clinically stable
* be 18 or older
* give informed consent