cyrilzakka/clinical-trials huggingface dataset:
Acute Whey Protein And Casein Supplementation: Effect On Protein Metabolism After Resistance Exercise

The proteins of human breast milk are the most important endocrine signaling system that promotes neonatal growth by increasing the release of insulin, insulin-like growth factor-1 (IGF-1), and the leucine-mediated mammalian target of rapamycin complex 1- (mTORC1) signaling of pancreatic β-cells. Remarkably, the branched-chain amino acids (BCAAs) leucine, isoleucine, and valine are involved in the growth-promoting effects of milk, protein biosynthesis, and metabolism because they physiologically stimulate insulin secretion The present study sought to investigate the effects of the combination of whey protein and casein in the ratio of 80:20 ("whey protein: casein" or "casein: whey protein") as breast milk proportion on the peak and the period of the permanence of branched-chain amino acids in the blood circulation, final metabolites of protein metabolism and delayed onset muscle soreness (DOMS) after a single bout of fasting or a resistance exercise session.

The present study investigated the effects of the association of WP and casein in the ratio of 80:20, a similar ratio of human breast milk, on blood branched-chain amino acids (BCAAs) profile by HPLC technique, markers of protein metabolism (creatinine, urea, and urine nitrogen) and delayed onset muscle soreness (DOMS) after a single bout of resistance exercise. A double-blind, crossover and acute study was conducted with ten men (age 29 ± 8 y; BMI: 25.4 ± 2.9 Kg/m2; 77 ± 12 kg; 1.74 ± 0.09 m) that were randomly assigned to five supplementation treatments: WP - whey protein; CAS - casein; WP/CAS - 80% WP/20% CAS; CAS/WP - 80% CAS/ 20% WP; PLA - placebo. Participants were submitted to the following evaluations: performance sessions, blood collection for each session for the BCAAs profile determination, two food records, 3-days assessment of DOMS (24h, 48h, 72h) after each treatment.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* practice resistance training at least 3x a week

Exclusion Criteria:

* Smokers
* Muscle injures
* cardiovascular diseases
* Diabetes mellitus
* Lactose intolerance
Autologous Bone Marrow-Derived Stem Cell Transplantation in Patients With Premature Ovarian Failure (POF)

This is an open label, single arm, single center investigation to assess the safety and efficacy of purified adult autologous bone marrow derived specific populations of stem cells and mesenchymal stem cells injected into the ovaries (intraovarian injection), through a 12 week follow-up period. The investigators' chosen model of study is based on increasing the efficiency of the approach by choosing an autologous model which preserves the genetic composition of an individual that is vital in infertility conditions. Additionally the approach involves transplanting a combination of specific purified stem cell types which all aid in ovarian function recovery.

Premature ovarian failure (POF) is characterized as hypergonadotropic ovarian failure mostly prevalent before age 40. It is astonishingly frequent and affects around 1% of women below the age of 40. The clinical findings include amenorrhea and abnormally high levels of luteinizing (LH) and follicle stimulating hormone (FSH). The etiology of POF is unidentified in the majority of cases. It can occur due to a combination of genetics, immunological diseases, and environmental factors. POF is characterized by lack of secondary follicles, arrested folliculogenesis, decreased estrogen levels, and female infertility.

Currently, no available therapeutic intervention has been verified effective in retrieving fertility in patients with POF. Several trials at ovarian stimulation are typically ineffective. Consequently, the diagnosis of POF can cause great physical and emotional distress among patients. Hence, there is serious need to develop innovative treatment plans for POF.

The latest research shows that reduced ovarian reserve is caused by aging of the niche rather than a defect in germ cell lines. Current scientific evidence suggests that bone marrow-derived mesenchymal stem cells (BMSCs) could repair injured tissues and holds great promise in treating many diseases including male and female infertility.

The uniqueness of this study is demonstrated in the transplantation of purified specific populations of autologous bone marrow derived stem cells and mesenchymal stem cells (BMSCs) into patients with POF without in vitro expansion or culture, with minimal manipulation. Stem cells are withdrawn and transplanted back into the patient on the same day of the procedure, thus presenting the highest safety and efficacy parameters.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age : 20-39
* FSH\>20

Exclusion Criteria:

* Thyroid dysfunction
* Immunological Conditions
* Past history of malignancy/cemotherapy/radiotherapy
* Infectious diseases: HIV+, hepatitis B+, C+
* Abnormal karyotype
* Previous surgical management of ovarian pathology
* Severe endometriosis
Biomarkers of Isolated Coronary Arteritis and Related Pathogenic Mechanism

The design of this study is generally divided into two parts: First, establish an isolated coronary arteritis cohort. Then, through the case-control study, the clinical characteristics of patients with isolated coronary arteritis and patients with coronary artery disease are compared and the preliminary screening criteria for patients are constructed. Then, through mass spectrometry flow cytometry and cytokine detection, the biomarkers related to immune inflammation related to the occurrence of coronary artery disease are discussed to provide clues for further exploring the pathogenesis; Subsequently, a prospective cohort study was conducted to compare the clinical characteristics and biomarkers of patients with or without adverse cardiovascular events by following up patients with coronary inflammation, and to explore the prognostic factors of patients with coronary inflammation.


Eligibility Criteria:
Inclusion Criteria:

isolated coronary arteritis group inclusion criteria

1. Age ≥ 18 and ≤ 75;
2. Patients with coronary heart disease, complete revascularization, standardized medication, and repeated hospitalization for myocardial infarction or ischemia within 1 year.
3. Coronary angiography showed coronary artery stenosis or occlusion.
4. The patient (or legal guardian) is fully informed of the test process and signs the informed consent form.

coronary artery disease group inclusion criteria

1. Age ≥ 18 and ≤ 75;
2. Patients with coronary heart disease (at least one vessel underwent coronary stent implantation) and regular medication.
3. No hospitalization with myocardial infarction or ischemia drive occurred within 1 year.
4. The patient (or legal guardian) is fully informed of the test process and signs the informed consent form.

Exclusion Criteria:

1. The patient has the following conditions:

   1. Have other serious diseases (malignant tumor, heart failure, etc.), and the life expectancy is less than 12 months;
   2. The patient has known rheumatic immune diseases such as systemic lupus erythematosus, Takayasu arteritis, Behcet's disease, nodular polyarteritis, Wegener granuloma, eosinophil arteritis, giant cell arteritis, rheumatoid arthritis and immunoglobulin G4 related diseases;
   3. Variant angina pectoris;
   4. Coronary artery dissection;
   5. Thrombophilia;
   6. Incomplete expansion of stent;
2. Mental illness;
3. Failure to complete the expected study follow-up for any known reason;
4. The investigator judged that it was not suitable for the enrolled patients.
Maintenance Treatment With BGB-290 Versus Placebo in Participants With Platinum-sensitive Recurrent Ovarian Cancer

To evaluate the efficacy, safety and tolerability of maintenance therapy with BGB-290(Pamiparib) versus placebo in Chinese participants with recurrent ovarian cancer who achieved a complete response (CR) or partial response (PR) after platinum-based chemotherapy


Eligibility Criteria:
Key Inclusion Criteria:

1. Histologically diagnosed high-grade serous or endometrioid ovarian cancer (including primary peritoneal and fallopian tube cancer)
2. Completion of ≥2 previous platinum-containing regimens (eg, carboplatin or cisplatin)
3. Complete response (CR) or partial response (PR) achieved with last platinum-based chemotherapy regimen as determined by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
4. Ability to be randomized ≤8 weeks after last dose of platinum

Key Exclusion Criteria:

1. Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor
2. Progressive disease (PD) as per CA-125 criteria before randomization
3. Diagnosis of myelodysplastic syndrome (MDS)
4. Known history of intolerance to the excipients of the Pamiparib capsule

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Long Term Study of Canakinumab (ACZ885) in Patients With Gout

This 24-week open-label extension study is designed to provide additional long-term safety data up to a total of 1-year for patients rolling over from the core study, and to collect further efficacy and tolerability data for all the patients, irrespective whether they have an acute flare of gout or not. Patients will be treated on demand with canakinumab (ACZ885) in this extension study.


Eligibility Criteria:
Inclusion Criteria:

* Patients who completed the core study CACZ885H2251. A patient is defined as completing the core study if he/she completed the study up to and including the last visit (Visit 9).
* Patients who have signed a written informed consent before any trial procedure is performed.

Exclusion Criteria:

* Patients for whom continuation in the extension 1 is not considered appropriate by the treating physician.
* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive pregnancy test (serum or urine).
* Female patients who were physiologically capable of becoming pregnant, unless they were:

  * Female patients whose career, lifestyle, or sexual orientation precluded intercourse with a male partner.
  * Female patients whose partners had been sterilized by vasectomy or other means.
  * Using an acceptable method of contraception with a failure rate (Pearl Index (PI)) \< 1.
  * Reliable contraception had to be maintained throughout the study and for 2 months after study drug discontinuation.

Other protocol defined inclusion/exclusion criteria may apply
A Pivotal Investigational Device Exemption Study on Laminar Left Atrial Appendage Elimination

The purpose of this study is to compare the safety and effectiveness of Laminar Left Atrial Appendage Closure (LAAC) device as compared to the commercially available LAAC devices in participants with non-valvular atrial fibrillation (NVAF) to reduce the risk of stroke (blocked blood vessel or bleeding in brain) and systemic embolism (blockage in a blood vessel harming vital organs).

This prospective, randomized, controlled, multicenter, open-label pivotal clinical study will enroll participants with non-valvular atrial fibrillation who are eligible for short-term anticoagulation therapy but have a rationale to seek non-pharmacologic alternative. Participants will be randomized 1:1 to the Laminar Left Atrial Appendage Closure System or commercially available device (WATCHMAN™ left atrial appendage closure device / Amulet™ left atrial appendage occluder).

Eligibility Criteria:
Inclusion Criteria:

* Documented evidence of paroxysmal, persistent, or permanent non-valvular atrial fibrillation (NVAF)
* CHA2DS2-VASc score greater than or equal to (\>=) 2 in men and \>= 3 in women
* Deemed to be clinically indicated for left atrial appendage (LAA) closure by the Site Investigator and a clinician not a part of the procedural team using an evidence-based decision-making tool in accordance with standard of care
* Recommended for chronic oral anticoagulation therapy (OAC) but has an appropriate rationale to seek a non-pharmacologic alternative
* Eligible for the protocol-specified post-procedural antithrombotic regimen
* Willing and able to comply with the protocol, and has provided written informed consent (participant or legally authorized representative) per institutional review board (IRB) requirements

Exclusion Criteria:

* Single episode, transient, or reversible atrial fibrillation (AF) (example, secondary to thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
* Prior cardiac surgery or any procedure that involved pericardial access
* Stage IV kidney disease or Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) less than (\<) 30 milliliters per minute per (mL/min)/1.73 square meters (m\^2) or participants with end stage renal disease who are dialysis dependent
* Any cardiac or non-cardiac interventional or surgical procedures within 60 days prior to or any planned general surgery, cardiac surgery, or interventional procedure within 60 days after implant (including, but not limited to cardioversion, percutaneous coronary intervention (PCI), cardiac ablation, cataract surgery)
* Left atrial appendage anatomy which cannot accommodate either commercially available control device or the laminar implant per manufacturer instructions for use (IFU) (that is, the anatomy and sizing must be appropriate for a control and the Laminar device to be enrolled in the study)
Preoperative Methylprednisolone to Patients Suspected of Appendicitis Undergoing Laparoscopy

To test whether 125 mg preoperative methylprednisolone intravenously can reduce postoperative pain after laparoscopy for suspected appendicitis and to test whether preoperative methylprednisolone can reduce postoperative fatigue, increase quality of sleep, reduce nausea or vomiting, reduce duration of convalescence and increase overall quality of recovery after laparoscopy for suspected appendicitis.

Patients enrolled are randomized to active substance or placebo approximately 30 minutes prior to skin incision.

Patients are followed for 30 days postoperative with registration of outcomes on a postoperative questionnaire. Patients are contacted by telephone at every registration time. The primary outcome is also secured over the telephone in case patients do not return their questionnaire.

With a power of 80% and a significance level of 5% we need 64 patients (32 in each arm) to show a 30% reduction in postoperative pain during the first 3 postoperative days with 5 measurements and we need 42 patients (21 in each arm) to show a 15% increase in the QoR-15 during the first 3 postoperative days. With an anticipated loss to follow up of 20% we need 80 patients ( 40 in each arm).

Eligibility Criteria:
Inclusion Criteria:

* Laparoscopy for suspected appendicitis
* Age 18 years or older
* American Society of Anesthesiologist (ASA) class I-III.
* Gives written and oral consent

Exclusion Criteria:

* Known inflammatory bowel disease.
* Known autoimmune disease.
* Chronic pain patient.
* Presumed poor compliance.
* Pregnant or breastfeeding.
* In systematic treatment with glucocorticoids or other immunosuppressive treatment.
* Known renal disease, GFR\<30.
* Known liver cirrhosis.
* Known heart failure, EF\<40%.
* Known glaucoma.
* Known ocular herpes simplex.
* Known cushings disease.
Bone Remodeling and Non-surgical Periodontal Therapy

Previous studied have investigated the pathophysiological role and expression of Cathepsin K (Ctsk) , receptor activator of the NF-κB ligand (RANKL) and periostin in active periodontitis and peri-implantitis lesions. However, the potential influence of non-surgical periodontal therapy including scaling and root planning on the bone remodeling markers level over different trial times have not well determined. Thus, the current research is conducted to address this influence. Thus, the research question will be: In patients with periodontitis, does the level of bone remodeling markers altered after successful NSPT during different healing time periods?


Eligibility Criteria:
Inclusion Criteria:

1. Both males and females.
2. Unstable periodontitis.
3. No previous periodontal treatment is conducted during the past 6 months.
4. Good general health without history of any systemic diseases.
5. Present with at least 20 teeth.
6. Non-smokers.

Exclusion Criteria:

1. Subjects have any intraoral plaque retentive factors such as those wearing partial denture, crown and bridges, and orthodontic appliances.
2. Subjects receiving antibiotic therapy during the previous 3 months.
3. Pregnant or lactating women.
4. Smokers.
5. Not willing to participate or continue to conduct the study.
Determining the Feasibility of Outpatient Parenteral Antibiotic Therapy for Persons Who Inject Opioids

Patients with a history of injection drug use are historically excluded from home outpatient parenteral antibiotic therapy programs. Recent small pilot programs have demonstrated that these patients may be safely included in home OPAT programs when they are provided with medications for opioid use disorder such as suboxone or methadone. However nothing is known about the effect of additional social support services including case management and health coach navigation on the feasibility and acceptibility of home OPAT programs for persons who inject drugs. This observational study will provide pilot data on the feasibility of such a program in anticipation of a larger scale trial.


Eligibility Criteria:
Inclusion Criteria:

* English speaking males and females
* 18-100 years of age
* Being considered for discharge from Barnes-Jewish Hospital on OPAT\* (PICC/Midline only) for a serious injection related infection including; endocarditis, osteomyelitis, discitis, septic arthritis, epidural abscess, or S. aureus bacteremia. \*Note that outside of this protocol patients with a history of substance use disorder are considered for discharge on OPAT to skilled nursing facilities or other health-care locations such as BJH extended care. Patients being considered for discharge on OPAT to any of these locations are eligible for inclusion.
* History of injection opioid use within the last 1 year
* Evaluated by the joint toxicology/psychiatry addiction medicine consult service during the current inpatient admission
* Started or maintained on medications for opioid use disorder (MOUD) of either methadone, buprenorphine or buprenorphine-naloxone during admission to Barnes-Jewish Hospital
* Have a scheduled follow-up for continuation of medications for opioid use disorder in place prior to discharge. For patients on methadone this should include a scheduled appointment at a methadone clinic, or for patients on buprenorphine this can include a plan for ongoing buprenorphine/ buprenorphine-naloxone based therapy at the Washington University Infectious Diseases Clinic.
* Have met with a health coach or a member of the Bridge To Health team during their inpatient hospitalization and agree to ongoing supportive counseling after discharge.
* Be willing and able to attend in-person clinic visits within 60 days post-discharge at the Washington University Infectious Diseases Clinic.
* Have a working phone number with active voicemail, running water and electricity.

Exclusion Criteria:

* Prisoner status
* Unable to provide own informed consent
* Current homelessness
* Other house-hold members reported as having active untreated substance use disorders
* Unable to attend outpatient appointments. This may include patients who are from rural areas where transportation vouchers may not provide sufficient means of making it to follow-up appointments, or other disability that would preclude transportation (paralysis, broken limbs) where the patient is unable to provide specific details as to how they would arrive at clinic appointments.
A Phase III Study of PA21 in Hemodialysis Patients With Hyperphosphatemia

The purpose of this study is to evaluate the efficacy and safety of PA21 in hemodialysis patients with hyperphosphatemia


Eligibility Criteria:
Inclusion Criteria:

* Patients age 20 or older, regardless of gender.
* Receiving stable maintenance hemodialysis 3 times a week.
* Patients not having changed their phosphate binder agent dose, for 4 weeks or more before their observation period start.

Exclusion Criteria:

* Patients having history of a pronounced brain / cardiovascular disorder.
* Patients having severe gastrointestinal disorders.
* Patients having severe hepatic disorders.
The Effect of NAD Supplementation on Brain Vascular Health in Aging

Daily consumption of one of the forms of Vitamin B3, the Nicotinamide Riboside (NR), energizes the body and combats cellular aging. This study is designed to test whether NR can also improve brain health and memory.

This study is designed to test the hypothesis that restoration of Nicotinamide Adenine Dinucleotide (NAD) levels with Nicotinamide Riboside (NR) in older adults will improve neurovascular coupling (NVC) responses and micro- and macrovascular endothelial function. This hypothesis will be tested by assessing the effects of treatment with oral NR (1g/day per os for 8 weeks) or placebo (8 weeks) in community dwelling older adults (60-85 years of age).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥60 and ≤85 years of age
* Adequate hearing and visual acuity to participate in the examinations
* Ability to read and write in English
* Competence to provide informed consent.
* Mini-Mental State Exam score ≥24

Exclusion Criteria:

* Vision or hearing impairment that would impair the ability to complete study assessments
* Active CNS disease including multiple sclerosis, uncontrolled seizures, active brain cancer
* Cerebrovascular accident other than TIA within 60 days prior to Visit 0
* Major psychiatric disease, including major depression not currently controlled on medications, alcohol or drug abuse
* Abnormal kidney function (creatinine \>2mg/dL or EGFR \<30mL/min) by most recent labs within 6 months prior to Visit 0
* Elevated liver enzymes (AST and/or ALT above x2 upper limit of normal) by most recent labs within 6 months prior to Visit 0
* Treatment with other NAD enhancers (Nicotinamide riboside or nicotinamide mononucleotide) within 4 weeks prior to randomization.
* Any other medical condition which, in the opinion of investigator, would render the patient inappropriate or too unstable to complete the study protocol