cyrilzakka/clinical-trials huggingface dataset:
Clinical Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LEZ763

This study is a three part study to assess the safety and efficacy of LEZ763 on normal healthy volunteers and patients with Type 2 Diabetes.


Eligibility Criteria:
Inclusion criteria:

* All subjects: (suggest this will reduce duplication)
* Male or female aged 18-65 yr,
* Subjects must weigh at least 50 kg to participate in the study. Body mass index (BMI) must be within the range of 18-37 kg/m2 (inclusive
* Only postmenopausal females or female subjects who report surgical sterilization (women without child bearing potential) will be allowed in this study.
* Subjects with stable conventional sleep-wake cycle

Normal Healthy Volunteers

* Healthy male or female subjects,
* must be in good health (as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at Screening).

Type II Diabetic Patients

* Type 2 diabetes diagnosed by American Diabetes Association criteria for at least 3 months prior to screening.
* Patients either drug naïve or on stable dose of metformin (stable dose for at least 4 weeks prior to Screening). The metformin dose should remain constant during the course of the study.
* HbA1c 6.5 to 9.5 % inclusive at screening

Exclusion criteria:

All subjects:

* Smokers (use of tobacco products in the previous 3 months).
* Donation or loss of 400 mL or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation.
* Significant illness within two weeks prior to dosing.
* Have (or have history of) drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations

Normal Healthy Volunteers

• History of diabetes, or adrenal disorders.

Type II Diabetic Patients

* Type 1 diabetes mellitus; positive anti-GAD antibodies; acquired or secondary forms of diabetes such as those resulting from pancreatic surgery/injury, cystic fibrosis related diabetes
* Evidence of clinically significant diabetic complications (such nephropathy, retinopathy, neuropathy) Other protocol defined inclusion/exclusion criteria may apply
Comparison of Two Different Methods for Reducing Pain After Lung Surgery

The goal of this clinical study is to compare the effectiveness of the Rhomboid Intercostal Block and Sub-Servitus plan block and the effectiveness of the Rhomboid intercostal block in patients with video-supported thoracoscopic surgery. The main question it aims to answer is:

Which of these two blocks more effectively reduces the patients' pain?


Eligibility Criteria:
Inclusion Criteria:

* Patients in American Society of Anesthesiologists (ASA) classes I, II and III for whom VATS is planned

Exclusion Criteria:

* Known or suspected local anesthetic allergy
* coagulopathy
* injection site infection
* history of thoracic surgery
* serious neurological or psychiatric disorder
* severe cardiovascular disease
* liver failure
* renal failure
Acupuncture With Press Tack Needles for Perioperative Pain After Open Radical Prostatectomy

Acupuncture has been shown in several meta-analyses and clinical studies, in different surgical settings and chronic back pain, to be a safe adjuvant option for postoperative pain treatment. In this study, the investigator hypothesize that acupuncture can decrease postoperative pain intensity and amount of given analgesics, and accelerate recovery of bowel motility, in patients after open radical prostatectomy.

The investigator will also investigate whether or not acupuncture with needle skin penetration is more efficacious than acupressure.

This study will be a randomized, controlled and partially blinded study with three arms: 1) press tack needle acupuncture (ACU) and routine postoperative analgesic care, 2) press tack placebo acupressure (SHAM) and routine postoperative analgesic care, and 3) only routine postoperative analgesic care (CONTROL).

Eligibility Criteria:
Inclusion Criteria:

* Males aged 18-70 years
* Diagnosis with prostate cancer and scheduled for open radical prostatectomy
* Ability and willingness to follow study instructions and complete all required questionnaires during hospitalization and follow-up
* Written informed consent

Exclusion Criteria:

* Inability to understand the terms of this study
* Simultanously participation in other clinical trials possibly influencing primary or secondary endpoints or any acupuncture-related clinical trials within 30 days prior to inclusion

  * Prior surgery within the last three months
  * Received acupuncture within 6 weeks before surgery
  * Known hypersensitivity or fear of acupuncture
  * Known abuse of drugs, medications and alcohol
  * Chronic pain for more than 3 months
  * Continuous opioid analgesic medications for more than 3 days during the 4 weeks prior to surgery
Strength Training and ADLs in Childhood Leukemia and Lymphoma Patients

Reduced activity levels and reduced muscular strength could severely impair the activities of daily living (ADLs) in pediatric leukemia and Non-Hodgkin lymphoma patients. Increased muscle strength is associated with improved accomplishment of ADLs and consequently greatest possible normality, autonomy and mobility. Primary outcome of this RCT (n=20/20) is the analysis of effects of a treatment-associated and close to every day life strength training (2-3 times/week) compared to a general exercise program (standard care).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Acute Leukemia or Non-Hodgkin Lymphoma
* Diagnosed and/or treated at the Kinderklinik München Schwabing, Technische Universität München
* Informed consent as documented by signature

Exclusion Criteria:

* Medical contraindications regarding strength training (e.g. risk of bleeding, ...)
* Contraindications to one of the inclusion criteria mentioned above
* Inability to follow the procedures and understand the intervention and assessments of this study, e.g. due to cognitive impairment, language problems, psychological disorders etc.
Safety and Immunogenicity of 20vPnC Coadministered With SIIV in Adults ≥65 Years of Age

Study of the safety and immunogenicity of 20vPnC and influenza vaccine administered at the same visit or separately


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants ≥65 years of age at the time of consent
* Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease
* Adults who have no history of ever receiving a pneumococcal vaccine, or have a history of receiving a licensed pneumococcal vaccination ≥6 months prior to first study vaccination.

Exclusion Criteria:

* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis)
* Previous vaccination with any investigational pneumococcal vaccine, or planned receipt of any licensed or investigational pneumococcal vaccine through study participation.
* Vaccination with any influenza or pneumococcal vaccine \<6 months before investigational product administration, or planned receipt of any licensed or investigational non-study influenza vaccine during study participation.

  -- Serious chronic disorder, that in the investigator's opinion would make the participant inappropriate for entry into the study
* Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results
Evaluate Safety and Effectiveness of XenoSure® Biological Patch in the Application of Peripheral Vascular Repair

The purpose of this trial is to collect safety and effectiveness data to support peripheral vascular indication of XenoSure biologic patch. This trial is performed to meet the China FDA regulation in this kind of device. The clinical trial will be performed solely inside China under GCP regulation and all applicable China regulations on medical device clinical trial.

The purpose of this trial is to collect safety and effectiveness data to support peripheral vascular indication of XenoSure biologic patch. This trial is performed to meet the China FDA regulation in this kind of device. The clinical trial will be performed solely inside China under GCP regulation and all applicable China regulations on medical device clinical trial.

144 subjects for peripheral vascular repair, including respective 72 subjects for the trial group and the control group.

Eligibility Criteria:
Inclusion Criteria:

- 1) Any man or woman aged between 18\~80 years old 2) The expected lifetime of no less than 12 months 3) The subject can be considered for suturing with XenoSure Biological Patch after the peripheral vascular repair surgery. The subject's targeted arterial diameter is less than 5mm or the arterial incision length is more than 4cm and less than 9cm.

4) Physical conditions and vital signs meet requirements for the surgery. 5) The subjects and/or their guardians sign the written Informed Consent Form.

Exclusion Criteria:

1. Patients with severe visceral diseases in heart, liver, kidney, etc.
2. Patients have unstable vital signs and not suitable for the surgery indications
3. Patients need vascular outflow stenting repair in the same location with XenoSure® Biological Patch.
4. Pregnant or lactating women
5. Patients With severe allergic history (especially allergic to bovine materials)
6. Patients with the past medical history of severe immunodeficiency disease
7. The subject has used or plans to use immunomodulatory drugs for more than half a year.
8. The subject with poor blood clotting function is defined as that pre-operative INR or APTT is prolonged over 30% than the reference value without drug intervention, or that blood platelet count is less than 100\*10\^9/L.
9. The subject has severe kidney disorders or diseases with the estimated glomerular filtration rate \[GRF\]\<30mL/min/1.73m2.
10. The subject's ALT or AST level is 2.5 times higher than the upper normal limit or the subject has active liver disease or icterus.
11. The subject has participated in another clinical study within 3 months or is participating in another clinical study now.
12. The investigator believes that the subject has other reasons unsuitable for inclusion.

    -
A Phase 1/2 Study of BPI-361175 in Subjects With Advanced Solid Tumors

This is a phase I/II, open-label study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of BPI-361175 tablets in patients with advanced solid tumors including advanced Non-small cell Lung cancer (NSCLC).This is a three-stage study, consisting of Phase Ia dose escalation, Phase Ib dose expansion and pivotal Phase II Study. The pivotal Phase II study will be designed based on data generated from the Phase I studies.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 years old;
* Patients with histologically or cytologically confirmed diagnosis of inoperable locally advanced or recurrent/metastatic non-small cell lung cancer (NSCLC) with EGFR sensitive mutations. Patients must have progressed from or be intolerant to or be unfit for standard treatment, or the standard treatment does not exist;
* For dose expansion and Phase II, patients must be willing to provide tumor tissues (archived tumor tissue samples within 2 years or fresh tumor tissues) and/or blood samples for central lab testing;
* Measurable or evaluable disease;
* Adequate bone marrow, liver, and renal function.

Exclusion Criteria:

* Unstable, symptomatic primary CNS tumors/metastasis or leptomeningeal metastases which are not suitable for enrollment, as judged by investigators;
* Pregnancy or lactation;
* Other protocol specified criteria.
PK/PD Study of Posaconazole for Empiric Treatment of Invasive Fungal Infections in Neutropenic Patients or Treatment of Refractory Invasive Fungal Infections (Study P01893)

This phase II study will be conducted to:

1. evaluate the pharmacokinetics, safety, tolerance, and efficacy of different dosing schedules of Posaconazole in immunocompromised hosts with a variety of refractory invasive fungal infections or in subjects who require empiric antifungal therapy and
2. identify the dosing schedule that provides the most consistent therapeutic drug exposure in this patient population.

This is an open-label, randomized, parallel group, study of pharmacokinetics, safety, tolerance, and efficacy of Posaconazole in the treatment of immunocompromised hosts with refractory invasive fungal infections or in subjects who require empiric antifungal therapy.

The projected number of subjects planned for enrollment is 100 evaluable subjects. The number of planned study sites is approximately ten in the United States and approximately eight in the rest of the world.

Eligibility Criteria:
Inclusion Criteria:

* A proven, either probable or possible invasive fungal infection which is refractory to standard antifungal therapies.
* Subjects who received \>72 hours of systemic empiric antibacterial therapy and are neutropenic (\<500 neutrophils per mm3 and, have had fever that has reached an oral temperature \>38c (or \>100.4f)twice in the last 48 hours, or

have a recurrence of fever (oral temperature, \>38c or \>100.4F) while receiving broad spectrum antibacterial therapy after prior resolution of fever while on antibacterial therapy.

* Able to take oral medication or take medication via enteral feeding tube.
Progression Rate of Pseudoxanthoma Elasticum-associated Choroidal and Retinal Degeneration

This study aims to systematically assess the retest reliability and ability to detect a change of new visual function tests and ophthalmological imaging methods for observing the natural course of pseudoxanthoma elasticum (PXE).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with Pseudoxanthoma elasticum according to the Plomp criteria or adult patients with a PXE-mimicking phenotype (angioid streaks and peau d'orange \[e.g., ENPP1 or GGCX-associated disease\])
* Best-corrected visual acuity (BCVA): ≤1.0 LogMAR

Exclusion Criteria:

* Inability to give informed consent
* Claustrophobia
* Prior surgery (other than anti-VEGF injections, cataract surgery, YAG laser capsulotomy, or laser retinopexy) that - according to the investigator's judgment - may affect visual function assessments (e.g., retinal detachment surgery, glaucoma filtration surgery, or a history of a corneal transplant in the study-eye)
* Concurrent ophthalmic conditions in the study eye that (according to the investigator's judgment) may contribute to loss of vision, such as clinically significant opacification of the ocular media (corneal dystrophies, cataract), other retinal diseases, or disease of the optic nerve head and visual pathway (including amblyopia)
* Major surgery planned or other events that (according to the investigator's judgment) could hinder follow-up examinations (e.g., knee replacement)
Efficacy of Extracorporeal Shockwave Myocardial Revascularization

Clinical research to justify effectiveness of the Extracorporeal Shockwave Myocardial Revascularization (ESMR) Therapy for treatment of patients with reversible myocardial ischemia secondary to Coronary Artery Disease (CAD) and therapy resistant stable angina pectoris.


Eligibility Criteria:
Inclusion Criteria:

* Patient with a signed Informed Consent Form.
* Patient's current and past medical condition and status be assessed using previous medical history, complete physical examination and the physicians (principle investigator's) medical opinion.
* Patient is diagnosed with chronic angina pectoris for at least 6 weeks. Diagnosis is based on medical history, complete physical examination, and core labs.
* Patients who no longer receive benefit from additional revascularization procedures (i.e. CABG or Angioplasty). Certification will be made by Heart Team.
* Patient demonstrates Exercise Tolerance Time (ETT) duration \< 10 minutes on Modified Bruce protocol.
* Patient had at least one documented myocardial segment with reversible ischemia.
* Patient is under optimum medical therapy for angina for at least 6 weeks. The optimal treatment plan is tailored to a person's age, the presence of other medical conditions, lifestyle, medication side effects, etc. Medical therapies for stable angina include ACE-inhibitors, Nitrates, Beta Blockers and Calcium Channel Blockers, trimetazidine, ivabradin. Combination of any of 3 above mentioned drugs will be considered as optimum medical therapy.
* Patient has an echocardiographic acoustic window to the target area in the myocardium utilizing one of the following views: apical 2 chamber view (2CH), apical 4 chamber view (4CH), modified parasternal long axis view (LAX) and parasternal short axis view (SAX).

Exclusion Criteria:

* Patient who will substantially benefit from additional revascularization procedures such as additional CABG or angioplasty therapies. This determination will be made and certified by the Heart Team.
* Patient has active endocarditis, myocarditis or pericarditis.
* Patient with moderately severe or severe valvular disease.
* Patient with known intraventricular thrombus.
* Patients who have active or non-active implantables, such as pacemakers, defibrillators, abandoned leads, or electrodes.
* Patient for who shock waves applied over any implanted device that releases substances or medications to the periphery (such as insulin pumps).
* Patient is pregnant.
* Patient with severe chronic lung disease (emphysema, pulmonary fibrosis) with difficult access to ultrasonic acoustic window.
* Patients for who shock waves applied over the area of healing fracture.
* Patients for who shock waves applied over the area of bone growth.
* Patients for who shock waves applied to the area of malignancy.
* Prior invasive malignancy, except non-melanomatous skin cancer or other malignancies with a documented disease-free survival for a minimum of 5 years.
* By the physician decision there is underlying concomitant disease or circumstance what may negatively influence the management of the patient.
Evaluation of the Optimal MTX Dose as an Add-on Therapy to Adalimumab for RA Patients in Japan, South Korea and Taiwan

This study will be conducted in Japan, South Korea and Taiwan to evaluate the optimal dosage of methotrexate (MTX) as an add-on therapy to adalimumab (ADA) in participants with rheumatoid arthritis (RA) who have not achieved remission by MTX monotherapy.

The erythrocyte MTX-polyglutamates (MTX-PG) concentration will be measured to evaluate its relationship to the efficacy and safety of MTX therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥18 years (≥20 years in Taiwan) at the time of informed consent
2. Patients who meet the 1987 revised ACR criteria or 2010 ACR/EULAR criteria
3. Patients who have RA within 2 years from initial diagnosis to informed consent
4. Patients who were previously untreated with MTX, JAK inhibitor, or bDMARDs
5. Patients who have disease activity of SDAI \>11 at screening
6. Patients who are no need for concomitant use of DMARDs other than hydroxychloroquine (only in South Korea and Taiwan) and study drugs during the study as judged by principal investigator/sub-investigator at screening
7. Patients who are no need for concomitant use of corticoid steroid equivalent to \>10 mg/day prednisolone during the study as judged by principal investigator/sub-investigator at screening.
8. Female of child-bearing potential who can use appropriate contraceptive during the study, female in whom time from menopause to informed consent is ≥1 year, or female of no child-bearing potential through sterilization (bilateral tubal ligation, bilateral ovariectomy or hysterectomy, etc.)
9. Virile male who can use appropriate contraceptive during the study
10. Patients who can adequately understand this study procedures, and voluntarily consent in writing to take part in this study (consent of a legally-acceptable representative is also required for patients aged \<20 years in Japan and aged \<19 years in South Korea)

Exclusion Criteria:

1. Patients who currently have a malignant tumor, except for non-melanoma forms of skin cancer limited within epidermis, and uterine cervix cancer limited within epidermis
2. Patients who have serious infections such as sepsis
3. Patients who have active tuberculosis
4. Patients who have a history or current complication of demyelinating disease such as multiple sclerosis
5. Patients who have congestive heart failure
6. Pregnant female, or female who intend to conceive during the study period
7. Patients who have bone marrow depression and whom investigator considered ineligible
8. Patients who have chronic liver disease and whom investigator considered ineligible, and who is positive for HBs antigen
9. Patients who have nephropathy and whom investigator considered ineligible
10. Lactating female
11. Patients who have pleural effusion or ascites
12. Patients with a known hypersensitivity to MTX or ADA
13. Patients otherwise whom principal investigator/sub-investigator considered medically ineligible to participate in the study
An Open Label Extension Study to Evaluate the Safety of Continued Therapy of Subcutanous Remodulin® in Pulmonary Arterial Hypertension

This is a multicenter, open-label trial to evaluate the safety of continued therapy with subcutaneous Remodulin® in subjects with pulmonary arterial hypertension (PAH) who complete the CVT-CV-003 study. The study will include about 50 subjects at up to 10 clinical trial centers in China who completed all required assessments in the CVT-CV-003 study. Study visits for data collection will occur at month 6 and 12 with yearly visits beyond 12 months until the study is discontinued by the sponsor.


Eligibility Criteria:
Inclusion Criteria:

A subject is eligible for inclusion in this study if all of the following criteria apply:

1. The subject voluntarily gives written informed consent to participate in the study.
2. The subject participated in and completed study CVT-CV-003.
3. Sexually active women of childbearing potential must practice true abstinence from intercourse when it is in line with their preferred and usual lifestyle, or use two different forms of highly effective contraception. Medically acceptable forms of effective contraception include: (1) approved hormonal contraceptive (such as birth control pills), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, (3) an intrauterine device (IUD), or (4) partner vasectomy. Women of child bearing potential include any females who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or are not postmenopausal (defined as amenorrhea for at least 12 consecutive months).

   Males participating in the study must use a condom during the length of the study, and for at least 48 hours after discontinuing study medication.
4. The subject has not developed a concurrent illness or condition during the conduct of the previous study (including but not restricted to, sleep apnea, chronic renal insufficiency, anemia, uncontrolled systemic hypertension or left sided heart disease) that would make participation in this study detrimental to the subject's health in the opinion of the Investigator.
5. In the opinion of the Principal Investigator, the subject is able to communicate effectively with study personnel, is considered reliable, willing and likely to be cooperative with protocol requirements, including attending all study visits, and is mentally and physically capable of administering Remodulin by continuous SC infusion using a micro infusion pump.

Exclusion Criteria:

A subject is not eligible for inclusion in this study if any of the following criteria apply:

1. The subject permanently discontinued Remodulin during study CVT-CV-003.
2. The subject is pregnant or lactating.