cyrilzakka/clinical-trials huggingface dataset:
Open-Label Trial to Determine the Long-Term Safety of Safinamide in Parkinson's Disease Patients

Parkinson's Disease (PD) is a major neurodegenerative disorder in which there is a progressive loss of dopamine-containing neurons. The understanding that PD is a syndrome of dopamine (DA) deficiency led to the introduction in the clinical practice of L-dopa, a precursor of DA that crosses the blood brain barrier, and also to the use of selective inhibitors of MAO-B, the major DA metabolising enzyme in humans.

Safinamide is an inhibitor of MAO-B. This study is to evaluate the long term safety and tolerability of safinamide in PD patients, that have already completed a previous clinical study with Safinamide. The physical and neurological conditions as well as other safety parameters will get compared from baseline to subsequent visits.


Eligibility Criteria:
Inclusion Criteria:

1. the subject has completed a previous clinical study with Safinamide in PD
2. the subject successfully completed all trial requirements of the antecedent trial
3. if female, they must be either post-menopausal for at least 2 years, surgically sterilized or have undergone hysterectomy or, if of child bearing potential, they must be willing to avoid pregnancy by using an adequate method of contraception for four weeks prior to, during and four weeks after the last dose of study medication. For the purpose of this trial women of child bearing potential are defined of all female subjects after puberty unless they are postmenopausal for at least two years, are surgically sterile or are sexually inactive
4. subjects must be willing and able to participate in the trial and provide written informed consent

Exclusion Criteria:

1. the subject experienced a clinically significant adverse effect to attributable to Investigational Medicinal Product (IMP) during a previous trial that could put the subject at risk for further treatment with Safinamide
2. if female, the subject is pregnant or lactating
3. any medical issues, which have emerged since the initial clinical trial, that in the opinion of the investigator precludes a subject's ability to participate in this open-label trial
Safety and Efficacy Study of Add On Aliskiren in Patients With Heart Failure and Renal Impairment

The main purpose of this study is to examine the effect of add-on therapy with the direct renin inhibitor Aliskiren in comparison to placebo on renal blood flow in patients with heart failure and reduced renal function.

* Primary outcome measure: change in renal blood flow at 6 months
* Secondary outcome measures: changes in renal function, N-terminal pro Brain natriuretic peptide, left ventricular function, blood pressure and neurohormones

This study is a randomized, double-blind, placebo controlled, parallel group comparison trial, enrolling 100 patients (67 vs. 33) with stable CHF. Patients will be randomized to Aliskiren 300 mg once daily or corresponding Placebo for a period of 6 months. Efficacy measures will be performed at baseline and at the end of the study. Primary efficacy outcome is change in renal blood flow as measured by 131I-Hippuran clearance. Secondary outcome include change in renal function, neurohormones, left ventricular function and blood pressure. Safety assessments include renal function, changes in electrolytes, and blood pressure. Patients will be uptitrated to maximum tolerated doses of Aliskiren, and safety visits are planned 1 week after initiation and on a 2 month interval afterwards. A total of 8 visits are planned during the entire study period.

Eligibility Criteria:
Inclusion Criteria:

* NYHA II-IV Heart Failure
* Left ventricular ejection fraction \< 45%
* Stable heart failure medication
* eGFR by sMDRD formula between 30 and 60 mL/min/1.73m2

Exclusion Criteria:

* Known hypersensitivity to study drug or ACEi
* Concomitant treatment with both ARB and Aldosterone Receptor Antagonist
* Symptomatic Hypotension
* Acute Heart Failure
* History of stroke, acute coronary syndrome, PCI or angioplasty within past 3 months
* Serum potassium \> 5.2 mmol/L
* Right heart failure due to severe pulmonary disease
* Other protocol-defined inclusion/exclusion criteria may apply
Tolerability and Pharmacokinetics of M2ES in the Treatment of Advanced Solid Tumor

1. MTD and DLT of M2ES
2. Pharmacokinetics of M2ES

Patients received infusion of M2ES for 120 minutes weekly（d1,d8,d15）by calculated pump and underwent evaluation of vital signs including blood pressure, pulse, respiratory rate, and temperature before treatment, at intervals during infusion, and hourly for 6 hours after infusion. After infusion, patients underwent serial pharmacokinetic sampling. All patients were seen weekly during the study therapy and follow-up and underwent evaluation with physical examination including ECOG performance status, vital signs, and laboratory evaluation with complete blood count with manual differential, chemistry evaluation, prothrombin time/partial thromboplastin time, and urinalysis.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years;Genders eligible for study: both;
* Histologic diagnosis of solid malignancies ;
* Performance status of 0 or 1;
* Tumor not amenable to standard curative or palliative therapy;
* life expectancy beyond 3 months;
* Ability to give signed informed consent

Exclusion Criteria:

* Pregnancy or lactation;
* Had a history of brain metastasis or a primary brain tumor;
* An active, potentially severe autoimmune disease;
* Serum creatinine ≥1.5mg/dl or a calculated creatinine clearance \<60ml/min; WBC count \< 2.0×109/L，hemoglobin \< 90g/L，and platelet count \< 100×109/L; Total bilirubin value \< 2.0 times the upper limit of normal (ULN), ALT level \< 2.0 times ULN, AST \< 2.0 times ULN;
* Positive of anti-HIV antibodies;
* An active infection;
* had received chemotherapy or immunotherapy within the prior 4 weeks before study entry
* Participation in a clinical study during the last 28 days
* QTc with Bazett's correction unmeasurable or ≥ 480 msec on screening ECG
ESM Versus OM ：A Randomized Controlled Trial

The consideration of quality of life issues has led to the development of alternative surgeries for breast cancer patients, particularly in the case of localized disease. Nipple-sparing subcutaneous mastectomy (SM), for example, was designed to preserve the nipple-areola complex which facilitates breast reconstruction. However, SM still leaves behind a conspicuous scar.There have already been some observation study show that endoscopic subcutaneous mastectomy(ESM) can improve the cosmesis outcomes and at the same time as safe as the traditional SM.However there is no RCT in this field.That is why the investigators design this study.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of stages I or II ductal carcinoma
2. The distance from the tumor to the edge of the papilla is more than 3cm, the tumor volume is less than 3cm, the axillary lymph nodes have no obvious fusion and no adhesion with the axillary vein and brachial plexus
3. Age from 18\~70
4. ECOG scores 0\~2
5. Normal function of liver, kidney and bone marrow

Exclusion Criteria:

1. Through physical examination and MRI, it was confirmed that the tumor did not invade the skin, but was confined to the gland and did not invade the surface of the gland.
2. There are serious medical diseases
3. Pregnant or lactating women women of childbearing age -
A Study of Ipatasertib (GDC-0068) in Combination With Paclitaxel as Neoadjuvant Treatment for Participants With Early Stage Triple Negative Breast Cancer

This is a randomized, double-blind, placebo-controlled, multicenter, pre-operative Phase II study designed to estimate the efficacy of ipatasertib combined with paclitaxel chemotherapy versus placebo combined with paclitaxel chemotherapy in women with Stage Ia - IIIa triple-negative breast adenocarcinoma. The anticipated time on study treatment is 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal or postmenopausal women
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Histologically documented, Stage Ia to operable Stage IIIa, triple-negative carcinoma of the breast with primary tumor greter than or equal to (\>/=) 1.5 centimeters (cm) in largest diameter (cT1-3) by MRI
* Adequate hematologic and organ function within 14 days before the first study treatment
* Availability of tumor tissue from formalin-fixed, paraffin-embedded (FFPE) core biopsy of breast primary tumor
* For female participants of childbearing potential, agreement to use highly effective form(s) of contraception for the duration of the study and for at least 6 months after last dose of study treatment

Exclusion Criteria:

* Known human epidermal growth factor 2 (HER2)-positive, estrogen receptor (ER)-positive, or progesterone receptor (PgR)-positive breast cancer
* Any prior treatment for the current primary invasive breast cancer
* Participants with cT4 or cN3 stage breast tumors
* Metastatic (Stage IV) breast cancer
* Bilateral invasive breast cancer
* Multicentric breast cancer
* Any disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications
Evaluation of Killing Activity of Expanded Natural Killer Cells From Blood in Patients With Pancreatic Cancer

Pancreatic cancer, one of the deadliest epithelial malignancies, has a 5-year survival rate of only about 8%. The mortality rate has decreased slightly, but the incidence rate has been steadily increasing, and it is predicted to be the second leading cause of cancer mortality in 2030. Early diagnosis of pancreatic cancer and the development of innovative therapies are needed, and various basic and clinical studies based on pancreatic cancer biology are underway. Recently, studies on the effect of natural killer (NK) cells on cancer progression and the development of therapeutic agents using them have been actively conducted. NK cells are a component of innate lymphoid cells, accounting for approximately 5-15% of total peripheral blood mononuclear cells (PBMC).

Investigators will apply a new method to evaluate the activity of NK cells in pancreatic cancer patients, and to analyze the correlation with the progression of the tumor and the prognosis of the patient. And investigators will analyze the multifactorial factors affecting the activity of NK cells and conducted this study to help establish new diagnostic and therapeutic strategies for pancreatic cancer.

Eligibility Criteria:
Inclusion Criteria:

* The patient who is admitted to the pancreatic surgery department for the treatment of pancreas tumor
* Patients must have the ability to read, understand, and sign an informed consent and must be willing to comply with study treatment and follow-up.
* Life expectancy of at least 6 months based on discretion of treating
* Adequate hematologic function defined by the following laboratory parameters: Hemoglobin \> 100, Platelet count \> 100 and Absolute granulocyte count \> 1.5.

Exclusion Criteria:

* Patients who received preoperative chemotherapy or radiotherapy.
* Previous or concurrent malignancies.
* Any serious medical condition within 6 months prior to study entry such as myocardial infarction, uncontrolled congestive heart failure, unstable angina, serous infection.
Intralesional Injection Of Methotrexate Versus Triamcinolone Acetonid In Treatment Of Localized Psoriasis

The aim of the present study is to evaluate the efficacy of intralesional injection of methotrexate in comparison with Intralesional Injection of Triamcinolone Acetonid in localized psoriasis (body surface area \< 10%) .

study enrolling 30 patients of localized psoriasis. 15 patients received intralesional methotrexate :

* Taking aseptic condition ,One psoriatic plaque will treated with Intralesional injection of methotrexate (25mg /ml) at dosage of 0.1 ml /cm2.
* Another plaque will treated with intralesional ingection of distilled water as controlled plaque.
* patient will receive oral folic acid 5mg tablet every day except the day of injection.

Other 15 patients received intralesional trimethinolone acetonide:

* Taking aseptic condition , One plaque will treated with Intralesional injection of trimethinolone acetonide (10mg/ml) at dosage of 0.1 ml/ cm2 .
* another plaque will treated with Intralesional injection of distilled water as controed plaque.
* Patients will take 6 sessions every 2 weeks for 3 months and will followed up at 2 month and 3 months after treatment .

Eligibility Criteria:
Inclusion Criteria:

* patients with localized Psoriasis (body surface area\<10%)

Exclusion Criteria:

* Patient refusal. Generalized psoriasis. Pregnancy. Lactation. Immunocompromised patients . Patients with history of hypersensitivity to methotrexate. Patients with other inflammatory skin disorders. Patients with chronic hepatic, renal , pulmonary ,or haematological disorders. patients on treatment for psoriasis .
Clinical Proof-of-concept Study for the Combination BAY60-4552 / Vardenafil for the Treatment of Erectile Dysfunction Not Sufficiently Responsive to Standard Therapy With PDE5 Inhibitors

This study examines the efficacy and safety of the combination treatment BAY60-4552 plus vardenafil in patients with erectile dysfunction, who do not sufficiently respond to therapy with PDE5 (Phosphodiesterase 5) inhibitors.

Patients meeting the entry criteria, will receive vardenafil alone in the first four weeks of the study to assess the effect of PDE5 inhibitor therapy given alone.

Patients with an insufficient therapeutic response to vardenafil alone will enter the next part of the study, and will be randomly assigned to one of 3 treatments. There is a 1 in 3 chance of receiving either the combination BAY60-4552 plus vardenafil, or vardenafil alone, or placebo. Neither patient nor the treating physician will know which treatment is given (double-blinded design).This part of the study will last four weeks Patients will have to go to the clinic/hospital for 7 visits during the 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Open-label run-in phase (first four weeks):

  * Written informed consent signed before any study-specific procedure
  * History of ED (Erectile Dysfunction) for at least 6 months prior to screening, defined as "the inability to achieve and maintain an erection of the penis sufficient to complete satisfactory sexual intercourse"; the diagnosis of ED has to be confirmed by a physician
  * Stable, heterosexual relationship for at least 6 months prior to screening
  * Aged 18 to 64 years (inclusive) at the first screening examination
  * History of previous use of at least 1 marketed PDE5 (Phosphodiesterase 5) inhibitor and insufficient therapeutic efficacy despite use of the highest approved dose
* Double-blind treatment phase (last four weeks):

  * At least 4 attempts at sexual intercourse on 4 separate days during the open-label run-in phase with use of 20 mg vardenafil approximately 1 hour before attempting intercourse
  * IIEF EF (International Index of Erectile Function - Erectile Function subscale) score \<17
  * At least 50% of attempts at sexual intercourse during the open-label run-in phase were unsuccessful

Exclusion Criteria:

* Contraindication to use of vardenafil
* History of prostatectomy due to prostate cancer, including nerve-sparing techniques.
* Concomitant use of adrenergic blockers
* History of spinal cord injury
* Resting hypotension, i.e. SBP (Systolic Blood Pressure) \<100 mmHg at rest
* Moderate / severe hypertension, i.e. SBP \>170 mmHg or DBP \>110 mmHg at rest
* Symptomatic orthostatic hypotension with a decrease in SBP \>20 mmHg or in DBP (Diastolic Blood Pressure) \>10 mmHg subsequent to change from the supine to standing position
An Exploratory Investigation of Dietary Supplementation and Its Effect

The primary objective of this study is to understand if the test product (HUM supplement) improve symptoms experienced.

This will be a 2-arm randomized, double-blinded, placebo-controlled study.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Willing to maintain the current dietary pattern, activity level, and stable body weight for the duration of the study
* Must be in good health (don't report any medical conditions asked in the screening questionnaire)
* Willing and able to provide written informed consent

Exclusion Criteria:

* Allergies to any test product ingredients
* Any other severe chronic disease
* Pregnant, want to become pregnant for the duration of the study, or who are breastfeeding
* Participating in an investigational health product research study
24 Months Follow-up, Two Arm Study to Compare the Cardiovascular Profile in a Regimen With Everolimus + Mycophenolic Acid (MPA) Versus (vs.) a Regimen of CNI+MPA in Maintenance Renal Transplant Recipients

The objective of the study is to compare the cardiovascular profile of an everolimus and mycophenolic acid immunosuppressive regimen with a calcineurin inhibitor and mycophenolic acid regimen in maintenance renal transplant patients


Eligibility Criteria:
Inclusion Criteria:

* Received kidney transplant \> 6 months and \< 3 years prior to study enrollment
* Receiving immunosuppressive regimen that includes tacrolimus and mycophenolic acid
* Between 18 and 70 years of age
* Willing to provide written informed consent

Exclusion Criteria:

* Patients with an actual serum creatinine ≥ 2 mg/dl and/or eGFR≤ 40 ml/min and/or proteinuria≥ 500mg/day
* Patients who suffered from severe humoral and/or cellular rejection (≥ BANFF IIb, recurrent acute rejection or steroid resistant acute rejection in the previous years
* Patients who have severe hypercholesterolemia (\>350 mg/dL; \>9 mmol/L) or hypertriglyceridemia (\>500 mg/dL; \>8.5 mmol/L). Patients with controlled hyperlipidemia are acceptable.
* Diabetic patients
* Woman of child-bearing potential who is planning to become pregnant or is pregnant and/or lactating who is unwilling to use effective means of contraception
* Presence of psychiatric illness (i.e., schizophrenia, major depression) that, in the opinion of the site investigator, would interfere with study requirements
* Any other medical condition that, in the opinion of the site investigator based on recall or chart review would interfere with completing the study
* Receiving any investigational drug or have received any investigational drug within 30 days prior to study enrollment
A Phase 1 Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Repotrectinib in Advanced Cancer Patients

This is a Phase 1 study to evaluate the effect of moderate or severe hepatic impairment on the PK of repotrectinib in patients with advanced cancer.

This is a Phase 1, multicenter, multiple-dose, open-label, nonrandomized study to evaluate the effect of moderate or severe hepatic impairment on the PK of repotrectinib following single and multiple dose administration of repotrectinib in patients with advanced cancer. This study will enroll 8 patients each with moderate hepatic impairment, severe hepatic impairment and normal hepatic function.

Eligibility Criteria:
Key Inclusion Criteria:

1. Histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumor for which standard curative or palliative measures do not exist or are no longer effective. In case of hepatocellular carcinoma, the diagnosis should be based on at least 1 of the following:

   1. The presence of at least 1 lesion, measuring ≥2 cm, with characteristic arterial enhancement and venous washout in the setting of liver cirrhosis and/or hepatitis B or C infection.
   2. The presence of liver lesion(s) (as defined in inclusion criteria 3a) with alphafetoprotein ≥ 400 ng/mL.
   3. Tissue confirmation.
2. For patients with genetic ROS1 or NTRK 1-3 gene fusion, tissue-based local testing should be documented.
3. Biliary obstruction for whom a biliary drain or stent has been placed are eligible.
4. Eastern Cooperative Oncology Group Performance Status scores 0 to 2.
5. The patient must have no clinically significant change in hepatic disease status within the last 30 days before screening.
6. Patient with ascites must not have a paracentesis within 3 months of screening.
7. Protocol specified baseline hematology and kidney function laboratory values

Key Exclusion Criteria:

1. Concurrent participation in another therapeutic clinical study.
2. Symptomatic brain metastases or leptomeningeal involvement.
3. Major surgery within 4 weeks.
4. Clinically significant cardiovascular disease.
5. History of non-pharmacologically induced prolonged QT interval corrected for heart rate interval.
6. Known active infections requiring ongoing treatment (bacterial, fungal, or viral, including human immunodeficiency virus positivity).
7. Gastrointestinal disease or other malabsorption syndromes.
8. Current use or anticipated need for drugs that are known to be strong cytochrome P450 (CYP) 3A inhibitors or inducers.
Sodium Creatine Phosphate in Heart Valve Surgery

To explore the effect of intraoperative sodium creatine phosphate on myocardial protection in patients undergoing valve surgery

Objective: To explore the effect of intraoperative sodium creatine phosphate on myocardial protection in patients undergoing valve surgery Methods: 250 patients undergoing valve surgery were randomly divided into experimental group and control group. 5g creatine phosphate was dissolved in 50ml saline solution. After induction of anesthesia, the patients were first given a load dose of 1g, 20min (30ml / h) , And then pumped at a rate of 1 g / h (10 ml / h). The control group was treated with saline in the same manner. The cTnI level was measured at the corresponding time points. Hemodynamic indexes and postoperative complications were recorded.

Eligibility Criteria:
Inclusion Criteria:

* valvular disease patients requiring valvular replacement or repair surgery with cardiopulmonary bypass(CPB)

Exclusion Criteria:

* thoracoscopic valve surgery
* other organ dysfunction: such as cancer, organ failure, severe anemia, infection
* patients with mental disorders
* coagulopathy, active ulcer, ischemic or hemorrhagic stroke (within 6 months), trauma
Cell Transplant in Spinal Cord Injury Patients

This study is designed to assess the safety of autologous bone marrow derived cell transplant in chronic spinal cord injury patients. The hypothesis is that the availability of bone marrow derived mesenchymal stem cells at the sites of injury promote neuronal regeneration.


Eligibility Criteria:
Inclusion Criteria:

* Traumatic spinal cord injury
* No concomitant systemic disease
* No progress on physiotherapy for at least 6 months
* Duration of injury from 10 months to 3 years

Exclusion Criteria:

* Non-traumatic spinal cord injury whether transverse myelitis or demyelination
* Concomitant systemic disease
* Progress can be observed on physiotherapy
* Acute injury or duration of injury less than 10 months