cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures on the Improvement of Blood Flow

This study was conducted to investigate the effects of daily supplementation of Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures on the Improvement of Blood Flow.

This study was a 12-week, randomized, double-blind, placebo-controlled human trial. 80 subjects were randomly divided into Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures group and a placebo group. It is to evaluate the changes in the displayed evaluation items when taking Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures once a day, in comparison with taking a placebo.

Eligibility Criteria:
Inclusion Criteria:

* Participants who meet three or more items
* Smoker
* Total cholesterol 180\~239 mg/dL before a meal
* LDL cholesterol 130\~159 mg/dL before a meal
* Glucose 100\~125 mg/dL before a meal
* systolic blood pressure(SBP) is 120\~140 mmHg
* Body mass index(BMI) is 23\~30 kg/m\^2
* Waist/Hip ratio(WHR) is 0.9 over for man, 0.85 over for a woman

Exclusion Criteria:

* Participants with marked impairment of platelet function and platelet coagulation
* Participants who have anticoagulation within 4 weeks before the screening test
* Participants with a clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry system, musculoskeletal system, Inflammation, blood tumor, gastric disease, etc.
* Participants with BMI(Body mass index) less than 18.5 kg/m\^2 or more than 35 kg/m\^2 at the screening test
* Participants who take medicine or healthy functional foods for platelet function, blood circulation improvement, and hyperlipidemia within 4 weeks before the screening test
* Participants receiving antipsychotic medication within 3 months prior to the screening test
* Participants suspected of alcoholism(21 unit/week) or substance abuse
* Participants who have participated in other clinical trials within 3 months prior to the screening test
* Participants who show the following relevant results in a Laboratory test º Aspartate Transaminase(AST), Alanine Transaminase(ALT) \> Reference range 3 times upper limit º Serum Creatinine \> 2.0 mg/dl
* Women who are pregnant or breastfeeding
* Women who may become pregnant and have not used appropriate contraceptives
* Participants who the principal investigator judged inappropriate for the participant in this study because of a laboratory test result, etc
Trial to Assess the Effects of Vorapaxar (SCH 530348; MK-5348) in Preventing Heart Attack and Stroke in Patients With Atherosclerosis (TRA 2°P - TIMI 50) (P04737)

The study is designed to determine whether vorapaxar, when added to the existing standard of care (SOC) for preventing heart attack and stroke (eg, aspirin, clopidogrel) in participants with a known history of atherosclerosis, will yield additional benefit over the existing standard of care without vorapaxar in preventing heart attack and stroke.

The study is also designed to assess risk of bleeding with vorapaxar added to the standard of care versus the standard of care alone.


Eligibility Criteria:
Inclusion Criteria:

Men and women at least 18 years old with evidence or a history of atherosclerosis involving the coronary, cerebral, or peripheral vascular systems by one or more of the following:

* history of myocardial infarction (heart attack)
* history of ischemic stroke (stroke due to a blocked artery)
* history of peripheral arterial disease

Exclusion Criteria:

* history of intracranial hemorrhage or of central nervous system (CNS) surgery, tumor, or aneurysm
* any bleeding disorder or abnormality
* sustained severe hypertension or valvular heart disease
* current or recent platelet count \<100,000 mm\^3
* planned or ongoing treatment with a blood thinning medication
* pregnancy
* any significant medical or physiological condition or abnormality that could put the subject at increased risk or limit the subject's ability to participate for the duration of the study
Compassionate Use of Omegaven

This expanded access protocol is for infants or children with conditions preventing them from taking in enough nutrients from food and must receive nutrition intravenously. Standard intravenous nutrition contains fat emulsion made from soybean. If this fat emulsion is given over a long period of time, it can cause problems within the liver and if persistent and not addressed can even lead to severe and/or permanent injury to the liver.

It is believed that a type of fish oil blend, called Omegaven®, may be used in place of the soybean fat blend. The Omegaven® fish oil blend may greatly reduce the risk of liver injury.

Omegaven® is not approved by the Food and Drug Administration (FDA). It is only offered under an "expanded access" protocol as an alternative to the soybean fat blend.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female
2. Older than 14 days and less than 5 years of age
3. Direct bilirubin value is greater than 2 mg/dL
4. Be expected to require intravenous nutrition for at least an additional 28 days
5. Parent/legal guardian has agreed to provide consent/parental permission

Exclusion Criteria:

1. Patients who have a congenitally lethal condition (e.g. Trisomy 13).
2. Patients who have clinically severe bleeding not able to be managed with routine measures.
3. Patients who have evidence of a viral hepatitis or primary liver disease as the primary etiology of their cholestasis.
4. Patients who have other health problems such that survival is extremely unlikely even if the infant's cholestasis improves.

5 The parent/legal guardian is unwilling to provide consent/parental permission.
COMPression of Left Main coRonary artEry in patientS With Pulmonary Arterial Hypertension aSymptomatIc fOr aNgina

The prevalence of critical ab extrinsic compression of left main coronary artery (LMCA) is very high in patients with pulmonary arterial hypertension (PAH) symptomatic for angina (up to 40% according to a recent study of 121 patients with PAH). The element that most of all correlates with the degree of coronary stenosis is the diameter of the pulmonary artery (PA). In particular, a diameter ≥ 40 mm has a sensitivity of 83% and a specificity of 70% in patients with angina. Critical stenosis of LMCA is a risk factor for sudden death and in these condition percutaneous coronary angioplasty with stent implantation has proven to be a safe and effective long-term procedure. Preliminary data from a retrospective analysis of the registry of patients with PAH in Bologna (ARCA registry, 109/2016/U/Oss) highlights that even in PAH patients asymptomatic for angina, compression of LMCA can occur in up to 13% of patients and the main predictive parameter of compression was found to be a diameter ≥ 42 mm (with a sensitivity of 87% and a specificity of 77%). Performing a screening test by coronary-CT scan in all subjects suffering of PAH with a PA diameter ≥ 40 mm even if asymptomatic for angina could therefore help to identify patients with PAH at increased risk for sudden death at an early stage.


Eligibility Criteria:
Inclusion Criteria:

* Patients with PAH (group 1 of World Health Organization pulmonary hypertension classification) who have undergone at least one pulmonary CT angiography with a PA trunk diameter ≥ 4 cm
* Age ≥18 years
* Asymptomaticity for angina pectoris or anginal equivalent

Exclusion Criteria:

* Severe chronic kidney disease \[Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) estimated glomerular filtration rate \<30 ml/min) or need for dialysis
* Major allergy to iodinated contrast agent
* Intolerance or allergy to acetylsalicylic acid or clopidogrel
* History of stroke or transient ischemic attack in the last 6 months or a history of intracranial haemorrhage
* Known cerebral arteriovenous malformation or aneurysm
* Known moderate or severe hepatic insufficiency (Child Pugh B or C)
* Thrombocytopenia (\<100.000/μL) or anemia (hemoglobin \<10 g/dL)
* Active bleeding or factors which, in the investigator's judgment, significantly increase the risk of bleeding
* Major surgery in the past 30 days
* Cancer in the active phase
* Pregnancy or breastfeeding
* Patient prognosis \<1 year in the opinion of the investigator
* Any condition that increases the risk of non-compliance or of being lost to follow-up
* Patients who have already undergone a LMCA angioplasty
* Failure to obtain informed consent
A Clinical Study of Pyrotinib in Patients With HER2-positive Advanced Colorectal Cancer

To Observe the Efficacy and Safety of Pyrotinib Maleate in Patients With HER2-positive Advanced Colorectal Cancer

This study is an investigator-initiated, open-label, two-cohort phase II trial, assessing the objective response rate (ORR) of pyrotinib monotherapy (Cohort 1) or in combination with trastuzumab (Cohort 2), in HER2-positive advanced colorectal cancer.

HER2 positivity is centrally established by immunohistochemistry (IHC) and silver in situ hybridization (SISH). To be HER2 eligible the original tumor, or the biopsied metastasis (whichever is last available), must be IHC 3+ or 2+ in more than 50% of cells, confirmed by SISH or fluorescence in situ hybridization (FISH) with a HER2:CEP17 ratio ≥ 2.0. For IHC a positive staining (3+) is defined as an intense membrane staining which can be circumferential, basolateral, or lateral of the tumor cells.

Eligibility Criteria:
Inclusion Criteria:

* 1. Aged 18-75 years, male or female;
* 2. ECOG performance status 0-2;
* 3. Recurrent/metastatic advanced colorectal cancer diagnosed by histology or cytology;
* 4. Patients who progressed on or were intolerable to standard therapy, or those who refused chemotherapy;
* 5. At least one measurable lesion according to RECIST v1.1;
* 6. HER2 positivity (including amplification, mutation, and overexpression) detected by clinically recognized methods (including PCR, FISH, immunohistochemistry, and NGS), and the data obtained by NGS at the pathology department of hospital or qualified gene testing organization could be accepted;
* 7.The functional level of the major organs must meet the following requirements (no blood transfusion within 2 weeks prior to screening, no use of leukocytes- or platelet-raising drugs):

  1. Blood routine: neutrophils (ANC) ≥ 1.5 × 10\^9 / L; platelet count (PLT) ≥ 90 × 10\^9 / L; hemoglobin (Hb) ≥ 90 g / L;
  2. Blood biochemistry: total bilirubin (TBIL) ≤ upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2 × ULN（Patients with liver metastases were ≤5 × ULN）;
  3. Cardiac color doppler ultrasound: left ventricular ejection fraction (LVEF) ≥ 55%;
  4. 12-lead electrocardiogram: The QT interval corrected by the Fridericia method (QTcF) \< 470 msec;
* 8. Sign the informed consent and agree to collect the clinical efficacy and information of the patient.

Exclusion Criteria:

* 1. The presence of third interstitial effusion (such as a large amount of pleural fluid and ascites) that cannot be controlled by drainage or other methods makes it impossible to evaluate the clinical treatment effect;
* 2. History of substance abuse and cannot be cured or with mental disorders;
* 3. Pregnant or lactating women; patients with fertility who are unwilling or unable to use effective contraception;
* 4. Severe concomitant disease, or unsuitable to participate in this study decided by the investigator.
* 5. Prior use of pyrotinib.
Anlotinib Hydrochloride Capsules Combined With Penpulimab Injection for the Treatment of Hepatocellular Carcinoma at High Risk of Recurrence.

The primary objective of this study was to evaluate the efficacy of anlotinib hydrochloride capsules combined with penpulimab injection (test group) versus placebo (control group) for adjuvant therapy after radical surgery or ablation in HCC patients with high risk of recurrence by assessing recurrence-free survival (RFS).


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 1; Predicted survival ≥12 weeks.
* Subjects with hepatocellular carcinoma (HCC) confirmed by histopathology or cytology or who meet the diagnostic criteria for Primary Liver Cancer 2022 or the American Association for the Study of Hepatology (AASLD) hepatocellular carcinoma.
* Subjects who received radical excision or ablation (Radio Frequency Ablation (RFA) or Microwave Ablation (MWA) only) within 4 to 12 weeks prior to randomization (multiple modalities or combined or multiple treatments are not acceptable).
* No major vena portae 3 (Vp3) or vena portae 4 (Vp4) in the portal vein or any level of vascular invasion in the hepatic vein or inferior vena cava.
* No extrahepatic metastasis.
* High risk factors for recurrence after radical resection or complete ablation.
* Complete recovery from surgical resection or ablation within 4 weeks before randomization.

Exclusion Criteria:

* Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology.
* Evidence of residual, recurrent, or metastatic disease at randomization.
* More than one surgical treatment for hepatocellular carcinoma; Received more than 1 prophylactic Transcatheter Arterial Chemoembolization (TACE) treatment after surgery; or received Hepatic Artery Infusion Chemotherapy (HAIC) therapy after surgery.
* Previous use of antiangiogenic drugs or PD-1, Programmed Cell Death-Ligand 1 (PD-L1) and other related immunotherapy drugs or systemic chemotherapy drugs.
Intraoperative Cell Salvage and Postoperative Acidosis

Metabolic acidosis is a common complication that patients experience in the early postoperative period following cardiac surgery. Increasingly, the composition and volume of intravenous fluids administered during surgery have been implicated in the development of postoperative acidosis. Intraoperative Cell Salvage (ICS), an autologous blood transfusion technique employed by Cardiac/Perfusion Units to minimize blood loss during surgery, involves the infusion of of one such fluid, 0.9% sodium chloride. The rapid infusion of large volumes of 0.9% sodium chloride has previously been linked with the development of hyperchloraemic acidosis. It was therefore hypothesized that the volume of mechanically salvaged of red blood cells re-infused into patients undergoing heart surgery contributes to the acidosis that occurs in the early postoperative period.

To test this, the investigators have designed an observational cohort study to check for correlation between the volume of cell salvaged blood infused during surgery and the severity of postoperative acidosis (which will be assessed using data from routine arterial blood gas samples).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients scheduled for cardiac surgery including both on- and off-pump coronary artery bypass grafting surgery, heart valve surgery, septal surgery, and aortic surgery)
* Patients must have consented to participate

Exclusion Criteria:

* Patients under 18 years of age
* Patients who are unable or unwilling to provide informed consent
Surface Hardness and Wear Characteristics of Prefabricated and CAD/CAM Milled Artificial Teeth

Purpose: This study aimed to assess the 3-dimentional wear )3D) (volumetric loss) and 2-dimentional wear (2D) (vertical loss) and surface hardness of ready-made (prefabricated) and CAD/CAM milled artificial denture teeth.

material and methods: In a cross-over study design, ten completely edentulous patients were randomly chosen for this study and given two complete dentures. The first complete denture was constructed with pre-fabricated teeth. The second complete denture was constructed with CAD\\CAM milled teeth. The complete denture teeth were 3D scanned at the time of insertion (T0), after three months (T3), and after six months (T6) of denture insertion. Utilizing 3D surface superimposition techniques, the vertical (2D wear), and Volumatic (3D wear) material loss were measured. The hardness of the teeth were evaluated at the time of denture insertion (T0) then after 6 months (T6) of denture insertion by Vickers hardness test. Statistical analysis was done using SPSS software. Paired groups were compared by paired t test. Significant difference was considered if P ≤ 0.05.


Eligibility Criteria:
Inclusion Criteria:

* completely edentulous
* angle class I maxillomandibular relations

Exclusion Criteria:

* Angle's class II, III maxillomandibular relation
* systemic disease that affect the bone and soft tissue health
Renal and Bone Outcome After Switching Tenofovir to Different Antiretroviral Strategies

Renal outcome could be different after switching tenofovir to different antiretroviral strategies, in case of renal toxicity. Therefore, it is necessary to evaluate the importance of renal evolution in these patients, in terms of grade and time to renal improvement, according to the different options after interrupting tenofovir. The aim of this study was to explore the renal outcome after tenofovir according to new antiretroviral regimen.

Renal toxicity has become an important issue in a large number of HIV infected patients receiving a tenofovir-containing regimen. However, there are no data about the best antiretroviral regimen in patients switching tenofovir because of renal toxicity, in time, grade or persistence of renal improvement. Thus, patients with renal toxicity on tenofovir, defined as:

* a progressive decrease of at least 25% of estimated glomerular filtration rate (GFR, by chronic kidney disease-epi equation), or
* confirmed value of GFR below 60 ml/min in two successive determinations, or
* proximal tubular renal dysfunction, as indicated by the presence of at least 3 of the following parameters: proteinuria\> 150 mg/g; excretion fractional of phosphorus in urine \> 20%; glucosuria \> 150 mg; or/and tubular proteinuria/albuminuria ratio above 0.4.

who changed to the combination of abacavir plus a third drug, or to a nucleoside analogues-free antiretroviral combination (dual therapy, monotherapy) will be followed for 1 year to establish the time and grade of improvement (defined as the lack of above criteria).

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected patients
* Older than 18 years
* Receiving a Tenofovir-containing regimen, and with criteria of renal toxicity (see above)
* Switching the antiretroviral regimen

Exclusion Criteria:

* Pregnancy
* Patients receiving prolonged therapy with other nephrotoxic drugs
* Patients not receiving or interrupting antiretroviral regimen
Survey of Sensory and Motor Tricks in Focal Dystonia

This study will collect information on (tricks) patients with focal dystonia use to relieve their symptoms. Dystonia is a movement disorder caused by sustained muscle contractions often causing twisting and abnormal posturing. Dystonia may be generalized, affecting at least one leg and the trunk of the body, segmental, affecting adjacent body parts, or focal, affecting a single body part, such as the hand or eyelid. It may be task-specific, such as writer's, musician's or sportsman's cramps. Some patients with focal dystonia use (tricks), such as touching the face or hand, to stop or alleviate the abnormal movement. This study will survey the types of tricks people with focal dystonia use in order to learn more about the disorder.

Patients 18 years of age and older with focal dystonia may be eligible for this study. Candidates will be screened for eligibility with a medical history, clinical evaluation, and review of their medical records.

In one 30- to 45-minute clinic visit, participants will be interviewed about their dystonia symptoms and the tricks they use to relieve the symptoms. They may be asked to show the investigators how the tricks work

The purpose of this study is to collect and organize information concerning a phenomenon known as 'sensory tricks' or Geste antagoniste in focal dystonia. Sensory tricks, which we will refer to as 'tricks' since some involve motor as well as sensory input, are various stimuli used by dystonic patients to transiently diminish their spasms (Jankovic and Fahn 1993). The phenomenon of tricks is evidence for the abnormality of sensorimotor integration in focal dystonia, yet it is little studied or understood. A survey of the history and characteristics of tricks will lead to a better understanding of this puzzling phenomenon, and a step toward the understanding of the mechanism of focal dystonia.

Eligibility Criteria:
INCLUSION CRITERIA

Patients with focal dystonia diagnosed by review of medical record, history, and clinical evaluation.

EXCLUSION CRITERIA

Any individual without focal dystonia.

Any individual who is unable to provide accurate history, or is critically ill.
Safety and Efficacy of Atherectomy on VasculaR Functions

Interventional strategies aim to restore tissue perfusion. However, despite the simple reopening of a narrowed artery they affect endothelial function, perpetuating dysfunctional vascular homeostasis. PTA and atherectomy might alter the endothelial function but the mechanisms are incompletely understood. The primary goal of atherectomy is vessel preparation and improving compliance, which could aid in preserving vessel functions. Aim of this study is to determine safety, efficacy, patency and vessel functions in the femoropopliteal artery following atherectomy and DCB.


Eligibility Criteria:
Inclusion Criteria:

* Peripheral artery disease, lesions in the SFA and popliteal artery.
* Clinical diagnosis of chronic, symptomatic lower limb ischemia as defined by Rutherford 2, 3, or 4
* Planed peripheral intervention TASC A-D
* Subject must be between 18 and 85 years old
* Female of childbearing potential must have a negative pregnancy test within 10 days prior to index procedure and utilize reliable birth control until completion of the 12-month angiographic evaluation
* Vessel diameter ≥3.0 mm and ≤7.0 mm
* Willing to comply with the specified follow-up evaluation
* Written informed consent prior to any study procedures

Exclusion Criteria:

* Thrombolysis within 72 hours prior to the index procedure
* Aneurysm in the femoral artery or popliteal artery
* Concomitant hepatic insufficiency, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy
* Unstable angina pectoris at the time of the enrollment
* Recent myocardial infarction or stroke \< 30 days prior to the index procedure
* Life expectancy less than 12 months
* Septicemia at the time of enrollment
* Known or suspected active infection at the time of the index procedure, excluding an infection of a lower extremity wound of the target limb
* Known or suspected allergies or contraindications to aspirin, clopidogrel or heparin Presence of other hemodynamically significant outflow lesions in the target limb requiring a planned surgical intervention or endovascular procedure within 30 days after the index procedure
Combination Therapy in Patients With Depression

The purpose of the study is to compare sertraline and atomoxetine/sertraline combination therapy in patients with persistent depressive symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Meet DSM-IV criteria for major depression with a HAMD-17 rating scale score of at least 18 at visit 1
* Adult men or women, 18 years of age or older
* Must be able to swallow capsules
* Laboratory results must show no clinically significant abnormalities
* If suicidal ideation is present, the investigator should assess its severity and the potential need for other interventions and determine whether these are compatible with study participation

Exclusion Criteria:

* Have a documented history of Bipolar I or II disorder, or of psychosis.
* Have a history of any seizure disorder (other than febrile seizures) or patients who have taken (or are currently taking) anticonvulsants for seizure control.
* Have a history of ADHD
* Have a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions
* Are currently using alcohol, drugs of abuse, or any prescribed or over-the-counter medication in a manner which the investigator considers indicative of abuse