cyrilzakka/clinical-trials huggingface dataset:
Study of Phenoptin in Subjects With Phenylketonuria Who Participated in Protocols PKU-004 or PKU-006

The objective of this study is to evaluate the safety of long-term treatment with Phenoptin in subjects with phenylketonuria (PKU) who participated in Phase 3 clinical studies with Phenoptin.


Eligibility Criteria:
Inclusion Criteria:

* Participation in study PKU-004 or PKU-006
* Willing and able to provide written, signed informed consent or, in the case of subjects under the age of 18 years, provide written assent (if required) and written informed consent by a parent or legal guardian, after the nature of the study has been explained, and prior to any research-related procedures
* Negative urine pregnancy test at screening (females of child-bearing potential)
* Willing and able to comply with all study procedures

Exclusion Criteria:

* Non-responsive to prior treatment with Phenoptin based on participation in PKU-004 or PKU-006
* Perceived to be unreliable or unavailable for study participation or, if under the age of 18 years, have parents or legal guardians who are perceived to be unreliable or unavailable
* Terminated early from PKU-004 or PKU-006, except for subjects in PKU-004 that rolled into PKU-008 at Week 22, subjects in PKU-006 that rolled into PKU-008 at Week 10, or subjects in PKU-006 that terminated due to elevated Phe levels following dietary Phe increases
* Use of any investigational product other than Phenoptin within 30 days prior to screening, or anticipated requirement for any investigational agent prior to completion of all scheduled study assessments
* Positive urine pregnancy test at screening (non-sterile females of child-bearing potential only), already known to be pregnant or breastfeeding or planning a pregnancy in self or partner during the study
* Female subjects of childbearing potential must be using an effective method of birth control, as determined by the PI, and willing to continue to use acceptable birth control measures
* Concurrent disease or condition that would interfere with study participation or safety (e.g., seizure disorder, oral steroid-dependent asthma or other condition requiring oral or parenteral corticosteroid administration, or insulin-dependent diabetes)
* Any condition that, in the view of the PI, renders the subject at high risk from treatment compliance and/or completing the study
* ALT \> 2 times the upper limit of normal (i.e., Grade 1 or higher based on World Health Organization Toxicity Criteria) at screening (see Appendix 2)
* Serious neuropsychiatric illness (e.g., major depression) not currently under medical control
* Prior history of organ transplantation
* Requirement for concomitant treatment with any drug known to inhibit folate synthesis (e.g., methotrexate)
* Concurrent use of levodopa
* Clinical diagnosis of primary BH4 deficiency
Agility Training for Older Adults to Improve Fall Risk Factors

In this randomized controlled trial the effect of 4 months of multi-component (strength, balance, cognition, endurance) exercise training intervention on measures of neuromuscular performance, cognition, and endurance as well as neural adaptations on a central and peripheral level is investigated. 40 subjects are recruited that are generally health and between 60 and 80 years of age. The interventions is based around exercises, where different tasks have to be solved simultaneously rather than serially, as has previously been done.


Eligibility Criteria:
Inclusion Criteria:

* willing to be randomized to either arm
* ability to travel to the sports facility twice a week
* understanding the german language

Exclusion Criteria:

* smoking, obesity
* history of cardiovascular, pulmonary or chronic inflammatory disease
* vision impairments
* orthopaedic problems preventing them from participating in an exercise program
* history of osteoporosis or recent low trauma fracture
* less than two weeks during the intervention period
* not have taken part in a structured exercise program more than once a week in the past three months
ShearWave™ Elastography to Assess Liver Fibrosis in Chinese Patients With Hepatitis B

This study will evaluate how liver stiffness measurements made with ShearWave™ Elastography (SWE) correspond with a biopsy result (currently the gold standard). The population that will be evaluated are Chinese patients infected with the Hepatitis B virus.

Hepatitis B is becoming increasingly common. The liver becomes stiffer and this is called fibrosis. A non-invasive method to accurately stage fibrosis is necessary in order to begin the correct treatment. Currently, liver biopsy is used to do this, but there are many disadvantages with this technique.

ShearWave Elastography (SWE), available on the ultrasound machine Aixplorer®, is a non-invasive method to evaluate liver fibrosis.

This study will evaluate how liver stiffness measurements made with SWE correspond with a biopsy result (currently the gold standard).

The sensitivity, specificity, positive predictive value and negative predictive value of liver stiffness measurements with Aixplorer to evaluate the different stages of fibrosis will be analyzed.

Liver stiffness measurement made by the Aixplorer will also be compared to blood markers

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a liver ultrasound exam due to confirmed Hepatitis B infection ,
* Patients having reached the age of majority in China,
* Patients with a liver biopsy for histological evaluation of liver fibrosis, performed within 3 months after the SWE measurement date, and having the recommended quality criterion:

  * minimal length of biopsy samples of 15 mm, stored in paraffin
  * Minimal number of portal tracts of 6 per biopsy samples
* Patients of Chinese ethnic origin

Exclusion Criteria:

* Any patient presenting with combined etiologies of chronic liver diseases, including non-Hepatitis B viral infection（Hepatitis A, C, D, E, chronic alcoholic liver disease, hemochromatosis, autoimmune hepatitis, etc)
* History of antiviral therapy at any time
* Any patient presenting with a co-infection of HIV
* Any patient presenting with combined liver malignant tumor
* Previous liver transplantation
* Pregnant women
* Any patient with combined hepatic congestive condition such as Budd Chiari Syndrome, congestive heart failure, chronic constrictive pericarditis...
* Any patient combined with intrahepatic cholestasis
Study of Gemcitabine, Irinotecan and Panitumumab in Patients With Advanced and Metastatic Biliary Tract Adenocarcinoma

This study evaluates the combination chemotherapy with gemcitabine, irinotecan and panitumumab in patients with advanced biliary cancer.


Eligibility Criteria:
Inclusion Criteria:

* histologically or cytologically confirmed local advanced unresectable/metastatic adenocarcinoma of biliary tract
* measurable disease
* available tumor tissue for investigational immunohistochemical evaluations
* ECOG PS 0-2
* No prior chemotherapy, biologic therapy or radiation therapy
* Age Eighteen and older
* Lab values per protocol

Exclusion Criteria:

* Life expectancy less than three months
* Concurrent use of chemotherapy not indicated in the study protocol or any other investigational agents and patients who have received investigational drugs less than four weeks prior to enrollment
* Prior therapy, which affects or targets the EGF pathway
* Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer
* Recovery from major surgery within three weeks of the start of study treatment
Cryosurgery in Treating Patients With Liver Cancer or Liver Metastases

RATIONALE: Cryosurgery kills cancer cells by freezing them during surgery.

PURPOSE: Phase I/II trial to study the effectiveness of cryosurgery in treating patients with unresectable primary liver cancer or liver metastases.

OBJECTIVES: I. Assess the safety and efficacy of liquid nitrogen necrosis of liver lesions using a commercially available intraoperative cryosurgical system, with placement of the cryoprobe and subsequent monitoring by high-resolution ultrasound. II. Use this technique on selected patients with surgically unresectable metastatic or primary liver cancer whose disease appears confined to the liver and who are potentially curable if all tumor in the liver can be destroyed. III. Quantitate the quality and duration of survival, identify recurrence of hepatic malignant disease, and identify any morbidity from the procedure.

OUTLINE: Cryosurgery. Liquid nitrogen freezing of tumor using a cryoprobe placed and maintained under ultrasound guidance.

PROJECTED ACCRUAL: 50 patients will be treated.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Biopsy-proven metastatic or primary malignant disease of the liver No extrahepatic regional or distant metastases No primary tumors commonly associated with local spread or metastases to other sites, e.g.: Gastric cancer Pancreatic cancer Breast cancer Lung cancer Liver lesions considered unresectable because of location in relation to major vascular structures or involvement of multiple hepatic segments Tumor extent and location such that cryosurgery expected to destroy all tumor and render patient disease-free Tumor volume no greater than 50% of total hepatic volume on CT No more than 12 lesions

PATIENT CHARACTERISTICS: Age: Over 21 Other: Overall health permitting safe laparotomy Blood/body fluid analyses and imaging/exams for tumor measurement within 1 month prior to registration

PRIOR CONCURRENT THERAPY: Prior liver resection, radiotherapy, or chemotherapy allowed
Danicopan Early Access Program

This is an EAP, designed to provide early access to danicopan for participants with PNH experiencing clinically significant EVH who have failed, not tolerated, or are unable to receive other approved treatments; in the Treating Physician's opinion, the participant is not eligible for or is not able to participate in an ongoing clinical trial of danicopan or a comparable treatment; and according to the Treating Physician, the benefit of danicopan treatment outweighs the potential risks.


Eligibility Criteria:
Key Inclusion Criteria

* Male or female, aged 18 years and older
* Diagnosed with PNH with clinically significant EVH as defined by anemia (Hgb ≤ 9.5 g/dL) with absolute reticulocyte count ≥ 120 × 109/L.
* Currently receiving treatment with SOLIRIS® or ULTOMIRIS® for at least 6 months prior to initiation of danicopan treatment.
* Platelet count ≥ 30,000/µL without the need for platelet transfusions.
* Absolute neutrophil counts ≥ 500/µL.
* Vaccinated against N meningitidis.

Key Exclusion Criteria

* Participants who are nursing or pregnant (or women who are planning to become pregnant during treatment with danicopan).
* Laboratory abnormalities at screening, as follows:
* Alanine aminotransferase (ALT) \> 2 × upper limit of normal (ULN)
* Direct bilirubin \> 2 × ULN, with the exception of:

  * participants with increased bilirubin due to EVH in the opinion of the Treating Physician or
  * participants with documented Gilbert's syndrome
* Active bacterial or viral infection, a body temperature \> 38°C on 2 consecutive daily measures, evidence of other infection, or history of any febrile illness within 14 days prior to initiating danicopan treatment.
Pharmacokinetic and Efficacy Study of Fluocinolone Acetonide Inserts in Patients With Diabetic Macular Edema

This study will evaluate the pharmacokinetics, safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years with diabetic macular edema
* Diagnosis of diabetes mellitus types 1 or 2
* Best corrected visual acuity of ≥ 19 letters
* Retinal thickness \> 250 microns by OCT
* Investigator is comfortable deferring macular laser treatment for 6 weeks

Exclusion Criteria:

* Glaucoma, ocular hypertension, IOP \>21 mmHg or concurrent therapy at screening with IOP lowering agents
* Retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy
* Prior intravitreal, subtenon, or periocular steroid therapy within the last 3 months
* Prior intravitreal or subtenon anti-VEGF therapy within the last 2 months
* Any ocular surgery within the last 3 months
* Retinal laser treatment within the last 3 months
* History of uncontrolled IOP elevation with steroid use that did not respond to topical therapy
* Any lens opacity which impairs visualization of the posterior pole
Procalcitonin-guided Treatment on Duration of Antibiotic Therapy and Cost in Septic Patients

This clinical trial is aimed to show a procalcitonin-guided treatment algorithm may shorten duration of antibiotic therapy safely and cost-effectively in sepsis patients of Korean ICU.


Eligibility Criteria:
Inclusion Criteria:

* All patients with suspicious or confirmed sepsis at admission or during stay in ICU
* Patients with antibiotic duration of less than 48 hours before enrollment

Exclusion Criteria:

* Age less than or equal to 18 years
* Known pregnancy
* Specific infections for which long-term antibiotic treatment for 3 weeks more is strongly recommended: infective endocarditis, empyema, osteomyelitis et al.
* severe immunocompromised patients : HIV infected patients (CD4 count \< 200 cells/mm3), Neutropenia (ANC count \< 500/mm3)
* Presence of do-not-resuscitate order
A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations

The purpose of this study is to characterize the safety and tolerability of ALTA3263 in adults with advanced solid tumors with KRAS mutations.

This is an open-label, multicenter, Phase 1/1b study of ALTA3263, an orally bioavailable KRAS isoform-selective inhibitor that inhibits multiple mutant forms of KRAS, in adults with advanced solid tumor malignancies with KRAS mutations. This study will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity of ALTA3263, and aims to find the best dose. The study consists of two parts: Part 1 - Dose Escalation and Part 1b - Dose Expansion.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of a solid tumor malignancy harboring a KRAS mutation identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic test.
* Unresectable or metastatic disease.
* Progressed on, intolerant to, or declined prior standard-of-care therapy (including targeted therapy, if applicable) appropriate to tumor type and stage
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate organ function

Exclusion Criteria:

* Prior treatment with a KRAS inhibitor, certain exceptions are described in the full study protocol
* Known condition that prohibits the ability to swallow or absorb an oral medication.

Other inclusion/exclusion criteria may apply.
A Study to Assess the Effect of Ceftobiprole on the PK of Pitavastatin and on Plasma Levels of Coproporphyrin

The goal of this clinical study is to determine the effect of the test drug ceftobiprole (a drug approved for the treatment of bacterial infections) on the elimination of pitavastatin (a drug approved for the treatment of increased levels of cholesterol in blood) from the body. This interaction will be investigated by pharmacokinetic (PK) assessments.

The PK of pitavastatin will be assessed when administered alone and when administered together with ceftobiprole in a study design including two treatment periods.

The clinical study will also investigate the safety of ceftobiprole and how well ceftobiprole is tolerated by healthy subjects when it is administered in combination with pitavastatin. In addition, the effect of ceftobiprole on a specific marker, called coproporphyrin I, will be assessed in the blood.

The duration of the study will be a maximum of 38 days.


Eligibility Criteria:
Main Inclusion Criteria:

* Body mass index: 18.0 to 30.0 kg/m2, inclusive
* Good physical and mental health
* Normal renal function (creatinine clearance ≥ 90 mL/min as determined by the Cockcroft-Gault equation)
* Female participants of childbearing potential must not be pregnant or lactating and must must agree to use adequate contraception
* Male subjects, if not surgically sterilized, must agree to use adequate contraception
* All prescribed medication must have been stopped at least 30 days prior to admission to the clinical research center (an exception is made for hormonal contraceptives)
* All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (e.g., St. John's wort) must have been stopped at least 14 days prior to admission to the clinical research center
* Ability and willingness to abstain from alcohol from 48 hours (2 days) prior to Screening and admission to the clinical research center
* Ability and willingness to abstain from methylxanthine-containing beverages or food from 48 hours (2 days) prior to admission to the clinical research center

Main Exclusion Criteria:

* History of relevant drug and/or food allergies, particularly to antibiotics.
* Subject received a known potent inhibitor of OATP1B activity within 30 days prior to admission
* Subject received a potential inducer of OATP1B activity within 30 days prior to admission
* Subject has a history of seizures
* Subject has a history of frequent diarrhea
* Smoking more than 5 cigarettes, 1 cigar, or 1 pipe daily; the use of tobacco products in the 48 hours (2 days) prior to admission
* History of alcohol abuse or drug addiction within 12 months prior to Screening.
* Average intake of more than 24 units of alcohol per week
* Positive drug and/or alcohol screen
* Donation or loss of more than 450 mL of blood within 60 days prior to the first pitavastatin administration on Day 1 of the current study. Donation or loss of more than 1.5 liters of blood (for male subjects)/more than 1.0 liters of blood (for female subjects) in the 10 months prior to the first pitavastatin administration on Day 1 of the current study.
Comparison of 5-ALA Photodynamic Therapy and CO2 Laser for Treating Persistent Low-Grade Cervical Lesions With High-Risk HPV Infection

Non-RCT clinical trial comparing 5-ALA photodynamic therapy and CO2 laser for persistent high-risk HPV-related low-grade cervical lesions.

This non-randomized controlled trial aims to compare the effectiveness of two treatments, 5-aminolevulinic acid (5-ALA) photodynamic therapy and CO2 laser, for women with persistent low-grade cervical lesions associated with high-risk HPV infection lasting more than one year. The study's primary objective is to assess which treatment option yields better results. Participants in both groups will undergo specific therapeutic procedures, including 5-ALA photodynamic therapy or CO2 laser treatment. The study will analyze and compare the effects of these therapies on the regression or elimination of cervical lesions, offering valuable insights into the management of persistent low-grade cervical lesions among high-risk HPV-infected women.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-65 years old with a history of sexual activity.
2. Subclinical infected individuals who have been confirmed as HR-HPV positive (if there is the same positive type in the typing test) for more than 1 year using HPV typing test, HPV E6/E7 mRNA test, HPV DNA test, and cervical triple step diagnostic procedure (cytology colposcopy histopathology).
3. Patients diagnosed with LSIL by pathological examination of cervical biopsy under colposcopy with an interval of more than 1 year.
4. No fundamental diseases of important organs.
5. Agree to receive treatment and/or follow-up according to regulations and sign an informed consent form.
6. There has been no history of using other drugs related to HPV infection in the past 3 months.

Exclusion Criteria:

1. HR-HPV persistent infection.
2. A total hysterectomy has been performed.
3. Concomitant endometrial cancer, ovarian cancer, and other reproductive tract tumors.
4. Complicated with abnormal heart, liver, and kidney functions, immune dysfunction, or immune system diseases such as systemic lupus erythematosus (SLE).
5. Using drugs such as immunosuppressants, antiviral agents, and glucocorticoids.
6. Pregnant and lactating women.
7. Acute reproductive tract inflammation.
8. Diabetes patients with uncontrolled blood sugar.
9. Patients who do not receive full treatment and follow-up.
10. Those who fail to sign the informed consent form.
Hepatic Vein Flow During Orthotopic Liver Transplantation as Predictive Factor for Postoperative Graft Function

Hepatic vein flow (HVF) assessment using transesophageal echocardiography (TEE) has a potential to predict postoperative graft function in orthotopic liver transplant (OLT). Investigators will measure HVF using TEE and assess the correlation with postoperative graft function indices such as early allograft dysfunction(EAD), prolonged INR, platelet, and total bilirubin.

During OLT, intraoperative TEE assessment of HVF (systolic and diastolic) were measured, and adjusted with donor graft weight. This index, HVF index, was assessed for correlation with EAD. HVF was calculated with hepatic vein area (cm2) x hepatic vein velocity (ml/s) in systole and diastole during the neohepatic phase. Investigators did ROC analysis to assess the predictive power for EAD, prolonged INR, platelet, and total bilirubin.

Eligibility Criteria:
Inclusion Criteria:

Orthotopic liver transplants which uses TEE intraoperatively Must be Piggy back technique

-

Exclusion Criteria:

TEE absolute contraindication patient refusal
Small and Steatotic Hepatocellular Carcinoma

Percutaneous thermoablation in an effective local curative treatment in patients with cirrhosis and HCC smaller than 3 cm in diameter (BCLC 0-A).

Around 30% of HCC patients referred for percutaneous ablation were regarded as non-feasible because of a difficult-at risk location or undetectable nodules.

We used percutaneous thermoablation to treat HCC on high risk locations (subcapsular or liver dome) with or without lipiodol marked (for undetectable HCC).

No clinical study has been published so far to compare percutaneous thermoablation of HCC on liver dome CT guided with artificial pneumothorax and lipiodol marked, and percutaneous thermoablation of HCC guided by ultrasonography (non subcapsular, distent form diaphragm).

This retrospective study evaluate the overall survival, the local tumor progression or distant liver progression after percutaneous ablation for HCC and determine prognostic factors.

We performed 412 percutaneous thermoablations on 238 patients for HCC between January 2015 and November 2019.

All thermoablation procedures were performed percutaneously under ultrasound or CT guidance, with ou without artificial pneumothorax or ascites, with ou without lipiodol marked.

Purposes:

* Tumor response upon mRECIST criteria
* Progression-free survival
* Overall survival
* Local tumor progression
* Distent liver progression
* Prognostic factors

Eligibility Criteria:
Inclusion criteria:

* HCC according to histological examination or Barcelona criteria
* BCLC0 or A
* Measurable targets according to mRECIST v1.1
* Child A or B7 cirrhosis
* HCC \< 4 cm, \< 3 nodules, Age ≥ 18 years
* No extrahepatic metastasis, no vascular invasion
* Performance status 0 or 1
* Thrombocytes ≥ 50 000/mm3, TP \> 50%

Exclusion criteria:

* Follow-up \< 1month
* Lobar/main portal venous thrombus
* Abundant ascites
* Antecedent of bilio-digestive anastomosis or endoscopic sphincterotomy
* Combined treatment with embolization or chemo-embolization