cyrilzakka/clinical-trials huggingface dataset:
A Pharmacologic Study of CYC065, a Cyclin Dependent Kinase Inhibitor, in Patients With Advanced Cancers

This is an open-label, single arm, dose escalation study in patients with advanced cancers.

This is an open-label, single arm, dose escalation study in patients with advanced cancers. Treatment will be administered on an outpatient basis.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed solid tumors or lymphomas that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
* 18 years or older
* ECOG performance status 0-1
* Life expectancy ≥ 3 months
* Evaluable disease
* Adequate organ functions
* 4 weeks from prior chemotherapy ( 6 weeks for mitomycin C and nitrosourea) , immunotherapy, investigational anti-cancer therapy, radiation therapy; and have recovered from prior toxicities
* At least 4 weeks from major surgery
* Agree to practice effective contraception
* Agree to follow protocol required evaluations
* Ability to understand and willingness to sign the informed consent form

Exclusion Criteria:

* Previously untreated CNS metastasis or progressive CNS metastasis
* Currently receiving radiotherapy, biological therapy, or any other investigational agents
* Uncontrolled intercurrent illness
* Pregnant or lactating women
* Known to be HIV-positive
* Known active hepatitis B and/or hepatitis C infection
Use of Omega-3 Fatty Acids (Fish Oil) in Patients With Chronic Hepatitis C Infection

Hepatitis C virus infection is the most common blood-borne infection in the United States and is a leading cause of chronic liver disease affecting 130 million people around the world. It is estimated that 1.6% of the US population may be affected by Hepatitis C infection. The only recommended treatment that has been approved for your condition is the use of interferon and ribavirin. In patients with chronic Hepatitis C, there tends to be an accumulation of fat in the liver. Fatty liver has been associated with failure of treatment.

The accumulation of fat in the liver has been blamed on a particular type of fat called triglycerides. Fish oil, by reducing a type of fat called VLDL, can lower the triglyceride concentration by as much as 50 percent or more. This study seeks to determine if the administration of fish oil along with standard treatment to patients with Hepatitis C will increase the treatment response rates.

Hepatic steatosis may be present in up to 66% of cases of chronic Hepatitis C infection. Previous studies have reported steatosis to be an independent predictor of treatment failure in patients with chronic hepatitis C infection.

The pathogenesis of hepatic steatosis in chronic Hepatitis C infection has not been fully elucidated. Hepatic steatosis is a manifestation of excessive triglyceride accumulation in the liver. Hypertriglyceridemia may benefit from Omega-3 fatty acid (fish oil supplements) which, by reducing VLDL production can lower the serum triglyceride concentration by as much as 50 percent or more.

The treatment of chronic hepatitis C results in an average sustained viral response rate of 54%-63%. We have found response rates of around 50% on treatment of patients. We hypothesize that by giving omega-3 fatty acids along with interferon therapy for patients with Hepatitis C, we may be able to increase the treatment response rates. Thus, the purpose of the study is to look at the effect of omega 3 fatty acids on early and sustained viral response rates in patients with chronic HCV infection.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients \> 18 years of age
* Patients with chronic hepatitis C infection
* Patients receiving interferon for treatment of hepatitis C

Exclusion Criteria:

* pregnant or lactating patients
* End stage target organ damage in diabetes mellitus: advanced renal failure (serum creatinine \>2.0 mg/dl) with or without dialysis, severe neuropathy, advanced peripheral vascular disease.
* Anticipated life expectancy less than 2 years
* Co-existent etiologies for liver disease
* Alcohol consumption more than 30 g per day in men and more than 20 g per day in women.
* Patients on Omega-3 fatty acid supplementation or those patients who report eating oily fish such as salmon, albacore tuna, sardines, etc. twice a week or more frequently.
CERAMENT™| Bone Void Filler Device Registry

A device registry to compile data on the performance of CERAMENT BONE VOID FILLER in normal use.

A device registry to compile data on the performance of CERAMENT BONE VOID FILLER in normal use.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and over (on the day of surgery)
* Receive CERAMENT BVF as a component of their treatment at a participating, contracted center or healthcare provider, in accordance with the IFU for the implanted product
* In receipt of patient information leaflet and have signed appropriately designed informed consent

Exclusion Criteria:

* Any exclusion criteria as per IFU for CERAMENT BVF
* Any off-label use
Safety of a Herpes Simplex Candidate Vaccine (gD2t) With MPL and Its Efficacy to Prevent Genital Herpes Disease

The purpose of the study is to evaluate the safety of Herpes Simplex candidate vaccine (gD2t) with adjuvant and its efficacy to prevent genital herpes disease in HSV positive or negative consorts of subjects with genital herpes disease.

This study was monitored by a Data Safety Monitoring Board At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 45 years of age at the time of first vaccination
* Written informed consent
* Females of childbearing potential must have a negative pregnancy test at enrollment and be using an accepted method of birth control
* The volunteers must have a regular sexual partner with genital herpes disease confirmed by medical history

Exclusion Criteria:

* Any previous history of or current clinical signs or symptoms of genital herpes disease.
* Any previous vaccination against herpes simplex.
* Any previous administration of MPL.
* History of herpetic keratitis.
* History of erythema multiforme.
* Female subjects who are pregnant, lactating or planning a pregnancy before one month after the last vaccine dose.
* Patient is immuno-compromised or is receiving immuno-modifying therapy of any kind. Topical corticoid therapy is allowed.
* HIV positive at the time of enrollment
* Clinical signs of acute or febrile illness at the time of entry into the study.
* Any continuous suppressive antiviral oral therapy within the 6 months prior to entry.
* Any administration of immunoglobulins during the vaccination course or within one month prior to the first vaccination.
* Any vaccine administration less than one week before or after a study vaccination.
* Previous known hypersensitivity to vaccination or to any component of the vaccine.
* Simultaneous participation in any other clinical trial of an investigational compound.
* Recent history of alcoholism or drug abuse
* Recent clinical history or evidence of significant hepatic disease
* Recent clinical history or evidence of renal dysfunction
* Life-threatening or serious cardiac (NYHA grades III-IV), gastrointestinal, haematological or immunological disorder which, in the opinion of the investigator, would preclude entry into the study.
* Inability or unwillingness to comply with the protocol or not expected to complete the study period
Effect of Modified Air-pulse Stimulation on Tracheotomised Patients With Dysphagia After Stroke

To evaluate the efficacy of flexible endoscopy-mediated modified air-pulse stimulation in restoring of swallowing function in this group of patients.Forty-two subacute stroke patients with tracheotomy and dysphagia need to be recruited and divided into a control group of 21 cases and a trial group of 21 cases. On the basis of receiving personalized swallowing rehabilitation training, the control group received traditional air-pulse stimulation therapy, while the trial group received modified air-pulse stimulation therapy mediated by flexible endoscopy. Murray secretion scale (MSS), penetration-aspiration scale (PAS) and spontaneous swallowing frequency were used to assess dysphagia. Moreover, clinical pulmonary infection score (CPIS) was used for evaluating the degree of pneumonia, hemoglobin(Hb) and serum prealbumin (PAB) were used to assess the nutritional status of patients.


Eligibility Criteria:
Inclusion Criteria:

* patients who met the diagnostic criteria for stroke formulated in the 4th National Academic Conference on Cerebrovascular disease;
* patients with relatively stable vital signs, with a NIHSS score of 21 points;
* patients with tracheotomy accompanied by dysphagia;
* no previous history of dysphagia;
* age ≥ 30 years and ≤80 years;
* informed consent signed by the patient and his family.

Exclusion Criteria:

* patients with medullary haemorrhage/infarction;
* patients that experienced cerebral hernia and recurrent stroke;
* patients with unstable arrhythmia, fever, infection, severe restlessness and inability to cooperate with treatment;
* patients with gastro-oesophageal reflux, bilateral paralysis of the vocal cord, laryngopharyngeal stenosis/haemorrhage/tumour;
* patients in which there was an inability to accurately locate epiglottis and arytenoid cartilage due to throat disease;
* patients with a history of epilepsy or risk of seizures.
Prophylaxis With Caspofungin in High-Risk Liver Transplantation

This is a non-comparative, open, multisite prospective estimation study to evaluate the efficacy and safety of caspofungin in the prophylactic treatment of adults who have received an orthotopic liver transplant and are at high risk of developing an invasive fungal infection. It is expected that the proportion of high-risk liver transplant recipients who develop a documented (proven or probable per European Organization for Research and Treatment of Cancer/Mycoses Study Group \[EORTC/MSG\] modified criteria) invasive fungal infection during the first 100 days after the onset of prophylaxis with caspofungin will be lower than 15%. It is also expected that the incidence of serious drug-related adverse events will be less than 25%.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Patient has received an orthotopic liver transplantation
* Patient meets criteria, as defined per protocol, for being considered at high risk of developing an invasive fungal infection post-liver transplantation
* For women of childbearing potential, patient must have a negative serum or urine pregnancy test

Exclusion Criteria:

* Any systemic antifungal therapy (other than fluconazole for a maximum of 7 days) within 14 days of the administration of the study drug.
* Documented (proven/probable) or suspected (possible) invasive fungal infection at the time of enrollment.
* Abnormal laboratory values as defined per protocol.
* Allergy, hypersensitivity, or any serious reaction to an echinocandin antifungal.
* Patient not expected to survive at least 5 days.
* Patient is pregnant or breast feeding.
A Uremic Toxin Absorbent (AST-120) to Treat Hospital Acquired Acute Kidney Injury

Hospital acquired acute kidney injury is an important negative outcome predictor for hospitalized patients. Uremic toxins accumulated after a given renal insult. Some of these uremic toxins are protein bound and may accumulated after renal impairment, owing to both impaired filtration, and inflammation. Recent animal studies have reported that accumulation of uremic toxins, namely indoxyl sulfate and p-cresol, would down regulate endothelial progenitor cells and in turn affect renal recovery. Elimination of these protein bound uremic toxins with an activated charcoal would help restore endothelial function. We will conduct a double blinded randomized placebo controlled trial, which aims to determine that if oral activated charcoal will retard progression of AKI. Also, a panel of markers for endothelial function will also be determined.


Eligibility Criteria:
This is a prospective randomized placebo controlled trial. All patients admitted to participating centers with newly diagnosed acute kidney injury (AKI) will be screened for eligibility. The diagnosis of AKI will be determined and staged according to the KIGO-AKI Guideline.11 The inclusion criteria include:

1. Age ≥ 20 years old on the day of admission
2. AKI develops during admission, as defined with KDIGO-AKI Guideline,11 namely, elevation of serum creatinine above 0.3mg/dL within two days, above 1.5times baseline.

Patients with the following conditions will be excluded:

1. Baseline estimated glomerular filtration rates (eGFR) less than 30ml/min/1.73m2 or greater than 90ml/min/1.73m2 according to MDRD equation.
2. Acute kidney injury diagnosed in the indexed admission (according to baseline creatinine)
3. Ileus or under fasting status
4. Previous gastrointestinal operation.
5. Chronic constipation, as defined with bowel movement less than three times a day. If usage of oral laxatives can achieve bowel movement of more than 3 times a day, this patient will not be excluded.
6. Patients had ever undergone any modality of renal replacement therapy (RRT)
7. Patients with major hemorrhage, as defined with requirement of blood transfusion during index admission.
8. Patients with a biopsy proved or clinically diagnosed liver cirrhosis, Child classification B or C.
9. Patients with a congestive heart failure of NYHA Class III or IV, or requirement of inotropic agents.
10. Patients with a chronic lung disease requiring non-invasive or invasive positive pressure ventilation.
11. Solid organ or hematological transplantation donors.
12. Patients who had been diagnosed as AKI in the index hospitalization, as defined with KDIGO 2012 criteria.
13. Patients with oliguric acute kidney injury, as defined with less than 500cc/day.
14. Evidence of obstructive acute kidney injury under kidney echosonography.
Evaluation of 18F-DCFPyL PSMA- Versus 18F-NaF-PET Imaging for Detection of Metastatic Prostate Cancer.

The objective of this study is to evaluate a radiolabeled urea-based small molecule inhibitor of prostate-specific membrane antigen (PSMA), \[18F\]DCFPyL (DCFPyL) PET/CT (or PET/MRI imaging if available) for detection of metastatic prostate cancer. PSMA is a well characterized histological marker of prostate cancer tumor aggressiveness and metastatic potential. Preliminary first-in-human studies demonstrate high specific uptake of a first generation less avid compound, DCFBC, in metastatic prostate cancer and demonstrated feasibility for prostate cancer metastatic detection. Investigators propose to assess the ability of DCFPyL PET to detect metastatic prostate cancer by visual qualitative and quantitative SUV analysis. Correlation will be made to sites of suspected metastatic disease detected by ultra sensitive but less specific \[18F\]Sodium Fluoride (NaF)-PET/CT imaging for prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Histological confirmation of prostate cancer
2. Radiologic evidence of new or progressive metastatic disease demonstrated on anatomical imaging (CT, MRI, or ultrasound), bone scintigraphy, \[18F\]Sodium Fluoride PET, and/or \[18F\]FDG PET
3. Rising PSA on two observations taken at least 1 week apart
4. Adequate peripheral venous access or available central venous catheter access for radiopharmaceutical administration
5. Patient can remain on androgen deprivation therapy if on the same regimen prior to documentation of progressive metastatic disease
6. Patient cannot start a new therapy for prostate cancer prior to study radiopharmaceutical imaging
7. Patient is judged by the Investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits
8. Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures

Exclusion Criteria:

1. Patient has been treated with an investigational drug, investigational biologic, or investigational therapeutic device within 14 days prior to study radiotracer administration
2. Prior radiation therapy, chemotherapy, or androgen-deprivation therapy within 2 weeks prior to study radiotracer administration (Washout is one half-life of the drug or 2 weeks, whichever is longest)
3. Initiation of new therapy for progressive metastatic disease since radiographic documentation of progression.
4. Serum creatinine \> 3 times the upper limit of normal
5. Total bilirubin \> 3 times the upper limit of normal
6. Liver Transaminases \> 5times the upper limit of normal
7. Unable to lie flat during or tolerate PET/CT (or PET/MRI imaging if available)
8. Prior history of any other malignancy within last 2 years, other than skin basal cell carcinoma or superficial bladder cancer.
Comparison of Air and Expansile Gas in Pneumatic Retinopexy

The objective of the study is to evaluate the results of using air versus expansile gas (perfluoropropane) in the treatment of rhegmatogenous retinal detachment by pneumatic retinopexy, comparing the retinal reattachment rate and post-operative visual recovery.

To the best of the investigators' knowledge there have been no clinical trials to compare air and expansile gas in pneumatic retinopexy. The investigators hypothesize that both air and expansile gas have the same properties of gas and remain in the eye for 5-6 days which is long enough to have moderate chorioretinal adhesion to seal the retinal break. If the investigators can prove that air is equivalent to expansile gas in this procedure, it can save a lot of money for the country. Therefore, the investigators are conducting a randomised controlled double-blind study to compare the results of using air and perfluoropropane in pneumatic retinopexy for treatment of rhegmatogenous retinal detachment.

Eligibility Criteria:
Inclusion Criteria:

* Superior retinal break from 8 o'clock to 4 o'clock
* Single retinal break not greater than 2.5 clock hours in size
* Multiple breaks not greater than 3 clock hours away
* No (or minimal) proliferative vitreoretinopathy
* Physically and mentally co-operated in post-operative head positioning
* Signed informed consent form for the study

Exclusion Criteria:

* Ocular media opacities
* Advanced glaucoma
* Aphakia or pseudophakia
* Previous ocular surgeries
* One-eyed patients
* Subject did not sign informed consent form
Clinical Study and Gene Mutation Analysis of Adrenoleukodystrophy in Taiwanese Children

Study the clinical manifestations and gene mutation of Taiwanese ALD patients


Eligibility Criteria:
Inclusion Criteria:

* X-ALD patients and family

Exclusion Criteria:

-
QL Block in Laparoscopic Myomectomy

This study aims to determine the efficacy of a quadratus lumborum (QL) block in decreasing postoperative pain in patients undergoing myomectomy for uterine fibroids. A QL block is a temporary anesthetic injection in the quadratus lumborum muscle, a muscle in the lower back, that has been previously shown to significantly reduce postoperative pain levels in patients undergoing abdominal and pelvic surgery. Because of its demonstrated effects, the QL block is becoming a standard of anesthesia and surgical care. Since participants will be undergoing a myomectomy procedure, the investigators believe that participants may qualify to participate in this study. The investigators will be comparing patients who receive the QL block (in addition to standard anesthesia and postoperative pain care) with patients who do not receive the QL block (in addition to standard care). The participants will be randomly assigned to one of the two groups and may or may not actually receive the block.


Eligibility Criteria:
Inclusion Criteria:

* Presence of uterine fibroids requiring surgical excision with preservation of the uterus
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Provision of signed and dated informed consent form

Exclusion Criteria:

* Pre-existing diagnoses of anxiety or depression
* Pre-existing coagulopathies
* Pre-existing neuropathic or chronic pelvic pain
* Chronic opioid use
* Illiteracy due to inability to read and understand plain questionnaire
* Non-English speaking
* BMI \>38
A Study of Parsaclisib, a PI3Kδ Inhibitor, in Combination With Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma

This is a Phase 3, double-blind, randomized, placebo-controlled, multicenter study of parsaclisib plus BR versus placebo plus BR as first-line treatment of participants with newly diagnosed MCL.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants aged 18 years or older. (Japan aged 20 years or older.)
* Have received no previous systemic anti-lymphoma therapies.
* Pathologically confirmed MCL by local laboratory.
* Histologically confirmed CD20 expression (by flow cytometry or immunohistochemistry) of the MCL cells as assessed by pathology.
* Ineligible for high-dose chemotherapy and autologous stem cell transplantation.
* Radiographically (CT, MRI) measurable lymphadenopathy per the Lugano criteria for response assessment (Cheson et al 2014).
* ECOG PS of 0 to 2.
* Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

* Presence of any lymphoma other than MCL.
* Presence of CNS lymphoma (either primary or secondary) or leptomeningeal disease.
* Requires treatment with potent inducers and inhibitors of CYP3A4
* Inadequate organ functions including hematopoiesis, liver, and kidney significant concurrent, uncontrolled medical condition, including, but not limited to, renal, hepatic, hematological, GI, endocrine, pulmonary, neurological, cerebral, or psychiatric disease.
* History of other malignancy within 2 years of study entry.
* Known HIV infection, HBV or HCV.
* HBV or HCV infection: Participants positive for HBsAg or anti-HBc will be eligible if they are negative for HBV-DNA; these participants must receive prophylactic antiviral therapy. Participant's positive for HCV antibody will be eligible if they are negative for HCV-RNA.
* Clinically significant cardiac disease, congestive heart failure, including unstable angina, acute myocardial infarction, or cardiac conduction issues, within 6 months of randomization.
* Abnormal ECG findings that are clinically meaningful per investigator's assessment.
* Women who are pregnant or breastfeeding
* Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study treatment and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.