cyrilzakka/clinical-trials huggingface dataset:
TC or BEP in Treating Patients With Ovarian Malignant Sex Cord-Stromal Tumors

Investigators will conduct the trial to determine whether paclitaxel and cisplatin (PT) has the same curative effects and less adverse effects than bleomycin, etoposide and cisplatin(BEP) among newly diagnosed ovarian malignant sex cord-stromal tumor patients after surgery.

PRIMARY OBJECTIVES:

To assess the activity of paclitaxel and carboplatin with respect to progression free survival (using bleomycin, etoposide, and cisplatin \[BEP\] as a reference) for newly diagnosed ovarian malignant sex cord-stromal tumors.

SECONDARY OBJECTIVES:

1. To estimate the toxicity of paclitaxel and carboplatin, and bleomycin, etoposide, and cisplatin in this patient population.
2. To estimate overall survival for paclitaxel and carboplatin relative to that of BEP.
3. To evaluate response rate in the subset of patients with measurable disease.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

ARM 1: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.

ARM 2: Patients receive bleomycin IM daily for days 1-3, etoposide IV daily for days 1-5, cisplatin IV for days 1-5. Treatment repeats every 21 days for 3 or 4\* courses in the absence of disease progression or unacceptable toxicity.

NOTE: \*Patients who have good risk will have 3 courses and those who have poor risks will have 4 courses.

Patients undergo blood sample collection at baseline and periodically during study for laboratory biomarker analysis.

After completion of study therapy, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Age≤65 years; female, Chinese women;
* Histologically confirmed ovarian stromal tumor, including the following cell types:

  * Granulosa cell tumor
  * Granulosa cell-theca cell tumor
  * Sertoli-Leydig cell tumor (androblastoma)
  * Steroid (lipid) cell tumor
  * Gynandroblastoma
  * Unclassified sex cord-stromal tumor
  * Sex cord tumor with annular tubules
* Newly diagnosed, stage IIA-IVB disease;

  * Has undergone initial surgery (for diagnosis, staging, or cytoreduction) within the past 8 weeks.
  * May or may not have measurable residual disease.
* Laboratory tests: WBC≥4×10(9)/L, NEU≥2×10(9)/L, PLT≥80×10(9)/L, serum bilirubin≤ 1.5 times the upper limit of normal, transaminase≤ 1.5 times the upper limit of normal, BUN, Cr≤ normal
* Performance status: Karnofsky score≥60;
* Provide written informed consent.

Exclusion Criteria:

* With severe or uncontrolled internal disease, unable to receive surgery and/or unsuitable for chemotherapy;
* History of organ transplantation, immune diseases;
* History of serious mental illness, a history of brain dysfunction;
* Drug abuse or a history of drug abuse;
* Suffering from other malignancies;
* Concurrently participating in other clinical trials
* Unable or unwilling to sign informed consents;
* Unable or unwilling to abide by protocol.
A Phase I Study of SU101 in Pediatric Patients With Refractory Malignancy

A dose escalation scale consisting of 5 dosage levels is being used to determine the maximum tolerated dose (MTD) of SU101. A minimum of 3 and a maximum of 6 patients will be enrolled at each dose level. MTD is defined as the dose level immediately below that at which 2 or more patients exhibit dose limiting toxicity.

Each treatment cycle is 21 days. Patients receive a 96 hour continuous IV infusion of SU101 on days 1-4.

SU101 is a member of a novel class of antineoplastic agents, platelet-derived growth factor (PDGF) receptor inhibitors. Preclinical data suggests that SU101 might be an effective agent against neuroglial tumors as well as a variety of sarcomas. A pediatric phase I trial of SU101 in children with these malignancies will be conducted to find the maximum tolerated dose of SU101 and define the toxicity profile of this agent. In addition, we will define the pharmacokinetics of SU101 and its active metabolite SU0020 in pediatric patients and gather preliminary information regarding response.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

Histologically proven primary CNS malignancy, neuroblastoma or sarcoma that is refractory to standard therapy or for which no standard therapy exists and disease can not be cured by surgery.

PRIOR/CONCURRENT THERAPY:

Recovered from toxic affects of all prior therapy.

No investigational agent within past 2 weeks.

BIOLOGY THERAPY: Not specified.

CHEMOTHERAPY:

No myelosuppressive therapy within past 3 weeks.

No nitrosourea within past 6 weeks.

ENDOCRINE THERAPY: If receiving dexamethasone dose must be stable for at least 2 weeks.

RADIOTHERAPY: Not specified.

SURGERY: Not specified.

PATIENT CHARACTERISTICS:

Age: 3 to 21.

Performance status: ECOG 0-2.

Life expectancy: At least 8 weeks.

HEMATOPOIETIC:

AGC greater than 1500/mm(3).

Hemoglobin greater than or equal to 8.0 g/dL percent.

Platelet count greater than 100,000/mm(3).

For patients with bone marrow involvement or history of bone marrow transplantation or craniospinal radiotherapy: AGC greater than 750/mm(3), Hemoglobin greater than 6.0 g/dL, Platelet count greater than 50,000/mm(3).

HEPATIC:

SGOT, SGPT or alkaline phosphatase less than 3 times upper limit of normal.

Bilirubin no less than or equal to 1.5 times upper limit of normal.

RENAL:

Ages 3-5 Creatinine no greater than 0.8 mg/dL.

Ages 5-10 Creatinine no greater than 1.0 mg/dL.

Ages 10-15 Creatinine no greater than 1.2 mg/dL.

Ages 16-21 Creatinine no greater than 1.5 mg/dL.

OTHER:

All patients or their legal guardians (if the patient is under 18 years old) must sign a document of informed consent indicating their understanding of the investigational nature and the risks of this study.

For patients with brain tumors who are over 18 years of age, a DPA should be signed.

Not pregnant or nursing.

Not allergic to etoposide.

No acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risks associated with study participation/study drug administration or may interfere with the interpretation of study results.
Effects of Simple Sodium Alignment on Clinical Outcomes

A difference between dialysate and serum sodium concentration leads to diffusive sodium transfer across the dialyzer membrane. The consequences of diffusive sodium flux into the patient can be chronic sodium overload leading to overhydration, hypertension, cardiovascular disease, and other problems. Diffusive sodium flux out of the patient can lead to intradialytic blood pressure instability. A simple strategy for alignment of dialysate and serum sodium concentrations was implemented starting in April/May 2010 in order to minimize the problems particularly associated with chronic sodium overload.

The purpose of this database analysis is to assess the impact that this operational change has had in the short, medium and long term on key clinical and laboratory parameters in the patients, including blood pressure, body weight, interdialytic weight gain, serum electrolytes, intradialytic saline administration, missed treatments, hospitalizations, medication, inflammatory markers, etc. All subjects included in the final dataset will be matched with dialysis patients receiving treatment in other dialysis clinics of the Renal Research Institute who were not subject to the operational change. This will lead to the development of a matched cohort of equal size unexposed to dialysate to serum sodium alignment.

The analysis is planned to investigate treatment effects, and test the effects of dialysate to serum sodium alignment for interactions and associations between those laboratory and clinical parameters. The extent and magnitude of sodium alignment (the operational change) will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Subjects on hemodialysis

Exclusion Criteria:

* None
Study of Complex Intracranial Aneurysm Treatment

The investigator expects that endovascular flow-diversion is superior over revascularization by postoperative modified Rankin scale (mRS) in patients with complex intracranial aneurysms.

Open, prospective, controlled randomized superiority trial is conducted. The hypothesis is that endovascular flow-diversion is better than revascularization in treatment of complex intracranial aneurysms by postoperative modified Rankin Scale (mRS). Sample size was measured by Fisher exact test. Depending on a type of the procedure, the patients are divided into two groups: Endovascular Flow Diversion Procedure (include 55 patients) and Revascularization Procedure (include 55 patients). Randomization is performed by random number generation.The study was approved by Institutional Review Board

Eligibility Criteria:
Inclusion Criteria:

* anterior circulation complex intracranial aneurysm
* neck is more than 4 mm wide
* dome/neck ratio of aneurysm equals or less than 2:1
* age less than 75 years
* ability to give informed consent (subject or legally authorized representative)
* aneurysm is suitable for treatment to both procedures

Exclusion Criteria:

* subarachnoid hemorrhage less than 30 days ago
* contraindications to endovascular treatment
* atypical aneurysms (mycotic, flow-related in patients with AVM, traumatic, false)
* informed consent refusal
Momelotinib in Transfusion-Dependent Adults With Primary Myelofibrosis (PMF) or Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)

This study will evaluate the transfusion independence response rate in transfusion-dependent adults with myelofibrosis after treatment with momelotinib (MMB).


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of PMF or Post PV/ET-MF
* Requires myelofibrosis therapy, in the opinion of the investigator
* High risk OR intermediate-2 risk defined by dynamic international prognostic scoring system (DIPSS) OR intermediate-1 risk defined by DIPSS and associated with symptomatic splenomegaly and/or hepatomegaly
* Transfusion dependent at baseline, defined as ≥ 4 U red blood cell (RBC) transfusion in the 8 weeks prior to first dose of MMB
* Acceptable organ function as evidenced by the following:

  * Platelet Count ≥ 50 x 10\^9/L
  * Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 3 x upper limit of normal (ULN) or AST or ALT ≤ 5 x ULN if liver is involved by disease process as judged by the investigator
  * Serum creatinine ≤ 2.0 mg/dL or calculated creatinine clearance of ≥ 60 mL/min
  * Direct bilirubin ≤ 2.0 x ULN
* Life expectancy of \> 24 weeks
* Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
* Lactating females must agree to discontinue nursing before MMB administration
* Able to understand and willing to sign the informed consent form

Key Exclusion Criteria:

* Prior splenectomy
* Splenic irradiation within 3 months prior to the first dose of MMB
* Prior treatment with MMB
* Known positive status of human immunodeficiency virus (HIV)
* Chronic active or acute viral hepatitis A, B, or C infection (testing required for hepatitis B and C), or hepatitis B or C carrier
* Use of strong cytochrome P450 3A4 (CYP3A4) inducer within 2 weeks prior to the first dose of MMB
* Uncontrolled intercurrent illness per protocol
* Treatment with a Janus kinase (JAK) inhibitor within 21 days of the planned first dose of MMB
* Presence of peripheral neuropathy ≥ Common Terminology Criteria for Adverse Events (CTCAE) Grade 2
* Unwilling or unable to undergo a MRI per requirements in the study protocol
* Unwilling to consent to genomics sampling

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Treatment of Upper Trapezius Muscle Myofascial Pain Syndrome

The aim of this study is to compare the effects of superficial and deep dry needling techniques, guided by ultrasound, on pain, disability, functional impairment, and quality of life in patients diagnosed with myofascial pain syndrome of the upper trapezius muscle.

Myofascial Pain Syndrome (MAS) is a common condition encountered in the daily practice of musculoskeletal medicine. Dry needling is a commonly used technique by clinicians in the treatment of myofascial trigger points. Dry needling can be classified into two main categories based on the depth of needle insertion: superficial and deep dry needling. Dry needling can be performed using either manual palpation techniques or ultrasonographic imaging. Ultrasound allows for more precise needle placement. It must be recognized that the depth of needling (superficial insertion vs. deep insertion) varies for every structure and that without ultrasound guidance, differentiation between needling into the superficial fascia and beyond the deep fascia maybe difficult. In clinical settings, using ultrasound can help visualize the different layers and guide the needle to the appropriate depth. The aim of this study is to compare the effectiveness of deep fascia and intramuscular trigger point dry needling techniques, guided by ultrasound, on pain, disability, functional impairment, and quality of life in patients diagnosed with myofascial pain syndrome of the upper trapezius muscle.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of MPS in the upper trapezius muscle in accordance with criteria defined by Travell and Simons
2. Ages between 20 and 50 years
3. No treatment, including injections, dry needling, and physical methods, applied to the cervical region in the last three months

Exclusion Criteria:

1. Bleeding Tendency
2. History of Neck and Shoulder Trauma
3. Other Conditions Affecting Neck and Shoulder Pain: including malignancy, infection, rheumatic diseases, degenerative joint disease, fibromyalgia, cervical radiculopathy, neuropathy, myelopathy, myopathy, adhesive capsulitis, etc.
4. Cases Where Evaluation Could Not Be Completed for Any Reason
5. Patients Who Refuse to Complete the Evaluations
Electrosurgical Bipolar Plasmakinetic Vessel Sealing During Abdominal Hysterectomy: A Randomized Controlled Trial

Objective: To compare the safety and efficacy of the use of bipolar plasmakinetic vessel sealing (Gyrus Pk) usage versus standard technique when performing total abdominal hysterectomy for benign disease.

Material and Methods: controlled randomized trial involving 94 women who underwent total abdominal hysterectomy. 47 procedures were performed using bipolar plasmakinetic vessel sealing and the remaining 47 with the standard sutures technique. The primary outcomes were improvement in terms of blood loss, procedure time, length of hospital stay, and overall cost of the procedure. Statistical methodology considered significant P \<0.05.

All patients were right-holders of the Petroleos Mexicanos (Mexican oil company) medical network who required hysterectomy surgical treatment for benign causes All patients included in the study signed an informed consent form, knowing all possible implications of the procedure Patients were randomly assigned to one of the two techniques: 1. plasmakinetic bipolar energy forceps (Gyrus PK) and 2. Standard technique using sutures The surgical steps other than placement of suture are identical to those used during standard abdominal hysterectomy. Time of the procedure was considered from the moment skin was first cut-open, until it was fully closed, previously checking satisfactory homeostasis.

Blood loss was estimated by the anesthesiology service. Further data compiled included time spent in hospital and the total cost of the procedure.

Post-surgery complications were recorded at the follow up visits one and 4 weeks after the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Any patient with a benign disease as indication for hysterectomy

Exclusion Criteria:

* Hysterectomy for malignant pathology
* Laparoscopic or vaginal hysterectomy
* Any patient in which the procedure used both techniques
* Obstetric hysterectomy
The Effects of Transcutaneous Electrical Nerve Stimulation on People With Knee Osteoarthritis (OA) and or Chronic Pain

The purpose of this study is to evaluate the effect of TENS at the knee pain.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female between the ages of 45 years or older
* Ultrasonography scale of 0-3 for grading of primary Knee OA of the knee(s)
* Pain perceived as a minimum of 3/10 on a 0-10 pain scale with 24 hours of the each visit
* No phobia of electrical stimulation
* No pain or anti-inflammatory medication will be taken during study
* OA and or Chronic knee pain, Injury/pain that began minimum of 6- weeks before the beginning of the study.

Exclusion Criteria:

* Pregnancy
* Diabetes Mellitus
* Neuropathy
* Smoker
* Uncontrolled HTN
* Past surgery in the region to be treated by TENS or had received an intra-articular corticosteroid or hyaluronic acid injection within 6 months prior to enrollment
* Arthritis (RA) in the area to be treated by TENS
* Allergic to tape/electrodes
* Dementia
* History of knee joint replacement or tibial osteotomy
* Undergoing physical therapy
* Any major joint pain (e.g., back, hip, or ankle) that could limit functional ability
* Contraindications to TENS (pacemakers, dermatological conditions, and abnormal sensation in the knees)
* Severe medical or neurological conditions (e.g. Chronic obstructive pulmonary disease, cardiovascular disease, arteriosclerosis obliterans, cerebrovascular accident, lumber disc, herniation, and rheumatoid arthritis)
* The subject does not utilize stairs in daily living
* The subject is unable to walk without ambulatory assistive devices.
Evaluation and Management for Prostate Oncology, Wellness, and Risk (EMPOWeR)

The EMPOWeR study is proposed as a cohort study with longitudinal follow-up to determine rates of genetic mutations among men with or at-risk for prostate cancer to address the various facets of genetic education and counseling for optimized genetic assessment and wellness of men. The results will inform practice guidelines and future studies for maximal impact of genetic evaluation of men for inherited prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Men with a personal history of prostate cancer
* Unaffected males who are at higher risk for prostate cancer (family history of prostate cancer or African American males)
* Men who previously tested positive for a mutation may be eligible for Specific Aims 2-7
* Men with a known familial mutation
* Men who previously participated in the Genetic Evaluation of Men (GEM) study (IRB#14S.546) will be offered participation in EMPOWeR -

Exclusion Criteria:

* Age \< 18 years
* Mental or cognitive impairment that interferes with ability to provide informed consent
Safety Study of Analgesia After Craniotomy Surgery With End Tidal (ET) Carbon Dioxide (CO2) Monitoring

This research is being done to compare two methods of giving fentanyl, a narcotic often given to patients following brain surgery and determine if one method has more side effects than the other. Both of these methods are available in the postoperative treatment of pain. This research also is being done to determine if patients receiving narcotic pain medicine will benefit from additional monitoring of carbon dioxide levels. Since narcotic pain medicines can slow down breathing, The investigators want to see if measuring exhaled carbon dioxide levels will help identify a slower breathing rate and improve safety.

See brief summary

Eligibility Criteria:
Inclusion Criteria:

* Adult male and female, English speaking patients undergoing supratentorial craniotomy for tumor under general anesthesia at the Johns Hopkins Hospital will be eligible for this study.

Exclusion Criteria:

* pregnant women
* patients with post operative neurological changes
* patients who remain intubated post-operatively
* patients who require the use of concomitant administration of sedatives

  * patients who are unable to initiate a PCA bolus
  * patients who are unable to communicate verbally
  * patients who are allergic to fentanyl
* patients who have a history of narcotic abuse
* patients who have a history of chronic pain requiring opioids
* patients who have been in any investigational drug trial within 1 month of the treatment day
* patients who have chronic respiratory insufficiency
Determine the Effects of Gene Differences and Voriconazole on Enzyme CYP2B6 Activity in the Liver in Healthy Volunteers

The purpose of this study is to see if administration of medicines and genetic differences affects the activity of a liver enzyme called CYP2B6 in healthy volunteers.

The investigators will test the hypothesis that CYP2B6 genetic variants that show effects in vitro also influence the in vivo activity of CYP2B6 and its responsiveness to metabolic inhibition, using the metabolism of efavirenz (100 mg dose) as a marker of activity. The metabolism and pharmacokinetics of efavirenz will be determined in a total of 60 healthy volunteers with CYP2B6\*1/\*1, CYP2B6\*1\*6 and CYP2B6\*6\*6 at baseline (control) and after pretreatment with voriconazole.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subject between 18 and 55 years of age.
* Healthy individuals without any significant medical conditions as determined by a screening performed at University.
* Adherence to the study dietary and medication restrictions.
* Willingness to refrain from smoking or use of tobacco or marijuana one week before the start of the study and until completion of the study which will be a total of 17 days.
* Ability to commit the time requested for this study.

Exclusion Criteria:

* Underweight (weighs less than 50kg or 110lb) or over weight \[body mass index (BMI) greater than 32\].
* Drug or alcohol abuse (more than 3 alcoholic drinks per day on a regular basis).
* History of intolerance or allergic reaction (e.g. rash) to efavirenz and/or voriconazole.
* Significant health conditions such heart, gastrointestinal disorders, liver, or kidney diseases that may be exacerbated during the course of the study.
* History or current psychiatric illness (e.g. depression, anxiety, or nervousness).
* History or current eye sight disturbances (e.g. blurred vision).
* Serious infection within the last 2 weeks.
* Blood donation within the past two months.
* Screening results that do not fall in a healthy range.
* Regularly taking prescriptions (except hormonal agents, e.g. oral contraceptives), over-the-counter, herbal or dietary supplements, and alternative medications and are unable or unwilling to stop taking them one week before and during the study periods.
* Female with a positive pregnancy test.
* Female breastfeeding.
* Females of child-bearing potential who are unable or unwilling to either practice abstinence or use appropriate birth control up until the study completion, which will take a total of 17 days.
* Participation in a research study involving intensive blood sampling and/or have use study drugs in the last two months.
* Employed or student under supervision of any of the investigators of this study.
* Inability to state a good understanding of this study including risks and requirements, and inability to follow the rules of this study.