cyrilzakka/clinical-trials huggingface dataset:
Study of Microbiota in Bile From Patients With Common Bile Duct Stone During ERCP

In this study, investigators will investigate the microbiota of bile in common bile duct stone participants. Three key questions are of concern. The first one is whether there is bacteriria in bile in participants without common bile duct stone. The second one is whether the microbiota of bile is similar with that of gut mucosa in common bile duct stone participants. The third one is whether the bacteria in bile of common bile participants with intact papillar is the same as that of participants underwent sphinctomy.


Eligibility Criteria:
Inclusion Criteria:

* CBD tumor or CBD calculi

Exclusion Criteria:

* contraindication for ERCP
Chemotherapy Followed by Radiation Therapy in Treating Adults With Supratentorial Glioma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of procarbazine, lomustine, and vincristine followed by radiation therapy in treating adults who have supratentorial glioma.

OBJECTIVES: I. Estimate the response rate of patients with newly diagnosed supratentorial low-grade glioma following neoadjuvant chemotherapy with PCV (procarbazine/lomustine/vincristine). II. Describe the toxicity of PCV. III. Determine the incidence of disease progression in these patients during PCV treatment.

OUTLINE: The following acronyms are used: CCNU Lomustine, NSC-79037 PCB Procarbazine, NSC-77213 PCV PCB/CCNU/VCR VCR Vincristine, NSC-67574 3-Drug Combination Chemotherapy Followed by Radiotherapy. PCV; followed by external-beam cranial irradiation using at least 6 MV photons.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed supratentorial \* grade I/II glioma, including: Diffuse fibrillary astrocytoma No pilocytic astrocytoma No mixed tumor with ependymoma elements \* Supratentorial sites include: Frontal, temporal, parietal, or occipital lobes Thalamus, basal ganglia, or midbrain Lateral or third ventricles Pons, medulla, or optic chiasm tumors allowed only if secondary to eligible tumor More than 1 separate tumor allowed Diagnosis based on surgical biopsy or subtotal resection Measurable or evaluable disease on T2-weighted MRI required

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Hematopoietic: WBC greater than 3,500/mm3 Platelet count greater than 130,000/mm3 Hemoglobin greater than 9 g/dL Hepatic: Bilirubin less than 2 times upper limit of normal (ULN) AST less than 2 times ULN Alkaline phosphatase less than 2 times ULN Renal: Creatinine less than 1.5 times ULN Other: No active or uncontrolled infection No second malignancy within 3 years except: Nonmelanomatous skin cancer In situ cervical cancer No pregnant or nursing women Negative pregnancy test required within 7 days prior to entry Effective contraception required of fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: At least 1 week since prior steroids OR Stable steroid dose for at least 1 week prior to study Radiotherapy: No prior cranial or head and neck irradiation Surgery: See Disease Characteristics
Efficacy and Safety of Favipiravir in the Treatment of COVID-19 Patients Over 15 Years of Age

This study is an observational study (Non-interventional study) to evaluate the safety and efficacy of favipiravir in patients older than 15 years of age, diagnosed with COVID-19 and initiated treatment with favipiravir before enrollment to the study. Patients who have already had a routine favipiravir treatment decision or alternatively favipiravir treatment started at the time of enrollment, will be included in this study.

The clinical picture of 2019-nCoV disease is in a broad spectrum, which includes asymptomatic infection, a mild upper respiratory tract infection, respiratory failure, and even severe viral pneumonia with death. Although the mortality rate is not yet clear, the reported case-fatality risk was 11-14% during the initial studies which included patients with severe disease. The overall case fatality rate was reported as approximately 2%. In addition, most cases have resulted in a pneumonia requiring supplemental oxygen therapy and ventilator support. The alarming levels of spread and severity of COVID-19 caused a global emergency and this outbreak has been characterized as a pandemic by the World Health Organization (WHO).

Studies have suggested that investigational product favipiravir can improve the recovery of patients with mild disease and reduce the treatment duration from less than 11 days.

The main purpose of this study is to obtain efficacy and safety data for favipiravir use in the Turkish patient cohort diagnosed with COVID-19 and decided to be treated with "Favipiravir" before enrollment to this observational study. This study is designed as an observational drug study which will evaluate the safety and efficacy of favipiravir in patients and diagnosed with COVID-19 and older than 15 years of age.

This study is designed as an observational drug study to evaluate the safety and efficacy of favipiravir in patients diagnosed with COVID-19 and older than 15 years of age with a favipiravir treatment decision. Patients who have already had a routine favipiravir treatment decision or favipiravir treatment started will be included in this study.

A total of 1000 female and male patients aged 15 years or older will be included in the study. The planned observation duration for each patient is 7 days.

This study will be conducted in 14 sites.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients, diagnosed with Covid-19 disease who are 15 years of age or older at the time of enrollment
* Patients who have understood all study procedures that will be applied under the study protocol
* Patients with confirmed diagnosis of COVID-19 by PCR and/or other accepted methods and have a treatment decision with favipiravir
* Patients who will accept oropharyngeal sample and venous blood sample collection periodically within the scope of the study protocol

Exclusion Criteria:

* Patients who are pregnant or females who are breast feeding
* Patients under the age of 15
Doxorubicin Hydrochloride Liposome in Treating Women With Ductal Carcinoma in Situ Undergoing Surgery

RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This clinical trial is studying the side effects of doxorubicin hydrochloride liposome and to see how well it works in treating women with ductal carcinoma in situ undergoing surgery.

OBJECTIVES:

* To demonstrate the efficacy and safety of neoadjuvant intraductal pegylated liposomal doxorubicin hydrochloride in women with ductal breast carcinoma in situ undergoing surgery.
* To demonstrate the ability to identify and cannulate the duct demonstrating precancerous disease in these women.
* To integrate the Humboldt Community Breast Health Project into the planning and execution of this study.

OUTLINE: Patients undergo identification of the intraductal lesions via cannulization. Patients receive pegylated liposomal doxorubicin hydrochloride (PLD) intraductally through the inserted cannula. Some patients are randomized to receive saline instead of PLD. Within 4-6 weeks, all patients undergo surgery.

Patients undergo tissue and ductal fluid sample collection at baseline and at surgery for correlative laboratory studies. Tissue samples are assessed for histomorphology, proliferation (Ki67), cell death (apoptosis index), genetic markers, necrosis, inflammation, and loss of heterozygosity by HE stain, IHC, TUNEL, and PCR. Nipple aspirate and ductal lavage fluid samples are analyzed for cytomorphology (cellular atypia), proliferation (Ki67), cell death (TUNEL), differentiation (G-actin), and genetic markers (FISH) by quantitative fluorescence image analysis. Samples are also analyzed for bFGF and CEA by ELISA, and methylation by PCR.

After completion of study therapy, patients are followed every 6 months for at least 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of ductal breast carcinoma in situ by core needle biopsy

  * No pathological invasive or microinvasive disease in the affected breast
* Mammographic microcalcifications are limited to one ductal system or one quadrant of breast
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Menopausal status not specified
* Must be able to undergo necessary surgery
* Not pregnant

PRIOR CONCURRENT THERAPY:

* No prior surgery or radiotherapy to the recently diagnosed breast
* More than 12 months since prior chemotherapy
* No prior subareolar breast surgery to the affected breast
* Not concurrently involved in a research protocol for unapproved new drug evaluation
Interpreters as Advocates for Hypertensive Patients

The purpose of the study is to determine if medical interpreters trained to advocate on behalf of their patients deliver improved care compared to standard medical interpreters

Over 21 million Americans have limited English proficiency. About two-thirds of these individuals speak Spanish. Limited English proficiency has major adverse impacts on health and health care. Using trained medical interpreters may help overcome this language barrier. Compared to patients who need but don't get an interpreter, patients who use trained medical interpreters have better satisfaction, quality of care, and health outcomes. However, the outcomes of patients using interpreters is often poorer than that of English-speaking patients. This randomized controlled trial will test the utility of using interpreters as advocates for Spanish-speaking inner city patients with hypertension.

Eligibility Criteria:
Inclusion Criteria:

* Spanish speaking
* Limited English proficiency
* Uncontrolled hypertension
* Regular visit with primary care provider who is not proficient in Spanish

Exclusion Criteria:

-
Comparative Study of Use of Alpha-Blockers to Treat Symptoms in Prostate Cancer Patients Undergoing Radiation Therapy

Approximately 50%-95% of prostate cancer patients undergoing radiation therapy (RT) develop symptomatic urinary problems .These symptoms can significantly diminish a patient's quality of life during and shortly after therapy. Alpha1-blockers, such as Rapaflo, act to decrease resistance to urinary flow.

This multi-institutional phase III trial is designed to compare standard of care versus preventive treatment with Rapaflo for prostate cancer patients, regardless of risk group, whose treatment consists of radical radiation therapy. We plan to recruit 188 patients across Quebec who will be randomized into two arms: rapaflo prescribed at start of radiation therapy or if/when symptoms appear.

The efficacy of Rapaflo treatment will be assessed using the International Prostate Symptom Score (IPSS). The IPSS will be assessed at baseline before RT, 4 weeks into RT, the last day of RT, and monthly thereafter for a total duration of 6 months from start of RT. Patients will have 2 more IPSS assessments at 9 and 12 months. The total duration of follow-up will be one year from start of RT. We will compare the rate of IPSS increase in the Rapaflo group compared to the standard arm at different time point (4 weeks, 6 weeks and at the end of treatment). We will also determine the rate of IPSS return to baseline at 4 and 12 weeks after the end of treatment. The rate of therapy dependence in the 2 arms will be evaluated at 20 and 26 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Adult male 18 years of age or older
* Patients with confirmed diagnosis of adenocarcinoma of the prostate.
* The primary treatment should be external beam radiation therapy (EBRT) with or without high dose rate (HDR) brachytherapy boost.
* Clinical or radiological diagnosis of T1a - T3b.
* No limitation with respect to Gleason score.
* No limitation with respect to total Prostate-specific Antigen (PSA) value.
* Karnofsky performance score (KPS) of ≥ 70.

Exclusion Criteria:

* Small cell cancer of the prostate
* T4 disease, invading bladder or rectum.
* Adjuvant or salvage radiation therapy
* Brachy monotherapy
* KPS \< 70
A Post-Market Retrospective Study on Revision Total Knee Arthroplasty Using Medacta GMK® Revision Prosthesis

This is a retrospective, single-site observational study, designed to assess the clinical outcomes and collect safety data of GMK Revision knee system used for primary or revision total knee arthroplasty at minimum two years post-treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to any study procedure.
* Patients with ability to understand and provide written authorization for use and disclosure of personal health information
* Patients must be willing to comply with the post-operative evaluation schedule.
* Patients underwent either a primary or revision total knee replacement for any type of etiology (Osteoarthritis, Avascular necrosis, Rheumatoid Arthritis, Post-traumatic Arthritis, Polyarthritis, Primary implantation failure).
* Patients must have received a GMK Revision component
* Patients must be at minimum 2 year (24 months) post-treatment
* The operation was performed or supervised by the investigator.
* No age limit criteria

Exclusion Criteria:

* History of alcoholism
* Currently on chemotherapy or radiation therapy
* Habitual use of narcotic pain medications prior to surgery or after surgery for reasons other than knee pain
* History of a metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis
* History of chronic pain issues for reasons other than knee pain
* Women that are pregnant
Effect of Non-essential Amino Acids on Protein Requirements for Endurance Athletes

Protein requirements in individuals who participate in endurance-based exercise training have been suggested to be greater than the current recommended dietary allowance (RDA).

The biological value of protein depends on its amino acid composition. Essential amino acids are believed to have main role on whole body protein metabolism. However, it remains to be determined what role non-essential amino acids (NEAA) may have in regulating protein metabolism and contributing to the increased protein requirements after endurance exercise.

The indicator amino acid oxidation (IAAO) method has clarified the individual amino acid requirement in children, normal healthy adult and clinical populations. However, the IAAO method has never been utilized for assessing the effect of NEAA on protein requirements after endurance exercise.

The objective of the current study is to investigate the importance of NEAA for endurance-trained male subjects.


Eligibility Criteria:
Inclusion Criteria:

* endurance-trained participants who regularly run more than 40 km/week
* Participants who are categorized at least "very good" based on a study by Shvartz \& Reibold, in which VO2peak is used as an index. (i.e. the participants whose VO2peak is ≥57 ml/kg/min (18-24 y), ≥54 ml/kg/min (25-29 y), ≥52 ml/kg/min (30-34 y), ≥49 ml/kg/min (35-39 y)
* Ability to complete the 16-km familiarization run in session 2

Exclusion Criteria:

* Inability to meet health and physical activity guidelines according to the physical activity readiness questionnaire (PAR-Q+)
* Inability to adhere to any of the protocol guidelines (i.e. alcohol, caffeine consumption)
* Regular tobacco use
* Illicit drug use
Study to Evaluate Immunological Response to PD-1 Inhibition in Squamous Cell Carcinoma of the Head and Neck (SCCHN)

This is a single-center cross-sectional imaging and correlative biomarker study in patients with Squamous Cell Carcinoma of the Head and Neck (SCCHN). Cohort 1 will be patients with unresectable or metastatic SCCHN cancer receiving standard of care (SOC) anti-PD-1 treatment and Cohort 2 will be neoadjuvant study participants who will receive one dose of anti-PD-1 treatment prior to tumor resection or radiation. Blood sampling and tissue biopsies will be collected from both cohorts and both cohorts will undergo two whole body PET(Positron Emission Tomography)/CT(Computed Tomography) imaging with \[18F\]F-AraG. First scan prior to initiating anti-PD-1 treatment and second scan post initiation of anti-PD-1 treatment in Cohort 1 and prior to tumor resection or radiation in Cohort 2

This is a single-center cross-sectional imaging and correlative biomarker study in patients with Squamous Cell Carcinoma of the Head and Neck (SCCHN). Cohort 1 will be patients with unresectable or metastatic SCCHN cancer receiving standard of care (SOC) anti-PD-1 treatment and cohort 2 will be neoadjuvant study participants who will receive one dose of anti-PD-1 treatment prior to tumor resection or radiation. Blood sampling and tissue biopsies will be collected from both cohorts and both cohorts will undergo two whole body PET(Positron Emission Tomography)/CT(Computed Tomography) imaging with \[18F\]F-AraG. First scan prior to initiating anti-PD-1 treatment and second scan 6-12 weeks post initiation of anti-PD-1 treatment in Cohort1 and within 2-3 weeks of administration of one dose of anti-PD-1 in Cohort 2.

This study will help us assess if \[18F\]F-AraG can be used for noninvasive imaging and assessment of T cell activation and expansion in the tumor microenvironment. Specifically, we will be assessing if there is a correlation between an increase in the imaging signal and an increase in T cell activation (measured directly from the T cells obtained from biopsy specimens).

Patients and care providers will not be blinded to any part of this study. Patients will be evaluated one day and one week via telephone visit after each radiopharmaceutical injection for safety follow-up. All adverse events will be recorded. Due to the noninvasive and non-therapeutic nature of the study, potential risks of the study are anticipated to be low.

Eligibility Criteria:
Inclusion Criteria:

* Unresectable or metastatic SCCHN.
* Localized SCCHN.
* \>18 years old.
* Willing and able to sign consent form.
* Have standard of care biopsy or resection planned or tumors amenable to serial biopsies.
* For patients with reproductive potential must undergo counseling to understand unknown risks to resultant progeny.

Exclusion Criteria:

* Diagnosis of immunodeficiency or active autoimmune condition.
* Active tuberculosis
* Prior exposure to PD-1 or PD-LI treatment
* Prior systemic chemotherapy within 2 weeks of planed anti-PD1 treatment.
* Received a live vaccine within 30 days of planned PD-1 start date.
* Pregnant or breastfeeding.
Efficacy of Scalp Block on Hemodynamic Stability and Opioid Consumption During Craniotomy

Prospective randomised double-blinded placebo-controlled trial on the efficacy of scalp blocks on hemodynamic stability and opioid consumption during and after craniotomy.


Eligibility Criteria:
Inclusion Criteria:

* Elective craniotomy for supratentorial lesion

Exclusion Criteria:

* Allergy to local anaesthetic
* Psychiatric disease
* Inability to consent
* Uncontrolled intracranial hypertension
Fertilix Supplements and Assisted Reproductive Technology

This is a double blind, randomized, placebo controlled clinical trial to test the efficacy of the antioxidant formulation Fertilix® in lowering the levels of damaged sperm DNA in men diagnosed with moderate to high Sperm Oxidative DNA Damage (SODD)


Eligibility Criteria:
Inclusion Criteria:

* Males with a sperm sample containing 8-OHdG levels \> 15% and must be capable of producing an ejaculate containing \>10million sperm upon study enrollment.
* Male is between 20-55 years of age seeking treatment for infertility with his partner at URA and who is a candidate for an IUI, IVF or IVF-ICSI (excluding donor egg) procedure.
* Female is between 20-42 years of age
* Female exhibits tubal patency on hydrosonogram or hysterosalpingogram (HSG)
* Female exhibits normal uterine cavity by hysteroscopy, hydrosonogram or hysterosalpingogram (HSG).

Exclusion Criteria

* Subjects with initial semen analysis of an ejaculate containing \< 10 million sperm.
* Men who have been taking nutraceuticals, vitamins or other compounds known to have antioxidant activities within4 weeks of the study. No other supplements may be taken with Fertilix.
* Men who have hypersensitivity or an allergy to any of the ingredients in Fertilix®.
* Men who have been treated with a chemotherapeutic agent known to cause sterility, such as cyclophosphamide.
* Men who have taking anabolic steroids or testosterone replacement within 4 months of the study.
* Men currently being treated with a Ca++ channel blocker or other medical treatment known to adversely affect sperm production or function.
* Men with HIV, hepatitis B and C.
Patient-operated Valved Catheter Versus Indwelling Transurethral Catheter

Following surgery for female urinary incontinence and/or pelvic organ prolapse, women are sometimes temporarily unable to empty their bladders and are sent home with a transurethral indwelling catheter attached to a bag which holds urine. The goal of this study is to compare a new type of patient-operated catheter without a bag to the catheter with a bag for ease of use, comfort and quality of life for patients during the postoperative recovery period. This new catheter, the OPTION-vf, is approved by the FDA and is available on the market.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing surgery for urinary incontinence and/or pelvic organ prolapse at the UMass Memorial Medical Center with one of the Urogynecology/Reconstructive Pelvic Surgery faculty.

Exclusion Criteria:

* inability to provide consent
* \<18 years old
* non-English speaking
* patients using intermittent self-catheterization
* patients sustaining bladder injury during surgery
* prisoners
* pregnant women
A Study to Assess Efficacy of HL036 in Subjects With Dry Eyes

The objective of this study was to compare the safety and efficacy of 0.10% and 0.25% HL036 Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.


Eligibility Criteria:
Inclusion Criteria:

* Have a patient-reported history of dry eye for at least 6 months prior to enrollment
* Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1
* Have in the study eye a Schirmer's Test score of ≤ 10 mm and ≥ 1 mm at Visits 1 and 2

Exclusion Criteria:

* Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1
* Have used Restasis® or Xiidra® within 60 days of Visit 1
* Be currently taking any topical ophthalmic prescription (including medications for glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial (excluding medications allowed for the conduct of the study)
* Have an uncontrolled systemic disease
* Be a woman who is pregnant, nursing or planning a pregnancy