cyrilzakka/clinical-trials huggingface dataset:
Safety Study of a Monoclonal Antibody to Respiratory Syncytial Virus (RSV) in Children Hospitalized With RSV Infection

The purpose of this study is to determine the safety of motavizumab (MEDI-524) following a single intravenous dose in children hospitalized with respiratory syncytial virus (RSV).

This study was designed as a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation, multicenter clinical study to evaluate the safety, tolerability, serum concentrations, and immunogenicity of a single intravenous dose of motavizumab (MEDI-524) and the effect on the amount of respirtory syncytial virus (RSV) in the respiratory tract (nasopharynx) of otherwise healthy children hospitalized with RSV infection.

Eligibility Criteria:
Inclusion Criteria:

* Previously healthy
* Age 24 months and younger at the time of randomization
* Gestational age of 36 weeks gestation and older
* Randomization within 24 hours after hospitalization
* Hospitalized for lower respiratory tract illness (ie, respiratory syncytial virus (RSV) bronchiolitis and/or pneumonia) documented by positive RSV antigen detection or culture in respiratory secretions within 72 hours before randomization

Exclusion Criteria:

* Already received or would receive ribavirin or other anti-viral treatment for the current episode of RSV infection prior to randomization
* Required intubation for ventilatory support
* Any medically significant underlying ongoing chronic illness or organ system dysfunction or other known acute illness, other than RSV infection
* Known renal impairment, hepatic dysfunction, hematologic abnormalities, seizure or other neurologic disorder or immunodeficiency
* Requirement for supplemental oxygen at any time prior to the current RSV infection (brief use of oxygen in the immediate postnatal period to treat a transient condition was allowed)
* Mechanical ventilation at any time prior to the onset of the current RSV infection
* Congenital heart disease (children with medically or surgically corrected patent ductus arteriosus \[PDA\], small atrial septal defect \[ASD\] or ventricular septal defect \[VSD\] were allowed)
* Previous reaction to intravneous immunoglobulin (IVIG), blood products, or other foreign proteins
* Prior use of IVIG, RSV-IGIV (RespiGam), palivizumab (Synagis), or other immunoglobulin products within the past 2 months
* Currently receiving other investigational agents or have received any other investigational agents within the last 3 months
* Prior or current participation in any investigational study with a therapeutic agent or vaccine for RSV
Tenofovir in Chronic Hepatitis B With Mild ALT Elevation

This study aims to clarify whether patients with chronic hepatitis B with high viral load will benefit from oral antiviral therapy despite only mildly elevated serum liver enzyme.

Chronic hepatitis B (CHB) is a serious disease in Taiwan, leading to substantial morbidity and mortality including hepatic failure, liver cirrhosis, and hepatocellular carcinoma (HCC). Recently a large body of evidence supports that high level of serum HBV DNA is an independent risk factor for late complications in CHB patients. Nucleos(t)ide analogues (NUC) are effective antiviral therapy that can potently inhibit replication of hepatitis B virus (HBV), and has been widely used in management of patients with CHB. Current practice guidelines recommend using serum alanine aminotransferase (ALT) \> 2 times of the upper limit of normal (ULN) as the prerequisite to initiate antiviral therapy in compensated CHB patients without liver cirrhosis. However, serum ALT level does not exactly correlate with serum HBV DNA or liver tissue injury. Whether antiviral therapy improves outcomes of patients with slightly elevated ALT (i.e. 1-2 folds of ULN) remains unknown.

Eligibility Criteria:
Inclusion Criteria:

* age between 25 to 70 years,
* serum HBsAg positivity for more than 6 months,
* positive or negative serum HBeAg,
* serum HBV DNA more than 2,000 IU/mL,
* highest serum ALT \> 1 fold of ULN, but \< 2 X ULN on at least two occasions (≧ 3 months apart) in the preceding one year,

Exclusion Criteria:

* co-infection with HIV, HCV, or HDV,
* previous exposure to HBV antiviral therapy for more than 12 weeks,
* presence of cirrhosis on histopathology,
* hepatic decompensation defined as serum bilirubin \> 2mg/dl and prolonged prothrombin time \> 3 seconds,
* concurrent malignant diseases including hepatocellular carcinoma,
* severe co-morbidity with life expectancy \< 1year,
* pregnant or lactating women,
* organ transplantation except cornea or hair transplant,
* suspected or confirmed chronic liver diseases from etiologies other than HBV (e.g. alcoholic hepatitis, Wilson disease, Hemochromatosis...etc),
* serum creatinine \>1.5mg/dL
Mass Balance Study of MT-1303

The purpose of this study is to investigate the absorption, metabolism and excretion of MT-1303 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian male aged 30 to 65 at Screening.
* Body weight of ≥60 kg, and a BMI ranging from 18.0 to 32.0 kg/m2 at Screening and Day -1.
* Normal or not clinically significant ECG as defined by a HR between 50 and 100 bpm inclusive at Screening, Day -1 and pre-dose.
* Vital signs within the following ranges at Screening and Day -1,Body temperature: 35.0 to 37.5 °C,SBP: 90 to 140 mmHg,DBP: 50 to 90 mmHg.
* Regular daily bowel movements.

Exclusion Criteria:

* Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study.
* Previous medical history of tuberculosis, or in the opinion of the Investigator, a recurrent medical history of cold sores, pharyngitis, urinary tract infection, diarrhoea/dysentery, chest infections or fungal infections.
* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardise the subject in case or participation in the study. The investigator should be guided by evidence of any of the following:

  * history of inflammatory bowel syndrome,gastritis, ulcers, gastrointestinal or rectal bleeding;
  * history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection
Effects of L-Carnitine in Amyotrophic Lateral Sclerosis Patients With CHCHD10 Mutations

The study was designed as a single-center, open-label, single-arm pilot study to estimate the safety and efficacy L-carnitine in ALS patients with CHCHD10 mutations.

The study was designed as a single-center, open-label, single-arm pilot study and was performed at the ALS inpatient clinic of the Xuanwu Hospital in Beijing, China. ALS patients with CHCHD10 mutations were recruited to participate in the clinical trial. The patients were given L-carnitine therapy administered every 8 weeks, consisting of 1g L-carnitine diluted in 500 mL of 0.9% sodium chloride solution via intravenous infusion once daily. Each treatment cycle lasted 2 weeks, repeated at 8-week intervals for a total of 3 cycles, with L-carnitine 1g is administered orally once daily during the intervals between intravenous therapies. Primary end point was the changes of ALS-FRS-R scores, and secondary end points were the changes of plasm NfL level, FVC%, weight and ALSAQ-40 scores. Eligible patients were assessed at baseline and after 2, 10, 12, 20 and 30 weeks. At each visit, a detailed neurological examination, including assessment of general nerve function as well as quantitative and qualitative evaluation of the motor system, were performed for the patients. All adverse events (AEs) encountered and any serious events were to be recorded as true. Severity was graded according to the modified WHO criteria for toxicity (http://www.regsource. com/_Adverse_Event_Reporting/_adverse_event_ reporting.html) where applicable.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18-80 years old
* ALS diagnosed as definite or probable as defined by the World Federation of Neurology revised El Escorial criteria
* Carrying pathogenic CHCHD10 mutations
* Capable of providing informed consent and following trial procedures
* Forced Vital Capacity (FVC) \>40% of predicted value for gender, height, and age at the Screening Visit
* Subjects develop at less moderate degree of motor dysfunction, with ALS-FRS-R total scores less than 46
* Both male and female patients must agree to use adequate birth control for the whole duration of the study within 30 weeks
* Subjects are willing and expected to complete the 30-week follow up, including 3 times hospitalization.

Exclusion Criteria:

* Presence of tracheostomy
* History of known allergy to L-carnitine
* Abnormal liver function defined as AST and/or ALT \> 3 times the upper limit of the normal
* Renal insufficiency as defined by eGFR \< 60 mL/min/1.73m2
* Pregnant women or women currently breastfeeding
* Clinically significant unstable medical condition (other than ALS) that would pose a risk to the subject if they were to participate in the study
* Anything that, in the opinion of the Site Investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study.
Epigallocatechin Gallate and Other Antural Compounds in HPV Infections

The investigators enroll patients with a PAP-test cytology reporting LSIL or ASCUS.

Pateitns undergo HPV-DNA test for screening. Patients are treated with Epigallocatechin galalte, hyaluronic acid, folic acid and Vitamin B12 by oral route.

After three months of treatment PAP-test and HPV-DNA test will be repeated.


Eligibility Criteria:
Inclusion Criteria:

* Positivity to HPV-DNA test
* PAP-test reporting LSIL or ASCUS

Exclusion Criteria:

* HPV-related pathologies or complicances apart from LSIL or ASCUS
* Diagnosis of cancer
Safety and Efficacy of Activated Recombinant Human Factor VII in Haemophilia Patients With Inhibitors During and After Major Surgery

This trial is conducted in North America. The aim of this trial is to compare the safety and efficacy of activated recombinant human factor VII in patients with haemophilia A or B undergoing major surgical procedures.


Eligibility Criteria:
Inclusion Criteria:

* Have haemophilia A or B with inhibitors to factor VIII or IX, respectively
* Have had a historical inhibitor level of at least five Bethesda units or have had an inadequate haemostatic response to 250 U/kg of factor VIII or IX or have had an inadequate response to FEIBA
* Require pre-planned major surgery in hospital

Exclusion Criteria:

* Have participated in or have been treated with any investigational drug other than activated recombinant human factor VII within the last thirty days
* Have been treated with any haemostatic agent, including rFVIIa, within 48 hours of preoperative dose
* Have any haemostatic disorder other than haemophilia
Magnetic Resonance Imaging Guided Gynecologic Brachytherapy

The primary goal of this pilot study is to assess the feasibility of using magnetic resonance (MR) imaging guidance in the Magnetic Resonance Therapy (MRT) unit at the Brigham and Women's Hospital during the implantation of brachytherapy applicators in patients with gynecologic malignancies. Patients with gynecologic malignancies requiring brachytherapy are currently treated under either fluoroscopic or CT visualization of the brachytherapy applicator. Magnetic resonance imaging has been shown in many studies to provide superior visualization of the cervix, vagina and uterus compared to CT. However no prior study has examined the feasibility of using real-time magnetic resonance imaging to assist in the guidance of gynecologic brachytherapy applicators

The primary endpoint involves the ability of the MRT guided procedure to protect bladder and rectal tissues from inadvertent insertion of the interstitial needles used to deliver brachytherapy. MR images obtained on the MRT unit should provide clear delineation of the bladder and rectum and allow for greater accuracy and avoidance of these normal tissues upon interstitial needle insertion. CT images will be obtained following the insertion of needles using the MRT unit. The procedure will be considered a failure if CT imaging identifies the insertion of needles into the bladder or rectum that was not detected using MR. Secondary endpoints include the ability of MR imaging to accurately reconstruct dosimetric plans and to construct dose volume histograms after the implantation of interstitial needles as well as the ability of MR imaging to accurately determine tumor, bladder and rectal volumes. Secondary endpoints will also include the assessment of acute skin, genitourinary and gastrointestinal toxicities as well as an assessment of tumor progression or recurrence during a 180 day follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Histologic documentation of carcinoma. Carcinoma of the cervix: Stage IIIB, IVA or vaginal recurrence
* Carcinoma of the cervix: Stage IB, IIA, IIB or IIIA with obliteration of the cervical os (tandem and ovoid implant not feasible)
* Carcinoma of the uterus: Stage IIIB (vaginal involvement) or vaginal recurrence
* Carcinoma of the vagina: Stage II, III, IVA or vaginal recurrence
* Carcinoma of the vulva: T3 (vaginal extension) or T4 (inoperable - any N stage), or vaginal recurrence
* MRI and CT of the pelvis within 2 months before registration
* ECOG performance status of \< 2
* Age \> 18
* Signed informed consent
* No metallic objects or pacemakers in the patient
* Negative pregnancy test for those of child-bearing potential
* Patients who have received prior radiation or chemotherapy may be enrolled on this study.
* Documented complete blood count (CBC) with hematocrit (Hct)\>30, absolute neutrophil count (ANC)\>500, platelet (Plt) \>40

Exclusion Criteria:

* Patients with distant metastasis.
* Baseline studies not obtained.
* Patients who are pregnant or lactating.
* Significant history of cardiovascular disease.
Management of Acute Tinnitus With Migraine Medications

Tinnitus represents one of the most common and distressing otologic problems, and it causes various somatic and psychological disorders that interfere with the quality of life. Despite too many research projects on finding the mechanism of tinnitus, its pathophysiology remains poorly understood. It is well understood that many factors, such as poor education, lower income, or occupational, and recreational activity associated with high noise exposure, influence the prevalence and risk of tinnitus. Although the economic and emotional impact of tinnitus is large, there is currently no FDA-approved medication to treat this condition. However, there are pharmacological options to address the stress, anxiety, and depression that are caused by tinnitus. In this project, the investigators intend to use medications for patients with acute tinnitus to decrease the impact of tinnitus in their daily lives and activities. There are some studies on medications treating tinnitus; however, there are few randomized clinical trials to prove the efficacy of the treatment. The frequency and loudness of tinnitus will be measured before and after the course. Functional MRI of the brain will be obtained to view any changes that may occur before and after the treatment.

This study is 8-weeks in duration. There are two arms in the experiment: the first is nortriptyline (7.5 mg) plus topiramate (10 mg), the second is verapamil (240 mg) plus paroxetine (32 mg). This is a double-blinded trial. Participants will be randomized to one arm for the duration of the trial using simple randomization with a computer-generated number. Both groups may receive dosage increases weekly if symptoms do not improve. Symptomatic survey scores from each arm will be obtained before and after treatment and weekly. An unblinded clinical researcher will also become involved with patients\&#39; treatments as they start to report changes in symptoms in order to monitor their safety and provide advice on change in dosage if patients have questions.

Eligibility Criteria:
Inclusion Criteria:

* Patients with mild to moderate tinnitus.
* Male or female between the ages of 25 to 85 years.
* Subjects must be compliant with the medication and attend study visits.
* Must be able to read and write in the English language to provide consent.

Exclusion Criteria:

* Pregnancy will result in automatic exclusion from the study. Rule out of pregnancy will be done by urine pregnancy test to confirm the situation for all women who are of childbearing potential.
* Subjects with a history of an adverse reaction to medication being prescribed.
* Subjects suffering from a medical condition or have a history that may be concerning to the investigator's clinical opinion.
* All contraindications for the medications that prevent subjects from randomization will be considered as exclusion criteria.
Focal Vibration for Enhancing Athletic Speed and Ppower

A focal vibration device will be used to perform an activation and warm-up protocol before performing a set of 7 repetitions of squat with 60% of your 1RM.


Eligibility Criteria:
Inclusion Criteria:

* Study participants must have signed the informed consent form to assess their inclusion in the study.
* Familiarity with the technique and practice of the weighted free squat.
* Training at least 3 times per week.

Exclusion Criteria:

* Volunteers who have suffered a sports injury during the last two months or are unable to perform physical activity.
* Have previously received an intervention with focal vibration.
* Not understanding the information provided by the therapist.
* Participate in other research studies.
* Be undergoing pharmacological medical treatment that may interfere with the measurements, such as treatment with anticonvulsants, antidepressants, etc.
Evaluation of the Irritation Potential of Sunscreen Products in Human Eyes

Evaluation of the human eye irritation potential of a test sunscreen formulation.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be healthy males or females between the ages of 18 to 60 years inclusive.
* Subjects do not wear contact lenses or willing to refrain from wearing them during the day of and day after the study.
* Subjects are willing to report any medications taken during the study and refrain from taking any medication during the study.
* Subjects are willing to have the test materials instilled into the eyes and follow all protocol requirements.

Exclusion Criteria:

* Subjects have ocular disease or peri-orbital dermatitis or trauma.
* Subjects have a systemic illness which contra-indicates participation.
* Subjects must not have a history of pre-existing sensitivity or other types of allergy to any eye products.
* Subjects must not have a history of allergies or sensitivities to cosmetics, toiletries, dermatological products, or any ingredients contained in the test or control products.
Bone Marrow Transplantation in Treating Patients With Lymphoma

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells, and may be an effective treatment for lymphoma. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells.

PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation in treating patients with recurrent or residual low-grade lymphoma.

OBJECTIVES: I. Examine the potential role of high dose etoposide, cyclophosphamide, total body irradiation and bone marrow transplantation for patients at high risk for disease progression. II. Determine the value of monitoring the quality of remission by PCR assessment of BCl-2. III. Evaluate the efficacy of alpha interferon for patients with evidence of residual or recurrent lymphoma. IV. Evaluate the efficacy of bone marrow purging by PCR assessment of BCl-2.

OUTLINE: Patients receive a brief 2-3 cycles of intensive chemotherapy to achieve minimum disease state. Etoposide is administered intravenously on day -8. Cyclophosphamide is infused intravenously over 2 hours daily on day -7 and -6. Patients receive mesna beginning 1 hour after initiation of the cyclophosphamide treatment. Total body irradiation is received on days -4, -3, -2 , and -1. On day 0 allogeneic or autologous bone marrow is infused intravenously. Patients with residual or recurrent lymphoma receive interferon alpha daily.

PROJECTED ACCRUAL: 35 allogeneic and 40 autologous patients are expected to be enrolled.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven low grade lymphoma in the following settings: Consolidation of newly diagnosed stage IV high-risk patients after 6-9 months of intensive conventional dose chemotherapy involving doxorubicin High risk is defined as \>=5 cm adenopathy and \>=2 extranodal sites at diagnosis, or males with \>=5 cm adenopathy and \> 20% marrow infiltrate at diagnosis) Failure to achieve CR within 6 months in newly diagnosed patients with intensive doxorubicin treatment Relapse patients who are sensitive to doxorubicin or ESHAP chemotherapies Patients with resistant chemotherapy failure (allogeneic BMT only) Patients with HLA-identical sibling donors are eligible for allogeneic bone marrow transplantation; other patients are eligible for autologous marrow transplantation Bone marrow must be in complete or near complete remission (\< 15 % malignant cells) in autologous transplant patients

PATIENT CHARACTERISTICS: Age: 15 to 60 years Performance Status: Zubrod 0-2 Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: Cardiac ejection fraction at least 50% Pulmonary: DLCO at least 50% Other: No concomitant severe medical illnesses No psychosis

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: No prior extensive radiotherapy Surgery: Not specified
Feasibility Study Assessing the Treatment of Fibroadenomata With a Circumferential Sonication Treatment With HIFU

The purpose of this study is to assess the treatment of fibroadenomata with a circumferential sonification treatment with HIFU..

Primary endpoint: fibroadenomata size reduction post-treatment on ultrasound imaging.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years of age
* Fibroadenomata diagnosed according to local hospital protocol; ultrasound alone on patients \<25 and ultrasound plus core-biopsy in patients \>25 (Graded B2 or less)
* Visible on ultrasound (Graded U2/U3)
* Definitive diagnosis of fibroadenomata confirmed by the Breast multi-disciplinary team meeting (MDT).

Exclusion Criteria:

* Lesion with atypia or suspicion of phyllodes (Graded B3 or greater)
* Pregnant or lactating women
* History of laser or radiation therapy to the targeted breast
Investigation of Subsequent and Co-infections Associated With SARS-CoV-2 (COVID-19)

Multicenter retrospective chart review of patients admitted to any of the four Methodist Health System hospitals

Multicenter retrospective chart review of patients admitted to any of the four Methodist Health System hospitals (Methodist Richardson, Methodist Mansfield, Methodist Charlton, or Methodist Dallas) between February 1 and April 30, 2020. All study center utilize Epic ® electronic health record (Verona, Wisconsin; www.epic.com) for which all data will be extracted from.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to Methodist Richardson, Methodist Mansfield, Methodist Charlton, or Methodist Dallas Medical Centers between February 1, 2020 and April 30, 2020
* \>18 years old
* Positive SARS-CoV-2 (COVID-19) PCR test

Exclusion Criteria:

* Outpatient or emergency department visit
* Not admitted to an inpatient or observation status for \>24 hours