cyrilzakka/clinical-trials huggingface dataset:
Monoclonal Antibody 3F8 and Sargramostim in Treating Patients With Neuroblastoma

RATIONALE: Monoclonal antibodies, such as monoclonal antibody 3F8, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood. Combining monoclonal antibody 3F8 with sargramostim may cause a stronger immune response and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining monoclonal antibody 3F8 with sargramostim in treating patients who have neuroblastoma.

OBJECTIVES:

* Determine the efficacy of sargramostim (GM-CSF) in enhancing monoclonal antibody 3F8-mediated ablation in patients with high-risk neuroblastoma.
* Determine the prognostic impact of minimal residual bone marrow disease on relapse-free survival of patients treated with this regimen.
* Compare the effects of short-term (2-hour intravenous) vs prolonged (subcutaneous release) daily GM-CSF on granulocyte activation, in order to establish the optimal route for tumor-cell kill in these patients.

OUTLINE: This is an open-label study. Patients are stratified according to evaluable disease (yes \[primary refractory bone marrow disease\] vs no \[no evidence of disease\]).

Patients receive sargramostim (GM-CSF) subcutaneously on days -5 to 4 and monoclonal antibody 3F8 IV over 0.5-1.5 hours on days 0-4. Treatment repeats every 3 weeks for 4 courses and then every 8 weeks for up to a total of 24 months in the absence of disease progression or unacceptable toxicity.

Beginning after 2 courses of GM-CSF and monoclonal antibody 3F8, patients also receive oral isotretinoin twice daily on days 1-14 (when no monoclonal antibody 3F8 is administered). Treatment with isotretinoin repeats approximately every 28 days for 6 courses.

PROJECTED ACCRUAL: A total of 340 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of neuroblastoma by histopathology OR bone marrow metastases and high urine catecholamine levels
* Disease must meet risk-related treatment guidelines and any of the following International Neuroblastoma Staging System stages:

  * Stage 4 with (any age) OR without (\> 18 months of age of age) MYCN amplification
  * MYCN-amplified other than stage 1
* No evidence of disease (i.e., in complete response/remission or very good partial response/remission) OR disease resistant to standard therapy (i.e., incomplete response in bone marrow)
* No progressive disease or MIBG-avid soft tissue tumor

PATIENT CHARACTERISTICS:

* No existing renal, cardiac, hepatic, neurologic, pulmonary, or gastrointestinal toxicity ≥ grade 3
* No human anti-mouse antibody (HAMA) titer greater than 1,000 Elisa units/mL
* No history of allergy to mouse proteins
* No active life-threatening infection
* Not pregnant
* Negative pregnancy test

PRIOR CONCURRENT THERAPY:

* Not specified
A Single Centre Randomized Study Evaluating The Safety And Tolerability Of GSK573719 In Healthy Volunteers

GSK573719 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being developed for once daily treatment of chronic obstructive pulmonary disease (COPD). The long duration of action of GSK573719 when administered via inhalation in animal models supports the potential for use as a once-daily bronchodilator for COPD

A single-centre, randomised, double-blind, placebo-controlled, dose-ascending, 3-cohort parallel-group study to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of GSK573719 administered as single doses (750µg and 1000µg) and repeat doses over 14 days (250µg-1000µg once-daily) of GSK573719 in healthy male and female subjects

Eligibility Criteria:
Inclusion criteria:

* Healthy Caucasian male subjects or healthy Caucasian female subjects of non-childbearing potential
* Aged between 18-55 years
* Non-smokers
* Normal spirometry (FEV1 = 80% of predicted, FEV1/FVC = 70%)
* A signed and dated written informed consent is obtained from the subject
* The subject is capable of giving informed consent
* Available to complete the study
* Subject has a BMI within the range 18.0-30.0kg/m2 inclusive

Exclusion criteria:

* Any clinically important abnormality identified at the screening medical assessment
* A history of breathing problems
* A mean QTc(B) value at screening \>450msec, the QTc(B) of all 3 screening ECGs are not within 10% of the mean, or an ECG that is not suitable for QT measurements
* A history of elevated resting blood pressure or a mean blood pressure equal to or higher than 140/90 mmHg at screening
* A mean heart rate outside the range 40-90 bpm at screening
* History of use of tobacco products within 6 months of screening, or positive urine cotinine at screening
* Subjects with a 2D6 poor metabolizer genotype (Caucasian)
* The subject has donated a unit (400ml) of blood within 60 days of screening, or, intends to donate during the study
* The subject is currently taking regular (or course of) medication, whether prescribed or not
* The subject has taken prescription medications within the past 2 weeks prior to dosing or OTC medications within 48 hours prior to dosing
* The subject has participated in a study with a new molecular entity or any other trial within a period of 3 months prior to dosing
* The subject has tested positive for hepatitis C antibody, hepatitis B surface antigen or HIV
* The subject has a positive pre-study drug screen
* The subject has a positive pre-study alcohol screen
* The subject has a suspected history of alcohol abuse within the six months previous to the screening visit
* The subject is unable to use the DISKUS
* The subject has a known allergy or hypersensitivity to ipratropium bromide, atropine and any of its derivatives
* The subject has a known allergy or hypersensitivity to milk protein or the excipient lactose monohydrate
* Subjects who might have prostatic hypertrophy, bladder outlet obstruction, or narrow angle glaucoma
Prospective Exploratory Study to Evaluate the Safety and Efficacy of Telbivudine in the Fifth Year of Treatment in Chinese Patients With Compensated Chronic Hepatitis B

This study will explore efficacy and safety of Telbivudine in the fifth year of treatment.


Eligibility Criteria:
Inclusion criteria

* Patient completed Omnibus study and will be available to immediately rollover into this study without discontinuation of study drug.
* Patient was not discontinued from the previous Omnibus study.
* Male or female, adult patients with CHB (HBeAg positive or HBeAg negative).
* Patient is willing and able to provide written informed consent to participate in the study.
* HBV DNA PCR undetectable in recent 12 months.

Exclusion criteria

* Pregnant or breastfeeding, or has plan of pregnant during study period.
* Patient is co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV), r HIV at screening visit.
* Patient needs any anti-HBV treatment combination (add-on therapy) or switch to other anti HBV treatment from Telbivudine at investigator's discretion.
* Patient has any laboratory value abnormality that physicians think he/she may not be suitable to continue the Telbivudine treatment.
* Patient has any clinically significant concurrent severe or unstable disease conditions that physicians think he/she may have any additional risk or not be suitable to participate the study.
* Patient has evidence of renal insufficiency defined as patient requiring dialysis or having an estimated creatinine clearance below 50mL/min, as estimated by the cockcroft-Gault formula.
* Patient is currently abusing alcohol or illicit drugs.
* Patient is enrolled or plans to enroll in another clinical trial of an investigational agent while participating in this study.
* All other treatments for hepatitis B, including commercially available treatments indicated for conditions other than chronic hepatitis B that are being investigated to treat or may have activity against HBV (e.g., ribavirin, famciclovir, ganciclovir, etc.)
* Prolonged use of systemic acyclovir or famciclovir defined as episodic treatment with these agents for periods exceeding 10 days every 3 months, or chronic suppressive therapy.
* Systemic immunomodulators of any type.
* Systemic corticosteroids ( topical and inhaled corticosteroids are permitted).
* Herbal medications known to cause hepatotoxicity (e.g., St. John's Wart, Kava, Jin Bu Huan, Yuzhitang, germander, chaparral, shark cartilage, mistletoe, slim 10, Lipokinetix, etc.).
* Patient has any of the following laboratory values:

  * Hemoglobin \< 9 g/dL for menor \<8 g/dL for women.
  * Total WBC \<1,500/mm3
  * Absolute neutrophil count (ANC)\<1,000/mm3
  * Platelet count \<30,000/mm3
  * Serum albumin \<2.5g/dL
  * Total bilirubin ≥4×ULN
  * Serum creatinine \>1.5×ULN
Follow-up of Prader Willi Syndrome Infants Treated by Oxytocin and Comparison With Not-treated Infants.

The objective of this study is to collect data on tolerance and effects of early treatment with oxytocin in children with Prader Willi Syndrome aged from 3 to 4 years and to compare these infants with not treated age-matched infants with Prader Willi Syndrome.

In accordance with recommendations of regulatory authorities, we want to collect long term data of patients treated with oxytocin before the age of 6 months. Moreover clinical observations of these infants support long term effects on communication skills, global development and behaviour.

Eligibility Criteria:
Inclusion Criteria:

* Infants with Prader Willi Syndrome (genetic diagnosis confirmed)
* For treated group : infant included in the ancient study
* For not treated group: infant never treated with oxytocin

Exclusion Criteria:

* Subject involved in another search including an exclusion period still in progress at the time of inclusion.
* Impossibility to give parents or legal guardian informed information
* No coverage by a Social Security scheme
* Refusal of parents or legal representative to sign consent.

If a patient has a contraindication to Magnetic resonance imaging, it may be included in the study but Magnetic resonance imaging will not be performed.
A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Lichen Sclerosus

The purpose of this study is to evaluate the efficacy and safety of Ruxolitinib cream in participants With Lichen Sclerosus. This is randomized, double-blind, vehicle-controlled (DBVC) study with a DBVC period of 12 weeks followed by an open label period (OLE) period of 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven LS in the anogenital area.
* Baseline IGA score ≥ 2 for LS.
* Baseline Itch NRS score ≥ 4 in anogenital area.
* Willingness to avoid pregnancy.

Exclusion Criteria:

* Participants who do not have LS involving anogenital area.
* Concurrent conditions and history of other diseases:

  1. Are suspected clinically (or confirmed diagnostically) of having alternative causes of vaginal symptoms including: candidiasis, chlamydia trachomatis, trichomonas vaginalis, neisseria gonorrhoeae, bacterial vaginosis, or herpes simplex.
  2. Have active genital/vulvar lesions at screening and Day 1, not related to LS
  3. Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before baseline.
* Laboratory values outside of the protocol-defined criteria
* Pregnant or lactating participants or those considering pregnancy during the period of their study participation..
* Other exclusion criteria may apply.
Immune Response to the COVID-19 Vaccine

Explore the effects on immune response to include a potential third vaccine for the cancer cohort.

In recent work performed by the University of Arizona Cancer Center team, 59 patients with a known diagnosis of a solid tumor malignancy on active immunosuppressive cancer therapy were enrolled through the University of Arizona Cancer Center during their routine care. These subjects had a decreased response with the vaccine when compared to the health cohort. The investigators are amending this study to explore the effects on immune response to include a potential third vaccine for the cancer cohort. This will increase the visits required to approximately two more visits. It will require two additional blood samples, one 48 hours prior to third vaccine and the second, 5-11 days after the third vaccine. The following protocol will be for the subjects that decide to continue onto a third vaccination.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have active solid tumor malignancy diagnosis
2. On active chemotherapy
3. Received two prior SARS-COV2 Pfizer vaccines
4. Age ≥ 18 years
5. Ability to understand and the willingness to sign a written informed consent
6. Agree to comply with study procedures
7. Subjects previously enrolled under the main study

Exclusion Criteria:

1. History of HIV or organ/bone marrow transplant
2. Actively receiving immunotherapy
3. On active, chronic immunosuppression (\>10 mg daily dose of prednisone equivalent)
4. Currently incarcerated or residence of another state
5. Speaks a language other than English.
Assess Bioequivalence of One 150 mg Risedronate Tablet Versus Two 75 mg Risedronate Tablets in Healthy Subjects

This study is a randomized, open-label, crossover study to assess the bioequivalence of 1 risedronate 150 mg tablet versus 2 risedronate 75 mg tablets administered as a single oral dose. Approximately 320 subjects will be enrolled from 4 study centers in the U.S.

The data to support the interchangeability of one risedronate 150 mg tablet versus two risedronate 75 mg tablets as monthly dose forms is primarily based on the similarity of in vitro dissolution and an in vivo study, which showed risedronate absorption is not dissolution rate limited. These results suggest that monthly dosing of risedronate may be accomplished by administration of either one risedronate 150 mg tablet or two risedronate 75 mg tablets. The purpose of this study is to provide additional clinical data to support the interchangeability of these 2 dose regimens.

Eligibility Criteria:
Inclusion Criteria:

* be in good general health based on medical history, physical examination, and laboratory evaluation
* have a body mass index (BMI) ≤ 32 kg/m2 at screening

Exclusion Criteria:

* has clinically significant uncontrolled cardiovascular, hepatic, renal, or thyroid disease
* has any disease or surgery known to alter normal GI structure or function
* has a creatinine clearance of \< 60 mL/min, estimated by serum creatinine using the Cockcroft-Gault formula
Using Phenazopyridine for In-office Cystoscopy

The investigators propose to conduct a randomized controlled trial to evaluate whether administration of phenazopyridine prior to the procedure decreases office cystoscopy time. Women undergoing in-office cystoscopy at Boston Urogynecology will be recruited.

All potentially eligible participants will have had a complete history, physical examination, urinalysis and urine culture for clinical purposes. After eligibility is confirmed and written, informed consent is obtained, participants will be randomized to one of the two study arms. Participants randomized to phenazopyridine arm will receive 200 mg by mouth approximately 60 minutes prior to the scheduled cystoscopy. During the cystoscopy, at various time points, the time will be recorded.The color of the efflux will also be documented.

Eligibility Criteria:
Inclusion Criteria:

* Female patients undergoing in-office diagnostic cystoscopy at Boston Urogynecology Associates

Exclusion Criteria:

* Women who have taken vitamin B the day of the cystoscopy
* Cystoscopy with concurrent treatments such as botulinum toxin or periurethral bulking injections
* Allergy to phenazopyridine
Monotherapy With Rapamycin in Long-standing Type 1 Diabetes

This study is a phase 2, single-center, prospective, randomized, double-blind, placebo-controlled, 3-arm parallel group (1:1:1) intervention trial to determine the efficacy of 4 weeks rapamycin treatment and 4 weeks rapamycin treatment plus 3 months vildagliptin treatment versus placebo in increasing endogenous insulin production and correcting glycemic lability. It will involve 60 patients with long standing type 1 diabetes (T1D). Patients will receive for one month placebo (Group 1), rapamycin plus placebo (Group 2), or rapamycin plus Vildagliptin (Group 3). Rapamycin will be administered at an initial dose 0.2 mg/kg orally on day 0 followed by 0.1 mg/kg/die (target trough levels: 8-10 ng/ml). Vildagliptin will be administered at a dose of 50 mg x2/die starting from day 0. After 4 weeks of treatment (period A), patients will discontinue rapamycin or relevant placebo treatment, but continue Vildagliptin or placebo for a further 8 weeks and be monitored over this period (period B).


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged \>18 years, inclusive
* Clinical history compatible with T1D with onset of disease at \< 40 years of age, insulin dependence for ≥ 5 years at the time of enrolment
* C-peptide concentrations under the threshold of preserved beta cell function: fasting C peptide \<0.23 ng/ml
* Detectable fasting proinsulin concentrations (\>0.5 pmol/l)
* Ability to provide written informed consent
* Mentally stable and able to comply with the protocol procedures for the duration of the study, including scheduled follow-up visits and examinations

Exclusion Criteria:

* Body mass index (BMI) \>30 kg/m2 or patient with body weight ≤40kg;
* Insulin requirement \>1.0 IU/kg/day or \<10 U/day;
* HbA1c \>11% (normal value: 3.5-6.0%) at the time of enrolment
* estimated glomerular filtration rate \<60 mL/min/1.73m2 calculated using the subject's measured serum creatinine and the Modification of Diet in Renal Disease \[MDRD\] study estimation formula)
* Presence or history of macroalbuminuria (\>300mg/g creatinine)
* For female subjects: positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 4 months after discontinuation of treatment
* Active infection including hepatitis B, hepatitis C, HIV, or tuberculosis (TB) as determined by a positive skin test or clinical presentation, or under treatment for suspected TB
* Any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin
* Lymphopenia (\<1,000/μL), neutropenia (\<1,500/μL), or thrombocytopenia (platelets \<100,000/μL).
* Severe unremitting diarrhea, vomiting or other gastrointestinal disorders potentially interfering with the ability to absorb oral medications
* Any medical condition that will interfere with safe participation in the trial;
* Any immunosuppressive treatment at the time of enrollment.
* Allergy to active ingredients or to any of excipients
Construction of a Database for the Life-cycle Sepsis-specific Disease Cohort

Establish a structured clinical database for sepsis screening, and establish a special data set standard for sepsis throughout the life cycle.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with sepsis who meet the Sepsis 3.0 standard proposed by the 2016 International Sepsis Expert Consensus, that is, for patients with infection or suspected infection, when sepsis-related sequential organ failure (Sequential (Sepsis-related) Organ Failure) Assessment (SOFA) score increased by ≥ 2 points from the baseline can be diagnosed as sepsis;
2. It is estimated that the patient's ICU stay ≥24 hours;
3. Obtain informed consent and sign an informed consent form.

Exclusion Criteria:

1. The patient's ICU hospital stay is less than 24 hours;
2. Participated in other clinical research;
3. Failed to sign the informed consent form.
Fetuin-A as a Marker in Obesity and Type 2 Diabetes Mellitus

The aim of this study is to assess the significance of serum fetuin-A as a marker of obesity and type 2 diabetes mellitus. We used multiple statistical approaches to determine that the fetuin-A level is correlated to body mass index (BMI) as well as random blood sugar in type 2 diabetic patients. Also, we found that there is a Positive correlation between the serum fetuin-A levels and the level of glycosylated hemoglobin (HbA1c) in diabetic patients.

The study was a case-control study. We started the study to be performed on eighty subjects divided into four groups:

The first group: include twenty subjects with type 2 diabetes mellitus The second group: include twenty obese subjects whose body mass index is 30 or over The third group: include twenty obese subjects with type 2 diabetes mellitus The fourth group includes twenty apparently healthy subjects as control.

In this study, we concluded that:

1. Serum fetuin-A can be used as a biomarker and independent risk factor and marker for diagnosis of DM and DM has a detrimental effect on serum fetuin-A fetuin-A could be of relevance for the development of insulin resistance
2. Higher fetuin-A concentrations were associated with type 2 diabetes and insulin resistance
3. Increased serum fetuin-A levels constitute an independent marker of lipid profile.
4. fetuin-A may play a role in the pathogenesis of T2DM.
5. The inhibition of insulin receptor by fetuin-A may lead to increased lipolysis and efflux of free fatty acids from adipose tissue. This could explain associated dyslipidemia observed in type 2 diabetic patients in the present study.

Finally, our finding that high plasma fetuin-A levels predict the incidence of type 2 diabetes independently of other established risk factors supports the hypothesis that fetuin-A may play a role in the development of type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* • The study included obese and type 2 diabetic patients aged 45-60 years old. and control healthy adult persons

Exclusion Criteria:

* • Cardiac disease and Hypertensive disease

  * Respiratory disease
  * Renal disease
  * GIT and Liver disease
  * Rheumatologic disease
  * Blood disease
  * Endocrine disease except for type 2 diabetes mellitus
  * All with a specific therapeutic drug history.
Pilot Study to Evaluate the Use of OroScience Topical Oral Wound Emulsion in Post Operative Wound Healing

The purpose of this pilot study is to determine if Topical Oral Wound Emulsion (TOWE) assists with dental wound healing and relieves pain from oral wounds.


Eligibility Criteria:
Inclusion Criteria:

* Planned dental treatment includes intraoral surgery involving full thickness mucoperiosteal flaps with at least one vertical releasing incision

Exclusion Criteria:

* Complicated medical history
* History of poor patient compliance
* Presence or placement of materials beneath the suture site
Effect of Vitamin D Supplementation on Coronary Calcification and Parathyroid Hormone in CKD Patients

The investigators hypothesize that the chronic kidney disease patients who suffer from vitamin D deficiency will be benefit from given Vitamin D2 because coronary artery calcification and hyperparathyroidism will be improved.

We will call for 350 CKD patients (250 CKD3-5stage and 100 CKD5D stage)who suffer from vitamin D deficiency.They will be divided into 2 groups. One group will be given vitamin D and the other will not. They will take coronary artery CT test every year(in 2 years).We will compare the coronary calcification progression between the 2 groups.

Eligibility Criteria:
Inclusion Criteria:

* chronic kidney disease patients (3-5D)
* serum 25（OH）D \< 40nmol/L(16ng/ml)，serum calcium \< 2.55mmol/L（10.2mg/dL）；
* willing to sign
* could obey the follow up design

Exclusion Criteria:

* allergy to vitamin D
* heart failure (NYHA more than 2 grade)
* pregnant
* malignant tumor
* critical hepatic disease
* taking Vitamin D or analogue in 3 recent months
* taking other clinical trial