cyrilzakka/clinical-trials huggingface dataset:
Biomarkers of Molecular Risk in Smokers

Doctors at MSKCC are doing this research study to see if smokers are interested in the idea that genes might be markers of cancer risk, and to see if smokers would want to learn this information about their risk if it were available.

Different versions of the gene called UGT1A7 are found in different people. Certain versions of this gene can increase the risk of cancer in people. In this study, doctors will determine the different types of UGT1A7 in smokers and find out whether smokers show good interest and understanding. The information from this study will be used in future studies to identify smokers at increased risk for cancer, and to help smokers quit.

This study consists of two arms; both of which are observational studies of molecular assessments of risk for tobacco related cancer. Arm A of the protocol is a pilot crosssectional study that evaluates the feasibility of obtaining and testing a genetic marker of cancer susceptibility (UGT1A7 polymorphisms) in smokers. It also explores smokers' interest in and comprehension of genetic risk assessments as possible tools for increasing motivation for smoking cessation. The second arm of this protocol, Arm B, is an observational prospective evaluation of a putative noninvasive biomarker of tobacco smoke exposure - urinary prostaglandin E-metabolite (PGE-M) - in smokers motivated to reduce and/or cease smoking.

Eligibility Criteria:
Inclusion Criteria:

* Arm A
* 18 years or older;
* \>5 packyear history of smoking;
* Ability to understand and sign informed consent.
* Arm B
* 18 years or older;
* \>10 packyear history of smoking;
* Intention to taper and/or quit smoking within 6 months
* Ability to understand and sign informed consent.

Exclusion Criteria:

* Arm A
* Diagnosis of any cancer in the preceding twelve months; (excluding non melanoma skin cancer).
* Arm B
* Diagnosis of any cancer in the preceding twelve months; (excluding non melanoma skin cancer).
* Use of any COX-2 inhibitor, steroid, or non-steroidal anti-inflammatory medication (excluding cardioprotective aspirin \> 81mg/d) within one week of urine collection
Phototherpy Versus Tapwater Iontophoresis for Management of Atopic Dermatitis in Children.

this study is conducted to compare the effect of phototherapy" psoralen plus UVA " bath puva to tap water iontophoresis in the treatment of atopic dermatitis in children.

Sixty children were selected from the department of dermatology, Banha University Hospital. Patients were randomly assigned to (Group- A):- 20 children Patients, aged between 6-16 years old. be treated with Phototherapy, for 3 sessions per week for 8 weeks Plus the traditional medical treatment. which is the betamethasone dipropionate 0.05% " diprolene for 2 times a day for 8 weeks. (Group B): 20 children Patients, in Group-B are treated with tap water iontophoresis, for 8 weeks, 3 sessions /week: the intensity were increased according to the patient's tolerance, for 20 minutes. Plus the traditional medical treatment. (Group -C) the control group will treated by only the traditional medical treatment which is the betamethasone dipropionate 0.05% " diprolene" cream, two times a day for 8 weeks Skin thickness by ultrasonography and Patient Oriented Eczema Measure(POEM) are measured before and after 8 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age between 9 to 16 years.
* Suffering from AD of dyshidrotic as well as dry types of more than 6-months duration
* Traditional types of treatment options, including oral or topical corticosteroids, proved ineffective.

Exclusion Criteria:

* Intolerance history to UV radiation.
* Skin malignancy at the area to be treated.
* Acute infection at the treated area.
* Children received radiotherapy in the area to be treated during the last 6 months.
* Children received corticosteroid therapy topically within 14 days before treatment, or systemic corticosteroids or any immunosuppressive drugs within the last 4 weeks.
* Circulatory and sensory disorders and children with diabetes mellitus.
Dose-escalation Study to Evaluate the Safety and Tolerability of GS030 in Subjects With Retinitis Pigmentosa

The objective of this study is to evaluate the safety and tolerability of escalating doses of a gene therapy called GS030-DP (injected study treatment) administered via a single intravitreal injection and repeated light stimulation using a medical device called GS030-MD (stimulating glasses) in subjects with documented diagnosis of non-syndromic Retinitis Pigmentosa


Eligibility Criteria:
Main selection criteria:

* Age ≥18 years to ≤75 years at the time of ICF signature.
* Diagnosis of non-syndromic RP defined as:

  * Clinical diagnosis of non-syndromic RP based on history, mid-peripheral visual dysfunction, and fundoscopic appearance.
  * Diagnosis of non-syndromic RP is confirmed on full-field ERG
* Visual acuity:

  * Visual acuity in the dose-escalation cohorts of no better LP.
  * Visual acuity in the extension cohort of no better than CF pending review of dose-escalation cohort data by the DSMB.
* Relatively preserved ganglion cell layer volume and retinal nerve fiber layer thickness, as measured with spectral domain optical coherence tomography (SD-OCT).
* Interpupillary distance of ≥51 mm and ≤72 mm.
* Refractive error of the study eye between -6 diopters and +6 diopters.

Main non-selection criteria

* Prior receipt of any gene therapy.
* Subjects who have undergone significant ocular surgery (per investigator determination) within 3 months prior to Visit 1.
* Presence of narrow iridocorneal angles contraindicating pupillary dilation.
* Presence of disorders of the ocular media which interfere with visual acuity and other ocular assessments, including SD-OCT, during the study period.
* Presence of any systemic or ocular diseases, or pathologies, other than non-syndromic RP, or their associated therapies, that can cause or have the potential to cause vision loss.
* Prior vitrectomy or vitreomacular surgery.
* Presence of vitreo-macular adhesion or traction, epiretinal membrane, macular pucker and macular hole, evident by ophthalmoscopy and/or by SD-OCT examinations and assessed by the investigator to significantly affect central vision.
* Current evidence of retinal detachment assessed by the investigator to significantly affect central vision.
* Active ocular inflammation or recurrent history of idiopathic or autoimmune associated uveitis.
* Presence of an Active Implantable Medical Device.
* Subjects who have undergone thermal laser procedure to the retina within 3 months of trial entry, or any prior thermal laser procedure to the macular region.
Prospective Evaluation of the Predictive Criteria of Severity for Respiratory Infection Due to COVID-19 Virus

Emergency call centers are very solicited in epidemic situations. It is necessary to detect early Predictive Criteria of Severity in COVID respiratory infection to identify patients at risk of complication or aggravation from an emergency call center in order to adapt their orientation and their medical management.


Eligibility Criteria:
Inclusion Criteria:

* patient (more than 15 years old) calling the emergency call center (15 center) for Low or High Respiratory Infection With or Without Fever and Suspected to be COVID

Exclusion Criteria:

* unknown contact facility
* call not regulated by a practitioner from the medical emergency help team
Use of Localized NB-UVB (Levia®) in the Treatment of Plaque-psoriasis

The purpose of the study is to test the effect of a localized narrow band ultraviolet (NB-UVB) phototherapy compared to visible light that does not produce UVB on the clearance of psoriasis plaques and resolution of itching. Localized NB-UVB (Levia®) phototherapy device is cleared by the U.S Food and Drug Administration (FDA).

This will be an ascending dose study with treatments three times per week, initial treatment dose and increasing regimen is adjusted according to the subject skin type. A suggested treatment regimen schedule provided from Lerner Medical Devices, Inc:

For subjects with skin type I: starting dose of 195 mj/cm2, for subjects with skin type II: starting dose of 330 mj/cm2, for subjects with skin type III: starting dose of 390 mj/cm2, for subjects with skin type IV: starting dose of 495 mj/cm2, for subjects with skin type V: starting dose of 525 mj/cm2, for subjects with skin type VI: starting dose of 600 mj/cm2.

The dose will be increased by 15% with each treatment, as long as there are no side effects with treatment such as burning or redness.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years or older with bilateral psoriasis plaques, in general good health as determined by the Principal Investigator by medical history and physical exam.
* Able to understand consent procedure
* Able to comply with protocol activities
* Must have baseline symmetric target lesions with baseline Target Lesion Score (TLS) of 6 or higher (scale of 0-12), i.e., moderate in intensity for each target.

Target Lesion Scoring: Thickness, scaling and erythema of the plaques are rated each on a scale of 0-4. The three scores are summed. The minimum score is 0; the maximum is 12. Scores of 6 or greater are considered moderate to severe.

Exclusion Criteria:

* Patients less than 18 years old
* Patients not able to understand consent procedure
* Patients unable to comply with protocol activities
* Non-English speakers: the study assessments/questionnaires/evaluations are not scientifically validated in languages other than English
* Baseline target lesions scores of less than 6
* Patients with a photosensitive disorder or on a medication which has been demonstrated in these patients to cause photosensitivity
* Patients receiving concomitant phototherapy to test sites
* Patient receiving topical medication to test sites within 2 weeks of study initiation
* Patient receiving Methotrexate, Acitretin, Cyclosporine, or other oral medications for psoriasis within 4 weeks of study initiation
* Patients receiving Etanercept (Enbrel®) within the past 2 months of study initiation
* Patients receiving Infliximab (Remicade®), Ustekinumab (Stelara®), Golimumab (Simponi®) Adalimumab (Humira®) or Alefacept (Amevive®) within the past 3 months prior to study initiation
* Receipt of an investigation agent within the past 4 weeks (or within 5 half lives) prior to study ignition
* Systemic corticosteroid therapy within the past month
* Concurrent use of prohibited medications
Early Mobilization of Patients With Community-acquired Pneumonia

Pneumonia is a common health problem.This thesis may clarify whether early mobilization influence the time these patients are hospitalized, whether they are rehospitalized and whether it is possible to reduce the mortality rate.

Pneumonia is a common health problem. More than 100,000 Danes contract pneumonia every year, and around 15,000 of these are hospitalized. The main treatment is antibiotics. An American study indicates that patients who are mobilized early are hospitalized for a shorter period of time. The objective of the thesis is: to determine the effect of mobilization within 24 hours after hospitalization of patients with pneumonia. The result will be number of hospitalization days, rehospitalisation and mortality.

Patients with pneumonia hospitalized in the period 1 September 2012 - 28 February 2013 in the Medical Centre, lung unit 204B at Vendsyssel Hospital will be included in the project. Within the first 24 hours of hospitalization, they will be tested by a physiotherapist and mobilized.

There are significant costs associated with the treatment of patients with pneumonia - both economic costs and human costs. This thesis may clarify whether early mobilization influence the time these patients are hospitalized, whether they are rehospitalized and whether it is possible to reduce the mortality rate.

Eligibility Criteria:
Inclusion Criteria:

* patients with community-acquired pneumonia

Exclusion Criteria:

* dementia
Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry

This is an observational study to evaluate safety and efficacy outcomes in renal transplant recipients in whom post-transplant care is managed using AlloSure®. AlloSure® is a non-invasive test to measure donor-derived cell-free DNA (dd-cfDNA). The AlloSure test is intended to assess the probability of allograft rejection in kidney transplant recipients with clinical suspicion of rejection and to inform clinical decision-making regarding the necessity of renal biopsy in such patients at least 2 weeks post-transplant in conjunction with standard clinical assessment.

Amendment 1 (A1): Is an observational study to develop and validate the clinical use of KidneyCare®.

The AlloSure test has been approved for Medicare coverage for clinical use when a physician determines there is a need to assess the probability of allograft rejection in kidney transplant recipients. The DART study suggests that use of the non-invasive AlloSure test to measure donor-derived cell-free DNA (dd-cfDNA) can be used to discriminate active rejection in a renal transplant recipient. Use of the test may reduce invasive percutaneous renal biopsy procedures among patients with a suspicion of rejection.

Amendment 1 (A1) is intended to enable the development of KidneyCare® which is a panel test which includes the clinically validated commercial AlloSure dd-cfDNA test, combined with AlloMap Kidney which is a peripheral blood gene expression profiling test currently under development, and iBox, which is an analytic platform that predicts allograft survival at 3, 5, 7 and 10 years using a proprietary software algorithm based on a number of clinical inputs. The AlloMap Kidney and the iBox components are not yet clinically validated and so will not be used for patient management and are being developed through this study.

Eligibility Criteria:
KOAR Inclusion Criteria:

1. Patient's health care provider adopts and intends to apply the center's AlloSure Routine Testing Schedule as part of the information used to manage the patient.
2. Subjects willing to provide written informed consent to participate.

KOAR Exclusion Criteria:

___________________________________________________________

Exclusions for AlloSure® Intended Use

Specimens from patients for whom any of the following are true will not be tested:

1. Recipients of transplanted organs other than kidney
2. Recipients of a transplant from a monozygotic (identical)
3. Recipients of a bone marrow transplant
4. Recipients who are pregnant
5. Recipients who are under the age of 18
6. Recipient who are less than 14 days post-transplant
Generic Zoledronic Acid Versus Original Zoledronic Acid in Postmenopausal Osteoporotic Women

This study compares the efficacy and safety of generic zoledronic acid (Yigu®) and original zoledronic acid (Aclasta®) in the treatment of postmenopausal osteoporotic women in China. Four hundred and sixty-six subjects will be randomised (1:1ratio) to either Yigu® 5mg IV or Aclasta® 5mg IV treatment arms.

A single infusion of intravenous zoledronic acid decreases bone turnover and improves bone density at 12 months in postmenopausal women with osteoporosis, and it significantly reduced the risk of vertebral fractures additionally.

In this research, the efficacy and safety of generic zoledronic acid injection in the treatment of postmenopausal osteoporosis will be evaluated, using original drug as control drug. It will provide evidence for reasonable clinical administrations.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women between the ages of 46 and 80（cessation of menses for 12 months for any reason）
* Subjects with osteoporosis diagnosed according to the World Health Organization (WHO) criteria：they had a BMD T-score of -2.5 or less at the spine or femoral neck；or they had low bone mass，defined as BMD T-score less than -1.0 and more than -2.5 at the spine or femoral neck，with the history of fragility fracture(Fracture site included vertebra, hip,proximal humera, distal radius, distal ulna)
* Subjects signed informed consent voluntarily

Exclusion Criteria:

* Any non-primary osteoporosis skeletal disease
* Subjects with abnormal hepatic function and renal function（alanine transaminase(ALT) and aspartate transaminase(AST) are 2 times higher than the upper limits of normal(ULN);plasma creatinine concentration and blood urea nitrogen are more than 1.5 ULN or calculated creatinine clearance less than 60 ml/min）
* Subjects with serum calcium greater than 2.75 mmol/L (11.0 mg/dL) or less than 2.00 mmol/L (8.0 mg/dL)
* Subjects with severe heart disease, blood disease, mental diseases
* Subjects with cancer and other serious progressive disease
* Prior therapy with bisphosphonates within 12 months before trial entry, prior therapy with parathyroid hormone 1-34 or 1-84, estrogen, selective estrogen receptor modulators, strontium more than 2 weeks within 6 months, prior therapy with oral or intravenous glucocorticoid more than 3 months within 6 months
* Subject is hypersensitivity to experimental drugs, comparator drugs and their metabolites
* Subjects who participated in other drugs or medical devices clinical studies as subjects within 3 months before this study
* Subjects judged unfit for this study by investigators
Computerized Tool for Preventing Prenatal Drinking

An innovative, self-administered computerized screening and brief intervention (SBI) for drinking during pregnancy will be adapted for use with non-pregnant childbearing age women and its efficacy will be tested in a small trial. Study findings will inform a larger randomized control trial for a primary prevention tool with the potential for broad health impact.

This study evaluates a recently piloted, self-administered, computerized tool for reducing prenatal drinking that added novel components of drink size assessment and drink size feedback to traditional screening and brief intervention (SBI). The bilingual (English and Spanish) electronic SBI or "e-SBI" will be adapted for use with non-pregnant women and a small trial of its efficacy will be conducted in two public health clinics. The effects of drink size assessment by itself and of depression as a modifier of e-SBI efficacy will also be studied. Study findings will help design a larger trial of e-SBI's efficacy for reducing prenatal alcohol use.

An experimental design will be used for the proposed small trial. Two hundred women, who have not been pregnant in the past year and report alcohol at risky levels will be randomly assigned to e-SBI or usual care. Participants will complete baseline, 3-month and 6-month follow-up assessments. These assessments will examine drinking and pregnancy as well as possible negative outcomes, such as increased drug use associated with the e-SBI. To address methodological limitations in prior research, the study design incorporates drink size assessment to better measure drinking outcomes, minimizes assessment reactivity for controls at baseline, and includes a booster e-SBI at the 3-month follow up. This allows for the examination of whether drink size assessment reduces drinking by itself and if its effects are equivalent to that of the full e-SBI. With these design innovations, the study is expected to provide information that can be more rigorously assessed in a subsequent multi-arm trial. Because it sets the stage for a Phase II trial of e-SBI efficacy for reducing prenatal alcohol use, our proposed study is of significance for improved maternal and child health. Findings will also impact the larger intervention literature on cost-effective strategies to reduce alcohol-related harm.

Eligibility Criteria:
Inclusion Criteria:

* not pregnant in the last 6 months, drank alcohol in the past year, alcohol consumption was at risky levels,

Exclusion Criteria:

* not fluent in english or spanish,
Cyclophosphamide, Abatacept, and Tacrolimus for the Prevention of GvHD

This is a single arm, open label, phase II clinical trial. Adult patients with hematological malignancies undergoing allogeneic HSCT from first- or second-degree haploidentical donor are eligible for the study if they meet the standard criteria defined in our institutional standard operation procedures (SOPs), meet all inclusion criteria, and do not satisfy any exclusion criteria. Patients will receive non-myeloablative, reduced-intensity or myeloablative conditioning regimen followed by peripheral blood hematopoietic stem cells. Patients will receive dosed reduced cyclophosphamide, abatacept, and short-duration tacrolimus for GvHD prophylaxis.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Karnofsky score ≥ 70%
* No evidence of progressive bacterial, viral, or fungal infection
* Creatinine clearance \> 50 mL/min/1.72m2
* Total bilirubin, Alanine Aminotransferase and Aspartate Aminotransferase \< 2 x the upper limit of normal (except for diagnosed Gilbert's syndrome)
* Alkaline phosphatase ≤ 250 IU/L
* Left Ventricular Ejection Fraction (LVEF) \> 45%
* Adjusted Carbon Monoxide Diffusing Capacity (DLCO) \> 60%
* Negative HIV serology
* Negative pregnancy test: confirmation per negative serum β-human chorionic gonadotropin (β-hCG) for women of childbearing age and potential.

Exclusion Criteria:

* Donors are excluded in case of donor-specific HLA antibodies or positive cross-match.
* Pregnant or nursing females or women of child bearing age or potential, who are unwilling to completely abstain from heterosexual sex or practice 2 effective methods of contraception from the first dose of conditioning regimen through day +180. A woman of reproductive capability is one who has not undergone a hysterectomy (removal of the womb), has not had both ovaries removed, or has not been post-menopausal (stopped menstrual periods) for more than 24 months in a row.
* Male subjects who refuse to practice effective barrier contraception during the entire study treatment period and through a minimum of 90 days after the last dose of study drug, or completely abstain from heterosexual intercourse. This must be done even if they are surgically sterilized (i.e., post-vasectomy).
* Inability to provide informed consent.
* Patient had myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see Appendix E), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening must be documented by the investigator as not medically relevant.
* Known allergies to any of the components of the investigational treatment regimen.
* Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
* Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial.
* Prisoners