cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Mometasone Furoate (SCH 032088) vs Beclomethasone Dipropionate or Placebo in Seasonal Allergic Rhinitis (C93-013)

The objectives of this study are to determine the safety and efficacy in seasonal allergic rhinitis of a four-week course of mometasone furoate compared to beclomethasone dipropionate or placebo.


Eligibility Criteria:
Inclusion Criteria:

* Nonpregnant women of childbearing potential must be using a medically acceptable form of birth control for at least 3 months prior to Screening, and must continue its use for the duration of the study. Women not of childbearing potential must be surgically sterilized or at least one year post menopausal, or be otherwise incapable of bearing children
* 2-year history of seasonal allergic rhinitis
* Positive skin test response to a local seasonal allergen within last 2 years
* Good health and free of any unstable, clinically significant disease, other than allergic rhinitis, that would interfere with the study schedule or evaluation of seasonal allergic rhinitis

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Women of childbearing potential who are not using an acceptable form of birth control
* Pre-menarchal females
* Asthma requiring therapy with inhaled or systemic corticosteroids
* Significant renal, hepatic, neurologic, cardiovascular, hematologic, metabolic, cerebrovascular, respiratory, gastrointestinal, or other significant medical illness or disorder which, in the judgment of the investigator, may interfere with the study, or require treatment which might interfere with the study
* On immunotherapy (unless maintenance therapy)
* Upper respiratory tract or sinus infection that requires antibiotic therapy within the previous 2 weeks
* Use of any investigational drug within the previous 90 days unless the investigational drug is a nasal corticosteroid or has a short (12 hours or less) duration of action, in which case the washout period will be 30 days
* Large nasal polyps, marked septal deviations or any other nasal structural abnormality that significantly interferes with nasal air flow
* Allergy to corticosteroids, or a history of multiple drug allergies
* History of posterior subcapsular cataracts
* Dependence upon nasal, oral or ocular decongestants or who are diagnosed with rhinitis medicamentosa
* Chronic use of any medication which could affect the course of seasonal allergic rhinitis
* Clinically significant abnormal electrocardiogram (ECG)
Alteration of Thrombelastography and Coagulation Function in Patients Undergoing Total Knee Arthroplasty With Intra-articular Tranexamic Acid Administration

The main aim and scope of this study is making comparison about the thrombelastography and coagulation function in patients before and after the total knee arthroplasty with intra-articular tranexamic acid administration. The results may identify the influence of the intra-articular tranexamic acid administration on the relative coagulability monitoring.


Eligibility Criteria:
Inclusion Criteria:

* The patients received primary total knee arthroplasty;
* Normal pre-operative coagulation function;
* Complete surgery document, transfusion document and relative blood test.

Exclusion Criteria:

* The patients received complicated total knee arthroplasty;
* Abnormal pre-operative coagulation function caused by some diseases such as hepatic inadequacy, thrombocytopenia et al.
* Incomplete documents.
Secondary Cancers in Myeloproliferative Neoplasms (MPN-K Study)

The incidence of secondary cancer (SC) in patients with myeloproliferative neoplasms (MPN) is high and comparable to that of thrombosis. However, the identification of patient subgroups that might be at increased susceptibility of developing SC has not been systematically addressed. This international case-control study (MPN-K) is aimed to elucidate the prognostic role of JAK2V617F mutation in predicting the occurrence of SC in patients with classical MPN, polycythemia vera (PV), essential thrombocythemia (ET) and myelofibrosis (MF)

For each recruited case with concomitant diagnosis of myeloproliferative neoplasms (MPN) and secondary cancer each participating center will provide up 3 control patients (1 control for each case could be accepted but the optimal number is 3). Controls are patients with myeloproliferative neoplasms and no history of cancer. Each control will be matched to the paired case for sex, age (+/- 3 years), date of MPN diagnosis (+/- 5 years), and MPN disease duration (+/- 3 years).

Each control is censored at the date of the secondary cancer occurrence in his matched case (index date).

Data will be collected retrospectively from pre-existing medical records and reported by each center on a web-based and validated eCRF developed to record y all study data. In order to maintain patient privacy, all data records will be treated anonymously and no personal data to identify patient will be recorded: patients will be identified in the study by an alphanumeric code.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Philadelphia-negative Myeloproliferative Neoplasms (MPN) according to PVSG, 2008 and 2016 WHO criteria, including:
* Polycythemia Vera (PV)
* Essential Thrombocythemia (ET)
* Myelofibrosis (MF), including both primary and secondary MF
* Diagnosis performed between 1st January 2000 to 31 December 2016
* Diagnosis of secondary cancer(s) performed concurrently or subsequently the diagnosis of MPN

Exclusion Criteria:

- Diagnosis of cancer occurred before the diagnosis of MPN (PV, ET, MF)
Preemptive Analgesia for Primary Dysmenorrhoea

Preemptive analgesia before the release of pain mediators

spasmodic dysmenorrhea is one of the most distressing symptoms in women. adolescents shows a usual absence from school . prostaglandin release is one of the most accepted theory responsible for spasmodic dysmenorrhea.

Non steroidal anti inflammatory Drugs were proved to be one of the alternative medications for spasmodic dysmenorrhea.

Getting the idea of what is called preemptive anesthesia by blocking the receptors before catching pain mediators the study participants will be divided randomly into 2 group group 1 receiving ttt 2 days before the anticipated menstruation and group 2 receiving ttt only during menstruation as analgesia

Eligibility Criteria:
Inclusion Criteria:

* nulliparous ladies
* with regular menstrual cycle pattern
* those experienced history of dysmenorrhea (primary or spasmodic)
* patients able to sallow tables

Exclusion Criteria:

* irregular cycles
* any associated local causes( pelvic infection, endometriosis, fibroid or others)
* patients with familial Mediterranean fever or other intermenstrual attacks of abdominal pain
* gastric or duodenal ulcers or gastritis
* other contraindications to non steroidal anti-inflammatory drugs
* patients with severe diminution of vision or color discrimination
* patients with any depressive or mood disorders
* patients receiving any hormonal treatment
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Primary CNS 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 tumor cells. Combining radiation therapy with chemotherapy may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of methotrexate and cytarabine plus radiation therapy in treating patients who have primary CNS lymphoma.

OBJECTIVES: I. Determine the efficacy of methotrexate and cytarabine chemotherapy in combination with whole-brain radiation therapy for patients with non-AIDS related primary central nervous system lymphoma. II. Assess the response rate and safety of this chemotherapy regimen.

OUTLINE: Patients receive the first course of chemotherapy as soon as possible after diagnosis and staging. Methotrexate (MTX) IV is administered over 40-60 minutes on days 1 and 15. Cytarabine (AraC) is administered intrathecally on days 1 and 15. The second course of chemotherapy begins on day 29 or after bone marrow recovery. Radiation therapy begins no later than 3 weeks after completing chemotherapy. Patients are followed until death.

PROJECTED ACCRUAL: A maximum of 50 patients will be accrued.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven non-Hodgkin's lymphoma of the central nervous system (CNS) including leptomeninges and the spinal cord No Burkitt's lymphoma or low grade T-cell lymphoma Must have at least 1 measurable lesion No AIDS-related primary central nervous system lymphoma (PCNSL) No disease confined to the eye without other localization in the CNS

PATIENT CHARACTERISTICS: Age: 16 to 60 Performance status: Karnofsky 40-100% Neurological functional status 0-3 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: No serious impairment of hepatic function Renal: No serious impairment of renal function Creatinine no greater than 1.5 mg/dL OR Creatinine clearance no less than 50 mL/min Cardiovascular: No serious impairment of cardiac function Other: HIV negative No congenital or acquired immunodeficiency syndrome No prior/concurrent systemic lymphoma No prior malignancy except: Adequately treated non-melanoma skin cancer Carcinoma in situ of the cervix uteri Not pregnant No severe uncontrolled infection

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent treatment with immunosuppressive drug Chemotherapy: No prior chemotherapy Endocrine therapy: Corticosteroid use for less than 3 weeks allowed Radiotherapy: Not specified Surgery: No prior organ transplantation
Determination of the Predictive Factors in the Reversibility or the Aggravation in the Disorders of the Glucose Metabolism in Cystic Fibrosis Patients

For some years, the investigators observe an increase of the arisen of diabetes in cystic fibrosis patients However, this diabetes may be reversible. The investigators speak about " Cystic fibrosis related diabetes.". The objective of this project, is to know better what facilitates the appearance and the reversibility of the diabetes, such as the genetic mutations, the respiratory state and the lung infections. Theses knowledges should allow to adapt the screening of diabetes, and its treatment, for the patients affected by cystic fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* Cystic fibrosis patients with at least one visit in Cystic fibrosis Center in Rhône-Alpes (France) during the second half-year 2008
* Patients with disorders or not of the glucose metabolism
* Patient with pancreatic insufficiency

Exclusion Criteria:

* Patient with hypoglycemia treatment : insulin or oral antidiabetic
* Patient with an age \< 10 years
* Patient with lung transplant
Japanese Bridging Study Conducted in the United States

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics following single oral and multiple oral doses BMS-791325 in healthy Japanese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects aged 20 to 49 years, with BMI of 18-30 kg/m2
* First generation Japanese. Subject born in Japan and has not lived outside of Japan for \> 10 years, and subject can trace maternal and paternal Japanese ancestry

Exclusion Criteria:

* Any significant acute or chronic medical illness.
* Women who are pregnant, breastfeeding, or unwilling or unable to use an acceptable method of birth control.
* Gastrointestinal disease that may impact the absorption of study drug or that required treatment with a protocon inhibitor, antacid or H2 blocker.
* History of eczema, psoriasis, or any intermittent or active dermatitis.
* Positive for HIV or HCV
Hepatic Artery Stenosis and Thrombosis After Liver Transplantation in Children

The goal of this observational study is to investigate the incidence, current management practices, and outcomes in pediatric patients with HAC after liver transplantation.

Research question:

* What are the overall incidence of HAC and the effectiveness of all treatment strategies for HAC after pediatric LT?
* What are the current management practices in the experience of centers, anticoagulant therapy, screening protocol, and assessment criteria for HAC after pediatric LT?

The burden of participation is considered to be minimal, and limited to the questionnaires.


Eligibility Criteria:
Inclusion criteria:

* Liver transplantation between January 1st 2002 and January 1st 2022, diagnoses of HAC after LT
* The age of the patient is below 18 years at the time of diagnosis and intervention
* The date of diagnosis of HAC or intervention was before January 1st 2023. HAC occurring after first or subsequent LTs are included.

Exclusion criteria:

N/A
A Study of Response to Standard Treatment Before Surgery in People With Rectal Cancer

The purpose of the study is to learn more about how the body responds to standard treatment (chemoradiation and chemotherapy). The study will use the results of testing down on participants' blook, tissue, and scans to learn more about how people with rectal cancer respond to chemoradiation and chemotherapy treatment and if it is useful for predicting whether a person's cancer get better, gets worse, or stats the same after treatment.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older on day of signing informed consent.
* Have a histologically confirmed diagnosis of invasive adenocarcinoma of the rectum with no known mismatch repair deficiency or Her2 amplification.
* Eligible for and plan to initiate standard-of-care therapy with any of the following regimens:

  * Induction fluoropyrimidine (capecitabine \[preferred\] or 5-FU) based chemoradiation
  * With plan for consolidative CAPEOX, FOLFOX, or FOLIRINOX
* Woman with childbearing potential who are negative for pregnancy test (urine or blood) and who agree to use an effective contraceptive method. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant. Reliable contraception should be used from the time of screening and must be continued throughout the duration of treatment as per standard of care.

Exclusion Criteria:

* Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
* Patients with prior external beam radiation therapy to the pelvis or brachytherapy seed implantation of the prostate.
* Patients who are pregnant or breastfeeding.
* Men or women not using effective contraception.
* Patients with a contraindication to MR imaging.
* Patients on blood thinners prohibiting endoluminal tumor biopsies.
Using Shear Wave Ultrasound Elastography for Follow up After Anti-spastic Intervention Among Stroke Patients

Spasticity of stroke patient, a very common complication in clinical practice, affects performance of hand function and gait pattern. It also interferes with quality of life of patients severely. Currently first line clinical approach to spasticity consist of physical therapy and pharmacological management. However, there are still some refractory cases that needed local intervention such as Botox injection.

So far, we only can use subjective methods to measure muscle tension, such as modified Ashworth scale and Tone Assessment Scale. In our previous study, we found that ultrasound shear wave image could correlate with muscle stiffness caused by poststroke spasticity. With this new method, we aim to establish a more objective method in measuring abnormal poststroke muscle tension before and after treatments and further monitor therapeutic effect. We also include several assessment scales to evaluate the correlation between measured muscle spasm and activity of daily living.

We hypothesize that the rheological changes in muscles muscle spasm after Botox injection can be detected by ultrasound shear wave image. Therapeutic effect can also be seen in its effect on daily functions.

In this project, we will use shear wave imaging of ultrasound to investigate the elasticity (and hardness) of the biceps brachii and brachialis muscle in stroke patients with unilateral hemiplegia before and after Botox injection. The findings of this project will provide the objective evaluation of muscle spasticity and its correlation with functional status, which will provide new points of view toward treatment of spasticity.


Eligibility Criteria:
Inclusion Criteria:

\[Intervention group\]

* Stroke patients with unilateral involvement
* Patient's spasticity over affected upper extremities scored at least 1+ with Modified Ashworth Scale
* Patient required botulinum toxin injection at affected upper limb muscle per primary care physician.

\[Control group\]

* Stroke patients with unilateral involvement
* Patient's spasticity over affected upper extremities scored at least 1+ with Modified Ashworth Scale

Exclusion Criteria:

* Patients ever diagnosed with cerebral diseases other than stroke, such as traumatic brain injury, encephalitis and brain tumor
* Patients failed to cooperated due to cognition, consciousness or speech problem
* Patients with illness that could affect muscle stiffness, such as spinal cord injury and Parkinson's disease
* Patients with upper limb contracture
* Patients receiving botulinum toxin injection or shock wave therapy over upper extremities during past three months
Prevention of Iron Deficiency in Breastfed Infants

With early screening and appropriate iron supplementation, iron deficiency in the first year of life can be prevented in breastfed infants.

Infants with low ferritin at 1 month are at high risk of iron deficiency. They will receive iron drops starting at 2 months. All other infants are at low risk of iron deficiency. All infants will receive iron-fortified cereal starting at 4 months of age.

Eligibility Criteria:
Inclusion Criteria:

* Term infants
* gestational age 37-42 weeks
* birth weight \> 2500 g
* exclusively breastfed at 28 d of age
* intend to breast feed until 9 mo of age

Exclusion Criteria:

* supplemental formula before 4 mo of age
Physical Activity and Metabolic Risk Factors in Postmenopausal Women

Hormonal changes associated with menopause, chronological aging, and lifestyle, especially physical inactivity, may increase the risk of metabolic syndrome in postmenopausal women. Women exhibiting "the metabolic syndrome" have multiple coronary artery disease risk factors, including insulin resistance, hyperlipidemia, and hypertension. This study will be conducted to test the hypotheses: (1) physical activity and physical fitness levels may have effects on individual risk factors of the metabolic syndrome in postmenopausal women; (2) endurance exercise training may have a favorable effect on components of the metabolic risk variables in these women.

In this study, the associations among physical activity (including daily energy expenditure and energy expenditure from moderate to vigorous activity), cardiopulmonary fitness level, and metabolic risk profile of the women will be assessed. The investigators will perform a randomized trial to compare the effects of moderate-intensity aerobic exercise training regimens on metabolic risk factors. Postmenopausal women who exhibit at least one risk factor for metabolic syndrome will be randomized in the exercise group or control groups. Metabolic risk factors (e.g., body mass index, waist-to-hip ratio, glucose, insulin, blood pressure, lipid profile and adiponectin level) will be measured at baseline, and 12 weeks of the study. Differences from baseline to follow-up will be calculated and compared across groups.

Results of this study may help health care providers providing advice to postmenopausal women for life style changes to reduce risk of insulin resistance, coronary heart disease, and diabetes.


Eligibility Criteria:
Inclusion Criteria:

* have one or more metabolic risk variables as defined by the ATP III (2001)
* age between 35 and 64 years
* absence of known heart disease
* resting BP: 130 \< SBP \< 160 and 85 \< DBP \< 100
* currently physical inactive (\< 30 min of physical activity per week)

Exclusion Criteria:

* None of the participants has a diagnosis of type 2 diabetes, physical illness or disabilities that will limit daily physical activities.
A Clinical Study Comparing Basic Performance and Hemocompatibility of 3 Different Dialyzers in Hemodialysis Patients

The aim of the study is to confirm the safety and clinical effectiveness of Nipro ELISIO-15H and to compare its performance characteristics and hemocompatibility with those of the commercially available dialyzers in U.S.A., Gambro Polyflux Revaclear and Fresenius F160NRe.

10 stable patients will be dialyzed 3 times/week with each dialyzer over 3 weeks. Blood samples for several parameters will be collected during hemodialysis to assess the performance and hemocompatibility of the dialyzers under study. Data thus collected will be analyzed for comparison by standard statistical analysis.

Current patients receiving dialysis treatment for end stage renal disease and who meet the inclusion/exclusion criteria will be entered into the study. These patients will continue on their standard dialysis regimen as stated in the clinics Standard Operating Procedures. Each patient will be studied for three weeks with each week starting with a dialyzer of a different manufacture but of comparable characteristics. Solute clearances and removal will be determined at each of the three dialysis sessions during the week. During session 2 of each week additional specimens will be taken to analyze for hemocompatibility. At the end of the study all clearances and the hemocompatibility markers for each dialyzer will be compared to one another as well as to the manufactures stated characteristics. Blood for the clearance and removal calculations will be taken at time 0, 60 minutes and 240 minutes. Blood for the hemocompatibility determinations will be taken at time 0, 15, 30, 60 and 240 minutes. Flow rates, anticoagulant therapy, erythropoietin therapy, venous and arterial pressures will also be recorded.

Eligibility Criteria:
Inclusion Criteria:

* ESRD patients 18 years or older
* Stable on hemodialysis for more than 3 months
* Stable hemoglobin between 11-12 g/dl
* Stable arteriovenous (AV) fistula vascular access
* Stable anticoagulation and ESA regimen
* No active infection
* Able to sign informed consent and able to participate in the study
* Medically stable

Exclusion Criteria:

* Participation in another study which may interfere with the planned study
* Active infection
* Medical conditions which may interfere with the study (cardiac, liver disease, Hepatitis)
* Allergy to dialyzer membrane materials e.g. polysulfone
* Patients which cannot tolerate Heparin
* Female who are pregnant or planning to be pregnant
* Problem with or allergy to anticoagulation