cyrilzakka/clinical-trials huggingface dataset:
Sugar Sweetened Beverage Labeling Support

This is an online survey assessing consumer support for different labeling policies related to sugar sweetened beverages. The investigators will present consumers with three labels that are being considered for sugar sweetened beverages: a calorie label, a text warning label that says "Warning drinking beverages with added sugar(s) can lead to health problems like obesity, diabetes and tooth decay" and a graphic warning label that includes graphic images to correspond with each of the health problems listed with the text warning. The investigators will ask participants their support for each label. The investigators will also see if support for the labels change after learning of the effectiveness of these labels. The investigators will share the results of a recent field study that suggested calorie and textual warning labels had no influence on the purchasing of sugar sweetened beverages while the graphic label decreased purchasing by 11 percent.


Eligibility Criteria:
Inclusion Criteria:

* The investigators will recruit a nationally representative sample using ClearVoice, a company that recruits online survey takers.

Exclusion Criteria:

-
Dose Escalation Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous ALN-VSP02 In Patients With Advanced Solid Tumors With Liver Involvement

The purpose of the study is to determine the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous ALN-VSP02, an RNAi therapeutic, in patients with advanced solid tumors with liver involvement.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically or cytologically confirmed advanced solid tumors that have recurred or progressed following standard therapy, or that have not responded to standard therapy, or for which there is no standard therapy, or who are not candidates for standard therapy
* Patient has measurable tumor in the liver
* At least 28 days have elapsed since the patient's prior systemic therapy, radiotherapy, or any major surgery
* Patient has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1
* Patient has adequate hematologic, liver, and renal function
* Patient is seronegative for hepatitis B virus (HBV) and hepatitis C virus (HCV)
* Patient has a life expectancy \> 12 weeks

Exclusion Criteria:

* Patient is receiving full-dose (therapeutic) anticoagulation therapy and/or aspirin \> 325 mg/day or other platelet inhibitory agents
* Patient has clinically significant cardiovascular disease or uncontrolled serious cardiac arrythmia
* Patient has known active brain or leptomeningeal metastases
* Patient has clinically significant cerebrovascular disease
* Patient has a seizure disorder not controlled on medication
* Patient has a known or suspected viral, parasitic or fungal infection
* Patient previously experienced a severe reaction to a liposomal product
* Patient has a known hypersensitivity to lipid products
Single Rising Dose Study With Intravenous Infusion and Subcutaneous Injection of BI 1005273 in Healthy Male Volunteers.

To investigate the safety and tolerability of BI 1005273 in healthy male volunteers following intravenous (i.v.) infusion of single rising doses and subcutaneous (s.c.) injection. Secondary objectives are the exploration of the pharmacokinetics and early pharmacodynamics of BI 1005273.


Eligibility Criteria:
Inclusion criteria:

1. Healthy male subjects

Exclusion criteria:

1. Any deviation from healthy conditions
Clinical Efficacy of Platelet Transfusion

The aim of this study is to analyze the effect of the storage time of platelet concentrates on the occurrence of bleeding events during prophylactic platelet transfusions in patients with hematological malignancies.

Since 2017, the preparation processes and shelf life of platelet concentrates (PCs) have been changed to increase transfusion safety and optimise transfusion processes. These changes have led to an increase in the total number of PCs transfused, a decrease in the number of platelets per PC and an increase in the number of platelets transfused per patient. Previous studies have shown that longer storage of platelets contributes to less in vivo recirculation of transfused platelets. Studies of haemostatic efficacy have generally not reported a significant effect. However, the haemostatic efficacy of PC stored for more or less than 5 days has not been evaluated. The ECLAT multicentre prognostic cohort study will prospectively and comparatively evaluate the haemorrhagic event in haematology patients with severe thrombocytopenia transfused according to the duration of PC storage.

Eligibility Criteria:
Inclusion Criteria:

* Patients with haematological malignancies or bone marrow aplasia with severe thrombocytopenia due to bone marrow failure related to the disease or treatments received
* Severe thrombocytopenia requiring transfusion
* Patient able to self-assess bleeding events
* Non-opposition of the subject to participate in the study
* Registered with the French social security system or benefiting from such a system.

Exclusion Criteria:

* Acute promyelocytic leukaemia
* Curative dosage of anticoagulants
* Treatment with antiplatelet agents
* Patient with proven thrombocytopenia of immunological origin, or disseminated intravascular coagulation
* Patients with a clinically significant haemorrhagic event (WHO grade 2) in the 48 hours prior to transfusion
* Indication for deplasmatised, cryopreserved and reduced-volume PCs
* Patient refusing transfusion of labile blood products
* Pregnant women or breast-feeding mothers
* Adults subject to a legal protection measure or unable to express their consent
* Persons deprived of their liberty by a judicial or administrative decision; persons under compulsory psychiatric care; persons admitted to a health or social care institution for purposes other than research
* Subject in the exclusion period of another study
Rituximab in Treating Patients With Refractory or Recurrent Hairy Cell Leukemia Following Cladribine Therapy

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy consisting of rituximab in treating patients with refractory or recurrent hairy cell leukemia following cladribine therapy.

OBJECTIVES:

* Determine the rate of complete and partial remission, remission duration, and relapse free survival after treatment with rituximab in patients with refractory or recurrent hairy cell leukemia who previously received cladribine.
* Determine the acute and long term toxicity of rituximab in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive rituximab IV over several hours once a week for 4 weeks.

Patients are followed every 3 months for 3 years and every 6 months thereafter.

PROJECTED ACCRUAL: A total of 8-25 patients will be accrued for this study within 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven hairy cell leukemia (HCL)

  * Classic HCL

    * Hairy cells in the bone marrow and/or peripheral blood which co-express CD20/CD25 or CD20/CD11c, and/or which are positive for tartrate resistant acid phophatase (TRAP)
  * Prolymphocytic HCL variant

    * Lymphoid cells in the bone marrow and/or peripheral blood with morphology intermediate between typical hairy cells and prolymphocytes, which co-express CD20/CD11c but lack CD25 expression, and which are negative for TRAP
* Progressive or recurrent disease after prior treatment with cladribine

  * Greater than 1 month since standard dose cladribine OR
  * Greater than 3 months since low dose cladribine

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* WHO 0-2

Life expectancy:

* At least 3 months

Hematopoietic:

* Not specified

Hepatic:

* Bilirubin no greater than 2.0 mg/dL

Renal:

* Creatinine no greater than 2.3 mg/dL

Cardiovascular:

* No serious cardiac disease

Other:

* No acute or chronic infection
* HIV negative
* No psychosis
* Not pregnant or nursing
* No other prior or concurrent malignancy except carcinoma in situ of the cervix or basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* See Disease Characteristics
* Recovered from prior chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* Not specified

Other:

* Recovered from prior therapy
* No concurrent cytoreductive therapy
Secondary Prophylaxis Gastric Variceal Bleed

The investigators conducted a randomized, controlled trial (RCT) to study the efficacy of beta blockers versus endoscopic cyanoacrylate injection in the prevention of gastric variceal (GOV2 or IGV1) rebleeding and improvement in survival.


Eligibility Criteria:
Inclusion Criteria:

* Patients with GOV2 without esophageal varix or IGV1, who had bled from GV were included

Exclusion Criteria:

* Presence of esophageal varix
* GOV2 with GOV1; contraindications to beta-blocker therapy and cyanoacrylate injection
* Prior injection of cyanoacrylate or sclerotherapy for GV or GV ligation, transjugular intrahepatic portosystemic shunt, balloon-occluded retrograde transvenous obliteration, balloon-occluded endoscopic injection sclerotherapy of GV, shunt operation for prevention of rebleeding from GV
* Patients already on beta-blocker or nitrates
* Undetermined origin of bleeding from esophageal varix or gastric varix
* Hepatic encephalopathy grade III/IV
* Hepatorenal syndrome
* Hepatocellular carcinoma
* Presence of deep jaundice (serum bilirubin \> 10 mg/dl)
* Uremia
* Cerebrovascular accident
* Cardiorespiratory failure
* Pregnancy or patients not giving informed consent for endoscopic procedures
The Relationship Between Pre-pregnancy BMI and Weight Gain and Outcomes in Women With Twin Pregnancy

Prepregnancy body mass index (BMI) and gestational weight gain (GWG) have Significant effects on the risk of pregnancy outcomes such as gestational hypertension disease and gestational diabetes mellitus in singleton pregnancies. This paper is to investigate the relationship between pre-pregnancy body mass index (BMI) and weight gain during pregnancy and pregnancy outcomes in women with twin pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 \~ 41 years old;
* The gestational age of the first diagnosed twin pregnancy is ≤10weeks;
* Double chorionic double amniotic sac pregnancy;

Exclusion Criteria:

* with heart disease, liver disease, kidney disease, complications (chronic hypertension, hyperthyroidism, diabetes and others ), genetic diseases, psychological and mental diseases;
* with history of habitual abortion and cervical insufficiency;
Assess the Safety, Tolerability and Pharmacokinetics of AZD5213 After Single and Multiple Ascending Oral Doses in Healthy Young and Elderly Japanese Subjects

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of AZD5213 in healthy young and elderly Japanese subjects


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures
* Japanese healthy male subjects aged 20 to 45 years (young) and male and female subjects aged 65 to 80 years (elderly)
* Male subjects should be willing to use barrier contraception ie, condoms, from the first day of dosing until 3 months after the last dose of investigational product
* Have a body mass index (BMI) between 17 and 27 kg/m2 and weigh at least 45 kg and no more than 100 kg
* Clinically normal physical findings, supine BP, pulse rate, ECG and laboratory assessments in relation to age, as judged by the investigator(s)

Exclusion Criteria:

* History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
* History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, and personality disorder including borderline according to the criteria in the Diagnostic and Statistical Manual of Mental Disorders
* History of psychotic disorder among first degree relatives.
* History of use of antipsychotic, antidepressant or anxiolytic drugs, prescribed as well as non-prescribed use.
The Effect of Short-term Insulin Intensive Therapy Based on the Application of Insulin Pump and Real-time Dynamic Glucose Monitoring Technology on Reversing the Newly Diagnosed Type 2 Diabetes

This study aims to explore the effectiveness and safety of the in-hospital-out-of-hospital synergistic short-term insulin intensive therapy model based on patch insulin pump and continuous glucose monitoring technology through a randomized controlled study, and evaluate the possibility of blood glucose parameters derived from continuous glucose technology in predicting long-term blood glucose remission, so as to provide important reference data for the precision, intelligence, and integrated improvement of short-term insulin intensive therapy.


Eligibility Criteria:
Inclusion Criteria:1: Have never received any hypoglycemic treatment (including oral hypoglycemic drugs, traditional Chinese medicine hypoglycemic drugs, insulin) Type 2 diabetes patients, or type 2 diabetes patients with diagnosis time less than 1 year, use hypoglycemic drugs No more than 1 type, with a usage time of no more than 1 week, and discontinuation of medication for more than 1 week when selected

2: A1c of glycosylated hemoglobin ≥ 8.0%, and abdominal blood glucose\>7.0mmol/L during enrollment

3: Age range from 18 to 70 years old, with a body mass index (BMI) of 20-35kg/m2

4: agrees to use contraception during the study process

5: Able and willing to use a dynamic blood glucose system and monitor blood glucose according to project requirements, and accept out of hospital lifestyle management and insulin hypoglycemic management.

-

Exclusion Criteria:1: Not type 2 diabetes

2: The medication used is allergic or intolerable

3: Acute complications of diabetes

4: Severe microvascular complications

5: Severe macrovascular complications

6: Blood pressure consistently exceeds 180/110mmHg and cannot be controlled within 160/110mmHg within 1 week

7: The clearance rate of blood creatinine is less than 45ml/min/1.73m2, the ALT is ≥ 3 times the normal upper limit, and the total bilirubin is ≥ 2 times the normal upper limit and lasts for more than 1 week

8: Hemoglobin\<100g/L or requires regular blood transfusion treatment

9: Accumulated time of using drugs that may affect blood sugar within 12 weeks for more than 1 week

10: Systemic infection or severe accompanying diseases

11: Patients with malignant tumors or chronic diarrhea

12: Uncontrolled endocrine gland dysfunction

13: Mental disorders

14: Chronic heart failure, with a heart function grading of III or above

15: Pregnant, breastfeeding, women of childbearing age who are unwilling to use contraception during the study period, or have surgery plans that require general anesthesia in the near future (within 6 months)

16: The subject is uncooperative, unable to follow up, or the researcher determines that it may be difficult to complete the study.

17: Other situations that the researcher determines are not suitable for inclusion

-
Identification of Breast Cancer Specific Markers in Patients Compared to Healthy Participants

This is an exploratory research study with the aim of identifying specific cancer biomarkers in various subtypes of breast cancer. Blood samples will be collected from 60 participants divided into 40 patients and 20 healthy donors. An amendment to the research has been proposed to enroll 24 additional participants divided into 12 patients and 12 healthy donors.

In this research study different commercial RUO (Research Use Only) antibodies will be purchased and then tested on blood samples obtained by participants affected by breast cancer and by healthy participants as control. Sixty participants will be enrolled belonging to different categories: 20 participants affected by early breast cancer, 20 participants affected by metastatic breast cancer, and 20 healthy volunteers to be used as negative control.

After signing the informed consent form, participants will be screened to evaluate if they meet the eligibility criteria. If all the criteria are met, participants will be enrolled into the study and will be asked to provide some demographic and other data. A 13 ml blood sample will be collected by the subjects and shipped to Tethis laboratories in order to be processed and analysed.

An amendment has been proposed to enroll 24 additional participants divided into 12 patients and 12 healthy donors. During the amendment, participants will be enrolled to test the analytical capacity of the antibodies evaluated in the first part on samples processed with different methods in order to select the optimal one for future development.

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give and sign a written informed consent for participation in the study.
* Female aged 18 years or above.
* Diagnosed with early breast cancer (stage I and II) or metastatic breast cancer.
* Healthy participants who visit the site for reason other than cancer diagnosis (including breast cancer).

Exclusion Criteria:

* History of other malignancies other than breast cancer (for healthy participants includes also breast cancer).
* Undergone surgery or treatment for breast cancer before enrollment (only for early breast cancer).
* Presence of known severe coagulation or haematological disorder
* Known Pregnancy
* Absence of written signed informed consent for participation in the study
Nutritional Education and the Prevention of Iron Depletion in Children 9 Months to 2 Years

Iron depletion in young children is common and may progress to iron deficiency anemia which is associated with irreversible neurodevelopmental effects. Efforts to prevent iron depletion are key to preventing these effects. In a recent study of 150 young children (12 to 38 months), we found that bottle fed children were almost three times as likely to be iron depleted compared with cup fed children (37% vs 18%). Thus, we hypothesize that an educational intervention designed to encourage timely bottle weaning will lead to a reduction in iron depletion.

We plan to undertake a randomized controlled trial to evaluate the effectiveness of an office-based educational intervention for the prevention of iron depletion in young children. Healthy children will be recruited from a community pediatric office which serves a diverse, urban population. Children will be randomized to the intervention education group or the control education group at 9 months of age. Blood work (\~4mL) for complete blood count and ferritin along with additional measures such as transferrin, iron, and reticulocyte count will be obtained at 24 months of age. Rates of iron depletion and anemia will be compared in the two groups. The two groups will also have 25-hydroxy vitamin D, calcium and alkaline phosphatase levels analyzed at the 24 month visit to ensure that the intervention for prevention of iron depletion does not adversely affect these measures.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 9 months who are attending a routine primary care well-child visit.
* Children who are in good general health.
* Children whose parents provide informed consent to participate.

Exclusion Criteria:

* Children with chronic illness.
* Children with birth weight less than 2.5 kg.
* Children with previously diagnosed anemia (including known iron deficiency anemia). This includes children with marrow failure (aplastic anemia, Fanconi anemia), hemoglobinopathies (sickle cell disease, thalassemia), lead intoxication, sideroblastic anemia, megaloblastic anemia, enzymopathies (G6PD deficiency, pyruvate kinase deficiency), or membranopathies (hereditary spherocytosis).
* Children currently receiving medications associated with anemia. This includes children taking antimetabolites or phenytoin.
* Children currently receiving iron supplementation other than iron fortified formula.
Can Interval Walking Influence on Fatigue in the Danish Cohort of Myasthenia Gravis Patients

The study is a controlled, randomized intervention trial. Patients are randomized into either an intervention group or a control group. The duration of the study is 10 weeks. Patients in the intervention group participate in a 10 weeks exercise program consisting of 150 minutes interval walking per week administered by an app on the patient's telephone. Patients in the control group live as usually, with a maximum of 30 minutes aerobic exercise per week.

Before and after the 10 weeks study period, patients (from both the intervention and the control group) participate in a 2 hours session of functional testing (e.g. walk tests, test of muscle strength ect.) at Rigshospitalet.


Eligibility Criteria:
Inclusion Criteria:

* Able to provide signed informed consent.
* Able to read and understand Danish or English.
* Diagnosed with mild to moderate myasthenia gravis (I-IV on the Myasthenia Gravis Foundation of American Clinical Classification, MGFA).
* Documented history of acetylcholine receptor (AChR) or Muscle Specific Kinase (MuSK) antibody positive, or abnormal repetitive nerve stimulation testing (decrement \> 10%) on EMG or abnormal single fiber EMG (conduction block or jitter) or based on their clinical history and symptom improvement with acethylcholinesterase inhibitors.
* If the patient is on oral corticosteroids, the dose must be stable for at least 1 month prior to inclusion.
* If the patient is on cholinesterase inhibitors the dose must be stable 2 weeks prior to inclusion.

Exclusion Criteria:

* MGFA grade V disease
* Other disorders that are not related to MG, or drugs, that interfere with muscle strength, balance and fatigue.
* Serious medical illness (e.g. uncontrolled insulin dependent diabetes mellitus, symptomatic coronary artery disease, and cancer).
* Dementia or pregnancy.
* Unspecified reasons judged by the investigator.
Exact Localisation of Impacted and Supernumerary Teeth by Cone Beam Computer Tomography

The purpose of this investigation is an exact preoperative 3D-localisation of impacted and supernumerary teeth in the maxilla using Cone Beam Computer Tomography

An exact localisation of impacted teeth is often difficult to assume by using conventional radiological techniques like OPT or dental films. In contrast to these two-dimensional imaging methods the Cone Beam Computer Tomography (CBCT) respectively the Digital Volume Tomography (DVT) offers a three-dimensional imaging of the maxillofacial region, providing the opportunity to study objectives in all standard plans with 3D-reconstruction in multisection views.

A preoperative radiological investigation using CBCT on patients who are supposed to undergo surgery for impacted and supernumerary teeth in the frontal maxilla shall clarify the certainty and safeness of this 3D-imaging method. Therefore a comparison between the findings on the CBCT, on eventually former conventional x-rays and the intraoperative finding as gold standard is done.

Eligibility Criteria:
Inclusion Criteria:

* supernumerary and impacted teeth in the maxilla (wisdom teeth excluded)
* need for surgical removement
* uncertain clinical and conventional radiological finding

Exclusion Criteria:

* refused approval
* CBCT not practicable