cyrilzakka/clinical-trials huggingface dataset:
Vascular Risk Progression in Normal and Diabetic Control Subjects.

The purpose of this study is to look at the progression of cardiovascular disease (CVD) in normal control individuals and in patients with controlled diabetes.

Cardiovascular disease remains the greatest cause of mortality in people with diabetes mellitus. This observation study will evaluate non-traditional risk factors for their contributions to vascular disease progression as determined by carotid intima media thickness and history of vascular disease events over 1 year. This study requires annual checks of blood, urine, history, and carotid ultrasound for carotid intimal medical thickness.

Eligibility Criteria:
Inclusion Criteria:

* 19 years old or more and willing to return for annual testing for 2 years.
* Those with Diabetes need to have the condition for at least 5 years.
* Normal controls need to have no diabetes, kidney disease, or chronic disease.

Exclusion Criteria:

* Estimated GFR \<60 (mL/min/1.73m2)
* Any condition that would change weight dramatically in the near future such as malabsorption, pregnancy, malignancy
* For Normal: BMI\>30, BP \> 140/90 , LDL \> 130.
* For Diabetes: BP\> 135/85, A1C\> 8%. LDL \> 100.
Advanced Robotic Training With Additional Degrees of Freedom: Towards a Free-walking System

The objective of the study is to compare a new medical devices with an established medical device for lower limb rehabilitation regarding training outcome and patient comfort / patient satisfaction (primary objective) and treatment effect (exploratory objective).

Primary study endpoints will be a significantly higher rated patient comfort and or patient satisfaction using the new versions, compared with the established Lokomat. Furthermore, muscle activity and kinematic movement patterns will be expected to show more involved muscle groups and a walking pattern involving more degrees of freedom during use of the new version compared with the established Lokomat.

Exploratory endpoints will be a significantly stronger involvement of muscles needed for balance, more physiological walking patterns and more change on the lateral positioning of the feet due to training with the new version, compared with the established Lokomat.


Eligibility Criteria:
Inclusion Criteria:

* Lower extremity weakness due to stroke
* minor functional impairment (MRC \< 5)
* ability and willingness to participate

Exclusion Criteria:

* severe spasticity of the lower extremities
* severe dementia
* severe depression
* any other contraindications against Lokomat training
* body weight \> 135 kg
Incentives to Promote Sustained Linkage to HIV Care

This study aims to test if small incentives promote linkage to care and 6-month viral suppression among individuals recently tested for HIV at selected sites within Johannesburg, South Africa. Individuals who obtain a reactive HIV test result will be randomized to receive either the standard of care (SOC) for linkage to care or to receive financial incentives for confirmatory testing, linkage to care and viral suppression.

This study is in collaboration with Ezintsha, a sub-division of Wits Reproductive Health and HIV Institute (WRHI) in South Africa. This study will leverage on the existing research infrastructure of Ezintsha, including, HIVSS testing through the STAR initiative (Self-Test Africa), as well as HIV positive persons identified through other Ezintsha research studies and at Eztinsha affiliated health clinics.

This study will use a randomized trial design to test the effectiveness of incentives to increase confirmatory testing, linkage to care and viral suppression. The aim of this study is to determine whether HIV-infected men and women are more likely to achieve or maintain HIV virologic suppression if offered financial incentives vs. no incentives (standard of care).

Individuals who report receiving a reactive HIVSS test result on the STAR programme, or a HIV reactive test in another research study or at a affiliated clinic, will be randomized into one of two groups: a) a control group that receives the standard of care (SOC) for linkage to care; and b) an intervention group that receives financial incentives for confirmatory testing, linkage to care, and viral suppression.

Eligibility Criteria:
Inclusion Criteria:

* Reported HIV positive
* Have a personal and/or valid phone number, that will remain active for 6 months
* Have a phone with WhatsApp, or text message feature
* Understand the Informed Consent form

Exclusion Criteria:

* Unwilling to provide informed consent
* Any condition which would make the participant unsuitable or unsafe for enrollment, i.e. being unable to see or read by forgetting to bring reading glasses, being intoxicated or acute sickness
A Study of Ridaforolimus in Pediatric Participants With Advanced Solid Tumors (MK-8669-056)

The main objectives of this trial are to determine the recommended dose of ridaforolimus for pediatric participants with advanced solid tumors by measuring the number of participants experiencing dose-limiting toxicities (DLTs) while on different doses of ridaforolimus, and to characterize the pharmacokinetics of ridaforolimus in these participants. The primary hypotheses of this study are that 1) the DLTs observed will be dose-dependent and allow for definition of a maximum tolerated dose (MTD) and 2) at a safe and well tolerated dose, ridaforolimus geometric mean (GM) Day-5 blood area under the concentration-time curve at 24 hours (AUC0-24) exceeds 75% (or 1304-ng\*hr/mL) of the estimated GM Day-5, 40-mg AUC0-24 in adults.

Study-related visits concluded in August 2013. Participants who did not have disease progression, adequately tolerated therapy, and continued to meet eligibility criteria for 6 months after the enrollment period had been completed could continue treatment in an extension phase until they met discontinuation criteria or voluntarily withdrew.


Eligibility Criteria:
Inclusion criteria:

* Histologic or cytologic diagnosis of a malignant solid tumor, including tumors of the central nervous system and lymphoma, that have progressed despite standard therapy or for which no effective standard therapy is known. Participants who have received standard therapy and continue to have biopsy-proven residual stable disease are eligible
* Measurable or non-measurable disease
* Must be able to swallow tablets
* Performance Status: Lansky Play Scale ≥70 for children \<10 years of age; Karnofsky score ≥70 for children ≥10 to \<16 years; or Eastern Cooperative Oncology Group (ECOG) Status 0-2 for patients age 16 and older
* Adequate organ function
* For females of reproductive potential, a negative pregnancy test must be documented within 72 hours of receiving the first dose of study medication
* Participants of reproductive potential must agree to use (or have their partner use) adequate contraception throughout the study, starting with Visit 1 through 30 days after the last dose of study drug

Exclusion criteria:

* Currently receiving any other investigational agents or using any investigational devices
* Leukemia
* Participant previously received ridaforolimus, rapamycin, or other rapamycin analogs
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ridaforolimus
* Persistent acute toxicity from previous therapy ≥Grade 2 (excluding alopecia, neuropathy, or hearing loss)
* Uncontrolled intercurrent illness despite adequate therapy
* Pregnant or breastfeeding
* Requirement for concurrent treatment with medications that are inducers or inhibitors of cytochrome P450 (CYP3A)
* Poorly controlled Type 1 or 2 diabetes
Lactoferrin Efficacy Versus Ferrous Sulfate in Treatment of Patients With Iron Deficiency Anemia

Lactoferrin (Lf) is a mammalian cationic iron binding glycoprotein belonging to the transferrin family which was discovered 70 years ago, and isolated simultaneously from human and bovine milks in 1960. It is widely distributed in all biological fluids and is also expressed by immune cells, which release it under stimulation by pathogens


Eligibility Criteria:
Inclusion Criteria:all patients with iron deficiency anemia from 2 to 15 years old

-

Exclusion Criteria:

* Anemia rather than iron deficiency anemia.
* Family history of blood disease.
* Patients with thalassemia trait.
* Patients with chronic illness.
Second eFramngham Heart Study

In the electronic Framingham Heart Study (eFHS), the investigators developed and deployed a mobile app to collect cardiovascular risk factors and event data and test them against cardiovascular data collected in the Framingham research clinic for the FHS.

Participants enrolled in eFHS receive a series of digital surveys modules to complete on a regularly occurring schedule. The objective of the planned randomized trial is to test the effect of administering half of survey modules every 2 weeks versus all survey modules every 4 weeks on improving participants' response rates.

There will be 4 survey periods. Period 1 encompasses all survey modules administered from baseline up to week 8 (19 surveys/tasks per participant); period 2 from week 8 up to week 16 (18 surveys/tasks per participant); period 3 from week 16 up to week 24; period 4 from week 24 (16 surveys/tasks per participant).

Participants in eFHS are invited to enroll from the FHS Offspring and Omni Group 1 Cohorts during the in-person examination 10/5 at the FHS Research Center in Framingham, Massachusetts (MA), USA or remotely from home after the in-person examination. All eFHS participants have the eFHS myDataHelps mobile app (developed by FHS investigators with CareEvolution our industry partner) installed on their smartphone. The eFHS app allows communication with participants through notifications and data collection. Participants are asked to answer health surveys administered through the app.

Survey assessments will include 6 modules: cognition, pain, mood, physical function and performance, physical activity, and events. The interventions are defined by the patterns of administration of survey modules to the experimental and control groups. The administration of the cognition, pain, mood, and psychosocial modules follow the same pattern for both groups. However, the administration of the physical function, physical activity, and events modules is delayed by 2 weeks in the experimental group as compared to the control group.

Eligibility Criteria:
Inclusion Criteria:

* Invited to enroll from the FHS Offspring and Omni Group 1 Cohorts during the in-person examination 10/5 at the FHS Research Center
* English speaking
* English language reading proficiency
* Owns an iPhone with compatible iOS (version 10.0 or higher) or Android (version 5.0 or higher)
* Residence in the United States
* Provision of permissions for notifications and data sharing with the Research Center
* Provision of signed and dated informed consent (within the eFHS mobile app)

Exclusion Criteria:

* Limited and non-readers
PROCLAIM: Effect of AC2592 Administered by Continuous Subcutaneous Infusion in Subjects With Advanced Chronic Congestive Heart Failure

This Phase 2, randomized, placebo-controlled, multicenter outpatient study is designed to test the safety and tolerability of AC2592 as well as examine the effect of AC2592 on oxygen consumption during maximal tolerated exercise in adult subjects with chronic congestive heart failure.


Eligibility Criteria:
Main Inclusion Criteria:

* Has heart failure classified as New York Heart Association (NYHA) Class III or Class IV at screening despite treatment with standard therapy.
* Is able to perform a treadmill test.
* Has an HbA1c of \<= 11%.
* Is physically and mentally capable of operating the continuous subcutaneous infusion (CSCI) pump (i.e., adequate vision, manual dexterity, and mental capacity), or has a dedicated caretaker or adult family member who meets this requirement.

Main Exclusion Criteria:

* Has received metformin or nesiritide within 2 weeks prior to screening visit.
* Is currently participating in any other clinical study, or has received an investigational drug within 1 month of the screening period.
* Has participated previously in a study using GLP-1, exenatide, or exenatide LAR.
* Is using a left ventricular assist device or other mechanical circulatory support.
Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines

The purpose of this 2016/17 pilot study is to improve the combination of a card-based adverse drug reaction (ADR) system and the use of routine data to collect adverse events following vaccination with seasonal influenza vaccines, as per European Medicines Agency (EMA) guidance and Pharmacovigilance Risk Assessment Committee of EMA (PRAC) requirements, and to identify additional data which may need to be collected in order to appropriately address the requirement.


Eligibility Criteria:
Inclusion Criteria:

• Volunteers receiving an influenza vaccine and receiving an ADR card at the beginning of the 2016/17 season.

Exclusion Criteria:

• In the database analysis, registered patients who have explicitly opted out of data sharing will be excluded from the analysis.
Body Weight Support Harness System in Spinal Muscular Atrophy

The goal of this pilot interventional study is to learn about the use of an in-home harness system in children who have been treated for spinal muscular atrophy. The main questions it aims to answer are:

1. Is the in-home body weight support harness system a feasible option for families to use?
2. Is the in-home body weight support harness system a useful tool for children treated for spinal muscular atrophy?
3. Is the in-home body weight support harness system a safe tool for children treated for spinal muscular atrophy?

Participants will be given an in-home body weight support harness system and taught how to use it. Families will document how often and for how long they use the system over 6 months. Children will be given tests of motor function at the beginning, 3-months, and 6-months. At the end of the study, families will be asked to fill out a questionnaire about thier experience using the system.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed heterozygous mutation in SMN1 gene and 2 or 3 copies of SMN2 (historically, SMA Type 1 and Type 2)
* Past or current treatment with nusinersen, onasemnogene abeparvovec, or risdiplam
* Upright head control (defined as the ability to lift head from full forward flexion)
* Weight under or 50lbs
* Confirmed motor delay

Exclusion Criteria:

* 4+ copies of SMN2 (historically, SMA Type 3 and 4)
* Evidence of lower limb injury or recent fracture
* In the opinion of the investigator, it was unsafe for the child to participate
Application of Needle-free Injection of Insulin in Patients With Gestational Diabetes Mellitus

This study is about the application of needle-free injection device in GDM patients in order to observe the variation of blood glucose and patients' experience compared to the traditional insulin pen injection. To provide evidence for the application of needle-free syringe injection in GDM patients.

This study is a prospective, randomized, unblinded,crossover and controlled clinical trail. The first patient was enrolled on November 1, 2019. The follow-up visit of all enrolled patients in our center will be finished on June 30, 2021. There are two arms in our study : Test Group(IG,n=20) and Control Group(CG,n=20), 40 patients totally.

Test group: "Needle-free injection device, Then traditional insulin pen" Patients first received needle-free syringe for insulin injection 3\~4 times per day for 2 weeks. After the period of 2 weeks, they then received conventional insulin pen for insulin injection 3\~4 times per day for 2 weeks.

Control group: "Traditional insulin pen , Then Needle-free injection device" Patients first received conventional insulin pen for insulin injection 3\~4 times per day for 2 weeks. After the period of 2 weeks, they then received needle-free syringe for insulin injection 3\~4 times per day for 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients'diagnostic criteria of gestational diabetes mellitus(GDM) is according to the Guidelines for the prevention and control of type 2 diabetes in China (2017 Edition).
* fasting glucose or 2h post prandial glucose was abnormal after 3days' dietary control (fasting glucose ≥ 6.1 mmol/L, or 2h post prandial glucose ≥7.8 mmol/L).
* Aged≥20 years, Han, singleton pregnancy.
* Patients who gave informed consent voluntarily participated in the study, and had regular perinatal examination at our hospital and intended to deliver at our hospital.

Exclusion Criteria:

* Patients with multiple pregnancy or undergoing assisted reproductive technology.
* Patients with polycystic ovary syndrome in preconception.
* Patients with other endocrine metabolic disorders such as gestational hypertension and hyperthyroidism.
* Patients with severe anemia and hypoproteinemia, abnormal liver and kidney function, severe heart failure, respiratory failure and other systemic diseases.
* Patients on long-term medications that affect glucose metabolism.
Novel Form of Nutritional Supplementation in Cancer Patients

This study evaluates if a novel form of oral nutritional Supplement application in the form of gumdrops may serve as an alternative to common sip Feeds in cancer patients with high risk for malnutrition. Within this context the Impact of these two different supplements on General condition, Quality of life, muscle function, Body composition, Appetite and Nutrition Status are investigated. Patients are randomly allocated either to a study group with oral Supplementation in the form of sip feed or to a study Group receiving gumdrops for 4 weeks. After a washout period of 5-7 days study Groups are switched for another 4 week Intervention period.


Eligibility Criteria:
Inclusion Criteria:

* adult patients with solid and hematological malignancies
* BMI \< 20 kg/m² and/or NRS-2002 Score ≥ 3

Exclusion Criteria:

* pregnant or nursing women
* persons with psychiatric disorders with doubts about legal and cognitive capacity
* participation in nutritional Intervention Trials within the last 4 weeks
A Clinical Study to Evaluate the Safety, Tolerability and Activity of a New Phosphate Binder (SBR759) in Patients With Chronic Kidney Disease on Hemodialysis

The primary objective of this study is to assess the safety, tolerability and activity of escalating multiple doses of SBR759 in patients with chronic kidney disease on hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be treated with maintenance hemodialysis and prescribed a phosphate binder.
* A controlled serum phosphorus.
* Constant dose of concomitant medications.
* Women of child bearing potential must be practicing an acceptable form of birth control (i.e. double barrier method - intrauterine device plus condom, spermicidal gel plus condom). All female patients must have a negative pregnancy test at screening in order to be eligible to participate in the study.

Exclusion Criteria:

* Patient has been hospitalized within 30 days prior to screening or has a surgery scheduled during the study.
* Patient has an unstable medical condition, an active infection, active malignancy (except for basal cell carcinoma of the skin), a history of major GI tract surgery, or a history of hemochromatosis.
* Patient is receiving or has received an investigational drug (or is currently using an investigational device) within 30 days prior to screening.

Other protocol-defined inclusion/exclusion criteria may apply.
Treatment of Tension Headache Using Soft Tissue Techniques VS Vagus Stimulation Techniques.

A treatment based on manual therapy and vagus nerve stimulation is more effective than manual therapy only to reduce frequency, intensity and pressure pain threshold in patients with tension type headache.

Participants will be randomly assigned to two groups:

* Experimental group, to which soft tissue techniques and vagus nerve stimulation techniques will be applied.
* Control group, to which only soft tissue techniques are applied. Treatment will consist of four sessions, with an interval of seven days between them, for both study groups. Each session with a duration of 20 minutes for both groups.

In the control group, treatment using soft techniques will consist of the application of manual techniques that have already been shown to have some efficacy in other studies.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with episodic or chronic tension type headache

Exclusion Criteria:

* Pregnant women
* Patients who have received in the previous 3 months some type of treatment for headache
* Recent history of syncope or seizures
* Heart / cardiovascular disease
* Electrical or neurostimulation devices
* History of intracranial / carotid aneurysm or bleeding; brain tumors / lesions; significant head trauma.
* Change in prophylactic medication type or dose \<1 month before the intervention
Are Corneal Epithelial Defects Related to Changes in Ocular Bacterial Flora in Patients With ANLDO

Comparison between patients with nasolacrimal duct obstruction and healthy patients and the influence of their bacterial flora on the corneal epithelium.

Any patient with nasolacrimal duct obstruction above the age of 18 Comparing changes in their bacterial ocular flora to healthy patients without obstruction and above 18 years of age

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older, nasolacrimal duct obstruction

Exclusion Criteria:

* younger then 18 years of age
* ocular infections
* patients after repair of lacrimal duct surgery
* systemic active diseases
* patients taking medication that are know to influence bacterial flora of the eye
Clinical Investigation to Evaluate the Suitability of StrokeWave in Distinguishing Haemorragic From Ischaemic Strokes

This is a pilot, monocentric clinical investigation to evaluate the suitability of StrokeWave in distinguishing haemorragic from ischaemic strokes. The StrokeWave is a microwave device which employs a novel technique to generate images by processing very low power (\<1mW) microwaves. The trial design has been developed in order not to interfere with thw standard diagnostic approach used for the hyperacute stroke patients, nor to modify the usual standard timing of the routine assessment.

The number of participants will be 60. Patients with hyperacute stroke (within 4 hours from the onset) or with awake or unknow time of onset strokes will be enrolled in the study. All patients will be registered at emergency room of Hospital, and according to the internal procedure will be clinically evaluated by the Neurologist of the stroke team. NIHSS and mRS will be administered and scores registered. The scanning with StrokeWave will be performed in 5 minutes, after NCCT and before the CTA acquisition, in the CT room. StrokeWave will be placed on the head of the patients in the CT room passing toward the gantry of the CT avoiding any loose of time. After the StrokeWave scanning, the system will be removed. The data collected will be processed through an imaging algorithm which is integrated in the device. The final output will be composed by one or more images, plus one or more parameters describing the images.

Eligibility Criteria:
Inclusion Criteria:

* Adult \> 18 years old
* Patients with hyperacute stroke, i.e. which are referred to the emergency room with a 'stroke code'

Exclusion Criteria:

* mRS \>3 before the stroke onset
* Life expectancy \<3 months
* GCS=3