cyrilzakka/clinical-trials huggingface dataset:
Effect of SBG in Patients With Breast Cancer

This study is set up to determine whether soluble beta-glucan (SBG) has

* unfavourable side effects
* beneficial treatment effects when given in combination with standard antibody and chemotherapy to patients with breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Women with histologically/cytologically confirmed locally advanced or metastatic breast cancer
2. Primary tumor or metastases are HER2-ICH3+ or FISH+
3. Measurable or non-measurable disease
4. The patients must not have received treatment with the combination trastuzumab and vinorelbine previously
5. Expected lifetime of more than 12 weeks
6. Age ≥ 18 years
7. Performance status ≤ 2 according to World Health Organization (WHO) scale
8. The patient must be able to comply with the protocol
9. Verbal and written informed consent

Exclusion Criteria:

1. Women who are pregnant or breast-feeding. A negative pregnancy test must be provided during the screening period for fertile women. Fertile women must use effective contraceptive methods
2. Clinical symptoms indicating central nervous system involvement
3. Other current or former malignant disease, with the exception of adequately treated and cured carcinoma in situ cervicis uteri and basocellular skin carcinomas
4. Left ventricular ejection fraction (LVEF) \< 50% of normal range
5. Reduced bone marrow function defined by leukocyte counts \< 3.0 x 109/l and neutrophil counts \< 1.5 x 109/l, or thrombocyte counts ≤ 100 x 109/l
6. Reduced liver function defined by bilirubin \> 3 x upper normal limit and/or ASAT/ALAT \> 3 x upper normal limit and/or alkaline phosphatase \> 3 x upper normal limit.
7. Reduced renal function defined by serum creatinine \> 2 x upper normal limit
Human Factors Study of Methotrexate Prefilled Pen (50 mg/mL) in Patients With Juvenile Idiopathic Arthritis

This study is planned to evaluate the human factor (HF)/usability of pediatric or adolescent JIA patients and the caregivers of Juvenile Idiopathic Arthritis (JIA) patients with the Methotrexate Prefilled Pen (including a label comprehension assessment and a device robustness evaluation).


Eligibility Criteria:
Main Inclusion Criteria:

* patient of either gender aged ≥2 to \<21 years of age
* is a suitable candidate for treatment with injectable methotrexate for JIA per the patient's primary rheumatologist, with the previous or current diagnosis of active polyarticular course JIA

Main Exclusion Criteria:

* Is a female patient who is pregnant, trying to become pregnant, or breastfeeding, or of childbearing potential, sexually active but not practicing a highly reliable method of birth control during the study and at least 6 months thereafter
* Has contraindications for methotrexate
* Has a history of or current inflammatory arthritis or rheumatic autoimmune disease other than JIA
* Is unable, or does not have a caregiver able to comprehend written labeling and training materials
Cardiovascular Responses to Exercise in People Living With HIV/AIDS: Effects of Exercise Training

Patients living with HIV (PLWHIV) have compromised muscle metaboreflex, which can cause exercise intolerance. This randomized controlled clinical trial will verify the effects of regular exercise on autonomic and hemodynamic responses to muscle ergoreflex activation in these patients. PLWHIV without regular physical exercise will be randomly assigned into an exercise training or a control group. The exercise training group will undergo regular physical exercise during 12 weeks (60-min session performed 3 times/wk with moderate intensity), while the control group will keep inactive. Another group consisted of inactive HIV-uninfected group will be included. The primary endpoints will be blood pressure and autonomic markers in response to the Stroop Color-Word Test and the activation of muscle ergoreflex, by means of the post-exercise circulatory arrest (PECA), which will be performed with and without the topical application of a capsaicin-based analgesic balm. Secondary endpoints will include heart rate, peripheral vascular resistance, stroke volume, cardiac output, blood lactate concentration, anthropometrics, and handgrip strength. The active and inactive PLWHIV groups will be evaluated before and after the exercise training, while the healthy group only at baseline.

HIV-infection is associated to a reduced maximal cardiac output and blunted pressor reflex response to static handgrip exercise, which are suggestive of impaired ergoreflex activation. An abnormal ergoreflex activation may lead to exercise intolerance and increases in cardiovascular risk. Despite the importance of therapeutic strategies in reducing the cardiovascular risk among patients living with HIV, exercise-related effects on ergoreflex sensitivity in these population have not been previously investigated.

Eligibility Criteria:
Inclusion Criteria for people living with HIV:

* diagnosis of HIv infection for at least 5 years;
* use of combined antiretroviral therapy for at least 3 years;
* asymptomatic and free from opportunistic diseases at enrollment.

Exclusion Criteria:

* regular physical exercise;
* malnutrition;
* presence of coronary artery disease, ischemic diseases, pulmonary disease, diabetes, Chagas disease, tuberculosis, heart failure, hypertension;
* using pacemakers and/or antidepressant, antiarrhythmic or antihypertensive medication, especially beta-blockers.
Manuka Honey Eye Drops VS Conventional Treatment of Meibomian Gland Dysfunction Related Dry Eye Disease

Assessor-masked (Single blind, randomized controlled trial comparing the conventional treatment group to an interventional group using 16% Manuka Honey topical eye drops.

Purpose To evaluate the effects of conventional treatment compared to use of Manuka Honey eye drops in the treatment of meibomian gland dysfunction related dry eye disease.

Design Assessor-masked (Single blind, randomized controlled trial comparing the conventional treatment group to an interventional group using 16% Manuka Honey topical eye drops.

Methods Patients were randomized into two groups, one group given conventional treatment for meibomian gland dysfunction. The other group was given additional manuka honey 16% eye drops which are registered as a medical device by the australian FDA. SPEED score was taken at baseline and upon follow up. Multiple parameters were graded from slit lamp examination by a masked assessor. Results were compared from baseline to follow up date 3 weeks later.

Eligibility Criteria:
Inclusion Criteria:

* meibomian gland dysfunction stage 2-4

Exclusion Criteria:

* \<18 years old Unable to consent Recent ophthalmic surgery \<6m Abnormalities of lid position Allergy to honey/bee products Contact lens wearers Patients on long term topical medications apart from lubricants
Study of CPI-006 as Immunotherapy for Hospitalized COVID-19 Patients

This Phase 1 single-dose, dose-escalation study is an open label trial evaluating the safety of CPI-006, a humanized monoclonal antibody targeting the CD73 cell-surface ectonucleotidase, as immunotherapy for stable hospitalized mild or moderately symptomatic COVID-19 patients with a parallel non-randomized Control Arm for treatment with standard of care only.


Eligibility Criteria:
Inclusion Criteria:

* Nasal swab test positive by reverse transcriptase PCR for SARS CoV-2 within past 7 days, and onset of COVID-19 symptoms no more than 10 days prior to the positive test
* Hospitalized and have stable mild to moderate symptoms of COVID-19
* Blood oxygen saturation of a minimum of 92% on either no oxygen or up to 5L/min supplemental oxygen
* Patients with cancer must be in remission or have stable, controlled disease and may be actively receiving drugs or biologics not deemed by the investigator to likely affect immune response.
* Women must not be of child bearing potential or agree to use contraceptive guidance for 6 weeks

Exclusion Criteria:

* Patients receiving previous invasive mechanical ventilation or non-invasive ventilation (CPAP, BiPAP) for COVID-19 illness
* Patients hospitalized \>7 days prior to receiving study intervention
* Other diseases or conditions that are not controlled
* On drugs or biologics that are immunosuppressive, cytotoxic or immunomodulatory
* Patients with autoimmune disease must be controlled on non immunosuppressive or immune modifying agents
* Have received cytotoxic, immunosuppressive or immunomodulatory agents within past 3 months (other than for treatment of COVID-19).
* Patients receiving experimental therapies that are immunosuppressive
* Patients receiving non-immuno-suppressive experimental therapies within 7 days prior to receiving CPI-006
* Patients receiving convalescent plasma within 24 hours prior to receiving CPI-006
* Patients receiving experimental anti-SARS CoV-2 monoclonal antibodies within past 30 days
Comparison of Insulin Mix25 Versus Mix50

The purpose of this study is to determine the efficacy and safety of insulin Lispro Mix25 (LM25) compared to insulin Lispro Mix50 (LM50) as an insulin starter in participants with Type 2 diabetes mellitus (T2DM).


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of Type 2 Diabetes Mellitus (T2DM) for at least 6 months
* Have been taking sulfonylureas, biguanide, thiazolidinedione, alpha-glucosidase inhibitor, glinide, or dipeptidyl peptidase IV inhibitor, or any combination of these
* Have a qualifying hemoglobin A1c (HbA1C) value ≥7.0% and ≤11.0% at screening
* Have a body mass index (BMI) ≥18.5 and \<35.0 kilogram per square meter (kg/m²)
* Have given written informed consent to participate in the study in accordance with local regulations and the ethical review board (ERB) governing the study site

Exclusion Criteria:

* Have a diagnosis of type 1 diabetes
* Have had more than 1 episode of severe hypoglycemia within the 6 months before screening
* Have any of the following cardiovascular conditions within 3 months prior to screening: acute myocardial infarction, New York Heart Association (NYHA) class III or class IV heart failure, or cerebrovascular accident (stroke)
* Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alanine aminotransferase levels ≥3.0 times the upper limit of the reference range at screening, as determined by the central laboratory
* Have an estimated creatinine clearance (CrCl), Cockcroft-Gault formula \<30 milliliter per minute (mL/min), as determined by the central laboratory at screening
* Have evidence of a significant, active, uncontrolled endocrine or autoimmune abnormality, as judged by the investigator
* Have an active or untreated malignancy or have been in remission from a clinically significant malignancy for \<5 years
* Have any other condition (such as, known drug or alcohol abuse or a psychiatric disorder) that may prevent the participants from following and completing the protocol
* Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL) Clinical Study in Japan

The purpose of this study is to evaluate safety and effectiveness of AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Models SND1T3, SND1T4, SND1T5, and SND1T6 when implanted to replace the natural lens in Japanese cataract patients.

Eligible participants completed a preoperative examination of both eyes, implantation of the IOL at the operative visit for each eye, and up to 8 postoperative visits: Day 1-2, Day 7-14, and Day 30-60 after each implantation, and Day 120-180 and Day 330-420 after second eye implantation. The second implantation occurred within 30 days of the first.The primary eye was defined as the eye with higher astigmatism, with the other eye defined as the secondary eye. If both eyes had the same level of astigmatism, the first implanted eye was set as the primary eye.

Eligibility Criteria:
Inclusion Criteria:

* Sign informed consent;
* Diagnosed with bilateral cataracts;
* Planned cataract removal by phacoemulsification;
* Potential postoperative visual acuity of 0.6 decimal or better in both eyes;
* Preoperative astigmatism ≥ 0.75 diopter;
* Clear intraocular media other than cataract in study eyes;
* Calculated lens power and astigmatism within the available range;
* Pupil size greater than or equal to 6 mm after dilation;
* Able to undergo second eye surgery within 30 days of the first eye surgery;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Irregular corneal aberration as demonstrated by corneal topography;
* Any inflammation or edema (swelling) of the cornea;
* Diagnosed degenerative visual disorders predicted to cause future acuity losses to a level worse than 0.6 decimal;
* Diabetic retinopathy;
* Previous refractive surgery, retinal detachment, corneal transplant;
* Glaucoma;
* Pregnant, nursing, or suspected of being pregnant;
* Currently participating in another investigational drug or device study;
* Other protocol-defined exclusion criteria may apply.
Research of Systemic Management for Late Preterm Infants Nutrition in China

The purpose of the project is to investigate the status of nutrition management of late preterm infants in the member hospitals in the Beijing association of preterm infants, and set up the systemic nutritional management of late preterm infants, Including parenteral nutrition and enteral feeding. And to compare the differences of growth and complications of these infants between groupings applicationg and not applicating the systemic nutritional management of late preterm infants,and to validate its feasibility and validity.

The research content of the project includes three parts:

1. Investigation on nutritional status of late preterm infants.
2. Setting up systemic nutritional management of late preterm infants
3. Comparing nutritional and growth status of the late preterm, short-term and long-term complications between the groups applicating and not applicating the systemic nutritional management of late pretern infants.

Eligibility Criteria:
Inclusion Criteria:

* preterm infants with gestational age 34 weeks to 36 weeks and 6 days

Exclusion Criteria:

* preterm infants with gestational age\<34 weeks or \>36 weeks and 6 days
* abnormality of digestive system
* genetic and metablic disease
* severe congenital heart disease( with hemodynamic changes that influencing enteral feeding)
SIOPEN BIOPORTAL, an International Registry Linked to a Virtual Biobank for Patients with Peripheral Neuroblastic Tumours

The SIOPEN BIOPORTAL is a prospective non-therapeutic multi-centre international study aimed at developing an international Registry linked to a Virtual Biobank for all the patients with peripheral neuroblastic tumor within countries of the SIOPEN network. The overall aim of this study is to provide a GDPR-compliant framework to collect basic clinical annotations, biological and genetic features and information about the location on biospecimens for all the patients with a peripheral neuroblastic tumor including neuroblastoma, ganglioneuroblastoma and ganglioneuroma in the SIOPEN network.

This study will support data and sample management and intensify cross-borders data and sample sharing fostering translational and clinical research. The post-hoc hypothesis formulated based on the data generated in this study will be used as statistical basis for future precision medicine programs based on improved biological characterization, patient stratification and therapeutic management.


Eligibility Criteria:
Inclusion Criteria:

I-1. Patients with PNT: ganglioneuroma or ganglioneuroblastoma or neuroblastoma, I-2. At the time of initial diagnosis of neuroblastic tumour, or at relapse/progression if not yet registered I-3. Written patient informed consent, or parents or legal representative written informed consent and assent of the child, adolescent or young adult

Non-Inclusion Criteria:

R-1. (Adult) Patients with olfactory neuroblastoma R-2. Central nervous system (CNS) neuroblastoma (as per the WHO classification)
Safety and Efficacy the Medigus SRS Endoscopic Stapling System in Gastroesophageal Reflux Disease (GERD)

The study is designed to test the safety and efficacy of the Medigus SRS endoscopic stapling system for the treatment of GERD.

The system allows the operator to staple the stomach to the esophagus,in order to restore the gastroesophageal flap valve. The effect of the stapling is similar to a common operation for GERD (partial fundoplication) but is done through the mouth, and incision into the abdomen is not needed.

The hypothesis of the study is that the treatment will be effective in improving GERD related quality of life by 50% or more in the majority of the subjects, and that the procedure will be as safe as surgery.


Eligibility Criteria:
Inclusion Criteria:

* History of GERD related symptoms for at least 2 years.
* Recent objective evidence of GERD, demonstrated by a 24h pH acid exposure test.
* History of daily intake of proton pump inhibitors (PPIs) for at least 6 months, with significant relief of symptoms (i.e., difference in GERD Health Related Quality of Life (GERD HRQL) scores on and off PPI \> =6).
* GERD-HRQL ≥20 off of PPI's

Exclusion Criteria:

* Hiatal hernia \> 3 cm or a paraesophageal hernia
* Barrett's esophagus or grade IV esophagitis
* Esophageal stricture, ring or web causing symptoms of dysphagia
* Grade I Flap valve according Hill's classification
* History of co-morbidity
BOTOX® Treatment in Pediatric Lower Limb Spasticity

This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in pediatric patients with lower limb spasticity.


Eligibility Criteria:
Inclusion Criteria:

* Minimum weight of 10 kg/22 lb
* Cerebral palsy with dynamic muscle contracture /spasticity of the ankle

Exclusion Criteria:

* Muscular dystrophy, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or mitochondrial disease
* Uncontrolled epilepsy
* Botulinum Toxin therapy of any serotype for any condition within the last 6 months
* History of surgical intervention of the lower study leg or planned surgery of any limb during the study
* Previous casting of the study limb for spasticity within 6 months or with a dynamic splint within 3 months, or planned casting or dynamic splinting for spasticity of the study limb or affected upper limb during the study
Triptolide-Containing Formulation as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Triptolide was shown in experimental studies to inhibit the cyst formation and growth in ADPKD models, while triptolide-containing formulation was revealed to potentially slow the disease progression in several proteinuric ADPKD patients in our clinical practice. It remains to be shown the effect of triptolide-containing formulation on total kidney volume (TKV) enlargement and renal function protection in ADPKD patients.

Randomized Controlled Trial

Eligibility Criteria:
Inclusion Criteria:

* ADPKD patient older then 40 years of age without gender limitation
* Estimated glomerular filtration rate (eGFR) higher than 60 ml/min 1.73m2
* documented kidney volume progression with yearly increasing rate more than 6%
* informed consent

Exclusion Criteria:

* Female who is planning to become pregnant, who is pregnant and/or lactating, who is unwilling to use effective means of contraception
* impaired liver function as increased liver enzymes (2-fold above normal values)
* uncontrolled hypercholesterolemia (fasting cholesterol \> 8 mmol/l) or hypertriglyceridaemia (\> 5 mmol/l) under lipid lowering therapy
* granulocytopenia (white blood cell \< 3,000/mm3) or thrombocytopenia (platelets \< 100,000/mm3)
* hepatitis B or C, HIV infection
* malignancy
* mental illness that interfere with the patient ability to comply with the protocol
* drug or alcohol abuse
* known hypersensitivity to similar drugs as Triptolide-Containing Formulation
Targeting Weight and Shape Concern Among Women with High Body Weight

This study is a randomized controlled trial to evaluate the effect of an adapted version of the Body Project program among adult women of higher body weight who want to lose weight. The study will evaluate treatment effects on weight and shape concern and explore the impact of intervention on weight loss outcomes.

The objective of this study is to conduct a randomized controlled pilot trial to test the effects of a 28-week treatment protocol that combines a modified body image intervention (The Body Project: weeks 1-4) with a 6-month standard behavioral weight management treatment (weeks 5-28). The combined protocol will be evaluated in comparison to a control group that receives an education only program during weeks 1-4 followed by the same 6-month weight management treatment. It will be tested among women with high body weight who report High Weight and Shape Concern and would like to lose weight.

The goals of the study are:

1. To evaluate effects of a manualized intervention on Weight and Shape Concern prior to starting weight management.
2. To evaluate the effects of the modified Body Project intervention on momentary weight/shape-related thoughts and overeating episodes during behavioral weight management.
3. To conduct exploratory analyses comparing effects of the two treatment conditions on weight loss and other weight-related behaviors (e.g., exercise, adherence to self-monitoring).

Eligibility Criteria:
Inclusion Criteria:

* Female
* Body Mass Index between 25-40
* Eating Disorder Examination-Questionnaire weight concern subscale greater than or equal to 4
* Eating Disorder Examination-Questionnaire shape concern subscale greater than or equal to 4.25
* Personal use of cell phone
* Able to engage in moderate intensity activity
* Desire for weight loss

Exclusion Criteria:

* No eating disorder history
* Not pregnant
* Not breastfeeding
* No childbirth/delivery within 9 months
* No substance use disorder
* No weight loss medication or history of bariatric surgery
* No other weight loss program participation