cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Tolerability of Apevitin BC Comparing to Vitamin Complex in Stimulating the Appetite

Lack of appetite is one of the most common reasons for visits to pediatric clinics.The symptoms usually manifest after weaning when they are introduced into the diet of infant foods containing salt.Is normally used to cyproheptadine in conjunction with vitamins C and B and also vitamins complex.

Study Design:

* Multicenter
* Phase III
* Randomized
* Double Blind
* Prospective and Comparative
* Experiment duration: 30 days
* 3 visits (day 0, day 15 and day 30)
* Increased appetite
* Adverse event

Eligibility Criteria:
Inclusion Criteria:

* Patients with inappetence;
* Wash out 20 days after ingestion before similar drug;
* The charge of the patient must understand and consent in writing;
* Responsible for the minor must be able to understand the study procedures, agree to participate and give written consent.

Exclusion Criteria:

* Patients with intestinal parasitoses infection;
* Patients with glaucoma open or closure angle;
* Patients with predisposition to urinary retention;
* Patients with stenosis peptic ulcer or pylorus - duodenal obstruction;
* Debilitated patients or in acute attack of asthma;
* Patients who have lass of appetite caused by any serious disease;
* Patients who make use of any drugs central nervous system depressants;
* Patients who make use of medicines monoamineoxidase inhibitors, tricyclic antidepressants, phenothiazines, probenecid, levodopa, phenytoin, Phenobarbital, chloramphenicol, cyclosphosphamide, cyclosporine, chlorambucil,corticotropin, mercaptopurine, isoniazid , penicillin, estrogens, contraceptives, haloperidol, ipratropium, barbiturates, primidone, salicylates.
* Hypersensitivity to components of the formula
* Patients who is participating in another clinical study;
* No able to adhere to protocol;
* Any pathology or past medical condition that can interfere with this protocol.
* Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.
Effect of a Fresh Fermented Dairy Drink Product Consumption on Antibiotic Associated Diarrhea and Gastro-Intestinal Disorders

The purpose of this clinical study is to evaluate the effect of a four-week consumption of a fresh fermented dairy drink containing probiotic strains on Antibiotic-Associated Diarrhea and Gastro-Intestinal disorders in adult subjects treated for Helicobacter pylori eradication.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have read and signed the Study Informed Consent Form
* Subjects positive for Helicobacter pylori infection and symptomatic due to Helicobacter pylori infection
* Subjects with an indication, as stated by a Gastroenterologist, for the eradication of Helicobacter pylori

Exclusion Criteria:

* Female subjects with a positive pregnancy test (based on serum test), or planning to become pregnant during the study or breast-feeding women
* Subjects enrolled in another interventional clinical study in the last 4 weeks or in an exclusion period following participation in another clinical trial
* Subject who have a history of alcohol abuse
* Subjects having diarrhea within the preceding 4-weeks
* Subjects with severe life-threatening illness, severe evolutive or chronic pathology
* Immune-suppressed subjects
* Subjects with benign peptic ulcer or pre-malignant or malignant lesion
* Subjects presenting with an infection of the gastrointestinal tract
* Subjects with any past severe gastro-intestinal or metabolic pathology
* Subjects with history of Helicobacter pylori eradication therapy
* Subjects with history of cardiac or renal clinically significant disease
* Subjects that have had any surgery or intervention requiring general anesthesia in the last 4 weeks, or that have any planned
* Subjects with allergy or hypersensitivity against the medication for the eradication of Helicobacter pylori
* Subjects taking treatments likely to interfere with the evaluation of study parameters.
* Subjects with allergy or hypersensitivity to any component of the study products
VitaFlow™ Transcatheter Aortic Valve System Post-market Study-The LAUNCH Study

The study objective is to evaluate safety and effectiveness/performance of the Microport™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System for the treatment of severe aortic stenosis in the real world settings.

This is a prospective, single-arm, multi-center, observational, post-market registry study. The purpose is to evaluate the safety, performance, and effectiveness of the VitaFlow™ Transcatheter Aortic Valve System in the real world settings.Patients will be seen at pre and post procedure, discharge, 30 days, 1 year and annually up to 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Age≥70 years;
* Symptomatic , calcified, severe, degenerative, native aortic valve stenosis : peak velocity ≥4.0m/s, or mean transvalvular gradient ≥40mmHg(1 mmHg=0.133kPa), or aortic valve area\<0.8cm² (or EOA index\<0.5cm²/m²);
* The patients considered to be not suitable for surgical aortic valve replacement (SAVR);
* The patient has been informed of the nature of the study, is willing to enroll in the study by signing a patient informed consent and agreeing to the scheduled follow up requirement.

Exclusion Criteria:

* Aortic root anatomy not suitable for the implantation of the transcatheter aortic valve；
* Vascular diseases or anatomical condition preventing the device access；
* Previous implantation of mechanical or bioprosthesis valve in the aortic position；
* Known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens, to nitinol, contrast media or other relevant elements；
* Ongoing sepsis, including active endocarditis；
* Estimated Life expectancy\< 12 months；
* Participating in another trial and the primary endpoint is not achieved.
* Inability to comply with the clinical investigation follow-up or other requirements.
Very Low Frequency Magnetic Fields Versus the Supplement "Xinepa" in the Treatment of the Carpal Tunnel Syndrome

The purpose of the study is to determine the effectiveness of the treatment with very low frequency magnetic fields (ELF) on the reduction of pain and the relief of the associated signs such as sensitivity disorders that affect the first three fingers and half of the fourth finger of the hand in patients with carpal tunnel syndrome versus the supplement (= Xinepa).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of carpal tunnel syndrome

Exclusion Criteria:

* Pregnancy;
* Pacemaker or other metallic implants;
* Systemic infectious disorders;
* Neoplastic disorders;
* Epilepsy;
* Severe heart disease.
* Known hypersensitivity to the components of Xinepa
Mechanical Insufflation-exsufflation and Hypertonic Saline in Nosocomial Bacterial Respiratory Tract Infection

Multicenter, randomized open label clinical trial to evaluate IEM and HS as concomitant therapy for respiratory tract infection in patients under artificial ventilation in the ICU.

Lung infection is a serious complication that may occur during hospital stay and may need artificial respiration or even develop during artificial ventilation for other causes.

Current specific treatment consists of intravenous antibiotics. The current study evaluated whether aspiration and drainage of infected sputum helps curing this severe complication and whether nebulized HS has additional benefits, like loosening of secretions, eradicating bacteria or reducing inflammation.

Open label, randomized, multicenter (7 ICUs at 7 hospitals in Spain). The study has 2 main arms, pneumonia and tracheobronchitis.

If the diagnosis is pneumonia, subjects will be randomization to one of 3 study groups:

1. IV Antibiotic therapy
2. IV Antibiotic therapy + mechanical insufflation-Exsugglation (MI-E)
3. IV Antibiotic therapy + MI-E + nebulized hypertonic saline-hyaluronic acid (HS)

If the diagnosis is tracheobronchitis,subjects will be randomization to one of 3 study groups:

1. No specific therapy (recommendation of the Infectious Diseases Society of America)
2. IV Antibiotic therapy (common practice to prevent progressión to pneumona and shorten duration of intubation)
3. MI-E + HS

Safety will be compared by number of adverse events, severe adverse events and mortality between study groups in each main arm. Efficacy will be compared by duration of respiratory support and number of cases with worsening organ dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Nosocomial pneumonia (vHAP or VAP) or nosocomial tracheobronchitis
* Intubated with a cuffed endotracheal tube or tracheostomy cannula.

Exclusion Criteria:

* Ominous prognosis
* Frank hemoptisis
* Barotrauma (pneumothorax or pneumomediastinum)
* Bronchospasm (patients on bronchodilators for previous bronchospasm may be included
* Unstable thoracic cage
* Suspected unmonitored intracraneal hypertension
FoodImage 3 Laboratory

The Laboratory Study will be conducted at PBRC and will include participants (N=25) from a wide array of social and economic groups will be recruited and trained on the use of the FoodImage app. Participants use the app to measure food waste (including foods with inedible parts) created during a simulated meal preparation setting, a simulated meal consumption setting with plate waste, and a simulated cabinet and refrigerator clean-out of spoiled and out-of-date foods, where the number of items and the amounts of waste for each task is randomly assigned across participants and blinded from the research staff evaluating images and coding data. These participants will denote the normal discard destination (I.e., garbage, sink/disposal, feed to animal, compost) for each item as if the waste had occurred in their own home.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 18-65 years
* Willing to be recontacted

Exclusion Criteria:

* Refusal or unable to use an iPhone for study related purposes.
* Not willing to adhere to study procedures and study visit timelines.
* PBRC employee
* Any condition or circumstance that in the judgement of the PI could interfere with study participation
The Impact of Charcot-Marie-Tooth Disease in the Real World

An observational, non-interventional registry study to collect real-world data from people living with Charcot-Marie-Tooth disease (CMT) and its treatment, which will be available to researchers to further the knowledge of Charcot-Marie-Tooth disease and improve patient care.

The registry uses Vitaccess' digital real-world evidence platform and has been developed in collaboration with CMT experts, Patient Advocacy Organizations (PAOs) and the biopharmaceutical company Pharnext.

Eligible participants install a study app on their smartphone. Researchers access aggregated, anonymised data via a cloud-based research portal.

The platform provides benefits to participants, which it is hoped will encourage persistence with data submission; these include options to download a copy of their symptom diary, a clinically-validated Knowledge feature, and access to high-level results from the study data.

The aggregated data are available in close to real time via "dashboards" and can be analysed according to a number of pre-set criteria (e.g. disease stage, age, geographic location).

State-of-the-art technologies and security policies are used in the platform to ensure industry-standard data storage and privacy for all users. Participants' personally identifiable information will remain confidential at all times, and researchers will not be able to identify individuals.

The study is ethics-approved in all scope countries and led by a Scientific Advisory Board comprising representatives from international PAOs, patients and key opinion leaders from each country, and study leads from both Pharnext Société Anonyme (SA) and Vitaccess Ltd.

Eligibility Criteria:
Inclusion Criteria:

(\*) Aged 18 years and over (\*) Diagnosed with any stage and any subtype of Charcot-Marie-Tooth disease (\*) Resident in France, Germany, Italy, Spain, the UK, or the USA (\*) Have a National Health Service (NHS) or Community Health Index (CHI) number, or equivalent (\*) Willing to use their own smartphone

Exclusion Criteria:

(\*) No specific exclusion criteria.
Kidney and Blood Pressure Changes in Patients Receiving Bevacizumab, Aflibercept, Sunitinib, or Cediranib for Cancer

This research study is looking at kidney and blood pressure changes in patients receiving bevacizumab, aflibercept, sunitinib, or cediranib for cancer. Studying samples of blood and urine from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment with an antiangiogenic drug.

OBJECTIVES:

I. To study the renal and blood pressure changes in patients treated with bevacizumab, aflibercept, sunitinib malate, or cediranib for their cancer.

II. To determine the physiological mechanisms behind proteinuria and hypertension induced by antiangiogenic therapies (i.e., rarefaction; imbalance in eNOS, prostacyclin \[PGI_2\], prostaglandin E2 \[PGE_2\], and thromboxane A2 \[TXA2\]; renin/aldosterone; or renovascular hypertension).

III. To determine whether soluble factors (like tyrosine kinase 1 \[sFlt1\], bFGF, and VEGF) and steady state drug concentration are predictive of the development of proteinuria/hypertension.

OUTLINE: This is a multicenter study.

Patients undergo blood and urine sample collection periodically. Urine samples are assessed for PGI2 and TXA2 levels using validated ELISA methods. Urine is also assessed for protein and creatinine levels, microalbumin, osmolality, and electrolytes. Blood samples are assessed for pharmacokinetics and sFlt1, VEGF, and bFGF levels by validated ELISA methods. Blood samples are also assessed for steady state drug concentration, renin, and aldosterone levels.

Eligibility Criteria:
Inclusion Criteria:

* Planning to start treatment with one of the following antiangiogenic drugs as single agents or in combination with chemotherapy for their cancer:

  * Cediranib (AZD2171 )
  * Bevacizumab (Avastin)
  * Sunitinib (Sutent)
  * Aflibercept (VEGF Trap)
* Urinalysis negative for protein OR 24-hour urine for protein \< 500 mg
* Prior chemotherapy within the past 12 months allowed
* More than 12 months since prior antiangiogenic drugs, including monoclonal antibodies that bind to VEGF or tyrosine kinase inhibitors that block VEGFR2
* At least 6 weeks since prior and no concurrent aldosterone receptor antagonists (e.g., spironolactone \[aldactone\] or eplerenone)
* No other concurrent investigational agents
A Study to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Rheumatoid Arthritis Enrolled in Study GA29350

A study to evaluate the long-term safety and efficacy of GDC-0853 in participants with moderate to severe active Rheumatoid Arthritis (RA) who have completed 12 weeks of study treatment in Study GA29350. Eligible participants from Study GA29350 who elect to participate will receive treatment with GDC-0853 twice daily (BID) in an open-label fashion for 52 weeks, followed by a safety follow-up period of 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Completion of treatment as specified in Study GA29350, including completion of the Day 84 study visit assessments
* Acceptable safety and tolerability during Study GA29350 as determined by the investigator or Medical Monitor
* Have not received any prohibited medications in Study GA29350
* While taking methotrexate, must be willing to receive oral folic acid (at least 5 milligrams per week \[mg/week\])
* If receiving oral corticosteroids (less than or equal to \[\</=\] 10 milligrams per day \[mg/day\] prednisone or equivalent) and/or non-steroidal anti-inflammatory drugs, doses have remained stable for the duration of Study GA29350

Exclusion Criteria:

* Met protocol defined treatment stopping criteria during Study GA29350
* Treatment with any investigational agent (i.e., other than study drug) or live/attenuated vaccine or any other prohibited medication during Study GA29350 or since the last administration of study drug in Study GA29350
* In the opinion of the investigator, any new (since initially enrolling in the Phase II Study GA29350), significant, uncontrolled comorbidity that would increase the risk to the participant in Study GA30067
* Pregnant or lactating, or intending to become pregnant during the study
* Participants who experienced a de novo or reactivated serious viral infection such as hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) during the Phase II Study GA29350
* Any major episode of infection requiring hospitalization or treatment with intravenous antibiotics during the Phase II Study GA29350
* Participants who developed a malignancy during the Phase II Study GA29350
* 12-lead electrocardiogram (ECG) on Day 84 in Study GA29350 that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
* Current treatment with medications that are well known to prolong the QT interval
Impact of Beetroot Supplementation in Athletes

Several previous studies observed a positive effect of beetroot supplementation on sports performance in athletes, mainly in endurance performance. However, less attention has been paid to its effects on short-duration performance, especially in youth athletes. Moreover, only a few previous investigations performed biochemical analyses, including pro-oxidant balance assessments. It is especially important because chronic nitrate intake might directly cause the production of reactive nitrogen species and reactive oxygen species in other subcellular compartments, leading to more oxidative stress. Additionally, no previous study verified the impact of beetroot intake on sleep.


Eligibility Criteria:
Inclusion Criteria:

* male
* good general health assessed by physician
* highly trained
* written consent to participate

Exclusion Criteria:

* medication or dietary supplements used within the previous month, which could potentially impact the study outcomes
* history of sleep nor neurological disorders
* chronic use (6 months) of any antibacterial mouthwash products.
An Exploratory Trial to Evaluate Efficacy and Safety for Combination Treatment of Adenovirus Double Suicide Gene Therapy

Replication-competent Adenovirus-mediated Double Suicide Gene Therapy (Theragene®,Ad5-yCD/mutTKSR39rep-ADP) showed safety and anti-cancer effect in patients with pancreatic cancer in phase I study.

From the experience of phase I study, the safety and efficacy of combination with standard chemotherapy and radiation therapy with Theragene treatment will be assessed in this study.

Phase IIa study of Replication-competent Adenovirus-mediated Double Suicide Gene Therapy (Theragene®,Ad5-yCD/mutTKSR39rep-ADP) with radiation therapy

Eligibility Criteria:
Inclusion Criteria:

* Patients with borderline resectable or locally advanced pancreatic cancer
* Patients with histologically confirmed pancreatic adenocarcinoma
* Patients with no evidence of peritoneal or hematogenous metastasis
* Patients with ECOG performance status 0-1
* Patients with renal function (Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 50 mL/min/m²)
* Patients with bone marrow function (WBC \> 4,000/uL or absolute neutrophil count ≥ 1500/uL, PLT ≥ 100,000/uL, and Hemoglobin \> 10 g/dL)
* Patients with liver function (Bilirubin \< 2.0 mg/dL and SGOT and SGPT \< 3 times upper limit of normal (ULN))
* Patients with agreement with informed consent

Exclusion Criteria:

* Patients with a history of other cancer
* Patients with recurred pancreatic cancer
* Patients with a history of radiation on more than 25% of bone marrow
* Patients with a history of major surgery except laparoscopic examination, endoscopic intervention, or gastrojejunostomy
* Patients who have contraindication of radiation therapy
* Patients with HIV infection, chronic hepatitis B, chronic hepatitis C, or liver cirrhosis
* Female patients with childbearing age or pregnancy or breast feeding
* Patients who are considered as inappropriate candidate by investigators
Growth of Healthy Term Infants Fed Formula Containing DHA-B

The primary objective is to determine if the weight gain of healthy term infants fed a commercially available term infant formula supplemented with DHASCO® is similar to that of infants fed the same formula supplemented with a new product, DHASCO®-B.


Eligibility Criteria:
Inclusion Criteria:

* full term infant (gestational age 37-42 weeks)
* birth weight \> or equal to 2500 g
* singleton infant \< or equal to 14 days of age in good health
* parent must be \>21 years of age
* parental consent

Exclusion Criteria:

* congenital malformation or genetic disorder
* metabolic anomalies
* maternal infectious diseases, alcoholism, substance abuse
* mothers with gestational diabetes
* participation in another clinical study
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) Administered to Patients With Familial Chylomicronemia Syndrome (FCS)

The purpose of the study was to evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.

This was a multi-center, double-blind, Phase 3 study in up to 60 patients with FCS. Participants were randomized in a 2:1 ratio to receive Olezarsen or matching placebo in a 53-week treatment period. The length of participation in the study was approximately 74 weeks, which included an up to 8-week screening period, a 53-week treatment period, and a 13-week post-treatment evaluation period. Following the treatment period, eligible patients had the option to enroll in the Open-label Extension (OLE) Study ISIS 678354-CS13 (NCT05130450).

Eligibility Criteria:
Key Inclusion Criteria:

* A diagnosis of genetically confirmed Familial Chylomicronemia Syndrome (type 1 Hyperlipoproteinemia)
* Fasting TG ≥ 880 mg/dL (10 millimoles per liter (mmol/L) at Screening
* History of pancreatitis. Patients without a documented history of pancreatitis are also eligible but their enrollment will be capped at 35%
* Stable doses of statins, omega-3 fatty acids, fibrates, or other lipid-lowering medications are allowed

Key Exclusion Criteria:

* Acute coronary syndrome within 6 months of Screening
* Major surgery within 3 months of Screening
* Have any other conditions, which, in the opinion of the Investigator would make the participant unsuitable for inclusion, or could interfere with participating in or completing the study