cyrilzakka/clinical-trials huggingface dataset:
Influence of Plantago Major on Mineral Metabolism and Selected Biochemical Parameters in Obese Women

Effect of oral supplementation with Plantago major on cardiometabolic risk factors and mineral content and lifestyle in obese women: double-blind, randomized clinical trial.

The purpose of the study is to determine whether oral Plantago major supplementation affects cardiometabolic risk factors, mineral content, and lifestyle in obese women.

In previous research it was found that the Plantago maxima extract counteracts the development of adipose tissue in rats on a high-fat diet. In addition, antioxidative, anti-inflammatory and antidiabetic action of Plantago has been demonstrated. Moreover, it has been shown that Plantago influences lipolysis in obese mice and ameliorates metabolic processess in obese rats.

The project is due to evaluate the effect of oral supplementation with selected Plantago species - Plantago major in obese patients on:

* the content of minerals in blood, hair and urine
* total cholesterol, HDL and LDL cholesterol and triglycerides blood concentration,
* blood glucose and insulin concentration,
* blood pressure,
* anthropometric parameters: body mass, body height, waist and hip circumferences
* body content measured by bioimpedance: % of fat tissue and % of muscle tissue
* quality of life

  70 subjects will be randomized into two groups and receive oral Plantago major extract (the first group) or oral placebo (the second group) once daily for 12 weeks. At baseline and at completion (after 12 weeks) fasting blood, urine and hair samples will be collected and abovementioned parameters will be measured.

Eligibility Criteria:
Inclusion Criteria:

* body mass index (BMI) equal to or greater than 30 kg/m2

  * age 18 to 60 years
  * stable body weight (\< 3 kg self-reported change during the previous three months)
  * written informed consent to participate in the study,
  * abdominal obesity - waist circumference\> 80 cm;
  * body fat content measured by bio-impedance ≥ 33%;
  * female

Exclusion Criteria:

* secondary obesity or secondary hypertension
* diabetes type I
* gastrointestinal disease;
* dyslipidaemia, type 2 diabetes, hypertension requiring the implementation of pharmacological treatment in the last 3 months prior to observation or follow-up;
* a history of use of any dietary supplements within the one month prior to the study
* clinically significant acute or chronic inflammatory disease in the respiratory, gastrointestinal or genitourinary system or in the mouth, throat, paranasal sinuses and / or connective tissue disease, arthritis;
* simultaneous participation in a study that affects body mass or use of diet / medication / nutritional behaviors affecting body mass;
* a history of infection in the month prior to the study
* nicotine, drug or alcohol abuse
* or other condition that, in the opinion of the investigators, would make participation not in the best interest of the patient or could prevent, limit, or confound the study results
A Study of RC88 Combined With Sintilimab for Advanced Solid Tumours

This study will evaluate safety , clinical pharmacology and efficacy of intravenous RC88 combined with Sintilimab in advancedsolid tumours


Eligibility Criteria:
Inclusion Criteria:

1. Voluntary agreement to provide written informed consen
2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
3. Predicted survival ≥ 12 weeks
4. Phase I (Phase I) was included and confirmed as MSLN positive (≥1+ after IHC test by central laboratory).Failure, intolerance, or lack of standard treatment has been identified by tissue or cytology The MSLN test is not required for patients with advanced malignant tumor and for subjects diagnosed with malignant mesothelioma;
5. Adequate organ function required
6. Male and female participants are eligible to participate if they agree to the contraception use as per study protocol.

Exclusion Criteria:

1. Cancer metastases in the brain
2. Active infection or past hepatitis B or C infection
3. Major surgery less than 1 month before the start of the study
4. Uncontrolled heart disease
5. History of allergy to mesothelin-directed antibodies, tubulysin, monoclonal antibodies related compounds
Food Effect on the Eradication Rate of H. Pylori With Triple Therapy With Esomeprazole

The purpose of the study is assess whether the various forms of triple regimen of administration of treatment of Helicobacter pylori (before meals (fasting), after meals, and any independent mealtime) influence the rate of eradication of this bacterium.

Phase IV, open, randomized, prospective study.

* Length of experience: 180 days.
* 06 visits.
* Evaluation of the efficacy of differences regimens of administration.

Eligibility Criteria:
Inclusion Criteria:

* Participants of both sexes;
* Age greater than or equal to 18 and less than or equal to 50 years;
* Participant diagnosed with type dyspepsia epigastric pain carriers of Helicobacter pylori infection, according to the classification of ROME III;
* Ability to understand and consent to participate in this clinical study, manifested by reading, understanding and signing of the Informed Consent (IC).

Exclusion Criteria:

* Any finding of clinical observation (clinical evaluation / physical) that is interpreted by the investigator as a medical risk to participate in the clinical trial;
* Any laboratory examination found that the investigator doctor considers a risk to the research participant for their participation in the clinical trial;
* Known hypersensitivity to the drug components used during the study;
* Women in pregnancy or breastfeeding period;
* Women in reproductive age who do not agree to use acceptable methods of contraception (oral contraceptives, injectable contraceptive, IUD, hormonal implants, barrier methods, abstinence, hormonal patch and tubal ligation); except surgically sterile (bilateral oophorectomy or hysterectomy);
* Participating in the research that has participated in clinical trial protocols in the last twelve (12) months (CNS Resolution 251 of August 7, 1997, Part III, sub-item J), unless the investigator considers that there may be direct benefit to it;
* Party that has some kinship to the second degree or bond with employees or employees of Sponsor and Research Center;
* Patients with predominant symptoms of reflux or irritable bowel syndrome, warning symptoms, peptic ulcer history or previous surgery in the upper segment of the gastrointestinal tract;
* Patients with prior treatment history of eradication of Helicobacter pylori;
* Patients with kidney, liver or heart failure;
* Patients with past or current history of alcohol abuse;
* Patients with a history of use of antibiotics or bismuth in the 4 weeks prior to study entry, PPIs or H2 blockers, NSAIDs or aspirin in the last two weeks;
* Patients whose endoscopy show changes except hyperemic gastritis, erosive gastritis den considering the maximum of 5 erosions in this location or hiatal hernia;
* Patients whose ultrasonography show hepato-biliopancreatic changes except steatosis.
Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Lens Wearers

The purpose of this trial is to evaluate the extent to which symptoms improve in symptomatic contact lens wearers when fit with one of 5 different daily disposable contact lenses.


Eligibility Criteria:
Inclusion Criteria:

* Currently wear spherical, soft contact lenses replaced at intervals of 2 weeks or monthly.
* Habitually wear lenses for at least 8 hours per day, 4 days per week, for at least the past 6 months.
* Report 2 or more qualifying symptoms with current contact lenses with a frequency of "frequently" or "all the time"
* Able to achieve VA of at least 20/40 in each eye with habitual correction and with study lenses at dispense.
* Other protocol inclusion/exclusion criteria may apply.

Exclusion Criteria:

* Eye injury or surgery within twelve weeks immediately prior to enrollment.
* Currently enrolled in any clinical trial.
* Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
* History of corneal refractive surgery.
* Cylinder correction greater than 1.00 D.
* Current monovision contact lens wearers.
* Other protocol inclusion/exclusion criteria may apply.
A Comparison of Rapid Immunoassays for the Detection of Ruptured Membranes

Specific objectives include analysis of performance of ROM Plus® in diagnosing ROM, as compared to Amnisure® and the conventional clinical assessment confirmed by a thorough chart review after delivery.

Inclusion Criteria:

* English speaking
* pregnant woman \>15 weeks gestation undergoing an exam for ruptured membranes

Exclusion Criteria:

* Known placental previa
* Active vaginal bleeding


Eligibility Criteria:
Inclusion Criteria:

* complaint of ruptured membranes
* IUP \> 15 weeks gestation
* English speaking, over the age of 18yrs old

Exclusion Criteria:

* active bleeding
* placenta previa
Reference Range Study for the Quantra System With the QStat Cartridge in Obstetric Patients

This study will determine reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge in the last trimester of non-laboring pregnant women with an uncomplicated pregnancy

During pregnancy, there is a progressive shift of hemostasis toward a hypercoagulable state that is protective against postpartum hemorrhage. To assess the clinical utility of the Quantra System in high-risk OB patients during delivery, it is important to understand how the normal physiological changes of pregnancy impact Quantra results. This study will determine reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge in the last trimester of non-laboring pregnant women with an uncomplicated pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Subject is female, age 18 to 45 years old.
* Subject is pregnant with a single fetus and duration of pregnancy is \>28weeks
* Subject is willing to participate and has provided informed consent.

Exclusion Criteria:

* Subject has a history of a coagulation disorder (including excessive bleeding, thrombosis, VWD, or any factor deficiencies).
* Subject has taken medications known to alter coagulation during pregnancy including heparin, warfarin/Coumadin®, antiplatelet drugs including Plavix® or aspirin at a dose greater than 81 mg/day, Xarelto® or Eliquis®, or other anticoagulants.
* Subject has experienced one or more complications during pregnancy such as gestational diabetes, high blood pressure, pre-eclampsia or eclampsia, hypovolemia or pre-term labor.
* Subject had a blood transfusion during pregnancy.
* Subject has a history of smoking/vaping during pregnancy
At-Home Cardiac Rehabilitation for Adolescents At Risk for Heart Failure

The goal of this clinical trial is to explore the impact that an at-home cardio-oncology rehabilitation (CORE) may have on short-term cardiovascular fitness and psychosocial wellness in pediatric cancer survivors. The main question it aims to answer are

* To evaluate the efficacy of an at-home CORE model on short-term cardiovascular fitness and psychosocial wellbeing in adolescent cancer survivors.
* To evaluate the exercise adherence rate among adolescents at risk for heart failure and assess barriers to compliance.
* To explore which specific CORE resources are of most value to patients in creating sustainable healthy lifestyle modifications.
* Hypothesis: Pediatric cancer survivors who implement exercise and dietary recommendations will demonstrate improvement in cardiovascular fitness and general wellness. A multidisciplinary team approach can facilitate adherence to a moderately rigorous exercise prescription, and thus enhance the health benefits of a CORE program at CHLA.

Participants will undergo cardiovascular studies and a quality-of-life survey prior to exercise intervention, and at the end of the 6-month study period.


Eligibility Criteria:
INCLUSION CRITERIA

* Patients aged of 10-21 years at enrollment
* Parent/legal guardian available for consent (if applicable), and patient available for assent and consent
* History of anthracycline exposure +/- radiation
* Currently in remission, with at least 6 months off chemotherapy
* Able to perform CPET
* Baseline CPET with VO2 \<80% (at start of study, or CPET at CHLA after January 2020)
* Smartphone compatible with Fitbit (own or parent/legal guardian's)
* Ability to complete and send diary and Fitbit information on a weekly basis
* Ability to participate in monthly virtual check-in visits
* Baseline activity prior to intervention \<30min/day, 2x/week

EXCLUSION CRITERIA

* Inability to obtain consent/assent
* Unable to accurately perform quality of life survey independently
* No other primary medical diagnosis (e.g., Down Syndrome, Wolff-Parkinson-White Syndrome, congenital heart disease) or history of cardiothoracic surgery
* Contraindication to moderate activity (\>3 METs). Examples include history of malignant arrhythmias, exercise-induced syncope, severe symptoms of HF (NYHA IV, ACC/AHA Stage D)
* Unable to perform CPET, echocardiogram, EKG, or obtain laboratory studies
* Unable to perform mild activity for at least 0.5h/day and at least 2x/week
* Unable to come to hospital for study visits at 0 and 6 months
* Unable to complete study-related surveys
* Unable to complete and send diary and Fitbit information on a weekly basis
* Unable to check-in monthly on virtual platform
* On beta blockade
* Pregnancy
Prochymal Expanded Access Treatment for Pediatric Patients Who Have Failed Steroids for Acute GVHD

This protocol allows for the treatment of pediatric patients, male and female, between the ages of 2 months and 17 years. Patients must have failed steroid treatment for Grade B-D acute GVHD.

For the treatment of pediatric patients who have failed to respond to steroid treatment for acute graft-versus-host disease (GVHD). Failing steroid treatment for acute GVHD is defined as any Grade B-D (IBMTR grading) of acute GVHD that is not improving after at least 3 days of methylprednisolone (≥ 1 mg/kg/day) or equivalent.

Patients will be treated with Prochymal twice per week at a dose of 2 x 10\^6 hematopoietic stem cells (hMSC)/kg (actual body weight) for each of 4 consecutive weeks. Infusions will be administered at least 3 days apart.

Eligibility Criteria:
Inclusion criteria:

* Patients must sign an informed consent form (ICF) before any protocol-related procedures, including any pre-treatment procedures, are performed.
* Since patients being treated with Prochymal® under this protocol are under 18, a parental signature of informed consent will be required.
* Patients must be 2 months to 17 years of age, inclusive.
* Patients must have failed to respond to steroid treatment for Grades B-D acute GVHD • Failure to respond to steroid treatment for acute GVHD is defined as any Grade B-D acute GVHD that is not improving after at least 3 days of methylprednisolone (≥1 milligram per kilogram per day \[mg/kg/day\]) or equivalent.

Exclusion criteria:

* Patient must not have a known allergy to bovine or porcine products.
* Patient must not have received a transplant for a solid tumor disease.
* Patients must not have evidence of a pulmonary infiltrate or diffuse alveolar hemorrhage and must be unlikely to require more than 2 liters (L) of oxygen via face mask or an estimated fraction of inspired oxygen (FiO2) of 28% via other delivery methods in order to sustain an O2 saturation of 92% during the next 3 days.
Optimizing Protein Intake and Nitrogen Balance in Adult Critically Ill Patients

The purposes of the study are:

* To strictly ensure the appropriate level of protein and caloric provision in critical illness, according to the latest literature recommendation;
* To determine if an association exists between protein intake and nitrogen balance in the context of a nutrition with appropriate protein provision based on the latest literature recommendations, rather than in a standard diet with a caloric target weight-based. Creatinine clearance will also be evaluated to determine if there is any harmful effect to the kidney secondary to an elevated BUN.
* To determine if there is a difference in ICU mortality rate between the current nutrition standard and a hyperproteic nutrition protocol.


Eligibility Criteria:
Inclusion criteria:

* Age \> 18 years
* Receiving PN and/or EN nutrition
* Indwelling urinary catheter
* Mechanically ventilated patients

Exclusion criteria:

* Age \< 18 years
* Chronic renal or hepatic failure
* Current or history (past 6 months) of GI bleeding
* BMI \>30 kg/m2 o \<18 kg/m2
* Terminally ill patients
* Pregnancy
Minimal Invasive Rehabilitation of Tooth Loss in the Anterior Segment

Tooth loss can be addressed by different rehabilitative strategies. Implant-supported crowns and conventional bridges (fixed dental prostheses \[FDPs\]) are well established treatment alternatives. Implant therapy is sometimes impossible, however, because of patient-related risk factors or economic issues. In such cases therapy with an FDP requires extensive removal of tooth structure to provide enough space for the restoration and to ensure mechanical retention if the abutment teeth are sound. Alternatives for rehabilitation requiring minor or no preparation of the anchoring teeth are desirable. Resin-bonded bridges meet this demand for minimal invasiveness and have been used clinically successfully. Sometimes, however, patients choose a conventional FDP over a resin-bonded one (RBFDP) for esthetic reasons since the adhesive wings, which are traditionally made of a cobalt-chromium alloy, might be exposed while speaking or smiling or account for a colour change of the abutment teeth. Such patients profit from an all-ceramic RBFDP. Today, the clinical performance of metal-based and all-ceramic RBFDPs has not yet been evaluated under randomized controlled conditions. The aim of this pilot study is to calculate the sample size that allows us to accept the hypothesis that metal- and all-ceramic RBFDPs are similar regarding their clinical performance with adequate statistical power.


Eligibility Criteria:
Inclusion Criteria:

* missing central or lateral incisor
* regular patient of the department of prosthodontics of the university hospital of heidelberg
* willingness to return for recall examinations on a regular basis
* written informed consent
* abutment teeth are vital or sufficiently endodontically treated
* abutment teeth are periodontally stable
* abutment teeth have only little or no defects of the hardsubstances

Exclusion Criteria:

* Pregnancy or breastfeeding
* medically compromised condition not allowing for standard dental treatment
* Patient is not able to give written informed consent
* alcohol or drug abuse
* positive bruxism and parafunctions questionaire
* Bite-Strip \> 2
* Attrition Score \> 3
* deep bite (Angle class II/2)
* abutment tooth height \< 4mm
* untreated symptomatic periodontal or endodontic lesions
* abutment tooth mobility \> grade I
* known allergies to materials used in this study
* poor dental hygiene
* planned change of residency
Physical Activity and Nutrition to Halt Elevated Risk in the Pancreas Interception Center

The purpose of this Study is to assist in implementing a practical, easy-to-adopt lifestyle intervention that optimizes patient outcomes and minimizes pancreatic ductal adenocarcinoma (PDAC) risk.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Endoscopically, radiologically, or biopsy-proven pancreatic intraductal papillary mucinous neoplasm (IPMN) over 15 mm in size
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Ability to sign informed consent
* Ability to read and speak English or Spanish
* Body Mass Index (BMI) greater than or equal to 25 kg/m2
* Visceral obesity based on MRI quantification of visceral and subcutaneous fat; ratio of visceral to subcutaneous fat area greater than 0.4 and/or elevated cytokine, incretin or adipokine biomarkers

Exclusion Criteria:

* No diagnosis of an IPMN
* IPMN with high grade dysplasia, cancer or other high-risk features
* Screen failure for exercise safety
* Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease
* Recent fracture or acute musculoskeletal injury
* Numeric pain rating scale of 7 or more out of 10
* Myopathic or rheumatologic disease that impacts physical function
Aflibercept in Recurrent or Persistent CNV

Age-related macular degeneration (AMD) and diabetic retinopathy are among the most common disorders causing visual disability in elderly people. AMD leads to dysfunction and loss of photoreceptors in the central retina. Neovascular AMD (nAMD) affects visual function early in the disease process.

The purpose of the study is to evaluate the effect of switching from ranibizumab therapy to the current routine therapy using aflibercept in eyes with treatment naive, recurrent or persistent nAMD, treatment naive diabetic retinopathy and pretreated diabetic retinopathy.

20 patients with recurrent or persistent nAMD, previously treated with intravitreal ranibizumab for up to one year will be included in this trial. Patients will be examined in monthly intervals over 12 months follow-up.

Examinations carried out will include: Best-corrected visual acuity (BCVA) using ETDRS charts at 4m distance, Reading Performance (RP), Standard ophthalmic examinations (SOE incl. funduscopy and applanation tonometry), Optical coherence tomography (OCT), Autofluorescence fundus image (AF) \& red-free autofluorescence fundus image (RF), Color fundus photography (CFP), Fluorescein angiography and indocyaningreen angiography (FLA/ICG), Microperimetry (MP), as well as Non-invasive OCT based optical angiography (AngioVue).


Eligibility Criteria:
Inclusion Criteria:

Adults ≥ 50 years

* Patients who have been treated with ranibizumab due to wet age-related macular degeneration for up to one year
* BCVA \>= 20/400 in the study eye using ETDRS
* Willingness and ability to comply with regular visits
* Signed informed consent

Exclusion Criteria:

* Any surgical treatment of the eye within 3 months prior to baseline in the study eye
* History of uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma mediation)
* Aphakia or absence of the posterior capsule (excluding YAG-capsulotomy) in the study eye
* Retinal pigment epithelial tear involving the macula in the study eye