cyrilzakka/clinical-trials huggingface dataset:
Effects of Plyometric Training on University Female Tennis Players' Physical Fitness and Serve Performance

The main objective of this study is to examine the effects of upper and lower limb plyometric training on the selected physical fitness and serve performance among university female tennis players in China.

The main hypothesis of this study is to evaluate whether there are significant effects of 8 weeks of upper and lower limb plyometric training on selected physical fitness and serve performance among university female tennis players in China.

This intervention lasted for 8 weeks, two times each week, for 30-60 minutes of low-high intensity exercise. The content of the experimental group and control group of exercises mainly includes warm-up, primary content, and cool down. The intervention included push-ups and medicine ball exercises for the upper limbs and jumping, hopping exercises for the lower limbs. Exercises for the upper limbs were immediately followed by lower-limb exercises, with no intervening rest periods. all plyometric exercises, including those involving the upper and lower limbs, were executed with maximal effort, with the goal of reducing contact time during each repetition, and with no allowance for rest periods between jumps. During the intervention, the control group just continued with their regular training regime (e.g., normal fitness training, and injury prevention drills), twice a week, for the duration of the experiment.

Eligibility Criteria:
Inclusion Criteria:

1. University female tennis players (aged 18-24 years old);
2. Players who had been trained professionally for more than three years
3. No history of recent surgery, no rehabilitation for the past 12 months;
4. Not systematically trained in plyometric training;

Exclusion Criteria:

1. Tennis-specific training time less than 3 years;
2. Players with a history of recent fractures or any injury;
3. Presently involved in a plyometric training program;
Biomarkers of Whole Grain Wheat and Rye Intake

Alkylresorcinols (AR) are a group of lipids found in the bran fraction of wheat and rye grains. AR are absorbed into the bloodstream and their metabolites are excreted in urine in measurable amounts following ingestion of wholegrain (WG) wheat or rye cereal. As AR are absent in refined cereals, plasma AR and urinary AR metabolites are proposed as suitable biomarkers of dietary intake of WG wheat and rye cereal, with a number of studies supporting this proposal. Different AR species are present in characteristic quantities in WG wheat in comparison to WG rye cereals, which can allow identification of the main source of WG (wheat or rye) in individuals by analysing the AR concentrations in blood. However the patterns of urinary AR metabolite excretion following wheat or rye intake have not yet been investigated to determine if there are differences according to WG source.

The present study aims to:

(i) investigate the differences in AR metabolite excretion pattern in spot and 24 hour urine samples after following a predominantly WG rye-based diet in comparison to a predominantly WG wheat-based diet and in comparison to control (refined cereal diet) (ii) compare the validity and reproducibility of AR metabolites in spot urine samples in comparison to 24 hour urine samples.


Eligibility Criteria:
Inclusion Criteria:

* Body mass intake 18.5-30.0 kg/m2
* Weight stable for 2 months
* Generally healthy

Exclusion Criteria:

* Previous or current chronic disease including heart disease, diabetes, gastrointestinal, liver, renal or endocrine disorders
* Drug or alcohol misuse in the last year
* Current pregnancy or lactation
* Weight change of \>3 kg in the last two months
* Current regular user of certain prescription medications (except contraceptives)
* Unwilling to consume or to stop consuming WG wheat, WG rye or refined cereals
* Unwilling to discontinue multivitamins/dietary supplements during study
A Study to Compare the Effectiveness of Two Types of Ultrasound Technologies in Women Who Have Had Breast Cancer

This clinical trial evaluates automated breast ultrasound (ABUS) and handheld ultrasound (HHUS) for the screening of women who have undergone breast reconstruction after breast cancer. Ultrasounds use high-frequency sound waves to create pictures of internal organs and tissues. ABUS has been found to be equal to HHUS for whole breast screening, but no data exist on its use for screening of reconstructed patients. This clinical trial evaluates the feasibility of using ABUS versus HHUS to screen women who have undergone reconstruction.

PRIMARY OBJECTIVE:

I. To show that ABUS reduces artifact compared to HHUS in terms of detection of the residual tissue in reconstructed nipple sparing mastectomy (NSM) and skin sparing mastectomy (SSM) patients.

SECONDARY OBJECTIVES:

I. To evaluate both the performance and interpretation times for ABUS and HHUS so that these factors can be considered when scheduling patients and for ease of implementation into practice.

II. A short survey will be administered immediately after both ultrasounds performed to enrolled patients to assess their experience with HHUS and ABUS, specifically addressing their perceived comfort level on a numerical scale and if they would be interested in obtaining subsequent annual screening HHUS or ABUS.

EXPLORATORY OBJECTIVE:

I. The appearance of native and reconstructed anatomy on ABUS and HHUS will be studied.

OUTLINE:

Participants undergo HHUS and ABUS in no required order over 1 hour.

Participants with ultrasound results indicating Breast Imaging Reporting and Data System (BI-RADS) 4 or 5 (suspicious and needs biopsy) undergo biopsy within 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Female
* \>= 18 years of age at time of consent
* Free of focal breast symptoms and with no suspicious breast physical exam findings
* Previous unilateral NSM or SSM with implant (silicone, saline) or flap reconstruction performed at Thomas Jefferson University Hospital
* Must be able to understand and provide signed and dated informed consent form. If a patient understands the informed consent but is unable to sign, a legally authorized representative (LAR) may sign
* Willing to comply with all study procedures and be available for the duration of the study
* Willing to honor any bills that may be incurred if the insurance company does not pay for the billed bilateral hand held ultrasound

Exclusion Criteria:

* History of breast cancer recurrence
* Current focal breast symptoms since NSM or SSM with reconstruction
* NSM or SSM with reconstruction was performed years prior to study enrollment
* Bilateral NSM or SSM with reconstruction
* Females who are pregnant
Clinical Examination of Metal Free Interdental Brushes

The aim of the study was to evaluate the clinical efficacy (Eastman Interdental Bleeding Index, Quigley and Hein) of a novel metal-free interdentalbrush compared to a classig metal-core interdental brush.

Self-performed interdental cleaning is a crucial element in preventing gingival or periodontal diseases. Interdental cleaning is most efficiently performed through usage of interdental brushes. Commonly used metal-core interdental brushes can harbour the risk of hard tissue damage when used inappropriately.The aim of the study was to evaluate the clinical efficacy and patient satisfaction of a novel metal-free interdental brush. This was tested on healthy participants. The control group performed interdental cleaning with a commonly used metal-core interdental brush.

Eligibility Criteria:
Inclusion Criteria:

* minimum age: 18 years

Exclusion Criteria:

* allergy against one or more parts of the interdental brushes
* non-treated periodontitis
* soft-tissue changes of the mucosa
* orthodontic treatment
* removable prosthesis
* pregnancy
* anticoagulants
* drugs causing gingivahyperplasia
* indications for antibiotics
Clinical Trial of Ridaforolimus Compared to Progestin or Chemotherapy for Advanced Endometrial Carcinoma (MK-8669-007 AM6)

The purpose of this study is to compare progression-free survival (PFS) of patients with advanced, recurrent or metastatic endometrial cancer who have received one, but not more than two, prior lines of chemotherapy either as adjuvant therapy or treatment for advanced disease, and then when treated with ridaforolimus or the investigators' choice of progestin or chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Endometrial cancer
* Patients must have been treated with at least one line of chemotherapy, but not more than two lines of chemotherapy, and experienced progressive disease
* At least one measurable lesion
* ECOG performance status less than or equal to 1
* Minimum life expectancy of 3 months
* Adequate renal and hepatic function
* Adequate bone marrow function
* Serum cholesterol \<350 mg/dL and triglycerides \< 400 mg/dL
* Able to understand and give written informed consent
* Females of childbearing potential must have a negative pregnancy test and use approved contraception from screening to 30 days after the last study drug is given

Exclusion Criteria:

* Two lines of chemotherapy for recurrent or metastatic disease
* Chemotherapy for recurrent or metastatic disease administered within six months of adjuvant therapy
* More than two lines of chemotherapy of any type
* Prior therapy with hormonal agents
* Women who are pregnant or lactating
* Presence of brain or other central nervous system metastases
* Prior therapy with rapamycin, rapamycin analogues or tacrolimus or known sensitivity to these agents
* Anticancer treatment (chemotherapy, radiotherapy) within 4 weeks prior to randomization
* Ongoing toxicity associated with prior anticancer therapy
* Inadequate recovery from any prior surgical procedure or having undergone any major surgical procedure within 2 weeks prior to randomization.
* Another primary malignancy within the past five years (except for non-melanoma skin cancer and cervical carcinoma in situ)
* Known Grade 3 or 4 hypersensitivity to macrolide antibiotics
* Significant uncontrolled cardiovascular disease
* Active infection
* Known HIV infection
* Known Hepatitis B or C infection
* Newly diagnosed (within 3 months before enrollment) or poorly controlled Type 1 or 2 diabetes
* Concurrent treatment with immunosuppressive agents
* A requirement for concurrent treatment with medication that strongly induce or inhibit cytochrome P450 (CYP3A)
Application of Functional Renal MRI to Improve Assessment of Chronic Kidney Disease

Research question: Can multiparametric renal Magnetic Resonance Imaging (MRI) provide structural and functional assessment of the kidneys to deliver prognostic information and guide treatment options in chronic kidney disease (CKD)?

Aims and objectives:

1. To establish a multiparametric renal MRI protocol in CKD cohorts.
2. To use multiparametric MRI to characterise people with and without CKD progression.
3. To compare multiparametric renal MRI with 'gold-standard' renal biopsy to determine pathological processes of CKD progression that are detectable by MRI.

The study will have three stages.

Stage 1: 45 people with CKD from nine UKRIN centres will undergo multiparametric MRI to test patient tolerance, data completeness and central data collection processes.

Stage 2: A multicentre, prospective cohort study of 450 people with CKD, collecting multiparametric renal MRI at baseline and 2 years. Long-term outcomes will be determined with efficient tracking of kidney failure events via the UK Renal Registry at 5 and 10 years.

Stage 3: A mechanistic sub-study of 45 patients (from Stage 2) who have had a routine renal biopsy. Detailed comparisons will be made between multiparametric MRI and histopathological changes. Tissue blocks will undergo quantitative analysis of fibrosis, capillary density and inflammation using immunohistochemistry techniques.

Eligibility Criteria:
Inclusion Criteria

* Age 18-75 years
* CKD category G3-4 or CKD category G1-2 with overt albuminuria (urine ACR\>30mg/mmol)
* Capable of giving informed consent

Exclusion Criteria

* Autosomal dominant polycystic kidney disease (ADPKD)
* Glomerulonephritis (GN) actively receiving immunosuppression, or within the preceding 90 days.
* Multiple myeloma (MM)
* Acute Kidney Injury (AKI) within the preceding 90 days
* Solid organ transplant
* Known single kidney
* Contraindications to MRI (e.g. permanent pacemaker, metallic foreign bodies, claustrophobia etc.)
Oral Probiotics on the Shift in Gut Microbiome and Skin Carotenoid Levels

The purpose of this study is to determine how probiotics affects circulating carotenoid levels.

Certain probiotic strains are rich in the production of carotenoids. This study will evaluate if probiotic supplementation with a carotenoid rich strain will augment circulating carotenoids.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 40+
* Must be willing to comply with all protocol requirements
* Must be willing to have flash photo facial images taken with the imaging systems
* Fitzpatrick skin type II, III, or IV

Exclusion Criteria:

* Any systemic or antibiotics (injected or oral) within 6 months of starting study
* Any topical antibiotic or Vitamin A within 1 month of starting study or any subject unwilling to refrain from washout of topical antibacterial or vitamin A ingredient.
* Any oral probiotic or prebiotic supplementation within past 1 month at the discretion of the investigator.
* Limit total fruit and vegetable intake to 2.5 servings (1 serving=1 cup) per day of high carotenoid foods. High carotenoid foods include spinach, summer squash, carrots, citrus fruits, celery, kale, tomatoes, and cantaloupe
* Subjects must have no history of malignancy or cancer (excluding skin cancer unless there is a history of metastasis) or diagnosis of gastrointestinal inflammatory diseases, no history or diagnosis of epilepsy, no history or diagnosis of immunologic or infectious disease (e.g. hepatitis, tuberculosis, HIV or AIDS, lupus, rheumatoid arthritis)
* Has a condition or is on medication the investigator and/or designee believe could jeopardize the safety of the subject, interfere with the evaluation, or confound the interpretation of the study results
* Women who have been pregnant in the last three months, are pregnant, preparing to be pregnant or lactating.
* Is participating in a concurrent intervention based clinical research study
* Those with BMI higher than 35 kg/m²
* Commencement of a new diet (such as the ketogenic diet) or supplements within the 1 month prior to initiating participation, at the discretion of the investigator.
* Is participating in or has participated in a intervention based facial study at this or any other facility in the past 2 weeks. Participation in survey-based studies are approved at the discretion of the investigator.
* Has a skin disease on face that will interfere with image collection and assessment in the opinion of the investigator
* Refusal to shave or remove facial hair that may interfere with image collection and assessment.
* Persons unwilling to avoid the following during the 4 weeks prior and during the duration of the study: self-tanning, spa tanning, sun tanning, or artificial tanning.
* Known allergy or irritation to the supplement utilized in the study
* Persons unwilling to avoid sun exposure to the inner forearm
* Current tobacco smokers, OR those that have smoked tobacco over the past year, OR a 5 year-pack year history of smoking tobacco
* Cutaneous photosensitivity at wavelengths of 400-450 nm
* Porphyria or known allergies to porphyrins
* Prisoners
* Adults unable to consent
Assessing Renal Function in Patients With an Antibiotic Laden Spacer

The purpose of this study is to monitor the renal function of patients who have an antibiotic laden spacer in place to treat an infected hip or knee arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

1. All patients undergoing a hip or knee resection arthroplasty by the primary investigator
2. Ages 18+
3. Ability to adhere to follow up schedule

Exclusion Criteria:

1. Unable to give informed consent
2. Age \<18
3. Previous history of infected Total Knee Arthroplasty or Total Hip Arthroplasty
4. History of renal failure or impaired renal function
5. Allergies to aminoglycosides or Vancomycin
Use of DNA Testing and Gene Expression Profiling to Help Transition Kidney Transplant Recipients to Belatacept-only Immunosuppression

The purpose of the study is to provide immunosuppression weaning and/or monitoring for an additional 12-months to evaluate the safety and efficacy of belatacept monotherapy in patients previously enrolled in the clinical trial: "Use of donor derived-cell free DNA (AlloSure) and gene expression profiling (AlloMap Kidney) to facilitate Belatacept monotherapy in kidney transplant patients."


Eligibility Criteria:
Inclusion Criteria:

* Completion of the parent study (STU-2020-1339)
* Able to provide informed consent
* Absence of donor specific antibodies
* Stable renal function (eGFR\>40mL/min for 3 months prior to enrollment)

Exclusion Criteria:

* Female participant who is pregnant, lactating or planning pregnancy during the course of the trial
* Significant hepatic impairment
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
* Proteinuria \> 0.5 g/g creatinine on spot urine sample within 3 months of enrollment
Autonomic Nervous System and Sickle Cell Disease

Sickle cell disease (SCD) children and adults with asthma have an increased rate of vaso-occlusive crisis, acute chest syndrome episodes, and premature mortality when compared to those without asthma. We hypothesised that either asthma diagnosis and/or bronchodilator treatment may aggravate SCD via their modulating effect on autonomic nervous system.

Heart rate variability during pulmonary function tests (spirometry, static volumes, DLCO/DLNO, exhaled NO at multiple flow rates) including salbutamol administration will be evaluated in patients with SCD (n=60) receiving asthma treatment or not, as compared to asthmatic children without SCD (n=30) matched for ethnicity

Eligibility Criteria:
Inclusion Criteria:

* age from 8 to 16 years (≥ 8 years and \< 16 years) (spirometry and DLCO study feasible)
* Sub-Saharan African or Caribbean ethnic origin.
* child with sickle cell disease referred for monitoring of respiratory function in the framework of its sickle cell disease and whether or not it presents a possible disease asthmatic (asthma treatment prescribed in the past year)
* or asthmatic child (typical functional signs + history of exacerbation severe hospitalized or reversible obstructive pulmonary disorder) not sickle cell
* addressed for respiratory function monitoring

Exclusion Criteria:

* Refusal to participate (lack of consent)
* Sickle cell child of North African origin
uPAR-PET/MRI in Patients With Prostate Cancer for Evaluation of Tumor Aggressiveness

Prospective study to evaluate the value of uPAR-targeted PET/MR scan using the tracer 68Ga-NOTA-AE105 in patients with newly diagnosed prostate cancer

Prostate cancer is one of the most frequent types of cancer in men. The characteristics of the disease varies significantly among patients where some have an indolent type of cancer, from which they will never experience symptoms while others have highly aggressive malignant disease that requires prompt therapeutic action.

Treatment of localized prostate cancer is based on a risk stratification, where patients are either offered therapy with curative intent - surgery or radiotherapy - or in case of low-risk disease an "active surveillance" strategy can be advised. In active surveillance the disease is monitored by PSA measurement, repeated biopsies and digital rectal examination. Some patients progress during active surveillance to a higher risk classification, which may lead to selection of active therapy.

The aim of this study is to investigate positron emission tomography (PET) with the radiolabelled tracer 68Ga-NOTA-AE105, combined with magnetic resonance imaging (MRI) in patients with newly diagnosed prostate cancer. 68Ga-NOTA-AE105 targets the receptor urokinase-type plasminogen activator receptor (uPAR), which is a known marker for aggressive disease in prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

* Histologically verified prostate cancer
* Capable of understanding written information and giving informed consent
* Planned to enter active surveillance strategy or undergo therapy with curative intent (surgery or radiotherapy)

Exclusion Criteria:

* Obesity (Body weight over 140 kg)
* Known allergy to 68-Ga-NOTA-AE105
* Metallic components in the body that contradicts MRI scan
* Severe claustrophobia making the person unable to complete an MRI scan
The Efficacy and Safety of Montelukast Sodium in the Prevention of Bronchopulmonary Dysplasia

This study is multicentered, prospective, randomized, opened, parallel, intervention study.

The aim of this study is to evaluate the efficacy and safety of Montelukast sodium in the prevention of bronchopulmonary dysplasia (BPD) in preterm infant, below 32weeks gestational age.

The investigators evaluate the first effectiveness through the morbidity and mortality of bronchopulmonary dysplasia. And then, the investigators evaluate the second effectiveness through the oxygen index, the usage of mechanical ventilator about taking medicine after 2 Weeks, Oxygen Utilization After 4 Weeks, Proinflammatory Cytokine through the bronchial lavage fluid.


Eligibility Criteria:
Inclusion Criteria:

* Preterm infants born at less than 32 weeks
* Birth 14 days after, oxygen or artificial ventilation who are using patient
* more than 20cal/kg/d by enteral feeding
* written consent of the parents

Exclusion Criteria:

* congenital anomaly
* cardiovascular collapse
* investigator's opinion
A Single-arm Study to Evaluate Safety and Effectiveness of VX-548 for Acute Pain

The purpose of this study is to evaluate the safety and effectiveness of VX-548 in treating acute pain.


Eligibility Criteria:
Key Inclusion Criteria:

* Body mass index (BMI) of greater than or equal to (≥) 18.0 to less than (\<) 40.0 kilogram per meter square (kg/m\^2)
* Non-surgical participants with pain of new origin (not related to a prior known condition) that is moderate or severe on the verbal categorical rating scale (VRS) and ≥4 on the numeric pain rating scale (NPRS)
* Surgical participants reporting pain at the surgical site that is moderate or severe on the VRS and ≥4 on the NPRS

Key Exclusion Criteria:

* Surgical participants:

  * History of previous surgery due to the same condition, except for procedures for which a previous surgery on the contra-lateral limb or organ is allowed
  * History of a prior surgical procedure in the same region of the body that resulted in any perioperative complications or that, in the opinion of the investigator or medical monitor, would preclude participation in the study
* History of any illness or any clinical condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant

Other protocol defined Inclusion/Exclusion criteria may apply.