cyrilzakka/clinical-trials huggingface dataset:
Interval Training in Young Healthy Individuals

Individuals who participate in regular physical exercise possess a lower prevalence of cardiovascular risk factors such as hypertension, type 2 diabetes, obesity and hypercholesterolemia, and aerobic exercise is therefore considered an important adjuvant therapy in risk factor modification and to promote health.

The main focus of the present study is therefore to detect how rapid it is possible to increase aerobic capacity with interval running exercise.

The hypothesis is that it is possible to improve maximal oxygen uptake faster when increasing training frequency. The total gain in maximal oxygen uptake will however be the same between the two groups when they have performed the same amount of training

We will perform aerobic interval training at an intensity of 90-95% of maximum heart rate in healthy individuals. The subjects will be randomly assigned to carry out a total of 24 exercise-sessions, either at 3 times per week or 8 times per week.

The two groups will carry out 24 training sessions before 8 weeks of detraining will provide how rapidly aerobic capacity is lost due to inactivity. After the detraining period a retraining phase is introduced to detect if improvements in aerobic capacity occur more rapidly compared to before the first training period

The subjects will be tested for oxygen uptake, pumping capacity of the heart, blood volume, skeletal muscle enzyme activity, endothelial function.

Eligibility Criteria:
Inclusion Criteria:

* BMI\<27, non-smokers, train less that 1-2 times per week, VO2max \<60 for male and \<50 for female.

Exclusion Criteria:

* Hypertension, diabetes and cardiovascular disease.
Clinic-Based AMES Treatment of Stroke

This study investigates whether assisted movement with biofeedback and muscle vibration applied to the lower limb reduces impairment and improves gait.

The hypothesis of this study is that chronic stroke survivors, more than one year post-stroke, with a motor problems in the lower extremity will be able to walk and move the affected leg better after 30 treatments with a new robotic therapy device, the AMES device. The device rotates the ankle while vibrators stimulate the tendons attached to muscles that move the ankle. Testing will be done before, during and after the treatments to determine response to the therapy.

Eligibility Criteria:
Inclusion Criteria:

* At least 12 months post-stroke
* Cognitively and behaviorally capable of complying with the regimen
* Functioning proprioception
* Less than 50% of normal strength in the affected ankle, but able to stand with or without assistive devices

Exclusion Criteria:

* Fractures of treated limb resulting in loss of range of motion
* Spinal cord injury
* Deep vein thrombosis
* Peripheral nerve injury or neuropathy in the limb affected with motor disability
* Osteoarthritis limiting range of motion
* Skin condition not tolerant of device
* Progressive neurodegenerative disorder
* Uncontrolled seizure disorder
* Botox treatment within the last 5 months
* Baclofen pump
Lymph Node Mapping Using Indocyanine Green Solution in Diagnosing Patients With Malignant Melanoma

This clinical trial compares and contrasts lymph node mapping using indocyanine green (IC-GREEN), isosulfan blue (ISB), and TSC and Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC).

Study participants with malignant melanoma will undergo all 3 evaluations to assess the extent of the spread of the melanoma.

PRIMARY OBJECTIVES:

I. To show that indocyanine green (ICG) (indocyanine green solution) is equal to both isosulfan blue (ISB) and technetium Tc 99m sulfur colloid (TSC) and will allow all lymph node mapping to occur in the operating room (OR).

OUTLINE:

Patients receive peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution. During surgery, patients undergo identification of the sentinel lymph node and imaging using a laser with videocamera (SPY Elite camera).

Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and willingness to sign informed consent document
* Signed written informed consent
* Malignant melanoma (MM) undergoing sentinel lymph node biopsy (SNLB)
* 18 years of age or older
* Complete blood count (CBC) and metabolic panel within 6 months

Exclusion Criteria:

* History of hepatic or renal failure
* Allergy to iodine containing products
* Pregnant or may be pregnant
* Psychiatric or addictive disorders that in the opinion of the research team, may not be able to meet study requirements
* Undergoing dialysis
Patient-Reported Outcomes in Head and Neck Cancer

Weekly electronic reporting of patient-reported outcomes will be tested in a national trial in participants undergoing radiotherapy for head and neck cancer.

The study is a national study under the Danish Head and Neck Cancer Group (DAHANCA) and all 6 centers in Denmark will participate.

The clinical endpoints will be:

* Quality of life
* Objective toxicity score (DAHANCA)
* Opioid treatment
* Tube feeding
* Weight loss
* Hospitalization
* Compliance to treatment

There is a high level of evidence for improved disease control in head and neck cancer (HNC) using regimens with accelerated radiotherapy and concomitant chemotherapy. These intense regimens can result in severe acute and late side effect. The standard approach for documenting symptomatic adverse events (AEs) in cancer clinical trials involves investigator reporting using the National Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events (CTCAE). In Denmark, the Danish Head and Neck Cancer Group (DAHANCA) toxicity score has been used as an instrument in assessing objective treatment induced toxicity. New research in other cancer treatments indicate, that systematic patient assessment of side effects may improve treatment outcome. Patient Reported Outcomes (PROs) can be used for symptom monitoring. Interactive use of PRO may secure early recognition of specific symptoms in the individual patient and timely management of side effects.

This trial it is a prospective nationwide, single armed sequential cohort study will investigate the effects of active use of PROs in clinical counselling and decision making during primary or post-operative curative radiotherapy for squamous-cell carcinoma of the head and neck (HNSCC). It will investigate quality of life and the management of side effects in standard clinical counselling (control group) versus standard clinical counselling plus the PRO (PRO group). The EORTC QLQ-C30 (quality of life questionnaire) and EQ-D5-L5 will be answered in both groups. In the PRO group the participants will be asked to complete the electronic PRO (PRO CTCAE™ HNC relevant items supplemented by HNC specific items fra the EORTC library) weekly. The electronic PRO questionnaire is designed to give feedback to treating physician and nurses at visits during and shortly after radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Primary or post-operative curative radiotherapy (photons) plus/minus concomitant Cisplatinum for squamous-cell carcinoma of the head and neck (HNSCC)
* No serious cognitive deficits
* Read and understand Danish

Exclusion Criteria:

•Prior radiotherapy in the same area (head and neck)
Topical Lidocaine: Predictors of Response in Peripheral Nerve Injury

The primary purpose is to study the predictive value of preserved nociceptors and large afferent fibers and dynamic mechanical allodynia on the effect of lidocaine patch. The primary outcome measure is the predictive role for these three measures for obtaining a response to lidocaine. A responder is defined as a person with at least a 2-point pain reduction to lidocaine (change in median pain intensity (measured on a 10 point numeric rating scale) of pain from the baseline week to the last week of lidocaine treatment). Secondary effect variable will be efficacy of lidocaine on pain reduction (baseline week versus last week of each treatment) and pain relief (complete, good, moderate, slight, none, or worse) for spontaneous and evoked pain, and effect on ongoing pain, brush evoked allodynia, cold and warm allodynia, and pinprick hyperalgesia evaluated on each visit.


Eligibility Criteria:
Inclusion Criteria:

* patients aged 18 or more with neuropathic pain after a peripheral nerve injury with a pain intensity of at least 4 on a 0-10 point numeric rating scale.

Exclusion Criteria:

* pregnancy or lactation,
* allergy to lidocaine,
* alcohol abuse,
* psychiatric disorders,
* skin diseases in the area where the patches are to be applied,
* treatment with class I antiarrhythmic agents,
* any treatment within the past one month or concomitantly with Na2+-channel blockers (e.g., mexiletine, phenytoine, propafenone),
* any topical treatment with capsaicin within the last three months before entering the study, or any other topical treatment in the area of neuropathic pain,
* concomitant therapy with TENS or acupuncture.
Comparison of RF and crYoballoon ablatiOn Therapy of AF（CRYO-AF）

It's a multi-center, prospective, randomized, controlled clinical trial of cryoballoon versus radiofrequency ablation for paroxysmal atrial fibrillation.

The hypothesis of this study is that pulmonary vein isolation with cryoballoon ablation is not inferior to radiofrequency ablation with 3D mapping with respect to clinical safety and efficacy.

Eligibility Criteria:
Inclusion Criteria:

* ECG recording of atrial fibrillation
* first time of ablation
* refractory to at least one anti-arrhythmia drug
* sign informed consent for participation in the study

Exclusion Criteria:

* had ablation before
* serious heart failure
* left atrial diameter\>55mm
* Myocardial infarction, heart surgery or coronary intervention in 3 months before the ablation
* Stroke in 6 months before the ablation
* Endocardial thrombosis
Meropenem Versus Meropenem Plus Glycopeptide in Patients With Febrile Neutropenia After Allogenic Blood Stem Cell Transplantation

Observational study to compare the treatment in neutropenic patients after allogenic blood stem cell transplantation, with meropenem or meropenem plus glycopeptide.

Observational study cost-effectivity to compare the treatment in neutropenic patients after allogenic blood stem cell transplantation, with meropenem or meropenem plus glycopeptide.

The study will be done in two consecutive cohorts of patients. First cohort: meropenem 1g/8h ev Second cohort: meropenem 1g/8h and glycopeptide (vancomycin 1g/12 h or teicoplanin 400 mg/24h)

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Patients submitted to allogenic transplant
* Neutropenia: neutrophils account \< 500/mm3 or neutrophils account \< 1000/mm3 with prevision to decrease until 500/mm3 at the next 24-48 h
* Signs and symptoms to infection
* Fever: Temperature\> 38,3 ºC registered one time, or 38 ºC en two times separated 60 minutes in a period of 12 h.

Exclusion Criteria:

* Medical history of meropenem or glycopeptides hypersensitivity
* Renal failure or creatinine in serum \> 2,25 mg/dl or creatinine clearance \< 40 ml
* Liver insufficiency
* Childbearing potential or breast feeding period
* Contraindications to meropenem, vancomycin or teicoplanin
Injection Technique Assessment of Restylane Lyft With Lidocaine for Cheek Augmentation

This is a multi-center, open-label, single-arm study to evaluate an injection tool with Restylane Lyft with Lidocaine for cheek augmentation and correction of age related midface contour deficiencies.


Eligibility Criteria:
Primary Inclusion Criteria:

* Subjects willing to comply with the requirements of the study and providing a signed written informed consent.
* Males or non-pregnant, non-breastfeeding females, 22 years of age or older.
* Mild to Substantial Midface Volume Loss

Primary Exclusion Criteria:

* Allergy or hypersensitivity to any injectable hyaluronic acid gel or to gram positive bacterial proteins
* Allergy or hypersensitivity to lidocaine or other amide-type anaesthetics, or topical anaesthetics or nerve blocking agents
* Undergone prior surgery to midface
Obstructive Sleep Apnea Influences Efficacy of PD-1-Based Immunotherapy Against Non-Small Cell Lung Cancer

This prospective, observational cohort study aims to explore the influence of obstructive sleep apnea(OSA) on the efficacy of PD-1-based immunotherapy in patients with non-small cell lung cancer(NSCLC). Patients who had no prior treatment for advanced NSCLC and are intended to receive PD-1/PD-L1 antibody will be recruited. According to sleep monitor results, participants will be divided into Group NSCLC and Group OSA+NSCLC. Primary outcome is the objective remission rate(ORR).

This is a single-center, prospective, observational cohort study. Patients who had no prior treatment for advanced NSCLC and are intended to receive PD-1/PD-L1 antibody will be recruited and followed for 4 years. According to the baseline sleep monitor results, participants will be divided into Group NSCLC(AHI\<15), and Group OSA+NSCLC(AHI≥15), and then explore the influence of obstructive sleep apnea on the efficacy of PD-1-based immunotherapy. The baseline level of white blood cell count (WBC); absolute neutrophil count (ANC); absolute lymphocyte count (ALC); ANC to ALC (ANC:ALC) ratio; interleukin 6 (IL-6); C-reactive Protein (CRP) in peripheral blood, lymphocytes classification and count by flow cytometry, and gut microbiome analysis by quantitative metagenomics will also be measured to further search for the possible mechanisms. Primary outcome is the objective remission rate (ORR), secondary outcomes include overall survival (OS) and progression free survival (PFS).

The study protocol has been approved by the Peking University First Hospital Institutional Review Board (IRB). Any protocol modifications will be submitted for the IRB review and approval.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed, advanced NSCLC
2. Participants with no prior treatment for advanced NSCLC
3. Measurable disease as defined by RECIST v1.1
4. Eligible to receive first-line treatment including PD-1 antibody
5. Adequate hematologic and end organ function

Exclusion Criteria:

1. Severe infection within 4 weeks prior to recruitment.
2. Significant organ dysfunction or other serious diseases.
3. Previous or current OSA related treatment, including oral appliance, surgery, mechanical ventilation therapy.
4. Illness or condition that interferes with the participant's capacity to understand, follow and/or comply with study procedures.
Garden of Life Once Daily Women's Probiotic: Vaginal pH and Quality of Life Study

This decentralized observational study is designed to understand the effects of daily consumption of once daily woman's probiotic (ODWP) on vaginal pH levels in healthy female populations ages 19-70 years of age across the United States.

This decentralized observational study is designed to understand the effects of daily consumption of once daily woman's probiotic (ODWP) on vaginal pH levels in healthy female populations ages 19-70 years of age across the United States. Participants will be divided into two cohorts of 100 participants each; one with a history of vaginal bacteriosis and one with no history of bacterial vaginosis, with between 20-30 percent of the total participants being post-menopausal. Participants will be provided and trained to use pH tests on a daily basis over the course of four menstrual cycles (or equivalent time for amenorrheic participants). During the first cycle (or equivalent timeframe) of measurement, participants will not consume neither placebo or once daily woman's probiotics (ODWP); allowing the establishment of a baseline or wash out period prior to active consumption and measurement of effect.

Participants will receive ODWP at no charge for consumption over the course of the study. Participants will be instructed to start and continue consumption over three menstrual cycles (or equivalent timeframe) based on participant's menstrual status and her demonstrated ability to self-measure and report vaginal pH via the Validcare Study app based platform (aka "the app), which is provided as a free, downloadable 21 CFR Part 11 compliant interface for all patient facing activities and communication with/from the principal investigator for the study duration.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 19-70 (21-70 for residents of Mississippi)
2. Non-menopausal women must have a regular menstrual cycle (26-32 days)
3. Using birth control
4. Sexually active (intercourse at least 2x/month)
5. Agree to not introduce any other probiotic during the three months of study

Exclusion Criteria:

1. OCP or systemic hormonal contraception
2. No antibiotic treatment for at least 30 days
3. No active vaginal infection or symptoms of infection
4. No probiotic use for 30 days
5. Routine douching (except for immediately after menses)
Community Outreach-based Study to Increase Cervical Cancer Screening Among Hispanic Women in Cleveland

This study offers Hispanic women who are eligible for cervical cancer screening residing in the Cleveland metropolitan area one of two possible community outreach-based cervical cancer screening modalities, self-collection home HPV test or clinic-based pap test, which is the current standard of care, to assess if these strategies improve cervical cancer screening rates in this population group.

This study is an observational community outreach-based feasibility study. The study intervention that is being evaluated includes two different strategies of cervical cancer screening: 1) a self-collection home HPV test and 2) an in-office pap test. Study subjects who choose the self-collection home HPV test will be provided with the following materials: 1) research information sheet that explains the study objective, the expected timeline of the results, 2) a letter recommending a routine pap test regardless of whether they chose to complete the self-sampling HPV test, 3) educational materials on how to self-collect and return a sample, and 4) a FDA-approved self-sampling kit. Self-collected samples will be tested by the FDA-approved procedure. Study subjects will be asked to choose the screening method of their preference: a self-collection HPV testing kit at home and return the kit within 1 month to the study team or a pap test at a local clinic, which is scheduled within a month. The at-home test only includes vaginal swab and not collection from the cervix. The study team will be notified of the results of HPV test or of pap test and inform the study subjects. If the study subject reports the study team of the loss of her home HPV test kit, it will be recorded as a study outcome of "loss of home HPV test kit". Study subjects who do not return their HPV test kit within 4 weeks will receive 3 reminder calls within a week.

Study subjects who choose an in-office pap test will be scheduled for an annual gynecological exam that includes a pap test at a local clinic that the participant prefers by the study team. The standard-of-care in gynecology at the local clinic involves annual gynecological exam. Study subjects who choose an in-office pap test will receive two appointment reminder calls by the study team a week and three days prior to the scheduled appointment, respectively. No returning of the self-sampling home HPV kit and no show to the scheduled appointment for pap test will be recorded as study outcomes, and these study subjects will be considered enrolled in the study.

Eligibility Criteria:
Inclusion Criteria:

* Hispanic women aged 30 and 65 years
* Residing in the City of Cleveland

Exclusion Criteria:

* Women who are pregnant
* Had a hysterectomy
* Women who had pap test in the past three years or hrHPV test in the past five years or co-testing (hrHPV + pap test) in the past five years.
Pravastatin Reduces Acute Phase Response of Zoledronic Acid

Acute phase response (APR) is one of the most common adverse events in osteoporosis with zoledronic acid treatment. It's reported that this reaction is related to the blockade of the mevalonate pathway, leading to isopentenyl pyrophosphate (IPP) accumulation. And the latter can active γδT cells in the circulation, resulting in inflammatory cytokine release. Statins can inhibit the conversion of HMG-CoA to mevalonate that may reduce the accumulation of IPP. Therefore, it is possible that statins can be taken in advance to reduce APR caused by zoledronic acid infusion.


Eligibility Criteria:
Inclusion Criteria:

1. Chinese Han ethnic postmenopausal women.
2. Bone mineral density values of less than 2.5 standard deviations (SD) below the normal adult mean.
3. Willing to participate in this study.

Exclusion Criteria:

1. Prior treatment with biphosphonates (oral or intravenous).
2. Fever and/or any viral or bacterial infections within 30 days prior to randomization.
3. Patients with evidence of any cancer or with a history of cancer.
4. Contraindication to zoledronic acid:

   Known hypersensitivity to zoledronic acid or other bisphosphonate or zoledronic acid formulation (excipients); Serum calcium level \< 2.13 mmol/L (8.5 mg/dL), free serum calcium level \<0.95 mmol/L (3.8 mg/dL) or untreated hypocalcemia; Childbearing or child-breastfeeding women; Creatinine clearance \< 35 mL/min;

   Restrictions:

   Patients currently receiving aminoglycoside, diuretics or thalidomide.
5. Contraindication to pravastatin:

   Known hypersensitivity to pravastatin or other excipients in pravastatin sodium formulation.

   Restrictions:

   Patients with severe liver insufficiency, history of severe liver insufficiency, active liver disease or continuously elevated transaminase; Patients with severe renal insufficiency or history of severe renal insufficiency; Patients currently receiving fibrates (e.g., bezafibrate), immunosuppressive drug (e.g., cyclosporine) or niacin.
6. Any physiological or medical condition which, in the opinion of the investigator, would preclude the participant from this trail.