cyrilzakka/clinical-trials huggingface dataset:
Heart Rate Variability During the Menstrual Cycle

In this study, women will be required to wear a chest heart rate monitor and wrist heart rate monitor daily and collect daily early morning urine samples for the duration of one complete menstrual cycle. This will enable comparisons between data collected from the heart rate monitor and hormone analysis in urine samples to be made.

This study is a prospective observational study of women's heart rate and heart rate variability throughout one complete menstrual cycle. A minimum of 10 volunteers aged 18 years of age or over will be recruited via a variety of methods according to the criteria detailed in section 9. They will be required to wear a chest heart rate monitor and wrist heart rate monitor for 1 hour each day, and throughout the night for one menstrual cycle. In addition, a daily early morning urine sample will be collected throughout the study.

Urine samples will be returned to SPD on a regular basis for measurement of urinary hormones related to pregnancy and fertility. Data collected via the monitors including heart rate and heart rate variability will be downloaded for comparison.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years of age and over
* Regular menstrual cycles (23-35 days in length)-

Exclusion Criteria:

* Taking any hormonal medications
* Taking any medications that may affect heart rate
* Known heart condition or use of a pacemaker
* Skin condition where there is sensitivity to wearing a skin monitor
* Currently suffering with anxiety or panic attacks
* Pregnant or breastfeeding
* Undertaking any frequent travel or long-haul flights during the course of the study
* Does not have access to an Apple iPhone or iPad with Bluetooth 4.0 (or later) and iOS 10.0 (or later)
Study to Evaluate the Efficacy of the Synera Patch Compared to Naproxen Sodium for Epicondylitis of the Elbow

The purpose of the this study is to evaluate the sfaety and efficacy of Synera(R)for patients with lateral and medial epicondylitis and compare it to Naproxen sodius.

The objective of this single center is to evaluate the safety and efficacy of Synera ® in lateral and medial epicondylitis . This is an open-label, comaparative study study where the subjects will be randomized to one of the following groups:

1. Synera patch ®: A single patch applied for 4 hours twice daily approximatey 12 hrs apart to the medial or lateral side of the index elbow
2. Synera patch ®: A single patch applied for 12 hours/day to the medial or lateral side of the index elbow
3. Naproxen Sodium: 500mg bid

Eligibility Criteria:
Inclusion Criteria:

* Individuals with clinical evidence of lateral or medial epicondylitis of the elbow.
* Age 18 or higher
* Minimum of 4 on Question 5 of BPI

Exclusion Criteria:

* Peripheral neuropathy of any origin in the index limb
* Cubital tunnel syndrome in patients with medial epicondylitis
* Cortisone injection in the last 4 weeks into the index limb
* Surgical intervention in the past for the epicondiitis
* Participants in any other clinical trial in the last 30 days
* Known allergy to lidocaine, tetracaine, NSAIDs or PABA
* Uncontrolled pain in the upper extremity or neck that may interfere with evaluation of study drug's response as deemed by the investigator
* Patient who is deemed to be medically unstable by the principal investigator including but not limited to Liver disease or Cardiac arrhythmias
* Patients who are pregnant, lactating or breast feeding
* Vaccination within the last weeks or planning on any vaccinations during the study or for 4 weeks after the study completion.
Does Environmental Factors Affect Accuracy in Pre-hospital Non-invasive Temperature Measurement?

The aim of this study is to assess the impact of different environmental factors on the ability for a thermistor-based epitympanic thermometer to accurately read the temperature of a normothermic individual and thereby estimate their feasibility and reliability in the austere pre-hospital setting.

The aim of this study is to assess the impact of different environmental factors on the ability for a thermistor-based epitympanic thermometer to accurately read the temperature of a normothermic individual and thereby estimate their feasibility and reliability in the austere pre-hospital setting.

Healthy volunteers will be recruited. As reference value for core temperature we will use a standard rectal probe (Mon-a-Therm, General purpose Temperature Probe 12Fr/Ch, Covidien) attached to an external monitor. The study will be in a field setting in the mountains of Hemsedal, Norway.

For measuring the epitympanic temperature we will use the Metraux Thermometer (Walpoth, Galdikas et al. 1994). The Metraux Thermometer is widely used in pre-hospital care in Norway and internationally. The ear-sensor will after induction of anaesthesia be inserted according to the manufacturers specifications in the auditory canal and activated. The sensor is two tiny and soft metal wires covered in a plastic wrapping integrated in a soft rubber earplug. The depth of the measuring point is pre-set from the manufacture to be approximately 10 mm from the tympanic membrane. The display will then show the epitympanic temperature in real-time.

The volunteers will be exposed to four different scenarios. 1. Ambient air with no protection of head/measuring site. 2. Ambient air with local protection of measuring site. 3. Snow in the ear-canal before placing the thermometer (to resemble avalanche conditions). 4 Cold water in the ear canal (to resemble water immersion/submersion).

The temperature will be measured in degrees Celsius. A baseline will be established before exposing the volunteers to the different environmental factors. After exposure the temperature will be recorded every 15 seconds for a total of 10minutes.

Eligibility Criteria:
Inclusion Criteria:

* Adult 18-60 years
* no medication
* healthy, no chronic illness
* no acute illness on study day
* No pathology in ear canal on otoscopy

Exclusion Criteria:

* Pathology in ear canal
* non-consent
Post-Marketing Clinical Follow-Up of a Spine Implant

Post-Marketing Clinical Follow-up of an Anular Closure System (Barricaid®) to Confirm Comparability of Outcome between Devices with Subcomponents from Two Different Suppliers

Comparison of device integrity (anchor fracture and/or mesh detachment) and device movement/migration in patients implanted with the Barricaids with anchors from two different suppliers.

Eligibility Criteria:
Inclusion Criteria:

* Each site will enroll all patients who were implanted with a Barricaid with an anchor manufactured by the second manufacturer.
* Patients must be 18 years of age or older and able to understand and consent to participate in the study.

Exclusion Criteria:

* Not defined
Efficacy and Safety of a Citrate-based Anticoagulation With Calcium-free Phosphate-containing Fluid in Renal Replacement Therapy

In the present prospective multicenter RCT we will evaluate the effects on efficacy, acid-base status and serum phosphate levels of a new RCA protocol for Continuous Venovenous Hemodiafiltration (CVVHDF) using an 18 mmol/l citrate solution in combination with a calcium-free phosphate-containing solution, acting as dialysate and replacement fluid. The new protocol will be introduced with the following targets: a) to refine buffers balance of a previously adopted RCA protocol for Continuous Venovenous Hemofiltration (CVVH), based on a 18 mmol/l citrate solution (Regiocit) combined with calcium and phosphate-free dialysate fluid (PrismOcal B22) and a conventional phosphate-containing replacement fluid (Phoxilium) to prevent CRRT-related phosphate depletion


Eligibility Criteria:
Inclusion Criteria:

1. Acute renal failure requiring CRRT
2. Suitability for regional anticoagulation of the CRRT circuit
3. Clinical equipoise regarding the method of circuit anticoagulation
4. Subject is affiliated with a social security system (if required by individual country regulations).
5. Subject meets national regulatory criteria for clinical trial participation.
6. Subject or subject's Legally Authorized Representative (LAR) has signed the study Informed Consent form

Exclusion Criteria:

1. Age less than 18 years
2. Expected stay in ICU less than 24 hours
3. Pregnant or breastfeeding
4. Suspected ischemic hepatitis or liver failure
5. Chronic kidney disease requiring dialysis prior to ICU admission
6. As applicable by French law, subject who is a protected individual such as an incompetent adult or incarcerated person
7. Metformin and acethaminophen intoxication
Real-world Analysis of Workup at Disease Progression and Implementation of Osimertinib for EGFR+ NSCLC

Tyrosine kinase inhibitors (TKI) have greatly improved prognosis of epidermal growth factor receptor (EGFR)-positive non-small cell lung cancer (NSCLC), with tumor responses in the majority of cases and a median overall survival currently exceeding 2.5 years. However, clinical courses vary widely and eventual treatment failure is inevitable. The most common resistance mechanism against first- and second-generation EGFR inhibitors is the EGFR T790M mutation, which emerges in about 50% of cases and is amenable to next-line treatment with the third-generation compound osimertinib. However, experience in everyday clinical practice shows that implementation of EGFR TKI sequencing is often problematic, for example because a considerable number of EGFR+ NSCLC patients failing first- and second-generation EGFR inhibitors do not undergo T790M mutation testing at the time of disease progression. This study will use patient records to analyze the clinical course of EGFR+ NSCLC patients treated with first- and second-generation EGFR inhibitors at the Thoraxklinik Heidelberg (Germany) during the past years. The main aim is to analyze the diagnostic and therapeutic measures, including implementation of osimertinib, taken at the time of disease progression as well as their effect on patient outcome in a real-world, routine clinical setting.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed locally advanced (stage III) and not suitable for definitive local treatment, or metastatic (stage IV) NSCLC
* activating EGFR mutation confirmed
* treatment with EGFR TKI

Exclusion Criteria:

none
Impact of Low Nicotine Cigarette Messaging on Perceptions and Cigarette Choices

The purpose of this research is to evaluate the effects of low nicotine content cigarette (LNC) educational messaging on perceptions of low nicotine cigarettes, tobacco/nicotine product choice preferences (hypothetical), LNC cigarette subjective ratings, and LNC cigarette abuse liability among adult smokers.

This randomized single-site study will assess the subject's risk perceptions and hypothetical tobacco product choices based on their exposure to an educational messaging condition related to nicotine content in cigarettes.

Subjects (N=40 in each group) will be given a pack of low nicotine content cigarettes (LNC; 0.4 mg/g) and will be randomly assigned to read one of two messaging conditions on low nicotine cigarettes.

Smokers will undergo a telephone screening to assess eligibility, then move on to the next steps of the study depending on eligibility:

1. Virtual Zoom Screening - Completed after telephone screen: Informed consent is obtained and then an interview where data is collected and eligibility is further assessed.
2. Curbside Visit - Completed after the screening and if eligible: Breath test, and if necessary a urine test, is performed to assess smoking levels and urine pregnancy test is attained (if applicable). If eligible, randomization to messaging condition occurs and participants provided a pack of low nicotine content cigarettes.
3. Virtual Zoom Home Session - Completed after curbside and if eligible based on curbside: Surveys assessing main outcome variables assessed.
4. Follow-up - Completed 1 week after the virtual Zoom session: Interview where assessment of health and product usage is assessed.

Except for the initial telephone screening, participants will receive compensation for each part of the study.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* At least 21 years of age
* Biochemically confirmed smoker

Exclusion Criteria:

* Unstable health condition
* Unstable medications
* Pregnant or nursing
* Unreliable access to a computer, smart phone or tablet without working camera and internet access for telehealth visits and online questionnaires
Phase II Clinical Trial of Concurrent Chemoradiotherapy Combined Nimotuzumab for Stage IIB-IVA Cervical Cancer

The purpose of this phase II trial is to determine the feasibility and efficacy of nimotuzumab injection combined with concurrent chemoradiotherapy for initially inoperable locally advanced cervical cancer.

For locally advanced cervical cancer, radical radiation with concurrent chemotherapy remains the standard treatment recommended by NCCN. However, in more than 35% of cases, tumor persistence recurrence or metastasis would occur after chemoradiation. Nimotuzumab, belongs to anti-EGFR monoclonal antibodies, has proved to be useful in multiple solid tumors, such as NPC, colorectal cancer, etc.

In recent years, nimotuzumab was also applied in recurrence or metastasis cervical cancer. It was proved to be well tolerated and might have a role in the treatment of advanced cervical cancer. However, there is no publication about nimotuzumab used in locally advanced cervical cancer.

Eligibility Criteria:
Inclusion Criteria:

* 18 Years to 70 Years，female
* Histological diagnosis of squamous cell carcinoma of cervix, FIGO stage IIB-IVA,with diameter 4-6 cm, without distant metastasis.
* no chance of surgery confirmed by more than two deputy chief doctors of gynecology.
* Moderate or high expression of EGFR
* The function of main organ is normal, including blood, heart, lung, liver, and kidney. Without history of hypertension, stroke. Blood pressure is normal before treatment.
* WBC≥3.5×10E9/L，ANC≥1.5×10E9/L；HB≥90g/L，PLT≥100×10E9/L
* ALT, AST and Cr below 1.5 times of normal level
* Willing to accept treatment
* Ability to comply with trial requirements KPS≥70

Exclusion Criteria:

* Evidence of distance metastasis
* Impossible to measure the diameter of tumor, or the tumor is too huge (diameter\>6cm)
* Couldn't examine with pelvic MRI due to a variety of reasons
* Used to treat with radiotherapy chemotherapy or molecular target therapy and immune therapy
* Diagnosed with another malignant tumor in 5 years
* Used to be a volunteer of other clinical trial.
* Used to be allergic reaction with grade 3 or 4 degree to any experimental drugs
* Severe medical history of lung ,liver, kidney or heart.
* Active infection in any part of the whole body.
* Examination results showed radiotherapy contraindications
Inflammatory Markers in Patients With Active Migraine Headaches

The purpose of this study is to determine whether C-Reactive Protein (CRP) is elevated in patients with active migraine headaches. Secondary goal is to determine whether other inflammatory markers, such as Calcitonin Gene Peptide (CGRP), Vasoactive Intestinal Polypeptide (VIP) or Substance P (SP) are elevated in patients having a migraine headache.

A random selection of patients both male and female from a primary care practice with a diagnosis of having migraine headaches will be enrolled. Thirty (30) patients will be recruited mainly from the primary care practice. Recruitment will include males and females aged 21-65. The patients who meet the inclusion criteria will be enrolled. The patients who do not have migraine headaches will also be enrolled and function as controls. Non-migraine patients will meet inclusion criteria 1, 2 and 3 and all of the exclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must sign a written informed consent.
2. Enrollment population would include males and females 21 years of age to 65 years of age.
3. Non-migraine subjects will be allowed in the control group
4. Have episodic migraine headaches
5. Patients to satisfy the diagnosis of migraine headaches with aura, without aura or mixed.
6. Must be able to differentiate migraine headaches from other headaches

Exclusion Criteria:

1. Any medical condition in the opinion of the investigator that would make the subject unsuitable for enrollment.
2. Basilar or hemiplegic migraine headaches.
3. Pregnant woman or a nursing mother
4. History (within 1 year) or current evidence of drug or alcohol abuse.
5. More than 15 migraine headaches per month
6. Chronic daily headaches
7. Chronic use of NSAIDs
8. Current participation in a research study or within the last 30 days.
A Study of AMDX-2011P in Participants With Primary Open Angle Glaucoma

The purpose of this research study is to assess the ability of AMDX- 2011P to identify amyloid deposits in the retina of participants with Primary Open Angle Glaucoma (POAG).

This open-label, masked endpoint assessment study will evaluate safety, tolerability, plasma pharmacokinetics (PK) and biological activity of intravenous (IV) doses of AMDX-2011P in participants with POAG. Assessments of retinal images will be conducted by centrally masked assessors.

Participants will be admitted to the study site where eye examination and retinal imaging will be conducted before administration of the study drug. AMDX-2011P will be administered through a single IV bolus injection followed by safety assessments, retinal imaging, and blood collection and PK.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of primary open angle glaucoma in both eyes
2. Able to fixate
3. Glaucomatous optic nerve damage in both eyes, as determined by an investigator as part of an eye exam

Exclusion Criteria:

1. Participants unable to read or write
2. Ocular media is not sufficiently clear to obtain acceptable quality images
3. Participants with presence of any ocular pathology other than glaucoma in the study eye (cataracts are acceptable)
Convalescent Plasma for Treatment of COVID-19

Convalescent plasma has been shown to be safe and effective for treatment of several diseases. Preliminary data indicate that it is safe for treatment of COVID-19. We found that viremia upon admission identifies patients at 7 fold increased risk of admission to intensive care and 8 fold increased risk of death. CP treatment appeared to result in rapid viral clearance in a small case series. CP appeared to be well tolerated in a phase I study in which patients only received one dose of CP and a phase II study in which CP was given until viremia disappeared (unpublished data).

Randomised controlled studies assessing the efficacy of CP are lacking and thus the efficacy of CP is unknown. Preliminary data indicate that treatment should be given early, prior to development of severe illness. Detection of viremia upon admission identifies a group at high risk of severe disease and death that has the most to benefit from CP. Phase II study data indicates that treatment should be given until SARS-CoV-2 is no longer detected in serum and the donor antibody neutralization titres should be ≥1/640. A randomised controlled trial in which viremic patients are treated with CP with the equivalent of an antibody titre ≥1/640 is thus required to determine if CP can be an effective COVID-19 treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18
* Admitted to a study hospital
* Active COVID-19 defined as symptoms + SARS CoV-2 identified from upper or lower airway samples and blood
* Negative pregnancy test taken before inclusion and use of an acceptable effective method of contraception until treatment discontinuation if the participant is a woman of childbearing potential
* Written informed consent after meeting with a study physician and ability and willingness to complete follow up

Exclusion Criteria:

* No matching plasma donor (Exact matching in the ABO system is required)
* Unavailability of plasma
* Estimated glomerular filtration rate \<30 (kidney failure stage III or more)
* Pregnancy (urinary-hcg)
* Breast feeding
* Inability to give informed consent
Effects of Structured Exercise Program in Bilateral Vestibular Hypofunction

Background: The vestibular rehabilitation is an exercise-based method, aiming to maximize central nervous system(CNS) compensation at vestibular nuclear and other CNS levels for vestibular pathology. A minimal number of studies have documented the impact of Vestibular rehabilitation on the recovery rate of patients with Bilateral Vestibular Hypofunction(BVH).

Objective: The purpose of this study was to investigate the effectiveness of structured vestibular rehabilitation (VR) programs on severity of dizziness, kinesiophobia, balance, fatigue, quality of sleep, activities of daily living( ADL) and quality of life(QoL) in subjects with chronic BVH.

Method: Twenty-five participants diagnosed with BVH were included in the study. A structured VR program was applied in 50-minute sessions once a week and as a home exercise program 3 days a week over 8 weeks. Participants were evaluated for severity of dizziness with the Visual Analog Scale (VAS), for kinesiophobia with the Tampa Scale of Kinesiophobia (TSK), for balance with the Semitandem, tandem, and standing tests, for quality of sleep with the Pittsburgh Sleep Quality Index (PSQI), for ADL with the Vestibular Disorders Activities of Daily Life (VADL), for QoL with Dizziness Handicap Inventory (DHI) and for fatigue with the Fatigue Severity Scale (FSS) at the baseline (T0), at 4th week (T1), 8th week (T2), and 20th week (T3) after study started.


Eligibility Criteria:
Inclusion Criteria:

* Being between 20-80 years old
* Diagnosed with bilateral peripheral vestibular hypofunction by videonystagmography
* Have symptoms for more than three months from onset of illness

Exclusion Criteria:

* having no symptoms of bilateral peripheral vestibular hypofunction
* having Meniere's disease, vestibular migraine and other undulating vestibular disorders, cognitive, visual, neurological or general motor impairment
* having previously received vestibular rehabilitation