cyrilzakka/clinical-trials huggingface dataset:
Accuracy of the Apple Watch Series 4 for Detection of Heart Rhythm: A Pilot Study

The objective of this study is to assess the accuracy of the Apple Watch 4 Series watch in generating an ECG that is suitable for determination of heart rhythm compared to rhythms monitored via telemetry. Secondary objective is to assess the accuracy of the Apple Watch 4 series watch in identifying atrial fibrillation when it is present.

The study will assess the accuracy of the Apple watch 4 series watch when worn by post-operative cardiac surgery patients after they have transferred from the ICU to the cardiac telemetry unit.

During testing each subject will wear:

1. An Apple Watch 4 series watch for no more than 5 minutes.
2. Standard continuous telemetry monitor

The location of the watch (left or right wrist) will be randomly assigned.

Heart rate and rhythm will be assessed by obtaining tracings from the Apple Watch 4 series watch while at the same point in time obtaining tracings from a standard telemetry monitor.

ECGs from the Apple Watch 4 will be collected by asking the patient to place his/ her finger on the digital crown of the Apple Watch 4 for 30 seconds. The rhythm displayed by the Apple Watch 4 will be viewed on the Apple health app (available on the iPhone 8) and will be saved for subsequent viewing and analysis.

Each enrolled patient will have a minimum of three assessments of heart rhythm per day for at least two days, generating a minimum of six data points per patient.

After conclusion of the study for each subject, the ECG's from the health app pertaining to that subject will be reviewed by a board certified cardiologist as will the telemetry tracings.

In order to obtain tracings of new onset post-operative atrial fibrillation. 50% of the subjects enrolled will be in sinus rhythm and 50% will be in atrial fibrillation at the time of enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Post-operative cardiac surgery patients on the cardiac telemetry floors at the Cleveland Clinic Main Campus

Exclusion Criteria:

* Presence of a cardiac pacemaker
* Use of a radial artery graft for coronary artery bypass grafting
* Tattoos located on the skin of the wrist or forearm where the Apple Watch 4 will be placed
A Randomized Study of Safety and Efficacy of Pazopanib and Gemcitabine in Persistent or Relapsed Ovarian Cancer

Ovarian cancer is the leading cause of gynecologic cancer deaths, and the fifth most common cause of cancer deaths in women. While approximately 75% of patients with epithelial ovarian cancer will respond to first-line chemotherapy with platinum and paclitaxel, most patients with advanced stage epithelial ovarian cancer will experience disease recurrence. Pazopanib is a novel agent has recently been approved for the treatment of subjects with advanced renal cell carcinoma (RCC), and preclinical studies suggest it may be effective in other cancers such as ovarian cancer. Therefore, the purpose of this study is to test the efficacy and safety of a novel agent, pazopanib, as an adjunct to a standard treatment, gemcitabine, for recurrent or persistent ovarian cancer. This is an open label study in which subjects will be randomized 1:1 to receive 4 cycles of either gemcitabine, or gemcitabine with pazopanib. Gemcitabine will be administered as an IV infusion weekly on days 1 and 8 of a 21 day cycle. Subjects randomized to receive pazopanib will take 800 mg daily during the 21 day cycle. All subjects will be monitored for toxicity and other indicators of safety (labs, physical exams, vitals) at intervals throughout the treatment cycles. Subjects will be followed for up to 5 years following the conclusion of treatment to evaluate efficacy. The primary endpoints of the study are progression free survival and overall survival, which will be assessed at three years.


Eligibility Criteria:
Inclusion Criteria:

* Must be at least 18 years old
* Must have measurable or detectable ovarian, fallopian or primary peritoneal cancer
* Must have been treated previously with carboplatin, cisplatin or another organoplatinum compound

Exclusion Criteria:

* Women who are pregnant or nursing
* History of congenital long QT syndrome
* Active bleeding or at risk of a bleeding disorder
* Other significant medical condition or history of medical condition which may put the patient at risk
Impact of Facemasks on Running During COVID-19 Pandemic

Randomized crossover clinical trial in which a group of runners are ask to complete a 15 minutes standardized physical test on a treadmill. The same group of participants are randomized to the order in which they use a facemask (surgical mask, polyester reusable cloth mask) or no mask, while running.

Each test, according to the type of mask or no mask, are held on different dates. Heart rate, oxygen saturation and shortness of breath are measured every 3 minutes during the test.

Between 15-20 recreational runners are included in a crossover trial to run under three different conditions the same 15-minutes treadmill running test. They Will run wtih surgical mask, polyester reusable cloth mask or without mask. The order in which they use or not the mask is randomized. Each test is done on a different day.

Heart rate, oxygen saturation and shortness of breath are measured every 3 minutes during the test.

The primary outcomes are the differences in heart rate, oxygen saturation and shortness of breath at the end of the test, between groups.

Eligibility Criteria:
Inclusion Criteria:

* Recreational runners.
* Age between 16-65 years.
* Workers or students from the health area.

Exclusion Criteria:

* None.
LITT Followed by Hypofractionated RT for Recurrent Gliomas

The purpose of this study is to evaluate the treatment regimen of using Laser Interstitial Thermal Therapy (LITT) and Hypo-fractionated Radiation Therapy to treat patients with recurrent gliomas.

Radiation therapy is preferably used as an adjunct to surgery for patients with a newly diagnosed or recurrent glioblastoma. LITT offers an alternative to surgical resection, and due to its minimally invasive nature, does not delay initiating radiation therapy. Another advantage of LITT prior to radiation therapy is the ability to obtain a tissue diagnosis of recurrent tumor prior to initiating radiation therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with history of a WHO Grade II-IV glioma with radiographic evidence of recurrent or progressive tumor

   * Patient must have received prior radiation therapy for initial treatment of glioma
   * Patients with any number of recurrences are allowed as long as the patient has not undergone re-irradiation
2. Brain MRI with contrast demonstrates an enhancing tumor ≤ 6 cm in largest diameter within 60 days prior to registration
3. History and physical including neurological exam within 30 days prior to registration
4. Karnofsky performance status ≥ 60% within 30 days prior to registration
5. Age ≥ 22 years old
6. Minimum interval since completion of prior radiation treatment is 8 weeks

   * Patients will only receive re-irradiation if pathology from LITT is consistent with recurrent tumor
7. Patients must have signed an approved informed consent
8. Patients with the potential for pregnancy or impregnating their partner must agree to practice effective contraceptive methods to avoid conception while on study and for 6 months after study completion.
9. Female patients of child-bearing potential must have a negative pregnancy test within 28 days prior to study registration.

Exclusion Criteria:

1. Patients that are not surgical candidates for stereotactic biopsy or laser ablation
2. Patients with impaired cardiac function or clinically significant cardiac diseases, including any of the following:

   * History or presence of serious uncontrolled ventricular or significant arrhythmias.
   * Any of the following within 6 months prior to registration: myocardial infarction, severe/unstable angina, coronary artery bypass graft, congestive heart failure, cerebrovascular accident, transient ischemic attack , pulmonary embolism
3. Infratentorial tumor or evidence of leptomeningeal spread
4. Inability to undergo a MRI
5. Pregnant or breast-feeding women
Determination of Core Body Temperature in Parturient Warmed With Upper or Underbody Forced Air Cover (Bair Hugger)

This study is intended to calculate the core body temperature in patients who are having a Cesarean Section (C/S) and are kept warm with an Upper Body Forced Air Warming device (Bair Hugger) or underbody forced air warmer. These warming devices are approved and are a required item in many if not all surgical procedures. They are used daily throughout the hospital. The research question is: Where is the best place to position the warming blanket in pregnant mothers undergoing Cesarean section delivery. The researchers hope to compare post - operative core body temperatures in patients getting an Upper Body forced air device versus those getting an Underbody Body forced air warming device.


Eligibility Criteria:
Inclusion Criteria:

* Age =/\> 18 years
* Elective non-emergent C-section

Exclusion Criteria:

* BMI\<18/\>40
* Bleeding Disorders e.g. hemophilia, coagulation abnormality, clotting disorders, bleeding diathesis
* Perioperative hemorrhage \>1500ml
* Non-Singleton Pregnancies
* Complicated Pregnancy (e.g. Eclampsia, Pre-eclampsia)
* Conversion to Emergency C-section
* Endocrine Pathology- e.g. Thyroid Disease, Insulin Dependent Diabetes
* Inmates
Renal Denervation Therapy in Hypertensive Patients Undergoing A-Fib Ablation

We propose a pilot study to assess safety and benefit of renal artery ablation at the time of planned atrial fibrillation ablation.

Symptomatic atrial fibrillation (AF) refractory to anti-arrhythmic drugs is commonly treated with ablation therapy. Pulmonary vein isolation along with additional substrate medication is commonly performed during ablation procedures is associated with 60-80% success rate for maintenance of sinus rhythm. After AF ablation hypertension (HTN) is a strong predictor for recurrence of atrial fibrillation. Drug resistant hypertension can be effectively treated with catheter based renal denervation therapy. Our primary hypothesis is concomitant renal denervation therapy along with AF ablation is associated with improvement in success rates of AF ablation along with adequate control of blood pressure. The specific objectives of this study are to prospectively compare success rates, time to AF recurrence, AF burden and blood pressure controls in patients randomized to concomitant renal denervation arm when compared to patients with AF ablation alone.

Eligibility Criteria:
Inclusion Criteria:

1. Paroxysmal and Persistent Atrial Fibrillation refractory eligible for AF ablation as per HRS/ECAS/EHRA consensus statement.\[23\] Paroxysmal AF is defined as two or more episodes of AF lasting less than 7 days in duration during the last 6 months before enrollment. Persistent AF is defined as AF lasting more than 7 days or requiring cardioversion for termination.
2. Hypertension (\>140/80 mm Hg) on treatment with at least 1 hypertensive medication.
3. GFR \>60ml/dl using Cockcroft- Gault equation

Exclusion Criteria:

1. Secondary causes of hypertension
2. Severe renal artery stenosis or dual renal arteries
3. Congestive heart failure with NYHA class III or IV status
4. EF\< 35%
5. LA Diameter \>6 cm
6. Previous AF ablation
7. Previous renal artery stent or angioplasty
8. Severe contrast allergy
9. Inability to give informed consent
10. Solitary kidney
Prediction Of Serious Adverse Event in Emergency Department With dysKAlemia, Retrospective Study

Dyskalemia, hypo- and hyperkalemia are common in the emergency department and are associated with increased morbidity and mortality.

The potential seriousness of dyskalemia results from the potential alteration of intracardiac conduction and the increase in cardiac rhythm disorders, all associated with a lethal risk. Given the aspecific symptoms of dyskalemia and the complex causal links to be acquired, it is difficult to judge the severity of the disorders in front of an initial clinical presentation of a patient in the emergency room, as the patient may present a serious condition during his stay in the emergency room, related to the dyskalemia and not prejudged at first. The ECG is recommended to judge the severity of the disorder, in association with the level of kalemia, but the electrical changes of its pattern in the context of dyskalemia are sometimes so fine that even the eye of the practitioner is not able to detect them. To date and to our knowledge, there is no tool for predicting the risk of RTA or death in dyskalemia. The existing studies on the subject, including ECGs, seek to detect dyskalemia and not its complications, and the proposed tools only take into account the ECG and not the clinical context of the patient.


Eligibility Criteria:
Inclusion Criteria:

* Major patient consulting in an emergency department participating in the study
* who received at least a digital ECG AND an ionogram in the emergency department during the study period

Exclusion Criteria:

* Patient who has expressed opposition to the reuse of their data for the study
Examining the Role of Improved NSAID Management in Treating Dysmenorrhea and Bladder Pain

The goal of this study is to see if optimized use of naproxen for treatment of dysmenorrhea will improve pain report from baseline. In addition, we will determine whether cross-organ influences from the uterus on bladder pain sensitivity change from baseline after reduced menstrual pain experience over six months. Finally, a battery of quantitative sensory tests and EEG measures of sensory sensitivity will be used to evaluate mechanisms associated with improvements in menstrual and bladder pain.

Endometrial shedding during the menstrual cycle elicits profound changes in neuronal activity and cytokine concentrations producing moderate to severe pelvic pain in more than 20% of reproductive-age women. One out of every five of those women in turn will experience chronic pelvic pain (CPP) which may be in part due to cross-organ neural sensitization.

In this study we will establish whether prophylactic and adequate dosages of naproxen are capable of reducing menstrual pain more than \*\*\* use.

Eligibility Criteria:
Inclusion Criteria:

* Reproductive-age women (age 18-45) with dysmenorrhea
* Average menstrual pain ≥ 5/10 (0=no pain and 10=the worst imaginable pain) on at least one day during menses or during withdrawal uterine bleeding from cyclic OCs without painkillers
* Menstrual pain in the region between the umbilicus and the perineum, above the level of the inguinal ligament
* Indication the participant has attempted to resolve pain by medical means (including NSAIDs and/or OCPs)

Exclusion Criteria:

* Presence of active pelvic or abdominal malignancies (primary or metastatic)
* Absence of regular menses (including current pregnancy, recent pregnancy, or active breast feeding)
* Active genitourinary infection in the last four weeks
* Unable to read or comprehend the informed consent in English
* Unwilling to complete study procedures
* Presence of hypertension or risk for developing hypertension
* Unwillingness to take naproxen and/or placebo
* Contradictions to taking naproxen (allergies, kidney disease, anemia, alcoholism, cardiovascular disease, stomach or intestinal ulcer or abnormal liver function)
* Formal urological diagnosis such as overactive bladder or bladder pain syndrome.
Neoadjuvant Chemotherapy Plus Chemoradiation in Patients With Potentially Resectable Gastric Carcinoma

To investigate the feasibility, safety and tolerability of Preoperative Chemoradiation in Patients With Localized Gastric Cancer. Primary endpoint: R0 resection rate. Secondary endpoint: resection rate, pathological complete regression (pCR), effectiveness and safety of regime, disease free survival(DFS) and overall survival(OS).

The prognosis of gastric cancer is poor partially due to low R0 resection rate. Neoadjuvant chemoradiotherapy was reported to be effective in this setting by several phase II studies. The investigators aim to evaluate the efficacy and toxicity of neoadjuvant chemoradiotherapy in a prospective phase II study.

Eligibility Criteria:
Inclusion Criteria:

1.18 ≤ age ≤ 70, Male or Female; 2.Minimum life expectancy of 6 months; 3.Patients with localized, histologically confirmed gastric or gastroesophageal adenocarcinoma; 4.Patients must have a performance status of \< 2 Eastern Cooperative Oncology Group (ECOG); 5.No prior major surgery of the stomach or radiation therapy to the stomach or immunotherapy or chemotherapy; 6.CT or MRI, endorectal ultrasonography (EUS), laparoscopic exploration are required to stage; 7.Without other benign diseases such as lung, kidney, liver infections; 8.Without participating other clinical trials; 9.Patient must sign an informed consent prior to study entry; 10.Patients must have adequate bone marrow function (defined as peripheral absolute granulocyte count of \>1,500/µL, and platelet count of \> 100,000/µL), adequate liver function (bilirubin \<= 1.5 mg/dl), and adequate renal function (creatinine \<= 1.5 mg/dl). 11)Patients without cardiac disease , severe uncontrolled diabetes, hypertension, cerebrovascular disease, or infection.

Exclusion Criteria:

1. Pregnant women are excluded from study entry due to the potential teratogenic effects of the study treatment;
2. Female patients who planed to have a baby;
3. Prior radiation therapy to the stomach, liver or kidney;
4. Dysfunction of important organs such as liver, kidney or heart; 5.Abnormalities of mental status;

6.Active coronary artery disease; 7.Cardiac arrhythmia, and need to receive medication therapy; 8.Severe uncontrolled hypertension; 9.Active clinical serious infection; 10.The known human immunodeficiency virus (HIV) infection history; 11.The known central nervous system diseases, including brain metastatic tumors; 12.Patients have had clinical clear gastrointestinal bleeding in 6 months; 13.Drug abuse; 14.Swallowing difficulties for drugs; 15.Poor compliance; 16.Presence of concurrent or previous malignancies (except for cervical carcinoma in situ or basal cell carcinoma of the skin); 17.Presence of peritoneal metastasis, distant organs or lymph nodes metastasis; 18.Presence history of major surgery in the past three months; 19.Poor tolerability; 20.Prior history of medication; 21.allergy for chemotherapeutic drugs.
Study of Bariatric Surgery

The aim of this cohort study is to collect prospectively clinical data on all the patients admitted in the investigators department for bariatric surgery or for any complication of a bariatric procedure. The investigators goal is not only to improve the follow-up but also to assess and publish the investigators results regarding weight loss and the complication rate.


Eligibility Criteria:
Inclusion Criteria:

* History of bariatric surgery procedure

Exclusion Criteria:

* Patients \< 16 years
* Patients \> 80 years
Hysteroscopic Surgery; Retrospective Cross-sectional Study of Reproductive Outcome

study of the effect of hysteroscopic sptoplast and hysteroscopic myomectomy on reproductive performance of patients with infertility and /or miscarriages

Retrospective study and analysis of the reproductive outcome in patients who underwent hysteroscopic surgery for infertility at Jordan university hospital and Al-Noor fertility centre in Amman, Jordan in the period September 2016-october 2021. Patients were followed up for a minimum of 6 months after surgery. Resection of uterine septum or submucosal fibroids were included. Data was obtained from the electronic and paper-based clinical files for patients who were operated upon at these hospitals. Patients who missed follow up after the operation will be contacted by phone or invite them for a clinic review to know of their fertility status and pregnancy outcome.

Eligibility Criteria:
Inclusion Criteria:

* those with primary or secondary infertility of more than 1 year with normal seminal fluid analysis, normal female hormonal profile, patent fallopian tubes bilaterally (as confirmed by hysterosalpingography HSG), normal thyroid function, no previous uterine surgery and no medical diseases.
* Cases with recurrent miscarriages were those with 2 or more first or second trimester miscarriages of an apparently normal singleton fetus with no hormonal, endocrine or maternal or paternal karyotype abnormalities and with no previous history of term pregnancy(s).

Exclusion Criteria:

* All patients who were operated upon outside the context of infertility (heavy bleeding...etc), patients with combined (maternal and paternal) infertility factors,
* Patients with history of any number of term pregnancy,
* Previous uterine surgery,
* Patients with medical diseases,
* Those with abnormal female hormonal profile,
* Those with other potential factors for infertility including endometriosis
* Patients with incomplete or missing data and could not be contacted.
* Patients who had myomectomy or septal resection done using bipolar hysteroscopy
Abbott Brady 3T MRI PMCF

The objective of this post-market, clinical follow up (PMCF) study, is to confirm the long-term safety of the Tendril STS and Isoflex leads, implanted with the Assurity MRI™ or Endurity MRI™ pacemakers, in patients undergoing a clinically indicated 3T MRI (3 Tesla Magnetic Resonance Imaging) scan.

This prospective, non-randomized, observational study will be conducted at 35 centers worldwide where the study devices have 3T MR Conditional labeling; up to 110 patients will be enrolled, and will satisfy the recent PMCF requirement to maintain the CE mark.

Eligibility Criteria:
Inclusion Criteria:

1. Subject must be willing and able to provide informed consent for study participation (legal guardian or legally authorized representative is NOT acceptable).
2. Subject must be implanted with a St. Jude Medical Tendril STS 2088 or Isoflex 1944/1948 lead, and Assurity MRI or Endurity MRI pacemaker.
3. Capture threshold is stable and \< 2.5V @ 0.5ms at the time of enrollment.
4. Subject is clinically indicated for a 3T MRI scan without sedation NOTE: Antianxiety agents (e.g. minor tranquilizers, etc.) may be used as long as the patient can communicate with site personnel during the MRI scan
5. Subject is willing and able to comply with the prescribed follow-up tests and schedule of evaluations.

Exclusion Criteria:

1. The subject is currently participating in a clinical investigation that includes an active treatment arm that may confound the results of this study as determined by Abbott.
2. The subject is \<18 years old (pediatric).
3. That subject has a life expectancy of less than 12 months due to any condition.
4. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
5. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
6. Any contraindication to MRI scan, including the presence of additional hardware (e.g. lead extenders, lead adapters, surgical staples, stents, dental braces, or abandoned leads).