cyrilzakka/clinical-trials huggingface dataset:
Improving Patient Outcomes by Selective Implantation of the Zephyr EBV - Study

The aim of this prospective, randomized, controlled, one-way crossover study is to assess and compare the efficacy of the Zephyr endobronchial valves vs. Standard of Care (SoC) in patients suffering from COPD with Homogeneous Emphysema. Patients will be followed up for 12 months after randomization. Patients in the SoC arm will crossover to the EBV treatment arm after the 6-month visit and will be followed up for 6 additional months.The primary objective is the variation of FEV1 between baseline and 3-month follow-up visit. The secondary objectives will evaluate quality of life, exercise capacity, dyspnea (including BODE index) changes, target lobe volume reduction, as well as safety outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Homogeneous emphysema
* 15% ≤ FEV1 ≤ 45% predicted
* TLC \> 100% predicted
* RV ≥ 200% predicted
* 6MWT ≥ 150 m
* Non-smoker \> 8 weeks prior to study entry
* Absence of Collateral Ventilation in the target lobe

Exclusion Criteria:

* Active pulmonary infection
* More than 3 exacerbations with hospitalizations over the past 12 months
* Pulmonary hypertension (sPAP \> 45 mmHg)
* MI or other relevant CV events in the past 6 months
* Alpha-1 antitrypsin deficiency
* Bronchiectasis
* Prior LVR or LVRS procedure
* \> 20% difference in perfusion between right and left lung
* Hypercapnia (paCO2 \> 55 mmHg
* Asthma
* Use of more than 25 mg/day prednisolone or equivalent
* Severe bullous emphysema
* Systemic or malignant disease with high death probability within 12 months
Holter Versus Zio Patch Electrocardiographic Monitoring in Children

This prospective study aims to compare the diagnostic yield, or ability to detect an arrhythmia, of the traditional Holter monitor versus the novel Zio patch monitor in pediatric patients referred for ambulatory electrocardiographic (ECG) monitoring. Children will wear both devices simultaneously for 48 hours and the incidence of clinically significant arrhythmias will be compared.

Patients under age 22 years at Children's Hospital of New York (CHONY) who are referred for ambulatory ECG monitoring will be consented and enrolled prospectively to have the Holter monitor and the Zio patch placed simultaneously in the pediatric cardiology clinic. Patients will be instructed to wear both devices for 48 hours. Demographic data will be collected, including date of birth, age, gender, weight, height, chest circumference, body surface area, indication for ambulatory ECG monitoring, prior congenital heart disease, prior cardiac surgery, and prior Holter or Zio patch use. A patient satisfaction survey will be given to the patient and parent/guardian after completion of the study to compare the comfort, interference with daily activities, adverse events (such as skin irritation or if either device fell off), and preference for each device. Holter monitors will be returned to the clinic along with the patient satisfaction survey, and the Zio patch will be mailed back to manufacturer headquarters and the report will be returned to the investigators.

Eligibility Criteria:
Inclusion Criteria:

* Any patient under age 22 years who has been referred for ambulatory ECG monitoring at Children's Hospital of New York.

Exclusion Criteria:

* Any known skin allergy or sensitivity to adhesive material.
Fascia Iliaca Compartment Blockade as Analgesia for Hip Fractures in the Acute Phase

To evaluate the analgesic potential of an neural blockade (Fascia iliaca compartment) with local anaesthetics in patients with hip fracture immediately after arrival in the emergency department.

Hip fracture patients have severe pain in the acute phase. Traditional analgesic treatment have consisted of intramuscular morphine with its associated side effects. The trial evaluates the Fascia iliaca compartment compared to regular opioid pain therapy in hip fracture patinets immediately after arrival at the emergency department.

Eligibility Criteria:
Inclusion Criteria:

* Primary hip fracture suspected
* able to give informed consent
* no substance abuse
* no regular opioid therapy
* no opioid treatment within the last 6 hours
* morphine intolerance
* allergies to local anaesthetics

Exclusion Criteria:

* Fracture ruled out on x-ray
The Effect of Hydrogen Rich Water Intake on Acute Body Response and Following Recovery After 5 km Run in Untrained Men

The aim of this randomized, double blinded, placebo controlled cross-over study is to evaluate the effect of hydrogen rich water intake on running performance, physiological and biochemical variables during endurance exercise and following recovery in endurance-untrained men.

This study involves 16 endurance-untrained men aged 18-30 years. All participants drink hydrogen rich water (HRW) or placebo during the two days before the experiment (total volume 2100 ml) and during the testing day (total volume 1680 ml). All participants undergo one laboratory session (entry diagnostic) and two experimental sessions in the field with a washout period of 7 days. In the two experimental sessions, participants receive HRW or placebo in a randomized order. Each experimental session consisted of a pre-exercise phase, an exercise phase (5 km run), and a 24 h passive recovery phase. The following variables are assessed: running times (5 km distance and 200 m laps), heart rate, rating of perceived exertion, blood lactate, reactive strength index, subjective perceived muscle soreness, protein carbonyl content, malondialdehyde content, heart rate variability. Statistical analysis is based on analysis of variance for repeated measures with the factors water (HRW and placebo), time, and interaction. Fisher´s post hoc tests is used for pairwise comparison. The significance level is set at 0.05.

Eligibility Criteria:
Inclusion Criteria:

* No experience with endurance training.
* Good health condition.
* Signed informed content.

Exclusion Criteria:

* Acute health problems.
* Not following instructions (free of any supplements three weeks before experiment, free of any medicaments, no caffeine at least 24 hours before experiment).
Retrospective Study of Intracerebral Hemorrhage Patients in Hospital Parc Taulí

This is a retrospective observational study to investigate the clinical, analytical and neuroimaging data generated during routine clinical management of intracerebral hemorrhage. The study will review the data from about 500 patients attended during the last ten years in the Neurology Department of Hospital Parc Taulí de Sabadell.

The aim is to measure the size of the lesion in neuroimage (TC and MRI), the edema, the alterations in diffusion weighted images and to correlate this data with clinical parameters and analytical measurements. With this approach investigators plan to investigate the incidence of hematoma growth, the role of perilesional edema and diffusion changes, and the relation between neuroimaging findings and clinical outcome. The study also try to establish significant correlations between clinical and analytical data, the clinical outcome and and the magnitude of changes in neuroimaging.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have been attended at the Hospital Parc Taulí for the last 10 years after presenting an intraparenchymal hemorrhage.
* The patients have had to undergo a computed tomography at the admission and a cranial magnetic resonance during the hospitalization in the time course specified in point in the protocol
* The patients must present in their clinical story the analytical determinations detailed in the protocol.

Exclusion Criteria:

* Intracerebral hemorrhage secondary to head trauma
* Intracerebral hemorrhage secondary to neoplasm
A Comparison of Visual Function After Bilateral Implantation of Presbyopia Correcting Intraocular Lenses

To prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with AcrySof ReSTOR +3 vs. those bilaterally implanted with LENTIS MPlus Intraocular Lens (IOL).


Eligibility Criteria:
Inclusion Criteria:

* are willing and able to understand and sign an informed consent
* \<= 1.0 Diopters of regular corneal astigmatism in both eyes. NOTE: look for consistency between manual keratometry, auto-keratometry and simulated keratometry measures to ensure "regular" astigmatism prior to enrollment. Subjects who wear contact lenses must discontinue its use for at least 2 weeks (soft contact lens) and at least 3 weeks (gas permeable contact lens) and until corneal topography shows stability prior to preoperative study measurements.
* are willing and able to attend postoperative examinations per protocol schedule
* are more than 21 years of age, of either gender and any race:
* require bilateral cataract extraction followed by posterior intraocular lens (IOL) implantation used as on-label procedure
* be willing to have second eye surgery within one month of first eye surgery
* are in good ocular health, with the exception of cataracts
* are free of disease(s)/condition(s) listed in the "Precautions" section of the AcrySof IQ ReSTOR +3 and LENTIS Mplus package inserts
* are able to read and understand one of the following languages: Dutch or Spanish

Exclusion Criteria:

* Planned multiple procedures, including limbal relaxing incision (LRI), during cataract/IOL implantation surgery
* An ocular disease and/or condition that may compromise visual acuity levels (i.e. glaucoma, diabetic retinopathy, macular degeneration, amblyopia, pupil abnormality such as corectopia, etc.)
* Previous corneal surgery and/or reshaping
* Clinically significant corneal endothelial dystrophy (e.g. Fuchs' dystrophy)
* History of corneal disease (eg. herpes simplex, herpes zoster keratitis, etc.)
* History of retinal detachment
* Subjects that have an acute or chronic disease or illness that would increase the operative risk or confound the results of this investigation (eg, immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness).
* suturing of incision required at time of surgery
Lamictal in the Treatment of Post-Herpetic Neuralgia

To assess the efficacy of Lamictal for the treatment of pain and reduction of allodynia in patients with post herpetic neuralgia.


Eligibility Criteria:
Inclusion Criteria:

* All patients will be over the age of 18,
* Need to have a diagnosis of Post-Herpetic Neuralgia,
* Minimum of 4 on the Likert Pain Scale,
* If currently taking TCA and/or Gabapentin, need to have been on stable dose for minimum of 4 weeks

Exclusion Criteria:

* Currently on any antiepileptic drugs (AED), except for Gabapentin.
* Currently taking opioid or unwilling to washout prior to the study,
* Pregnant and lactating,
* Have active severe systemic disease,
* History of Stevens-Johnson syndrome or TEN,
* Clinically significant abnormal lab values,
* Known drug allergy to Lamictal,
* Patients on Fibrates (Tricor and Lopid),
* History of major psychiatric disturbance and substance abuse.
* Valproate due to increase chances of severe rash,
* Lidocaine Patch,
* Use of hormonal contraceptives (birth control pills, patch, ring, injection)
Validation of Software for Assessment of Sleep Apnea From Data Acquired by a Wearable Smartwatch

This clinical validation study aims to evaluate the utility of Fitbit's Sleep Apnea Alert software for minimally invasive monitoring of sleep apnea events to alert users of their risk of sleep apnea. The Sleep Apnea Alert software analyses data from a Fitbit commercially available wrist photoplethysmogram (PPG) device. The Sleep Apnea Alert software is an investigational software as medical device (SaMD) and is designed to retrospectively process data and flag users who have physiological signals consistent with an apnea-hypopnea index (AHI) of 15 or greater. This clinical validation study will be used to validate Fitbit's PPG-based sleep apnea algorithm. The outputs of the Fitbit Sleep Apnea Alert software will not be available to study participants, as the scope of this study is to gather validation data only and does not include testing product usability components.


Eligibility Criteria:
Inclusion Criteria:

* Capable of giving informed consent
* Comfortable reading the provided written study instructions in English (and/or local language) and using a smartphone in English (and/or local language).
* Have medical insurance either in the form of private insurance or a national health program.

Exclusion Criteria:

* No implanted cardiac devices
* Not pregnant. Pregnancy status will be confirmed per patient report of medical history, i.e., patients will be asked if they are pregnant or may be pregnant, and date of last menstrual cycle.
* No medical conditions which might lead to consistently low levels of perfusion in the vasculature at the wrist
Evaluating Surface Area Reduction Using MolecuLight Imaging Device

12-week single-blind, prospective, randomized, controlled, pilot clinical trial assessing The MolecuLight i:X Imaging Device in chronic wounds. This device guides clinicians to inspect, sample, debride or further evaluate areas within or around a wound where potentially harmful bacteria appear under violet light illumination resulting in better overall care and accelerated surface area reduction compared to current standard care. The study aims to determine if this device aids in the healing of chronic wounds by reduction in size of wound compared to current standard of care.

This is a prospective, 12-week, single-blinded, randomized, controlled clinical trial has been designed with two primary objectives needed to inform more comprehensive studies at a later date. We propose to evaluate the following two primary outcomes: (1) the ability of the MolecuLight i:X Imaging Device to predict non healing wounds and wounds at risk or infection (control arm) and (2) whether utilization of the MolecuLight i:X Imaging Device in guiding clinicians to inspect, sample, debride or further evaluate areas within or around a wound where fluorescent bacteria are present (treatment arm) increases wound healing rates relative to standard care (control arm) for the treatment of chronic wounds.

Both arms will receive standard procedures associated with wound care (e.g., sampling, debridement, preventative care, infection control, etc.) according to best practice guidelines. Patients will be randomly assigned to either the control or treatment arm and be followed as per the study protocol every time their wound is cared for over a 12-week period. The effectiveness of the MolecuLight i:X Imaging Device will be assessed with evaluation of wound surface area reduction rate and infection rates (incidence of infection and time to eradicate infection) compared to standard care.

All subjects randomized will be evaluated for 12 weeks from the date of enrollment and treatment initiation. Subjects who may have wound closure within the 12-week study period will continue to have scheduled study evaluation visits up to the end of week 12.

Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 18 years
2. having a chronic wound that is not a diabetic foot ulcer
3. presence of the wound for ≥ 6 weeks and ≤ 2 years.
4. wound size surface area ≥ 2 cm2 and ≤ 50 cm2.
5. Willingness to comply with prescribed wound care regimen

Exclusion Criteria:

1. candidate for surgery in the next 12 weeks
2. a wound with necrotic tissue unable to tolerate debridement
3. uncontrolled diabetics (defined as HbA1c of \>85.5mmol/mol)
4. presence of a diabetic foot ulcer
5. currently taking medication that may interfere with wound healing (e.g., oral systemic steroids, immunosuppressive drugs, unfractionated heparin infusion)
6. women who are currently pregnant or are breast feeding; or women of child bearing potential who are not currently taking adequate birth control
7. participation in another investigative drug or device trial currently or within the last 30 days
QL1706 in Combination With Neoadjuvant Chemotherapy Versus Neoadjuvant Chemotherapy for Locally Advanced, Resectable Esophageal Squamous Cell Carcinoma

This is a randomized, double-blind, placebo-controlled Phase II/III clinical trial to evaluate the perioperative treatment with QL1706 in combination with neoadjuvant chemotherapy for locally advanced resectable esophageal squamous cell carcinoma. The primary objective of the Phase II is to evaluate the pathological complete response rate of QL1706 perioperative treatment in combination with neoadjuvant chemotherapy for locally advanced resectable esophageal squamous cell carcinoma; the primary objective of the Phase III is to compare event-free survival of QL1706 perioperative treatment in combination with neoadjuvant chemotherapy versus placebo in combination with neoadjuvant chemotherapy for locally advanced resectable esophageal squamous cell carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1.
* Patients with thoracic esophageal squamous cell carcinoma diagnosed by pathologic histology or cytology and cT1-2N1-3M0 or cT3-4aN0-3M0 according to AJCC/UICC 8th edition.
* Expected to undergo surgery after completion of neoadjuvant therapy and expected to achieve R0 resection.
* Have not receiv any anti-tumor therapy for esophageal cancer.
* Have adequate organ function.

Exclusion Criteria:

* Significant tumor invasion into organs adjacent to the esophageal lesion;
* a history of gastrointestinal bleeding or those with a high bleeding tendency;
* The presence of supraclavicular lymph node metastases;
* the presence of uncontrollable third interstitial fluid;
* poor nutritional status.
Regional Anesthesia and Lung Cancer Recurrence

Test the effect of combined regiona/general anesthesia on lung cancer recurrence compared to general anesthesia alone.

Surgery is the primary treatment of lung cancer, but surgery releases tumor cells into the systemic circulation. Whether this minimal residual disease results in clinical metastases is a function of host defense. At least three perioperative factors shift the balance toward initiation and progression of minimal residual disease. (1) Surgery per se depresses cell-mediated immunity, reduces concentrations of tumor-related anti-angiogenic factors (e.g., angiostatin and endostatin), and increases concentrations of pro-angiogenic factors such as VEGF. (2) Anesthesia impairs numerous immune functions, including neutrophil, macrophages, dendritic cells, T lymphocytes (T-cell), and Natural killer cell (NK-cell) functions. (3) Opioid analgesics inhibit both cellular and humoral immune function in humans, and promote tumor growth in rodents. Regional analgesia attenuates each of these adverse effects. For example, regional anesthesia largely prevents the neuroendocrine stress response to surgery by blocking afferent neural transmission. With combined regional and general anesthesia/analgesia, the amount of general anesthetic required is much reduced - as is, presumably, immune suppression. And finally, regional analgesia provides superb pain relief, essentially obliterating the need for postoperative opioids. Animal studies show that regional anesthesia improves natural kill cell function and reduces the metastatic burden in animals inoculated with carcinoma cells. Preliminary retrospective data in cancer patients showed, that paravertebral analgesia for breast cancer surgery reduced risk of recurrence or metastasis by 40% during a 2.5 to 4-year follow-up period.

The investigators thus propose to evaluate the effect of combined epidural-general anesthesia compared to general anesthesia on cancer recurrence semi-annually over a period of 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Primary non-small cell lung cancer (stage 1-3) as determined according to the IASLC Lung Cancer Staging Project;
* Scheduled for potentially curative tumor resection;
* Written informed consent, including willingness to be randomized to epidural anesthesia/analgesia plus general anesthesia or to general anesthesia and postoperative opioid analgesia.

Exclusion Criteria:

* Any contraindication to epidural anesthesia, (including coagulopathy, abnormal anatomy).
* Any contraindication to midazolam, propofol, sevoflurane, fentanyl, morphine, or hydromorphone.
* Age \< 18 or \> 85 years old.
* Other cancer not believed by the attending surgeon to be in long-term remission.
The Effect of Foot Reflexology Massage on Neuropathic Pain

This study is conducted to measure the effect of foot reflexology massage on neuropathic pain in diabetic patients.Is reflexology foot massage applied to type 2 diabetic patients effective on neuropathic pain?

Controlling pain in individuals with diabetes; It is important for the individual to relax, increase the quality of life, reduce complications and shorten the duration of hospital stay. For this reason, the importance of neuropathic pain and its treatment is increasing in terms of public health. In this study, the effect of foot reflexology massage applied to women with type 2 diabetes on neuropathic pain was measured.

Eligibility Criteria:
Inclusion Criteria:

1. Those diagnosed with type 2 diabetes,
2. Being 18 years or older
3. Individuals who do not have any fractures in the extremities, skin diseases, past wound history, open wounds and unilateral or bilateral amputation, tendonitis in the ankle, active foot ulcer and infection.
4. Those who volunteer to participate in the study,
5. Those who do not have problems with verbal communication,
6. Those who have not been diagnosed with any psychiatric disease.
7. Those with neuropathic pain of 12 points and above according to the LANS score
8. Patients receiving duloxetine drug therapy
9. Those who are not pregnant
10. Patients without peripheral artery disease, deep vein thrombosis and gonatosis will be included in the study. -

Exclusion Criteria:

1. Those who did not agree to participate in the study
2. Those under 18 years of age
3. Individuals with no fractures in the extremities, skin diseases, past wound history, open wounds and unilateral or bilateral amputation, tendonitis in the ankle, active foot ulcers and infections.
4. Those who have problems with verbal communication
5. Those with neuropathic pain below 12 points according to the LANS score
6. Patients receiving treatment other than duloxetine drug therapy
7. Those who are pregnant
8. Those with any psychiatric disorder
9. Patients with peripheral artery disease, deep vein thrombosis and gonatosis will not be included in the study.-