cyrilzakka/clinical-trials huggingface dataset:
Evaluation of a Respiratory Monitor in Surgical Patients With a BMI>35

This study proposes to evaluate the clinical applicability of the ExSpiron Respiratory Volume Monitor (RVM, ExSpiron™, Respiratory Motion, Inc.; Waltham, MA) in obese surgical patients undergoing general anesthesia. Previous work has demonstrated the ability of the ExSpiron monitor to provide non-invasive, real-time, continuous measurements of respiratory parameters such as tidal volume (TV), minute ventilation (MV) and respiratory rate (RR) mostly in normal weight patients but those studies did not specifically look at obese subjects. Respiratory depression, in the postoperative setting due to residual anesthetics and/or opioid administration, continues to be a significant cause of adverse outcomes. Obese patients are at increased risk for respiratory complications. Currently, there is no objective measure of early respiratory indicators for developing respiratory compromise. Current respiratory assessment in non-intubated patients relies on oximetry data and subjective clinical assessment. Pulse oximetry has been extremely helpful in recognizing oxygen desaturations but it is a late indicator of respiratory decline. There is no current device capable of giving real time ventilatory information such as tidal volume and minute ventilation of a patient that is not mechanically ventilated. The ExSpiron system utilizes an impedance based technology and proprietary algorithms (Respiratory Motion Inc.) to obtain these measurements. The study hypotheses are that the non-invasive, impedance-based RVM monitor will accurately reflect TV, RR and MV in obese surgical patients before induction of general anesthesia, during controlled ventilation and following extubation; that ExSpiron will accurately reflect the post-extubation respiratory status of the patient; and that apnea and hypopnea episodes in the recovery room as detected by the ExSpiron monitor are correlated with the individual risk for obstructive sleep apnea as determined by the STOP-Bang risk stratification.


Eligibility Criteria:
Inclusion Criteria:

* ASA 1 - 3 patients with a body mass index (BMI) ≥ 35kg/m2 presenting for elective surgery under general anesthesia aged \> 18 years. Ability to provide written informed consent.

Exclusion Criteria:

* Emergent surgical patients, patients with a BMI \< 35kg/m2, patients not competent to give informed consent, pregnant patients (women of child bearing potential who want to participate will have a pregnancy test done prior to enrollment in the study), patients with implantable electronic devices (pacemakers, stimulators, etc.); predictable interference with surgical procedure or standard of care.
Impact of Ophthalmic Surgeon Experience on Early Postoperative Central Corneal Thickness

To assess the impact of surgeon experience on early postoperative central corneal thickness (CCT) in eyes that have undergone phacoemulsification-based cataract surgery.

Cataract surgery is the most commonly performed surgical procedure. Although phacoemulsification is considered a safe method of performing cataract surgery, the risk of endothelial cell loss (ECL) remains.

Given that the surgical technique and speed typically improve with surgeon skill and experience, the purpose of this study was to evaluate the impact of surgeon experience on the occurrence of ECL, as reflected by the presence of corneal edema.

Eligibility Criteria:
Inclusion Criteria:

* Presence of senile cataract
* Age above 50 years
* History of visual acuity regression

Exclusion Criteria:

* Presence of white or Brown cataract
* History of previous ophtalmic surgery
* preexisting corneal pathology (cornea guttata, infectious keratitis or active inflammatory or old)
* Patients who developed intraoperative complications
ImmunoTEP for Patients With Medullary Thyroid Carcinoma.

The aim of this study is to optimize pretargeting parameters using pharmacokinetic and imaging data for immuno-PET using anti-CEA x anti-HSG TF2 BsMAb and 150 MBq of 68Ga-IMP-288 peptide in MTC patients with abnormal Ct serum level after initial complete surgery and at least one abnormal lesion

Variation of TF2 molar dose, IMP-288 molar dose and pretargeting interval will be performed in 4 to 5 cohorts of 3 patients, receiving 30 to 120 nmol of TF2 and 1.5 to 6 nmol of peptides 1 to 3 days apart. Blood samples will be obtained after TF2 and 68Ga-IMP-288 injections.

A last cohort (cohorte number 5 or 6) with optimal conditions will be proposed. Whole-body PET images will be recorded 60 and 120 minutes after 68Ga-IMP-288 injection to assess semi-quantitatively tumor targeting and tumor/background ratio. Moreover, the targeting sensitivity of the TF2-pretargeted 68Ga-IMP-288 will be compared to standard methods of tumor.

some patient will have a second immuno-TEP for their follow up in the first examen was the most sensible.

Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of CMT
* Calcitonin\> 150 pg / ml
* Complete treatment of the primary tumor
* at least one detectable lesion more than 10 mm on conventional imaging: bone lesions can be taken into account if they extend outside of the bone and the party extra bone is measurable.
* Age ≥ 18 years
* Negative pregnancy test for women of childbearing age in the previous 2 days immuno-PET. Women of childbearing potential should use effective contraception take continuously for 3 months.
* KPS ≥ 70 or ECOG 0-1 and life expectancy of at least 6 months
* Absence of serious illness or co-morbidity assessed risk
* Creatinine ≤ 2.5 normal
* Absence of cancer treatment within 6 weeks prior to the immuno-PET
* No history of cancer within 5 years, except skin cancer other than melanoma or carcinoma in situ of the cervix
* Lack of anti-antibodies in patients who have previously received antibodies and hypersensitivity to antibody or protein
* Informed consent signed
* Social Insurance

Exclusion Criteria:

* Pregnancy or breastfeeding
* Serious illness or co-morbidity assessed risk
* History of cancer within 5 years, except skin cancer other than melanoma or carcinoma in situ of the cervix
* Presence of anti-antibodies in patients who have previously received antibodies
* Known hypersensitivity to antibody or protein
* Need to establish a cancer treatment within 3 months of immuno-PET (before stock evaluation 3 months)
* Inability intellectual sign consent
* Patient protected by law
Telmisartan/Amlodipine (80/10) vs. Telmisartan/Amlodipine (40/10) vs. amlodipine10 in Resistant Hypertension

The primary objective of this trial is to demonstrate that the fixed dose combination of telmisartan 40mg + amlodipine 10mg (T40/A10) or the fixed dose combination of telmisartan 80mg + amlodipine 10mg (T80/A10) is superior in reducing blood pressure at eight weeks compared with amlodipine 10mg monotherapy (A10) in patients who fail to respond to six weeks treatment with A10.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of essential hypertension and blood pressure not adequately controlled before informed consent (inadequate control defined as seated diastolic blood pressure (DBP) \>= 95 mmHg if on existing antihypertensive treatment or seated DBP \>= 100 mmHg if treatment-naïve).
* failure to respond to six weeks treatment with amlodipine 10mg. (Failure to respond defined as seated DBP \>= 90 mmHg.)
* able to stop any current antihypertensive therapy without unacceptable risk to the patient.
* willing and able to provide written informed consent.

Exclusion Criteria:

* pregnancy, breast-feeding, unwilling to use effective contraception (if female of child-bearing potential).
* known or suspected secondary hypertension.
* mean seated systolic blood pressure (SBP) \>=200 mmHg and/or mean seated DBP \>= 120 mmHg during run-in treatment or mean seated SBP \>= 180 mmHg and/or mean seated DBP \>= 120 mmHg at the randomisation visit or at any time during randomised treatment.
* any clinically significant hepatic impairment or severe renal impairment bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post post-renal transplant.
* clinically relevant hyperkalaemia.
* uncorrected volume or sodium depletion.
* primary aldosteronism.
* hereditary fructose or lactose intolerance.
* symptomatic congestive heart failure.
* patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or ARBs.
* history of drug or alcohol dependency within the six months prior to signing consent.
* concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing consent.
* hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the aortic or mitral valve.
* known allergic hypersensitivity to any component of the formulations under investigation. (Includes known hypersensitivity to telmisartan or other ARBs or amlodipine or other dihydropyridine CCBs.)
* non-compliance with study medication (defined as less than 80% or more than 120%) during the open-label run-in treatment period.
* current treatment with any antihypertensive agents, whether or not prescribed for this indication, that cannot be safely stopped (investigator¿s decision) by the start of the run-in period.
* chronic administration of any medication known to affect blood pressure, other than the trial medication.
* any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan and amlodipine.
Melatonin Adolescent Research Study

The present study will use a within-person, randomized cross-over experimental design to test the effects of exogenous melatonin supplementation on the sleep and daytime functioning of typically developing adolescents with short or disrupted sleep of behavioral origins (i.e., difficulty falling asleep, staying asleep, or premature waking resulting in short or disrupted sleep not attributed to an organic sleep condition).


Eligibility Criteria:
Inclusion Criteria:

* Self-identified sleep difficulties (e.g., difficulty falling asleep, staying asleep, or premature waking resulting in short or disrupted sleep).
* Ages 13 to 17 years old
* Able to understand, read, and write in English
* Melatonin naive

Exclusion Criteria:

* Obesity
* Use of psychiatric medication
* Drug(s), or supplements known to affect sleep
* History of head injury or concussion with loss of consciousness \>1 minute
* Daily consumption of \>1 caffeinated beverage
* Risk for any organic sleep disorder (e.g., obstructive sleep apnea, restless leg syndrome)
Idylla IFV-RSV Panel Clinical Testing

This clinical study will collect fresh samples and perform laboratory testing on fresh and archived samples as described in the protocol.

The Idylla console, instrument, and Respiratory (IFV-RSV) Panel cartridge constitute the Idylla respiratory diagnostic system. The IFV-RSV Panel is an in vitro PCR-based molecular diagnostic assay for the simultaneous qualitative detection of nucleic acids for Influenza A (including H1, 2009 H1N1, H275Y mutation of 2009 H1N1, H3), Influenza B, and Respiratory Syncytial Virus (RSV) (A and B) on nasal swab (NS) direct to cartridge or nasopharyngeal swabs (NP) in viral transport media (VTM) in adults, adolescents, and children.

This clinical study will collect data in support of regulatory submission and the indications for use of the IFV-RSV panel and the Idylla diagnostic system. This protocol will demonstrate that the results of this assay, in conjunction with clinical information, may be used as an aid in the diagnosis of infection with Influenza A, Influenza B, and RSV in persons having both a high and low risk for respiratory viral infection.

During this study, participating sites will collect fresh samples, conduct a Reproducibility Study and test the fresh and previously collected frozen samples from individuals presenting with signs/symptoms of influenza like illness (ILI) and respiratory virus in accordance to the sample collection described in this protocol.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* All Ages
* Subject, or legally authorized representative, has provided IRB/EC approved written Informed Consent, privacy (e.g. HIPAA) authorization when required and Assent where applicable prior to any study-related procedure(s) being performed
* Patient presenting with ILI and/or Signs/Symptoms of RSV Infection as defined in this protocol
* Onset of ILI and/or Signs/Symptoms of RSV Infection was ≤ 5 days prior to subject screening (Refer to the definitions for detailed descriptions of ILI and Signs/Symptoms of RSV infection)
* Clinician's determination that illness is due to a viral infection
* Subject agrees to allow study specimens to be used for future studies

Exclusion Criteria:

* Onset of Influenza Like Illness (ILI) and/or Signs/Symptoms of RSV Infection was \> 5 days prior to subject screening (Refer the definitions for detailed descriptions of ILI and Signs/Symptoms of RSV infection)
* Subject received live intranasal attenuated influenza virus in last 3 weeks (e.g. FluMist, Fluenz)
* Subject received treatment with influenza directed antiviral (e.g. Zanamivir, oseltamivir (Tamiflu), amantadine, rimantadine) in the last 5 days
* The subject was previously enrolled in this study
* Clinician's determination that illness is NOT due to a viral infection (e.g. allergies)
* Subject had a nasal wash within last 8 hours. This exclusion includes any extraction of nasal secretions by nasal suctioning with fluid
* Subject does not agree to allow study specimens to be used for future research studies
Progressive Relaxation Exercises Before Mobilization:Effects on Pain, Anxiety and Physiologic Parameters CABG Patients

This study is planned as a randomized controlled experimental study to determine the effect of progressive relaxation exercises applied before mobilization on pain, anxiety and physiological parameters in patients undergoing coronary artery bypass graft surgery.

This study was planned as a randomized controlled experimental study to determine the effect of progressive relaxation exercises on pain, anxiety and physiological parameters before mobilization in patients undergoing coronary artery bypass graft (CABG) surgery. Ethics committee and institutional approval were obtained before starting the study. Patients were informed about the study and their verbal and written informed consent was obtained. The study will be conducted in a public hospital in Istanbul between May 2024 and May 2025 with 68 patients (experimental group = 34, control group = 34) who met the research criteria and underwent CABG surgery. The patients in the experimental group will be given progressive relaxation exercises twice at 6-hour intervals on postoperative day 1 and day 2. Each relaxation exercise session will last 20 minutes. Routine treatment and care will continue for the patients in the control group. Physiologic parameters, pain and anxiety levels will be evaluated on day 1 and day 2 in both groups. It was also stated that a smart wristband should be worn on the arms of the patients on postoperative days 1 and 2 to monitor the frequency and duration of mobilization in both the experimental and control groups.

Eligibility Criteria:
Inclusion Criteria:

* Ability to read and write in Turkish
* Conscious and communicative
* Elective coronary artery bypass graft surgery planned
* Patients undergoing coronary artery bypass graft surgery for the first time were included in the study.

Exclusion Criteria:

* Diagnosed with a psychiatric or neurological disorder
* Diagnosis of a musculoskeletal condition that could affect mobilization
* Patients who developed any complications during the postoperative period were excluded.
New Gentle Biopsy Method of Cervix Lesions Using Superficial Curettage/Protocol ID: CX-CUR

It is to investigate to what extent a gentle tissue extraction of CIN lesions of the cervix will bring the same conclusion than the conventional cervix biopsy, but with less pain and morbidity, after patients were undergoing a conisation in order to treat CIN.


Eligibility Criteria:
Inclusion Criteria:

* Women between 18 and 80
* Karnofsky-Index of 80 and higher
* Cytological suspicious CIN and a colposcopical impression of a major lesion (therapeutical endpoint: conisation)

Exclusion Criteria:

* Former malign disease oft he pelvic organs
* Pregnancy
* Serious internistic diseases
* Drug addiction
Functional and Self-reported Outcomes in Participants With a History of Musculoskeletal Knee Injury

Negative outcomes impact individuals with a history of ACL reconstruction (ACLR) despite completion of formal rehabilitation and clearance to return to physical activity (PA). Focused exercises and targeted health education may improve these negative outcomes and increase quality of life. The purpose of this study is determine the effects of an 8-week rehabilitation program on strength, sensorimotor function, functional performance and patient-reported outcomes in patients with a history of ACLR. A secondary aim will be to identify baseline PA levels and dietary intake patterns in these individuals. Participants will complete standard knee radiographs and all baseline measures, and resume normal activities of daily living for one-week while wearing an accelerometer to quantify PA levels and complete two, 24-hour dietary recalls to examine dietary patterns. After one-week, participants will come back to the laboratory and complete the pre-intervention assessments prior to randomization to the exercise or control group. After 8-weeks, participants will complete all outcome assessments 24-48 hours, 1-month and 3-months post exercise completion. The investigators hypothesize the intervention group will have significantly better outcomes post-intervention compared to the control group. In addition, the investigators hypothesize areas of educational and behavioral intervention related to PA engagement and dietary strategies to support weight management will be needed.


Eligibility Criteria:
Inclusion Criteria:

* History of unilateral ACL reconstruction,
* History of injuring their knee playing or training for sports (recreational or organized),
* Have been cleared to participate in activity, do not have radiographic evidence of post-traumatic osteoarthritis,
* Are free of neurological disorders, cardiopulmonary disease or any other condition that may impact their ability to participate

Exclusion Criteria:

* ACL reconstruction \>10 years,
* Injury to either lower extremity within the last 6-weeks,
* Surgery to either limb within the last year,
* A BMI \> 30
Prevalence of Malnutrition in Surgery

Nutritional disorders are highly prevalent in gastrointestinal cancer patients undergoing surgery and have shown to contribute significantly in short, mid and long-term clinical outcome. Although increasing evidence and expert suggestions there is still inadequate awareness about the clinical relevance of nutritional and metabolic alterations in surgical oncologic patients.

Nutritional disorders are highly prevalent in cancer patients and have shown to contribute significantly in short-, mid- and long-term clinical outcome. The prevalence of malnutrition is reported between 25% and over 70% based on nutritional assessments. Nutritional disorders represent an important risk factor for the occurence of postoperative complications.

Main obstacles to improving nutritional care include lack of awareness for the problem among the general public and lack of awareness among decision makers and even care providers.

Considering the high prevalence of malnutrition and its repercussions in patient morbidity-mortality and healthcare cost, nutritional screening measures must be included in an integrated nutritional care plan for patients before surgery and while in the hospital.

The PRoMiS study was conceived to quantify nutritional disorders among gastrointestinal cancer patients undergoing surgery in Italy. The data obtained will contribute to increase the awareness of nutritional disorders among oncology surgical patients and their impact on clinical outcome, favoring the inclusion of the initial assessment of nutritional status before surgery and of the nutritional intervention.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are candidates for surgery for gastrointestinal cancer (esophagus, stomach, small intestine, pancreas, biliary tract, colon, rectum, liver)
* Diagnosis of malignant solid tumor
* Age\> 18 years
* Informed consent

Exclusion Criteria:

* Uncontrolled metabolic disorders
* Uncompensated heart failure
* Severe psychiatric disorders
* Appropriate logistical support for participation in the study.
Platelet-rich Fibrin(PRF) Membrane in Ophthalmic Diseases

The goal of this clinical trial is to observe the role of PRF in treating ophthalmic diseases.The efficacy and safety of PRF were validated for four ophthalmic conditions: macular hole, pterygium, corneal ulcer, and patients undergoing trabeculectomy for glaucoma. The main question aims to answer is PRF's effectiveness in ocular surface and fundus diseases. Participants will be divided into 2 groups, the experimental group will be treated with PRF and the control group will be treated with conventional surgery, with a 12-month postoperative follow-up to determine the role of PRF on wound healing in ophthalmic diseases.

Patients suffering from pterygium, macular hole, corneal ulcer, and glaucoma requiring for trabeculectomy , who visited Renmin Hospital of Whuhan University, were chosen to participate in this study. The participants were randomly divided into the experimental group (PRF group) and the control group (conventional group). The PRF group received PRF membrane treatment, while the conventional group received conventional surgical treatment. Before and after surgery, participants underwent a comprehensive ophthalmological exam at 1 week, 1 month, 3 months, 6 months, and 12 months.

The outcome indicators are monitored and can vary depending on the disease. Participants with pterygium were examined for graft dissolution and complications. Participants with macular hole were monitored for hole closure, visual acuity recovery, and retinal blood flow recovery. Participants with corneal ulcer were monitored for lesion healing and complications such as degree of corneal vascularization and opacity. Participants with glaucoma were monitored for postoperative intraocular pressure (IOP), degree of conjunctival leakage in the filtration zone, and degree of scarring in the filtration zone.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of macular hole confirmed by fundus examination;
2. Diagnosis of pterygium by slit lamp;
3. Patients requiring trabeculectomy for glaucoma;
4. Diagnosis of corneal ulcer confirmed by slit lamp.

Exclusion Criteria:

1. Combination of other active ophthalmic diseases, such as acute conjunctivitis and uveitis;
2. Previous history of ophthalmic trauma and ophthalmic surgery;
3. Recent use of anticoagulant or antiplatelet drugs;
4. Combination of serious systemic diseases such as hypertension and diabetes mellitus.
Clinical Trial to Evaluate Ultrasonic Surgical Device in Chronic Pressure Ulcer

Study objective The purpose of this trial is to evaluate the efficacy and safety of the investigational device, ULSD-12D, as Compared to the comparator, SONOCA-180, in chronic wound.

* Study design Multi-center, randomized clinical trial
* Study population Adults with chronic wound
* Investigational device treatment procedure Before Treatment: The subject's eligibility (inclusion/exclusion criteria) will be assessed,and apply the Study Device or Comparator on their wound in a randomized manner. Post-Treatment: All subjects will take pictures of the wound area and measured the number of microorganism and wound size.

Eligibility Criteria:
Inclusion Criteria:

* over 20 years of age
* subject who has untreated wounds
* subject who has wound size over 3cm x 3cm
* subject who has wound over stage 2

Exclusion Criteria:

* cellulitis