cyrilzakka/clinical-trials huggingface dataset:
Liquid Bandage (2-Octyl-Cyanoacrylate) in Upper Lid Blepharoplasty

The aim of this randomized and masked prospective trial is to compare the effectiveness of Liquid Bandage (Octyl-2-Cyanoacrylate) and 6/0 nylon suture as a wound closure device in upper lid blepharoplasty surgery.

Tissue adhesives have been safely used in a variety of surgical procedures for several years. Butyl-2-cyanoacrylate (Histoacryl) and Octyl-2-cyanoacrylate (Dermabond) was also studied for cosmetic blepharoplasty with satisfactory results. Liquid Bandage (Johnson \& Johnson, Skillman, NJ, USA) is a more flexible formulation of octyl-2-cyanoacrylate available in many american drugstores for home use. Animal models shown that this product could accelerate the healing of lamellar wounds and studies in humans have demonstrated its safety and effectiveness as an occlusive protective film over cuts, abrasion and wound surgery. Liquid Bandage was also used as a temporary wound barrier in clear corneal cataract surgery with satisfactory applicability. There is no study in the literature using this device in blepharoplasty yet.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 25 years with diagnosis of dermatochalasis who presented surgical indication of primary blepharoplasty.

Exclusion Criteria:

* Prior eyelid surgery
* Concomitant ocular or systemic disease or current use of medications that could interfere in coagulation or wound healing (eg, diabetes mellitus, oral acetyl salicylic acid or corticosteroids)
* Pregnant female
* Known allergy to cyanoacrylate
* Inability to return for follow-up consultations
BFRT for Subacromial Pain

The goal of this pilot clinical trial is to learn if blood flow restriction training is safe and feasible in patients with subacromial pain. The main questions the investigators aim to answer are:

* What problems do participants with shoulder pain encounter when training with blood flow restriction?
* Is it feasible to apply blood flow restriction training as part of a physical therapy intervention?
* What are some preliminary effects of blood flow restriction training on the recovery of shoulder function and strength?

The investigators will compare active blood flow restriction training to sham (an inactive procedure designed to mimic the active training as closely as possible).

Participants will:

* Visit the clinic for physical therapy visits and exercise with blood flow restriction training for up to 8 weeks
* Visit the clinic for tests before starting the treatment, during the treatment (4 weeks), and after the end of the treatment (8 and 26 weeks).


Eligibility Criteria:
Inclusion criteria

* Between 18 and 50 years of age
* Unilateral pain in the anterolateral shoulder
* Self-reported shoulder function of ≤7 (10, full function)
* At least 90° of active shoulder elevation
* 3 out of 5 positive tests to define subacromial pain.

Exclusion Criteria (general):

* history of shoulder fracture, frozen shoulder, or shoulder surgery
* history of cardiovascular, neurologic, and pulmonary conditions that would impair the subject's ability to participate in physical therapy
* active treatment for cancer
* uncontrolled diabetes
* uncontrolled high blood pressure
* corticosteroid injection at the shoulder within 6 weeks
* imaging evidence of rotator cuff tears
* pregnancy

Exclusion criteria (Blood flow restriction training specific)

* contraindications to BFRT (sickle cell anemia, deep vein thrombosis, peripheral circulatory diseases)
* taking anticoagulant or antiplatelet drugs
0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Critically Ill Children

The primary objective of this study is to compare the mean serum sodium after 48 hours of therapy with either 0.45% NaCl/dextrose 5% or 0.9% NaCl/dextrose 5%, in critically ill children requiring IV maintenance fluid administration.

In patients without possibilities of oral intake, maintenance fluids provide electrolytes and water. Since the original descriptions by Holliday and Segar, the recommended standard maintenance solutions are based on "physiological needs", containing 30-50 mEq/L of sodium.

However hyponatremia has become increasingly recognized in hospitalized children suggesting that Holliday and Segar's recommendations are frequently inappropriately applied.

It has been described augmented intersticial lung water in patients receiving hypotonic maintenance solutions. Also, hyponatremia has been demonstrated in post-surgery critically ill children receiving hypotonic maintenance solutions.

More over, non-physiologic antidiuretic hormone (ADH) secretion has been described in the great majority of hospitalized children due to nausea, stress, pain, and/or surgical interventions.

It has been suggested that isotonic 0.9% NaCl/dextrose 5% should be the standard maintenance intravenous (IV) solution, to avoid the development of hyponatremia.

There are not studies in critically ill children evaluating the effect of isotonic solutions on sodium levels.

Eligibility Criteria:
Inclusion Criteria:

* Age 1 month to 18 years
* ICU stay \>24 hours
* Normal seric sodium (135 - 145 mEq/L).
* Requirement of IV maintenance solutions \>80% total fluids intake

Exclusion Criteria:

* Patients with diagnoses of renal failure (serum creatinine \>1 g/dl in \<3 years old children, \>1,5 in \>3 years), hepatic failure with ascitis and portal hypertension, adrenal failure, nephrotic - nephritic syndrome, Kawasaki disease, sickle cell anemia, Syndrome of inappropriate antidiuretic hormone secretion, diabetes insipidus,metabolic disease.
* Diuretics use in the first 48 hours thereafter indicated IV solutions.
* Plasma glucose is \>200 mg%.
* Any patients requiring IV fluids therapy different that maintenance (total parenteral nutrition, hyperhydration).
Fibrinolysis Compared to Thoracoscopy for Pleural Infection

The purpose of this prospective randomized clinical trial is to compare two currently accepted standard-of-care treatment strategies: Medical thoracoscopy as compared to instillation of intrapleural tissue Plasminogen Activator (TPA) and human recombinant Deoxyribonuclease (DNase) for the management of empyema or complicated parapneumonic effusion (CPPE) in adults.

Background: Pleural infection (empyema or complex parapneumonic effusion (CPPE)) represents one of the most common clinical diagnoses encountered in clinical practice in the United States (US) It is associated with substantial morbidity and mortality despite advances in medical diagnostic and therapeutic strategies.

Objective: Compare two standard of care treatments: TPA/DNase vs early medical Thoracoscopy

Methods: Investigators will conduct a prospective randomized clinical trial. Plan is to enroll total of 32 patients and randomize those patients to either Medical Thoracoscopy group or Fibrinolytic Therapy group.

Follow-up will be daily until hospital discharge and at 6 and 12 weeks in the outpatient setting

Potential Outcome and Benefit: Determine best strategy for treating patients with pleural infection

Eligibility Criteria:
Inclusion Criteria:

Subjects \>18 years old with:

Evidence of empyema or complex parapneumonic effusion

Exclusion Criteria:

Age \<18 years Pregnancy Inability to give informed written consent Previous thoracic surgery or thrombolytic therapy for pleural infection Medical thoracoscopy cannot be performed within 48 hours Hemodynamic instability or severe hypoxemia Non corrected coagulopathy Homogeneously echogenic effusion on pleural ultrasonography
Dyspnea in Patients With Pulmonary Fibrosis

This study has two aims:

1. To determine the relationship of shortness of breath (dyspnea) to other conditions present in patients with pulmonary fibrosis.
2. To define the relationship between shortness of breath and rate of functional decline in patients with pulmonary fibrosis.

Idiopathic Pulmonary Fibrosis is the most common form of chronic fibrosing lung disease seen by pulmonologists, with an estimated 128,000 cases in the United States alone. It is almost surely a disorder related to aging, with a median age at the time of diagnosis of approximately 65 years; IPF is almost unheard of under the age of 50. Dyspnea is common in patients with IPF, and is often the primary symptom of the disease. It is tightly linked to quality of life in IPF, suggesting that the experience of dyspnea has wide-ranging and clinically-significant consequences. Despite its importance, surprisingly little is known about the etiology or functional impact of dyspnea in this disease.

This research proposal focuses on defining the relationship of dyspnea to comorbidity and the rate of functional decline in patients with IPF

Aim 1: To determine the relationship of dyspnea to other conditions present in patients with IPF.

Dyspnea is a complex symptom, related to both mechanical and cognitive factors. The mechanisms of dyspnea in IPF remain unknown, but there are several likely contributors that are both IPF and non-IPF related. Although IPF is a chronic disease of the elderly, no one has investigated the relationship between common geriatric conditions and dyspnea. It is well established that the perception of dyspnea depends equally on factors that influence the intensity of the experience of breathlessness (such as thoracic restriction and weakness) and the distress which that intensity produces. Gender, ethnicity, anxiety, pain, and depression all may contribute to the distress caused by dyspnea (and therefore its intensity) in IPF.

Aim 2: To define the relationship between dyspnea and rate of functional decline in IPF.

Numerous studies have looked at predictors of survival in patients with IPF, and both baseline and change in dyspnea over time have been shown to be significantly associated. The prediction of future morbidity, however, is largely unstudied. Established markers of functional decline in geriatric patients include weight loss, decline in walking speed over 4 meters, and the onset of disability as defined by the ability to perform activities of daily living (ADLs) and instrumental activities of daily living (IADLs). Dyspnea likely impacts patients' activity levels and/or motivation to stay active, and may contribute to worsening functional decline.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older with pulmonary fibrosis, and able to travel to University of California San Francisco for study visits

Exclusion Criteria:

* None
International PMS Study - KOGENATE Bayer

To evaluate long-term safety (primarily by recording adverse events including inhibitors), efficacy and patient acceptance of KOGENATE Bayer in home treatment either on prophylaxis or on demand.

To evaluate both safety and efficacy with respect to lot variability, in particular regarding lot-groups formulated with or without fix between.


Eligibility Criteria:
Inclusion Criteria:

* Patients with severe haemophilia A (\<2% FVIII baseline plasma levels) treated with KOGENATE Bayer as their only source of recombinant FVIII

Exclusion Criteria:

* Exclusion criteria must be read in conjunction with the product information (SmPC)
RA Effect on Cell Surface Molecules in Vivo

This study will follow a group of healthy male participants for about 18 weeks to see the effect of taking Acitretin on their immune cells

Retinoids have been shown in in vitro and ex vivo models to have the ability to reverse latency reactivating the HIV reservoir and the potential for selective eradication of HIV-harbouring cells. We feel that acitretin shows significant potential as a potential adjuvant to current ART regimens, however, there is a lack of data to demonstrate that treatment with acitretin at normal are able to induce molecular and transcription changes consistent with the above activities. In order to provide a scientific basis for retinoid therapy in HIV infection, a Phase I trial of acitretin in human subjects is proposed.

Eligibility Criteria:
Inclusion Criteria:

1. Male gender
2. Age 18 - 65
3. Able to provide informed consent
4. Willingness to participate in study treatment and follow-up
5. Willingness for serial phlebotomy and storage and future viro-immunological assays

Exclusion Criteria:

1. Female gender
2. Participants with a known hypersensitivity/allergy to the acitretin.
3. Participants who are actively participating in an experimental therapy study or who have received experimental therapy within the last 1 year.
4. Participants who are a poor medical risk because of other systemic diseases or active uncontrolled infections including HIV, Hepatitis B or C, and tuberculosis
5. Participants with impaired glucose tolerance including prediabetes or diabetes mellitus, dyslipidemia, or liver dysfunction
6. Previous or current history of mood disorder, psychosis, or suicidality
7. Participants currently receiving ongoing treatment with methotrexate, tetracyclines, or other retinoids
Study of Efficacy and Safety of S 95005 (TAS-102) in Patients With Metastatic Colorectal Cancer Who Failed Standard Chemotherapies

The purpose of this study is to evaluate the efficacy of S 95005 in patients with metastatic colorectal cancer (mCRC) who are refractory or intolerant to standard chemotherapies in terms of Progression-Free Survival rate at 2 months in the Russian population.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged ≥18 years of age
* Has definitive histologically or cytologically confirmed adenocarcinoma of the colon or rectum
* Has received at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer (including fluoropyrimidines, irinotecan and oxaliplatin and, if accessible, an anti-VEGF monoclonal antibody and at least one of the anti-EGFR monoclonal antibodies for RAS wild-type patients (if RAS mutation status was evaluated)) and was refractory or intolerant to those chemotherapies
* Has Eastern Cooperative Group (ECOG) performance status of 0 or 1
* Has at least one measurable metastatic lesion(s)
* Has adequate organ function
* Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use a highly effective method of birth control during the study and for 6 months after the discontinuation of study medication

Exclusion Criteria:

* Pregnancy, breastfeeding
* Participation in another interventional study within 4 weeks prior to inclusion; participation in non-interventional registries or epidemiological studies is allowed
* Has previously received S95005 or history of allergic reaction attributed to compounds of similar composition to S95005
* Has a serious illness or medical condition(s) as described in the protocol
* Has had certain other recent treatment e.g. major surgery, field radiation, anticancer therapy, within the specified time frames prior to inclusion
* Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 attributed to any prior therapies.
Study Evaluating MOA-728 in Subjects on Stable Methadone Maintenance

This is a study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MOA-728 in subjects on stable methadone maintenance.


Eligibility Criteria:
Inclusion Criteria:

* History of methadone treatment for at least 1 month before day -1 at a dose of ≥ 30 mg/day, and a positive drug test result for methadone.
* Healthy as determined by the investigator on the basis of screening evaluations.

Exclusion Criteria:

* Allergy to opioids (eg, codeine, morphine, or oxymorphone) or opioid antagonists (eg, naloxone or naltrexone).
* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
Integrative Intervention Strategies for Binge Eating in Patients With Overweight or Obesity

The main goal of the clinical trial is to compare the short- and long-term outcomes of three 12-week interventions among outpatients with overweight/obesity and binge eating (BE):

1. treatment-as-usual for weight loss (TAU);
2. combined TAU and guided self-help for improving eating behaviors (TAU+GSH);
3. combined TAU, GSH, and biofeedback (TAU+GSH+BF). The primary outcomes will be self-reported reduction of days with objective BE episodes (OBEs).

The secondary outcomes will be impulsivity, emotion dysregulation, interoceptive awareness, distress, physiological correlates of arousal (skin conductance and heart rate variability), and inflammatory biomarkers.

The TAU+GSH arm is expected to be comparable to the TAU+GSH+BF arm in reducing the number of days with OBEs but is expected to be significantly less effective in improving secondary outcomes (impulsivity, emotional dysregulation, interoceptive awareness, distress, physiological inflammatory markers). The TAU arm is expected to show significant inferiority regarding the primary and secondary outcomes and cost-effectiveness compared to the TAU+GSH and TAU+GSH+BF conditions.


Eligibility Criteria:
Inclusion Criteria:(1) age 18-65 years; (2) BMI≥25 kg/m2; (3) ability to read and write in Italian; (4) Binge Eating Disorder (BED) or subthreshold BED status.

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Exclusion Criteria: (1) current treatment for BE with a registered psychologist; (2) severe psychiatric disorders; (4) cognitive impairment; (5) pregnancy; (6) severe medical comorbidity.

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Comparison of LASER Therapy and Desensitizing Agents in Dentinal Hypersensitivity

This study evaluates the effectiveness of laser therapy versus desensitizing agents in reducing pain among participants with dentinal hypersensitivity conducted in Saidu College of Dentistry. Pain will be measured at baseline, immediately post-treatment, one week, and three months using the Visual Analog Scale (VAS)

This study examines dentinal hypersensitivity treatment modalities, including laser therapy and desensitizing agents. The study is conducted in compliance with regional ethical guidelines

Eligibility Criteria:
Inclusion Criteria:

* Participants aged 18-50 years with a preoperative VAS score of ≥2 for dentinal hypersensitivity.
* Participants with sensitivity due to gingival recession, cervical abrasion, or enamel erosion.
* Participants with good systemic health.
* Minimum of two hypersensitive teeth present in two different quadrants.

Exclusion Criteria:

* Teeth with caries, defective restorations, or cervical defects \> 2 mm (may affect sensitivity measurements).
* Periodontal surgery or deep periodontal pockets (\> 6 mm) within the past three months (potential influence on periodontal health and sensitivity).
* Participants using desensitizing toothpaste within the past three months (could interfere with study outcomes).
* Presence of gross oral pathology or systemic diseases (e.g., eating disorders, chronic diseases, uncontrolled metabolic conditions) (may alter oral health status).
* Pregnant or lactating women (hormonal changes can influence oral health).
Utility of Real-Time Contrast Enhanced Ultrasound (CEUS) in the Evaluation of Soft Tissue Hematomas

Traumatic and non-traumatic soft tissue hematomas are frequently encountered in the acute care setting. The incidence of these hematomas appears to be on the rise secondary to the increased use of anticoagulants among older patients for a variety of medical conditions.

The management of soft tissue hematomas depends on the accurate diagnosis of any ongoing bleeding as well as of identification of the injured vessel type. While the majority of cases can be managed conservatively, expanding hematomas leading to hemodynamic instability or ongoing blood loss might require embolization or surgical intervention. The mainstay diagnostic imaging modality is multidetector computed tomography (MDCT) with intravenous contrast that allows accurate assessment of hematoma size, location as well as evaluation for active extravasation. However, many patients cannot undergo CT imaging due to underlying kidney disease, allergy to contrast, or due to concerns for radiation exposure, especially in young age. Currently there are no alternative tests for these patients with a similarly high diagnostic accuracy available.

This study intends to establish an imaging protocol and investigate the utility of contrast-enhanced ultrasound (CEUS) in the diagnostic work-up of soft tissue hematoma as an ionizing radiation-free alternative to computed tomography (CT) that can be used independent from the kidney function of the patient.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients over the age of 18 who have a clinical suspicion of an actively bleeding soft-tissue hematoma as determined by the treating emergency provider. Enrollment will be for one year or until a target of 20 patients is enrolled.

Exclusion Criteria:

* The investigators will exclude persons under the age of eighteen, vulnerable populations (pregnant patients and prisoners), need for immediate procedural intervention and those with known hypersensitivity to sulfur hexafluoride lipid containing microspheres as well as those who have a soft-tissue hematomas that are in an unfavorable anatomical location for ultrasound imaging.
Effect of Epidural Anesthesia and Analgesia on Quality of Recovery After Radical Prostatectomy.

Postoperative quality of recovery (QoR) could be related to anesthesia and postoperative analgesia. This study is exploring early QoR after radical prostatectomy in the two groups of anesthesia. The first group had a light general anesthesia with lumbal epidural anesthesia and postoperative epidural analgesia with morphine and ropivacaine. The second group had general anesthesia and a continuous postoperative analgesia with tramadol. The postoperative QoR was evaluated 24 hours after surgery.

All participants were premedicated with diazepam 5 mg 12 hours and 1 hour before surgery. Thromboprophylaxis ( 4,000 - 6000 IU) depending on the body weight was given at least 12 hours before surgery. All participants were warmed to prevent unintended hypothermia. Participants were allocated by permuted block randomisation into one of two groups: general anesthesia group and epidural anesthesia. The randomisation list was obtained from R program version 3.5.3. The group allocations were contained in a closed envelope that were opened before surgery after the completed enrollment procedure. All patients and infusions were wormed to prevent unintended hypothermia. Induction of general anesthesia was with midazolam 2.5 mg, fentanyl 100 μg, propofol 1-2 mg/kg and vecuronium 0.1 mg/kg. Balanced crystalloid fluids were used to treat hypovolemia. Additionally, 6% Hydroxyethyl starch was used before blood transfusion products to treat profound hypovolemia. Blood transfusions were given according to blood loss and clinical situation. Bradycardia was treated with atropine. Hypotension was treated with ephedrine boluses. Anti-inflammatory drug metamizole (dipyrone) 2.5 g was given intravenously before the end of the surgery and after 12 hours after the surgery. Neostigmine 2.5 mg with atropine 1 mg was used for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery. Participants were placed for one day in a urology high care unit provided with constant and vigilant nurse care. Crystalloid infusions were used for maintaining diuresis. Gastroprotection was done with pantoprazole 40 mg. Metoclopramid 10 mg was given for postoperative nausea and vomiting (PONV). The postoperative QoR was evaluated with three QoR scales. Scales for pain, anxiety and PONV were also examined. The 36-Item Short Form Survey (SF-36) questionnaire evaluated quality of life one month before and one month after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Elective radical Prostatectomy.
* American Society of Anesthesiologists (ASA) physical status classification system: I, II, III

Exclusion Criteria:

Dementia

* Delirium
* Acute psychosis
* Emergent surgery
* Hospitalisation in Intensive care unit
* American Society of Anesthesiologists (ASA) physical status classification system: IV
* Reoperations
* Muscular diseases
* Montreal cognitive test \<24 points
* Contraindications for epidural anesthesia