cyrilzakka/clinical-trials huggingface dataset:
BTL-785F Device for Non-invasive Lipolysis and Circumference Reduction of the Abdomen

This study will evaluate the clinical safety and the performance of the BTL-785F system equipped with BTL-785-1 applicator for non-invasive lipolysis (breakdown of fat) of the abdomen and reduction in circumference of the abdomen.

Safety measures will include documentation of adverse events (AE) during and after the procedures.

Follow-ups visits at 1 month and 3 months after the final treatment will be held.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects over 21 years of age seeking treatment for abdominal circumference reduction
* Subjects should be able understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form
* Presence of clearly visible fat deposits in the abdominal area as deemed appropriate by the Investigator (e.g. by pinch test or ultrasound fat thickness measurement)
* Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring and/or weight loss during study participation.
* No procedure for abdominal fat reduction (including cellulite treatment) in the last six months.
* Subjects willing and able to maintain his/her regular (pre-procedure) diet and exercise regimen without effecting a significant change of weight in either direction during study participation.
* Willingness to comply with study instructions and to return to the clinic for required visits.

Exclusion Criteria:

* Bacterial or viral infection, acute inflammations
* Impaired immune system
* Isotretinoin use in the past 12 months
* Skin related autoimmune diseases
* Radiation therapy and/or chemotherapy
* Poor healing and unhealed wounds in the treatment area
* Metal implants
* Permanent implant in the treated area
* Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body
* Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles
* History of any type of cancer
* Active collagen diseases
* Cardiovascular diseases (such as vascular diseases, peripheral arterial disease, thrombophlebitis and thrombosis)
* Pregnancy/nursing or IVF procedure
* History of bleeding coagulopathies, use of anticoagulants
* Any active condition in the treatment area, such as sores, psoriasis, eczema, etc.
* Any surgical procedure in the treatment area within the last three months or before complete healing
* Poorly controlled endocrine disorders, such as diabetes
* Acute neuralgia and neuropathy
* Kidney or liver failure
* Sensitivity disorders in the treatment area
* Varicose veins, pronounced edemas
* Previous liposuction in the treatment area in the last six months
* Unstable weight within the last 6 months (change in weight ± 3%)
* Previous body contouring or cellulite treatments in the abdominal area in the last six months
* Any other disease or condition (e.g. hernia) at the investigator discretion that may pose risk to the patient or compromise the study
Satiety Effects of Beef Compared to Beans

The satiety effects of beef will be compared to beans. Beef is hypothesized to be more satiating than beans.

Subjects will consume 2 different meatloaf lunches and satiety will be measured by visual analogue scales. They will consume an ad lib snack after 3 hours and food intake will be measured.

Eligibility Criteria:
Inclusion Criteria:

healthy, non-smoking, BMI of 18-27, non-dieting, typically consumes breakfast/lunch

Exclusion Criteria:

distaste for beans, vegetarian, current smoker, restrained eating habits, recent weight change, history of significant disease of past medical history, pregnant, lactating irregular menstrual cycle
Sonographic Follow up in Newborns Diagnosed With Prenatal Hydronephrosis

In this retrospective study the investigators will enroll newborns that were born between 01.01.2010 and 31.12.2012 in Hillel Yaffe Medical Center with the prenatal diagnosis of Pyelectasis according to prenatal sonographic screening test.

These babies underwent renal sonography at the age of 2-5 days according to the protocol and were invited to an additional renal sonographic screening test at the age of 1 month.

The investigators will compare the results of the 2 examinations and the investigators will try to reach conclusions whether there is correspondence between the severity of the pyelectasis in the first and second sonographic tests and the outcome of these newborn babies


Eligibility Criteria:
Inclusion Criteria:

* All newborns that were born at Hillel Yaffe Medical Center with prenatal diagnosis of Hydronephrosis between 01.01.2010-31.12.2012

Exclusion Criteria:

* None
Non-Inferiority Trial of Acute HFT Versus nCPAP

Order randomized crossover non-inferiority study evaluating the acute efficacy of High Flow Therapy (HFT) as compared to nasal Continuous Positive Airway Pressure therapy (CPAP) in the management of apnea / hypopnea index (AHI).

Study to evaluate the acute efficacy of a single night of High Flow Therapy (HFT) to treat mild-moderate predominantly obstructive Sleep Disordered Breathing, as compared to nasal Continuous Positive Airway Pressure (CPAP) therapy. Subjects will be order-randomized to receive HFT or CPAP in the laboratory, undergo a washout period, and return for the alternative therapy in the laboratory. The hypothesis is that HFT will be non-inferior to CPAP in controlling Apnea/Hypopnea events in this subject set during this study.

Primary outcome will be Apnea / Hypopnea Index (AHI) change on therapy as compared to baseline diagnostic polysomnography.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Previous diagnosis of primarily obstructive mild-moderate Sleep Disordered Breathing during in-laboratory polysomnography
* Ability to read and understand English Language
* Ability to provide informed consent

Exclusion Criteria:

* Unstable medical illness within the last month (30 days)
* Acute / recent upper airway infection
* Prior use of non-continuous positive airway pressure medical technology therapies prescribed by a physician for the management of obstructive sleep disordered breathing (e.g., Provent®, Winx™, mandibular advancement oral appliances, etc.)
* Prior use or exposure to CPAP / Bi-Level / or other non-invasive ventilatory modalities
* Craniofacial or other anatomical anomalies that may predispose patients to upper airway obstruction, or obvious blockage to nasal air flow
* Patients using opioids or amphetamines will be excluded from the study.
* Enhanced oxygen requirement (i.e., FiO2\>0.21)
* Patients requiring Bi-Level therapy upon CPAP titration attempt
* Surgery since the diagnostic PSG
* Significant recent sedative/hypnotic use likely, in the opinion of the principle investigator, to impair ventilatory control or impact the subsequent titration of either CPAP therapy or Flowrest therapy (including benzodiazepines, antihistamines, imidazopyridines)
* Significant use of stimulant medications likely, in the opinion of the principle investigator, likely to alter ventilatory or upper airway control and impact the subsequent titration of either CPAP therapy or Flowrest therapy (including amphetamines, high dose caffeine, etc.)
* Significant neurologic or cardiac pathology likely to seriously impact respiratory effort or ventilatory control (e.g., post CVA with ventilatory impairment)
* Presence of significant sleep disorders likely to induce hypersomnolence or interfere with the ability to titrate CPAP therapy or Flowrest therapy (including narcolepsy, PLMS/RLS, severe chronic insomnia, non-OSA obesity hypoventilation syndrome, etc.)
* Unsuitable for inclusion in the opinion of the investigators
Evalution of the Effects of PRP and LLLT on Postoperative Complications and Wound Healing After Impacted Third Molar

The aim of the study was to compare the possible effects of platelet-rich plasma (PRP) and low-level laser (BIOLASE) on postoperative complications after extraction of impacted mandibular wisdom teeth. 60 impacted wisdom teeth of 30 healthy individuals who applied to the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, XXX University, with the indication of extraction of impacted mandibular wisdom teeth were included in the study. 60 impacted wisdom teeth of the individuals were randomly divided into two groups (A and B). In a randomized controlled trial, platelet-rich plasma (PRP) was applied to the first group (A) (one side of the same patients) and low-level laser therapy (LLLT) was applied to the second group (B) (the other side of the same patient) immediately after surgery. VAS (Visual analog scale) for pain assessment, facial measurements for edema assessment and maximum mouth opening for trismus assessment were compared with preoperative values.

The aim of the study was to compare the possible effects of platelet rich plasma (PRP) and low level laser (BIOLASE) on postoperative complications after extraction of impacted lower wisdom teeth. Sixty impacted wisdom teeth of 30 healthy individuals who applied to XXX University, Faculty of Dentistry, Department of Oral, Dental and Maxillofacial Surgery with an indication for extraction of impacted lower wisdom teeth were included in the study. The 60 impacted wisdom teeth of the individuals were randomly divided into two groups (A and B). In a randomised, controlled study, the first group (A) (one side of the same patients) received platelet-rich plasma (PRP) and the second group (B) (the other side of the same patient): diode laser Low-level laser therapy (LLLT) were applied immediately to the patient after surgery. VAS (Visual analogue scale) was used for pain assessment and assessments were made at 3rd, 6th, 12th and 24th hours and at 2nd, 3rd, 4th, 5th, 6th and 7th days. For edema assessment, preoperative facial measurements were repeated on the 2nd and 7th postoperative days and recorded. For trismus evaluation, the maximum mouth opening measurement made preoperatively was repeated and recorded on postoperative days 2 and 7.

Eligibility Criteria:
Inclusion criteria;

* Individuals aged 18 and over,
* Patients with partially impacted wisdom teeth,
* Individuals with systemic status ASA0 and ASA1 according to ASA classification,
* Individuals who have not used any medication in the last two weeks,
* Individuals who do not have a lower second molar missing.

Exclusion criteria;

* Individuals with mouth opening less than 25 mm for various reasons,
* Pregnant and breastfeeding individuals,
* Individuals who do not come to postoperative check-ups,
* Individuals who use different medications other than the recommended medication.
Bioavailability of Dexmedetomidine After Intranasal Administration

In a recent study by Yuen et al it was shown that preoperative intranasal administration of dexmedetomidine is a useful alternative for oral midazolam in children. However, there is no information on the pharmacokinetics of dexmedetomidine after intranasal administration.

The aim of this study is to investigate the comparative pharmacokinetics of intranasally and intravenously administered dexmedetomidine in healthy volunteers. The absolute bioavailability of intranasally administered dexmedetomidine will be calculated. In addition, we will report the effects of intranasally and intravenously administered dexmedetomidine on plasma catecholamine levels, systemic blood pressure, heart rate and sedation. We will also monitor the local and systemic safety and tolerability of intranasally administered dexmedetomidine.


Eligibility Criteria:
Inclusion Criteria:

* Fluent skills in the Finnish language in order to be able to give informed consent and communicate with the study personnel.
* Age ≥ 18 years.
* Male gender.
* Weight ≥ 60 kg.
* Written informed consent from the subject.

Exclusion Criteria:

* Previous history of intolerance to the study drug or related compounds and additives.
* Concomitant drug therapy of any kind except paracetamol in the 14 days prior to the study.
* Existing or recent significant disease.
* History of hematological, endocrine, metabolic or gastrointestinal disease.
* History of asthma or any kind of drug allergy.
* Previous or present alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent, or limit the ability of the subject to comply with the protocol requirements.
* Donation of blood within six weeks prior to and during the study.
* Special diet or lifestyle factors which would compromise the conditions of the study or the interpretation of the results.
* BMI \> 30 kg / m2.
* Participation in any other clinical study involving investigational or marketed drug products concomitantly or within one month prior to the entry into this study.
* Smoking during one month before the start of the study or during the study period.
* Clinically significant abnormal findings in physical examination, ECG or laboratory screening \[routine haematology (haemoglobin, haematocrit, red blood cell count, white blood cell count, platelets), renal function tests (creatinine, urea) and liver function tests (bilirubin)\].
Study to Assess the Effect of Pharmacokinetics/Pharmacodynamics (PK/PD) Interaction After co-Administration of Cilostazol With Ginkgo Biloba or Placebo

TO assess the PK/PD effect of co-administerd Cilostazol with Ginkgo biloba or placebo, Phase I study in healthy Volunteers were designed


Eligibility Criteria:
Inclusion Criteria:

* healthy male adult volunteer between 19 and 45 years of age and within 15% of ideal body weight by broca's formula.
* the subjects who doesn't have any congenital or chronic diseases and symptoms or signs of diseases after physical examinations.\]

Exclusion Criteria:

* the subject who has abnornal lab. ( In particular, AST or ALT \> 1.25 times of upper limit / Total bilirubin \> 1.5 times of upper limit/170,000 \< Platelet \< 360,000 / PT or aPTT or BT\> \>upper limit
* the subject who receive any metabolic enzyme inducing or inhibiting drugs like barbiturates or drink excess alcohol within 1 month prior to the study.
Detecting Malposition of Trans-pedicle Screw From AP and LAT Plain Radiographs

Our study focuses on reducing the use of CT (Computer Tomography) for pedicle screw instrumentation, replacing CT with X-ray. We are writing a program to measure the position on X-ray seeing whether the position meets that on CT after operation. In the future,our method can be used in fluoroscopy, helping us detecting screw malposition efficiently during the surgeries, and hoping reduce complications.

Most of the spine surgeries are decompression, fusion, with instrumentation.Instrumentation needs screws. Pedicle screws are often used. If the pedicle screws are mal-located, that is breaking the pedicle wall; the consequence may be injury of the spinal cord, or nerve root. Some lucky patients may have no symptom; however, broken pedicle will reduce the fixation strength which may reduce fusion rate.

Detecting malposition screws, currently we use CT (computer tomography) method. The surgeon carefully read the CT slice by slice, looking for clues of screws malposition. However, CT is costly both price and radiation dose.We invented a plain radiograph method which has been pilot tested in one patient with good correction rate. The purpose of this study is to solve the following two clinical problems:

1. What are the inter-observer and intra-observer reliabilities of CT method?
2. The radiation dose for CT method is too high. Does our plain radiograph method has the same correction rate? Materials and methods We planned to collect about 100 patients received spinal fusion and instrumentation who has preoperative CT(or MRI) and postoperative plain radiographs and CT. We will firstly verify CT method's reproducibility by interobserver and intra-observer reliability test. With the same databank, we will use our plain radiograph method again, and test if the two methods' results are the same by Chi-square test.

Conclusion:

We hope our study can reduce some unnecessary CT examination. In the future,our method can be used in fluoroscopy, helping us detecting screw malposition efficiently during the surgeries, and hoping reduce complications.

Eligibility Criteria:
Inclusion Criteria:

* s/p pedicle screw insertion surgery
* good quality postoperative plain radiograph
* good quality postoperative CT

Exclusion Criteria:

* poor quality postoperative plain radiograph
* poor quality postoperative CT
A Study of Bevacizumab (Avastin) in Neoadjuvant Therapy in Participants With International Federation of Gynecology and Obstetrics (FIGO) Stage IIIC/IV Ovarian, Tubal, or Peritoneal Cancer, Initially Unresectable

This randomized, open-label study will evaluate the efficacy and safety of neoadjuvant bevacizumab in participants with initially unresectable, FIGO stage IIIC/IV ovarian, tubal, or peritoneal cancer. Participants will be randomized to receive 8 cycles of carboplatin plus paclitaxel with or without bevacizumab before surgery (interval debulking surgery \[IDS\]). Surgery will be scheduled 28 days after the last course of neoadjuvant treatment in participants with resectable cancer. Participants with unresectable cancer will go through the follow-up period. All participants will receive bevacizumab for Cycles 6 to 26.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed and documented high-risk FIGO stage IIIC/IV epithelial ovarian carcinoma, fallopian tube carcinoma, or primary peritoneal carcinoma
* Not eligible for primary complete debulking surgery during a laparoscopic procedure as judged by a surgeon experienced in management of ovarian cancer
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
* Life expectancy greater than or equal to (\>/=) 3 months
* Eligible for carboplatin and paclitaxel chemotherapy in accordance with local standards
* Beneficiaries of healthcare coverage under the social security system

Exclusion Criteria:

* Non-epithelial ovarian cancer, ovarian tumor with low malignant potential, mucinous and clear cell ovarian cancer, or carcinosarcoma
* Evidence of abdominal free air not explained by paracentesis or recent surgical procedure
* Previous systemic therapy for ovarian cancer
* Previous exposure to mouse CA-125 antibody
* Current or recent (within 28 days prior to Day 1 of Cycle 1) treatment with another investigational drug or previous participation in this study
* Current or recent (within 10 days prior to first study drug dose) chronic daily treatment with aspirin greater than (\>) 325 milligrams (mg) per day
* Planned intraperitoneal cytotoxic chemotherapy
* Inadequate bone marrow, liver, or renal function
* History of myocardial infarction, unstable angina, stroke, or transient ischemic attack within 6 months prior to Day 1 of Cycle 1
* Uncontrolled hypertension
* Clinically significant (active) cardiovascular disease such as New York Heart Association (NYHA) Class II or greater congestive heart failure, or aortic aneurism
* Pre-existing peripheral neuropathy that is Common Toxicity Criteria (CTC) Grade \>/=2
* Known hypersensitivity to bevacizumab or its excipients, Chinese hamster ovary cell products or other recombinant humanized antibodies, or to any planned chemotherapy
* Pregnant or lactating females
* History of other clinically active malignancy within 5 years of enrollment, except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal-cell or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix or breast
Evaluation of Adjuvant Use in Selective Trunk Block

"Evaluation of the Anesthetic and Analgesic Efficacy of Dexamethasone in Selective Trunk Blocks

the investigators hypothesize that the perineural application of dexamethasone as an adjuvant in selective trunk block for upper extremity surgeries will accelerate the onset time of anesthesia and analgesia, provide significant anesthetic and analgesic effects, and prolong the duration of anesthesia and analgesia.

In recent years, the brachial plexus block, performed with various approaches, has been preferred over general anesthesia for upper extremity orthopedic surgeries due to its numerous advantages. It maintains the patient's consciousness and spontaneous respiration, reduces airway interventions, provides effective postoperative pain control, minimizes opioid-related side effects, limits surgery-related metabolic and endocrine changes, enables early discharge, and reduces treatment costs.

Selective trunk block offers rapid block onset and high success rates. The use of ultrasound in peripheral blocks has also reduced the risk of various complications (e.g., vascular injury). The selective trunk approach, as described by Manoj Kumar Karmakar in 2020, involves blocking the upper, middle, and lower trunks at the C7 transverse process level, resulting in sensory/motor block in all ipsilateral upper extremity dermatomes except T2. This study aims to compare the anesthetic and analgesic efficacy of dexamethasone as an adjuvant to bupivacaine in the selective trunk block approach.

Dexamethasone is a widely used glucocorticoid with anti-inflammatory, anti-toxic, and other effects. It has strong lipophilic properties, is soluble in fat, increases pH, facilitates the penetration of local anesthetics into nerve sheaths, and extends the duration of local anesthetic effects, as supported by various studies. Additionally, dexamethasone is commonly used in pain management for its neuromodulatory effects.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing upper extremity surgery with ASA (American Society of Anesthesiologists) classification I-II
* aged 18-65 years, and with a body mass index (BMI) between 18-35 kg/m² were included in the study.

Exclusion criteria:

* included ASA III-IV patients
* those who refuse the block
* pregnant and breastfeeding women
* individuals with severe lung disease
* contralateral diaphragm paralysis
* nerve injury secondary to trauma
* neuromuscular diseases,
* peripheral neuropathy
* bleeding diathesis
* history of anticoagulant use
* allergies to local anesthetics or dexamethasone
* uncontrolled diabetes mellitus
* morbid obesity with BMI \>35 kg/m²
* severe cardiovascular, renal, or liver disease, and infections at the site where the nerve block is to be applied.