cyrilzakka/clinical-trials huggingface dataset:
Single Incision Laparoscopic Surgery vs Flexible Single Incision Surgery for Cholecystectomy

Prospective randomized pilot clinical trial, with 3 arms and one year follow up. The study will include 60 patients, with a 1:1:1 ratio, 20 patients per group. In 40 patients a transumbilical single site incision will be performed with two different manners: single-port device SILS TM (Single Incision Laparoscopic Surgery), and flexible endoscope and accessory trocars in a single incision (FSIS-Flexible Single Incision Surgery). The third group is the control one, a conventional laparoscopic approach.

The trial is designed as a pilot study to assess, as main objective, if these two endoscopic approaches have the same security and effectiveness in cholecystectomy.

Hypothesis:

Transumbilical approaches with single port and single incision with the flexible endoscope have the same efficacy and safety performing the endoscopic cholecystectomy.

Objectives:

Main objective:

Assess whether both approaches are equally safe in its application to endoscopic cholecystectomy.

Secondary objectives:

Investigate the differences in the rate of conversion to open surgery between different surgical approaches.

Investigate the differences in the rate of wound infection between the different surgical approaches.

Investigate the differences in the rate of postoperative incisional hernias between different surgical approaches.

Investigate whether there are differences in the rate of overall complications, all-cause mortality and the cost between different surgical approaches.

Inclusion criteria:

* Patients affected with symptomatic cholelithiasis with elective surgical indication, not urgent, aged between 18 and 65.
* Signing of informed consent for cholecystectomy and specific consent for the trial.
* Anesthetic risk ASA I-II.

Exclusion criteria:

* Presence of acute cholecystitis and / or suspicion of occupation of the main bile duct.
* ASA III and higher.

Eligibility Criteria:
Inclusion Criteria:

* age over 18 and under 65
* symptomatic cholelithiasis with an indication for laparoscopic surgery
* signed specific informed consent including specific information of the new surgical approach
* ASA 1 and 2.

Exclusion Criteria:

* current or previous cholecystitis
* current or previous suspected bile duct's problems
* previous abdominal surgery
* umbilical and other abdominal hernias
* some other condition with increased risk to infection or abdominal wall problems.
* ASA 3 and more
Effect of Preoperative Oral Pregabalin Versus Intraoperative Fentanyl on Postoperative Analgesia

Pregabalin is a structural analogue of gamma amino butyric acid (GABA). It binds to presynaptic alpha-2-delta subunit of voltage gated calcium channels in the brain and the spinal cord. Thus, it modulates the release of excitatory neurotransmitters, such as glutamate, norepinephrine, substance-P, and calcitonin gene related peptide. Also, it causes inhibitory modulation of overexcited neurons and restores them to a normal state.

Pre-emptive analgesia aims to reduce postoperative opioid consumption especially in ambulatory surgeries. Pregabalin (PGB) is an emerging drug in this field. Different doses of preoperative oral pregabalin (75, 150 and 300 mg) are described in the literature with a dose-response analgesic relationship and reduction of opioid use; however increasing the dose results in increasing the incidence of side effects mainly sedation and dizziness.

Perioperative use of opioids for analgesia may result in side effects; like nausea, vomiting, excessive sedation, respiratory depression, pruritus, and urinary retention.The concomitant use of opioids with pregabalin may result in excess sedation and somnolence, so, the use of opioids with pregabalin should be limited to patients with inadequate alternative options.

Our study aims to compare the postoperative analgesic effect of pre-operative oral pregabalin (Study group), to the intraoperative intravenous fentanyl (Control group) in diagnostic laparoscopic gynecologic surgery.

Patienrs will be selected by simple randomization by computer generated system. Pregabalin 150 mg oral capsule and a placebo capsule will be available on the morning of operation.

Also, 2 syringes of 10 ml volumes will be prepared; the first contains normal saline and the second contains the fentanyl dose of 1 µg /kg calculated according to the patient's body weight and diluted to a 10 ml volume.

Patients will then be divided into 2 equal groups of 40 patients each:

Group P: Patients will receive oral pregabalin capsule (150 mg) 90 min before induction of anesthesia, and will receive a bolus injection of 10 ml saline at induction of anesthesia.

Group F: Patients will receive oral placebo capsule identical to the trial drug in size, shape and color, 90 min before induction of anesthesia and will receive a bolus injection of 10 ml of 1µg /kg fentanyl at induction of anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I

Exclusion Criteria:

* Patients' refusal
* use of sedatives, hypnotics, anti-psychotic or antidepressant drugs
* history of drug/alcohol abuse
* history of chronic pain
* daily intake of analgesics
* history of epilepsy
Abuse Liability of Controlled-Release Oxycodone Formulations

The objective of this study is to examine the abuse liability of a single 40mg dose of 2 controlled release oxycodone formulations (Apo-Oxycodone CR® and OxyNEO®) in non-dependent recreational opioid users by assessing the self-reported acute effects of the drugs and taking blood samples to measure drug concentrations. The investigators think there may be differences in how well these drugs are liked when swallowed whole due to differences in how the products are formulated.

This is a single-center, single-dose, double-blind, placebo-controlled, randomized, crossover, abuse liability study conducted in healthy subjects who are non-dependent recreational opioid users. The study consists of 3 study days during which each subject will take one tablet of either 40mg OxyNEO®, 40mg Apo-Oxycodone CR®, or placebo. The participants will be assessed for both pharmacokinetic and pharmacodynamic outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects 18 to 50 years of age
* Willing and capable to give written informed consent
* Subjects must have used opioids recreationally to achieve a "high" on at least five occasions in the 12 months before screening and at least once in the 90 days before screening according to self-report
* Females of childbearing potential have to use a medically acceptable form of birth control and have a negative pregnancy test
* Pass medical assessment, which includes physical examination, assessment of medical history, vital signs, blood work, and urine toxicology screen
* Willing to abstain from alcohol 12 hours before and during the study days

Exclusion Criteria:

* Current or past Axis I psychiatric illness (including current drug dependence or past opioid dependence, except nicotine dependence)
* Current hepatic disease or renal failure
* Pregnancy or lactation in women
* Current medication that is known to interact with opioids
* Known contraindications or hypersensitivity to opioids
* Current opioid therapy
* Chronic pain disorder requiring regular medication
Home Pregnancy Test Evaluation Study

This study will evaluate consumer preference and consumer results from a number of commercially available home pregnancy tests.

The study is being conducted as a formal assessment home pregnancy tests sold in Western Europe.

The study will be conducted in two parts:

Part 1: Volunteers representative of pregnancy test users will use a range (4 of 7 different tests being evaluated) in their own home to gain usability data. All products will be used according to their instructions for use which, where required, will be translated into English prior to the study start. A study questionnaire will be completed after each test is used.

Part 2: The volunteers will attend the study site soon after completing their last home test and be required to read randomised results of tests conducted by study technicians (pregnant and not pregnant) to gain an understanding of their ability to correctly read results of the tests. The technician will also read and record the test results to enable both the laboratory agreement (technician read) and the consumer readability to be determined and compared for each product.

Each volunteer will be required to provide a urine sample for determining pregnancy status and quantitative urinary hormone measurement (this is done to confirm the result obtained at home using the HPTs).

At the end of the testing period the volunteers will also be asked to rank the four products they have used in the study, based on a series of statements regarding usability and readability of the tests

Eligibility Criteria:
Inclusion Criteria:

* Female
* Aged 18-45 years
* Willing to give informed consent
* Willing to conduct a personal home pregnancy test and reveal their pregnancy status

Exclusion Criteria:

* Currently or previously employed by SPD, Alere, Unipath, P\&G, Abbott, or affiliates
* Has an immediate relative\* currently or previously employed by SPD, Alere, Unipath, P\&G, Abbott or affiliates
* Taken a hormonal preparation containing hCG in the last month, e.g. Pregnyl®
* Recently miscarried and yet to have 2 complete menstrual cycles before study start
The Marker Expression of Corneal Surface From Penetrating Keratopathy After Collagenase A Assisted COMET Case Series

In order to examine the cells of the corneal epithelium in the patients who receive corneal transplantation after collagenase A assisted cultivated oral mucosa epithelium transplant (CA-COMET), we analyzed the specimens from penetrating keratoplasty with immunochemical staining.

Limbal insufficiency may cause persistent corneal erosion, turbidity, and even infection and blindness, leading to major eye damage. In patients with limbal stem cell insufficiency, due to the defect of the limbal stem cells, the new epidermal cells cannot be produced, and without the limbus as a barrier, the cells near the conjunctiva will move toward the center of the cornea, result in replacing the corneal cells and causing corneal conjunctivalization.

In recent years, many surgical methods for treating corneal stem cell defects include amniotic membrane transplantation, autologous limbal cell transplantation, and allogeneic limbal cell transplantation. However, in patients with bilateral total limbal insufficiency, there are no autologous limbal cells in the contralateral eye, and allografts may also have rejection and infection.

Cultured oral mucosa epithelium transplant is a method for treating bilateral full-limbal cell defects. The patient's own oral mucosal cells are cultured in the laboratory, and the cultured epithelium is transplanted to the patient's limbus. In the experiment, mouse cells are used as a feeder cell and transplanted to the human body, which is prone to potential problems such as rejection or infection. In order to resolve these problems, our laboratory modified the process of separating the limbal stem cells. By replacing the dispase II/trypsin-EDTA with Collagenase A, there were no needs to use a feeder cell. This experiment has been successfully completed under the national plan.

In this study, we want to investigate the cells on the ocular surface form the four patients who underwent corneal transplantation after receiving CA-COMET.

Dr.Kuan-Ting Kuo, a pathologist in NTUH, will assist us in the staining of the specimens of the cornea from four patients who underwent corneal transplantation after receiving CA-COMET. The specimens of the four patients will be stained (Immunohistochemistry) with markers of the cornea and conjunctival cells (K3, K4, K12, K13, K19, MUC5, P63).

Eligibility Criteria:
Inclusion Criteria:

* The patients who underwent corneal transplantation after receiving CA-COMET in five years.

Exclusion Criteria:

* The patients who NEVER underwent corneal transplantation after receiving CA-COMET.
An Investigational Study to Assess the Effect of BMS-986177 on Aspirin in Healthy Participants

The purpose of this study is to investigate the effect of taking multiple doses of BMS-986177 when aspirin is taken once-daily. Eligible participants will receive twice-daily doses of BMS-986177 or placebo, with a once-daily dose of aspirin. The safety, tolerability and movement of BMS-986177 into, through and out of the body (pharmacokinetics/PK) will be assessed, as will the effect of BMS-986177 on the PK of aspirin.


Eligibility Criteria:
Inclusion Criteria:

* Signed written consent form.
* Healthy male and female participants (not of childbearing potential), determined by no clinically significant deviation from normal in medical history, physical examination, ECGs (electrocardiograms) and clinical laboratory determinations.
* Women participants must have documented proof they are not of childbearing potential.
* Males sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for duration of treatment with BMS-986177, and for a total of 93 days after the last dose of BMS-986177; and must be willing to refrain from sperm donation during this time. Azoospermic males are exempt from contraceptive requirements.
* Normal renal function at screening (Glomerula Filtration Rate ≥ 80 mL/min/1.73 m2.
* Body Mass Index (BMI) of 18.0 kg/m2 to 32.0 kg/m2 inclusive.

Exclusion Criteria:

* Women who are of childbearing potential or breastfeeding.
* Any significant acute or chronic illness.
* History of gastroesophageal reflux disease, dyspepsia, protracted nausea or chronic diarrhea.
* History of upper gastrointestinal ulcer disease within 6 months or current symptomatic or recent gastrointestinal disease that could impact absorption of study treatment.
* Abnormal renal profile and/or hematuria (if male) within 3 months of study start.
* History or evidence of abnormal bleeding and/or coagulation disorder and/or evidence of coagulopathy, prolonged or unexplained clinically significant bleeding, or frequent unexplained bruising or thrombus formation, or a history of spontaneous bleeding.
* Any major surgery within 4 weeks of study treatment administration or planned within 2 weeks after completion of the study.
* Donation of blood to a blood bank or in a clinical study (except screening or follow-up visit) within 4 weeks of study treatment administration (within 2 weeks for plasma only).
* Blood transfusion within 3 months of study treatment administration.
* Use of tobacco- or nicotine-containing products (including, but not limited to cigarettes, pipes, cigars, e-cigarettes, chewing tobacco, nicotine patches, nicotine lozenges or nicotine gum) within 6 months prior to study treatment administration.
* History of allergy to aspirin or related compounds.

Other protocol-defined inclusion/exclusion criteria could apply.
Toddler Milk Intervention Trial

To assess growth of children (enrolled between 11.5 and 13.5 months) fed with two iso-energetic, young-child formulas with different protein content during the second year of life

This study is designed to investigate in a randomized double-blind parallel-group trial the growth and metabolic effects of different contributions of protein to total energy intakes in healthy children during the second year of life

Eligibility Criteria:
Inclusion Criteria:

* Having obtained his/her parents' (or his/her legally accepted representative \[LAR's\] written informed consent and having evidence of personally signed and dated informed consent document indicating that the child's parents/LAR have been informed of all pertinent aspects of the study
* Child was born full term (≥ 37 weeks of gestation)
* Age at enrollment: between 11.5 months and 13.5 months of age
* 2.5 kg ≤ birth weight ≤ 4.5 kg
* Born from a singleton pregnancy
* Child's parent(s)/LAR is of legal age of consent, has sufficient local language skills to complete the informed consent and other study documents, is able to be contacted directly by telephone throughout the study, and is willing and able to fulfill the requirements of the study protocol.

Exclusion Criteria:

* Diagnosed disorder considered to interfere with nutrition or growth (e.g. malabsorptive disorders as short bowel syndrome, inflammatory bowel disease; neurological and congenital disorders that may delay growth as cerebral palsy, agenesis of the corpus callosum, spina bifida, Down Syndrome, Cri Du Chat; disorders that may lead to obesity: Prader willi syndrome, Angelman syndrome, etc.)
* Cows' milk allergy
* Lactose intolerance
* Participation in any other interventional clinical trial during the 4 weeks prior to enrollment
* Infant who is being breastfed at the time of enrollment
* Infant who does not usually drink 300ml of cow's and/or formula milk per day
* Institutionalized children
* Child or child's family who in the Investigator's judgment cannot be expected to comply with the protocol or study procedures
Open-Label Long-Term Safety and Efficacy Study of Fixed Dose Combination of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Subjects With Moderate to Severe Essential Hypertension

This study examines the long term safety and efficacy of the Fixed Dose combination BAY98-7106 (nifedipine plus candesartan primarily at the highest dose in development) in patients with moderate to severe hypertension.

Patients meeting the entry criteria, will receive the Fixed Dose combination for 28 weeks, including 8 weeks with stepwise dose increase up to the high target dose. The first 200 subjects completing 28 weeks will continue treatment for additional 24 weeks (52 weeks in total).

Subjects who do not tolerate an increased dose will be treated at their highest tolerable dose.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have moderate to severe essential hypertension (Grade 2 or Grade 3, WHO classifications). At Visit 1, subjects not treated with antihypertensive medications are to have MSSBP of \>/= 160 mmHg and \< 200 mmHg, as measured by a calibrated electronic BP measuring device. For other subjects who are treated with antihypertensive medication before, they should have MSSBP \>/= 160 mmHg and \<200 mmHg after wash out.
* Women of childbearing potential and men must agree to use adequate contraception other than hormonal contraceptives when sexually active

Exclusion Criteria:

* Mean seated systolic blood pressure \>/= 200 mmHg and/or mean seated diastolic blood pressure \>/= 120 mm/Hg
* Mean seated diastolic blood pressure \< 60 mm/Hg
* Differences greater than 20 mmHg for systolic blood pressure and 10 mmHg for diastolic blood pressure are present on 3 consecutive blood pressure readings at visit 0
* Any history of hypertensive emergency
* Evidence of secondary hypertension such as coarctation of the aorta, pheochromocytoma, hyperaldosteronism, etc.
* Cerebrovascular ischemic event (stroke, transient ischemic attack \[TIA\])within the previous 12 months
* History of intracerebral hemorrhage or subarachnoid hemorrhage
* History of hypertensive retinopathy - known Keith-Wagener Grade III or IV
* Any history of heart failure, New York Heart Association (NYHA) classification III or IV
* Severe coronary heart disease as manifest by a history of myocardial infarction or unstable angina in the last 6 months prior to visit 0
* Type 1 diabetes mellitus (DM) or poorly controlled Type 2 DM as evidenced by HbA1C of greater than 9% on visit 0.
* Hyperkalemia: potassium above the upper limit of normal in the laboratory range
A RCT of Ultrasound Guided IUD Insertion

To determine the utility of ultrasound guided IUD insertion compared to the traditional blind insertion at an academic health institute where the skill level of the provider can vary greatly. We hypothesize that ultrasound-guided insertion will lead lower IUD discontinuation rates and greater patient satisfaction.

(Visit 1) All interested women undergoing a scheduled IUD insertion will be screened for inclusion/exclusion criteria by the study coordinator or investigator prior to their clinic visit.

(Visit 2) After meeting eligibility criteria and being consented for the study, a subject will be ready to be randomized. Subject in both groups will fill out a visual analogue score (VAS) before and after the procedure grading their pain. Subjects will be instructed to call the investigator if they experience any abnormal uterine bleeding or problems with their IUD.

Subjects will then be randomized to one of two groups:

Group A: traditional blind IUD insertion. Group B: transabdominal ultrasound guided IUD insertion. Subjects will be randomized to either US guided or traditional placement of IUD using 1:1 allocation. The randomization scheme for this study will use variable-size, random permuted blocks where the variable block sizes are 2,4 and 6.

(Visit 3) Subjects will be scheduled to return to REI clinic 4-6 weeks (Visit 2) after insertion of the IUD as routine follow-up. Subjects will be asked about any adverse events. A routine string check in the form of a speculum exam will be performed in addition to a transvaginal ultrasound to confirm positioning of the IUD. If malposition is determined, then routine care will be to remove the IUD. The ultrasound operator will be blinded to the subject's arm in the study

(Visit 4) At 6 months subjects will be scheduled to return to REI clinic to have an IUD string check and if no strings are visualized then this will be categorized as malposition and the investigator will continue with routine care and work up Subjects who return to clinic for Visit 4 will also have a transvaginal ultrasound performed.

If the subject does not present for a clinic follow up, then she will be contacted by the Study Coordinator or investigator via phone to see if they still have their IUD in place (and when it was removed or lost).

All subjects will be surveyed for pain with the VAS and any adverse events (including abnormal uterine bleeding) will be recorded. All subjects will be asked to categorically rate their satisfaction with the IUD on a Likert Scale.

The total duration of the study is 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing IUD Insertion in an Office Setting
* Fluent in Spoken and Written English
* Premenopausal

Exclusion Criteria:

* Less than 6 Weeks Postpartum at Time of IUD Insertion
* Intraoperative IUD Insertion
* Pregnant
* Prisoners
* Cognitive Impairment
* Unable to Read or Write
Change of Gut Microbiome in the Treatment of Graves' Disease

Graves' disease is the main cause of hyperthyroidism. Graves' disease has a prevalence of 0.5% in the general population. As a non-surgical treatment, antithyroid drug (ATD) and radioactive iodine treatment have been proposed and ATD is the first-line treatment in Korea. However, ATD has a rare but fatal side effect of agranulocytosis. Furthermore only half of its users maintain long-term remission and frequent recurrence is a problem to this disease. Therefore it is essential to distinguish between patients who respond well to ATD and those who resist it. The aim of this study is to verify the changes in gut microbiome in Graves' disease patients before and after six-month treatment with ATD. Patients first diagnosed with Graves' disease will participate in the study. The study design is a prospective longitudinal trial. The patients are asked to have their gut microbiome analyzed before and after the treatment of Graves' disease with ATD. Primary endpoint is the changes of analyzed gut microbiome before and after ATD treatment. Secondary outcome is to find species that can be used as a biomarker to differentiate the patients refractory to ATD.


Eligibility Criteria:
Inclusion Criteria:

* More than 19 years and lesser than 70 years
* First diagnosed as Graves' disease and planned to have antithyroid drug

Exclusion Criteria:

* Pregnancy and lactating women
* Inflammatory bowel disease
* Active malignancy
* Autoimmune disease
* Immune-deficiency patients