cyrilzakka/clinical-trials huggingface dataset:
A Study Evaluating Efficacy and Safety of CRO-SBT in the Treatment of Gonorrhea

This is a phaseIV, multicenter, open-label，single arm study which will be performed to evaluate efficacy and safety of Ceftriaxone sodium and Sulbactam Sodium for injection for the treatment of uncomplicated urogenital infection caused by Neisseria gonorrhoeae in adolescent and adult subjects.

In this study, adults will be administered as one 3g IV dose at the study site,Children under 12 will be administered as one 75mg/kg IV dose . Approximately 100 subjects will be recruited to receive study treatment. The duration of the study will be approximately 14 days.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be \>=6 or ≦80 years of age at the time of signing the informed consent,both gender
* Subjects having clinical suspicion of a urogenital gonococcal infection with or without gonococcal infection according to the laboratory test results of symptoms, physical symptoms, gonococcus smear, culture, etc.
* Subjects having clinical suspicion of a gonococcal infection must have both of the following risk factors:once used three generations of cephalosporin invalid, and sensitive to this product (including gonorrhea urethritis, cervicitis, proctitis, pharyngitis).
* Male and female subject must agree to use contraception (male condoms) during intercourse from the Baseline Visit through completion of the TOC Visit.

Exclusion Criteria:

* Subject has a history of sensitivity to the study treatments, or components thereof, or a history of a drug (including erythromycin and any macrolide or ketolide drug) or other allergy that, in the opinion of the investigator or medical monitor, contraindicates his or her participation
* Subject has received any cephalosporinl therapy for the treatment of a gonococcal infection
* Pregnant or lactating women, or women Subject of childbearing age who were unwilling or unable to use acceptable methods of contraception throughout the study period.
* Famale subject who were positive for pregnancy tests at the time of inclusion or before the start of study drug use.
* Subject has risk of potentially serious drug interactions
* Subject has major diseases such as cardiovascular disease, hepatorenal disease and mental disease, or other factors, the researcher should not participate in the study according to comprehensive judgment
* Subject has a known history of alcohol or drug abuse
* Subject has a known any complicated or systemic gonorrhea infection, such as pelvic inflammatory disease, arthritis, endocarditis
To Demonstrate the Relative Bioavailability of Clarithromycin 250 mg Tablets Under Non-Fasting Conditions

To demonstrate the relative bioavailability of Cilostazol 50 mg tablets under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Results Of Patient Rated Asthma Control Test In Comparison To Diary Card Data

The majority of asthma patients are not well controlled, despite the availability of asthma medication that could effectively treat the disease. In this study uncontrolled patients who are steroid-naive or on low dose inhaled corticosteroids will be treated with Seretide (salmeterol/fluticasone combination, SFC) 50/250 µg twice daily. The asthma control test (ACT) will be used to detect differences in the level of asthma control during treatment. The study aims to show a correlation between improvements of ACT und the level of asthma control which will be reached by the patients.

The aim of the study is to show that most of symptomatic asthma patients can reach 'well controlled asthma' with SFC. We get information about ACT in daily practice and physicians are trained to use the asthma control test as a screening tool and for follow up of asthma management. Correlations are expected between the improvements in ACT, Quality of Life and asthma control according to the Gaining Optimal Asthma controL (GOAL) criteria.


Eligibility Criteria:
Inclusion criteria:

* Diagnosis of asthma
* Reversibility \>12% after inhalation of 200 µg Salbutamol
* willingness and ability to complete daily record card on daily basis and to measure morning PEF on daily basis
* 80% compliance in diary card completion asthma control status: Uncontrolled based on the GOAL criteria

Exclusion criteria:

* Change of asthma medication during the last 4 weeks
* Asthma exacerbation characterized by use of oral corticoids during the last 3 months Pretreatment with inhaled corticosteroids more than 500 mcg Beclometasondipropionat or equivalent per day or other controller therapy during the last 3 months
* upper or lower respiratory tract infection during the RUN-IN period moderate or severe asthma exacerbation during the RUN-IN period
* Non compliance with use of Discus, PEF-meter and incomplete diary card data
The Effect of Calcium on Postprandial Lipid Profile and Appetite

The purpose of this study is to investigate the effect of calcium on postprandial lipid profile and appetite.

Several reports have found inverse associations between calcium intake and body weight. Intervention studies have shown that a high calcium diet resulted in a greater body weight loss than a low calcium diet. In addition, it seems that calcium from dairy products have a more profound effect than calcium from supplements. The mechanism of this additional dairy effect is not yet clear, but one possible explanation could be reduced absorption of fat in the gut. The increase in fecal fat excretion on a high calcium diet could be due to the formation of calcium-fatty acid soaps in the gut.

The long term effect of a high calcium intake have been under intense investigation, but as far as we know the acute effect of a high calcium intake have not yet been examined. A study concerning the acute effects could help us understand the effect of calcium on the absorption of fat. After a meal triglyceride (TG) is packaged with cholesterol, lipoproteins and other lipids into particles called chylomicrons. Earlier studies have shown that the fatty acid pattern of chylomicron lipids postprandial was very similar to that of the ingested fat. If we assume that calcium inhibits the absorption of fat, we would expect a reduced total plasma triglyceride concentration after a calcium-rich meal.

Appetite involves many different sensations among which hunger and satiety are the most investigated. Several different hormones are involved in the regulation of appetite. Some of these hormones are known to respond to the intake or absorption of fat. If the absorption of fat is inhibited the regulation of appetite most likely will be affected. In the long term this could be important because an increased appetite probably would increase energy intake and thereby reducing the weight loss we otherwise might have accomplished by the reduced absorption of fat.

Eligibility Criteria:
Inclusion Criteria:

* healthy meals
* BMI 24-31 kg/m2
* age between 18-50 years
* hemoglobin \>8 mmol/L

Exclusion Criteria:

* donation of blood 6 months before and under the study
* milk allergy, diabetes, hypertension, hyperlipidemia, cronic infectious disease
* use of dietary supplements 3 months before and under the study
* smoking
* elite athletes
* use of medication
Intravenous Interferon During Liver Transplant

The main goal of this study is to prevent liver allograft infection with Hepatitis C virus in hepatitis C positive patients undergoing liver transplantation. The hypothesis is that patients who receive ribavirin immediately before transplant and intravenous interferon alfa 2b during the anhepatic phase(while the liver is removed)will have sustained virologic response post liver transplant.

The study is evaluating intravenous interferon given during the anhepatic phase of lvier transplant. Ribavirin was given as well. Serial measurements for HCV RNA were determined 12, 24 72, 96 hrs and 4 weeks after liver transplant.

Eligibility Criteria:
Inclusion Criteria:

* liver transplant for hepatitis c

Exclusion Criteria:

* allergy to interferon
Effect of Superficial Neuromuscular Stimulation in Post-stroke Dysphagic Patients.

Swallowing disorder in stroke patients is a significant cause of morbidity and mortality as it can cause aspiration pneumonia. Electrical stimulation has proven to be effective in post-stroke dysphagic patients.10 patients who have symptoms of post-stroke dysphagia, meet the inclusion criteria and volunteer to participate will be included in the study. Included patients will be randomized into 2 groups. The exercise program will be applied to both groups as a home program for 4 weeks.

A randomized, prospective, controlled study will include 10 patients with post-stroke dysphagia. Groups will be randomized into 2 groups.

1. st group; One electrode will be connected to the suprahyoid region and the other electrode will be connected between the thyroid and hyoid cartilages. Superficial neuromuscular stimulation will be applied by the physiotherapist at 80 Hz, 0-25 µA (microampere) current range for 20 minutes, for 5 days for the patient, for a total of 4 weeks. At the same time, each patient will be taught the exercises included in traditional swallowing treatment and will be advised to practice them for 30 minutes every day.
2. nd group; Exercises such as progressively resistant oral-facial, lingual, laryngeal exercises, tongue strengthening exercises, effortful swallowing maneuver, thermal/tactile stimulation to oropharyngeal muscles, Masako maneuver, Mendelson maneuver, Shaker maneuver, which are included in traditional swallowing treatment, will be taught and practiced for 30 minutes will be recommended for one month.

Patients' dysphagia scales, quality of life survey and ultrasonography measurements will be performed before and after treatment.

Tests to be applied

* Functional Oral Intake Scale (FOAS)
* Swallowing Function Screening Test (EAT-10)
* GUSS (Gagging Swallowing Screening Test)
* Modified Mann Swallowing Ability Assessment Test (MMASA)
* SWAL-QOL (The impact of swallowing disorders on quality of life questionnaire),
* Measurements made by ultrasonography (measurement of tongue thickness, measurement of hyoid-larynx distance and measurements of other anatomical structures)

Clinic Responsible for Research: Physical Therapy and Rehabilitation Clinic of Kayseri City Hospital

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients over 40 years of age with post-stroke dysphagia
* Patients with Functional Oral Intake Scale (FOAS) 1-6

Exclusion Criteria:

* Patients younger than 40 years old
* Dementia, impaired consciousness or hypoesthetic /anesthetic patients
* Patients with low body mass
* Patients with pacemakers and severe heart disease
* Severe hypertension and hypotension
* Thrombosis or thrombophlebitis
* Pregnancy
* Epilepsy
A Quality Improvement Project to Assess and Refine the Handover Process at Morning Trauma Meetings

This project was intended to observe the handover of trauma and orthopaedic patients at a district general hospital in the UK. Following the implementation of a standard operating protocol, the handover of patient information improved including neck of femur fracture patients significantly. The study can therefore be utilised by other similarly structured departments to improve the handover process, thereby improving patient safety.

Poor handover and inadequate transmission of clinical information between shifts can result in patient harm. This study was designed to evaluate the impact of implementing a handover protocol on the quality of information exchanged in the trauma handover meetings in a UK hospital.

A prospective single centre observational study was performed at an acute NHS trust, using the Plan-Do-Study-Act (PDSA) methodology. Ten consecutive weekday trauma meetings, involving 43 patients, were observed to identify poor practices in handover. This data was used in conjunction with the Royal College of Surgeon's recommendations for effective handover (2007) to create a standard operating protocol (SOP). Following the implementation of the SOP, a further 8 consecutive weekday trauma meetings, involving a further 47 patients, were observed. The data collection was performed by 5 trained independent observers. The data was analysed using t test for quantitative variables and chi-square or Fisher's exact tests for categorical variables.

Eligibility Criteria:
Inclusion Criteria:

* All patients that were handed over were included in the study.

Exclusion Criteria:

* Nil.
Usefulness of Endocuff in the Adenoma Detection Rate. Comparative Study

Colorectal cancer (CRC) is one of the leading causes of cancer death worldwide. The cumulative risk of developing CRC is about 6% lifelong.

The benefit of screening colonoscopy depends on the detection and removal of all adenomas, however, some of these may be difficult to detect.

The "endocuff" (EC) is a polymer sleeve which joins the tip of the colonoscope to improve the image viewing of the mucosa during colonoscopy procedure.

There is insufficient evidence of the usefulness of endocuf

All patients requiring colonoscopy for screening and who agree to participate in the study will be included and randomized them to make an standard colonoscopy or colonoscopy with endocuff, for randomization system will be used in balanced blocks of 4, created on the page randomization.com.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult patients,
* Aged 18,
* Who would come to colonoscopy for colon cancer screening without prior colonoscopy studies

Exclusion Criteria:

* Boston colonic preparation \<5 points
* Suspected Lynch syndrome or familial adenomatous polyposis (FAP)
A Study to Learn About Somatrogon in Patients With Pediatric Growth Hormone Deficiency (p GHD) in India.

The purpose of this study is to learn about the safety of Somatrogon for the treatment of pediatric growth hormone deficiency (p GHD) in India.

Pediatric GHD is a condition caused by too less amounts of growth hormone in the body. Children with GHD have a short height. GHD can be present at birth or develop later. The condition occurs if the pituitary gland makes too little growth hormone. This is a small gland at the bottom of the brain that releases hormones that affect growth and other body functions.

This study is seeking for participants who are:

* confirmed with p GHD.
* given Somatrogon to be taken as an injection.

The safety of Somatrogon injection will be checked based on side effects. These side effects can happen within 3 years after taking Somatrogon. A side effect is something (expected or unexpected) that you feel was caused by a medicine or treatment you take. The study doctor will collect side effect information and put the information on patient's case form.

Follow-up of the patient's will be performed via clinic re-visit or over a call. It is not a rule for the participants to visit the clinic in this study.

This study will help to see if Somatrogon is safe.


Eligibility Criteria:
Inclusion Criteria:

* Prescription of Somatrogon for p GHD in participants aged 3 years or more.
* Evidence of a personally signed and dated informed consent document indicating that the participant (or a legally acceptable representative) has been informed and agree to all pertinent aspects of the study. Assent will also be sought from children of applicable age in line with national guidance. In all cases, the treating physician responsible for enrolling the participant into the study will assess the appropriateness of gaining assent from a participant (or a legally acceptable representative) at their discretion during routine clinical care.

Exclusion Criteria:

* Participation in any interventional clinical trials at the time of enrollment.
A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients with GEP-NET

The purpose of this study is to compare the effectiveness and safety of CAM2029 to octreotide LAR or lanreotide ATG in patients with advanced, well-differentiated GEP-NET. Patients who experience progressive disease in the randomized part of the study may proceed to an open-label extension part with intensified treatment with CAM2029.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient ≥18 years old
* Histologically confirmed, advanced (unresectable and/or metastatic), and well-differentiated NET of GEP or presumed GEP origin
* At least 1 measurable, somatostatin receptor-positive lesion according to RECIST 1.1 determined by multiphasic CT or MRI (performed within 28 days before randomization)
* ECOG performance status of 0 to 2

Exclusion Criteria:

* Documented evidence of disease progression while on treatment (including SSAs) for locally advanced unresectable or metastatic disease
* Known central nervous system metastases
* Consecutive treatment with long-acting SSAs for more than 6 months before randomization
* Carcinoid symptoms that are refractory to treatment (according to the Investigator's judgement) with conventional doses of octreotide LAR or lanreotide ATG and/or to treatment with daily doses of ≤600 µg of octreotide IR
* Previous treatment with more than 1 cycle of targeted therapies such as mTOR inhibitors or vascular endothelial growth factor inhibitors, or more than 1 cycle of chemotherapy or interferon for GEP-NET
* Treatment of GEP-NET with trans-arterial chemoembolization or trans-arterial embolization within 12 months before screening
* Previously received radioligand therapy (PRRT) at any time
Burke-Hocoma Efficiency Study

The ArmeoSpring device is an exoskeleton (3 joints and 6 degrees of freedom) with integrated springs. The investigators hypothesize that 3 days of training for 6 weeks with the Hocoma Armeo Spring device will be efficient and more effective than one on one ArmeoSpring therapy.

In the proposed study, 20 stable subacute and chronic stroke patients will be placed in two groups: 2:1 treatment for 3 weeks (2 patients on 2 robots with one therapist; 60 minutes on robot) then 1 on 1 intervention with the therapist (60 minutes of Hocoma Armeo Spring robotic training) or visa versa. Patients will be assessed using robotic kinematics and standardized occupational therapy motor assessments. The extreme precision afforded by robotic physical rehabilitation therapies makes them an appealing and growing field in rehabilitation.

Determining efficiency of new technologies, while maintaining the highest quality of care, is of priority in the medical field at this time. Devices such as the ArmeoSpring could lead to reduced disability, thereby increasing function and improving quality of life in patients experiencing neurological illness or injury. The ArmeoSpring has potential to decrease cost for both the provider and patient over time while providing more engaging, evidence-based therapy.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral or bilateral upper extremity hemiparesis/hemiplegia
* Upper extremity Fugl-Meyer Assessment Score between 7-60 (Neither hemiplegic nor fully recovered motor function of the shoulder, elbow, wrist)

Exclusion Criteria:

* Inability to follow 1-2 step commands
* Fixed joint contracture
* Unable to tolerate repetitious movement exhibited by pain greater than 5 on Likert Scale
* Any device dependent restrictions
Evaluation of the Performance of Monthly Replacement Sphere Lens Designs in Habitual Soft Contact Lens Wearers

The objective of the study is to evaluate the clinical performance of two monthly silicone hydrogel contact lenses in habitual wearers of frequent replacement (FRP) lenses when worn for one month.

This study is a prospective, bilateral eye, double-masked, randomized, 1-month cross-over, daily-wear design involving two different FRP lens types. Each lens type will be worn for approximately one month.

Eligibility Criteria:
Inclusion Criteria:

* Is at least 18 years of age and no older than 35 years, and has full legal capacity to volunteer;
* Has read and signed an information consent letter;
* Is willing and able to follow instructions and maintain the appointment schedule;
* Self-reports having a full eye examination in the previous two years;
* Self-reports spending on most days at least 6 hours cumulative (not necessarily in one single stretch) using digital devices such as a computer, laptop, tablet, e-reader, smartphone;
* Has healthy eyes with no health condition or medication that contra-indicate contact lens wear, in the opinion of the investigator;
* Anticipates being able to wear the study lenses for at least 8 hours a day, 6 days a week;
* Habitually wears soft frequent replacement contact lenses, for the past 3 months minimum (NOTE: the habitual contact lens brand is restricted such that no more than one third are to be the Biofinity brand (or their equivalent private label brand name) and no more than one third are to be an Alcon brand;
* Has refractive astigmatism no higher than -0.75DC in each eye;
* Can be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens parameters are sphere +6.00 to -6.00D, 0.25D steps).

Exclusion Criteria:

* Is participating in any concurrent clinical or research study;
* Has any known active ocular disease and/or infection that contraindicates contact lens wear;
* Has a systemic or ocular condition that in the opinion of the investigator may affect a study outcome variable;
* Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
* Has known sensitivity to the diagnostic sodium fluorescein used in the study;
* Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
* Has undergone refractive error surgery or intraocular surgery.
Mechanisms of Endothelial Dysfunction in Type 2 Diabetes

Endothelial dysfunction of conduit arteries plays an important role in the development of cardiovascular complications associated with type 2 diabetes. In order to propose targeted therapeutic approaches, this study aim to determine the mechanisms involved in endothelial dysfunction of conduit arteries in these patients.


Eligibility Criteria:
Inclusion Criteria:

- Type 2 diabetic patients or control subjects or healthy volunteers

Exclusion Criteria:

* Macroangiopathy
* Insulin treatment
* Chronic kidney disease (eGFR\<60 ml/min/m²)
* Hyperlipidemia (total cholesterol\>2.5 g/l)
* Smoking habit \> 5 cigarettes/day
* Pregnancy