cyrilzakka/clinical-trials huggingface dataset:
Relative Bioavailability and Drug-drug Interaction Study With MT-7117 and a Proton Pump Inhibitor

An open label, multicentre, randomised, 2-cohort, sequential and crossover study to assess the relative oral bioavailability of MT-7117 higher content tablets versus MT-7117 lower content tablets and the pharmacokinetics of MT-7117 under various gastric conditions (fed and fasted, and following administration of a proton pump inhibitor and an acidic beverage) in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

Additional screening criteria check may apply for qualification:

* Able to provide written informed consent to participate in this study.
* Healthy and free from clinically significant illness or disease.
* Caucasian male and female subjects aged 18 to 55 years (inclusive) that are willing and able to practice acceptable birth control for the duration of the study, as defined in the Protocol.
* A body weight of ≥50.0 kg and a body mass index (BMI) (Quetelet index) ranging from 18.0 to 30.0 kg/m2 (inclusive) at Screening.
* Subject is able to understand the nature of the study and any risks involved in participation, and willing to cooperate and comply with the protocol restrictions and requirements.

Exclusion Criteria:

Additional screening criteria check may apply for qualification:

* Previously having received MT-7117.
* Participation in more than 3 clinical studies\* involving administration of an Investigational Medicinal Product (IMP) in the previous year, or any study\* involving administration of an IMP within 12 weeks (or, if relevant, 5 half-lives, whichever is the longer) prior to the first dose. (\*Disregarding any study Follow-up Periods).
* Subjects who have received any prescribed systemic or topical medication within 14 days (or, if relevant, 5 half-lives; whichever is longer) prior to the first dose of IMP.
* Subjects who have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days (or, if relevant, 5 half-lives; whichever is longer) prior to the first dose of IMP.
* Clinically relevant abnormal medical history.
* Family history of long or short QT syndrome, hypokalaemia, syncope or Torsades de Pointes.
* Clinically significant 12-lead electrocardiogram (ECG) abnormalities.
* Blood pressure (supine) at Screening outside the range 90 to 140 mmHg (systolic) or 50 to 90 mmHg (diastolic).
* Presence or history of severe adverse reaction or allergy to any drug.
* Presence or history of drug abuse.
* Presence or history of alcohol abuse.
* Subjects who use tobacco or nicotine-containing products within 3 months.
* Test positive for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, or human immunodeficiency virus (HIV) 1 \& HIV 2 antibodies.
EPIONE Guided Lung Evaluation

Interventional clinical study to obtain performance and safety data of the EPIONE® device when used for percutaneous procedures in the lung.

The objectives are:

* to evaluate the technical success of the device
* to evaluate performance parameters (accuracy measures, adjustements, post-intervention ablation success, local tumor recurrence)
* to evaluate the safety of the device

  25 subjectsare planned and will undergo an intervention, during which the clinician will use the EPIONE device

Eligibility Criteria:
Inclusion Criteria:

* Patient ≥18 years old,
* Patient for whom a percutaneous CT-guided intervention in lung has been prescribed and agreed by a multidisciplinary team of radiologists, surgeons and clinicians,
* Patient with a signed informed consent form.
* Patient covered by a social security system.

Exclusion Criteria:

* Patient unable to undergo general anesthesia,
* Pregnant or nursing female, confirmed before the intervention
* Patient already participating in another clinical study
Earset Healthy Volunteer Study

The study will recruit healthy volunteers to undergo the Iontophoresis procedure using the Acclarent Iontophoresis System with Earset (IPSES).


Eligibility Criteria:
Inclusion Criteria:

* At least 12 months old

Exclusion Criteria:

* Pregnant or lactating females
* Subjects with history of sensitivity or reaction to lidocaine, tetracaine, epinephrine, or any hypersensitivity to local anesthetics of the amide type, or any component of the drug solution
* Significantly atrophic or perforated tympanic membrane
* Otitis externa
* Damaged or denuded skin in the auditory canal
* Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.)
* Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane
* Evidence of Otitis Media at day of procedure, or within the past three (3) months prior to procedure.
Clinical Risk Scores in Prediction Outcome of Acute UGIT Bleeding in Non Cirrhotic Patients

To compare the ability of 4 bleeding risk scoring systems (Glasgow -Blatchford score, MAP, H3B2 and ABC scores ) in prediction of: Need of intervention, Re bleeding, Thirty-day mortality, length of hospital stay

Acute upper gastrointestinal bleeding (UGIB) is a common medical emergency which has a variceal and non-variceal etiology. The non variceal etiology has higher incidence in many countries. In Egypt, non-variceal causes ranged from 26.1% to 61.6% among UGIB cases presented to the emergency departments of different University Hospitals. Guidelines recommend risk stratification early in the management of patients with acute UGIB to help triage patients into the appropriate level of care. Many scoring systems for UGIB were developed and validated from 1990s onwards. Their primary aim was to segregate the patients into low-risk and high-risk groups. High risk patients with UGIB includes those who reach some or all of the endpoints: requirement of blood transfusion, endo-therapeutic, surgical or radiological intervention to achieve hemostasis, re bleeding and mortality. Unfortunately, no single risk score has been shown to be accurate at measuring all relevant outcomes.

The most widely used score is Glasgow Blatchford "GBS" which is a pre endoscopic score. It is useful in prediction of therapeutic intervention for bleeding. More recently, other scores have been developed as ABC score which showed good performance for predicting mortality. MAP score highly predicted therapeutic intervention and mortality. H3B2 score predicted the need of urgent hemostasis.

Limited data are available on the validity of the new scoring systems in predicting the outcome of Egyptian non-cirrhotic patients with acute UGIB. Therefore, The investigators will conduct our study to shed some light on this topic.

Eligibility Criteria:
Inclusion Criteria:

* Adult non cirrhotic patients
* patients more than 18 years old
* Hematemesis or coffee grounds vomiting.
* Melena with or without hematemesis.
* Blood in nasogastric tube in emergency unit.

Exclusion Criteria:

* Patients younger than 18 years old.
* Patients known to be cirrhotic.
* Patients presented with GIT bleeding but refuse to be examined by GIT endoscopy.
Genetical Background of Non-alcoholic Fatty Liver Disease (NAFLD) in Diabetes Mellitus and in Chronic Kidney Disease

The present study investigates relationship between non-alcoholic fatty liver disease and its risk factors, such as genetic background and diseases, such as chronic kidney disease and diabetes mellitus.

Non-alcoholic fatty liver disease (NAFLD) is a multisystemic disease, also affecting extrahepatic organs (1,2,6). According to former data, not only the prevalence of chronic hepatic disease, chronic cardiovascular diseases, but also the prevalence of chronic kidney disease (CKD) is higher in NAFLD (4,7). A strong association has been shown between diabetes mellitus (DM) and NAFLD as well (3,5,10).

Many genetical factors have been studied in the background of NAFLD. Many studies have proved the effect of patatin-like phospholipase domain-containing protein 3 gene (PNPLA3) (8,9). Effect of numerous genetical polymorphisms has been suggested behind oxidative stress responsible for NAFLD (8).

Eligibility Criteria:
Inclusion Criteria:

* CKD (renal replacement therapy non excluded)
* DM
* CKD+DM

Exclusion Criteria:

* alcohol abuse
The Role of Oxytocin in Modulating the Effects of Social Feedback on Achieving Personal Goals

To examine potential differential effects of receiving various social feedback on achieving personal goals,and whether oxytocin would modulate these effects.

In the present study, 62 healthy male participants participated in the double-blind, placebo-controlled experiment. Investigators aimed to test the idea that whether oxytocin would modulate subjective responses during receiving various social reward and social punishment about the future outcomes of pursuing personal goals.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects without past or current psychiatric or neurological disorders.

Exclusion Criteria:

* Taking oral contraceptives;
* No history of head injury and medical or psychiatric illness.
Prospective Study of Extended Robotic Right Hemicolectomy With Complete Mesocolic Excision for Cancer

A single-center prospective study to elucidate whether extended robot-assisted right colectomy (e-RARC) performs as well as extended open right colectomy (e-ORC) in terms of specimen quality, and in addition, whether less postoperative morbidity and shorter length of stay (LOS) can be attained. Patients with colonic cancer near the right flexure or the oral part of the transverse colon will be compared excluding the most technically demanding and frail patients in both groups. A total of 40 patients undergoing e-RARC in a prospective series will be included and compared with 44 consecutive patients previously treated with e-ORC.

Complete mesocolic excision with central vascular ligation (CME) is an improvement of surgical technique in the operation for colonic cancer suggested to increase long-term survival. The concept was originally developed for open surgery by W. Hohenberger in Erlangen with excellent survival rates. However, if the tumor is located in the transverse colon or near the right colonic flexure, the procedure is particularly technically demanding, and for that reason most surgeons still prefer to do it by open operation (laparotomy) instead of the minimally invasive approach (laparoscopy) presently recommended for colonic cancer surgery. The advent of robotic surgery has improved the dexterity of instruments used in laparoscopic surgery and pushed the limits of what is possible with a minimally invasive approach. Since minimally invasive surgery is associated with better outcomes in terms of postoperative morbidity, pain, length of stay etc., it would be highly desirable if CME surgery could be done by robot-assisted laparoscopic operation instead of the current open approach. The current single-center study is proposed to elucidate whether extended robot-assisted right colectomy (e-RARC) performs as well as extended open right colectomy (e-ORC) in terms of specimen quality, and in addition, whether less postoperative morbidity and shorter length of stay (LOS) can be attained. Patients with colonic cancer near the right flexure or the oral part of the transverse colon will be compared excluding the most technically demanding and frail patients in both groups. A total of 40 patients undergoing e-RARC in a prospective series will be included and compared with 44 consecutive patients previously treated with e-ORC.

Eligibility Criteria:
Inclusion Criteria:

* Suspected or verified colonic cancer visualized by colonoscopy and on CT in the anal part of the ascending colon, in the right flexure or in the oral 2/3 of the transverse colon
* Patient is 18 years or older, legally competent and able to comprehend information and give consent
* Tumor is UICC stage I-III on preop CT
* Operation is elective

Exclusion Criteria:

* Previous major open intraabdominal surgery
* Ileus or other acute abdominal condition
* CT scan with suspicion of T4 tumor
* RITA score \> 3 (Preop risk and frailty score)
* BMI \> 35 kg/m2
* Project surgeon not available
Influence of the Antioxidant Treatment in the Oxidant-reduction Potential in Seminal Plasma in Men Whose Partners Will Undergo Through an Egg Donation Cycle

Evaluate the influence of antioxidant men supplements treatment (Fertybiotic Hombre) in the rate of sORP (stactic Oxidation Reduction Potential) defined as the balanced measure between the total oxidant activity (ROS, superoxides, nitric oxide, peroxide) and total reducing activity (alpha tocopherol, β carotene, uric acid) in sperm samples during egg donation cycles.

We will also evaluate the influence of the sORP rate in the embryo development during the egg donation treatments; taking in account the fecundation rate, percentage of blastocyst stage arrival embryos, number of frozen embryos, implantation rate, on-going pregnancy rate and miscarriage rate.

The sperm sample will be measured by electrochemical technology using Mioxsys system for a quantitative measurement in millivolts (mV), in those male patients who participate in an egg donation assisted reproduction treatment.

After 14 days, the pregnancy stage will be available. This information will be obtained from the patient's clinical history using the human chorionic gonadotropin hormone (shCG) in blood. It will be performed either in our Clinic or externally within the usual practice derived from the treatment carried out. These values will be compared with the results obtained from sORP.


Eligibility Criteria:
Male Inclusion Criteria

* Sperm count greater than 2 million per milliliter
* Sperm origin: ejaculate

Exclusion Criteria:

* Taking oral antioxidants in the 3 months prior to inclusion in the study
* Total astenozoospermia or Severe teratozoospermia (including balloonzoospermia)
Prediction of Pain After Total Knee Arthroplasty

Despite improvements in treatment, a significant part of patients have severe pain following knee arthroplasty. Preoperative identification of high-risk patients would allow for an intensive individualized analgesic treatment pre- and postoperatively and thus potentially in reduced pain acute and chronically.


Eligibility Criteria:
Inclusion Criteria:

* primary unilateral TKA
* caucasian
* 50 - 80 years
* osteoarthritis

Exclusion Criteria:

* deficient written or spoken danish
* impairment from psychological og neurological disease
* expected discharged to rehabilitation facility
* anticoagulant therapy
* allergies to analgesic treatment
* hypertension (systolic \> 160 / diastolic \> 100)
* ASA class ≥ 4
The Effect of Colon Cancer on Muscle Gene Expression, Body Composition, Muscle Function, and Muscle Metabolism

Rationale: Cancer cachexia is a complex metabolic syndrome characterized by clinically relevant loss of muscle mass with or without loss of fat mass. To determine how treatment methods can be most effective, full insight in changes in gene expression, body composition, muscle function and muscle metabolism are of great importance.

Objective: Main aim of the study is to investigate the differences in gene expression, body composition, muscle function and muscle metabolism in colon cancer patients compared to controls.

Study design: Observational study Study population: 40 colon cancer patients undergoing a tumor resection (30 primary tumor and 10 liver metastases) and 15 control patients undergoing an inguinal hernia repair (♂, 10) or an abdominal hysterectomy (♀, 5).

Main study parameters/endpoints: Primary study parameter will be gene expression (transcriptomic and polymerase chain reaction analyses of muscle biopsies). Secondary parameters will be body composition (determined in available CT scans and bio impedance analysis and with DEXA), muscle function parameters (grip and knee flexion/extension strength and measured in a biopsy), metabolic markers (measured in fat and muscle biopsies), biochemical markers (measured in blood/serum) and gene expression of fat biopsies.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The investigators expect no additional risk for the subjects due to the proposed measurements. Biopsies will be taken during the planned operation and therefore is not expected to cause a significant increase in burden for the patient. All other measurements are non-invasive, observational measurements with no risk of any harmful side effects.


Eligibility Criteria:
Inclusion Criteria:

* CC patients:

In order to be eligible to participate in this study, a subject must meet all of the following inclusion criteria:

* Diagnosed with primary colon cancer (30) or liver metastases due to colon cancer(10)
* Eligible for a primary tumor or liver metastases resection procedure

  * Controls:
* Eligible for an inguinal hernia repair (♂, 10) or an abdominal hysterectomy (♀, 5)

Exclusion Criteria:

* CC patients:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

* Having had chemotherapy or an operational procedure of the abdomen in the past 6 months
* Suffering from malabsorption

  * Controls:
* Having had treatment for previous or current tumors
Normal Parameters of Cranial Vessels Using Cranial Vascular Duplex Among Egyptian Population

the study will be carried out to standardize normal parameters of vascular duplex ultrasound of the cranial vessels in the Egyptian population.

Atherosclerosis is a major cause of ischemic stroke and a significant proportion of strokes are thromboembolic in nature, arising from atherosclerotic plaques. Several studies have reported racial differences in the severity and distribution of carotid atherosclerosis. In the United States and Western communities, Extra-cranial carotid artery disease was estimated to be responsible for 20-30% of strokes. Little is known about the prevalence and distribution of carotid disease among the populations in the developing countries.

Vascular duplex ultrasound is a useful, cheap and available diagnostic tool for assessing cranial vascular disease. Duplex ultrasound can be highly reliable with proper technique, without the risk of radiation in other imaging modalities, is well tolerated by all patients including those who are claustrophobic in MRI machines, and has much less risks compared to conventional angiography studies.

Although vascular duplex has been used for years yet there is little researches had been done on normal population in the developing countries to collect results and compare it to the parameters that was collected and reviewed in the western developed populations.

The parameters that would be used in this study include both the data collected by static and dynamic duplex scan which are the intimal-medial thickness, the vessels' diameter, peak flow velocity and peak flow volume both systolic and diastolic for either extra- or intra-cranial vessels.

Eligibility Criteria:
Inclusion Criteria:

* Normal subjects between 20-40 years

Exclusion Criteria:

* Diabetic patients, hypertensive patients, any evidence of vascular disease either peripheral or central, subjects refusing to participate
Non-Invasive Respiratory Monitor

This study will clinically evaluate a newly developed respiratory monitor - pneuRIP. The pneuRIP uses Respiratory Inductance Plethysmography (RIP) bands to measure key breathing indices non-invasively. This study compares the pneuRIP to an existing Respitrace system (Carefusion, Yorba Linda CA). 10 normal children and 10 children with breathing difficulties will be monitored with both systems.

Firstly, ten healthy children will participate in a trial to evaluate the pneuRIP. They will be fitted with the bands around their abdomen and chest. The pneuRIP will be connected to the bands through electrodes. Breathing is then measured wirelessly with an iPad. They will be asked to lie down. They are asked to breath normally then asked to breath with a resistive elements to place in their mouth. The resistive elements makes it difficult to breath (similar to breathing through a straw). They will breathe for 3 minutes for both conditions as we record their breathing with the pneuRIP and the Respitrace. These data will be compared.

Secondly, A group of 10 subjects from the outpatient muscle clinic will be fitted with the chest and abdomen bands. The Respitrace monitor and the pneuRIP will record their breathing patterns. Data from the two systems will then be compared.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Neuromuscular disease subjects with mild breathing difficulty
* Capable of following verbal instructions

Exclusion Criteria:

* Severe breathing difficulties
Drug Drug Interaction of Empagliflozin (BI 10773) and Warfarin in Healthy Volunteers

The objective of the current study is to investigate the bioavailability of BI 10773 and of warfarin after concomitant multiple oral administration of BI 10773 and a single oral dose of warfarin in comparison to BI 10773 and warfarin given alone, and to investigate the pharmacodynamics of a single oral dose of warfarin with and without concomitant multiple oral administration of BI 10773.


Eligibility Criteria:
Inclusion criteria:

Healthy male subjects
rTMS and Botulinum Toxin in Benign Essential Blepharospasm

Benign essential blepharospasm (BEB) is a functionally disabling focal dystonia. Botulinum neurotoxin (BoNT) therapy is suboptimal in many BEB patients. Repetitious transcranial magnetic stimulation (rTMS) therapy is a promising noninvasive therapy and has shown positive benefits in BEB. rTMS therapy can be easily combined with BoNT injections to enhance the effects of BoNT in BEB.

A two week course of rTMS therapy to achieve sustained benefits will be employed. With standard BoNT treatment, the peak-dose benefits are seen at about 4-6 weeks after the administration of injections. rTMS will be introduced during this peak-dose period (about 6 weeks after BoNT or T1).The effects of combined therapy at about 10 weeks after BoNT injections (T2) and at about 12 weeks after BoNT injections (T3) will be examined along with the physiological effects at these time points.

Eligibility Criteria:
Inclusion Criteria:

* subjects diagnosed with blepharospasm or cranio-cervical dystonia who receive BoNT therapy at the Center for Movement Disorders will be approached. The investigators will enroll only those subjects who report experiencing positive benefits with BoNT but lasting about 10 weeks or less.

Exclusion Criteria:

* pregnancy
* active seizure disorder
* significant cognitive impairment
* exposure to neuroleptics
* presence of a metallic body such as pacemaker, implants, prosthesis, artificial limb or joint, shunt, metal rods and hearing aid.
Investigating Participation Patterns of Patients in Atopic Dermatitis Clinical Trials

Clinical trials, specifically focused on atopic dermatitis, are crucial in assessing the safety and efficacy of new treatments. These trials serve as fundamental instruments in determining whether emerging medications outperform standard therapies, providing compelling evidence to support wider implementation.

The main goal is to thoroughly scrutinize trial completion rates and voluntary withdrawals among this particular group of patients.


Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and the willingness to sign a written informed consent document
* Participant must be 18 years of age or older
* Confirmed diagnosis of atopic dermatitis

Exclusion Criteria:

* Enrolled in another research study
* Is pregnant, breastfeeding or expecting to conceive within the projected duration of the study
* Inability to provide written informed consent