cyrilzakka/clinical-trials huggingface dataset:
Relative Bioavailability of BI 10773 and Glimepiride in Healthy Male Volunteers

The objective was to investigate whether there was a drug-drug interaction between BI 10773 and glimepiride when co-administered. Therefore, the relative bioavailabilities of BI 10773 and glimepiride were determined when both drugs were given in combination compared to multiple oral doses of BI 10773 once daily alone and a single oral dose of glimepiride given alone.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
* Age 18 to 50 years (incl.)
* BMI (Body Mass Index) 18.5 to 29.9 kg/m2 (incl.)
* Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation

Exclusion Criteria:

* Any finding of the medical examination (including BP (Blood Pressure, PR (Pulse Rate) and ECG (Electrocardiogram)) deviating from normal and of clinical relevance
* Any evidence of a clinically relevant concomitant disease
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of the gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
* Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
* Participation in another trial with an investigational drug within two months prior to administration or during the trial
* Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (more than 30 g/day)
* Drug abuse
* Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
* Excessive physical activities (within one week prior to administration or during the trial)
* Any laboratory value outside the reference range that is of clinical relevance
* Inability to comply with dietary regimen of trial site
* Glucose-6-phosphate dehydrogenase deficiency
Pharmacokinetics and Pharmacodynamics of Tranexamic Acid in Women Having Caesarean Section Birth [WOMAN-PharmacoTXA]

Intramuscular injection and oral solution of tranexamic acid (TXA) would increase its use in situations where administration of intravenous drugs is difficult. The investigators aim to assess the population pharmacokinetics (PK) and pharmacodynamics (PD) of intravenous, intramuscular and oral TXA in women undergoing undergoing caesarean section (CS) with at least one known risk factor for postpartum haemorrhage (PPH)

An open label, randomised controlled trial to assess the pharmacokinetics and pharmacodynamics of intramuscular, intravenous and oral solution administration of tranexamic acid in women giving birth by caesarean section. 120 women (30 receiving oral liquid, 30 receiving intramuscular, 30 receiving intravenous and 30 receiving no TXA who have at least 6 evaluable PK samples will be randomised.

Eligibility Criteria:
Inclusion Criteria:

* Women admitted to hospital giving birth by CS
* History of at least one risk factor for PPH
* Adult (≥18 years old)

Exclusion Criteria:

* Women giving birth vaginally
* Women with a known allergy to TXA or its excipients
* Women with current antepartum haemorrhage
* Women known to have received TXA within 48 hours prior to randomisation
* Women with known renal impairment
* Women with any known blood clotting disorder
Respiratory Muscle Endurance in Obesity Hypoventilation Syndrome

Obesity hypoventilation syndrome (OHS) is defined as a combination of obesity \[body mass index (BMI) ≥30 kg/m2\], chronic daytime hypercapnia (PaCO2 \>45 mm Hg), and sleep-apnea in the absence of other known causes of hypercapnia. Respiratory system compliance decreases and resistance increases in OHS. This causes increase in work of breathing and oxygen cost of breathing, which may result in respiratory muscle fatigue. Increase in respiratory workload and increase in resistance to respiration is expected to decrease in respiratory muscle endurance (RME) in subjects with OHS.

In the literature, studies evaluating RME in subjects with OHS are limited. No study has been found to evaluate RME using the incremental load test in subjects with OHS. Accordingly, it was aimed to evaluate and compare respiratory muscle endurance in subjects with OHS and a control group, and to determine factors associated with respiratory muscle endurance.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with OHS
* Obese subjects (30 \< body mass index \< 40 kg/m2) with low risk of obstructive sleep apnea (STOP-BANG score \< 3)

Exclusion Criteria:

* Severe respiratory disease
* Subjects with orthopeadic and/or neurologic disorders that could limit exercise tests
Human Requirements for the Nutrient Choline

The purpose of this study is to increase our understanding of how much choline humans need to get from their diet. Choline is an essential nutrient found in many foods, including eggs and milk. In addition to dietary sources, choline can be made in the liver. Choline is important in making membranes or wrappers for all the cells in the body and for making chemicals that allow nerve cells to work properly. In a previous study we found that the dietary requirement for choline varies greatly from person to person. This was caused, in part, by how much estrogen a person has and their genetic makeup. We are conducting this study to explore how estrogen levels and specific differences in genes influence choline requirements so that we can refine the dietary recommendations for this nutrient.

Choline is an essential nutrient essential used for the structural integrity and signaling functions of cell membranes, cholinergic neurotransmission, and lipid transport/metabolism. Choline is obtained from the diet and from endogenous biosynthesis catalyzed by the enzyme phosphatidylethanolamine N-methyltransferase (PEMT). The major premise for this proposal is that humans require a dietary source of choline and that this requirement has significant individual variation and is modulated by estrogen and common genetic polymorphisms. The promoter of the PEMT gene is estrogen responsive, and we hypothesize that estrogen status influences the dietary requirement for choline. We identified other common single nucleotide polymorphisms (SNPs) that increase or decrease the likelihood that a human will develop organ dysfunction when fed a low choline diet. Experiments are proposed that will refine our understanding of estrogen-mediated induction of the PEMT promoter; determine whether postmenopausal women treated with estrogen have a decreased susceptibility to developing organ dysfunction associated with choline deficiency; determine the prevalence of SNPs that increase susceptibility to choline deficiency in the population and examine dietary choline requirements in humans with these SNPs.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Non-smoker
* BMI between 18 and 34
* Normal mammogram in last 12 months (post-menopausal women only)

Exclusion Criteria:

* Hormone or estrogen therapy
* Allergic to soy, eggs, wheat
* History of breast, uterine, or other estrogen-dependent cancer
* Liver or kidney problems
* History of circulation, bleeding, or blood-clotting disorder
* Anemia or evidence of iron overload
* Hyperthyroidism, neurological disorder, or autoimmune disease
* Diabetes controlled by insulin
* Positive serology for HIV or Hepatitis B or C
* Alcohol or illegal drug misuse/abuse
* Pacemaker, aneurysm clip, cardiac heart valve, mechanical devices/implants
* Other metal in body (i.e. injured by a BB, shrapnel, or metallic object)
Efficacy of Pain Neuroscience Education and Pre-anesthetic Assessment in Reducing Levels of Anxiety, Stress and Pain in Patients Undergoing Elective Total Abdominal Hysterectomy (ENAH Study)

Through this quantitative, multivariate factorial experimental research of the Parallel Randomized Clinical Trial type, the investigators will try to analyze the effectiveness in reducing levels of anxiety, stress and pain through pre-anesthetic assessment and pain neuroscience education in patients undergoing elective total abdominal hysterectomy.

Hysterectomy is a common surgical procedure with a low risk of major complications. However, some women experience long-lasting complications, including chronic postsurgical pain, which can have a negative impact on their quality of life.

The population will be made up of women with elective total abdominal hysterectomy scheduled surgery at the University Hospital of Puebla BUAP, in the city of Puebla, Mexico.

Then the investigators will carry out an pre-anesthetic evaluation will be carried out and an pain neuroscience education session will be carried out.

Once patients are ready for surgery, the investigators will carry out an invasive monitoring will be performed in the post-anesthesia care unit. The blood pressure of the participants will be monitored non-invasively. They will also be monitored with electrocardiogram and pulse oximetry.

Eligibility Criteria:
Inclusion Criteria:

1. Anesthesia Physical Classification System: I, II or III according to the classification of the American Society of Anesthesiology.
2. Acceptance of informed consent
3. Schooling of at least 12 years (basic primary and secondary).

Exclusion Criteria:

1. Illiterate
2. Inflammatory rheumatic disease
3. Major neurological or psychiatric disease, Intellectual disability (mental retardation) or learning disorders at the premorbid level or severe language comprehension problems.
Diagnostic Outcomes Of The Females Presenting With Breast Lump In Surgical Department Services Hospital Lahore

It is a simple crossectional study in which we are trying to identify the outcomes of female breast lump presenting to surgical OPD of services hospital lahore.


Eligibility Criteria:
Inclusion Criteria:female patients with breast lump aged from 20 to onwards

-

Exclusion Criteria:

* female patients with breast abscess
The Long Non Coding MALAT1 as a Potential Salivary Diagnostic Biomarker in Oral Squamous Cell Carcinoma Through Targeting mi RNA 124

Objective: is to determine the diagnostic accuracy of lncRNA MALAT1 as a potential salivary biomarker of OSCC as well as assessment of the salivary expression level of miRNA 124 which is targeted by MALAT1. Materials and Methods: Saliva Samples were collected for the quantitative determination of salivary "MALAT1 and mi RNA -124" using quantitative Real-time Polymerase Chain Reaction technique for the two study groups, Group A: 20 patients with a diagnosis suggestive of OSCC and Group B: 20 age-and-sex-matched healthy individuals, as normal controls.

Materials and Methods: Saliva Samples were collected for the quantitative determination of salivary "MALAT1 and mi RNA -124" using quantitative Real-time Polymerase Chain Reaction technique for the two study groups, Group A: 20 patients with a diagnosis suggestive of OSCC and Group B: 20 age-and-sex-matched healthy individuals, as normal controls.

Eligibility Criteria:
Inclusion Criteria:

* The study included patients with OSCC and healthy controls of both sexes.

Exclusion Criteria:

* Patients having systemic diseases such as; liver diseases, cardiovascular disease, nervous system, pulmonary, renal, endocrine, gastrointestinal disorders, or other types of cancer were excluded.
Effects of Dynamic Surface Exercise Training on Trunk Control and Gross Motor Functions in Children With Diplegic Cerebral Palsy

The purpose of this study was to determine the effect of dynamic surface exercise treatment on trunk control and gross motor abilities in children with spastic diplegic cerebral palsy.

A clinical trial was conducted to assess the impact dynamic surface exercise training on gross motor and trunk control of children with spastic diplegic cerebral palsy. The trial enrolled 38 children with spastic diplegic cerebral palsy of GMFCS levels 3 and 4. Children were randomly assigned to either the DSET or conventional physiotherapy training groups. Both groups underwent 60-minute vigorous exercise program four days a week for two months. The trunk control measurement scale was used to assess trunk control, while the GMFM-88 was used to assess gross motor function. Trunk control and gross motor function scores were obtained at the beginning, the fourth week, and the eighth week.

Eligibility Criteria:
Inclusion Criteria

* Diplegic children having Cerebral Palsy
* Children of age 5 - 12 years
* Children of GMFCS- E \&R level III and IV
* Children who can follow verbal commands

Exclusion Criteria:

* Children with epileptic fits
* Children presenting with lower limb muscular contractures
* Children with scoliosis
Comparison Between Reciproc and Protaper Next

Comparing the postoperative pain resulting after mechanical instrumentation using Reciproc reciprocating files versus that resulting after using ProTaper Next rotary files in asymptomatic necrotic molars.

Asymptomatic Necrotic molars are selected according to the eligibility and exclusion criteria and patients are then randomized to receive treatment either using Reciproc Files or ProTaper Next files. Postoperative pain is then assessed using the Numerical Rating scale 6, 12, 24 and 48 hours post-instrumentation. The tooth is then temporized and after 1 week obturation is then and post obturation pain is assessed using the Numerical Rating scale after 12 and 24 hours following obturation. The time required to complete instrumentation is also measured and compared using the two files.

Eligibility Criteria:
Inclusion Criteria:

* Mandibular molar teeth with no pain, no response of pulp tissue to pulp testing and teeth with apical periodontitis

Exclusion Criteria:

* Patients on medication for chronic pain
* Patients with pre-operative pain.
* Patients having significant systemic disorders.
* Patients with two or more adjacent teeth requiring root canal therapy
* teeth that have vital pulp tissues, greater than grade I mobility, pocket depth greater than 5 mm, no possible restorability or previous endodontic treatment.
Low-dose Acetylsalicylic Acid Before Non-cardiac Surgery

This study aims to assess independent factors associated with the clinical decision to discontinue ASA preoperatively in patients undergoing elective non-cardiac surgery.

Acetylsalicylic acid (ASA) is widely used for primary and secondary prevention of cardiovascular diseases. A prothrombotic rebound phenomenon after aspirin cessation has been reported. ASA withdrawal is associated with an increased incidence of adverse cardiac events. In individuals with previous percutaneous coronary intervention (PCI), cessation of ASA may cause stent thrombosis or myocardial infarction. However, many patients undergo non-cardiac surgery within the first two years after PCI. Perioperatively, two counteracting risks have to be taken into account, first, the risk of thromboembolic complications, if ASA medication is discontinued and second, the risk of surgical bleeding, if ASA therapy is continued. However, factors contributing to preoperative decision-making for ASA-withdrawal are still unclear.

This study aims to assess independent factors associated with the clinical decision to discontinue ASA preoperatively in patients undergoing elective non-cardiac surgery. In particular this study aims to determine if the presence of coronary stents is independently associated with ASA discontinuation. Furthermore this study assesses, if benefit-risk-estimates (numerical rating scales) of the patients and the supervising physicians are associated with the decision to withdraw ASA.

Study design

Patients on long-term ASA undergoing non-cardiac surgery as well as their supervising anesthesiologist participate in a preoperative survey. Detailed information about ASA medication, perioperative ASA use, comorbidities, factors that might be associated with the decision to discontinue ASA preoperatively and benefit-risk-estimates (numerical rating scales) are sampled by questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* 18 Years and older
* Scheduled for elective non-cardiac surgery
* Regular long-term ASA use, defined as daily low-dose (≤100mg) ASA therapy, even if ASA-medication was interrupted within the last 30 days before study inclusion

Exclusion Criteria:

* \< 18 Years
* No consent given
Investigation of Clinical Spectrum, Bacterial Pathogens and Immune Response in Acute Pharyngotonsillitis

Acute pharyngotonsillitis is one of the most common infections encountered by pediatricians. Most children with acute pharyngotonsillitis have symptoms that can be attributed to viral infection. However 30-40% of cases is of bacterial etiology.

The purpose of this study is to examine frequency, age distribution, clinical picture and pathogen distribution in acute pharyngotonsillitis in children in a large urban setting.

According to the US Vital Health Statistics report, acute pharyngotonsillitis is responsible for more than 6 million office visits each year by children younger than 15 years of age. Approximately 30% of cases is of bacterial etiology and group A beta-hemolytic streptococci(GABHS) are responsible for most bacterial cases, although other pathogens, such as Neisseria gonorrhoeae, Arcanobacterium haemolyticum, Mycoplasma pneumoniae, and Chlamydia pneumoniae, may be the causative agents in sporadic cases. An accurate diagnosis of GABHS infection is important because it is the only common form of acute pharyngotonsillitis for which antibiotic therapy is definitely indicated. Effective antibacterial treatment can shorten the clinical course of GABHS pharyngotonsillitis, reduce the rate of transmission, and prevent suppurative and nonsuppurative complications, such as peritonsillar abscess and acute rheumatic fever.

This study enrolls patients who will present with acute fever and clinical signs of pharyngotonsillitis at three primary pediatric ambulances. A rapid A beta-hemolytic streptococcus (GABHS)-detection test will be performed in these patients. In one office, additional throat cultures are obtained of all patients, and blood is taken in a subgroup of 60 GABHS-positive and 60 GABHS-negative cases. In GABHS-positive patients, a second blood sample will be obtained at day 7th and day 28th, and stored until specific antibody response to GABHS will be measured.

Eligibility Criteria:
Inclusion Criteria:

* age 3 months to 18 years
* clinical signs of tonsillopharyngitis
* informed consent

Exclusion Criteria:

* age more than 18 years
* diagnosed chronic disease or infection (e.x. HIV, tuberculosis, malignancy)
* current participation in another research projects that may interfere with this study
* Incapability to perform all study procedure
ZEnith AlPHa for AneurYsm Repair

To prospectively collect 'real world' performance data on the Zenith AlphaTM Abdominal Endovascular Graft for endovascular aneurysm repair, inside and outside instructions for use. To assess clinical efficacy of the low-profile device to treat patients with abdominal aortic aneurysm (AAA), to assess the use of the new delivery and deployment system of the Zenith AlphaTM Abdominal Endovascular Graft. Primary endpoint is the proportion of subjects who experience successful treatment at 1 year post-implant; defined by technical success and clinical success.

The ZEPHYR registry has two major objectives:

1. to prospectively collect 'real world' safety, durability and clinical performance data on the Zenith AlphaTM Abdominal Endovascular Graft in subjects with infrarenal abdominal aortic or aorto-iliac aneurysms.
2. To increase the clinical evidence about the safety and effectiveness of the Zenith AlphaTM Abdominal Endovascular Graft by creating a database that can be pooled and/or compared with databases available on this and other stent graft systems.

The ZEPHYR registry is a multi-center, post-market, non-randomized, single-arm prospective study. The study has no controls, as it is descriptive in nature. It will recruit approximately 450 subjects from high-volume sites across Germany and the BeNeLux. Study is open to consecutively enrolled subjects (20-50 per site) whou in the opinion of the investigator are candidates for endovascular AAA repair. The sites are recommended to schedule the subject's post-operative follow-up visits based on the current standard care in endovascular aneurysm repair (EVAR) therapy, which is generally at 1 month, 1 year and annually thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years or minimum age as required by local regulations
* Non-ruptured AAA with maximum diameter ≥50mm or enlargement \>5mm over 6 months and neck length ≥10mm (site-reported)
* Elective EVAR
* Intention to electively implant the Zenith AlphaTM AAA Endovascular Graft
* Signed informed consent form

Exclusion Criteria:

* Intolerance to contrast media
* High probability of non-adherence to physician's follow-up requirements
* Current participation in a concurrent trial which may confound study results
Single-Use Negative Pressure Wound Therapy System vs. Traditional Negative Pressure Wound Therapy System (tNPWT)

The aim of this study is to compare the clinical efficacy of two types of NPWT systems; the traditional negative pressure wound therapy (tNPWT) system and the single-use negative pressure wound therapy (PICO) system.

The two types of NPWT systems include the tNPWT system that has successfully completed a coding verification request with CMS and has the following capabilities (e.g., range of negative pressure, connective tubing, canister, foam or gauze filler, and approved for home use), and a portable, canister-less, battery operated, disposable PICO system to see if there are any observed differences with regard to the clinical efficacy of the two devices.

Eligibility Criteria:
INCLUSION CRITERIA:

* Provide informed consent
* Age ≥ 18 years and of either sex
* Willing to comply with protocol instructions, including allowing all study assessments
* Have a Venous Leg Ulcer (VLU) between the knee and ankle (at or above the malleolus), with a surface area ≥ 2.0 cm2 and ≤ 36.0 cm2
* Target ulcer duration ≥ 4 weeks but ≤ 104 weeks (24 months)
* Have a Diabetic Foot Ulcer (DFU) present on any part of the plantar or dorsum surface of the foot, with a surface area ≥ 0.5 cm2 and ≤ 10.0 cm2
* Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon, muscle, or bone
* Target ulcer duration ≥ 4 weeks but ≤ 52 weeks (12 months)
* Acceptable state of health and nutrition

EXCLUSION CRITERIA

* Therapy with another investigational agent within thirty (30) days of Screening, or during the study Ulcers which are deemed as highly exuding, per the Investigator's discretion.
* Current diagnosis of osteomyelitis at the target wound location that is not currently receiving treatment \[Documented history of resolved osteomyelitis is allowed\].
* Subjects with a VLU: Refusal of or inability to tolerate compression therapy.
* Clinical evidence of target ulcer infection
* Current systemic therapy with cytotoxic drugs.
* Current therapy with chronic (\> 10 days) oral corticosteroids.
* Previous treatment with NPWT device or hyperbaric oxygen within 7 days of screening.
* Malignancy in the target ulcer, or history of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers)