cyrilzakka/clinical-trials huggingface dataset:
Ibuprofen Versus Mecillinam for Uncomplicated Cystitis

Although uncomplicated cystitis is considered to be a mild condition and mostly self limiting, most patients who see a doctor will be treated with antibiotics. Antibiotics are known to give a quick relief of symptoms and shorten the course of the condition by a few days. The aim of this study is to evaluate ibuprofen versus mecillinam in the treatment of uncomplicated cystitis in otherwise healthy, non-pregnant women. Our main objective is to see whether symptomatic treatment with ibuprofen is equally efficient as treatment with mecillinam in this group.

The design of the study will be a double blinded randomized controlled trial (RCT). Half of the patients will receive treatment with mecillinam and the other half will receive treatment with ibuprofen. The study will follow the principles of Good Clinical Practice (GCP).

Urine cultures will be obtained on day one and after two weeks. The patients will be given a diary where they daily will register symptom load, possible complications or adverse effects and on which day they feel completely cured. We will contact the patients after two weeks to make sure they have followed the study procedures. After four weeks we will perform a final interview with the patient.

Eligibility Criteria:
Inclusion Criteria:

* woman between 18 and 60 years of age
* dysuria and pollakiuria and/or urinary urgency
* ability to give written consent

Exclusion Criteria:

* pregnancy/breastfeeding child under one month of age
* diabetes
* kidney disease
* organic aciduria
* clinical suspicion of pyelonephritis; fever, reduced general condition, upper back pain
* vaginal symptoms such as discharge or irritation
* severe abdominal pain
* symptoms that have lasted for more than seven days
* one or more urinary tract infections within the lasts four weeks
* permanent bladder catheter or use of bladder catheter within the last four weeks
* use of antibiotics within the last two weeks
* participated in a clinical trial within the last four weeks
* previously undergone a pyelonephritis
* previous allergic reaction to penicillin
* previous allergic reaction to ibuprofen, or worsening of asthma when using nonsteroidal antiinflammatory drugs(NSAIDs)
* narrow oesophagus
* use of the drug probenecid
* severe gastritis or previous ulcer
* anticoagulative treatment
* ongoing use of steroids
* use of immunosuppressant drugs
* thrombocytopenia,
* Chrohn's disease or Ulcerative colitis
* heart insufficiency
* severe psychiatric illness or dementia
* severe drug addiction
* unable to communicate in Norwegian, Swedish or Danish language
Edoxaban Treatment in Routine Clinical Practice for Patients With Non-Valvular Atrial Fibrillation (NVAF)

In order to understand the risks and benefits of edoxaban use in a real-world clinical setting in the NVAF indication, Daiichi-Sankyo Thailand proposed this non-interventional study (NIS) to gain insight into the safety (bleeding, liver adverse events, all-cause mortality and other adverse events) of edoxaban use in non-preselected patients with NVAF.

Edoxaban was recently approved by The Thai Food and Drug Administration (Thai FDA) (date: 2nd December 2016) for the prevention of stroke and systemic embolism in adult patients with NVAF with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischemic attack (TIA). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrent DVT and PE in adults.

In order to understand the risks and benefits of edoxaban use in a real-world clinical setting in the NVAF indication, Daiichi-Sankyo Thailand proposed this non-interventional study (NIS) to gain insight into the safety (bleeding, liver adverse events, all-cause mortality and other adverse events) of edoxaban use in non-preselected patients with NVAF.

Real world evidence data of routine clinical practice use of edoxaban up to 2 years will be collected and evaluated in approximately 300 patients, treated by specialized as well as non-specialized physicians in hospital centres.

Eligibility Criteria:
Inclusion Criteria:

* Is a NVAF-patient whose physician has made the clinical decision to prescribe edoxaban therapy according to Package Information
* Has provided written informed consent to participate in the study

Exclusion Criteria:

* Is participating in an interventional study
Bimatoprost Monotherapy vs. Dual Therapy With Travoprost and Timolol in Patients With Glaucoma and Ocular Hypertension

Evaluate the IOP-lowering efficacy and quality of life in patients using bimatoprost 0.03% monotherapy versus dual therapy with travoprost 0.004% and timolol 0.5% for the treatment of glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* · Male or female \> 18 years of age

  * Diagnosis of primary open-angle glaucoma or ocular hypertension
  * Untreated IOP \> 18 mm Hg in each eye at the baseline evaluation
  * Ability to provide informed consent and likely to complete all study visits

Exclusion Criteria:

* · Known contraindication to bimatoprost, travoprost, timolol, or any component of any study medication

  * Uncontrolled systemic disease
  * Active ocular disease other than POAG or ocular hypertension
  * Required use of ocular medications other than the study medications during the study (intermittent use of OTC artificial tear products will be permitted)
  * History of intraocular surgery within the last 3 months
  * Patient must not have discontinued use of any medication included in this study in the past for reasons of efficacy or intolerance
Caregivers Preparing for Their Own Health Care Emergency

The proposed research will develop and test an online Emergency Preparedness Toolkit to help caregivers prepare for their own unexpected health events. Caregivers of persons with dementia often ignore their own health needs as their primary focus is the care of the person with dementia. This can lead to a caregiver delaying their own care and subsequently emergent health events. The Emergency Preparedness Toolkit provides guidance to the caregiver as to how to identify and transfer care to a standby caregiver. The goal is to provide a caregiver with the security and comfort that the person with dementia will be well cared for while they care for their own health needs.


Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years of age or older at the time of signing the informed consent
* Must self-identify as the spouse or partner of the PWD
* Must provide some caregiving to a PWD
* Must live in the same dwelling as the PWD

Exclusion Criteria:

* Diagnosis of dementia
* Unable to use or does not have access to a computer
* Complete deafness or blindness and/or unable to use a telephone
* Condition that prevents them from performing caregiving duties or providing physical/emotional support to the PWD
* Unable to follow directions
* Unable to read or write in English
* Participation in prior study involving the EPT
Non-Invasive Brain Stimulation to Control Large-Scale Brain Networks

This project will assess the feasibility of traveling wave transcranial alternating current stimulation (tACS) to modify working memory performance and large-scale brain connectivity in surgical epilepsy patients.


Eligibility Criteria:
Inclusion Criteria:

1. the patient can consent for themselves;
2. the patient has or is scheduled for surgically implanted electrodes for the purposes of phase II epilepsy surgical evaluation;
3. age 18+ years old;

Exclusion Criteria:

1. diminished capacity to consent;
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Intravenous and Multiple Subcutaneous and Intravenous Doses of PF-06480605 in Healthy Subjects.

This single and multiple ascending dose study is a first in human assessment of PF-06480605. The goal is to study the safety, tolerability, pharmacokinetics and pharmacodynamics.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects of non childbearing potential between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
* Female subjects of non childbearing potential must meet at least one of the following criteria:

  1. Achieved postmenopausal status, defined as: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle stimulating hormone (FSH) level within the laboratory's reference range for postmenopausal females;
  2. Have undergone a documented hysterectomy and/or bilateral oophorectomy;
  3. Have medically confirmed ovarian failure. All other female subjects (including females with tubal ligations and females that do NOT have a documented hysterectomy, bilateral oophorectomy and/or ovarian failure) will be considered to be of childbearing potential.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
* X-ray with no evidence of current, active TB or previous inactive TB, general infections, heart failure, malignancy, or other clinically significant abnormalities taken at Screening or within 3 months prior to Day 1 and read by a qualified radiologist.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Subjects with a history of or current positive results for any of the following serological tests: Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), anti Hepatitis C antibody (HCV Ab) or human immunodeficiency virus (HIV).
* Subjects with a history of autoimmune disorders.
* Subjects with a history of allergic or anaphylactic reaction to a therapeutic drug.
* History of tuberculosis or active, latent or inadequately treated tuberculosis infection.
* Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half lives or 180 days for biologics preceding the first dose of study medication.
* Pregnant females; breastfeeding females; and females of childbearing potential.
Evaluation and Training of Muscle Fitness in Pre-frail Individuals

Muscle strength and endurance are important indexes of fitness. The muscle strength is the most important single predict factor of functional ability in aged frail individuals. Frailty related muscle weakness and fatigue are adapted from the pre-frail stage. Finding the contributions of the central and the peripheral factors to the deficits of muscle fitness and developing an effective muscle fitness training program for pre-frail individuals are very important.

The muscle weakness and fatigue can be categorized into peripheral or central causes. The central fatigue and voluntary activation failure originate from the decrease in motivation or the reduction of the conduction within corticospinal tracts. Long term activation failure and central fatigue will cause disuse of muscle and result in peripheral weakness and peripheral fatigue. Studies found the selective type II fiber atrophy in aged people and this finding was different from the type I atrophy in conventional immobilization models. It is possible that the activation failure leads to the recruitment failure of high threshold type II fibers at the pre-frail stage. Quantifying the weighting of central versus peripheral factors contributing to the exercise limitation in pre-frail people is important.

Most of the conventional strength and endurance training programs are based on the researches of young groups. These programs are not able to prevent people become frail. It is possibly that, due to the limitation of central fatigue, the pre-frail individuals stop exercise before the effective intensity being achieved. Almost no training program has been design for enhancing the voluntary activation level and relief the central fatigue. Seeking an appropriate training program to enhance central activation at the pre-frail stage is very important for preventing people become frail.

Previous studies have shown that increasing afferent input by peripheral electrical stimulation (ES) at sensory threshold enhanced the plasticity of contralateral primary sensory cortex, the excitability of corticospinal tracts, and the functional performance in young adults. ES, which is easy to quantify the dose of afferent input, is a feasible method to be used in training. Combining afferent input with strength training might be able to overcome the central activation failure and help recruit high threshold motor unit in pre-frail individuals.


Eligibility Criteria:
Health subjects:

Exclusion Criteria:

Musculoskeletal injuries for knee. Osteoporosis. Diabetes.
NGS vs Culture Outcomes for Treatment of PJI

This multicenter, randomized controlled trial will compare the use of NGS and traditional culture in directing antimicrobial treatment for patients with periprosthetic joint infection.


Eligibility Criteria:
Inclusion Criteria:

* Adults (age \> 18 years)
* Undergoing single stage revision or 1st stage resection arthroplasty/spacer placement for PJI (ICM-positive) of the hip or knee
* Written informed consent

Exclusion Criteria:

* Ongoing participation in another clinical trial
* Megaprosthesis
Comparison of the Blood Sugar Lowering Effect of Biphasic Insulin Aspart 30 and Insulin Glargine Both Combined With Metformin and Glimepiride in Chinese and Japanese Subjects With Type 2 Diabetes New to Insulin Treatment

This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood sugar lowering effect of biphasic insulin aspart 30 once daily compared to insulin glargine once daily both in combination with metformin and glimepiride in Chinese and Japanese subjects with type 2 diabetes who have never received insulin before.

The trial is conducted as a phase 4 trial in China and phase 3 in Japan.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes treated with a maximum of three different types of oral anti-diabetic drugs (OADs) (including traditional Chinese medicine which contains active ingredients of known OADs) for more than 6 months
* Unchanged total daily dose of at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) metformin for the last two months
* Unchanged total daily dose of at least half maximum recommended total daily dose of any insulin secretagogue for the last two months
* Insulin naive
* HbA1c between 7.0% and 10.0%
* FPG (fasting plasma glucose) equal to or above 6.1 mmol/L (110mg/dL)
* Body Mass Index (BMI) below 40.0 kg/m\^2

Exclusion Criteria:

* Treatment with any thiazolidinedione (TZD) and GLP-1 (glucagon like peptide-1) receptor antagonists during the last 3 months before Visit 1 in this trial
* Any disease or condition which the Investigator feels would interfere with the trial
* Any contraindication to metformin or glimepiride (according to local labelling)
Fecal Microbiota Transplantation (FMT) in Patients With Advanced Gastric Cancer

This study is a randomized, double-blind and placebo-controlled study. The purpose of this study is to evaluate the efficacy and safety of FMT capsules combined with chemotherapy and anti-PD-L1 therapy in the advanced gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

Voluntarily participate in this study and provide written informed consent. Age ≥ 18 years , male or female. Pathological confirmed locally advanced, unresectable or metastatic gastric adenocarcinoma, esophagogastric junction adenocarcinoma.

Able and willing to provide tumor tissue. At least one measurable extracranial target lesion according to iRECIST. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. Life expectancy ≥3 months.

Exclusion Criteria:

Presence of absolute contra-indications to FMT administration:Toxic megacolon;Inflammatory bowel disease;Anatomic contra-indications to colonoscopy;Colectomy Patient is currently participating and receiving other study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of this study intervention.

Currently under any form of systemic antibiotics. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (\> 10 mg prednisone daily or equivalent) or any other form of immunosuppressive therapy two weeks prior to trial treatment. Patients receiving systemic steroids at physiologic doses are permitted to enroll assuming steroid dose is not above the acceptable threshold (\> 10 mg prednisone daily or equivalent).

Severe anaphylactic reaction to any food (food allergies). Had a severe hypersensitivity reaction to propofol. Has serious concomitant illnesses. The eligibility can be granted by the treating investigator on individual bases.

Has HIV infection or AIDS-related illness. Has active infection of HAV, HBV or HCV. Patients with a history of Hepatitis B/C infection who have received anti-viral therapy and are disease free may be considered for enrollment after discussion with Principal Investigator.

Patient has received a live vaccine within 4 weeks prior to the first dose of treatment. Seasonal influenza vaccines or COVID-19 vaccines for injection are generally inactivated virus vaccines and are allowed.

Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

Females who are pregnant or breastfeeding. Active central nervous system (CNS) metastases and/or leptomeningeal involvement
Hemodynamic Assessment During Spinal Anesthesia Using Transthoracic Echocardiography'

Rationale: Spinal anesthesia is a safe, frequently used anesthetic technique. The main side effect of spinal anesthesia is hypotension, occuring in up to 85 % of selected cases. This hypotension is often treated with fluid infusion. However, especially in elderly patients, high volume fluid infusion can lead to fluid overload.

The effects of spinal anesthesia on preload and fluid responsiveness are not exactly known. Hence, therapy for hypotension after spinal anesthesia might not be adequate. With transthoracic echocardiography, vena cava inferior diameter and collapsibility can be used to monitor fluid responsiveness and guide fluid management.

Objective: This study has two main objectives. The first is to explore the effects of spinal anesthesia on hemodynamic parameters of fluid status, especially vena cava inferior diameter and collapsibility. The second goal is to test the interrater variability transthoracic echocardiography exams when performed by (trained) anesthesiologists.

Furthermore, the correlation between vena cava inferior collapsibility and the occurence and degree of hypotension (defined as a decrease from baseline of \>20% or a systolic pressure \< 90 mmHg) after spinal anesthesia will be explored.


Eligibility Criteria:
Inclusion Criteria:

* Adult age (\>18 years)
* Written informed consent
* Minor surgery under the umbilicus, e.g. herniorrhaphy, transurethral resection of bladder or prostate, orthopaedic procedures
* ASA class I or II

Exclusion Criteria:

* No informed consent
* ASA class III or higher
* Obstetric surgery
* Emergency procedures
* Pre-existing neurological injury or disease
* Contra-indications for spinal anesthesia (e.g. coagulation abnormalities)
incidenCe and predictOrs of heaRt fAiLure After Acute coronarY Syndrome: CORALYS

Single-cohort retrospective study evaluating the incidence and prognostic markers of heart failure following acute coronary syndrome treated by percutaneous coronary intervention

Acute coronary syndrome (ACS) is the most common cause of heart failure (HF) world-wide. Primary percutaneous coronary intervention (PCI) has deeply improved short and long-term survival after ACS, but his impact on incidence of downstream heart failure still remains unclear and heart failure after ACS represents the major driver of late morbidity, mortality and healthcare cost.

Many predictors and determinant of heart failure after MI have been evaluated, however, to date, the optimal combination of parameters to predict heart failure after MI needs to be defined and very little is known about the prognostic markers in unstable angina setting

The aim of this retrospective study:

* to show the incidence of heart failure after acute coronary artery syndrome, and the relation between the type of ACS and following incidence of HF.
* to clarify which features could be routinely identified as prognostic markers. This study is a multi-center non-randomized, single-cohort retrospective study including consecutive patients with acute coronary syndrome treated by percutaneous coronary intervention between 2017 and 2019, without known previous heart failure (baseline EF \> 40% and no medical therapy with loop diuretics), with at least 12 months of follow-up.

It is possible to anticipate that the main findings of the present study will fill fundamental knowledge gaps regarding incidence of heart failure following coronary events.

Among this, the study could suggest specific clinical and epidemiological features related to the risk of development of HF, leading to a better medical treatment and reducing risk for further hospitalizations.

Eligibility Criteria:
Inclusion Criteria:

* • Informed consent

  * Age ≥ 18 years
  * Previous acute coronary syndrome with percutaneous coronary revascularization
  * Baseline EF \> 40%
  * At least 12 months of follow-up

Exclusion Criteria:

* • Significant valvular heart disease (greater than mild stenosis or moderate regurgitation) before ACS

  * Type 1, 3, 4, 5 pulmonary hypertension (14) before ACS
  * Constrictive pericarditis before ACS
  * Primary or infiltrative cardiomyopathies
  * Heart transplantation
  * Medical therapy with loop diuretics for heart failure before ACS
  * Previous hospitalizations for heart failure or clinical sign of heart failure detected outpatient before ACS
Long-term Follow-up of Prophylactic Mesh Reinforcement After Emergency Laparotomy.

Observational Study analyzing the long-term results of prophylactic mesh used for preventing incisional hernia after emergency midline laparotomies.

Background. Prevention of incisional hernias with a prophylactic mesh in emergency surgery is controversial. The present study aimed to analyze the long-term results of prophylactic mesh used for preventing incisional hernia after emergency midline laparotomies.

Methods. This study was a retrospective analysis of patients who underwent an emergency midline laparotomy between January 2009 and July 2010 with a follow-up period of longer than 2 years. Long-term outcomes and risk factors for the development of incisional hernias between patients who received a prophylactic reinforcement mesh (Group M) and suture (Group S) were compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing emergency midline laparotomy

Exclusion Criteria:

* Those with need of concomitant hernia repair.
* Those who received incisions outside the midline.
* Those with delayed abdominal closure.
* Those who died in the immediate postoperative period.
* Those without a minimum 2 years of follow-up.