cyrilzakka/clinical-trials huggingface dataset:
A Study of the Safety and Tolerance of Regadenoson in Subjects With Renal Impairment

This study is intended to assess the safety and tolerance of regadenoson in subjects with renal impairment.


Eligibility Criteria:
Inclusion Criteria:

* Subject has a Stage III or Stage IV renal impairment based on the National Kidney Foundation (NKF) Kidney Disease Outcomes Quality Initiative (K/DOQI) glomerular filtration rate (GFR) classification
* Subject has a diagnosis of Coronary Artery Disease (CAD) or risk factors for CAD as determined by a current medical diagnosis of at least 2 of the following conditions: Type 2 diabetes, hypertension, hypercholesterolemia, current or history of cigarette smoking (minimum 10 pack-years exposure) or obesity (Body Mass Index (BMI) \> 30)
* Subject must abstain from smoking 3 hours prior and 8 hours post study drug administration
* Subject must abstain from any intake of foods and beverages containing a methylated xanthine derivative (i.e. caffeine, theobromine, or methylxanthine) within 12 hours prior to study drug administration through the Follow-Up visit, as these foods may reduce the effects of regadenoson derivative (i.e. caffeine, theobromine, or methylxanthine) within 12 hours prior to study drug administration through the Follow-Up visit, as these foods may reduce the effects of regadenoson

Exclusion Criteria:

* Subject has a history of an additional clinically significant illness, medical condition, or laboratory abnormality within 2 weeks prior to Screening
* Female subject who is pregnant, lactating or of childbearing potential who refuses to use a medically acceptable form of contraception until the Follow-Up visit is complete
Elite Sport and Development of Asthma

International studies have shown that elite athletes have a high prevalence of respiratory symptoms and asthma as compared to normal subjects. It is unclear whether the increased prevalence of asthma in elite athletes reflects "traditional asthma" or whether it is a special form of "sports asthma". The treatment of elite athletes with asthma seems to vary widely, and only a few studies have focused on the treatment of elite athletes with asthma. Further knowledge of the pathogenesis of sports asthma would lead to a greater understanding and better treatment of the condition. This study will investigate the type of airway inflammation in elite athletes and examine the effect of treatment with inhaled steroids in combination with long-acting beta-agonists versus placebo in the same group.


Eligibility Criteria:
Inclusion Criteria:

* Elite athletes
* Informed consent
* Doctor diagnosed asthma

Exclusion Criteria:

* Current smoker or more than 10 pack-years
* Pregnancy, breast feeding or planning pregnancy during the study.
* ICS within the last 4 weeks prior to visit 1.
Alternative Measurements of Cough Pressure and Effects of Epidural Anaesthesia on Cough Pressure

Pressure generated by cough is an expression of expiratory muscle strength. Cough pressure (Pcough) is usually measured with gastric and/or esophageal catheters, but these are often either inconvenient or uncomfortable for the patient. The aim of this study was to evaluate whether central venous, vesical or rectal catheters could be useful to measure cough pressures as alternative sites to standard esophageal and gastric balloons.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 75 years and scheduled for colon cancer surgery were recruited.
* Informed consent signed.

Exclusion Criteria:

Rectal surgery, advanced cancer, abdominal wall disorders, respiratory or neuromuscular illness, body mass index \> 30, chronic pain, pregnancy and inability to cough adequately.
Systematic Initiative to Increase Activity in Schools

This initiative is a prospective study evaluating the effects of implementing physical activity strategies in Wisconsin schools with low socioeconomic status on childhood fitness.

This initiative is a prospective study evaluating the effects of implementing physical activity strategies in Wisconsin schools with low socioeconomic status on childhood fitness. Forty-nine schools participated in the study providing de-identified fitness data for students for 3 consecutive years. Twenty-five schools initiated physical activity interventions in year one and 24 schools initiating physical activity interventions in year two.

Eligibility Criteria:
Inclusion Criteria:

* all children between 3rd and 8th grade

Exclusion Criteria:

* children who could not perform PACER (exercise)
Compare The Effectiveness of SCT and PNF In Children With Cerebral Palsy

This study will evaluate the comparative effectiveness of Spider Cage Therapy (SCT) and Proprioceptive Neuromuscular Facilitation (PNF) in managing motor impairments in children with cerebral palsy (CP). Cerebral palsy often leads to motor deficits that limit movement and impair functionality.

SCT and PNF are therapeutic interventions that target these motor challenges but use distinct approaches. Spider Cage Therapy will involve the use of elastic cords within a supportive frame (the "spider cage") to stabilize the child, enhancing postural control and enabling dynamic movement training. This approach is expected to improve balance and alignment, promoting functional mobility. In contrast, PNF will focus on neuromuscular reeducation through specific movement patterns intended to enhance strength, coordination, and flexibility. By comparing SCT and PNF, this study aims to identify their respective impacts on motor function improvements, particularly in gross motor skills, balance, and postural stability, potentially guiding future rehabilitation protocols for children with CP.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 4-12 years.
* Clinical diagnosis of cerebral palsy.
* Classified within Gross Motor Function Classification System (GMFCS) levels I to III.
* Ability to follow instructions and participate in therapy sessions.

Exclusion Criteria:

* Severe cognitive impairments hindering participation.
* Severe musculoskeletal deformities or recent surgeries.
* Other medical conditions contraindicating participation in physical therapy.
Psychometric Testing and Cue Utilization During Cued Visual Search

The experimenters will examine the relationship between utilization of positive (target cue) and negative (distractor cue) templates during a cued visual search task with performance on a set of measures related to executive functions associated with attentional control: shifting, updating, and inhibition.

The experimenters will utilize the typical procedures for the cued attentional task, while also deploying the Miyake executive function analysis. Data will also include a working memory capacity measure.

Eligibility Criteria:
Inclusion Criteria:

* Normal or corrected-to-normal visual acuity, normal color vision

Exclusion Criteria:

* age
Effects of Prebiotic Oral Healthcare Products as an Adjunct to Non-surgical Periodontal Therapy

The aim of this study is to determine the impact of a prebiotic toothpaste and mouthrinse in periodontitis patients as an adjunct to scaling and rootplaning.

The aim of this study is to determine the impact of a prebiotic toothpaste and mouthrinse in periodontitis patients as an adjunct to scaling and rootplaning. Study design: this study will be a single centre (Department of Oral Health Sciences, University Hospitals Leuven), double blind, randomized, placebo controlled clinical trial. The randomization (by means of a computer program) and double blind design are thought to minimize the bias of the investigator and patients. Study population: adults, who consult at the department of Periodontology at the University Hospital Leuven and who fit the inclusion criteria will be asked to participate in this study.

Eligibility Criteria:
Inclusion Criteria:

* 40 patients
* ≥ 36 years of age

  - Page 4 of 4 \[DRAFT\] -
* No previous scaling and rootplaning
* Clinical diagnosis: severe generalized periodontitis characterized by the presence of \> 14 affected teeth when \> 14 teeth are present (if number of teeth present is \< 14, 8-14 teeth need to be affected) with an attachment loss of \> 6mm prior to initial non-surgical periodontal therapy.
* A minimum of 3 natural teeth in every quadrant
* Willing and able to give written informed consent

Exclusion Criteria:

* Patients with aggressive periodontitis or necrotizing periodontitis
* Patients who smoke
* Pregnant or lactating woman
* A history of diabetes, rheumatic fever, liver or kidney disease, neurological deficiencies, or use of medication which may affect periodontal tissue, (phenytoin, cyclosporin, nifedipine, chronic use of non-steroidal antiinflammatory drugs)
* Patients with poorly controlled diabetes
* Patients taking bisphosphonate mediation
* Patient who have taken systemic antibiotics 3 months prior to treatment
Screening of Gastric Cancer Via Breath Volatile Organic Compounds by Hybrid Sensing Approach

The study is aimed to determine the potential of volatile marker testing for gastric cancer screening.

The study will be addressing the role of confounding factors, including lifestyle factors, diet, smoking as well as addressing the potential role of microbiota in the composition of exhaled volatile markers.

Patients with established disease (gastric cancer, precancerous lesions) as well as patients investigated for the lesions and having been documented lack of the lesions will be enrolled to the study at clinical sites in Europe (Latvia, Ukraine) and Latin America (Colombia, Chile, Brazil). In addition, group of persons from general population at average risk for developing the target disease and individuals being referred for upper endoscopy according to clinical indications will be also enrolled.

Testing of volatile markers will be conducted by one of two methods: 1) gas chromatography coupled to mass spectroscopy (GS-MS) and 2) sensor technology. Various sensors will be used and evaluated for the purpose.

The potential sources of volatile organic compounds (VOCs) in the breath will be addressed by studying VOC emission by using headspace analysis from cancer tissue, gastric contents, cancer cell cultures and H.pylori.

The potential role of gastric and faecal microbiota in the origin of VOCs in the breath will be addressed. Metabolome in the circulation will also get correlated to VOCs in the breath and with microbiome.

Eligibility Criteria:
Inclusion Criteria:

* Patients with verified gastric cancer (Group 1 \& 2)
* Patients undergoing or having undergone upper endoscopy according to clinical indications (Group 3 \& 5)
* Average-risk population group aged 40-64 at inclusion without alarm symptoms (Group 4)
* Motivation to participate in the study
* Physical status allowing volatile marker sampling and other procedures within the protocol
* Signed consent

Exclusion Criteria:

* Known other active cancer
* Ventilation problems, airway obstruction
* Unwillingness or inability to co-operate
Vaginal Isonicotinic Acid Hydrazide Prior to Diagnostic Office Hysteroscopy in Primarily Infertile Patients

To compare the effectiveness of vaginal isonicotinic acid hydrazide with placebo in minimizing the pain experienced by primarily infertile patients during diagnostic ofﬁce hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the hysteroscopist.

hysteroscopy is commonly used in the diagnosis and treatment of intrauterine lesions such as polyps, ﬁbroids, septa, and adhesions, and in the presence of abnormal bleeding and during the removal of an intrauterine device or foreign body. Cervical ripening is made possible by the use of medication through different routes.

Eligibility Criteria:
Inclusion Criteria:

* nulliparous women with primary infertility requiring a diagnostic hysteroscopy as a part of an infertility diagnosis workup

Exclusion Criteria:

* women with suspected pregnancy
* heavy vaginal bleeding
* recent pelvic infection
* those known to have hypersensitivity or contraindication to isonicotinic acid hydrazide
* those who received analgesics prior to office heavy vaginal bleeding
* recent pelvic infection
* a concomitant neurologic disease that could affect the correct evaluation of pain
A Trial of Lipitor (Atorvastatin) for the Treatment of Polycystic Ovary Syndrome (PCOS) in Women With Elevated Low-density Lipoprotein (LDL) Cholesterol

The purpose of this study is to determine the efficacy of Lipitor (Atorvastatin) for the treatment of PCOS with elevated LDL cholesterol.

The investigators hypothesize that improving the lipid profile with atorvastatin will improve vascular function, increase the frequency of ovulation, decrease androgen levels, improve insulin sensitivity, and improve the lipid profile more efficiently than placebo.

Eligibility Criteria:
Inclusion Criteria: Women with PCOS

* 8 or fewer menstrual periods per year
* elevated serum total testosterone
* elevated LDL cholesterol

Exclusion Criteria:

* current pregnancy or breastfeeding
* current use of oral contraceptives, progestins
* insulin sensitizing medications
* thyroid disease, hyperprolactinemia, active liver disease, type 1 or type 2 diabetes
A Study to Evaluate ONM100, an Intraoperative Fluor Imaging Agent for the Detection of Peri Mets

Peritoneal carcinomatosis (PC) results from the metastasis of a primary cancer of the peritoneum (e.g., appendiceal, ovarian, uterine, colorectal, and gastric cancers) that then disseminates throughout the abdominal cavity. Historically progression to PC was considered terminal and resulted in survival times on the scale of a few months with palliative care being the best option for patients. More recently, cytoreductive surgery (CS) has emerged as a means to prolong and improve patient lives with a median increase in survival of up to \~5 years. It has been reported that for every 10% increase in cytoreduction there is a 5.5% increase in median survival time. In addition to surgical tumor debulking within the peritoneal space, it has also been shown that coupling surgical intervention with hyperthermic intraperitoneal chemotherapy (HIPEC) can have an even greater impact on patient outcomes. Pegsitacianine, a micellar fluorescence agent, exploits the ubiquitous pH differences observed between cancerous and normal tissues. This in turn, provides a highly sensitive and specific fluorescence response after localizing within the tumor microenvironment, thus allowing the detection of primary tumors, their margins, metastatic disease, and tumor-containing lymph nodes.


Eligibility Criteria:
Inclusion Criteria:

* Imaging and biopsy confirmed metastatic disease of peritoneal origin

Exclusion Criteria:

* Known hypersensitivity or allergy to any component of pegsitacianine
* Tumor locations the surgeon deems unfeasible to image intraoperatively
* Excessive and/or generalized metastatic disease deemed inoperative by the surgeon
Measuring Fear of Physical Activity in Patients With Heart Failure

The study's aims are twofold: First, to examine physiological correlates of fear of physical activity (PA) and second, to examine correlates between fear of PA and interoceptive abilities in patients with chronic heart failure and healthy persons. Patients' fear of PA will be assessed via the "Fear of Activity in Situations - Heart Failure" (FActS-HF) questionnaire. The patient group will be split into two subgroups: One with high fear of PA and the second with low fear of PA based on FActS-HF scores. Fear of PA will be assessed via an adapted version of FActS-HF in a sample of healthy persons (control group). Each member of the high-fear-of-PA group will be individually age- and sex-matched with one member of the low-fear-of-PA group and control group. The participants of all three groups undergo the same experimental trials.

Aim 1: The "startle paradigm" will be used to investigate the physiological component of fear of PA. The startle paradigm is based on empirical observations that the startle reflex is larger after the priming with unpleasant stimuli and inhibited after the priming with pleasant stimuli. The participants will be primed with various words including those words associated with physical activity that are expected to be unpleasant in patients with high fear of PA. The startle reflex will be triggered by air puffs on the eyes (startle probes) and measured via facial electromyography (EMG). We assume that startle responses primed with PA related words are stronger in patients with high fear of PA compared to the other groups.

Aim 2: Interoceptive accuracy will be assessed via the "Schandry test" and interoceptive awareness will be assessed via the "Multidimensional Assessment of Interoceptive Awareness" (MAIA) questionnaire. During the Schandry test the participants will be instructed to subjectively count their heart rate without any aid or tools. The heart rate will be objectively measured at the same time via ECG. A high congruence of the objective and subjective results indicates a high interoception ability, and is assumed to be correlated with fear of physical activity. Additionally, we expect the MAIA and FActS scores to be correlated.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Heart Failure stage B or C (Hunt et al., 2005), or: New York Heart Failure classification II to IIIb

  1. Systolic dysfunction: left ventricular ejection fraction \< 45% in the last 6 month
  2. Diastolic dysfunction: left ventricular ejection fraction \>= 45% in the last 6 month

Exclusion Criteria:

* complex ventricular arrhythmias
* acute myocarditis
* symptomatic cardiac valve stenosis
* instable angina pectoris
* other severe diseases, that impair physical activity (e.g. advanced stages of cancer)
* insufficient language skills in German to answer the questionnaires
* insufficient cognitive skills to answer the questionnaires
Study to Compare Efficacy and Safety of ABP 501 and Adalimumab (HUMIRA®) in Adults With Moderate to Severe Plaque Psoriasis

The purpose of this research study is to compare the efficacy and safety of ABP 501 and adalimumab (HUMIRA®) in adults with plaque psoriasis.


Eligibility Criteria:
Inclusion criteria:

1. Men or women ≥ 18 and ≤ 75 years of age at time of screening
2. Stable moderate to severe plaque psoriasis for at least 6 months before baseline
3. Moderate to severe psoriasis defined at screening and baseline by:

   Body surface area (BSA) affected by plaque psoriasis of 10% or greater, and PASI score of 12 or greater, and static physician's global assessment score of 3 or greater
4. No known history of active tuberculosis
5. Subject is a candidate for systemic therapy or phototherapy procedures
6. Previous failure, inadequate response, intolerance, or contraindication to at least 1 conventional anti-psoriatic systemic therapy

Exclusion Criteria:

1. Forms of psoriasis or other skin conditions at the time of the screening visit (eg, eczema)
2. Ongoing use of prohibited treatments
3. Prior use of 2 or more biologics for treatment of psoriasis
4. Previous receipt of adalimumab or a biosimilar of adalimumab

Other Inclusion/Exclusion criteria may apply
Study Efficacy and Safety in Comparative Use of Investigational Product Adjuvant Treatment in Onychomycosis

Single-center study, single blind, comparative with the objective of evaluating the efficacy and safety of an investigational product as an adjunct in the treatment of onychomycosis improvement of 90 days ± 2 days.


Eligibility Criteria:
Inclusion Criteria:

* Volunteers of both sexes;
* Volunteers aged 18-65 years;
* Volunteers with onychomycosis confirmed by positive direct mycological nail of hands or feet;
* Agreement to comply with the test procedures and attend the clinic in the days and times for certain applications and / or assessments;
* Understand, consent and sign the Instrument of Consent of Clarified.

Exclusion Criteria:

* Pregnancy or risk pregnancy / lactation;
* Use of anti-inflammatory / immunosuppressive drugs (in the last 30 days and during the study);
* Concomitant nail pathologies (psoriasis, lichen planus, etc.);
* Systemic conditions that may compromise the growth of the nail (vascular disease, diabetes, etc.);
* Irritation History to similar products to the investigational product;
* Treatment with antifungal medication prior to the study (up to 12 weeks for systemic medications and topical medications for four weeks);
* Other conditions considered by the investigator physician as reasonable for the disqualification of the individual's participation in the study.
Infectious Mediastinitis Among the Strasbourg Universitary Hospital

Mediastinitis are rare but serious infections, with mortality rates varying from 6 to 30% according to the literature. They are essentially linked to surgical management (cardio-thoracic in particular), but some forms can be spontaneous, after extension of an ENT infectious focus, for example.

Despite their seriousness, there is no strong recommendations to define their management, especially concerning antibiotic therapy and its duration.

The aim of this research is to make a descriptive analysis of the cases of mediastinitis at HUS in recent years, and to study the therapeutic strategy used


Eligibility Criteria:
Inclusion Criteria:

* Major subject (≥18 years old)
* Subject diagnosed with mediastinitis between 01/01/2010 and 31/12/2020
* Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.

Exclusion Criteria:

* Subject having expressed opposition to participate in the study
* Subject under guardianship, curatorship or safeguard of justice
Clinical Trial to Evaluate the Efficacy and Safety of 'DW1601' in Acute Bronchitis

A Multicenter, Randomized, Double-Blind, Parallel, Active-controlled, Superiority, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DW1601 Compared to DW16011 and DW16012 for Acute Bronchitis


Eligibility Criteria:
Inclusion Criteria:

* Both gender, 19 years ≤ age ≤ 80 years
* Bronchitis Severity Score\* ≥ 5point at Visit 2 (Randomized Visit)
* Acute bronchitis within 48hr based on Visit 2 (Randomized Visit)
* Those who can comply with the requirements of clinical trials
* Written consent voluntarily to participate in this clinical trial

Exclusion Criteria:

* Patients who investigators determines to severe respiratory disease that would interfere with study assessment
* Patients with systemic infections requiring systemic antibiotic therapy
* patient with hemostatic disorder
Physiotherapy Assessment of Patients Referred to Orthopaedic Surgeon

Many patients with musculoskeletal pain in primary healthcare are referred to orthopaedic surgeon, however, a relatively low percentage of these patients are considered suitable for orthopaedic intervention.

Physiotherapists are suitable for musculoskeletal assessments and are used as such in many countries i.e. Advanced Practice Physiotherapists or Extended Scope Physiotherapists, however, this is not an existing model of care in Sweden. To be able to consider this model for implementation in Sweden it is necessary to evaluate it from a healthcare as well as from a patient perspective.

The study is a randomised controlled trial. Overall aim is to evaluate if a orthopaedic manual therapy assessment (physiotherapy) assessment of patients referred to orthopaedic surgeon bring any changes to referral routines, patient satisfaction and health-related variables when compared to standard practice.

The study is a randomised controlled trial. Overall aim is to evaluate if a orthopaedic manual therapy assessment (physiotherapy) assessment of patients referred to orthopaedic surgeon bring any changes to referral routines, patient satisfaction and health-related variables when compared to standard practice. Patients were randomised to either physiotherapy assessment or standard practice (orthopaedic surgeon assessment).

Eligibility Criteria:
Inclusion Criteria:

* patients referred for orthopaedic surgeon with sub acute (four weeks to three months) or chronic (\>three months) musculoskeletal pain who had the ability to understand written and spoken Swedish.

Exclusion Criteria:

* diagnosed hallux valgus, ganglion or trigger finger.