cyrilzakka/clinical-trials huggingface dataset:
Folic Acid Supplement Versus Placebo for Treating Mucositis Adverse Events in Metastatic Renal Cell Carcinoma Patients Receiving Targeted Therapy

FASTERCC: Folic acid supplement versus placebo for treating mucositis adverse events in metastatic renal cell carcinoma patients receiving targeted therapy. A randomized, double-blind trial from the Danish renal cancer group (DARENCA study-4)

Mucositis (nasal, oral, pharyngeal, anal, or genital) is often experienced in relation to TKI, immunotherapy or mTOR inhibitor treatment in mRCC patients.

The present trial will assess whether 12 weeks complementary treatment with folic acid in mRCC-patients receiving TKI- or mTOR inhibitor treatment or immunotherapy and displaying CTCAE mucositis grade ≥2 can reduce the degree of mucositis, compared to PLACEBO.

This is a randomized, double-blind, placebo-controlled phase II trial of the effectiveness of folic acid supplement for 12 weeks on mucositis. Both arms will receive best supportive care. No crossover is allowed.

The investigators anticipate a 96-month accrual period. The power calculation indicates a total of 50 patients per group are required.

Block randomization based on received TKI/ mTOR inhibitor/IT-treatment will be performed.

Eligibility Criteria:
Target population: Patients with inoperable, locally advanced, or metastatic renal cell carcinoma.

Inclusion Criteria:

1. Patients displaying CTCAE ≥2 mucositis during TKI, mTOR inhibitor or immunotherapy treatment.
2. Signed written informed consent obtained prior to any study specific procedures.
3. Patient must be willing and able to comply with the protocol.
4. Age ≥ 18.
5. Biopsy proven locally advanced or metastatic renal cell carcinoma.
6. Females with a negative serum pregnancy test unless childbearing potential can be otherwise excluded (postmenopausal, hysterectomy or oophorectomy) and not lactating.
7. Fertile women of childbearing potential (\<2 years after last menstruation) and men must use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgical sterilization).
8. Karnofsky Performance status ≥ 60%.

Exclusion Criteria:

1. Known hypersensitivity to folic acid.
2. Use of prednisolone more than 10 mg daily.
Comparative Effects of Levator Ani Release and Post Isometric Relaxation Among Patients With Coccydynia

To compare the effects of levator ani release and post isometric relaxation on pain, disability and quality of life among patients with coccydynia

Coccygodynia, also known as coccalgia, coccygeal neuralgia, or tailbone pain, is the word used to describe the pain symptoms that develop in the coccyx region. The discomfort is typically brought on while the person is sitting down, but it can also start when the person stands up. The majority of instances get well within a few weeks to months, but for certain people, the pain might last longer and have an adverse effect on quality of life. Due to the complexity of coccygeal pain in these people, management can be challenging.

The aim of the study is to compare effects of levator ani release exercises and post isometric in patients with coccydynia. A randomized control trial will be conducted at Jinnah hospital Lahore through convenience sampling technique on 46 patients which will be allocated through simple random sampling through sealed opaque enveloped into group A and group B. Group A will be treated with levator ani release exercises and Group B will be treated with post isometric relaxation techniques. Outcome measure will be conducted through pain and disability questionnaire at baseline and after 4 weeks. Data will be analyzed using SPSS software version 21. After assessing normality of data by Shapiro - wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.

Eligibility Criteria:
Inclusion Criteria:•

* Both gender
* Age between 20-40 years
* Drivers
* Office workers
* Computer users
* Both gender
* Age between 20-40 years
* Drivers
* Office workers
* Computer users

Exclusion Criteria:

* Neurological disorders,
* Bone deficits,
* Vascular abnormalities,
* Rheumatoid arthritis
* Ankylosing spondylitis
* Fracture
* Tumor
Customized Crosslinking: Safety and Efficacy in an Epithelium-off Accelerated-pulsated Protocol for Thin Keratoconus

The goal of this clinical trial is to document corneal ectasia stability in patients with keratoconus diagnosis treated with personalized cross linking energy. The main questions it aims to answer are:

* Is it effective while using personalized (reduced) energy?
* Is it safe for corneas thinner than 400 microns? Participants will be treated with personalized energy corneal cross linking and posteriorly, will attend subsequent follow-up consults


Eligibility Criteria:
Inclusion Criteria:

* Keratoconus diagnosed with corneal tomography/topography
* Thinnest point pachymetry below 400 microns

Exclusion Criteria:

* Previous corneal cross linking history
* Corneal scars not allowing best corrected visual acuity of 20/100 or better
* Previous corneal hydrops history
* Psychomotor retardation history
Prospective Study With Adjunctive Once Daily Topical Nepafenac 0.3% Versus Placebo

Prospective, randomized, double-masked, placebo-controlled clinical study to define the effective use of a topical non-steroidal anti-inflammatory drug added to topical steroid use after uncomplicated phacoemulsification for the prevention of pseudophakic cystoid macular edema.


Eligibility Criteria:
Inclusion Criteria:

* Subjects, 18 and older subjects with visually significant cataracts and were to undergo phacoemulsification with implantation of an intracapsular positioned intraocular lens.

Exclusion Criteria:

* previous uveitis (\<1 year) previous anterior segment intraocular surgery hypersensitivity or allergy to NSAIDs
Effectiveness Study of Atrial Fibrillation

This is an international observational multicentre study to be conducted in Germany, Spain, Italy and USA. The main objective of the study is to evaluate the relative effectiveness of dronedarone in real world clinical practice versus other anti-arrhythmic agents of interest. The design of the study is a historic-prospective cohort with dynamic exposure and stratified competitive recruitment with balanced comparison groups of dronedarone versus alternative antiarrhythmic drugs of interest.


Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years old or above
* Patient with paroxysmal or persistent atrial fibrillation
* Patient using an AAi (antiarrhythmic drug of interest) or dronedarone (index drug)
* Patient's treatment changed from one AAi to another AAi or dronedarone OR from no antiarrhythmic therapy to the start of AAi or dronedarone therapy during previous 6 months before the date of recruitment
* Patient with at least 6 months of medical and treatment information prior to the start of the index drug
* Patient able to answer the telephone interview in a language of the participating country: English, German, Italian or Spanish (with or without proxy).

Exclusion Criteria:

* Patient with heart failure (NYHA class IV)
* Patient with permanent Atrial Fibrillation
* Patient with psychiatric conditions preventing the participation to the study according to the physician
Effect of Varying the Protein and Dietary Fiber Content of Energy Bars on Their Glycemic and Insulinemic Impact

The purpose of this study was to determine the effect of changing the amounts of resistant starch, whey protein and sugar on the blood glucose and insulin responses elicited by energy bars. The investigators also compared the glucose and insulin responses to the rates at which the food bars were digested in-vitro (in the test tube). The investigators thought increasing resistant starch and reducing sugar would reduce the glucose and insulin responses, and that adding protein would reduce glucose and increase insulin. The investigators also thought the glucose and insulin responses in people would be related to the rate of digestion of the food bars in-vitro.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index 20.0 to 34.9 kg/m²
* Fasting serum glucose \<7.0mmol/L
* Non-smoker

Exclusion Criteria:

* Known to have diabetes
* Use of medications or presence of a medical condition considered by the principal investigator to increase risk to the participant or affect the results
* Known food allergy of any kind
FAPI PET/CT in Various FAP-Related Disease Patients

To evaluate the potential usefulness of 68Ga/18F-FAPI positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various FAP-related disease patients.

Subjects with various FAP-related disease patients underwent 68Ga/18F-FAPI PET/CT either for an initial assessment or for recurrence detection. Lesions uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga/18F-FAPI PET/CT were calculated.

Eligibility Criteria:
Inclusion Criteria:

* (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled FAPI PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

* (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Non-invasive Neustimulation and Respiratory Rehabilitation

Introduction: Respiratory diseases are associated with high rate of morbidity and mortality in Brazil. Cardiopulmonary rehabilitation through respiratory muscle training, aerobic training and strengthening of upper and lower limbs emerges as one of the resources available for the treatment and monitoring of patients with respiratory diseases. To add in this perspective, the application of HD-tDCS induces significant neurophysiological and clinical effects in several body systems.

Objective: To identify the chronic effects of non-invasive neurostimulation associated with the rehabilitation of patients with respiratory disorders. Material and methods: This is a pilot study, quantitative, clinical trial type, randomized and controlled, double blind. The sample will be composed by patients with respiratory diseases, aged above 18 years old. The study will consist of two groups: (1) HD-tDCS will be applied - anodic current + respiratory rehabilitation with respiratory muscle training (RMT) and (2) Sham - Only respiratory rehabilitation with RMT without any type of cortical stimulation. The chronic effects of neurostimulation by HD-tDCS associated with cardiopulmonary rehabilitation, with TMR, during 12 sessions will be evaluated. Patients will be evaluated, before and after the protocol, in relation to cortical activation function, pulmonary function, subjective perception of effort, respiratory muscle function, functional capacity, sensation of dyspnea and quality of life. For statistical analysis, intention-to-treat analysis will be used and groups will be compared using Student's t-test, for continuous variables, or chi-square, for categorical variables. ANOVA split-plot, repeated measures for primary outcomes. Analyzes of covariance to identify differences between groups using baseline scores as covariates. Effect sizes and confidence intervals will be calculated using eta squared (η²). Expected results: Neurostimulation would enhance the effects of respiratory rehabilitation and reduce the symptoms of patients with these diseases.


Eligibility Criteria:
Inclusion Criteria:

* confirmed clinical diagnosis for respiratory disease;
* stable disease

Exclusion Criteria:

* develop disabling condition that prevents the implementation of the protocol;
* join another rehabilitation program
Role of Fenofibrate in Indirect Neonatal Hyperbilirubinemia: a Randomized Control Trial

Fenofibrate accelerates bilirubin conjugation and excretion, decreasing the side effects of prolonged unconjugated hyperbilirubinemia in neonates. It also reduces the duration of phototherapy and thus the duration of stay in the hospital. This research is carried out to improve standard protocol for the management of neonatal hyperbilirubinemia in the local settings.

Complete history and examination will be carried out while patients will be screened for enrollment. After taking informed consent, eligible patients will be selected and divided into two groups A and B by lottery method. Demographics like name, age (hours), gender, birth weight, and gestational age will be noted. Solutions will be prepared in the required strengths and labeled accordingly. Groups A will receive Solution A i.e. Fenofibrate suspension is prepared by dissolving 200 mg capsule in 10 ml distilled water and given as a single dose of 10mg/kg (0.5 ml/kg) and Group B will receive solution B i.e. 0.5ml/ kg normal saline as a placebo. Both groups will receive LED phototherapy under standard conditions. The serum bilirubin level will be noted at the time of admission and then at 12hr, 24hr, and 48 hours of treatment. All this information will be recorded on proforma.

Eligibility Criteria:
INCLUSION CRITERIA:

* Gestational age ≥ 35 weeks
* Birth weight ≥ 2 kg
* Age: 2-7 days of life
* Total serum bilirubin level ≥15mg/dl and ≤20 mg/dl

EXCLUSION CRITERIA:

* Neonates with total bilirubin \>20mg/dl
* Conjugated bilirubin level greater than 15% of total serum bilirubin
* Maternal hyperbilirubinemia (on medical record)
* Babies with congenital anomalies (on clinical examination)
* Those not consenting to participate in the study
The Safety, Tolerability and Pharmacokinetic Study of Yimitasvir in Healthy Adults Subjects

The Safety, Tolerability and Pharmacokinetic Study of Chronic Hepatitis C Treatment Drug Yimitasvir in Healthy Adults Subjects.

This was a Randomized，Double-blind, Placebo-controlled, Single Ascending Dose, Single-center Study to Assess the Safety, Tolerability and Pharmacokinetic of Yimitasvir in Healthy Adults Subjects

A total of 56 healthy subjects were divided into 7 groups, with each group consisting of 8 subjects. Six of the subjects received the investigational drug, and two received placebo. All of the subjects received a single dose.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, overall healthy subjects;
* Between 18 and 45 years of age, inclusive, similar ages;
* Body weight should be≥50 kg; Body Mass Index (BMI) is between 19 and 25 kg/m2, inclusive, similar body weights;
* Able to comprehend and sign the ICF voluntarily prior to initiate the study;
* Able to communicate well with the investigator and complete the study according to the protocol.

Exclusion Criteria:

* Pregnant or nursing female, or plan for pregnancy within 6 months;
* Female with positive urine pregnancy test results;
* Positive test results for HBsAg, anti-HCV Ab, anti-HIV Ab or syphilis;
* Have taken any drug inhibiting gastric acid secretion within 1 month prior to study drug administration, such as: H2 receptor antagonists (eg: Cimetidine, Ranitidine, Famotidine, Nizatidine and Roxatidine); Proton pump inhibitors (eg: Omeprazole, Lansoprazole, Rabeprazole, Pantoprazole and Esomeprazole); cholinoceptor blocking drugs (eg: Atropine and Pirenzepine);
* History of immune system disease (such as thymus disease);
* Have undergone major surgery within 6 months before enrollment;
* History of tumor;
* Drink frequently within 6 months prior to study drug administration, namely alcohol consumption are more than 20 grams per day;
* Smokers, who smoke more than 1 cigarettes/day within 3 months before the study;
* Participated in any clinical trial within 3 months prior to the study;
* Cannot be tolerant to oral drugs.
Comparing Treatment Efficacy With High and Medium Dose of Fluticasone in Combination With Salmeterol in COPD Patients

This study is to investigate and compare treatment efficacy with high and medium dose of fluticasone in combination with salmeterol in COPD patients.

Diagnosis and criteria for inclusion and exclusion:

Inclusion:

1. Male or female outpatients aged 40 years≧
2. Current or ex-smoker, with smoking history 10 pack≧- years
3. COPD (FEV1/FVC \< 70%) patients with post-bronchodilator FEV1 70% ≦predicted value, without bronchial reversibility (10% increase post ≦bronchodilator)

Exclusion:

1. Diagnosis or suspicion of sleep apnea.
2. Concurrent rhinitis, eczema, and asthma.
3. Clinically overt bronchiectasis, lung cancer, active tuberculosis, or other known specific pulmonary disease.
4. A chest X-ray indicating diagnosis other than COPD that might interfere with the study.
5. Major disease abnormalities are uncontrolled on therapy.
6. Alcohol or medication abuse.
7. Patients had lower respiratory tract infections or received systemic steroid in the 4 weeks prior to the commencement of study.
8. Unable or unwilling to comply with all protocol

Test product:

fluticasone125 mcg/salmetrol 25 mcg ( Seretide 125 Evohaler ) fluticasone250 mcg/salmetrol 25 mcg ( Seretide 250 Evohaler ) Formulation: fluticasone/salmeterol, 125/25 mcg/puff Dose: 2 puffs bid

Eligibility Criteria:
Inclusion Criteria:

1. Male or female outpatients aged 40 years≧
2. Current or ex-smoker, with smoking history 10 pack≧- years
3. COPD (FEV1/FVC \< 70%) patients with post-bronchodilator FEV1 70% ≦predicted value, without bronchial reversibility (10% increase post ≦bronchodilator)

Exclusion Criteria:

1. Diagnosis or suspicion of sleep apnea.
2. Concurrent rhinitis, eczema, and asthma.
3. Clinically overt bronchiectasis, lung cancer, active tuberculosis, or other known specific pulmonary disease.
4. A chest X-ray indicating diagnosis other than COPD that might interfere with the study.
5. Major disease abnormalities are uncontrolled on therapy.
6. Alcohol or medication abuse.
7. Patients had lower respiratory tract infections or received systemic steroid in the 4 weeks prior to the commencement of study.
8. Unable or unwilling to comply with all protocol
A Knowledge Translation Intervention for TB/HIV Treatment Adherence, in Zomba District, Malawi

Despite increased emphasis on evidence based practice in recent years a gap remains between evidence and practice, particularly in resource poor countries. Few studies to date have examined the use of knowledge translation strategies to improve health care outcomes in low income countries. However, given that the majority of health care in these settings is provided by workers with less training and limited resources, the theoretical potential for knowledge translation strategies to improve health care delivery and outcomes by integrating best evidence into routine practice may be greatest in these settings.

Knowledge translation (KT) is an approach to changing health care provider behavior to reduce the gap between evidence and practice in health care delivery. There has been a tendency for knowledge translation interventions to employ generic, "off the shelf", strategies, and apply them to deal with specific issues. This generic approach, fails to recognize the variability in the specific characteristics of health care settings, in terms of their patient populations, health care systems, and health care providers. These characteristics, whether they function as barriers or facilitators to change, make a generalized approach to KT ineffective, where a tailored strategy, which specifically adjusts its approach to measured local barriers and facilitators may achieve better alignment of practice to evidence. This is likely to be particularly true in low income countries where the majority of health care is provided by non-physician health care workers, working within a wider range of health care systems, with variable and unique patient populations and resource constraints. Given the potential to significantly impact health care outcomes at relatively low cost, further research is needed both to develop methods for identifying potential barriers and facilitators to KT strategies in specific resource poor settings, and to evaluate the effectiveness of KT strategies tailored to address the identified barriers.

This study will assess the effectiveness of a two part knowledge translation intervention tailored to address factors identified in a previous study as functioning as barriers and facilitators to treatment adherence among patients on treatment for tuberculosis or combined tuberculosis and antiretroviral treatment, targeting improved patient adherence and health outcomes, in a specific low income country.


Eligibility Criteria:
Inclusion Criteria:

* All health centers in Zomba District
Heparin Binding Protein as a Prognostic Biomarker of Sepsis Severity

the aim of the study is to correlate between the severity of sepsis and serum heparin binding protein in the patients admitted to ICU with sepsis., and detect its value as a prognostic biomarker in sepsis


Eligibility Criteria:
Inclusion Criteria:

* adult whose age between 20 to70 years old
* patients suffered from sepsis or septic shock (under the third international consensus definition of sepsis and septic shock)

Exclusion Criteria:

* Any pregnancy female
* Any patient who is Neutropenic secondary to malignancy
* Patients who is taking immunosuppressive therapy
* Patients who is suffering fromHematological malignancy
EEG-characteristics of Neuropsychiatric Symptoms in Chronic Pain

Chronic pain is a challenge for patients, physicians and society due to its high prevalence and its substantial individual and socio-economic burden.

In recent years, innovative EEG-techniques have been used to study rhythmic brain activities in a variety of neuropsychiatric populations and in chronic pain and various abnormalities in neuronal oscillation patterns and connectivity between brain regions have been observed. However, it remains unclear whether these alterations of brain activity in chronic pain patients reflect pain characteristics like intensity, duration or type (e.g. neuropathic pain), or whether they reflect other symptoms associated with chronic pain.

Neuropsychiatric comorbidities and cognitive deficits of chronic pain are being increasingly recognized, as they frequently cause substantial problems in social life and hinder patients from being able to work. However, it has not been studied yet whether neuronal oscillations and connectivity patterns in the brains of chronic pain patients covary with neuropsychiatric comorbidities (e.g. depression, anxiety, fatigue) and cognitive functioning.

To this end, the investigators will obtain resting state EEG data in large cohort of patients with chronic pain and assess clinical characteristics of chronic pain including a variety of neuropsychiatric symptoms as well as working memory capacity as a proxy for cognitive functioning.

Results from this study will offer valuable insights into and a better understanding of brain dysfunction of patients suffering from chronic pain. This can be helpful for diagnostic and therapeutic advances (e.g. brain stimulation and neurofeedback methods) in the near future.


Eligibility Criteria:
Inclusion Criteria:

* Chronic pain condition
* Willing and able to sign informed consent for study participation

Exclusion Criteria:

* Severe concomitant neurological or psychiatric disease
* Primary headache condition