cyrilzakka/clinical-trials huggingface dataset:
Study With Palonosetron Alone in Preventing Chemotherapy-induced Nausea and Vomiting in Untreated Patients With Aggressive Non Hodgkin's Lymphomas Who Underwent Moderately Emetogenic Chemotherapy

This is an open-label, multicenter phase II study in patients with aggressive Non Hodgkin Lymphoma scheduled to receive moderately emetogenic polychemotherapy (according to modified Hesketh classification for antiemetic therapy).


Eligibility Criteria:
Inclusion Criteria:

* Male or female, \>18 years of age;
* Histologically or cytologically confirmed aggressive NHL (any stage in accordance with the REAL Classification);
* Patients candidates to a initial chemotherapy treatment;
* ECOG performance status of 0-1;
* Scheduled to receive a single intravenous dose of at least one of the moderately emetogenic agents (according to the modified Hesketh classification) on Day 1;
* Written informed consent;
* Female of childbearing potential must be using reliable contraceptive measures;
* Acceptable hepatic and renal functions;
* Willing and able to complete the patient diary.

Exclusion Criteria:

* Highly emetogenic chemotherapy (containing cisplatin, mechlorethamine, streptozotocin, cyclophosphamide \>1500 mg/sqm; carmustine; dacarbazine; hexamethylmelamine; procarbazine), or single-agent chemotherapy with drugs having low/minimal emetogenic potential according to the Hesketh classification);
* Diagnosis of Hodgkin's Disease or Leukemia;
* Candidates to High-Dose Chemotherapy or Bone Marrow/Peripheral Blood Stem Cells Transplantation;
* Chemotherapy schedules considering the administration of emetogenic drugs in more than two consecutive days;
* Have received any investigational drugs within 30 days before study entry;
* Have received any drug with potential anti-emetic efficacy (with the exception of specific corticosteroids foreseen in the chemotherapy combination) within 24 hours of treatment initiation);
* Prior treatment with Palonosetron;
* Have a seizure disorder requiring anticonvulsant medication unless clinically stable and free of seizure activity;
* Experienced or ongoing vomiting or nausea from any organic etiology, in the screening phase;
* Clinical evidence of current or impending bowel obstruction, peritonitis, infection, uremia, severe mucositis;
* Clinically relevant electrolyte abnormalities;
* Have a known hypersensitivity to 5HT3 receptor antagonists;
* Radiotherapy within 30 days before chemotherapy administration, or scheduled to receive radiotherapy within two weeks after chemotherapy;
* Female patients who are pregnant or breast feeding;
* Inability to understand or cooperate with the study procedures.
Unsaturated Fatty Acids Enriched-diet to Improve Cardiorespiratory Fitness, Metabolic Flexibility and Glucose Tolerance in Obese Patients

The investigators hypothesize that a dietary intervention aimed at increasing unsaturated fatty acids (UFA) consumption is feasible and has the potential to improve cardiorespiratory fitness, metabolic flexibility and glucose tolerance in symptomatic obese heart failure with preserved ejection fraction (HFpEF) patients.

Twelve obese HFpEF subjects with exercise intolerance (reduce cardiorespiratory fitness measured at maximal cardiopulmonary exercise test \[CPX\]) will be assigned to a single-arm open-label dietary intervention in which subjects are encouraged and financially supported to increase daily UFA consumption. The investigators will measure dietary compliance with a validated 24-hour dietary recall and with objective operator-independent biomarkers of UFA consumption.

The investigators will also measure the effects of UFA supplementation on: metabolic flexibility, glucose tolerance and body composition. Participants will have the option to participate in overnight session in the whole indirect calorimeter room (WIC) at baseline and at the end of the study.

Eligibility Criteria:
Major Inclusion Criteria:

* Body Mass Index (BMI) ≥30 kg/m2 (obesity) or total body fat percentage \>25% in men and \>35% in women
* A confirmed clinical diagnosis of stable HF (New York Heart Association \[NYHA\] class II-III) on maximally tolerated heart failure (HF) optimal medical regimen (without major changes in the prior month)
* Left Ventricular Ejection Fraction (LVEF)\>50% documented in the prior 12 months

Major Exclusion Criteria:

* Concomitant conditions or treatment which would affect completion or interpretation of the study (i.e.,physical inability to walk or run on treadmill);
* Significant ischemic heart disease, angina, uncontrolled arterial hypertension, atrial fibrillation, moderate to severe valvular disease, chronic pulmonary disease, anemia (Hemoglobin\<10 g/dL)
* Electrocardiography (ECG) changes (ischemia or arrhythmias) that limit maximum exertion during cardiopulmonary exercise test
* Comorbidity limiting survival
* Stage IV-V kidney disease (estimated Glomerular Filtration Rate\<30)
* Fluid overload
* Pregnancy
* Current use of unsaturated fatty acids (UFA) supplement (i.e., omega-3).
* Inability to give informed consent
Single Ascending Dose Study of PRX002 in Healthy Subjects

This single ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX002 in approximately 40 healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* Body mass index (BMI) between 18-32 kg/m2 with a minimum weight of 46 kg
* Female subjects must be surgically sterile or post-menopausal or if of child-bearing potential must use contraception
* Male subjects and their partners of childbearing potential must use contraception

Exclusion Criteria:

* Positive test for drug of abuse
* Past or current history of alcohol abuse
* Positive for hepatitis B, hepatitis C or HIV infection
Effectiveness of Muscle Energy Technique (MET) Versus Stretching Exercises In Acute And Subacute Postural Neck Pain

This study will provide better evidence that which technique is more effective in acute and subacute postural neck pain. To find out the effectiveness of Muscle energy technique (MET) and stretching exercises in acute and subacute postural neck pain.

Study Design: Randomized Controlled Trial Study Setting: The study will be conducted at the Institute of Physical Medicine and Rehabilitation, Dow University of Health Sciences, Karachi, Pakistan.

Intervention: This study will identify effects of two intervention approaches. The Experimental group consists of muscle energy technique (MET) for upper trapezius and levetor scapulae muscle of neck. The Control group will receive a stretching exercises program for upper trapezius and levetor scapulae muscle of neck.

Eligibility Criteria:
Inclusion Criteria:

* Targeted population: Students of MBBS, Pharmacy and Doctor of physical therapy.
* Age between 18 and 30 years
* Patient having acute or subacute postural neck pain
* Acute postural neck pain should not last longer than 4weeks
* Subacute postural neck pain should not last longer than 4-12 weeks.

Exclusion Criteria:

* Cervicogenic headaches
* Musculoskeletal disorders involve the nerve root compression, i.e.; (Intervertebral disc dysfunction and derangement syndrome)
* Whiplash associated disorders
* Fibromyalgia
* Spinal cord injury
* Neurological disorders i.e.; (Multiple sclerosis, Young Parkinsonism etc.)
A Study to Evaluate the Efficacy and Safety of AK120 in Subjects With Moderate to Severe Atopic Dermatitis

This is a multicenter, open label phase II clinical study to evaluate the efficacy and safety of AK120 in the treatment of subjects with moderate to severe atopic dermatitis.

This is a multicenter, open label phase II clinical study to evaluate the efficacy and safety of AK120 in the treatment of subjects with moderate to severe atopic dermatitis. The total duration of the study (including screening period, treatment period and follow-up period) planned for each subject is approximately 25 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects aged ≥18≤75 years old.
2. Atopic dermatitis (AD) diagnosed at least half a year before screening.
3. Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline.
4. Subjects who are suitable for continue using biological treatment assessed by investigator

Exclusion Criteria:

1. Acute onset of AD within 4 weeks before drug administration.
2. The accompany disease have been assessed by the investigators during screening period as unsuitable for participation in this study.
3. Any history or symptoms of malignant tumors in any organ within 5 years prior to screening, regardless of whether treatment has been received and whether there are signs of recurrence or metastasis
4. Have a known or suspected history of immunosuppressive diseases, including a history of invasive infections.
5. Having undergone or planned major surgery within 4 weeks prior to drug administration, or unable to fully recover from surgery prior to drug administration.
6. any medical or psychological condition that puts subjects at risk or may affect the study results assessed by investigators.
Comparison of Safety and Efficacy of Four-Point Scleral Intraocular Lens Fixation and Yamane Techniques

Comparison of safety and efficacy of two scleral fixation intraocular lens (IOL) methods of four-point scleral fixation ( Akreos AO60) and the Yamane technique (AcrySof MA60AC)

Purpose of the study is to compare two methods of scleral fixation of IOL: two-point fixation of AcrySof MA60AC IOL (Alcon) using Yamane technique and four-point fixation of the Akreos AO60 IOL (Bausch \& Lomb) using polypropylene suture. The investigators rated the BCVA, refractive outcomes, intraocular pressure, and also determined intra- and postoperative complications.

Eligibility Criteria:
Inclusion Criteria:

* only adult men and women with aphakia without capsular support

Exclusion Criteria:

* Fuchs' dystrophy
* corneal haze or scarring
* history of corneal transplantation
* astigmatism of more than 2,0D
* clinically active uveitis
* advanced glaucoma
* macular diseases that affect visual acuity (age-related macular degeneration, diabetic maculopathy)
Influence of Triflusal on Cognitive Functions in Subjects Under Chronic Stress

The purpose of this study is to investigate the effects of the eNOS activating agent triflusal on episodic memory and cognitive functions in participants under chronic stress.

Randomised, placebo controlled, double blind, cross-over design

Primary study outcome is:

Performance in a verbal memory task.

Main secondary outcomes are: Performance in working memory and cognitive tasks and influence on mood, depression and anxiety and subjective memory impairment.

Once daily oral administration of 600 mg triflusal and placebo mannitol for 8 days in a cross-over trial with a washout period of at least 14 days between the two periods. Each participant will take triflusal as well as placebo

Eligibility Criteria:
Inclusion Criteria:

* male or female
* normotensive (BP between 90/60mmHg and 140/90mmHg)
* BMI between 19 and 29 kg/m2
* aged between 18 and 40 years
* experiencing chronic stress for at least 1 month (TICS sum score in subscale "overextension at work" \>= 55)
* native or fluent German-speaking
* able and willing to give written informed consent as documented by signature and comply with the requirements of the study protocol
* willing to donate saliva sample for DNA-analysis
* female: willing to perform a pregnancy test at the beginning of both medication phase and at the follow-up visit.

Exclusion Criteria:

* Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to salicylates and other NSAIDs
* acute or chronic psychiatric disorder (e.g. major depression, psychoses, somatoform disorder, suicidal tendency) except symptoms of chronic stress
* cognitive impairment as detected by DemTect
* concomitant acute or chronic disease state (e.g. renal failure, hepatic dysfunction, cardiovascular disease, acute infections etc.)
* women who are pregnant or breast feeding
* intention to become pregnant during the course of the study
* lack of safe contraception, defined as: female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases
* active peptic ulcer or antecedents or complicated peptic ulcer or history of peptic ulcer. Any other active pathological bleeding
* history of coagulation abnormality
* thyroid problems
* laboratory exclusion criteria: clinically significant values of blood count (incl. platelets), coagulation status or blood chemistry outside reference range of laboratory
* pathological ECG
* known or suspected non-compliance, drug or alcohol abuse
* inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* participation in another study with investigational drug within the 30 days preceding -
Therapeutic Strategy in Advanced Bronchioloalveolar Carcinoma

To evaluate among patients with untreated advanced ADC-CBA, impact on the disease control rate after 4 months treatment of an early therapeutic permutation with the first month in the absence of stabilization or objective answer.


Eligibility Criteria:
Inclusion Criteria:

* CBA histologically proven (or cytologically with pneumonic presentation) PS \< 3 signed and written informed consent

Exclusion Criteria:

* visible tumoral lesion in bronchial fibroscopy
Clinical and Laboratory Predictors of Respiratory Morbidities in CP Children

Relationship between respiratory morbidities and cerebral palsy in children

Identification of symptoms,signs,severity and outcomes of respiratory morbidities in children with Cp

Eligibility Criteria:
Inclusion Criteria:

* children with CP from 1 month to 18 years

Exclusion Criteria:

* neonates with Cp CP patients more than 18 years old
A Study of Motexafin Gadolinium (MGd) in Combination With Docetaxel and Cisplatin for Treatment of Non-Small Cell Lung Cancer (NSCLC)

The purpose of the study is to determine the dose limiting toxicities and maximum tolerated dose of motexafin gadolinium when administered with docetaxel and cisplatin in patients with Non-small Cell Lung Cancer.

A cycle consists of 3 weeks. During week 1, patients receive MGd, docetaxel, and cisplatin treatment followed by 2 weeks without treatment.

Eligible patients will receive 1 or 2 doses of MGd, depending on cohort, and a single dose of docetaxel and cisplatin at 75 mg/m² during the first week of each cycle. Additionally, tumor response will be evaluated at the end of even numbered cycles (2, 4, and 6). Patients may stay on the study a maximum of 6 cycles.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* ECOG score of 0, 1, or 2
* Histologically confirmed diagnosis of non-small cell lung cancer

Exclusion Criteria:

Laboratory values demonstrating inadequate function of the following:

* Bone marrow
* Kidneys
* Liver

and

* Peripheral neuropathy Grade 2 or higher
* Greater than 2 prior chemotherapy regimens
A MOBILE APPLICATION DEVELOPED FOR CHILDREN WITH URINARY INCONTINENCE

The study included 2 stages: In the first, a mobile application with content including urotherapy training and patient follow-up was developed. In the second, a pilot study with the developed mobile application was carried out with 10 children.

The study include two stages. In the first, a mobile application was developed that can be used by children with urinary incontinence and their parents. The mobile application includes the training on urinary incontinence and urotherapy in children as well as all the test results of the child and ensures the follow-up of the children's compliance with the treatment. The developed mobile application is operatable on smartphones and tablets with Android and IOS operating systems.

This was followed by the second phase, during which the mobile application developed was pilot tested with 10 children. Based on the feedback received from the users, the mobile application was finalized.

Mobile application development process

1. Content Creation For Goals
2. Interface design development on MS Word and Photoshop
3. Evaluation by specialists for content and design
4. Converting to mobile application on Android and IOS platforms
5. A pilot study with 10 children to evaluate the usability and suitability of the application
6. Get feedback on the mobile app
7. Based on this feedback, the mobile application was revised.
8. Its final version was created

Eligibility Criteria:
Inclusion Criteria:

* The child has day and/or night urinary incontinence,
* The child is between 7-12 years of age,
* Family members and children can use mobile applications,
* Family members have a smartphone,
* The child and family members volunteers to participate in the study.

Exclusion Criteria:

* The child has a mental or neurological disability,
* The child has a developmental delay,
* The child has previously received treatment for urinary incontinence,
* The child has a communication problem,
* The child has a history of surgery related to the urinary tract,
* The child has a psychiatric diagnosis,
* The child has a urinary tract infection,
* The child has a radiological pathology on ultrasound,
* The child has a diagnosis of neurogenic bladder.
A Rollover Study for Patients Who Received Tremelimumab in Other Protocols, to Allow the Patients Access to Tremelimumab Until This Agent Becomes Commercially Available or Development is Discontinued.

This study is intended to provide access to tremelimumab for patients who have previously received tremelimumab in a clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* The subject must have already received tremelimumab in another protocol
* Females of childbearing potential must agree to practice a form of effective contraception for 12 months following any dose of study drug. The definition of effective contraception will be based on the judgement of the investigator.
* Subject must be willing and able to provide written informed consent and to comply with scheduled visits and other trial procedures

Exclusion Criteria:

* None
Validation of the ApneaScan Algorithm in Sleep Disordered Breathing

Sleep disordered breathing, in which patients my breath deeply, shallowly or stop breathing for periods whilst asleep, is common in heart failure and associated with a poor prognosis. This study aims to validate a novel function available on certain pacemakers which is designed to detect this condition.The investigators hypothesize that ApneaScan can accurately detect moderate to severe sleep disordered breathing in patients with heart failure as compared against an Embletta sleep study. The investigators will also follow up our patients for 2 years to determine whether the severity of sleep disordered breathing as assessed by ApneaScan correlates with prognosis.

72 patients with heart failure with reduced ejection fraction (HFREF) who have been selected to receive an Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy Pacemaker or Defibrillator (CRT-P/D) will undergo pre-implant assessment with an echocardiogram, B-type Natriuretic Peptide (BNP) level, 6 minute walk test, Minnesota living with heart failure and Epworth sleepiness questionnaires. The patients will then have the device implanted. 6 to 8 weeks later the patent will undergo an Embletta home sleep study and download of the ApneaScan data from the device. The mean Apnoea-Hypopnoea Index (AHI) from the ApneaScan download will be compared with that derived from the sleep study. The patients will also have a repeat 6 minute walk test, echocardiogram and BNP level.

2 years after device implantation, all patients will be followed up to document deaths, hospital admissions, Atrial Fibrillation (AF) burden and appropriate therapies from ICD devices.

Eligibility Criteria:
Inclusion Criteria:

* Heart failure with reduced ejection fraction (EF \< 40%)
* Due to receive a device with ApneaScan function
* Able to give informed consent
* Ambulatory

Exclusion Criteria:

* Known sleep disordered breathing on Non-Invasive Ventilation therapy.
Propel Drug-Eluting Sinus Stent Family Open Cohort

The purpose of this study is to confirm the long-term clinical safety and performance, acceptability of identified risks, and to detect emerging risks based on factual evidence for the PROPEL family of products when used according to labeling (in patients with chronic rhinosinusitis (CRS) undergoing sinus surgery). Additionally, this study intends to collect data on use of corticosteroid-eluting implants in the European CRS population. Data collected will be used to ensure continued consistency between clinical data, the information materials supplied by the manufacturer, and the risk management documentation.


Eligibility Criteria:
Inclusion Criteria:

* Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements.
* Patient has or is intended to receive or be treated with an eligible Medtronic product
* Patient is consented within the enrollment window of the therapy received, as applicable

Exclusion Criteria:

* Patient who is, or is expected to be, inaccessible for follow-up
* Participation is excluded by local law
* Patient is currently enrolled or plans to enroll in concurrent drug/device study that may confound the PSR results
An Instrumented Wobble Board to Present the Distribution and Center of Pressure in Dynamic Balance

This study quantified the displacement of the center of pressure in the computer in real time and record this data for future analyzes

The wobble board is an unstable equilibrium platform, constant training on this platform generates an improvement in balance and strengthens the muscles, it is ideal for rehabilitation exercises and balance conditioning. However, these platforms do not provide quantitative data on exercises performed on it. And the force platform that provide this quantitative data is static, offering no difficulty in maintaining balance. In this way, a sensor board wobble board was developed using a conventional wobble board with a plate attached to it, between the plate and the platform are eight strain gauges sensors that are activated according to the position of the force applied on the platform, the values of the sensors are collected by software that demonstrates the point of greatest pressure on the disk and its displacement during the exercises, with this data it is possible to determine the stability of the user and observe their behavior during the exercises.

Eligibility Criteria:
Inclusion Criteria:

* Absence of musculoskeletal alteration in the lower limbs;
* consent form signed by the volunteer;
* with preserved cognitive

Exclusion Criteria:

* Present some impairment of the skeletal muscles of the lower limbs;
* Present cognitive deficit.