cyrilzakka/clinical-trials huggingface dataset:
Low Resistance Venous Blood Flow Restriction Training (LR-VBFRT) on Biceps Brachii Muscle Performance

Resistance training has been widely recognized as an effective stimulus for increasing skeletal muscle size and strength. This study intends to compare the effects of high resistance training without blood flow restriction and the low resistance training with blood flow restriction training on bicep muscle performance.

The study is Randomized Control Trail, which is being conducted in RIPHAH COLLEGE OF REHABILITATION SCIENCES. Sample size of 40 individual was calculated using Epitool with 95% confidence interval (CI) and power 80%. Individual will be screened out according to inclusion criteria. Individuals will be allocated randomly into two groups, 20 in high resistance training group and 20 in low resistance training with blood flow restriction group by sealed envelope method.

High resistance training will be use in control group.Low resistance with blood flow restriction training will be used in experimental group.

Assessment will be done on baseline 2-4 days prior to the intervention and after 8 weeks of training.

Data will be analyzed on SPSS version 21.

Eligibility Criteria:
Inclusion Criteria:

* Males
* Age: 20-28 year
* Body mass index: 18.5-24.9

Exclusion Criteria:

* Vascular Disease
* Upper Limb Pathology Requiring Surgical Intervention
* Upper Limb Musculoskeletal Issues
* Blood Pressure \>140/90
* Coronary Artery Disease
* Venous Thromboembolism
* Congenital Cardiac Diseases
* Syncope, Arrhythmias, Smokers
* Alcohol Use
* Supplements Intake
* whey Protein Intake
Protect - The Impact of a High Protein Diet on Preservation of Muscle Mass

The present study is designed to investigate whether a high protein diet will preserve muscle mass during caloric restriction in older adults.


Eligibility Criteria:
Inclusion Criteria:

* Overweight and obese subjects (BMI 27-40 kg/m2)
* Waist circumference male:≥ 102 cm, female: ≥ 88 cm
* Willingness and ability to comply with the protocol

Exclusion Criteria:

* Renal insufficiency
* Co-morbidities
* Type 1 \& 2 diabetics (Fasting glucose level ≥ 7 mmol/L)
* Cancer
* COPD
* Participation in weight loss program 3 months before the intervention
* Participation of any heavy resistance-type exercise training (\>1 wk) the last 2 y.
* Intentional or unintentional weight loss (\> 3 kg in the last 3 months)
* Severe loss appetite
* Diagnosed allergy to milk products
* Gastric bypass
* Supplements or medication use for weight loss
* Participation in any other intervention trial
* Women can only participate if they are postmenopausal (last period ≥ a year ago)
Imaging of Prostate and Breast Cancer Bone Metastases Using Magnetic Resonance Imaging and Nuclear Medicine Techniques

Prostate and breast cancer continues to be the most common cancer among men and women, respectively. The exact assessment of the cancer spread with detection of possible bone metastasis is crucial for treatment decision. In the current study 50 patients with prostate cancer and 50 patients with breast cancer at high risk for bone metastases or with know metastatic disease will be studied with multiple imaging modalities. Patients will be recruited from the Department of Oncology, Turku University Hospital. Planar bone scintigraphy (BS), single photon emission computed tomography combined with low-dose computed tomography (SPECT/CT), 18F-fluoride positron emission tomography computed tomography (PET/CT) and magnetic resonance imaging (MRI) will be performed to all patients. The primary objective is to determine the diagnostic accuracy of the four imaging modalities. The secondary goal is to calculate the sensitivities and specificities of the four imaging modalities on a patient-to-patient and lesion-to-lesion basis. Based on the results of this study an optimal imaging protocol for detection of prostate and breast cancer bone metastasis will be developed and validated.


Eligibility Criteria:
Inclusion Criteria:

* Age: 40 to 80 years
* Language spoken: Finnish or Swedish
* Performance status: Karnofsky score 70 or better or WHO performance status 2 or better
* Diagnosis: Histologically confirmed prostate or breast cancer
* Mental status: Patients must be able to understand the meaning of the study
* Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff
* strong suspicion of first bone metastatic disease (already diagnosed metastases in other organs, elevated tumor markers, destruction of bone in plain x-ray or otherwise specified reasons
* adjuvant chemo- or endocrine therapy is allowed

Exclusion Criteria:

* Ongoing treatment for metastatic disease
* Contraindications for MRI (cardiac pacemaker, intracranial clips etc.)
* Infections: Patient must not have an uncontrolled serious infection
* Claustrophobia
Music Intervention for Brain-Heart Disease in Myotonic Dystrophy Type 1 (DM1)

The goal of this interventional study is to demonstrate the feasibility and tolerability of Dalcroze music intervention for children with congenital DM1, while providing indications of its effectiveness in improving brain and heart symptoms of DM1. Additionally, information from the collection of biological samples and wearable devices (accelerometer, EEG headband and ECG chest strap) will be used to identify brain-heart biomarkers and outcome measures for use in future research and trials.

Researchers will compare the results of physical and cognitive assessments for each participant to assessments from baseline after 10 weeks of weekly music sessions. Qualitative measures (questionnaires and focus groups) will inform the feasibility of this intervention for this population. The main questions this study aims to answer are:

* Are weekly music education sessions feasible for children with DM1?
* Are weekly music education sessions tolerable for children with DM1?

Participants will:

* Attend 45-minute-long music sessions once weekly for 10 weeks.
* Attend two clinic visits for cognitive and physical assessments.
* Provide blood, saliva, stool and urine samples.
* Use wearable devices both at-home and during music sessions.
* Parents/caregivers of participants will complete questionnaires and participate in three focus groups.


Eligibility Criteria:
Inclusion Criteria:

* Participants between the ages of 6 to 18 with genetically confirmed congenital or infantile-onset myotonic dystrophy type 1 (DM1).
* Participants willing to stay on stable medication from the day of screening to end of study.

Exclusion Criteria:

* Insufficient English language skills to complete required assessments and questionnaires.
* Participant is non-verbal.
* Failure to provide signed informed consent by participant or designated decision maker (i.e. parent, legal guardian or power of attorney).
* Failure to provide signed informed consent by parents/caregivers for dyad participation.
* Participant is not a resident of Canada, due to risk of attrition.
* Patients for whom - in the opinion of the investigator - it would not be safe to participate in the study.
An Observational Study of Avastin (Bevacizumab) in Combination With Paclitaxel in First-Line Treatment in Patients With HER2-Negative Metastatic Breast Cancer

This prospective observational study will evaluate the use in clinical practice, efficacy and safety of Avastin (bevacizumab) in combination with paclitaxel in first line in patients with HER2-negative metastatic breast cancer. Data will be collected from eligible patients for up to 2.5 years.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Locally recurrent or metastatic breast cancer
* No prior treatment for metastatic or locally recurrent disease
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria:

* History or clinical evidence of brain metastases
* Pregnancy
* Uncontrolled hypertension ( systolic \> 150 mmHg and/or diastolic \> 100 mmHg) or clinically significant (i.e. active) cardiovascular disease
* Major surgical procedure or significant traumatic injury within 28 days prior to enrolment
An Exploratory Clinical Trial in Early Stage Huntington's Disease Patients With SEN0014196

The primary objective of this study is to provide biological samples from patients with Huntington's disease to allow characterisation of the pharmacological mechanism of action of SEN0014196.

This study will establish the acute phenotypical and biological effects of repeated dose application of SEN0014196 in patients with Huntington's disease, providing biomaterials for biomarker studies (levels of circulating huntingtin, acetylation status of mutant huntingtin, innate immune markers, transcriptional profiles). Evaluation of phenotypic effects will include UHDRS scores, total functional capacity. Safety assessments will include ECG, vital signs, laboratory safety tests and physical examination.

Eligibility Criteria:
Inclusion Criteria:

* Patients with early Huntington's Disease (age: 18 to 70 years), i.e. genetically confirmed (CAG repeat length ≥36) HD, motor signs of HD (motor score of the UHDRS \> 5) and a TFC of ≥7.
* All patients will have a body weight greater than 50 kg.
* Female subjects must be surgically sterile or post-menopausal, no spontaneous menstruation for at least one year before the first dose, non-lactating and have a negative urine pregnancy test. Male subjects participating in the trial and their female contraception from the time of taking the first dose of the study drug until three months after taking the last dose. This must include a condom or other barrier method.
* All subjects must be capable of providing written informed consent.
* Subjects must have no clinically significant and relevant history that could affect the conduct of the study and evaluation of the data, as ascertained by the Investigator through detailed medical history and screening assessments.

Exclusion Criteria:

* Participation in a study of an investigational drug within 30 days of the baseline visit.
* Subjects with presence of psychosis and/or confusional states.
* Subjects with clinically significant laboratory or ECG abnormalities at Screening.
* Subjects with clinically relevant hematological, hepatic, cardiac or renal disease.
* A medical history of infection with human immunodeficiency virus, hepatitis C and/or hepatitis B.
* Any relevant condition, behaviour, laboratory value or concomitant medication which, in the opinion of the Investigator, makes the subject unsuitable for entry into the study.
* Subjects who have previously received histone deacetylase inhibitors e.g. vorinostat or have participated in a clinical trial using compound suspected of interfering with protein acetylation status.
* A history of malignancy of any type within 2 years prior to screening. A history of surgically excised nonmelanoma skin cancers is permitted.
* Subjects with a significant history of drug allergy as determined by the Investigator.
* Subjects who have a significant history of alcoholism or drug/chemical abuse as determined by the Investigator.
Bioequivalence Study Comparing Artesunate Tablet To Arsuamoon® Tablets (Guilin-China) In Healthy Subjects

The study will determine if artesunate tablet (Pfizer), an antimalarial agent, is pharmaceutically equivalent to Arsuamoon® tablets (Guilin-China).


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive.
* BMI of 18 to 30 kg/m2; and a total body weight \>45 kg (99 lbs).
* An informed consent document signed and dated by the subject or a legally acceptable representative.

Exclusion Criteria:

* Evidence or history of clinically significant abnormalities.
* A positive urine drug screen, history of regular alcohol consumption.
The Effect of Low Dose Ketamine on Narcotic Consumption in Patients Undergoing Laparoscopic Cholecystectomy

This double-blinded randomized control trial aims to analyze the effect of low dose Ketamine on narcotic consumption, in patients undergoing Laparoscopic cholecystectomy.


Eligibility Criteria:
Inclusion Criteria:

* all ASA 1 and 2 patients undergoing Laparoscopic Cholecystectomy electively.

Exclusion Criteria:

* Hepatic and renal disease and ASA 3 and 4 patients.
IVN-CAT-001A Performance of CAST With Different Allergens in Patients With Cat Dander Allergy

Primary objective of the trial:

To determine at which concentration the fusion protein MAT Fel d1 degranulates basophils of cat dander allergic patients, in comparison to a cat dander extract and to Fel d1 alone


Eligibility Criteria:
Inclusion criteria: 1. Patient with Cat Dander Allergy evidenced by positive history 2. Age: 18 to 75 years

Exclusion criteria: 1. Use of oral corticosteroids, Chromoglycin, Ketotifen, or any immunosuppressive drugs within the last 2 months 2. Psychiatric disorder resulting in malcompliance 3. Neg. IgE to Cat dander
A Study of Subcutaneous Mircera for the Treatment of Anemia in Peritoneal Dialysis Patients.

This 2 arm study will compare the efficacy of monthly Mircera and epoetin alfa in peritoneal dialysis patients who self-inject at home or receive in-centre injections. The safety of subcutaneous (sc) Mircera and injection site reactions and patient satisfaction will also be assessed. Eligible patients will be randomized either to receive monthly sc injections of Mircera (and will be switched from sc epoetin alfa) at a starting dose of 120-360 micrograms, or to remain on standard of care sc epoetin alfa. Dose adjustments will be permitted to reach/maintain a hemoglobin level of 10-12g/dL. The anticipated time on study treatment is 3-12 months, and the target sample size is 380 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* chronic kidney disease stage V;
* on peritoneal dialysis for 3 months prior to screening;
* on epoetin alfa sc \>=3 months prior to screening.

Exclusion Criteria:

* patients expecting to change dialysis modality over course of study;
* patients hospitalized during previous 3 months for any clinically significant condition;
* active malignancy;
* bleeding episode necessitating transfusion, or overt gastrointestinal bleeding within 3 months prior to screening;
* transfusion of red blood cells within 3 months prior to screening.
Retention Rate of Self-etch Resin Based Sealant With and Without Prior Sandblasting

The aim of the study is to clinically assess the effect of sandblasting prior to self-etch resin based sealant on its retention after one year follow up.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have existing pits and fissures that are anatomically deep and caries susceptible.
* Stained pits and fissures with minimum decalcification of opacification and no softness at the base of the fissure (ICDAS 1 and 2).

Exclusion Criteria:

* An individual with no previous caries experience and well coalesced pits and fissures.
* Partially erupted teeth.

  * Teeth with cavitation or caries of the dentin.
* Teeth with dental fluorosis, Hypocalcification
Clinical and Biochemical Features for the Identification of Dominant Calpainopathies

Mutations in the CAPN3 gene cause muscular dystrophies with dysfunction in calpain-3. Calpainopathies are usually inherited in an autosomal recessive manner but in some families they can occur in a dominant inheritance. The significance of heterozygous variants is difficult to interpret in the absence of family history. In this study, the investigators will review the clinical and laboratory information in a cohort of patients identified in the participating centers, with the aim of improving the diagnostic strategy of dominant calpainopathies.

The investigators will review clinical and biomarker information in a cohort of 50 patients with heterozygous variants in the CAPN3 gene. Patients are referred by participating centers who will provide anonymised information on the clinical phenotype and laboratory test results. Suitable subjects will be contacted to obtain informed consent. Pseudonymised anamnestic data will be collected from the patient's clinical history and medical records.The aim is to identify a set of multidisciplinary data sufficient to define a diagnostic algorithm for the dominant calpainopathies.

Eligibility Criteria:
Inclusion Criteria:

* Clinical LGMD phenotype, family history with dominant inheritance or sporadic cases, single variant in CAPN3, second variant excluded by MLPA (Multiplex Ligation Probe Amplification) or by analysis of mRNA extracted from muscle.

Exclusion Criteria:

* No variants in CAPN3, two variants in CAPN3
Pharmacokinetics of Sirolimus and Tacrolimus in Liver Transplant Recipients With Tacrolimus Toxicity

Pharmacokinetics of Tacrolimus and Sirolimus alone and in combination in liver transplant recipients.

Liver transplant patients receiving tacrolimus, and who experience side effects such as hypertension and renal dysfunction, will be converted to sirolimus with low-dose tacrolimus, or Tacrolimus withdrawal. This study will evaluate allograft function by serial clinical lab testing, the pharmacokinetics of sirolimus and tacrolimus, the glomerular filtration rate (GFR) and the potential side effect of sirolimus, such as marrow suppression and hyperlipidemia. Two pharmacokinetic evaluations are planned: once around the third post-transplant month and another one at about 12 months. Expected outcomes are, a better understanding of sirolimus pharmacokinetic parameters over time in pediatric/adult liver recipients and early efficacy and safety data of the sirolimus as a non-nephrotoxic alternative to tacrolimus.

Eligibility Criteria:
Inclusion Criteria:

* Recipients of primary liver (cadaver/liver, whole/segmental) transplants 5- 30 years old.
* Rejection-free post-transplant course for at least 3 months
* Renal dysfunction (15% decrease in age-adjusted calculated creatinine clearance)
* Hypertension requiring anti-hypertensive mediations.
* Informed consent.
* Weight ≥15 kg.

Exclusion Criteria:

* Rejection or infections within 3 months of enrollment.
* Intent to continue TAC
* Active participation in ongoing studies of immunosuppressive agents.
* Lack of informed consent.
* Pregnant or breast feeding
* HIV positive
The Study of Koebner in Patients With Psoriasis and Psoriatic Arthritis

PSODEEP 1 is a descriptive digital interview study where we intend to include at least 900 individuals. Individuals with known psoriasis or known psoriatic arthritis will access the digital interview via a QR code distributed via their rheumatology or dermatology department using their smartphones. Data on answers results are stored digitally and can be accessed parallel to recruitment. Questions focus on following fields (all self reported): background information (age/sex), disease duration, disease course/fluctuation, disease diagnosis as given by MD, disease treatment, disease severity, disease classification, disease triggers, screening of psoriatic arthritis (questions derived from PEST questionnaire), Koebner occurence, variability in Koebner over time, deep-Koebner occurence and variability in Deep-Koebner over time.

PSODEEP1 is a descriptive digital interview study. Questions on self reported experience of following fields will be stated: background information, disease duration, disease course/fluctuation, disease diagnosis as given by MD, disease treatment, disease severity, disease classification, disease triggers, screening of psoriatic arthritis (questions derived from PEST questionnaire), Koebner occurence, variability in Koebner over time, deep-Koebner occurence and variability in Deep-Koebner over time.

Questions will be distributed using REDCap (REsearch Electronic Data CAPture) platform provided by Lunds university, University of Santiago and Copenhagen University (www.project-redcap.org). Patients with known psoriasis or psoriatic arthritis will reach the questionnaire using a QR-code on patient's information sheet distributed in clinical settings. In Sweden, patients will be recruited at dermatology and rheumatology outpatient clinics in Malmö, Lund, Göteborg, Örebro, Stockholm (Skåne University Hospital, Karolinska Hospital, Sahlgrenska Hospital, Ryhov Hospital, Örebro, Hospital). In Chile patients will be recruited at Hospital Clínico Universidad de Chile and CIEC-PMR Centro Internacional de Estudios Clínicos - Probity Medical Research. In Denmark, patients will be recruited at Gentofte Hospital and through Leo foundation skin immunology research center (Copenhagen University) and the Parker Institute.

Study inclusion criteria: Physician diagnosed psoriasis, psoriatic arthritis or both. Age of 18 years or older. Ability to comprehend instructions and read the Swedish, Spanish or Danish language (according to country). Having a smartphone with which one can access the study questions using a QR code. Study exclusion criteria: Having participated in the study already. Not having a mobile telephone number (used to identify duplicate answers).

Eligibility Criteria:
Inclusion Criteria:

* MD diagnosis of psoriasis and/or psoriasis arthritis
* Age over 18 years
* Ability to read and understand written questions
* Having/ability to use smartphone
* Given consent

Exclusion Criteria:

- Having participated previously
PECs for Implantable Cardiac Electronic Device Insertion

The aim of this study is to evaluate the feasibility of the Pectoralis Nerve (PECS) block for CIED insertion.

Implantable Cardiac Electronic Device (CIED) insertion can be performed under local anesthesia, regional anesthesia, or general anesthesia. Novel regional blocks may improve pain management for such patients and can shorten their length of stay in the hospital. At the study, the investigators aimd to evaluate the efficacy and feasibility of the PECS block for CIED insertion procedure.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anaesthesiologists grade II-IV patients
* in the age group of 18-80 years,
* Patients undergoing CIED insertion

Exclusion Criteria:

* pre-existing infection at the block site,
* coagulopathy,
* morbid obesity (Body mass index \>35 kg m-2 ),
* allergy to local anaesthetics,
* decreased pulmonary reserve,
* psychiatric illness