cyrilzakka/clinical-trials huggingface dataset:
Elaboration and Analysis of a New Cardiac Risk Stratification Protocol Based on Clinical and Physical Variables

This research project has as objective the elaboration and analysis of a new cardiac risk stratification protocol based on clinical and physical variables to predict the occurrence of signs and symptoms during a cardiac rehabilitation program. To this aim, the study will be developed in three stages. The first stage consists of a prospective longitudinal observational study, in which participants of exercise-based cardiac rehabilitation will undergo a physiotherapy evaluation in terms of physical and clinical aspects. After this initial assessment, participants will be followed for 2 months of rehabilitation, when the occurrence of signs and symptoms (chest pain, fatigue, dizziness, arrhythmias, and other minor events) during exercise will be recorded. Based on the data from the initial assessment and the occurrence of signs and symptoms a new cardiac risk stratification protocol will be developed. The second stage of this project consists of another prospective longitudinal observational study in which a new sample of individuals attending cardiac rehabilitation programs will be assessed and stratified for the risk of the occurrence of signs and symptoms during exercise by the new protocol developed. After the risk stratification, this sample will be followed for 2 months and the occurrence of signs and symptoms will be recorded. With this data, the reproducibility and efficacy of the protocol will be evaluated. The third stage of this project consists of a cross-sectional observational study, in which a new sample of participants will be evaluated by two independent physiotherapists for clinical and physical variables, and based on these data will be stratified by the new protocol by the same evaluators independently. After these procedures, the protocol´s agreement between evaluators will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Main medical diagnostic of any cardiovascular disease and/or presence of cardiovascular risk factors
* Be participating in exercise-based cardiac rehabilitation

Exclusion Criteria:

* Orthopedic and/or neurologic conditions that preclude the realization of any of the physical and clinical evaluations
* Do not complete 24 cardiac rehabilitation sessions during the follow-up period
Efficacy and Safety Study of MCI-196 Versus Simvastatin for Dyslipidaemia in Chronic Kidney Disease (CKD) Subjects on Dialysis

The primary objective of this study is to demonstrate the superiority of MCI-196 over placebo and non-inferiority with simvastatin in reducing serum low-density lipoprotein (LDL)-cholesterol in subjects with chronic kidney disease Stage V on dialysis. This study incorporates a Washout Period and two treatment periods - an active comparison phase and a placebo-controlled withdrawal phase.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, and is \>=18 years old
* Stable hemodialysis or peritoneal dialysis
* Subjects undergoing regular dialysis treatment
* If Female and of child-bearing potential, have a negative serum pregnancy test
* Male subjects must agree to use appropriate contraception

Exclusion Criteria:

* Current clinically significant medical comorbidities, which may substantially compromise subject safety, or expose him/her to undue risk, or interfere significantly with study procedures and which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study
* Serum albumin level \< 30 g/L
* Triglycerides level \> 6.76 mmol/L (600 mg/dL)
* LDL-cholesterol level \> 4.94 mmol/L (190 mg/dL)
* A History of significant gastrointestinal motility problems
* Biliary obstruction or proven liver dysfunction
* A positive test for HIV 1 and 2 antibodies
* A history of substance or alcohol abuse within the last year
* The subject has a history of rhabdomyolysis or myopathy
* Schedule to receive a kidney transplant within the next 6 months
* The subject has porphyria
* Participation in a clinical study with any experimental medication in the last 30 days or an experimental biological product within the last 90 days prior to signing of informed consent
First-in-human Phase I Study of a Selective c-Met Inhibitor PLB1001

This phase I, first-in-human dose-escalation study was conducted to determine the maximum tolerated dose (MTD), recommended phase II dose (RP2D), dose-limiting toxicities (DLTs), pharmacokinetics (PK) profile, and preliminary antitumor activity of PLB1001.

This is a Phase I, open-label, multicentre study of PB1001 administered orally to patients with Met-positive (Met+) advanced NSCLC. The study includes a Dose-escalation Part (part A)and a Dose Expansion Part(part B). The aim of the part A is to estimate the MTD and to identify the dose limited toxicity(DLT) and the recommended phase II dose (RP2D) for PLB1001 single agent as well as to determine the PK/PD profile .Once response has been observed in certain dose level ,then followed by the expansion part to further assess the clinical efficacy and safety of PLB1001 single agent. Aprox. 40 patients will be enrolled in PART A, while 20-30 patients for expansion cohort .

PLB1001 is a potent selective c-Met inhibitor. PLB1001 acts on cancer by blocking abnormal cmet-mediated signalling, leading to profound tumour growth inhibition in xenografts of non-small cell lung cancer (NSCLC) tumours. Preliminary data from a c-Met inhibitor INC 280 has provided possibility on the safety and clinical activity of PLB1001 monotherapy in this patient population.

Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form
* Age≥18 years
* Histologically or cytologically confirmed advanced non-small cell lung cancer
* Must have evidence of c-Met positivity from the results of molecular pre-screening evaluations
* At least one measurable lesion as per RECIST v1.1
* Patients must have recovered from all toxicities related to prior anticancer therapies to grade ≤ 1
* ECOG Performance Status of 0-2

Exclusion Criteria:

* Previous or current treatment with a c-Met inhibitor or HGF-targeting therapy
* Symptomatic central nervous system (CNS) metastases that are neurologically unstable or requiring increasing doses of steroids to control, and patients with any CNS deficits.
* Clinically significant, uncontrolled heart diseases. Unstable angina History of documented congestive heart failure (New York Heart Association functional classification \> II) Uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) ≥ 140 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 90 mm Hg Arrhythmias
* Active peptic ulcer disease or gastritis
* Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1, except for alopecia
* Major surgery within 4 weeks prior to starting PLB1001
* Previous anti-cancer and investigational agents within 4 weeks before first dose of PLB1001. If previous treatment is a monoclonal antibody, then the treatment must be discontinued at least 6 weeks before first dose of PLB1001.
* Pregnant or nursing women
* Involved in other clinical trials \< 30 days prior to Day 1
The Role of Neuroactive Steroids in Stress, Alcohol Craving and Alcohol Use in Alcohol Use Disorders

To use pregnenolone (PREG; 300; 500mg) daily versus placebo (PLA) as a probe to assess the role of neuroactive steroids in individuals with alcohol use disorder (AUD).

The study aims to examine the effects of PREG on a) alcohol craving, mood and neuroendocrine reactivity to brief, guided imagery exposure to stress, drug cues and neutral situations in the laboratory and b) daily alcohol intake, craving, cognition and mood in men and women with AUD; and c) sex differences in all of these outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Male or female individuals, ages 18 to 68.
* Subjects must meet current Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-V) criteria for alcohol use disorder; documented positive urine toxicology screen for alcohol at intake or collateral information from family members, significant others, room-mates etc., on recent use.
* Subject has voluntarily given informed consent and signed the informed consent document.
* Able to read English and complete study evaluations.

Exclusion Criteria:

* Women who are pregnant, or nursing or are of childbearing potential and not practicing an effective means of birth control.
* Meet current criteria for use disorder on another psychoactive substance, such as, heroin, amphetamines, hallucinogens/Phencyclidine (PCP), excluding alcohol and nicotine.
* Any current use of opiates or past history of opiate use disorder (assessed via urine toxicology and self report).
* Current use of any psychoactive drugs (urine toxicology), including anxiolytics, naltrexone or antabuse.
* Any psychotic disorder or current Axis I psychiatric symptoms requiring specific attention.
* Significant underlying medical conditions such as cerebral, renal, thyroid or cardiac pathology which in the opinion of study physician would preclude patient from fully cooperating or be of potential harm during the course of the study.
* Hypotensive individuals with sitting blood pressure below 90/50 mmHG.
Early Aerobic Training Program After Ischemic Stroke

The purpose of this study is to examine the feasibility and efficacy of an early supervised aerobic exercise program for patients following a minor ischemic stroke.

The purpose of this study is to examine the feasibility and efficacy of an early supervised aerobic exercise program for patients following a minor ischemic stroke. Patients after a minor ischemic stroke would be randomized within 1-3 weeks of stroke onset to a control group (6 weeks of low intensity stretching and coordination exercises followed by a supervised aerobic training program) or an experimental group (immediate aerobic training program). Patients will be evaluated for measures of ambulation endurance, mobility, gait, functional assessment and clinical follow-up after 6 weeks and again 3 months later.

Eligibility Criteria:
Inclusion Criteria:

* minor ischemic stroke

Exclusion Criteria:

* unstable angina
* severe lung disease
* severe symptomatic peripheral vascular disease
* dementia or other severe neurological disease
* other severe uncontrolled medical problem
Comparative Clinical and Radiographical Evaluation of Treatment of Angular Bone Defect Related to Over Erupted Tooth Using GTR Followed by Orthodontic Intrusion Versus Orthodontic Intrusion Followed by GTR

Occlusal prematurity leading to loss of vertical stopping points between teeth can lead to teeth over eruption creating abnormal contact area which favors food accumulation and plaque retention. All these factors can lead to gingival inflammation and bone loss which may be worsen by abnormal occlusal force. Thus, orthodontic evaluation and treatment with periodontic therapy is mandatory to achieve proper treatment.

Aim of the work: To evaluate and compare clinically and radiographically between effect of guided tissue regeneration (GTR) followed by orthodontic intrusion versus orthodontic intrusion followed by GTR in treatment of over erupted tooth with angular bone loss

Abstract Occlusal prematurity leading to loss of vertical stopping points between teeth can lead to teeth over eruption creating abnormal contact area which favors food accumulation and plaque retention. All these factors can lead to gingival inflammation and bone loss which may be worsen by abnormal occlusal force. Thus, orthodontic evaluation and treatment with periodontic therapy is mandatory to achieve proper treatment.

Aim of the work: To evaluate and compare clinically and radiographically between effect of guided tissue regeneration (GTR) followed by orthodontic intrusion versus orthodontic intrusion followed by GTR in treatment of over erupted tooth with angular bone loss Material and methods: Twenty teeth in ten cases were selected with at least two teeth with vertical over eruption and angular bone loss with presence of their opposing for spilt mouth study aged from 20- 35 years old. In group 1 (G1), ten teeth over erupted with angular bone loss were treated by GTR followed by Orthodontic intrusion whereas, in group two (G2) ten teeth over erupted with angular bone loss were treated by orthodontic intrusion followed by GTR. All cases were evaluated clinically for pocket depth (PD), bleeding on probing (BOP), tooth mobility prior starting phase one therapy, at re-evaluation and at six- and 12-months post starting either GTR or orthodontic intrusion. Also, radiographical evaluation was assessed using CBCT scan at end of re-evaluation, at six- and 12-months post starting either GTR or orthodontic intrusion to evaluate amount of orthodontic intrusion, amount of change of bone area and length related to angular defect in both groups.

Eligibility Criteria:
Inclusion Criteria:

* Over erupted tooth with angular bone loss with presence of opposing
* Mobility doesn't exceed grade two
* No gingival recession more than 3mm

Exclusion Criteria:

* Systematic diseases that complicate oral surgery such as hyperparathyroidism, bleeding disorders,....etc.
* Smokers
* Patients with negative attitude towards oral hygiene
Intraurethral Lidocaine After Endourology Procedures

Many urological conditions are diagnosed and treated with the use of endourology procedures. Unfortunately, dysuria is a common patient complaint following these procedures. Intraurethral lidocaine instillation is regularly used prior to office-based endourology procedures to alleviate dysuria, as well as, discomfort during the procedure.. Studies have confirmed that office-based procedures using intraurethral lidocaine have resulted in less patient reported dysuria. Many endourology procedures are done under general anesthesia such as urinary stone treatments or resection of bladder tumors. There is a paucity of data regarding the use of intraurethral lidocaine at the conclusion of these procedures evaluating patient reported dysuria. We have designed a prospective, randomized, placebo controlled trial to evaluate the role of intraurethral lidocaine instillation following endourology procedures in the anesthetized patient.


Eligibility Criteria:
Inclusion Criteria: Adult patients, age 18 and older scheduled to undergo endourologic procedure to include ureteroscopy, rigid diagnostic cystoscopy, bladder biopsy, laser lithotripsy, cystolithalopaxy, and transurethral resection of bladder tumor in the operating room under general anesthesia.

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Exclusion Criteria: active urinary tract infection, current dysuria symptoms, pregnant females, urethral stricture disease, indwelling foley catheter, and history of pelvic radiation

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Efficacy of Animation, Buzzy, and Multiple Interventions on Pain in Children

The aim of the study was to determine the effects of providing procedural informational animation, Buzzy application during the procedure, the combination of both interventions (Animated video and Buzzy), and standard care on pain management during venipuncture in children aged 6-12 years.

A prospective randomized controlled trial design was used to determine the effects of Buzzy, procedural informational animation, multiple interventions (Buzzy and Animated video), and standard care on the pain level of 6-12 years aged children during venıpunctrue. The study was conducted in the territory hospital pediatric blood collection unit The sample size was determined by power analysis and 45 child-parent pairs were included in each group. The patients who met the sample selection criteria were randomly and equally assigned into 4 groups using a computer-based program. As a data collection tools, Data Collection Form and Wong-Baker have been used. Venipuncture-related pain was self-reported by each child, as well as through parents and nurse. Children in the multiple interventions group were shown procedural informative animation and the venipunctıre procedure was performed with buzzy®. Standard care was applied to the control group, in which no local anesthetic was used and families could accompany the bloodletting process. The pain responses of the children were evaluated twice, immediately after the procedure (while the child was sitting in the blood collection chair) and 2-3 minutes after the procedure, both by the children's self-reports and by the parents and the nurse.

Eligibility Criteria:
Inclusion Criteria:

* being between the ages of 6 and 12 years,
* admitted to the hospital as an outpatient,
* having complete skin integrity at the place where the Buzzy device will be inserted
* having the ability to verbally communicate
* parents being literate.

Exclusion Criteria:

* having any acute pain at the time of the procedure
* having any audiovisual, cognitive sensitivity, or physical disability and having a chronic or life-threatening disease
* being under the influence of any sedative/anticonvulsant/analgesic drug,
* getting blood drawn in the last month
* failure to phlebotomy at the first attempt
* having nerve damage or peripheral neuropathy.
Exercise Training Six-Months After Discharge in Post-COVID-19 Syndrome

The goal of this study investigate the effects of 12-week exercise training on pulmonary function, symptoms, functional capacity, and quality of life (QoL) in patients with severe COVID 6 months after intensive care discharge. The main question it aims to answer are:

1-Does exercise training given in post-COVID-19 syndrome have an effect on pulmonary function, symptoms, functional capacity, muscle strength and quality of life?

25 severe post-COVID patients (35 M) were in exercise group (EG) (age=52.9±11 years, 18M), and 25 (age=53.6±11.9 years, 17M) were in the control group (CG). EG received aerobic exercise (30-min walking) and upper and lower extremity strength training for 12 weeks for 3 days/week. CG continued only routine follow-up.


Eligibility Criteria:
Inclusion Criteria:

* COVID-19 pneumonia patients were followed up for at least 24 h in the ICU. Those post-COVID six months who could cooperate with the tests and volunteered to participate were included.

Exclusion Criteria:

* Individuals with pulmonary, orthopedic, neurological, vestibular, and psychological problems diagnosed before COVID-19 infection; myocarditis developed after COVID-19 infection; and those pregnant and those having any other acute diseases (such as infection and trauma) that would prevent performing the tests and/or interfering with the test results were excluded.
Progressive Resistance Training for Adults With External Snapping Hip

External snapping hip is characterised by an audible and painful snap during hip movement among physical active people around 15-40 years old. Progressive resistance training has been suggested as a new potential treatment path in treating patients with external snapping hip. We conducted a feasibility study and found that patients reported less pain and improved their physical function, quality of life and muscle strength after 12 weeks of progressive resistance training. The overall aim of the project is to compare hip pain in patients with external snapping hip treated with progressive resistance training to a wait-and-see approach, in a randomised controlled trial. This study has the potential to establish a new and specific treatment option for patients with external snapping hip, to be used nationally and internationally.

This trial is an international multicentre randomised controlled assessor-blinded crossover trial, following the CONSORT guidelines. The intervention is a 12-week progressive resistance training programme, and the trial is designed with three follow-up time points. After the baseline test, the patients will be randomised in a 1:1 ratio to either the intervention or the control group using the Research Electronic Data Capture (REDCap) source hosted at Aarhus University. For the patients randomised to the intervention group, the first test will be the baseline test, conducted before the intervention. The second test will be conducted at week 13, and the third test after another 12 weeks of self-guided exercise, at week 25. Self-guided exercise is the period after the intervention, where the patients are recommended to continue training on their own. For the patients randomised to the control group, the first test will also be the baseline test, conducted before the waiting period. The second test will be conducted at week 13, and the third test after the 12 weeks of progressive resistance training at week 25. The primary outcome will be the change from baseline to the second follow-up, and the trial will be powered based on this period. The lasting effect of the intervention will be evaluated from baseline to the third follow-up test for the intervention group.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-40 years
* Experienced lateral hip joint "snapping" with pain within the last 14 days
* Able to demonstrate the audible "snapping" or popping sound when the hip joint moves
* Capable of commuting to the training facility
* Proficient in reading and understanding Danish or English

Exclusion Criteria:

* Previous surgery on the affected hip
* Planned surgery on lower extremities within the trial period
* Neurological, rheumatoid or mental conditions affecting the hip function
* Planned vacation for more than 14 days within the intervention period
* Has performed systematic resistance training exercises for the hip muscles more than once a week within the last six months prior to inclusion
* Pregnancy
Placebo Controlled Study of ONO2506PO in the Presence of Riluzole in Patients With Amyotrophic Lateral Sclerosis (ALS)

The purpose of this study is to determine if oral treatment with ONO-2506PO in patients diagnosed with ALS, who have had onset of muscle weakness within 14 months of randomization, could lead to the slowing of decline in respiratory function, functional status, muscle strength, quality of life and survival compared with placebo group.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of clinically possible, clinically probable laboratory-supported, clinically probable or clinically definite ALS (according to WNF EL Escorial diagnostic criteria, revised according to the Airlie House Conference 1998)
2. Onset of muscle weakness within 14 months randomization
3. Concomitant standard Riluzole therapy (50mg twice daily)

Exclusion Criteria:

1. Presence of a tracheotomy, mechanical ventilation or non-invasive ventilation
2. Requirement for prescription drugs used for potential neuroprotective benefit -
Pediatric Atorvastatin in Diabetes Intervention Trial (PADIT)

The purpose of this study is to determine if Atorvastatin can improve blood vessel stiffness and blood vessel function in children 10-18 years old with Type 1 and Type 2 diabetes. Subjects will receive atorvastatin 20mg or placebo daily for 3 months and will then switch therapies for the next 3 months.

Hypothesis: Atorvastatin will improve blood vessel function by decreasing arterial stiffness and improving blood flow.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM) for more than 1 year
* Age 10-18 years.

Exclusion Criteria:

* Cardiovascular disease (CVD)
* Liver disease
* Pregnancy
* Use of cholesterol or triglyceride lowering drugs
* Perceived inability to comply with the study protocol
* Endocrinopathy other than diabetes
Study Evaluating Two Different Sirolimus-based Immunosuppressive Regimens in Elderly Kidney Transplant Recipients

The purpose of this study is to test two different sirolimus-based immunosuppressive regimens for elderly kidney transplant recipients.


Eligibility Criteria:
Inclusion Criteria:

* End stage renal disease
* Kidney transplantation
* Both donor and recipient older than 60 years

Exclusion Criteria:

* Prior or concurrent transplant of any organ other than the kidney
* Current clinically significant infections