cyrilzakka/clinical-trials huggingface dataset:
Two-phase Transteoretic Model Research for Participation in Physical Activity

The purpose of the first phase of this study is to determine the physical activity (PA) barriers and motivational factors of university students and their body awareness using the transteoretic model (TTM).

The aim of the second phase of the study is to evaluate the effectiveness of interventions aimed at eliminating barriers determined in students who are in the "precontemplation", "contemplation" and "preparation" stages according to TTM. Also it will be examined the effects of these interventions on PA level.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-25
* Being educated at the Faculty of Health Sciences
* Being volunteer

Exclusion Criteria:

* Being audial and vision impaired
* Having orthopedic, neurological and metabolic problems that will prevent physical activity
* Being unable to communicate in Turkish
* No pedometer program on the smartphone or using it for less than 1 year
TACKLE-IT Trial - Treat Acute T Cell Rejection With Evidence and Confidence in Kidney Transplant Recipients

After a kidney or a simultaneous kidney-pancreas transplant, some patients may face problems with their new organs. This happens because the body sometimes makes a mistake and tries to get rid of the organ. This problem is called "rejection". One type of rejection is known as Acute T cell mediated rejection (TCMR). This can lead to many problems or even stop the transplant from working.

Doctors give strong steroids to treat this problem, but there are no rules for how much steroid to give. Too much steroids can cause problems like heart and bone problems, bad infections, and weight gain. That's why we need to find the right dose of steroids for each person to treat this.

TACKLE-IT is a study that will try to find the right steroid dose for treating rejection.

TACKLE-IT is an international, multi-centre, 2x2 factorial, registry-based, single-blind, randomised controlled trial (RCT) that compares the effectiveness and safety of high vs low dose IV MP, and high vs low dose oral prednisone taper as the first-line therapy for acute TCMR in kidney and SPK transplant recipients. This RCT was conceived and developed through extensive consultation and collaboration with our key stakeholders, including transplant recipients with lived experience and the International TCMR Working Group with sponsorship by 4 international transplant societies (The Transplantation Society (TTS), American Society of Transplantation (AST), European Society of Transplantation (ESOT) and Transplant Society of Australia and New Zealand (TSANZ). TACKLE-IT is led by an international multi-disciplinary team of transplant health professionals, clinical trialists, biostatisticians, health economist, social scientist, consumers.

Eligibility Criteria:
Inclusion Criteria:

* Participants or their legal guardian must be able to understand and provide written informed consent;
* Stated willingness to comply with all study procedures and availability for the duration of the study;
* All ethnic and gender groups will have equal access to the study;
* All children (aged 2+ years) and adults who have received a kidney or SPK transplant with biopsy proven acute TCMR (≥ Banff borderline (minimum i1 score) whether clinical or subclinical).

Exclusion Criteria:

* Mixed rejection.
* Active or chronic active ABMR.
* Chronic active TCMR. \*Patients with concomitant acute TCMR and chronic active TCMR will not be excluded from the trial.
* Isolated v1 without inflammation.
* Higher grade acute TCMR, ≥Banff 2A.
* Concurrent renal disease, such as recurrent glomerulonephritis or polyomavirus nephropathy.
* Active malignancies or active infection that preclude immunosuppression augmentation.
* Use of other immunomodulatory agents, including, but not limited to, rituximab, anti-TNF monoclonal antibody, belatacept, abatacept, Janus kinase inhibitors, eculizumab, pegcetacoplan.
* Enrolment in other interventional drug trials.
* Use of other investigational agents.
* Unable to adhere to the study protocol.
Comparison of Insulin Detemir Versus Insulin NPH on Weight Change in Overweight and Obese With Type 2 Diabetes

This trial is conducted in Europe. The purpose of the trial is to investigate the effect of insulin detemir on weight change in overweight and obese patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* HbA1c: 7.5-11.0%
* BMI: 25-40 kg/m2

Exclusion Criteria:

* Treatment with any OAD (Oral Antidiabetic Drugs) except metformin
Evaluation of the Pharmacokinetic Profile of Tranexamic Acid, After Injection in a Knee Neo-articulation.

Evaluate the pharmacokinetic profile of tranexamic acid injected intra-articularly with or without adrenaline, in a population of patients undergoing knee replacement.

Orthopedic population, especially during a knee surgery, is at risk of significant bleeding and blood transfusion in the perioperative period. Tissue damage is associated with the activation of a cascade of mechanisms, in which the activation of the fibrinolyse plays an important role. This is why anti-fibrinolytic agents are regularly used in this context to reduce the perioperative bleeding and the use of blood transfusions.

In the majority of cases, tranexamic acid, an analogue agent of lysine, is administered by an intravenous injection and more recently, by an intra-articular injection.

Several questions however remain unanswered.

* what is the clearance of this substance ?
* does an intra-articular resorbtion exist, resulting in a plasmatic rate of the substance ? If yes, what is the plasmatic rate ?
* Is the intra-articular effect of tranexamic acid predominant compared to its systemic effect ?
* Does the addition of adrenalin increase the effect of the tranexamic acid by acting on its absorption ?

The efficacy, safety and better administration route of the tranexamic acid remain unknown when injected intra-articularly. The goal of this study is to realize the first pharmacokinetic study after an intra-articular injection of tranexamic acid, alone of along with adrenalin, in a knee neo-articulation.

Eligibility Criteria:
Inclusion Criteria:

* programmed PTG, right or left
* surgery planned within the CHU Brugmann Hospital (Dr Reynders)
* ASA I to ASA III
* Signed informed consent within the patient file

Exclusion Criteria:

* re-do surgery
* urgent or multiple surgery
* ASA IV or higher
* Patients with a BMI superior or equal to 40
* Patient is a Jehovah Witness
* Allergy or contra-indication to tranexamic acid
* Coagulation troubles, defined as: Platelet count \< 80 000/mm3 and/or PTT \<70% and/or aPTT \>45s and/or Fibrinogen \<100mg/dL
* Preoperatory renal insufficiency defined as Creatinin \> 3mg/dL and/or Dialysis patients.
The Effect of an Exercise Program on the Health-quality of Life (HQL) in Older Adults

The present study aimed to investigate the effect of exercise program on health-quality of life (HQL) in older adults.

The questionnaire consisted of demographic data (such as age, gender, educational level, and employment) and the LEIPAD questionnaire used to measure HQL.

Eligibility Criteria:
Inclusion Criteria:

* sixty healthy adults volunteers
* over the age of 55 years

Exclusion Criteria:

* neurological disorder
* acute heart impairment
* unstable chronic illness
* severe musculo-skeletal impairment
Development and Feasibility Analysis of Verbal Expressive Skills Management Programme (VESMP) for Patients With Broca Aphasia

The present study was conducted to develop the verbal expressive skills management programme (VESMP) to enhance verbal expressive skills of patients with severe Broca aphasia. To determine the efficacy of VESMP in improving the quality of life and level of satisfaction of aphasic stroke patients.Control group received traditional therapy and experimental group received therapy through VESMP programme on their smart phones.

Speech therapy makes an integral part of the non-pharmacological, conservative management of Post stroke aphasia. Routine speech therapy aims to improve comprehension and verbal skills and also develop functional communication skills through augmentative Alternative communication devices. Disorders of communication, including aphasia (mainly post stroke) caused by the left hemisphere brain damage, is a major community health issue. Aphasia is a language disorder occurring mainly as a result of stroke. It is an acquired impairment of language that weakens people's ability of comprehension and expression, it does not show any affect to intellect ability. The verbal expressive skills management programme (VESMP) is the software which developed augmented management for patients to enhance verbal expressive skills for patients with severe Broca's aphasia from different geographic areas.

Eligibility Criteria:
Inclusion Criteria:

* The 40-60 year Broca aphasia patients
* The severe Broca aphasia patients (more than 03 month of onset of stroke) Both infarct and hemorrhagic stroke
* Either gender Informed consent

Exclusion Criteria:

* • Broca Aphasic patients having cognitive impairment

  * The patients having tumors, infections and trauma
Study of Inactivated Poliovirus Vaccine Given at an Earlier Schedule With Shorter Intervals

The purpose of this study was to evaluated the effectiveness of inactivated poliovirus vaccine at a vaccine schedule that is commonly used in developing countries. The effectiveness of inactivated poliovaccine given at this schedule is important to national policy makers as they consider vaccination policies after the use of oral polio vaccine is discontinued.

After polio eradication, access to live polioviruses will be highly restricted, and oral poliovirus vaccine (OPV) use must be discontinued. OPV-using countries must decide whether to switch to inactivated poliovirus vaccine (IPV) or stop polio vaccination. Because only limited data are available on IPV immunogenicity in tropical developing countries, we conducted a randomized controlled trial of IPV in Cuba. The objectives of this study were to assess the humoral and mucosal immunogenicity conferred by IPV administered at the WHO-EPI schedule (6,10,14 wks of age) vs. placebo. A third arm was added to evaluate the immunogenicity of IPV administered at 2 and 4 months of age. Antibody titers were measured prior to the first dose as well as 1 month after the last dose in each study arm. Target sample size was 100 children in each arm. Mucosal (intestinal immunity) was measured indirectly through assessing poliovirus excretion in each group after a "natural challenge" of trivalent oral polio vaccine (OPV)recieved by study participants through their participation in the annual OPV mass campaigns approximately 1 month after their last dose of vaccine.

Eligibility Criteria:
Inclusion Criteria:

Infants born 18 - 20 weeks prior to the first round of the 2002 National Immunization Days in cuba (in March 2002).

Born healthy at one of the 4 designated maternity hospitals in Cuba

Exclusion Criteria:

Serious congenital defect/disease at birth

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Real-life Data of Olaparib in Relapsed Ovarian Cancers Patients

This is a national, multi center, retrospective observational cohort study that will be carried out by reviewing the medical records of patients with relapsed epithelial ovarian, fallopian tube, or peritoneal cancer treated with olaparib following response to platinum-based chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be female ≥18 years of age
* Patients with histologically confirmed ovarian cancer, primary peritoneal cancer and / or fallopian-tube cancer that were treated with olaparib in a real life-setting, between May 2014 to March 2017, whatever the line of therapy
* Patients can be either alive or deceased at the time of medical record abstraction
* Patients should not have any objection that anonymized data will be collected and subjected to automated processing.

Exclusion Criteria:

* Patient that were given olaparib within a clinical trial
Comparison of Two Norepinephrine Bolus Doses for Management of Post-spinal Hypotension During Cesarean Delivery

In this study the investigators will compare two doses of norepinephrine bolus (6 mcg and 10 mcg) in management of maternal hypotensive episode after subarachnoid block during Cesarean delivery.

Maternal hypotension after subarachnoid block is a frequent and deleterious complication during cesarean delivery. Although prophylaxis against hypotension using vasopressors had become a standard recommendation; the incidence of hypotension is still ∼ 20% . Thus; management of maternal hypotension using vasopressor boluses is usually needed .

The commonly used vasopressors during cesarean delivery are ephedrine, phenylephrine, and recently norepinephrine. The use of ephedrine is usually accompanied with maternal tachycardia and fetal acidosis. Phenylephrine had been the first line for prevention and management of maternal hypotension; however, its use might result in bradycardia and decreased maternal cardiac output .

Norepinephrine is an alpha adrenergic agonist with weak beta adrenergic agonistic activity; thus, it does not cause significant cardiac depression as phenylephrine does. Norepinephrine was introduced for use during cesarean delivery with promising results . Few previous studies investigated the efficacy of Norepinephrine infusion for prevention of maternal hypotension. A dose-response study had investigated the best dose of Norepinephrine for prevention of maternal hypotension. In the aforementioned dose-response study, a dose of 6 mcg was reported as the best dose for prophylaxis against maternal hypotension.

No studies had investigated the best bolus dose of norepinephrine for management of a maternal hypotensive episode. In this study the investigators will investigate the efficacy and side effects of two doses of norepinephrine bolus doses (6 mcg and 10 mcg) in management of maternal hypotensive episode after subarachnoid block during cesarean delivery.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women
* Scheduled for cesarean delivery

Exclusion Criteria:

* Patients with severe cardiac dysfunction
* Patients with low blood pressure
* Patients with ante-partum bleeding
KinectROM Application for Assessing Range of Motion in Upper and Lower Extremity: A Development and Validation Study

The aim of the study is to investigate the validity and reliability of KinectROM application for objectively evaluating range of motion (ROM)

The application KinectROM called has been developed for assessing ROM with Kinect controller by our team. So, shoulder, elbow, knee, hip and ankle ROM measurements will be made with universal goniometer and developed KinectROM application.

Eligibility Criteria:
inclusion Criteria: -Healthy individuals with 18-40 years

Exclusion Criteria:

-Have any limited extremity between the ages of 18-40 years.
Clarification of Nurses' Expected Role in Health Promotion

The purpose of this study is to implement and evaluate ROLE-AP, a multi-component program to clarify primary care nurses' expected role in health promotion. It is hypothesized that, in comparison with the control group, participants in the experimental group will increase their degree of agreement on nurses' role in health promotion.

Role confusion is hampering the development of primary care nurses' capacity for health promotion. Organizations can implement role clarification programs to develop the description of an expected role in the organization and reduce the negative effects of role confusion. Literature on role clarification interventions reveal that they are complex interventions seeking discussion to reach agreement between professionals about the expected role activities. However, such interventions have shown several methodological shortcomings. This study aims to implement and evaluate a multi-component program to clarify primary care nurses' role in health promotion. An exploratory clinical trial will help evaluate the preliminary efficacy and understand if an intervention of these characteristics is feasible, if its components are appropriate and / or if it is accepted by the participants. This is a pilot cluster randomized exploratory trial, which corresponds to Phase II of the Medical Research Council (MRC) framework for the development and evaluation of clinical trials in complex interventions. The study will be conducted in the province of Navarra (Spain), in the primary health care service. The study will follow a cluster randomised design with primary care teams (PCT) as sampling units. A PCT consists of a group of family physicians who work in close cooperation with nurses and social workers to offer primary care services to registered individuals in the area. Each cluster will be randomly assigned to one of the two groups, control or intervention. The main reason for using a cluster design is to avoid contamination, which could occur among nurses working in the same PCT. The randomisation of the study groups will be stratified according to the scope of work (rural / urban), to guarantee the representativeness of the different segments of the study population. It has been considered that nurses' activities and the perception they may have about their health promoting role may be conditioned by two factors: the organization and structure of the PCT and the characteristics of the populations they attend. These two factors may vary depending on the team attending rural or urban population, so it will be considered as a possible confusing variable. The control group will continue with their routine.

Eligibility Criteria:
Inclusion Criteria:

* being a primary care nurse in the Navarre health service.
* have two years of professional experience in primary health care
* be a nurse attending either adult or pediatric population
* have signed the consent form for participation in the study

Exclusion Criteria:

- not planning to be in clinical practice for the whole duration of the study.
Efficacy Assessment and Monitoring of Subcutaneous Infliximab Levels.

Retrospective observational study in which the efficacy of infliximab is studied in patients with inflammatory bowel disease and its subcutaneous levels are monitored.

Retrospective observational study in which the efficacy of infliximab is studied in patients with inflammatory bowel disease and its subcutaneous levels are monitored.

Treatment is prior to and independent of the patient's participation in the study and is governed by clinical judgment criteria and routine clinical practice, not performing any diagnostic or follow-up intervention that is not routine clinical practice.

Patients are older than 14 years who suffer from inflammatory bowel disease and who receive remsima as routine treatment.

The source of information will be the patient's medical history.

Eligibility Criteria:
Inclusion Criteria:

* Patients with inflammatory bowel disease.
* Over 14 years old.
* Receive Remsin as a treatment for his disease. And always this treatment that the patient is going to receive is governed by the criteria of clinical judgment and routine clinical practice, not performing any diagnostic or follow-up intervention that is not routine clinical practice.

Exclusion Criteria:

* Patients with inflammatory bowel disease under 14 years of age.
* Or older than this age with inflammatory bowel disease who do not attend the established check-ups
Bispectral Index Monitoring for Sedation in Elective Colonoscopies of Adult Patients: a Randomized Controlled Trial

The primary aim of the study is to determine the rate sedation-induced adverse events, comparing BIS-guided sedation with clinical observation. Secondary outcomes were to examine patient characteristics who developed adverse events, propofol and remifentanil dosage and patient satisfaction analyzing different time points undergoing elective colonoscopy.

Randomized double-blind clinical trial in patients undergoing scheduled colonoscopies in endoscopy rooms of the Galdakao-Usánsolo Hospital (Bizkaia, Spain) and Mendaro Hospital (Gipuzkoa, Spain). The investigators will compare the rate of cardiorrespiratory adverse events as well as the anesthetic drugs dosage, need for rescue medication and patient satisfaction among the experimental group in which sedation is guided by BIS and the control group in which the anesthesiologist is blind to the result of the BIS. The investigators hypothesized that BIS monitoring would be associated with better outcomes than clinical observation.

The BIS is the parameter of anesthetic depth monitoring most used today. Its use was approved by the Food and Drug Administration (FDA) in 1996 as an aid to control the effects of certain anesthetic agents. It is validated in the operating room (Recommendation grade A), but not outside it due to lack of conclusive studies.

180 patients are needed to obtain statistically significant differences between both groups. Qualitative variables are expressed in the form of frequencies and percentages and continuous variables in the form of means and standard deviations. Comparisons of percentages will be made by the Chi square test (or Exact Fisher's test, when the expected frequencies are less than 5) and the difference of means in the continuous variables by the t test as well as by the Wilcoxon nonparametric test if the distribution of the variable requires it. The degree of agreement between the BIS and Ramsay scale will be made through the weighted Kappa test. Statistical significance will be assumed when p \<0.05. All statistical analyzes will be carried out using SAS V9.4. (SAS institute, Inc., Carey, NC).

Eligibility Criteria:
Inclusion Criteria:

* Indication of complete colonoscopy on a scheduled basis.
* Classification of physical status ASA I, II and III, with the exception of patients with moderate to severe kidney and / or liver disease.
* Intermittent or persistent mild asthma. It implies the absence of daily symptoms and FEV1\> 80% (GINA 2004).
* Body Mass Index (BMI) less than 35 kg / m2, and greater than 18 kg/m2.
* Intact neurological capacity.
* Acceptance to participate in the study after the contribution of written informed consent.

Exclusion Criteria:

* ASA IV.
* BMI greater than 35 kg / m2, and less than 18 kg/m2.
* Refusal to participate in the study.
* Allergy to any of the medications used in sedation, or its components.
* Known mental or neurological disease.
* Renal and / or moderate to severe Hepatic insufficiency.
* Chronic Obstructive Pulmonary Disease (COPD) or Obstructive Sleep Apnea.
* Chronic opiate users.
Pharmacological Modulation of the Intrarenal Pressure During Endourological Procedures in the Upper Urinary Tract

The purpose of the study is to examine the effect of endoluminally administrated isoproterenol on pelvic pressure increase during flexible ureterorenoscopy in 14 humans. We propose that isoproterenol has potential of reducing intrarenal pressure during ureterorenoscopies. Lower intrarenal pressures may have the advantage of facilitating the procedure and reducing intraoperative complications as bleeding and infections.


Eligibility Criteria:
Inclusion Criteria:

* Indication for ureterorenoscopy
* Age\> 18 years
* Normal blood pressure

Exclusion Criteria:

* Malignant disease in the upper urinary tract
* Heart disease
* Allergy to Isoproterenol
* Use of α-blocking or β-blocking medicine
* Use of Calcium-antagonists
* Use of NSAIDs the last 48 hours
* Present stone or JJ-stent in the ureter
* Neurologic disease in the bladder
* Pregnancy
* Nursing mothers