cyrilzakka/clinical-trials huggingface dataset:
A Phase 2, Safety and Dose-Finding Study in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children

The purpose of this study is to support selection of an appropriate safe and efficacious dose for study in further development.


Eligibility Criteria:
Criteria for Inclusion:

* Pre-pubertal boys ≥ 3 years to ≤ 11 years and pre-pubertal girls ≥ 3 years to ≤ 10 years growth hormone (GH) insufficiency
* Diagnosis criteria consistent with growth hormone research society consensus guidelines
* Patients with a previously treated pituitary tumor must have no tumor progression for at least the past year
* Physician determined rate of change in height less than 2 standard deviations per age group.
* Written Informed Consent
* Parent or legal guardian who is capable and willing to administer the study drug.
* Other criteria apply, please contact the investigator for more information

Criteria for Exclusion:

* Any clinically significant medical condition as determined by the investigator, that is likely to affect growth
* Contraindications to rhGH treatment;
* History of or currently active malignancy, including pituitary tumors;
* Bone age, greater than chronological age or greater than 9 for girls or greater than 10 for boys within 3 months of screening.
* Patients with known diagnosis of diabetes or pre-diabetes
* Growth altering medications
* Allergies to the study medication components;
* Participation in another investigational study within 30 days of screening
* Any medical condition as judged by the investigator to interfere with patient participation or the objectives of the study
* Other criteria apply, please contact the investigator for more information
Safety of Paracetamol as Antipyretic in Treatment of Dengue Infection in Adults

The purpose of this study is to determine whether regular dosage of paracetamol causes transaminitis (hepatitis) and evaluate its potency in the treatment of dengue infection.


Eligibility Criteria:
Inclusion Criteria:

* Patient age \>18 years
* Dengue infection diagnosed by NS1 antigen, Dengue immunoglobulin M antibody, or polymerase chain reaction
* Admitted to the hospital
* Written informed consent from patient or attending relative able to and willing to give informed consent

Exclusion Criteria:

* Other possible cause of fever other than dengue infection
* Pregnancy
* Unable to take medication
* Aminotransferase level above 3 times upper normal limit
* Allergy to paracetamol or tramadol
* Paracetamol indicated for condition other than dengue infection
* Critically ill patient who need ICU or invasive ventilation support
* History of cirrhosis
* Unable to comunicate
Freeze-all Policy in Poor Responders

To compare the effects of fresh embryo transfers (ET) and elective frozen-thawed embryo transfer cycles in poor ovarian responders.


Eligibility Criteria:
Inclusion Criteria:

* All patients that fulfill the Bologna criteria \[at least 2 of the following 3 features must be present: (i) advanced maternal age or any other risk factor for POR; (ii) a previous POR; and (iii) an abnormal ovarian reserve test (ORT)\]
* if the progesterone serum level was ≤1.5 ng/mL on the trigger day.
* body mass index 18-32 kg/m2
* Both partners are able to provide written informed consent.
* At least 1 good quality embryo on day 3 after egg collection on day 3 according to the Istanbul consensus (7-8 cells; with symmetric blastomeres and \<10% fragmentation by volume).
* Endometrial thickness ≥8 mm on trigger day.
* a normal uterine cavity on ultrasound.
* IVF/ICSI with only fresh semen

Exclusion Criteria:

* Pre-implantation genetic testing is being planned.
* if they had severe endometriosis, uterine pathology (myomas, adenomyosis, endocrinopathies, adhesions, acquired or congenital abnormalities), untreated tubal hydrosalpinges, ovarian tumor, recurrent spontaneous abortion, implantation failure after ≥ 2 fresh or frozen ET.
Visualization and Structured Attention Behaviour for Pain and Anxiety Reduction During Ablation of Atrial Fibrillation

The purpose of this study is to test the efficacy of visualization and relaxation exercises together with a structured behavioural attention from nurses during ablation of atrial fibrillation.

The study will test the following hypothesis which is also aim for intervention:

Relaxation and visualization performed in patients during ablation of atrial fibrillation combined with structured attention behaviour from the nurse reduces the patient's experience of pain and anxiety - and secondary reduces the consumption of painkillers and the number of episodes of adverse outcome that requires extra attention from staff.

The survey is conducted as a controlled trial with a control group and an intervention group.

Background:

Atrial fibrillation (AF) is the most common form of cardiac arrhythmia with a prevalence of 5% among people older than 65 years, and 0.4% of the total population. Ablation is a relatively new treatment that has proven to be effective in removing physical symptoms in patients with severe symptoms.

Compared to other ablation treatments, ablation of AF is complex and of longer duration. It can be accompanied by significant discomfort and pain, despite pharmacological analgesia.

Non pharmacological analgesia in the form of relaxation exercises and visualization has successfully been used to reduce the experience of pain intensity and anxiety of other invasive procedures.

Aim:

The study will test the following hypothesis which also acts as aim for intervention:

Relaxation and visualization performed in patients during ablation of atrial fibrillation combined with structured attention behaviour from the nurse reduces the patient's experience of pain and anxiety - and secondary reduces the consumption of painkillers and the number of episodes of adverse outcome that requires extra attention from staff.

Design / Methodology:

The Trial is conducted in a cardiac lab. The survey is conducted as a controlled Trial. The control group receives conventional care and treatment and the intervention group receives visualization and relaxation exercises together with structured behavioural attention.

The patient scores experienced pain intensity and anxiety in a validated linear numerical rank scale.

A Statistical calculation of power estimated the required number of patients to 70 in each group.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred for ablation of atrial fibrillation

Exclusion Criteria:

* Unable to give informed consent
* Impaired mental function, psychosis, severe chronic obstructive pulmonary disease, intolerance towards midazolam or fentanyl
* Undergoing the ablation in general anaesthesia
* Unable to speak or understand danish
A Multi-center Post-Market Surveillance Registry

This multicenter, prospective, observational registry will evaluate the safety and performance of the CYPHER SELECT™ Sirolimus-eluting Coronary Stent, and of all future generation of commercially approved Cordis Sirolimus-eluting Stents (SES), in routine clinical practice. Its objective is to measure the incidence and identify the predictors of acute, sub-acute and late stent thrombosis and Major Adverse Cardiac Events (MACE). Additional analyses will be performed in patient sub-populations, such as diabetes, in-stent restenosis (ISR), acute myocardial infarction (AMI) and multivessel coronary disease.

The data will be collected in consecutive subjects treated with commercially available product and following standard clinical practice. This registry will be limited to subjects who have received only the CYPHER SELECT™ Sirolimus-eluting Coronary Stent during the index procedure. While no inclusion or exclusion criteria have been specified, uniform, complete and accurate data will be collected peri-procedurally, during the index hospitalization, and during follow-up. All subjects should be treated according to the Instruction For Use (IFU) including conduct of the stenting procedure, application of antiplatelet medication and any other medical therapy should be provided according to local usual practice. Data collection (Electronic Data Capture), data management, statistical analyses, monitoring and core laboratory evaluations will be assigned to independent organizations.

Eligibility Criteria:
Inclusion Criteria:

* This registry will be limited to subjects who have received only the CYPHER SELECT™ Sirolimus-eluting Coronary Stent during the index procedure;
* Males and females;

Exclusion Criteria:

* None.
Immediate Versus Delayed Loading of Single Posterior Zirconia Implants

The main aim of the present study is to investigate implant success rate after 5 years of function of immediate (Test group; within 7 days of implant placement) versus delayed (Control group; 8 weeks after implant placement) loading of two-pieces zirconia implant, placed in pristine bone without bone regeneration. Implant success rate will be defined according to Buser's criteria. Secondary endpoints: Marginal bone level (MBL) evaluation by means of standardized radiographs; Clinical evaluation of biological (e.g. Plaque Index, PI; Probing Pocket Depth, PPD, Bleeding on Probing, BOP; suppuration upon probing/palpation) and prosthetic/technical complications; Clinical evaluation of soft tissue width, keratinized tissue, marginal and interproximal soft tissue recession; Patient reported outcome measures (PROMs) by questionnaire administration:


Eligibility Criteria:
Inclusion Criteria:

* Sistemically healthy patients
* partial edentulism
* premolar position
* molar position
* Bone width and height at least 6 and 10mm, respectively.
* Keratinized tissue, at least 1 mm at implant site
* Full understanding of the proposed surgical treatments and the protocol schedule
* Full comprehension and availability to sign the informed consent form

Exclusion Criteria:

* Heavy smokers (\>10 cigarettes a day)
* Serious kidney or liver diseases
* Uncontrolled diabetes
* Bisphosphonates intake
* History of radiotherapy of the head and neck
* Current antiblastic chemotherapy
* Congenital (primary) or acquired (secondary) immunodeficiency
* Pregnant women
* Connective tissue disorders

Local exclusion criteria:

* untreated stage III/IV periodontitis
* Autoimmune diseases
* oral parafunctions
An Open-label, Rollover Study Providing Continued Dosing of Gevokizumab in Order to Assess Long-term Gevokizumab Safety Data

The purpose of this study is to provide continued dosing of gevokizumab in order to obtain and assess long-term gevokizumab safety data.


Eligibility Criteria:
Inclusion Criteria:

* Completed either the X052130/CL3-78989-005 or the X052131/CL3-78989-006 study's masked D392 or OL-224 completion day visits or had controlled ocular inflammation after having received study drug in Part 2 of study X052133

Exclusion Criteria:

* Discontinued from the previous study

Other protocol-defined inclusion/exclusion criteria may apply
Pulse Oximetry_Performance Testing- PCBA-1 (Printed Circuit Board Assembly) NEO/PEDS

To determine accuracy specifications of the pulse oximeter in the NEO/PEDS subject population


Eligibility Criteria:
Inclusion Criteria:

1. Subject or legal guardian is willing and able to sign informed consent prior to study initiation.
2. Subject is able to participate for the duration of the evaluation. In most instances, the length of the study will not exceed twenty-four hours.
3. Subject satisfies a specified sensor requirement (see Table 1).
4. Requires use of an intra-arterial line for medical reasons such as continuous blood pressure monitoring or frequent arterial blood draws.
5. Subject is able to accommodate multiple sensors.
6. Neonatal subjects up to 1 month of age or Pediatric subjects 1 month up to 18 years old.

Exclusion Criteria:

1. Subjects that have an existing health condition, in which the investigators determine that safe or accurate oximetry measures may not be obtained at the areas where the pulse oximetry sensor could be placed, will not be included in the study. For example, anyone with burns, abrasions or surface lesions on the contact areas would be excluded.
2. Any subject whose treatment or condition would be compromised if they were to participate in this study and any patient whose use of a pulse oximeter and sensor would present a potential for serious risk to health, safety, or welfare.
3. Subject has severe contact allergies that may react to standard adhesive materials found in pulse oximetry sensors.
4. Subject cannot be reliably monitored with a pulse oximeter as a result of inadequate pulsatile signals.
5. Subject has had a procedure using injected intravascular dyes within 24 hours preceding testing
Deep Brain Stimulation for the Treatment of Obesity in Patients With Prader-Willi Syndrome

The purpose of this study is to investigate the safety and efficacy of deep brain stimulation in obese patients with Prader Willi syndrome refractory to conventional treatment.

The purpose of this study is to investigate the safety and efficacy of deep brain stimulation in obese patients with Prader Willi syndrome refractory to conventional treatment. Patients will be implanted with hypothalamic DBS electrodes. Calorimetric and anthropometric measures, body mass index, side effects, neuropsychiatric evaluations will be carried out at 6 months for measuring primary and secondary outcome. Side effects will be monitored at 1, 3, 6 and 12 months following surgery.

Eligibility Criteria:
Inclusion Criteria:

* 15 years or older
* Parents able to give informed consent
* Diagnosis of Prader-Willi syndrome confirmed by genetic analysis
* Refractoriness to medical treatment, defined as a weight loss lower than 10% of the body weight with nutritional, pharmacological or surgical interventions
* Severe or morbid obesity
* No contra-indications to the surgical procedure

Exclusion Criteria:

* Cardiovascular disease that might significantly increase the surgical risk
* Brain lesions detected clinically or during MRI
* Use of cardiac pacemakers/ defibrillators
* Clinical conditions that may require the use of MRI in the post-operative period
* Patients undergoing chemotherapy or immunosuppressive treatments
* Patients unable to return to the hospital at the required intervals
* Previous neurosurgical treatments that may increase the risk of DBS surgery
* Active medical conditions that may require in-hospital treatment in the nearby future
* Previous diagnosis of epilepsy or status epilepticus
* Chronic infection
* Plan to use diathermy
* Metallic implants that might preclude MRI imaging of the brain
* Active participation in other experimental studies
Pharmacokinetics of Imeglimin in Hepatic Impaired Subjects

This is a Phase 1, single-centre, open-label, parallel-group study in subjects with moderate hepatic impairment and subjects with normal hepatic function. Child-Pugh (CP) scoring will be used to determine hepatic impairment.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian
* BMI :18.0 and 40.0 kg/m2 and weight ≥50 kg.
* Stable hepatic impairment or normal hepatic function for healthy volunteer
* No clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations (Subjects with moderate hepatic impairment may have medical findings consistent with their hepatic dysfunction)
* Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception
* Informed consent signature

Exclusion Criteria:

* Clinically relevant abnormal findings at the screening assessment
* Severe adverse reaction to any drug or sensitivity to the trial medication or its componentsClinically significant vital signs outside the acceptable range at screening
* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
* Drug or alcohol abuse
* Positive test HIV
* Smoking more than 10 cig/day
* Participation in other clinical trials of unlicensed or prescription medicines

Exclusion criteria for healthy volunteer

* Positive test for HBV, HBC
* eGFR less than 90 mL/min/1.73 m2
* liver diseases

Exclusion criteria for hepatic impaired

* eGFR less than 80 mL/min/1.73 m2
* Hepatic impairment due to non liver disease
* History of hepatocellular carcinoma or acute liver disease
* CLinically significant change in liver disease status within 6 months
* ascites
* encephalopathy grade III or IV
Evaluation of Subclinical COronary Atherosclerosis for Risk Stratification Using Coronary Computed Tomography (CT) Angiography

To evaluate the prognostic value of coronary CT angiography (CCTA) for risk stratification in asymptomatic adults in comparison with conventional risk stratification (CRS) and coronary artery calcium scoring (CACS).

The risk stratification of cardiovascular disease (CVD) in asymptomatic individuals represents a major challenge. For this purpose, a lot of risk prediction models that take demographic and clinical characteristics into account have been developed. Although Framingham risk score (FRS) is most widely used among multiplr risk prediction models, it has some limitation for prediction of CVD especially in young adult and women. Recently, coronary artery calcium score (CACS) has known to be powerful screening method for CVD, however, it cannot detect the noncalcified coronary plaques (NCP), so it does not represent the entire spectrum of atherosclerotic plaques and it also cannot evaluate the degree of stenosis. On the contrary, Coronary CT angiography (CCTA)can provide detailed coronary artery anatomy and plaque imaging about the location, burden and characteristics of atherosclerotic plaque per se, which might give additional insight to stratify the risk of future cardiac events and therapy.

In this study, we will evaluate the prevalence and characteristics of subclinical coronary atherosclerosis on CCTA in asymptomatic population. And we will investiage the follow up data for major cardiac adverse event such as cardiac death, nonfatal myocardial infarction, unstable angina and revascularization. Therefore, we will finally evaluate the prognostic value of CCTA for risk stratification in asymptomatic adults in comparsion with conventional risk stratification such as FRS and CACS.

Eligibility Criteria:
Inclusion Criteria:

* asymptomatic subjects
* adults \> 20 years
* subjects who underwent both calcium score and coronary CT angiography

Exclusion Criteria:

* typical or atypical chest pain
* subjects who underwent previous percutaneous coronary intervention
* serious comorbid conditions(i.e. malignancy)
* insufficient medical record
* poor image quality
Long-term Remote Ischemic Preconditioning Improve Long-term Prognosis of Acute Myocardial Infarction Patients Without Emergency Reperfusion Therapy

Patients with acute myocardial infarction (AMI) are in critical condition especially without emergency reperfusion therapy. For example, heart failure, heart rupture, malignant arrhythmia are in high level. It was reported remote ischemic preconditioning (RIPC) may play an effective endogenous cardiac protection. This study will investigate whether long-term RIPC can improve the short-term and long-term (1 year) prognosis of AMI patients without emergency reperfusion therapy. 220 AMI patients without emergency reperfusion therapy were randomly divided into 2 groups: long-term RIPC group (once RIPC/day for a year) or control group (routine treatment). Cardiac troponin (TNI), high-sensitivity C-reactive protein (hsCRP), adenosine, vascular endothelial growth factor (VEGF), hypoxia inducible factor-1 (HIF-1), echocardiography and magnetic resonance（MR）were detected in hospital, 1 month and 1 year after discharge. Patients will be followed up by telephone at the end of one year. The major adverse cardiovascular events (MACE) include cardiovascular death, spontaneous myocardial infarction, unplanned revascularization and stroke.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-80 years;
* Acute myocardial infarction (STEMI);
* Without emergency reperfusion therapy.

Exclusion Criteria:

* Age more than 80 or less than 18 years;
* Renal failure with creatinine \>2 mg/dl;
* Reject taking part in the study.
Reliability and Validity of Modified Four Square Step Test

Functional improvements are reached in patients with primary total hip arthroplasty compared to the pre-operative term however some problems as continued range of motion limitations, loss of joint proprioception sensation, and resulting balance and gait disorders may result in failure of the Four Square Step Test. Therefore, the need for the apply of the Modified Four Square Step Test in individuals with primary THA is necessary. The aim of this study is to evaluate the test-retest reliability, concurrent validity and minimal detectable change of the Modified Four Square Step Test in individuals with primary total hip arthroplasty.

Roos et al. improved the Modified Four-Square Step Test to complete the test by stroke patients and not to fall due to practices of the test while performing the test. The Modified Four Square Step Test variates from the The Four Square Step Test is that the person is not asked to look ahead during the test, and instead of using a cane, tapes are used to prevent people from losing their balance by tripping over the obstacle. Thus, although the height of the obstacle is reduced, the boundaries of the obstacle are preserved.

Functional improvements are reached in patients with primary total hip arthroplasty compared to the pre-operative term however some problems as continued range of motion limitations, loss of joint proprioception sensation, and resulting balance and gait disorders may result in failure of the Four Square Step Test. Therefore, the need for the apply of the Modified Four Square Step Test in individuals with primary THA is necessary. The aim of this study is to evaluate the test-retest reliability, concurrent validity and minimal detectable change of the Modified Four Square Step Test in individuals with primary total hip arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-85.
* Having undergone primary total hip arthroplasty at least ≥6 months ago.

Exclusion Criteria:

* Having severe cardiovascular or lung disease
* Having severe dementia or communication difficulties
* Having a musculoskeletal or neurological problem that may affect participation in balance tests
* Having an uncorrectable visual impairment
* Having a body mass index of more than 40 kg/m2
Evaluation of a Conversational Information Collection Tool to Access Talk Therapy

This is an observational study evaluating a conversational information collection tool to access talk therapy.

The patient outcome data will be compared between people who refer to talk therapy via the conversational information collection tool and people who refer using other means.


Eligibility Criteria:
Inclusion Criteria:

* Participant meets minimum age requirements for the talk therapy service Participant's registered GP is within the talk therapy service's CCG catchment area

Exclusion Criteria:

* Participants who are in crisis (defined by requiring urgent care or being at an urgent risk of harm)
C-Reactive Protein as a Predictor of Stem Cell Transplant Complications

The purpose of this study is to determine if C-Reactive Protein levels are predictive for complications post transplant.


Eligibility Criteria:
Inclusion Criteria:

* Age 6 months to 20 years
* Patient undergoing a stem cell transplant (allogeneic, syngeneic, or autologous) at Childrens' Memorial Hospital
* IRB approved informed consent (and assent for children age 12-17)