cyrilzakka/clinical-trials huggingface dataset:
A Cross-specialty Collaboration Platform for Mucopolysaccharidosis Confirmative Diagnosis

In this study the investigators is aimed to establish the MPS screening algorithm for high risk patients who had medical history of previous surgical repair or presence of inguinal and/or umbilical hernia with combination of any ENT related surgery or examination in Taiwan.

Mucopolysaccharidoses (MPS) are a group of inherited lysosomal storage disorders. In individuals with MPS disorders, have deficiency or malfunction of specific lysosomal enzymes leads to an abnormal accumulation of certain complex carbohydrates (mucopolysaccharides or glycosaminoglycans) in the arteries, skeleton, eyes, joints, ears, skin, and/or teeth. These accumulations may also be found in the respiratory system, liver, spleen, central nervous system, blood, and bone marrow. This accumulation eventually causes progressive damage to cells, tissues, and various organ systems of the body. Due to such an extreme variability in clinical presentation as well as wide range of disease spectrum, but insufficient MPS disease awareness in Taiwan, these resulted in a delay diagnosis or even miss diagnosis with other clinical symptom thus patient often received inappropriate treatment. In order to address the current issue of delay diagnosis among MPS patient, it is critical to develop a MPS screening algorithm for high risk patients in Taiwan.

Eligibility Criteria:
Inclusion Criteria:

* The subject is 0-20 years of age.
* The subject had medical history of previous surgical hernia repair or presence of inguinal and/or umbilical hernia.
* The subject had or is scheduled for ENT surgery for any of the following, alone or in combination with adenoidectomy, tonsillectomy, ear tube insertion/tympanostomy, tracheotomy and bronchoscopy
* The subject who is willing and able to provide written, signed informed consent, or by a legally authorized representative after the nature of the study has been explained and prior to any research-related procedures.

Exclusion Criteria:

-The subject has a current confirmed diagnosis of any MPS disorder.
Improving Platelet Activity for Cerebral Hemorrhage Treatment - DDAVP Proof of Concept

The investigators intend to show that DDAVP improves platelet activity from baseline to 60 minutes after treatment start.


Eligibility Criteria:
Inclusion Criteria:

* Spontaneous intracerebral hemorrhage as documented by head CT scan
* Documented regular aspirin use or VerifyNow-ASA result of ≤ 550 aspirin reaction units (ARU), indicating anti-platelet medication

Exclusion Criteria:

* International normalized ratio (INR) of ≥ 1.7 from coagulopathy or warfarin use
* History of von Willebrand disease
* Pregnancy
* Known hypersensitivity to DDAVP or desmopressin
* Active cardiovascular disease or unstable angina
* Hyponatremia or history of hyponatremia
* Current or historical deep venous thrombosis or pulmonary embolism
Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression (BENEFIT)

The purpose of this study is to learn if Belatacept can provide protection from organ rejection following kidney transplantation while avoiding some of the toxic effects of standard immunosuppressive medications such as kidney damage. Effects on kidney function and patient survival as well as drug safety will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* The subject is a recipient of a living donor or deceased donor kidney transplant.
* Male or Female, 18 or older

Exclusion Criteria:

* First time recipient, PRA \>- 50% or for retransplantation PRA \>- 30%.
* If retransplantation, previous graft loss cannot be due to acute rejection.
* Positive cross match.
* Subject receiving extended criteria donor (ECD) organ
* For Long-term extension study-Subjects who have completed three years of study treatment (through Week 156)
Influence of Parents and Friends on Children and Adolescents

The objective of this study is to directly compare the effects of parents and friends on overweight and non-overweight children and adolescents' food intake and food selection using a cross-sectional design. Overweight and non-overweight children (5-6 year-old) and adolescents (13-14 year-old) will share a meal with a friend and with a parent on separate occasions. Participants' food selection and the amount of food they consumed will be compared across conditions.

Hypothesis 1: The investigators hypothesize that overweight children and adolescents will select more unhealthy food items and eat more in the presence of an overweight friend than when eating with a lean friend; whereas lean participants eating with an overweight friend will eat a similar amount of food than lean youth eating with a lean friend.

Hypothesis 2: The investigators predict that overweight children and adolescents (but not lean children and teens) will consume more food in the presence of their mother than in the presence of a friend.

Hypothesis 3: The investigators also predict that overweight youth's energy intake will be related to parental prompts.

Hypothesis 4: The investigators expect greater similarities in terms of food selection and food intake between adolescents and their friend than between adolescents and their parent.


Eligibility Criteria:
Inclusion Criteria:

* Boys and girls ages 5-6 yrs and 12-14 yrs and their mothers
* Children must have a BMI greater than or equal to 15th percentile for their age
* Children and their mothers must have at least a moderate liking of the study foods used

Exclusion Criteria:

* Participants should not have any food allergies
* Participants should have no dietary restraints
* Participants should have no psychopathology that can limit food choice and alter eating
* Participants should have no developmental disabilities that can limit food choice and alter eating
* Participants cannot have a cold or upper respiratory distress that could influence taste, appetite or olfactory sensory responsiveness
* Participants cannot be on any medications that could influence taste, appetite or olfactory sensory responsiveness
Evaluation of the Triage Risk Screening Tool

This study tried to describe diagnostic properties of TRST completed by an emergency doctor, for screening process for fragility of elderly subjects admitted at the accident and emergency department.

A constant increase of emergencies admission of elderly subjects is registered. The current problem is the identification and early screening of these patients upon admission at the accident and emergency department for early tracking in geriatric network. This early assessment could allow a shorter waiting time, a better orientation of patients and a decrease in the number of re-hospitalization.

There are many screening process for fragility tests but there seem to be nonspecifically. The advantage of TRST is its simplicity and speed of filling.

In 2015, Duc et al. have found that TRST may be a screening instrument for elderly subject and is going to require geriatric mobile team (GMT) for evaluation. Unfortunately, the threshold may be too sensitive and GMT solicitation is too high.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are more than 75 years old
* Admitted to the emergency department for medical or surgical reason
* Admitted from Monday to Friday (8h30 AM- 6h PM)

Exclusion Criteria:

* Patient with specific care (vital emergency, urgent surgery)
* Patient or his support person opposing the use of data
BIOSTEMI Extended Survival

The objective of the BIOSTEMI ES study is to assess the long-term clinical outcomes with the Orsiro ultrathin-strut biodegradable polymer sirolimus-eluting stent compared to the Xience thin-strut durable polymer everolimus-eluting stent up to 5 years of follow-up among patients with STEMI undergoing primary PCI, enrolled in the BIOSTEMI trial.

The objective of the BIOSTEMI ES study is to assess the long-term clinical outcomes with the Orsiro ultrathin-strut biodegradable polymer sirolimus-eluting stent compared to the Xience thin-strut durable polymer everolimus-eluting stent up to 5 years of follow-up among patients with STEMI undergoing primary PCI, enrolled in the BIOSTEMI trial.

* In the BIOSTEMI randomized controlled clinical trial, the Orsiro ultrathin-strut bio degradable polymer sirolimus-eluting stent was found superior to the best-in-class Xience thin-strut durable polymer everolimus-eluting stent with respect to target lesion failure at one-year follow-up among patients with STEMI undergoing primary PCI (Iglesias JF, et al., Lancet 2019). The difference was driven by a lower risk of clinically indicated target lesion revascularization with the Orsiro ultrathin-strut biodegradable polymer sirolimus-eluting stent compared to the Xience thin-strut durable polymer everolimus-eluting stent.
* Importantly, the difference between Orsiro stent and Xience stent accrues over time between one and two years of follow-up.
* As per study protocol, the planned follow-up of patients included in the BIOSTEMI randomized controlled trial was 2 years.
* The long-term clinical benefits the Orsiro ultrathin-strut biodegradable polymer sirolimus-eluting stent over the Xience thin-strut durable polymer everolimus-eluting stent beyond the polymer degradation period remain uncertain.

Eligibility Criteria:
Inclusion Criteria:

* Subjects that were enrolled in the BIOSTEMI trial (BASEC: 2016-00555),
* Subject willing and able to provide oral informed consent.

Exclusion Criteria:

* No specific exclusion criteria.
Influence of Gravity on Dexterity, Hand-eye Coordination and Perception of Orientation and Distances

If investigators know that the anticipatory mechanisms involved in precision grip take into account the gravity, however it is unclear how they adapt to changes in the gravitational level. The objectives of this study are to study and model the movement control and the mechanisms underlying learning and adapting to the condition of weightlessness. Specifically, i) investigators will determine if a change in the level of gravity is taken into account when controlling grip force and ii) investigators will examine the effects of gravity change on hand-eye coordination.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers, male or female
* 18 to 65 years
* Affiliated with a Social Security plan or holder of a European Health Insurance Card (EHIC - European Health Insurance Card - EHIC).
* Having an aeronautical medical certificate of fitness for flight personnel unprofessional functions in civil aviation.
* Agreeing to participate in the study
* Having given informed consent

Exclusion Criteria:

* person not affiliated to a Social Security Inssurance,
* person who participated in a clinical trial within the trial below the exclusion period,
* person with a medical history or any acute or chronic condition that can affect the test results, or by running a risk on during the protocol, especially topics: past or present history of neurological disease, rheumatologic or otologic (hearing or equilibration) OR person with a corrected visual acuity of less than 5 / 10th.
* pregnant women.
A Trial Comparing Routine Versus Selective Use of Completion Angiography After Surgical Thromboembolectomy in the Treatment of Acute Lower Limb Ischemia and Their Impacts on Limb Salvage Rates

this randomized controlled trial will compare the impact of routine use of completion angiography versus using it on selective bases after thromboembolectomy in patients with acute lower limb ischemia and their impact on limb salvage rates


Eligibility Criteria:
Inclusion Criteria:

* Grade I (1) (viable) acute ischemia which there is no immediate threat of limb loss; the patient is presented with neither sensory nor motor weakness and there are audible Doppler signals in both arteries and veins.
* Grade IIA (2 A) (marginally threatened) acute ischemia which needs proper treatment to save the limb; the patient is presented with a minimal sensory loss, no motor weakness, inaudible arterial Doppler signals but the venous Doppler signals are still audible.
* Grade IIB (2 B) (immediately threatened) acute ischemia which needs immediate revascularization to save the limb; the patient is presented with a sensory loss associated with rest pain, mild to moderate motor weakness, inaudible arterial Doppler signals but the venous Doppler signals are still audible.

Exclusion Criteria:

* Traumatic or iatrogenic acute limb ischemia
* Grade III acute ischemia (irreversible) with major tissue loss and major amputation is inevitable; the patient presented with sensory and motor loss, inaudible arterial and venous Doppler signals.
* Patients With occluded bypass graft.
* Acute limb ischemia due to intra-arterial injection
* Patients with chronic renal impairment (serum creatinine \> 1.2) or with a history of contrast-induced nephropathy.
* Acute lower limb ischemia due to thrombosed aneurysms
Physiotherapy Assessment Based on the ICF Model in The Lesch-Nyhan Syndrome: Case Report

Lesch-Nyhan Syndrome (LNS) is a genetic disorder that results in a deficit in the hypoxanthine-guanine phosphoribosyltransferase (HPRT) enzyme, which affects purine metabolism. It is a genetic disorder that is carried by an X-linked recessive gene.

LNS has 3 typical symptoms. These are increased uric acid, neurological symptoms and behavioral disorders. Dystonia is often seen among its neurological manifestations. Signs of primidal and extraprimidal system can be seen.

It is very important to create the syndrome-specific physiotherapy program. In order to achieve this, evaluations based on the International Classification of Functioning, Disability and Health (ICF) model are valuable in terms of showing the right way in the management of the disease.

Lesch-Nyhan Syndrome (LNS) is a genetic disorder that results in a deficit in the hypoxanthine-guanine phosphoribosyltransferase (HPRT) enzyme, which affects purine metabolism. It was described by Lesch and Nyhan in 1960. It is a genetic disorder that is carried by an X-linked recessive gene and is therefore predominantly seen in males.

LNS has 3 typical symptoms. These are increased uric acid, neurological symptoms and behavioral disorders. Self-harming behavior begins to appear from the age of 2. Dystonia is often seen among its neurological manifestations. Signs of primidal and extraprimidal system can be seen.

As developments in treatment methods continue in individuals with LNS, the expected life expectancy of these individuals is prolonged. However, these individuals require physiotherapy for symptoms specific to LNS.

Because of the developmental delay seen in babies with LNS, these babies may be diagnosed with cerebral palsy. It is very important to create the syndrome-specific physiotherapy program. In order to achieve this, evaluations based on the International Classification of Functioning, Disability and Health (ICF) model are valuable in terms of showing the right way in the management of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Having lesch-nyhan syndrome

Exclusion Criteria:

-
Serological Diagnostics of COVID-19 in Health Care Workers

All health care workers at the Department of Anesthesiology and Intensive Care at UMC Ljubljana will be tested for SARS-CoV2 with nasal swab test and blood withdrawal for SARS-CoV2 antibodies. At the same time a questionnaire with epidemiological anamnesis, risky contacts and the use of personal protective equipment will be fulfilled.

Health care workers at the Department of Anesthesiology and Intensive Care at UMC Ljubljana are working with COVID-19 patients in intensive care units, operating theaters, wards and emergency department. In the care of those patients different workgroups are involved: anesthesiologists, anesthesia and ICU nurses and respiratory therapeuts.There is insufficient data on the seroprevalence in different workgroups, different areas of the hospital, insufficient data on connection between SARS-CoV2 nasal swabs and antibodies and the rate of asymptomatic infections.

300 hundred HCW will be tested for SARS-CoV2 with nasal swab test and blood withdrawal for SARS-CoV2 antibodies. At the same time a questionnaire with epidemiological anamnesis, risky contacts and the use of personal protective equipment will be filled.

Eligibility Criteria:
Inclusion Criteria:

* employee of Department of Anesthesiology and Intensive Care at UMC Ljubljana
* active current employment at the department

Exclusion Criteria:

* current sick-leave
CAlcified Lesion Intervention Planning Steered by OCT.

Calcified lesions are very frequent among coronary artery disease stenotic lesions.

The prevalence of calcifications ranges from 30 to 40% (by angiography evaluation) but is higher when analyzed by intra coronary imaging.

Calcified lesions are very frequent among coronary artery disease stenotic lesions. The prevalence of calcifications ranges from 30 to 40% (by angiography evaluation) but is higher when analyzed by intra coronary imaging.

The presence of calcifications increases the risk of adverse evolution after PCI , including stent restenosis, thrombosis and need for repeat revascularisation. Specific and appropriate tools can be used for calcified lesions management , including high pressure non compliant balloons, intravascular lithotripsy and rotablator. Intra vascular OCT has a high sensitivity and specificity for calcium detection among coronary artery lesions. Compared to IVUS, OCT allows a better quantification of calcium sheets (depth extension ) . Several intra coronary imaging based calcified lesions management algorithms have been proposed , but none have been validated in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

1. Patient with chronic coronary syndrome
2. Angiographically moderately to severely calcified target lesion, defined as follows:

   * Moderate: lesion with radio-opacities noted only during the cardiac cycle before contrast dye injection (Aksoy et al., Circ Cardiovasc Interv 2019)
   * Severe: lesion with radio-opacities seen without cardiac motion before contrast dye injection, visible on both sides of the arterial lumen(Aksoy et al., Circ Cardiovasc Interv 2019)
3. Possibility to cross the target lesion with OCT catheter

Exclusion Criteria:

1. On-going cardiogenic shock
2. Acute coronary syndrome related to target lesion
3. Severe renal failure (Creatinine clearance: 30 ml/min/m2)
4. Impossibility to cross target lesion with OCT catheter \& balloons,
5. Indication for Rotablator device as first line therapy
6. Pregnancy
7. Age \< 18 y
8. Denial to provide consent
Safety and Immunogenicity Study of Revaccination With SCB-1019T in Healthy Adults

CLO-SCB-1019-002 is the first study of SCB-1019T vaccine for revaccination in older adults who were previously vaccinated with AREXVY. The safety, tolerability and immunogenicity of SCB-1019T are assessed.

The study design will compare heterologous revaccination with SCB-1019T, homologous revaccination with AREXVY, or placebo in adults who were previously vaccinated with AREXVY. The sample size for this study is not based on formal statistical hypothesis testing but is acceptable for safety and immunogenicity evaluation in a phase 1 study. The study will be overseen by a safety monitoring committee.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female participants 60-85 years of age at the screening visit and who received AREXVY before.
2. Individuals are willing and able to comply with study requirements, including all scheduled visits, vaccination, laboratory tests, and other study procedures.
3. Individuals willing and able to give an informed consent, prior to screening.
4. Healthy participants as determined by medical history, physical examination, and clinical judgment of the investigator; participants with pre-existing stable medical conditions can be included (a stable medical condition is defined as a disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment).

Please refer to Protocol for full list of Inclusion and Exclusion criteria.

Exclusion Criteria:

1. Acute disease or fever (≥38°C) at time of vaccination. Participants with a minor illness (mild diarrhea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. For participants with minor illness and/or fever at the time of vaccination, Visit 1 may be rescheduled within the allowed time-window.
2. Recurrent or un-controlled neurological disorders or seizures.
3. Serious or unstable chronic illnesses
4. Any history of dementia or any medical condition that moderately or severely impairs cognition
5. History of a severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccines.

Please refer to Protocol for full list of Inclusion and Exclusion criteria.
Irisin Expression and Gene Polymorphism in Type II Diabetic Patients With and Without CAD

This is an observertional study aimed at Study the association between the level of irisin expression and (Fibronectin Type III Domain Containing 5 (FDNC5) gene polymorphism and the presence and severity of coronary artery disease in patients with Type II DM.


Eligibility Criteria:
Inclusion Criteria:

* This study will include type II diabetic patients aged between 18 and 45 years old

Exclusion Criteria:

1. Recent acute myocardial infarction.
2. patients with Heart Failure
3. Active infection
4. End stage renal failure (GFR \< 30 ml/min) or on dialysis
5. Liver cell failure
6. Athletes or having heavy muscular exercise in the previous 3 days
Nonsurgical Periodontal Treatment in Patients With Social Phobia

Objective: To investigate the impact of nonsurgical periodontal treatment in patients with social anxiety disorder (SAD) and controls without phobia.

Study design: randomized controlled trial. Setting: Institute of Psychiatry from FMUSP (Ipq-FMUSP). Subjects: patients seeking for Social Phobia treatment at IPq-FMUSP ( before and under treatment). Controls: Hospital staff at the HC-FMUSP or volunteers from a list of other studies conducted at the Ipq-FMUSP. Methods: Dental evaluation: probing depth, clinical attachment level and bleeding on probing will be recorded at 6 sites per tooth, as well as the plaque and/or calculus indexes. The number of decayed, missing and filled teeth (DMFT index) will be also assessed. The visual analogue scale (VAS) will be applied for the assessment of pain after probing after the probing recording. Patients will receive a clinical evaluation for halitosis using a Halimeter® to verify the concentration of the volatile sulfur compounds (before and after periodontal treatment). Main psychiatric assessment: Structured Clinical Interview (SCID) for DSM-IV-TR adapted for DSM-5, the Liebowitz Social Anxiety (LSAs). Duration and frequency: after the initial clinical assessment (dental and psychiatric) patients will be randomized into three groups. Two groups (experimental- social phobia with no psychiatric treatment and control) will receive periodontal treatment after the initial psychiatric evaluation. One group will receive periodontal treatment after the improvement of psychiatric condition (3 months after the initial assessment). The non-surgical periodontal treatment will be performed preferably within 24 h. Patients will be reevaluated 3 and 6 months after the end of nonsurgical periodontal treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Social Phobia according to the DSM-IV TR adapted for the DSM-5
* Patients with cut-off score of 4 (moderately ill) in the Global Clinical Impression (GCI) rating scale
* Informed consent signature

Exclusion Criteria:

* Patients with severe major depressive disorder at risk for suicide; substance abuse or dependence, psychotic disorders or psychotherapy treatment
* Patients in psychotherapy treatment
* Systemic alteration that precludes periodontal clinical examination