cyrilzakka/clinical-trials huggingface dataset:
Immune Resolution After Staphylococcus Aureus Bacteremia

The purpose of this study is to determine how monocyte HLA-DR and other markers of immune function change with time in patients with and without prior immune dysfunction who survive sepsis from Staphylococcus aureus bacteremia.

We hypothesize that patients with prior immune dysfunction will have greater reductions in HLA-DR and other markers of immune function after an episode of sepsis than people who do not have prior immune dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* At least one blood culture positive for S. aureus
* Patients aged ≥18 years
* At least two of four systemic inflammatory response syndrome (SIRS) criteria on the day of positive blood cultures. SIRS criteria are:

  * Body temperature less than 36°C(96.8°F) or greater than 38°C(100.4°F)
  * Heart rate greater than 90 beats per minute
  * Tachypnea (high respiratory rate), with greater than 20 breaths per minute; or, an arterial partial pressure of carbon dioxide less than 32 mmHg
  * WBC less than 4000 cells/mm³ (4 x 109 cells/L) or greater than 12,000 cells/mm³ (12 x 109 cells/L); or the presence of greater than 10% immature neutrophils (band forms)

Exclusion Criteria:

* Sequential Organ Failure Assessment (SOFA) score \> 12 on day of positive blood cultures
* Survival expected to be \< 7 days from positive blood cultures
Optimizing Vibrational Therapy to Improve Gait and Balance in Parkinson's Disease

The purpose of this research study is to test the safety, tolerability, and the effect of vibration (delivered by an experimental device called PDVibe2) on freezing of gait (FOG) in persons with Parkinson's disease (PD). The PDVibe2 was developed by Resonate Forward, LLC (RF). This PDVibe2 was designed to administer vibration therapy to the wearer to improve gait and balance in persons with PD while wearing the device.

Enrolled patients with Parkinson's disease, Hoehn and Yahr Stage 2, will be randomized to receive either vibration or no vibration and then will be crossed over to receive the opposite intervention. The study will consist of two treatment periods of two days followed by a washout period of 2 weeks. Each treatment period will consist of four treatments within 2 days, no more than 2 sessions in one day.

Patients will participate in an additional day for screening and another for follow-up (6 days total). All visits will occur at the Virginia Commonwealth University Parkinson's Movement and Disorders Center in Richmond, VA. Participants will be asked to walk for a brief period of time while wearing the PDVibe2. The PDVibe2 will provide vibration therapy and study staff will measure the number of "freezes" before, during and after therapy. Participants will be asked to provide feedback on the device, the therapy session, and how they are feeling.

Eligibility Criteria:
Inclusion criteria:

* age 21 years or older
* PD diagnosed by a movement disorder specialist for 3 months or longer prior to recruitment
* PD medication regimen is stable over the last 3 months with no changes
* Hoehn \& Yahr stage 2 (N = 13)
* able to walk independently or with a simple assistive device (e.g., cane, walker)
* observed by the research team to have PD related gait disturbance such as FOG, shortened or irregular stride lengths, irregular step cadence, slowed speed while on their regular treatment regimen.

Exclusion Criteria:

* diagnosed with a known Parkinson plus syndrome
* were previously exposed to vibration treatment for gait and balance
* presence of dementia (Montreal Cognitive Assessment \< 21)
* additional disorders (not related to PD)impairing gait, stance, balance or coordination (e.g. stroke, leg amputations, or multiple sclerosis)
* history of implantable cardiac device or any other implanted electronic device except a deep brain stimulator (DBS)
* use of braces/orthotics that assist with walking
* are currently in physical therapy (PT) treatment for balance or gait
* peripheral neuropathy by exam
* any condition that, in the opinion of the PIs, would compromise participant safety, data integrity, or data interpretation.
* Children under the age of 18
* Prisoners
* Women who are pregnant or may become pregnant during the course of this study since the safety of this device for an unborn child is unknown.
The Study of Effectiveness Repetitive Transcranial Magnetic Stimulation in Bipolar Depression

The aim of this study is to investigate the effect of repetitive TMS in reduction of depressive symptoms in patients with bipolar disorder. In a randomized, single blind clinical trials, 30 patients with bipolar disorder in Atieh Neuroscience center will be assigned to receive bilateral TMS and unilateral TMS, daily; for 20 sessions. The depressive and anxiety symptoms and quality of life will be assessed before the treatment (pre test) during the treatment (10th session), and after the treatment (post test). QEEG apply before and after rTMS in all subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Outpatients male and female with the range of 18-65 years of age
2. The diagnosis of Bipolar disorder according to DSM-IV-TR
3. Completion of consent form
4. Being under supervision of a psychiatrist,
5. Having BDI\>14
6. Being able to adhere to treatment schedule,
7. Having stable symptoms as defined by not requiring a change in medication for at least 4 weeks .

Exclusion Criteria:

1. The history of rTMS treatment for any reason
2. Intracranial implant and other ferromagnetic materials close to the head
3. Cardiac pacemaker
4. Drug pumps
5. The risk of seizure with any reasons
6. High intracranial pressure
7. The history of epilepsy or seizure in the first relatives
8. Any metal in head
9. Pregnancy
10. Breastfeeding
11. High risk of suicide 12 Having personality disorder in axis II
Intravenous Versus Topical Administration of Low Dose Epinephrine Plus Combined Administration of Intravenous and Topical Tranexamic Acid (TXA)for Primary Total Knee Arthroplasty

The purpose of this study is to compare the blood loss of intravenous and topical administration of low dose epinephrine plus combined administration of intravenous and topical tranexamic acid for primary total knee arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* All patients between the ages of 20 and 75 who were diagnosed with osteoarthritis of the knee and scheduled for an elective primary total knee arthroplasty and those who were willing and able to return for follow-up over at least a 6-month postoperative period

Exclusion Criteria:

* Acute coronary syndrome \< 6 months
* Glaucoma,pheochromocytoma, thyrotoxicosis, digoxin intoxication, serum potassium \< 3.0 mmol, alcohol abuse, premenopausal women
* Current treatment with adenosine diphosphate (ADP) receptor antagonists, Factor Xa or thrombin inhibitors,heparin (excluding Low Molecular Weight Heparin (LMWH) for perioperative thromboprophylaxis), tricyclic antidepressants, or monoamine oxidase（MAO) or Catechol-O-methyltransferase (COMT) inhibitors
* Patients with history of thromboembolic disease, bleeding disorder
* Patients with history of renal impairment, cardiovascular diseases (previous myocardial infarction, atrial fibrillation) or cerebrovascular conditions (previous stroke or peripheral vascular surgery)
* Allergy to TXA
Focused Suicide Prevention Strategy for Youth

This study evaluates whether a Family-centered suicide prevention strategy, when added to usual care (F-SPS + UC), is more effective than enhanced usual care (EUC) in reducing suicide-related behaviors in 128 youth at high-risk of suicide. Half of the participants will be randomized to receive F-SPS + UC and half will receive EUC.

This is a RCT of a patient- and family-centered suicide prevention intervention added to usual care (F-SPS + UC) for adolescents aged 12 to 18 years who present to the Emergency Department (ED) with suicidal ideation or suicide risk behaviours. The investigators will determine whether the F-SPS + UC intervention is more effective than enhanced usual care (EUC) in reducing suicide-related behaviors in 128 youth at high-risk of suicide.

F-SPS is a 6-week, standardized, manualized outpatient program that teaches participants to the skills to manage suicidal thoughts and impulses effectively. The family component addresses conflictual relationships that may be present in the family as well as improving family communication.

Enhanced usual care consists of 6 weekly telephone calls to ensure that the participant has connected with community resources suggested by the ED team and provide additional resources as needed.

Eligibility Criteria:
Inclusion Criteria:

* Ages 12 to18 years
* Youth presenting in the Emergency Department with acute suicidal ideation or suicide risk behaviour
* SIQ-Jr score ≥ 31
* Parent or caregiver able to communicate in English, or is willing to communicate using a hospital-organized translator, and willing to participate in study
* Living in the greater Toronto area and access to a telephone.

Exclusion Criteria:

* Active psychosis or hypomania/mania
* Moderate to severe intellectual disability, autism.
Normal Saline Versus Plasmalyte in Initial Resuscitation of Trauma Patients

The purpose of this study is to determine whether an intravenous salt solution called "Plasmalyte" causes less abnormality of the body's acid levels than a solution called "Normal Saline."

Electrolyte-containing intravenous fluids are routinely administered to patients in the first few hours after acute traumatic injury. Although Normal Saline (0.9% sodium chloride) is commonly used in this setting, it causes a hyperchloremic acidosis that may exacerbate metabolic derangements that occur after acute injury. Plasmalyte A is a solution that more closely matches physiologic electrolyte levels. In this study, we will evaluate whether Plasmalyte A results in less disturbance of the base deficit 24 hours following traumatic injury than does Normal Saline.

Eligibility Criteria:
Inclusion Criteria:

* Triaged upon arrival to the hospital as severely injured
* At least 18 years of age
* Meets at least one of the following criteria:

  1. Intubated or likely to become intubated within 60 minutes of arrival at the hospital
  2. Likely to need an operation within 60 minutes of arrival
  3. Received or likely to receive a blood transfusion within 60 minutes of arrival

Exclusion Criteria:

* Greater than 60 minutes since arrival at the hospital
* Death likely within 48 hours
* Transfer from another hospital
* Pre-existing renal failure requiring dialysis
* Pregnancy
* Prisoner status
Post-neurosurgical Respiratory Muscle Dysfunction

Respiratory muscle dysfunction may contribute to the development of postoperative pulmonary complications. However, it prevalence in patients receiving neurosurgery is largely unknown. Therefore, in present study, respiratory muscle function (measured by the ultrasound) and their correlation with the post-operative pulmonary complications will be analyzed.

Postoperative pulmonary complications is common in patients receiving neurosurgery, and is associated with hospitalization cost and mortality. Respiratory muscle dysfunction is an important cause postoperative pulmonary complications, however, it's prevalence in patients receiving neurosurgery is unclear.

The diaphragm and abdominal expiratory muscles are the main inspiratory and expiratory driving muscles. Ultrasound can assess the function and morphology of these muscles invasively and in realtime. Studies has demonstrated their feasibility and repeatability in realtime monitoring of respiratory muscles.

In this study, our primary aim is to assess the respiratory muscle function after neurosurgery, and the correlation between diaphragm and expiratory muscle function. Our secondary aims including the correlation between the brain injury and the respiratory muscle function, and the impact of post-operative respiratory muscle dysfunction on the pulmonary complications.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* First elective operation during hospitalization
* ASA\<3

Exclusion Criteria:

* Brain stem and spinal spine lesions
* Preoperative chest imaging findings were abnormal
* Mechanical ventilation was required before surgery
* Clinical or radiological evidence of preoperative misaspiration
* History of neurosurgery in the last 6 months
* A history of neuromuscular disease
* BMI≥35kg/m2
* Pregnant women
* Skin lesions detected by ultrasound
Therapeutic Individualization for Patients With Locally Advanced Gastric and Gastroesophageal Cancer

The purpose of this study is to evaluate whether the R0 rate, pathological response degree, patterns of recurrence and long-term outcomes may be initially predicted in patients with locally advanced gastroesophageal junction and gastric cancer treated with a neoadjuvant approach and salvage surgery.

Patients with locally advanced gastroesophageal junction and gastric cancer with T3-4 and/or N+ are included. Initially, patients are diagnosed by computerized tomography scan and endoscopic ultrasound. The neoadjuvant strategy consisted of 3-4 cycles of preoperative chemotherapy (group A) or 3-4 courses of induction chemotherapy followed by concurrent chemoradiotherapy (group B). Chemoradiotherapy comprised weekly chemotherapy concurrently with daily external beam radiotherapy up to 45 Gy). Surgery is scheduled 4 to 6 weeks after the end of CRT. Pathological response is graded according to the Becker criteria. Statistical analysis is performed IBM SPSS v20. Nonlinear mixed effects (NLME) modelling is applied to evaluate the impact of dynamic changes in tumor size, neutrophil lymphocyte ratio (NLR) and platelet lymphocyte ratio (PLR) on the clinical outcome of these patients.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the stomach or gastroesophageal cancer
* Age ≥18 years old
* Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
* Body mass index ≥ 18
* No prior chemotherapy or chemoradiotherapy
* TNM stage of T3-T4 and/or positive regional lymph nodes (N+) by endoscopic ultrasound or computed tomography (CT)
* No evidence of metastasis (M0)
* Adequate hematological, liver and renal functions (ALT and AST≤2.5 UNL, total bilirubin ≤1.5 UNL, and serum creatinine ≤1.5 UNL)

Exclusion Criteria:

* Patients with previous (less than 10 years) or current history of malignant neoplasms, except for curatively treated
* Patients with evidence of severe or uncontrolled systemic disease
* Medically unfit for chemotherapy
Evaluation of 2 Interferon γ Assays in the Diagnosis of Latent Tuberculosis in HIV-infected Patients.ANRS EP 40 QUANTI SPOT

The aim of this study is to estimate the usefulness of QuantiFERON TB Gold In-Tube® and T-SPOT.TB® for the diagnosis of latent tuberculosis in HIV infected antiretroviral naive patients: 80 originated from low TB prevalence countries, without any active TB; 80 HIV infected antiretroviral naïve patients originated from high TB prevalence countries, without any active TB, 40 HIV infected patients with active TB and 40 HIV negative patients with active TB.

The aim of this study is to estimate the usefulness of QuantiFERON TB Gold In-Tube and T-SPOT.TB for the diagnosis of latent tuberculosis in this population. Concordance between TST, QuantiFERON TB Gold and T-SPOT.TB will be assessed in patients with different risks of TB, in a transversal study. This study will include 240 patients during 2 years: 80 HIV infected antiretroviral naïve patients originated from low TB prevalence countries, without any active TB (40 patients with CD4 cell count \> 350/mm3, 40 with CD4 \< 350/mm3), 80 HIV infected antiretroviral naïve patients originated from high TB prevalence countries, without any active TB, 40 HIV infected patients with active TB and 40 HIV negative patients with active TB. TST and the 2 blood interferon gamma assay will be compared according to the level of risk. The improvement of latent TB diagnosis in HIV infected patients may lead to the initiation of TB prophylaxis and decrease the incidence of this life threatening disease.

Eligibility Criteria:
Inclusion Criteria:

* sign an informed consent
* to be adult
* not to be pregnant
* to have a clinical examination and a medical questionnaire

Exclusion Criteria:

-
Evaluation of Safety Following Immune Tolerance Induction Treatment With Turoctocog Alfa in Patients With Haemophilia A Following Inhibitor Development in NN7170-4213 Trial

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to evaluate safety of immune tolerance induction (ITI) treatment with turoctocog alfa (a recombinant factor VIII) in patients who have developed neutralising antibodies against factor VIII after exposure to subcutaneous turoctocog alfa pegol during participation in NN7170-4213 (NCT02994407)


Eligibility Criteria:
Inclusion Criteria:

* Previous participation in the NN7170-4213 trial (male, age at least 18 years (part A) and age at least 12 years (part B))
* Development of a confirmed high titre neutralising antibody towards factor VIII (greater than 5 Bethesda Unit) after exposure to subcutaneous turoctocog alfa pegol in the NN7170-4213 trial or development of a confirmed clinically relevant low titre inhibitor (at least 0.6 to below or equal to 5 Bethesda Unit), defined as factor VIII activity measures (recovery) and/or bleedpattern indicating a lack of clinical response to factor VIII treatment

Exclusion Criteria:

* Known or suspected hypersensitivity to trial product(s) or related products, defined as allergic reactions
* Participation in another clinical trial within 1 month before screening (except participation in NN7170-4213)
* Any disorder, except for conditions associated with Haemophilia A which in the investigator's opinion might jeopardise patients' safety or compliance with the protocol
* Currently receiving immune tolerance induction treatment with a factor VIII containing product other than turoctocog alfa
Temperature of Extremities and Necrotizing Enterocolitis

Bloody stool and necrotizing enterocolitis(NEC) is two main focus in non-neonatal intensive care unit ward and usually lead to longed duration of hospitalization.

Neutral temperature is a environmental temperature where the infant's body temperature is normal under resting state, and the changes of body temperature and skin temperature are less than 0.2-0.3 centigrade. According the definition, a suggested temperature range is set. For example, if an infant's body weight is more than 2500 gram, the initial set of environmental temperature is 31.3 centigrade with a range of 29.8-32.8 centigrade.

low environmental temperature is a risk factor for Bloody stool and NEC. Therefore, how to set the optimal environmental temperature is a challenge.

After birth, newborns must adapt to their relatively cold environment by the metabolic production of heat because they are not able to generate an adequate shivering response. Under the condition, environment temperature should be given to protect an infant from cold stress and cold injury, even NEC.

Therefore, the setting of the optimal environment temperature is a key focus in neonatal ward. Here, the investigators suggest a hypothesis that environment temperature should be set to keep warmth of extremities temperature and infant's body temperature is between 36.7-37.3 centigrade.

In the present study, the investigators will test the hypothesis.

Eligibility Criteria:
Inclusion Criteria:

* body weight \>2500 grams and/or gestational age \>35 weeks
* an infant is diagnosed with hyperbilirubinemia and/or pneumonia without need for oxygen inhalation

Exclusion Criteria:

* congenital deformities
* refusal of parents' consent
Respiratory Virus Metagenomics After COVID-19

The study aims to characterize the distributive pattern of viruses in upper airway and its relationship with influenza seasons, symptomatology and exposure setting. A total of 500 adults residing in Hong Kong would be recruited, who would complete a questionnaire and return self-collected nasal and throat swabs for metagenomic analyses.

1. This is a serial cross-sectional study. Participants would be asked to complete a questionnaire and to self-collect nasal and throat swabs during a specified collection period with reference to an influenza season.
2. Subjects would be invited by post through randomly selected households throughout the territory of Hong Kong. Eligible persons are adults normally resident in the address who could communicate in written Chinese or English. Persons incapable of giving informed consent would be excluded. Other exclusion criteria are: individuals with mental illnesses, prisoners. Approval is obtained from the clinical research ethics committee.
3. A bilingual questionnaire would be administered, which consists of four parts, including: (a) Socio-demographics; (b) History of SARS-CoV-1 infection and vaccination; (c) Exposure settings preceding sample collection; (d) Presence and types (if any) of influenza-like illnesses (ILI) at the time of sample collection;
4. With the provision of nasal and throat swab collection kits, participants shall collect the nasal/throat sample within a 3-month period from the start of an influenza season when one presents with influenza-like illnesses (ILI), or at the end of the season if no such illnesses occur. The self-collected swabs would need to be returned with the questionnaire within 48 hours after sampling. After returning the swabs, a HK$50 voucher would be given to compensate participants' time.
5. RNA would be extracted from the collected samples, followed by by metagenomic analyses. The collected data would be tidied, checked and collated to form a research database. Descriptive statistics, including standard frequency tables and metrics, would be performed.
6. The key outcomes in this study are the change of abundance of viruses in different influenza seasons, and the difference in distributions of viral taxa in samples from participants.
7. On completion of the analyses, the transmission risk of respiratory infections could be assessed, and emerging viral infections could be identified. Certain exposure setting associated viruses could be identified to inform public health policies.

Eligibility Criteria:
Inclusion Criteria:

* adults normally residing in Hong Kong
* could communicate in English and/or Chinese
* provision of consent

Exclusion Criteria:

* individuals with mental illness
* prisoners