cyrilzakka/clinical-trials huggingface dataset:
Using Near Infra-red Spectroscopy to Measure Tissue Perfusion in Patients Receiving Coronary Artery Bypass Graft Surgery

Near infra-red spectroscopy (NIRS) was used to measure the tissue perfusion of the cerebral cortex with two noninvasive adhesive patches in recent years. This study is designed to compare the regional tissue perfusion of different body areas in patients receiving coronary artery bypass surgery under general anesthesia. The NIRS data will also be used to compare with other routine physiological monitors in the surgery.

Study Design:

Prospective observational study

Target Number of Participants:

To recruit 50 patients into this study.

Patient Selection:

1. Patients scheduled for elective coronary artery bypass surgery.
2. The American Society of Anesthesiologists physical status classification system(ASA) Class I\~III
3. Age ≧20 y/o, ≦75 y/o

Exclusion Criteria:

1. ASA Class IV
2. Current skin lesion over the sites where the NIRS patches are designed to be attached.
3. Patients received cardiopulmonary bypass during the surgery.
4. Patients with previous history of allergy to the NIRS patches.

Study Method:

After the induction of anesthesia, four NIRS patches are attached to the patients on the following sites:

1. Biceps brachii muscle area
2. Gastrocnemius muscle area
3. Posterior side of neck
4. central part of the forehead

The four non-invasive NIRS patches are only to measure the tissue oxygen saturation and have no other physiological effects on the participants.

The data will be collected every 5 minutes until the surgery is completed. The data from other routine monitors used during the surgery (including hear rate, blood pressure, and mixed venous saturation) will also be used to compare with the data from NIRS.

Eligibility Criteria:
Inclusion Criteria:

* Age ≧20 years old, ≦75 years old
* Patients scheduled for elective coronary artery bypass surgery
* ASA Class I\~III

Exclusion Criteria:

* Patients scheduled for cardiopulmonary bypass
* Allergy for NIRS
The Association Between SIRI and POD in Older Patients

Postoperative delirium (POD) remains one of most common complication in elderly patients receiving surgery, which is characterized by acute and fluctuating change in the level of cognition and consciousness. Previous studies have shown that surgery and anesthesia-induced acute peripheral inflammation and neuroinflammation may lead to delirium after surgery. Systemic Inflammation Response Index (SIRI) is a more easily accessible and comprehensive inflammation marker derived from monocyte, neutrophil, and lymphocyte count, which has been investigated to assess the prognosis of cancer and infectious diseases. However, the relationship between SIRI and POD has yet to be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Hospital stay of at least 3 days
* More than or equal to 65 years old
* Elementary education or above
* Able to communicate
* American Society of Anesthesiologists (ASA) physical status I-III
* Mini-mental State Examination (MMSE) scores ≥ 22 points

Exclusion Criteria:

* Preoperative delirium
* Severe mental diseases
* Autoimmune-illness, chronic infectious diseases, nervous system diseases and malignancies
Associations Analysis Between Lifestyle and Osteoporosis

A large-scale, community-based, cross-sectional study was conducted to evaluate the extent to which lifestyle was associated with osteoporosis among the Chinese population by using self-reported questionnaire methods.

A large-scale, community-based, cross-sectional study was conducted to evaluate the extent to which lifestyle was associated with osteoporosis among the Chinese population by using self-reported questionnaire methods. More than 3000 participants were recruited in communities in Shanghai. Data involved in demographic information, lifestyle, dietary habits, medical history and clinical biomarkers were collected. Every participants were measured bone mineral density (BMD g/cm2) at calcaneus by standardized quantitative ultrasound (QUS, Hologic Inc., Bedford, MA, USA) utilizing T-scores based on WHO criteria. A standard statistical analysis including univariate and multiple variables regression analysis to explore the risk or preventive factors involved in Chinese lifestyle associated with osteoporosis.

Eligibility Criteria:
Inclusion Criteria:

* Participants aged 30-90 years were recruited from rural and urban communities in Shanghai.

Exclusion Criteria:

* Some participants with chronic diseases and conditions that might potentially affect bone mass, structure, or metabolism were excluded. Briefly, the exclusion criteria were as follows: a history of

  1. serious residual effects of cerebral vascular disease;
  2. serious chronic renal disease (Glomerular filtration rate - GFR \< 30 mL/min/1.73m2);
  3. serious chronic liver disease or alcoholism;
  4. significant chronic lung disease;
  5. corticosteroid therapy at pharmacologic levels;
  6. evidence of other metabolic or inherited bone disease, such as hyper- or hypoparathyroidism, Paget disease, osteomalacia, or osteogenesis imperfecta;
  7. recent (within the past year) major gastrointestinal disease, such as peptic ulcer, malabsorption, chronic ulcerative colitis, regional enteritis, or significant chronic diarrhea;
  8. Cushing syndrome;
  9. hyperthyroidism; and
  10. any neurologic or musculoskeletal condition that would be a non-genetic cause of low bone mass.
Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) NX02-0018

This study will evaluate the safety and efficacy of a 2.5 mg dose of NX-1207 for the treatment of BPH (benign prostatic hyperplasia) as compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

1. Provide signed informed consent prior to enrolment in the study
2. AUASI ≥ 15
3. Prostate Volume ≥ 30 mL ≤ 70 mL
4. Qmax \< 15 mL/sec based on a minimum void of 125 mL
5. Agree not to use any other approved or experimental BPH or OAB medication anytime during the study

Exclusion Criteria:

1. History of illness or condition that may interfere with study or endanger subject
2. Use of prescribed medications that may interfere with study or endanger subject
3. Presence of a median lobe of the prostate
4. Previous surgery or MIST for treatment of BPH
5. Post-void residual urine volume \> 200 mL
6. PSA ≥ 10 ng/mL; prostate cancer must be ruled out (negative biopsy) for PSA ≥ 4 ng/mL
7. Participation in a study of any investigational drug or device within the previous 90 days
8. Prostate cancer
Characterization of Potential Biomarkers of Eye Disease and Vision

Characterize potential biomarkers of sight-threatening eye diseases based on the information acquired in clinical practice at CEC, AIBILI

This is a registry study. Only patients followed under the clinical practice at AIBILI Clinical Trial Centre, and with a signed informed consent form will be included.

Based on the clinical information collected under the clinical practice, and based on patients' characteristics, scientific questions will be raised and data will be collected and analysed accordingly.

Any procedure performed under clinical practice that may allow for the characterization of the disease and/or for the identification of potential biomarkers will be collected and analysed.

Eligibility Criteria:
Inclusion Criteria:

* Any patient followed under the normal clinical practice at AIBILI Clinical Trial Centre, and with a AIBILI signed informed consent form for data collection, Imp. 11-7-2 "Consentimento Informado para tratamento de dados".

Exclusion criteria:

* None
The Integration of a Mobile App Platform With Biomarkers in Kidney Transplantation

The purpose of this study is to examine the feasibility and acceptability of a mobile app to improve self-management skills and medication adherence in kidney transplantation, to assess the clinical benefit of mobile app in combination with tailored coaching using text messaging to enhance patient activation, self-management and medication adherence and to determine whether immunological biomarkers such as cell-free DNA and donor specific antibodies are associated with self-management and medication adherence.


Eligibility Criteria:
Inclusion Criteria:

* 1) age 12-40 kidney transplant recipients with stable kidney function at least one month from the time of transplantation
* 2) have and use a smartphone
* 3) patients without pre-formed antibodies

Exclusion Criteria:

* 1) Patients \<12 or \>40
* 2) patient with pre-existing antibodies
* 3) patients with rejection at the time of enrollment
* 4) patients without a smartphone
* 5) patients with developmental delay or psychological impairment and unable to use an app
Effect of Schroth Exercises Combined With Laser Acupuncture Therapy in Adolescent Idiopathic Scoliosis

The goal of this clinical trial\] is to explore the clinical effect of laser acupuncture combined with Schroth training on adolescent idiopathic scoliosis (AIS) . The main question\[s\] it aims to answer are:

* The effects of Schroth exercises on Cobb angles, angle of trunk rotation, spinal mobility, gait parameters and clinical efficacy in patients with AIS.
* Laser acupuncture combined with Schroth method on Cobb angles, angle of trunk rotation, spinal mobility, gait parameters and clinical efficacy in patients with AIS.

Participants will received Schroth exercise therapy and laser acupuncture therapy (MLS laser).

If there is a comparison group: Researchers will compare received Schroth exercise therapy to see the effects of Schroth exercises and laser acupuncture combined with Schroth method on Cobb angles, angle of trunk rotation, spinal mobility, gait parameters and clinical efficacy in patients with AIS

In this study, the standard control, control group receipts schroth exercise therapy, while trial group receives Schroth exercise therapy and laser therapy. The design of the individual Schroth exercise is carried out according to the c urve patterns of the Schroth classification. The Schroth classification criteria includes four curve patterns that are determined with reference to the location of the curves, the importance of lumbar and thoracic prominences, and the effect of the scoliosis on the pelvis. Laser therapy was performed w ith a dual wavelength, high power IR laser (Multiwave Locked System (MLS®) laser, Mphi, ASA srl, Vicenza, Italy) and the laser acupuncture points include DU2, GB30, DU9, SP6, LR8, DU6, DU4, DU12. Laser puncture acupuncture points had been identified according to Traditional Chinese Medicine (TCM) and treated with handpiece optical group following the detailed treatment parameters: 900Hz, FPW mode, 60 s per point, 29.12J, spot size 3 cm2, energy density 27J/cm2. All treatments are performed five times in a week for 4 consecutive weeks.

Eligibility Criteria:
Inclusion Criteria:

* Adolescent idiopathic scoliosis patients without history of traumas
* positive Adam's Forward Bend Test, Cobb Angle\>10°

Exclusion Criteria:

* functional scoliosis and other structural scoliosis
* Previous history of scoliosis surgery
* Wearing braces and being treated in other ways
* Unable to complete PSSE training actions as required
* Complicated with serious heart, liver, kidney and other systemic diseases
Effectiveness of a Cervical Cancer Stigma Reduction Intervention Program on Cancer Stigma Score and Cervical Cancer Screening Uptake in Nepal

It is a cluster randomized control trial to assess the effectiveness of the cervical cancer stigma reduction intervention on cancer stigma score and cervical cancer screening uptake in Nepal

Despite the presence of ample evidence, that stigma is one of the major reasons for low screening coverage, Nepal does not have a single stigma reduction intervention targeted among women to increase cervical cancer screening coverage. Therefore, we aim to assess the effectiveness of a stigma reduction education program on stigma score and cervical cancer screening uptake in Nepal. We will conduct a two-arm open-label cluster-interventional study in Budanilkhantha Municipality. A computer-based program will randomly allocate the 12 wards of Budanilkhantha Municipality with an allocation ratio 1:1; 6 wards in intervention group and 6 wards in control group. We will conduct a "stigma reduction education program" in the intervention group. After that we will follow up the participants for2 months to see the effectiveness of a stigma reduction education program on stigma score and cervical cancer screening uptake in Nepal. We will analyze data using STATA 14. We will use independent tests to find the mean difference between cervical cancer screening uptake and cervical cancer stigma score. The difference in mean among the two groups will actually be the difference due to intervention given. Findings from this study will help managers and stakeholders to formulate and improve strategies on screening programs and develop programs to reduce stigma on cervical cancer among women in Nepal.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 30-60 years (the age range recommended for VIA screening in Nepal
* Married women
* Residents of Budanilkantha Municipality

Exclusion Criteria:

* Women who have already undergone screening within 5 years.
* Women with hearing or mental disorders
* Pregnant women
* Less than 6 weeks postpartum
* Mothers who had lived in the community for less than 6 months to perform seasonal work (e.g. in brick kilns) or visitors in the family.
* Women who are already diagnosed with cervical pre-cancer and cancer and have undergone hysterectomy.
Optic Nerve Sheath Diameter for Prediction of Outcome After Cardiac Arrest

Early prognostication in resuscitated cardiac arrest (CA) patients, within the first day after admission in the intensive care unit (ICU), remains difficult. Optic nerve sheath diameter (ONSD) measurement could predict increased intracranial pressure. Preliminary works showed that ONSD measurement could be used to predict outcome in post-CA patients.

The aim of this study was to assess the ability of bedside ONSD ultrasonographic measurement to predict survival and Cerebral Performance Category (CPC) score at hospital discharge in post-cardiac arrest patients treated with therapeutic hypothermia (TH).

Prospective observational study including all consecutive successfully resuscitated and TH-treated CA patients without traumatic or neurological etiology of CA in two French ICUs. ONSD measurements were performed on day 1, 2, and 3 after return of spontaneous circulation (ONSD1,2,3 respectively).

The primary outcome is survival at hospital discharge (with an average follow-up of 3 month until ICU admission).

Eligibility Criteria:
Inclusion Criteria:

* Unconscious (Glasgow Coma Scale ≤6)
* ≥18 years old
* Admitted in ICU after successful resuscitation from CA
* Treated with TH targeted to 33°C

Exclusion Criteria:

* unavailable ONSD measurement within 24 hours after return of spontaneous circulation (unavailable investigator, early death, or major hemodynamic instability)
* Traumatic or neurological origin of CA
* Previous cerebrovascular disease
* Facial trauma affecting the orbits and/or eyeballs
* Previous history of ocular pathology such as exophthalmia, glaucoma or cataract.
NMES During the Day and Prior to Sleep

In the present study, the effect of a bolus of intrinsically labeled milk directly after one-legged NMES (Neuromuscular Electrical Stimulation) will be studied under two conditions: during the day and prior to sleep

In the present study, the effect of a bolus of intrinsically labeled milk directly after an hour of one-legged NMES (Neuromuscular Electrical Stimulation) will be studied under two conditions: during the day and immediately prior to sleep

Eligibility Criteria:
Inclusion Criteria:

* Age 65-85 years
* Male
* 18.5 ≤ BMI ≤ 30.0

Exclusion Criteria:

* Type II diabetes
* All co morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthrosis, arthritis, spasticity/rigidity, all neurological disorders, paralysis, hip/knee surgery).
* Use of anticoagulants, blood diseases, allergy for lidocaine
* Use of NSAIDs (non-steroidal anti-inflammatory drugs) and acetylsalicylic acid
* Patients suffering from PKU (Phenylketonuria)
* Presence of implantable cardioverter defibrillator and/or pacemaker
* Performed regular resistance type exercise in the past 6 months
* Use of any tools to assist during walking (cane/ crutches/ walker)
* (Partial) foot/ leg amputation
A Randomized Controlled Trial of a School Disinfection and Hand Hygiene Program

The objective of the trial is to assess the impact of a disinfection and hand hygiene program on absenteeism in elementary school classrooms. Students in intervention classrooms will use alcohol-based hand sanitizers at school, and their classrooms will be disinfected using quaternary ammonium wipes. We hypothesize that the use of disinfectants and hand hygiene products in elementary school classrooms will reduce absenteeism.


Eligibility Criteria:
Inclusion Criteria:

* Member of a designated elementary school classroom in the Avon school system
Ulinastatin in Inhalation Lung Injury

The purpose of this study is to evaluate the efficacy and effect of ulinastatin in inhalation lung injury patients.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe inhalation lung injury
* Within 48hours after inhalation injury
* Age 18 to 70 years old
* Burned area not more than 70% TBSA
* Signed the informed consent form

Exclusion Criteria:

* Pregnancy or lactation
* Allergy for ulinastatin
* Received an investigational drug or device within 90 days prior to entering study
Home-based Aerobic Training Among Adolescents With Chronic Diseases During COVID-19 Pandemic

Data show that the coronavirus disease 2019 (COVID-19) symptoms can be severe in 4% and 3% of the adolescents aged 11-15 years and ≥ 16 years, respectively. In addition, the prevalence of chronic diseases among adolescents has increased in the last years. About 20% of the adolescents have some chronic disease, resulting in increased morbidity and mortality. In march, 2020, the quarantine was officially implemented in Sao Paulo, while elective medical appointments for adolescents with chronic disease were temporarily suspended. To mitigate the deleterious effect of the social isolation on physical and mental health among these patients, this study aims to test the effects of an online, home-based, exercise training program.


Eligibility Criteria:
Inclusion Criteria:

Diagnosed with either one of the following chronic conditions:

* Inflammatory bowel disease;
* autoimmune hepatitis;
* liver transplant;
* renal transplant;
* systemic lupus erythematosus;
* juvenile dermatomyositis;
* juvenile idiopathic arthritis.

Exclusion Criteria:

* Patients with physical limitations that preclude exercise.
* Patients diagnosed with COVID-19.
* Patients diagnosed with mental disorders.
Vitamin D & Levothyroxine Combination Versus Levothyroxine on Lipid Profile in Hypothyroidism

The goal of this clinical trial is to study the improvement of lipid levels in hypothyroid individuals after staring treatment.

The main question it aims to answer is:

• whether adding Vitamin D to standard therapy has any additional benefits

Participants will be given Vitamin D in replacement doses according to their pre-existing Vitamin D level in addition to levothyroxine.

Researchers will compare them with another group receiving only levothyroxine to see how much lipids improve in them


Eligibility Criteria:
Inclusion Criteria:

* Patients of all genders.
* Age more than 12 years
* Biochemically hypothyroid (overt \& subclinical)
* Vitamin D level between 10-70ng/ml
* TC \<250mg/dl, LDL 70-144mg/dl, TGs 150-499mg/dl

Exclusion Criteria:

* Known Atherosclerotic Cardiovascular Disease
* BMI\>35kg/m2
* History of Alcoholism (\>14 units/day)
* History of Beta blocker intake
* Patient taking lipid lowering drugs
Deep Brain Stimulation of Nucleus Accumbens to Prevent Opiate Relapse

Nucleus accumbens plays important roles in the process of opiate addiction and initial of relapse after detoxification, deep brain stimulation of nucleus accumbens will inhibit its activity and thus to effectively prevent the relapse of the opiate dependence.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Long lasting heroin addiction (fulfilled diagnostic-criteria according to ICD-10)
* At least three detoxication-treatments without a long-term period of abstinence has already taken place
* Long-term inpatient treatment to support abstinence have occurred
* completion of detoxification treatment preoperatively with no somatic symptoms of withdrawal
* negative morphine urinalysis and naloxone tests
* Free patient's decision/informed Consent (existing comprehensive ability in meaning, methodology and execution of the study and ability of acceptance)

Exclusion Criteria:

* Clinical relevant psychiatric comorbidity (schizophrenic psychoses, bipolar affective diseases, severe personality disorder)
* Contraindications of a MRI-examination, e.g. implanted cardiac pacemaker/heart defibrillator
* Current and in the last six months existent paranoid-hallucinated symptomatology
* Foreign aggressiveness in the last six months
* Stereotactic respectively neurosurgical intervention in the past
* Contraindications of a stereotactic operation, e.g. increased bleeding-disposition, cerebrovascular diseases (e.g. arteriovenous malfunction, aneurysms, systemic vascular diseases)
* Serious and instable organic diseases (e.g. instable coronal heart disease)
* tested positively for HIV
* pregnancy and/or lactation
A Study on Efficacy and Safety of Menopur® Multidose in Korean Female Patients With Infertility

The purpose of this study is to investigate the ongoing pregnancy rates at 10-11 weeks after embryo transfer in patients treated with Menopur® Multidose


Eligibility Criteria:
Inclusion Criteria:

* Decision made to prescribe Menopur® multidose according to Summary of product characteristics
* The study cycle will be either

  * 1st controlled ovarian stimulation cycle ever, or
  * 2nd controlled ovarian stimulation cycle ever, or
  * 1st or 2nd controlled ovarian stimulation cycle after having achieved ongoing pregnancy in a previous controlled ovarian stimulation cycle (note: the subject cannot be included if she has had made more than one failed cycle before the cycle resulting in ongoing pregnancy)

Exclusion Criteria:

* Known ovarian disease (e.g. ovarian cysts, polycystic ovarian disease etc.)
* Diagnosed as "poor responder", defined as either

  * \>20 days of gonadotrophin stimulation in a previous controlled ovarian stimulation cycle, or
  * any previous cancellation of a controlled ovarian stimulation cycle due to limited follicular response, or
  * development of less than 4 follicles ≥15 mm in a previous controlled ovarian stimulation cycle
* Ovarian hyperstimulation syndrome (OHSS)