cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Parkinson's Disease Mild Cognitive Impairment (PD-MCI)

The primary purpose of this two-part study was to evaluate the safety and tolerability of SAGE-718 and its effects on cognitive, neuropsychiatric, and motor symptoms in participants with Parkinson's disease mild cognitive impairment (PD-MCI).


Eligibility Criteria:
Inclusion Criteria:

1. Meet the following criteria for PD-MCI: Have a confirmed diagnosis of idiopathic PD according to 2015 Movement Disorder Society (MDS) clinical diagnostic criteria; Meet MDS Task Force Criteria for MCI in PD.
2. Have a score of 20 to 25 (inclusive) on the Montreal Cognitive Assessment (MoCA) at Screening.
3. Meet criteria for Hoehn \& Yahr Stage I to III (mild to moderate motor severity) at Screening.
4. Have stable motor symptoms for at least 4 weeks prior to screening, in the opinion of the investigator.

Exclusion Criteria:

1. Have a diagnosis of dementia of any etiology, including but not limited to: Dementia associated with PD (probable or possible), Dementia with Lewy Bodies, Alzheimer's Dementia, and Vascular Dementia.
2. Have any indication of parkinsonism other than idiopathic PD.
3. In the opinion of the investigator, be experiencing unpredictable fluctuations in motor and/or nonmotor symptoms associated with PD.
4. Have an ongoing central nervous system condition other than idiopathic PD, including active neurologic and/or nonremitted psychiatric disorders, in the opinion of the investigator.
5. Have a history of brain surgery, deep brain stimulation, a significant head injury causing loss of consciousness greater than 30 minutes, or hospitalization due to a brain injury.
6. Have experienced significant psychotic symptoms within the past 3 months, including those associated with PD medications, as determined by the investigator.
School-based Treatment of Anxiety Research Study (STARS)

This research is being done to compare two types of talk therapy to see which is most effective in helping school children with anxiety disorders. The investigators will compare usual care (UC) with cognitive behavioral therapy (CBT). Both therapies will be administered by the school mental health counselors to see if they help children with anxiety disorders to feel less scared or worried.

This four year study involves a blocked randomized controlled trial (RCT) comparing the effectiveness of school-based CBT to usual care (UC) for approximately 375 students ages 7-17 diagnosed with an anxiety disorder. Randomization will occur at the school level and the investigators propose to conduct the study in approximately 46 schools (23 in CBT; 23 UC). Evaluations will be conducted by study staff to measure treatment progress at the end of the 12-week treatment program, at a three month follows up, and at natural termination.

Eligibility Criteria:
Inclusion Criteria:

* between the ages of 6-18 inclusively
* meet DSM-IV criteria for a primary anxiety disorder

Exclusion Criteria:

* presence of a medical or psychiatric condition contraindicating study treatment (e.g., suicidal intent)
* need more immediate or alternative treatment
* receiving psychosocial treatment for anxiety
* victim of previously undisclosed child abuse and require ongoing Department of Children and Families (DCF) supervision
Effects of Microprocessor-controlled Knee Joints on Community Outcomes

About 21% to 35% of people with limb loss are those who lost their limb at trans-femoral level (i.e. above the knee). The increasing number of diabetes-related limb loss (amputation) and the rising proportion of older adult amputees indicates more amputees with limited mobility in the future. Among other factors, prosthesis success highly depends on the function of the knee joints during daily activities.

Presently, there are two categories of prosthetic knee joints; microprocessor-controlled knees (MPKs) and non-microprocessor-controlled knees (n-MPKs). Whilst the n-MPKs are unable to change the knee stiffness, the MPKs alter the joint stiffness and speed of movement according to the users' walking speed.

Although past studies indicate that MPKs could result in reduced risk of falls, improved balance and activity in limited mobility amputees, there is a lack of strong evidence on the effect of MPKs on community outcomes. The aim of this study is to compare activity, mobility, social functioning, depression, anxiety, and health-related quality of life in limited mobility trans-femoral or through-knee (i.e. knee disarticulation) amputees who are users of MPKs prosthesis with users of a prosthesis with n-MPKs.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral transfemoral amputation or knee disarticulation
* ≤ K2 mobility grade OR SIGAM grade D or below; i.e. able to walk ≤ 50 meters on level ground,
* Users of either MPK or N-MPK for at least 6 months prior to the recruitment date.

Exclusion Criteria:

* Not meeting inclusion criteria
UB-621, a New Type of Anti-herpes Simplex Virus (HSV) Monoclonal Antibody for the Use in the Treatment of Adult Recurrent HSV-2 Infections of the Genitals

A randomized, single-blind, dose-selected phase II trial to evaluate the safety, efficacy and PK of UB-621 in adults with recurrent genital HSV-2 infection


Eligibility Criteria:
Inclusion Criteria:

* Subject must be at least 18 years of age inclusive.
* Subject must be HSV-2 seropositive
* Subjects have a history of recurrent genital herpes in the past year
* Subjects have a negative result on the HIV Ab/Ag assay
* Subjects must agree to use contraception during study participation
* Subjects must be willing to collect a swab each day from their genital area (non-lesional as well as lesional, if appropriate) during the swabbing periods, which are 8 weeks period after the administration of study drug.
* Subject must be willing to go back to the hospital within 72 hours after the new lesions are shown in the anal and genital area.
* Subject must be willing to observe the syndromes around the anal and genital area during study period, to evaluate the lesions according to the HSV lesion score, and to record in the patient dairy
* Female subjects must have a negative serum β-HCG at Screening and a negative urine pregnancy test prior to study drug administration.

Exclusion Criteria:

* Serious medical conditions, including poorly controlled diabetes, significant autoimmune diseases, co-existing sexually transmitted disease presentation (except HSV) in the anogenital area, etc. that may interfere with the assessment of the efficacy of UB-621.
* History or current evidence of malignancy except for a localized non-melanoma skin cancer
* Known immunosuppression
* Exposure to HSV vaccine
* Medical history of macular or maculopapular skin reactions to antibody (ie, as evidenced by IgG or plasma administration)
* Any other conditions that in the judgment of the Investigator would preclude successful completion of the clinical study
* Treatment with systemic steroids or other immunomodulating agents within 30 days prior to Screening or planned treatment with systemic steroids or immunomodulators during the study period.
* Renal impairment and/or hepatic impairment
* ECG abnormalities of clinical relevance or cardiovascular conditions
* Abnormal blood tests according to "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trial "in the Guidance for Industry, 2007:

  1. albumin\<3 g/dl
  2. ALP\>2.5\*ULN
  3. ALT\>2.5\*ULN
  4. AST\>2.5\*ULN
  5. Bilirubin\>1.5\*ULN
  6. CPK\>1.5\*ULN
  7. rGGT\>2.5\*ULN
  8. Hemoglobin: female\<11 g/dl; male\<12.5 g/dl
  9. platelet\<125\*10E3/ul
  10. WBC\<2.5\*10E3/ul or
  11. ANC\<1.5\*10E3/ul
The Role of Cxcr4Hi neutrOPhils in InflueNza

Influenza is still responsible for more than 650,000 deaths per year worldwide and no major improvements in patients' care has been made despite 50 years of research. Especially, there is no therapeutic strategy targeting the dysregulated host response. CXCR4-expressing neutrophils seem to be involved in the rupture of host resistance. The aim of this study is thus to compare the percentage of blood CXCR4-expressing neutrophils between influenza survivors and non-survivors.

Influenza is still responsible for more than 650,000 deaths per year worldwide and no major improvements in patients' care has been made despite 50 years of research. Most of severe influenza patients suffer from acute lung injury due to a dysregulated immune response. Neutrophils are involved in both host resistance and disease tolerance. Thanks to advances in technologies, the vast variety in neutrophils subpopulations has been revealed. In particular, the subpopulation of CXCR4-expressing neutrophils has been suggested to be involved in the rupture of disease tolerance in lung infections. Nevertheless, these data are from murine models and remain to be confirmed in humans. Moreover, the underlying mechanisms remain unknown as well as the place of primum movens, i.e. vascular or alveolar compartment. The aim of this study is thus to compare the percentage of blood CXCR4-expressing neutrophils between influenza survivors and non-survivors. Percentage of BAL CXCR4-expressing neutrophils will also be compared. To this aim, blood sampling and BAL within the 24 hours and at day 3 after admission to ICU, neutrophils isolation, immunostaining and flow cytometry acquisition will be performed within the 24 hours and at day 3 after admission to ICU. Mortality rate will be collected at Day 28 and Day 90.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 yo or above.
* Acute respiratory distress syndrome as defined by the Berlin classification.
* Invasive mechanical ventilation for less than 24 hours.
* Cause of ARDS:

  * Influenza infection proven by polymerase chain reaction OR
  * Bacterial infection (tracheal aspirate with more than 105 CFU/mL and BAL with more than 104 CFU/mL.
  * Pancreatitis according to the 2013 Working Group IAP/APA Acute Pancreatitis Guidelines.
  * Peritonitis according to the 2018 SFAR guidelines.
* Health insurance.
* Written informed consent from legal relative or representative.

Exclusion Criteria:

* Neutropenia (\< 500/mm3)
* Neutrophils qualitative defect.
* Patient included in an interventional research assessing an immunomodulatory or antiviral drug.
* Acquired ImmunoDeficiency Syndrome.
* Contraindication to BAL:

  * Severe bronshospasm.
  * Out-of-control shock.
  * Intracranial high pressure.
  * Refractory hypoxemia (PaO2/FiO2 \< 60 mmHg).
* Legal restriction: prisoners, pregnancy, legal protection.
Open Label Study of Duloxetine for the Treatment of Phantom Limb Pain

This is a study to assess the possible benefit of duloxetine in the treatment of chronic phantom limb pain.


Eligibility Criteria:
Inclusion Criteria:

1. Chronic PLP \> 6 months
2. Short-Form McGill Pain Questionnaire Sensory Pain Rating Index raw score ≥ 16
3. Age ≥ 18 years old
4. Inpatient or Outpatient
5. Able to come to all appointments, in the opinion of the investigator
6. Able to give informed consent, in opinion of investigator

Exclusion Criteria:

1. Current Major Depressive disorder, Anxiety Disorder, or Psychotic disorder assessed by the Mini International Neuropsychiatric Interview (MINI)
2. Substance abuse or dependence within the last six months, as assessed by the MINI
3. Known Diabetes Mellitus to exclude diabetic peripheral neuropathy
4. History of coronary artery disease, hepatic disease, renal disease
5. Other pain syndromes
6. Any unstable medical conditions in the opinion of the investigator
7. Other psychotropic medications excluding hypnotics
Bilateral Bronchoalveolar Lavage in Ventilator-associated Pneumonia

The purpose of this study is to assess microbiologic concordance rates between right- and left-lung bronchoalveolar lavage cultures from patients with suspected ventilator-associated pneumonia, identify predictors of concordance, and evaluate the impact of discordant microbiology on clinicians' ability to prescribe appropriate antibiotic treatments, the investigators conducted a prospective observational study in the general intensive care unit of a large university hospital.

Bronchoscopic sampling of lower respiratory tract secretions is widely used in intensive care units (ICUs) for the microbiological diagnosis of ventilator-associated pneumonia (VAP). However, the importance of selecting a specific lung segment for sampling is still a matter of debate.

Non-bronchoscopic blind mini-bronchoalveolar lavage (BAL) is currently used for the diagnosis of VAP with satisfactory sensitivity and specificity. In the presence of pneumonia, microbiologic concordance between the left and right lungs becomes crucial. If concordance is low, the reliability of blind sampling becomes questionable.

When the bacterial distribution in the right and left lungs of VAP patients has been investigated using bronchoscopic sampling techniques, rates of microbiological concordance between the two specimens have varied widely (from 53% to 92%). The factors potentially associated with concordant culture yields have never been explored, and it is unclear whether the use of guided, bilateral lung sampling would actually improve the appropriateness of the antibiotic regimens prescribed for patients with suspected VAP.

The primary objective of this study is to assess the frequency of microbiologic concordance between the right- and left-lung samples in ICU patients undergoing bronchoscopic BAL performed with two different fiberoptic bronchoscopes for the suspicion of VAP. Secondary objectives are to identify factors associated with such concordance and to evaluate the suitability of treatments prescribed based on unilateral vs. bilateral BAL cultures.

Eligibility Criteria:
Inclusion Criteria:

* invasive mechanical ventilation of ≥ 48 hours
* clinically suspected pneumonia (simplified Clinical Pulmonary Infectious Score exceeded 6 or chest radiographs with a new or progressive pulmonary infiltrate in a patient with at least two of the following: purulent respiratory secretions, temperature \>38°C or \<36°C, white blood cell count \>12,000/mm3 or \<4,000/mm3)

Exclusion Criteria:

* age \<18 years
* pregnancy
* absence of informed consent
* an arterial oxygen partial pressure to inspired oxygen fraction ratio (PaO2:FiO2) of ≤150
* use of positive end-expiratory pressure (PEEP) \>10 cmH2O
* active uncontrolled bronchospasm
* unstable angina or recent (\<6 weeks) myocardial infarction
* unstable arrhythmia
* intracranial hypertension
* platelet count ≤20,000/mm3
* international normalized ratio (INR) or activated partial thromboplastin time (aPTT) ratio \>1.5
* documented treatment-limitation orders in the patient's chart
Effect of Intelligent Intervention Strategies on Self-efficacy and Hospital Readiness of Parents of Preterm Infants

1. Construct intelligent management intervention plan for parents of preterm infants from hospital to family based on the medical and health system suitable for China's national conditions.
2. Clinical randomized controlled trials were conducted to verify and evaluate the feasibility and application effect of the intervention program.

Based on the previous literature analysis, this study builds an intelligent intervention scheme based on evidence-based methods and theories. Finally, we selected the parents of preterm infants in the neonatology department of a third class hospital in Shantou to carry out a similar experiment to verify the scheme. With data collected at five critical time points and different interventions provided according to baseline data, the study will reveal significant differences in personalized interventions, self-efficacy at different time points, and hospital discharge readiness among parents of preterm infants in the context of intelligent intervention, showing the relationship between self-efficacy and hospital discharge readiness. This study will fill in the single, traditional model of education and provide new perspectives and methods for future research and clinical practice.

Eligibility Criteria:
Inclusion Criteria:

1. Inclusion criteria for premature infants ① gestational age \&lt; 37 weeks；② Premature infants admitted to NICU；③ The duration of hospitalization is more than 5 days.
2. Inclusion and exclusion criteria of primary caregivers of preterm infants ① Preterm infants admitted to neonatology and family caregivers of preterm infants with gestational age \&lt; 37 weeks. ② Family members who volunteer to undertake primary care tasks. ③ No mental disorders and can carry out normal language communication； ④ ≥18 years old, proficient in WeChat use；⑤ Informed consent has been signed.

Exclusion Criteria:

1. Exclusion criteria for preterm infants ① intrauterine developmental retardation of preterm infants. ② Preterm infants with a history of major surgery. ③ Unplanned discharge, transfer, transfer or death of premature infants.
2. Exclusion criteria for primary caregivers of preterm infants ① There are recent major mental trauma injuries caused by non-hospitalization factors. ② the caregiver suffers from serious diseases of the heart, brain, lung, kidney and other organs. 3. Shedding criteria: Caregivers who voluntarily asked to withdraw for various reasons during the study.
Immune Response to SARS-CoV-2 (COVID-19) Vaccines in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

This study evaluates the immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). CLL and SLL are types of blood cancer that begin in cells of the immune system. CLL/SLL and the medications used to treat these conditions may change the way vaccines work in a patient's body. The purpose of this study is to find out if patients with CLL/SLL make antibodies, or have an immune response, to the SARS-CoV-2 vaccines. Information gained from this study may help researchers better understand how effective the vaccines work in preventing COVID-19 (coronavirus disease 2019) in patients with CLL and SLL.

OUTLINE:

For patients who have not been vaccinated at the time of enrollment, they will undergo collection of blood samples prior to the first vaccine dose, just before the second vaccine dose, and then at 1, 6, and 12 months after the second vaccine dose. Patients' medical records are also reviewed.

For patients enrolled after vaccination, they will undergo collection of blood samples at 1-4, 6, and 12 months after completing the vaccination series. Patients who receive booster dose also undergo collection of blood samples at 1, 6, and 12 months post final booster dose.

After completion of study, patients are followed up every 6 months for 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* A diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
* Willing and able to participate in all required evaluations and procedures in this study

Exclusion Criteria:

* Any evidence of prior SARS-CoV-2/COVID19 infection
Pre-hospital Advanced Therapies for Control of Hemorrhage - Pelvis

The purpose of this study is to determine whether the use of pelvic binders in the ambulance setting improves outcomes including mortality in patients with pelvic fractures.

The goal of this prospective, randomized clinical trial is to determine whether prehospital use of a commercial pelvic binder will improve morbidity and mortality in patients with pelvic fractures. We hypothesize that prehospital placement of pelvic binders will reduce hemorrhage and need for resuscitation and will improve overall mortality in patients with pelvic fractures. In addition, we hypothesize that pelvic splinting via external compression will improve patients' pain regardless of whether they have a pelvic, acetabular, or proximal femur fracture.

Eligibility Criteria:
Inclusion Criteria:

* Traumatic injury other than ground-level fall, and
* Complaint of pelvic groin or hip pain, or
* Pelvic or hip deformity, ecchymosis, or crepitus in an obtunded patient, or
* Hemodynamic instability

Exclusion Criteria:

* Ground level fall
* Penetrating pelvis injury without frank evidence of fracture
* Obviously pregnant patients
* Patients who are too small or too big for the binder
* Priority 2 or 3 Trauma
The Effect of Arginine on Biofilm Composition, Architecture and Metabolism

Arginine is an adjunct to oral health care that has the potential to modulate the composition and activity of the microbial community of dental biofilms towards a health-related status without harmful effects for the resident oral microbiota. The aim of the study is to investigate the effects of arginine treatment compared to placebo on the composition, metabolism, and microarchitecture of biofilms grown in situ in the oral cavity of caries-active participants.


Eligibility Criteria:
Inclusion Criteria:

* Males and females ≥ 18 years old.
* Three or more active carious lesions.
* Anatomically possible to manufacture an intraoral lower-jaw splint.
* Able to understand and follow instructions, as well as to read and sign the informed consent form.

Exclusion Criteria:

* History of allergies towards any of the ingredients in the test products
* Self-reported pregnant or nursing
* Antibiotic or anti-inflammatory medication within 90 days of the screening visit.
* Orthodontic appliances, including retainers, or removable partial dentures.
* Self-reported serious medical conditions.
Real World Evidence Study on Metastatic Prostate Cancer in the Pirkanmaa Hospital District in Finland

Comprehensive understanding of the epidemiology and disease burden of metastatic prostate cancer patients in Finland is lacking. This study will address the following questions:

* What are the demographic and clinical characteristics of metastatic prostate cancer patients?
* How are metastatic prostate cancer patients currently treated and how effective are these treatments?
* How does the development of castration-resistance affect patient outcomes?
* What is the economic burden of metastatic prostate cancer?


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of prostate cancer between 1/1/2007 - 12/31/2022
* Resident of Pirkanmaa at index date (diagnosis of mCSPC and/or mCRPC)
* Detection of metastatic prostate cancer

Exclusion Criteria:

* Prevalent mCSPC and mCRPC patients (mCSPC or mCRPC diagnosis date before 1/1/2014
* Patient has another cancer diagnosis or the patient has received chemotherapy other than docetaxel or cabazitaxel within 2 years of mPC diagnosis.
Heartrate Variability and Intraoperative Brain Conditions in Supratentorial Tumors

This study aims to determine the relationship between heart rate variability and intraoperative brain relaxation conditions in patients with brain tumors.

Patients undergoing brain surgery for treatment of brain tumors will be studied to determine the relationship between heart rate variability and intraoperative brain relaxation conditions.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 to 75 years
* ASA(American Society of Anesthesiologists ) I - III
* Patients undergoing surgery for supratentorial tumors
* Glasgow coma scale \> 10

Exclusion Criteria:

* Patient aged below 18 and above 75 years.
* Pregnancy
* ASA(American Society of Anesthesiologists) IV-V
* Previous cranial surgery
* Morbid obesity ( BMI\>40)
* Ocular injury/ Glaucoma
* Head injury
* Patient on beta blockers, ACE(angiotensin-converting-enzyme) inhibitors, Clonidine
* Diabetes mellitus for more than 5 years