cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of CAZ-AVI in the Treatment of Infections Due to Carbapenem-resistant G- Pathogens in Chinese Adults

This is an open-label, randomized, multi-center, interventional, active-controlled Phase 4 study to evaluate the efficacy and safety of CAZ-AVI versus BAT in the treatment of infected participants with selected infection types (Hospital Acquired Pneumonia \[HAP\] (including Ventilator-Associated Pneumonia \[VAP\]); Complicated Urinary-Tract Infection \[cUTI\]; Complicated Intra-Abdominal Infection \[cIAI\]; Bloodstream Infection \[BSI\]) due to carbapenem-resistant Gram-negative pathogens in China.This study will be an estimation study. The statistical inference will be based on point estimate and confidence interval.


Eligibility Criteria:
Inclusion Criteria:

* Male or female \>18 years of age
* Participant must have a diagnosis of an infection (HAP/VAP, cUTI, cIAI, BSI) due to confirmed carbapenem-resistant aerobic Gram-negative pathogens, requiring administration of IV antibacterial therapy
* Participant who had received appropriate prior empiric antibacterial therapy for a carbapenem-resistant pathogen must meet at least 1 of the following criteria: no or no more than 24h; worsening of objective symptoms or signs after at least 48 hours of antibacterial therapy; no change of objective symptoms or signs after at least 72 hours of antibacterial therapy.
* Capable of giving signed informed consent

Exclusion Criteria:

* Other medical or psychiatric condition may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* Participant is expected to require more than 21 days of treatment
* Participants who need more than 3 systemic antibiotics as part of best available treatment (BAT)
* Previous administration with an investigational drug within 30 days or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).
* Participant is pregnant or breastfeeding.
* Acute Physiology and Chronic Health Evaluation (APACHE) II score \>30 or \<10 using the most recent available data.
Optimizing Chronic Pain Care With Mindfulness and Chronic Pain Management Visits

The primary aim of this implementation-effectiveness trial is to examine the effectiveness of Mindfulness-Oriented Recovery Enhancement (MORE) and patient-centered chronic pain management visits in primary care as interventions to reduce chronic pain, improve quality of life, and reduce opioid-related harms among chronic pain patients on long-term opioid therapy.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 +
* Current chronic pain diagnosis (pain for ≥3 months) determined by physician assessment
* Current use of opioids for ≥3 months
* Score \>=3 on the Pain Enjoyment General Activity scale
* Score \>=9 on the Current Opioid Misuse Measure OR lifetime psychiatric or substance use disorder diagnosis OR benzodiazepine use OR history of overdose OR physician determination that risks of opioid use may outweigh the benefits of opioid use

Exclusion Criteria:

* Chronic pain due to a cancer diagnosis
* Active suicidal intent, schizophrenia, psychotic disorder
* Prior experience with Mindfulness-Based Stress Reduction, Mindfulness-Based Cognitive Therapy, Mindfulness-Based Relapse Prevention, or Mindfulness-Oriented Recovery Enhancement
KERatoconus and Metalloproteinases InvesTigation

Corneal stromal thinning observed in keratoconic eyes could result from an increased synthesis of MMP at the level of the anterior stroma and the corneal epithelium induced by an overexpression of the Extracellular Matrix Metalloproteinase Inducer (EMMPRIN) and Galectin-3 by epithelial cells. A differential expression of EMMPRIN, Galectin-3 and metalloproteinases (MMP) may be observed between the apex of the keratoconus and the peripheral cornea. Highlighting the implication of EMMPRIN and Galectin-3 could lead to the development of specific inhibitors to slow or to stop keratoconus evolution.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years old
* Patient with keratoconus undergoing corneal collagen cross-linking (epithelium-off methods)
* Patient with keratoconus undergoing his first corneal graft for optical indication (control)

Exclusion Criteria:

* Patient with keratoconus undergoing corneal graft for tectonic indication
* Patient undergoing corneal refractive surgery (refractive photokeratectomy) with a normal topography, a normal slit lamp examination and no previous ophthalmic condition (control)
* pregnant or breast feeding patient
* patient under judiciary protection
* patient opposition to participate in the study
Evaluation of Fatty Acid Levels and Growth in Infants Fed Amino Acid Based (AA) Formulas

This clinical trial will compare the amount of fatty acids in whole blood of babies fed one of two study formulas for 4 months.


Eligibility Criteria:
Inclusion Criteria:

* 0 to 6 months of age inclusive
* Born at ≥ 37 weeks gestation
* Birth weight of 2500 g (5 lb 8 oz) or more
* Infants suspected to be cow's milk allergic and who do not tolerate extensively hydrolyzed formula OR infants intolerant to breast milk
* Infants with symptoms suggestive of cow's milk allergy
* Signed Informed Consent

Exclusion Criteria:

* Infants who for whatever reasons were not discharged home as per routine
* Infants with metabolic illness requiring a special formula
* Infants fed with nasogastric tube
Clinical Validation of a Blood Biomarker Test to Detect Early-Stage Pancreatic Cancer (VERIFI)

This is a case-control study to clinically validate the performance of PancreaSure, a protein biomarker test, to differentiate Stage I and Stage II pancreatic ductal adenocarcinoma (PDAC) patient samples from samples acquired from control patients not diagnosed with PDAC but at increased risk of disease due to familial/genetic history or clinical symptoms.

This is the second case-control study to clinically validate the multi- analyte biomarker diagnostic model, PancreaSure. Serum samples will be collected for analysis from patients with pancreatic ductal adenocarcinoma (PDAC) Stages I and II and non-PDAC controls of similar demographics who were at increased risk of PDAC because of their familial or genetic history. Investigators and patients will not receive individual patient results, therefore patient care will not be impacted by test results. Analysis of blood samples will be conducted in Immunovia's laboratory in Durham, NC by personnel who are blinded to subject data. Biomarker results will be analyzed using a predefined (locked) algorithm with predefined (locked) cut-off resulting in a positive/negative test outcome.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent available
* \> 45 years of age
* PDAC cases

  * Treatment-naïve, pathologically confirmed PDAC Stage I or Stage II
  * Sporadic or familial/genetic PDAC
* Controls

  * Individuals at high risk for PDAC because of their familial and/or genetic history
  * Individuals at high risk for PDAC because of pancreatic cysts between 1.0cm and 3.0cm in diameter.
  * Controls will be selected to have similar demographic features (age/gender) to PDAC patients

Exclusion Criteria:

* Prior treatment for PDAC (i.e., prior resection, radiotherapy, or chemotherapy)
* Current immunosuppressive (e.g., systemic steroid therapy) or chemotherapy
* Major surgery or significant trauma within 12 weeks prior to blood sample collection
* Non-PDAC malignancies within 3 years prior to sample collection squamous or basal cell skin carcinoma is not an exclusion criteria)
* Control patients who currently have

  * biliary obstruction secondary to gallstones
  * prior diagnosis or imaging evidence of chronic pancreatitis
  * cystic pancreatic lesions \>3.0 cm in diameter or showing worrisome features according to Fukuoka Consensus Guidelines.
Keep Contraceptive Arm Long Acting-iMplant (CALM) and Carry On

The investigators will conduct an observational study comparing the number of bleeding days before and after contraceptive implant (Nexplanon) replacement.

There is very limited information regarding number of bleeding days after replacement of the contraceptive implants (Nexplanon). More detailed information on this topic will help clinicians counsel patients and help women decide if they would like to pursue contraceptive implant replacement.

The investigators will conduct a prospective cohort study of (N=114) among women replacing their contraceptive implant. The primary outcome of the study is the difference in number of bleeding days between the 4-week periods before and after implant replacement. Secondary outcomes include satisfaction with bleeding. Additionally, a secondary outcome will be the number of bleeding days in month 2 and month 3 after replacement of the contraceptive implant. The outcomes will be measured in bleeding diaries and satisfaction surveys.

Through a text messaging application, the investigators will send the participants hyperlinks to the diaries/surveys at the stated time points. Participants will report if they had bleeding and the amount based on the Pictorial Blood Assessment Chart (Higham). Participants will complete weekly surveys regarding their satisfaction with their bleeding utilizing a Likert scale. The investigators will also ask participants to complete a survey regarding their satisfaction with their bleeding at end of month 2 and at the end of month 3 after replacement of their contraceptive implant.

Eligibility Criteria:
Inclusion Criteria:

* Reproductive aged women 18-50 years old
* With a contraceptive implant (for patient participants)
* Able to consent in English
* Palpable contraceptive implant

Exclusion Criteria:

* Non-palpable contraceptive implant
Respiratory Consequences of N95-type Mask Usage in Pregnant Healthcare Workers - A Controlled Clinical Study

The study aims to find out if usage of N95 type respirators affects respiratory parameters in pregnant women so as to provide guidance on N95 respirator usage in pregnant healthcare workers.

The first phase of the study aims to determine the average workload of a nurse. In the second phase of the study, this workload is then translated to walking on a treadmill while pregnant subjects wore special masks open to air, then occluded with N95 mask materials.

Eligibility Criteria:
Inclusion Criteria:

* Subjects had spontaneously conceived singleton pregnancies and were between 21 to 40 years old. Their hemoglobin levels were ≥11g/dL

Exclusion Criteria:

* Any cardiorespiratory illness, influenza-like illness in the week prior to the trial, or any pregnancy-related complications such as gestational diabetes, hypertension, intrauterine growth restriction, placenta previa, ruptured membranes, or threatened preterm labor. Any neuromuscular conditions that would preclude them from using the treadmill.

Haemoglobinopathies.
Premature Ventricular Contractions (PVCs) and Blood Pressure Control

The purpose of this study is to determine if reduction in premature ventricular contraction (PVC) burden results in a decrease in blood pressure, sympathetic outflow, plasma catecholamines and an improvement in baroreflex gain. Flecainide will be used for PVC suppression in a randomized, double-blinded, crossover fashion.


Eligibility Criteria:
Inclusion Criteria:

* Frequent symptomatic premature ventricular contractions (PVCs) (\>10% of total QRSs on a 24-hour Holter)
* Willingness to participate in research

Exclusion Criteria:

* Age \> 65 years old
* Pacemaker implantation
* Implantable cardioverter defibrillator implantation requiring pacing
* Sick sinus syndrome
* Atrio-ventricular (AV) block
* Left ventricular dysfunction defined as left ventricular ejection fraction \< 50%
* History of myocardial infarction or coronary artery disease
* Severe left ventricular hypertrophy (wall thickness \> 1.5 cm by echocardiography performed within 3 months from enrollment)
* Severe liver dysfunction
* Creatinine clearance of 35 mL/min/1.73 square meters or less
* Pregnancy
* Known hypersensitivity to the drug
* QRS duration \> 120 ms
* Recent change in blood pressure medication within 30 days of enrollment
Autogenic Training Effects on Pre-eclampsia

The purpose of study is to find the effects of autogenic training on blood pressure and anxiety in preeclampsia females. There is little of evidence to allow conclusions about effectiveness of autogenic training on preeclampsia Therefore this study will add to the growing body of knowledge that if autogenic training is better than any other protocol for preeclampsia and anxiety then it should be a choice of therapy treatment. This study can provide help pregnant females and other society members to think about treatment of preeclampsia and anxiety other than medical approach.

Pre-eclampsia is a disorder of pregnancy characterized by the onset of high blood pressure and often a significant amount of protein in the urine. When it arises, the condition mostly begins after 20 weeks of pregnancy. In severe cases of the disease there may be red blood cell breakdown, a low blood platelet count, impaired liver function, kidney dysfunction, swelling, shortness of breath due to fluid in the lungs, or visual disturbances. Pre-eclampsia increases the risk of undesirable outcomes for both the mother and the fetus. Pre-eclampsia affects approximately 2-8% of all pregnancies worldwide. Pre-eclampsia is much more common in women who are pregnant for the first time or have obesity, diabetes and autoimmune disease.

Randomized controlled trial (RCT) will be conducted to find the effects of autogenic training on blood pressure and anxiety in females having pre-eclampsia, the data will be collected from National Hospital and Sofia clinic via sphygmomanometer and DASS-21 scale. Sample size of 26 females is taken. Non probability convenient sampling will be used. A written consent form will be taken from participants meeting inclusion criteria and will be randomly allocated into two groups through lo1.ttery method to either Group A or Group B. Treatment will be given 3 times per week for 4 weeks. Sphygmomanometer will be used to check the blood pressure reading and DASS-21 questionnaire will be used to access anxiety in the females. All participants in both groups will be evaluated before and after the treatment program. Total duration of the study will be ten months. Data will be analyzed by using SPSS 21.

Eligibility Criteria:
Inclusion Criteria:

* Diagnose Women with pre-eclampsia
* Blood pressure value more than 90/140
* 2nd trimester
* Age of 25 to 35 years

Exclusion Criteria:

* Women with cardiorespiratory diseases and diabetes
* Previous history of preterm labor or abortion
* History of serious mental illness
Brain Training System Using Electroencephalography (EEG) for Neurorehabilitation of Hand Function After Stroke

In this project we will design a control algorithm to identify the focalized motor-related clusters for hand function on each stroke patient. A real-time feedback will control the robotic hand when motor imagery is successfully identified. Finally, the focalized BCI-robot training will be compared in a randomized controlled trial to evaluate the training effectiveness and changes in the EEG patterns.


Eligibility Criteria:
Inclusion Criteria:

(1) sufficient cognition to follow simple instructions, as well as understand the content and purpose of the experiment (Mini-Mental State Examination (MMSE) score\>25) ; (2) subcortical location of the ischemic lesion within the territory of the middle cerebral artery; (3) have moderate to severe motor disability at the paretic upper limb (assessed by Fugl-Meyer Assessment (FMA), Modified Ashworth Score of fingers (MAS), and Action Research Arm Test (ARAT))

Exclusion Criteria:

(1) severe hand spasticity, open hand wound or hand deformity; (2) visual field deficits; (3) aphasia, neglect, and apraxia.
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine Catch-Up Regimens in Older Infants and Children

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent Pneumococcal conjugate vaccine (13vPnC) in older infants and children who have not previously been immunized with Pneumococcal vaccine.


Eligibility Criteria:
Inclusion Criteria:

1. Aged from 7 months to \<72 months at time of enrollment.
2. Available for entire study period and whose parent/legal guardian could be reached by telephone.
3. Healthy as determined by medical history, physical examination, and judgment of the investigator.
4. Parent/legal guardian had to be able to complete all relevant study procedures during subject participation.

Exclusion Criteria:

1. Previous vaccination with licensed or investigational pneumococcal vaccine.
2. A previous anaphylactic reaction to any vaccine or vaccine-related component.
3. Contraindication to vaccination with pneumococcal vaccine.
4. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
5. Known or suspected immune deficiency or suppression.
6. History of culture-proven invasive disease caused by S pneumoniae.
7. Major known congenital malformation or serious chronic disorders.
8. Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Does not include resolving syndromes due to birth trauma such as Erb palsy.
9. Receipt of blood products or gamma-globulin (including monoclonal antibodies) in the last 3 months.
10. Participation in another investigational or interventional trial. Participation in purely observational studies is acceptable.
11. Child is a direct descendant (child or grandchild) of a member of the study site personnel.
Bioactive Plant Foods: Effects on Functional Bioavailability and Genomic Stability

To achieve optimal health and to reduce the risk of age-related chronic diseases through an easily achievable dietary modification not achievable by the limited mixture of antioxidant supplements in older subjects, the investigators will focus their attention on the biological functions of bioactive plant food (Angelica keiskei and/or Glycine max) and its effect on genomic stability using noble assays.

The investigators propose to study the ability of bioactive plant-based food (Nutrition bar made from Angelica keiskei and/or Glycine max) to 1) exert biological functions: increase total antioxidant performance, decrease oxidative stress in vivo, and 2) affect genomic stability: decrease DNA damage and modify DNA methylation. The investigators hypothesize that bioactive plant food (green leafy vegetable power, and/or black bean power) will exert biological functions and affect genomic stability far more efficiently than the limited mixture of purified antioxidant supplements in the vulnerable population, older subjects (\> 50 years, men and postmenopausal women) with and without metabolic syndrome.


Eligibility Criteria:
Inclusion Criteria: healthy control group (n=20)

1. Age: over 50 years old
2. Female subjects must be post-menopausal
3. BMI: 18.5 - 30, waist/hip ratio \< 0.9 for men, \< 0.85 for women
4. TG\<150 mg/dL (1.7 mmol/L) and no medication for TG
5. Total cholesterol \< 200 mg /dL (5.18 mmol/L) and no medication for cholesterol
6. Blood pressure: SBP \< 130 mmHg and DBP \< 85 mmHg and no hypertensive medication
7. Plasma glucose: fasting blood glucose \< 100 mg/dL (5.6 mmol/L) and no diabetes medication

Inclusion Criteria: Metabolic syndrome (n=40)

1. Age: over 50 years old
2. BMI: \> 30 or waist/hip ratio \> 0.9 for men, \> 0.85 for women
3. Plus any two of the following four factors:

   * TG: 150-400 mg/dL (1.7 - 4.52 mmol/L) and/or medication for TG
   * HDL cholesterol: \<40 mg /dL (1.03 mmol/L) for men, \<50 mg/dL (1.29 mmol/L) for women and/or medication for cholesterol
   * Blood pressure: SBP, 130-160 mmHg and/or DBP 85-95 mmHg and/or antihypertensive medication
   * Plasma glucose: fasting blood glucose 100-125 mg/dL (5.55- 6.94 mmol/L) and no diabetes medication

Exclusion Criteria:

1. Study participants will be screened for normal hematologic parameters, normal serum albumin, normal liver function, normal kidney function, absence of fat malabsorption.
2. Subjects with a history of kidney stones, active small bowel disease or resection, atrophic gastritis, insulin-requiring diabetes, alcoholism, pancreatic disease, or bleeding disorders will be excluded from the study.
3. Exogenous hormone users will be excluded from the study.
4. Moreover, subjects will be non-smokers and will not have taken vitamin or carotenoid supplements for at least 6 weeks prior to the study and throughout the study for both healthy subjects and subjects with metabolic syndrome.
A Repeated Dose Study of KHK6640 in Japanese Patients With Alzheimer's Disease

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of KHK6640, given as a repeated dose in Japanese patients with Mild to Moderate Alzheimer's Disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients with mild to moderate Alzheimer's Disease
* Body weight ≥ 40 kg and \< 100 kg
* Clinical Dementia Rating (CDR) score of 1 or 2
* Mini Mental State Examination (MMSE) score of ≥ 17 amd ≤ 26

Exclusion Criteria:

* Previous active treatment with an Alzheimer's Disease immunotherapy in an investigational study
* Use of another investigational drug within 16 weeks prior to the enrollment
* Subjects who meet National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN) criteria for vascular dementia
* Subjects with a history of presence of clinically significant seizures, brain trauma, transient ischemic attack, and/or cerebrovascular disease
* Subjects with a presence of a neurological condition that could be contributing to cognitive impairment above and beyond that caused by the subject's Alzheimer's Disease
* Subjects who have evidence of infection, tumor, or other clinically significant lesions that could indicate a dementia diagnosis other than Alzheimer's Disease
IGF-I and Free Fatty Acids Isn Glucose Metabolism in Acromegaly

Background Glucose metabolism abnormalities are frequent in acromegaly. Insulin resistance (IR) correlates with the intensity of acromegaly and Insulin-like Growth factor-I (IGF-I) correlates better with IR than growth hormone (GH). Insulin secretion (IS) is significantly reduced in hyperglycemic acromegalics as compared with those with normal glucose levels. IS is independent of acromegaly intensity.

The aim of this study is to show that in active acromegaly: 1) IGF-I does not cause IR but is just a better marker of acromegaly intensity than GH; 2) high GH levels induce IR through free fatty acids (FFA); 3) hyperglycemia is caused by a defficient IS on a background of IR.

Methods Intensity of acromegaly will be assessed using serum levels of GH, IGF-I and IGF binding globulin-3. IR and IS will be assessd using an intravenous glucose tolerance test acording to Bergman model. FFA will be directly measured in plasma.


Eligibility Criteria:
Inclusion Criteria:

* active acromegaly based on following criteria: minimum GH in oral glucose tolerance test (OGTT) over 1 ng/mL and serum IGF-I over upper limit of normal for age and sex
* age between 18 and 65 years old

Exclusion Criteria:

* more than one previous pituitary surgical intervention for acromegaly
* present medical treatment for acromegaly (somatostatin analogs, GH-receptor blockers, dopaminergic agonists)
* previous pituitary radiotherapy
* present medical treatment for hyperglycemia (oral antidiabetic drugs, insulin, etc)
* pituitary failure, treated or not
* medical or surgical conditions which, in the oppinion of the principal investigator, could impact on study results or patient's safety
* fasting blood glucose over 200 mg/dL or HbA1c over 8%.
* body mass index less than 20 or over 35 kg/mp