cyrilzakka/clinical-trials huggingface dataset:
Pharyngeal Carriage Rates and Genetic Typing of Group A Streptococcus and Streptococcus Pneumonia Among Israeli Military Basic Trainees

The study is aimed at assessing pharyngeal and nasopharyngeal Streptococcus pneumonia carriage and pharyngeal Group A streptococcus carriage among field units new recruits.


Eligibility Criteria:
Inclusion Criteria:

* Israeli Military Basic Trainee

Exclusion Criteria:

* None
An Analysis of Adverse Events and Satisfaction Outcomes of Women Who Underwent Primary and Secondary Breast Augmentation Using Silimed® Breast Implants

The study investigates the safety and performance of Silimed® silicone gel breast implants with a textured surface and Silimed® silicone gel breast implants with polyurethane coated surface. Female patients who underwent primary or secondary breast augmentation using Silimed® breast implants will be followed-up through 10 years. The safety of each type of Silimed® breast implant is going to be assessed by estimating the known and unexpected short- and long-term risk / adverse event rates. The performance of each type of Silimed® breast implant is going to be assesses by estimating the satisfaction and quality of life after implantation.


Eligibility Criteria:
Inclusion Criteria:

* provide written informed consent.
* female at birth
* be 18 years of age or older
* have received breast implant(s) for indication of primary or secondary augmentation until 21 days before (including the visit window)
* having received a breast implant with a textured surface or a breast implant with a surface coated with Silimed® polyurethane foam
* ability to comply with the protocol throughout the follow-up period.

Exclusion Criteria:

* mammary reconstruction in at least one breast or augmentation after previous reconstruction,
* pregnancy informed or breastfeeding at the inclusion moment,
* advanced fibrocystic disease at the time of implantation,
* neoplasia of any type not yet treated or being treated at the time of implantation, infection in activity not yet treated or being treated at any site at the time of implantation,
* reporting or recording of adverse reactions or intolerance to polyurethane or silicone prior to implantation,
* immune diseases affecting active connective tissue or (eg, lupus erythematosus, discoid lupus, scleroderma, etc.) at the time of implantation,
* signs of inflammation of the breast or implant site at the time of implantation,
* Increased risk of immediate postoperative complications due to use of illicit drugs or medications,
* Increased risk of immediate post-surgical complications caused by illicit drug use or medication use,
* have participated in another clinical study up to 6 months prior to the placement of the implant,
* any other condition which, based on the opinion of the investigator or designee, may prevent the provision of informed consent, renders participation in the study is unsafe, compromises adherence to the protocol, complicates the interpretation of data from the study outcome, or otherwise interferes with the achievement of study objectives.
Construction of Special Disease Cohort Database and Biological Sample Holographic Database of Severe Pneumonia

The incidence rate and mortality of lung infection are high worldwide. It is a common and frequently occurring disease which seriously threatens human health. Severe pneumonia accounts for 18-36% of all pneumonia. Severe pneumonia has caused serious economic and medical burden. Therefore, it is urgent to carry out the real-world cohort study of severe pneumonia. Big data and sample library will provide useful clinical guidance and scientific research reserves for clinicians. Through further research, we can improve the treatment success rate and reduce the mortality.

The purpose of this study is to provide reliable biological samples and related data information for the relevant basic and clinical trials in the field of severe pneumonia by carrying out the construction of special disease cohort database and biological sample holographic database, and to establish a long-term sharing platform for the transformation of research results into clinical practice, improve the prognosis of severe pneumonia,and provide the evidence for improving the diagnosis and treatment of severe pneumonia suitable for China's national conditions.


Eligibility Criteria:
Inclusion Criteria:

* Recent cough, expectoration or aggravation of original respiratory diseases, with or without purulent sputum / chest pain / dyspnea / hemoptysis
* Fever
* Signs of pulmonary consolidation and / or moist rales
* Peripheral blood leukocytes \>10×10\^9/L or less than 4×10\^9/L, with or without nucleus shifting to the left.
* New patchy infiltration, consolidation of lobes / segments, ground glass opacity or interstitial changes, with or without pleural effusion on chest imagings
* Positive etiological examination
* Age \> 18 years old
* Need mechanical ventilation; septic shock need vasoactive drug treatment. Meet one of them.
* ① respiratory rate ≥ 30 beats / min; ② oxygenation index (PaO2 / FiO2) ≤ 250; ③ multilobar infiltration; ④ disturbance of consciousness / disorientation; ⑤ azotemia (BUN ≥ 20mg / dl); ⑥ cytopenia (WBC \< 4.0 × 109 / L); ⑦ thrombocytopenia (platelet \< 10.0 × 109 / L); Ⅷ low body temperature (T \< 36 ℃); Ⅸ hypotension, requiring strong fluid resuscitation. Meet the above three requirements at the same time.

Exclusion Criteria:

● Cannot understand and / or implement the investigation protocol.
The Comparative Trial of UFT + TAM With CMF + TAM in Adjuvant Therapy for Breast Cancer (CUBC)

This controlled study is designed to evaluate the relapse-free survival of UFT + TAM compared with CMF + TAM. Patients are randomly assigned to receive either CMF + TAM or UFT + TAM within 6 weeks after surgery. To assess treatment efficacy, data on recurrence and survival will be collected for 5 years after surgery. To evaluate the safety, data on adverse events will be collected during treatment. Patients'quality of life will be assessed by means of a questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Age 20 to 65
* Hematopoietic WBC ≥ 4,000/mm\^3 Platelet ≥ 100,000/mm\^3 Hemoglobin ≥ 11.0 g/dL
* Hepatic AST and ALT ≤ 40 U/L Total bilirubin ≤ 1.5 mg/dL
* Renal BUN ≤ 25 mg/dL Creatinine ≤ 1.5 mg/dL
Intraspinal Pressure Monitoring for Acute Traumatic Spinal Cord Injury: A Validation Study

Intraspinal pressure monitoring has been advanced as a potential technique for evaluating spinal cord perfusion after traumatic spinal cord injury. In this study, the investigators aim to validate the technique for insertion of a fiberoptic pressure monitoring device in the subarachnoid space at the site of injury for measurement of intraspinal pressure and spinal cord perfusion pressure. The primary objective of this study is to validate the methodology of invasive intraspinal pressure monitoring to derive parameters for optimal spinal cord perfusion pressure, spinal cord reserve capacity and spinal reactivity index using data obtained during the patient's stay in the intensive care unit.

Secondary objectives of this study will be to a) evaluate the safety of invasive intraspinal pressure monitoring, b) prospectively evaluate the overall relationship between spinal cord perfusion pressure and functional outcomes in patients with acute traumatic spinal cord injury and c) evaluate the relationship between spinal cord perfusion pressure, motor evoked potentials and functional outcomes after incomplete spinal cord injury.


Eligibility Criteria:
Inclusion Criteria:

* • patients with acute traumatic spinal cord injury ASIA A, B or C

  * age between 18-70yrs

Exclusion Criteria:

* patients with central cord syndrome
* patients presenting to hospital \>48hrs from time of spinal cord injury
* patients unable to communicate in english language
* pre-existing cognitive impairment
* penetrating spinal cord injury
* pre-existing neurodegenerative disorder involving brain or spinal cord
* patients with concomitant injuries requiring emergent surgical intervention
Supervised Exercise-based Rehabilitation for People With Intermittent Claudication in Denmark

The goal of this project is to implement a protocol for a supervised exercise therapy intervention including smoking cessation in the municipalities in region Zealand in Denmark. The participants are adults with intermittent claudication.

The objective of this project is to describe:

1. The development and design of the implementation process of a rehabilitative intervention including SET and smoking cessation in Region Zealand with a 6-month follow-up period after completion of the SET.
2. The ongoing quality monitoring process of the implementation in terms of referral, recruitment, retention, data completeness, intervention delivery and attendance and to collect feedback that will guide refinements of the intervention delivery and data collection.
3. Outcomes available for assessment of benefits and harms from the SET intervention.

Participants will be asked to do supervised exercise therapy by walking on a treadmill for 3 times a week for 12 weeks, and engage in smoking cessation, if they are smoking.


Eligibility Criteria:
Inclusion criteria:

* Relevant symptoms of intermittent claudication; leg pain when walking due to arteriosclerosis and relieve of symptoms during rest.
* Distal blood pressure with an ankle-brachial index (ABI) \> 50 mmHg for non-diabetics or toe brachial index (TBI) \> 40 mmHg for diabetics.

Exclusion criteria:

• Evaluated by a vascular surgeon: patients with contraindications e.g. medical issues or comorbidity that enables a participation in SET are not referred.
Uterine Natural Killer (uNK) Cell Expression in Patients With Repeated ICSI Failures: A Multicenter Cohort Study

uterine NK (uNK) cells are characterized by a high expression of CD56 (CD56brihgt), lack of CD16 expression, high secretion of cytokines and rather low cytotoxic activity. It has been shown that uNK cells increase in number during the late secretory phase and during early pregnancy. This study was designed to assess the possible role of uNK cells in repeated ICSI failure.

For occurrence of the "window of implantation", the endometrium must proliferate, increase in thickness, then, after ovulation, adequately respond to progesterone, and become receptive. Ultrasound examination of the thickness and appearance of the endometrium is an easily performed means of assessing morphological changes occurring in the endometrium during the follicular phase, and is thus used as a measure to predict successful implantation. Indeed, several studies have reported a strong association between endometrial thickness and successful implantation. However, others failed to confirm such an association. The minimal adequate endometrial thickness for successful implantation, as measured in the late proliferative phase, varies between studies, with a range of 6-8 mm. However, although rare, some investigators have reported successful implantation in an endometrium of no more than 5 mm thickness.

Uterine NK cell testing can only be done via an endometrial biopsy. Uterine natural killer cells never come into direct contact with the fetal cells-they only have direct access to placental cells.The biopsy is performed on day 21 of your menstrual cycle, when the NK cell count is at its highest. The procedure is done at outpatient clinics and results take about two weeks to receive. If your NK cell activity reading is greater than 14 % on day 21 biopsy, then diagnosed with high levels of NK cell activity.

Eligibility Criteria:
Inclusion Criteria:

* Patients with IVF/ICSI failures more than 2 times
* Age 20-40 years

Exclusion Criteria:

* prior uterine surgery
* immunological disease
* previous testing to uNK cells
Effectiveness of Metformin Compared to Insulin in Pregnant Women With Mild Preexisting or Early Gestational Diabetes

Many women come into pregnancy with diabetes that is controlled with either Metformin or diet control; however, the current standard of care for the treatment of preexisting diabetes in pregnancy is insulin. Metformin is widely used in the non-pregnant population for glycemic control, and has been used in pregnancy for other indications without adverse maternal or fetal outcomes. What remains unproven is the ability of Metformin to adequately control glucose in women during pregnancy.

Our goal is to randomize 100 women who enter pregnancy with diabetes that is controlled by either diet or an oral agent and women who are found to have an abnormal glucose challenge test at less than 20 weeks to either standard treatment with weight based Regular and neutral protamine Hagedorn (NPH) insulin or Metformin. Our hypothesis is that Metformin will provide glycemic control that is equivalent to insulin in these women.


Eligibility Criteria:
Inclusion Criteria:

* Receiving prenatal care at University of North Carolina (UNC), Chapel Hill Obstetric clinics and planning delivery at UNC Women's Hospital
* Diagnosis of Diabetes prior to pregnancy with use of an oral hypoglycemic agent or dietary control
* Diagnosis of early gestational diabetes prior to 20 weeks gestation via abnormal 3 hour glucose challenge testing using the national diabetes data group (NDDG)criteria
* Less than 24 weeks at study enrollment
* Singleton or twin pregnancy
* English or Spanish speaking
* Able to give informed consent

Exclusion Criteria:

* End organ complications of diabetes (retinopathy, renal insufficiency, etc.)
* Prior need for insulin for glycemic control
* History of diabetic ketoacidosis (DKA) or hyperosmolar state
* Prior adverse reaction (ie. lactic acidosis) or allergy to Metformin
* Kidney or liver disease
* Significant medical co-morbidities (lupus, cystic fibrosis, etc.) Hypertension controlled on one medication, well controlled asthma, and well controlled thyroid disease are not excluded.
Optimization of Hepatic Hemodynamics During Liver Surgery

The purpose of this study is to determine if vasopressin and nitroglycerin in combination will affect hepatic hemodynamics, in the setting of liver surgery.

The patients in this study (undergoing elective liver resection) will be anesthetized according to routine practice in our hospital. A radial arterial catheter and a central venous catheter will be inserted, as well as a femoral arterial catheter for Picco monitoring. After the dissection phase, catheters will be inserted in the portal and hepatic veins by the surgeon. Base line data (HR, CVP, MAP, CO from thermodilution, portal and hepatic venous pressure, blood gases from radial artery, vena cava superior, hepatic vein and portal vein) will be obtained twice, with 10 minutes of steady state in between. An infusion of vasopressin 4,8 U/h will then be started and continued for 20 minutes. Data will be collected again, and an infusion of nitroglycerine (to a target of MAP 60 mmHg) will be added. After 5 minutes of steady MAP 55-65, the last set of data is collected. 12 Patients will be recruited, and the total data collection is estimated to be completed and assessed after six to nine months.

Eligibility Criteria:
Inclusion Criteria:

* Patients within ASA-class I-II scheduled for open liver resection

Exclusion Criteria:

* ASA-class III and IV, more than 2 medications for hypertension, BMI \> 35, technical difficulties with insertion av catheters, extensive surgery.
Artificial Intelligence to Predict Surgical Outcomes and Assess Pain Neuromodulation in Trigeminal Neuralgia Subjects

Trigeminal neuralgia (TN) is the most common cause of facial pain. Medical treatment is the first therapeutic choice whereas surgery, including Gamma Knife radiosurgery (GKRS), is indicated in case of pharmacological therapy failure. However, about 20% of subjects lack adequate pain relief after surgery. Virtual reality (VR) technology has been explored as a novel tool for reducing pain perception and might be the breakthrough in treatment-resistant cases. The investigators will conduct a prospective randomized comparative study to detect the effectiveness of GKRS aided by VR-training vs GKRS alone in TN patients. In addition, using MRI and artificial intelligence (AI), the investigators will identify pre-treatment abnormalities of central nervous system circuits associated with pain to predict response to treatment. The investigators expect that brain-based biomarkers, with clinical features, will provide key information in the personalization of treatment options and bring a huge impact in the management and understanding of pain in TN.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of TN according to the International Classification of Headache Disorders, third edition (ICHD-3) criteria;
* age \>18 years;
* indication to undergo radiosurgical treatment;
* willingness and ability to comply with scheduled visits and other trial procedures.

Exclusion Criteria:

* Any person unable to lie still within the environment of the MRI scanner for the required period to perform the study and those where MRI scanning is contraindicated;
* metal implants, pacemaker, etc.;
* Pregnancy or breastfeeding;
* Any significant psychiatric disease;
* Use of illicit drugs;
* Brain pathology shown by brain MRI and/or neurophysiological examination;
* Any person unable to understand and follow the instructions of the investigators;
* Any other condition according to the Investigator would make the subject unsuitable for the study.
Peripherel Perfusion Index to Predict Sepsis in Very Low Birth Weight Infants

To explore the predictive value of peripheral perfusion index in late onset sepsis of very low birth weight infants , obtain the threshold by observing the perfusion index of very low birth-weight infants within one month after birth, this value can be used as a threshold to predict late onset sepsis in very low birth weight infants.

From the day the very low birth weight infant was admitted to hospital, monitoring was recorded once a day, and continuous monitoring was recorded for 1 month. Before collection, the infant was confirmed to be in supine position with neutral temperature, and at the same time, the infant was in a quiet state, without the contact and operation of medical personnel. This study will first use LMS curve to fit the trend of perfusion index in very low birth weight infants within one month after birth.The perfusion index threshold of the outcome index was determined by ROC curve.

Eligibility Criteria:
Inclusion Criteria:

* Infants weighting \<1500g
* Infants admitted to Children's Hospital of Fudan University
Gait Analysis in Ponseti Clubfoot

Patients with clubfoot treated with the Ponseti method from a prospective database are evaluated using gait analysis including a foot model and a disease specific instrument score and compared to a group of healthy children.

Patients with a minimum age of three years from a prospective, consecutive database of patients with clubfoot treated with the Ponseti method beginning in 2002 are considered for this study. Thereby patients will typically have a follow up of nearly three to eight years after initial clubfoot correction. Patients with unilateral or bilateral idiopathic clubfoot are included. Patients with clubfoot associated with syndromes or neurological diseases, with mild clubfoot that required fewer than three casts for initial correction, who first presented at an age older than three months, who were living outside of the country, and who were initially treated elsewhere with more than three casts are excluded. An invitation letter to participate in the study was sent out at the end of 2011, with a second letter being sent out three months after the first. After the second letter patients had a time frame of three more months to participate before the study was closed.

To comprise a control group for the purpose of collecting gait analysis data of healthy children, employees of our hospital are asked to allow their children to participate in this study.

Each patient will be physically examined, active and passive range of motion (ROM) of the ankle joint will be measured with a hand-held goniometer. Ability to walk on the heels and on tiptoes will be recorded. The disease-specific instrument questionnaire, which will be blinded for the treating physician will be handed out to fill in.

Patients will undergo gait analysis, including video recordings with a Vicon motion capture system (Vicon, Oxford, UK) with kinetic data collected from three AMTI force plates (Advanced Mechanical Technology, Inc., Watertown, MA). Placement of markers will be a combination of Cleveland (lower extremity), PlugInGait (upper body), and Oxford Foot (movement within the foot) models.

Eligibility Criteria:
Inclusion Criteria:

* unilateral or bilateral idiopathic clubfoot treated with the Ponseti method

Exclusion Criteria:

* clubfoot associated with syndromes or neurological diseases
* mild clubfoot that required fewer than three casts for initial correction
* clubfoot patients that first presented at an age older than three months
* clubfoot patients who were living outside of the Country
* clubfoot patients who were treated elsewhere with more than three casts
Dynamic Full-Field Optical Coherence Tomography for Structural and Microbiological Characterization of Central Venous Catheter-deposited Biofilm in Critically Ill Patients

29.3% of bacteremias in intensive care units (ICU) are linked to vascular devices, with a significant proportion related to central venous catheters, and an influence on both morbility and mortality.

It is now accepted that microbiological biofilm plays a key role on both bacterial and fungal development on inner surface of vascular devices but there is yet a lack of clinical relevant data documenting a causal relation between biofilm formation and bacteremias.

We assume that a more precise characterization of central venous catheter-deposited biofilm could help us better understand invasive medical device-related healthcare infections in critically ill patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient or relative informed of the study and having declared their nonobjection
* Patient over 18 years of age
* Patient exposed to central venous catheter for at least two calendar days

Exclusion Criteria:

* Patient unable to declare their nonobjection
* Patient whose central venous catheter collection is impossible
* Patient admitted in ICU with a central venous catheter already in place