cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Carriage of Pneumococci in Children Aged 1-5 Years, and Their Household Contacts

Pneumococci are bacteria which can cause serious and potentially life threatening illnesses like meningitis and blood poisoning.

Pneumococcal vaccines (PCV) have been given in the national immunisation schedule since 2006.Carriage studies allow assessment of how the strains in the nose change over time, in that by clearing some strains away which other strains take up those niches in their place both in children and in their close/household contacts. This helps to inform the best use of the vaccines available and for future vaccine development and which strains would be useful to include.

Pneumococci are bacteria which can cause serious and potentially life threatening illnesses like meningitis and blood poisoning. There are \~90 strains, some are more dangerous than others in the severity of the disease they cause. Around half of all children carry pneumococci at the back of their nose without any ill effect. Pneumococcal vaccines (PCV) have been given in the national immunisation schedule since 2006. Vaccines protect individuals by making antibodies to be made in the blood and these vaccines help to clear the pneumococci from the nose, which helps control disease in the population by stopping their onward transmission when children cough and sneeze. This clearing effect is specific to the strains that are included in the vaccine. The first vaccines used included seven (PCV7) strains and the one used currently includes 13 (PCV13).

This group has conducted three previous carriage studies, and this will be the fourth. The first was before any vaccine was used, the second just after PCV7 was introduced and the third after the UK moved to using PCV13. These carriage studies allow assessment of how the strains in the nose change over time, in that by clearing some strains away which other strains take up those niches in their place both in children and in their close/household contacts. This helps to inform the best use of the vaccines available and for future vaccine development and which strains would be useful to include.

All families registered at participating surgeries, with a child aged 1-5 years, will be invited to take part. The study involves a single nasopharyngeal swab and a saliva swab from the child and as many other household members as are happy to participate. Participants may be seen at their GP surgery or in the home if more mutually convenient

Eligibility Criteria:
Inclusion Criteria:

* At least one child aged 1 to 5 years in the household
* Written informed consent obtained from the child's parent / legal guardian for their participation, and for any participating household contacts

Exclusion Criteria:

* Moderate to severe cerebral palsy or other debilitating condition
* Syndromes and neurological disorders affecting swallowing.
* Ear, nose \& throat disorders affecting local anatomy for swabbing (e.g. malformed ears)
* Confirmed or suspected immunodeficiency (congenital or acquired) or receiving immunosuppressive therapy.
Adipogenic Capacity as a Mediator of Weight Gain

To demonstrate differences in response of subjects with a high, low or medium predisposition for weight regain after weight reduction in terms of: body composition; energy expenditure; physical activity; and adipogenic capacity.

The risk for weight regain after weight loss is a major problem for the current obesity treatments, and is largely genetically determined. It is believed that an elucidation of the genetic component in the prognosis of weight management could assist in the development of more effective and individually tailored treatments. However, current research on the genetic component of weight management, and in particular weight regain, is still limited and data available are sometimes inconsistent. The current research proposal aims to identify groups with a high, low or medium predisposition for weight regain, based on a genetic profile and to demonstrate differences in the response of these subjects to a weight maintenance period after weight reduction in terms of body composition, physical activity, adipogenic capacity and energy expenditure.

Eligibility Criteria:
Inclusion Criteria:

* BMI 28-35
* healthy, no medication
* no smoking
* stable weight (no weight loss/gain \> 5kg in 3 months prior to study)

Exclusion Criteria:

* 28\< BMI \>35
* use of medication
* smoking
* weight loss/gain \> 5kg in 3 months prior to study
Retrospective Medical Record Review of Mind Body Depression Group Participants

The purpose of this study is to assess the effectiveness of a Relaxation Response Intervention for Depression offered to low income populations at Massachusetts General Hospital (MGH) - Chelsea, Revere and Charlestown health centers.

This is a retrospective review of medical records. The study aims to evaluate the effects of participation in the Relaxation Response Intervention for Depression Clinical groups, on patient measures of: 1) depression, anxiety and perceived stress; 2) work productivity and activity impairment; 3) demand for, and adherence to behavioral medicine; 4) medication use for depression and/or anxiety; and 5) dose-response effects.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving care through MGH-Health Centers
* a diagnosis of depression and/or anxiety
* 21 years of age or older

Exclusion Criteria:

-
Performance of an Investigational Blood Glucose Monitoring System in a Clinical Setting

The purpose of this study is to evaluate the performance of an investigational blood glucose meter with the Contour sensor strip. It was decided that this investigational monitoring system would not be part of a regulatory submission and it will not proceed to marketed product.


Eligibility Criteria:
Inclusion Criteria:

* Males and females, 18 years of age and above
* Type 1 or type 2 diabetes
* Currently self-testing blood glucose at home at least twice daily
* Able to speak, read, and understand English
* Willing to complete all study procedures

Exclusion Criteria:

* Currently Pregnant
* Hemophilia or any other bleeding disorder
* Employee of competitive medical device company
* Cognitive disorder or other condition which, in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study
A Study of BMS-986036 in Subjects With Non-Alcoholic Steatohepatitis (NASH)

The purpose of this study is to determine whether BMS-986036 is effective in the treatment of subjects with Non-alcoholic Steatohepatitis (NASH).


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Male or female between 21 and 75 years old
* Body Mass Index (BMI) of 25 or more

Exclusion Criteria:

* Chronic Liver disease other than NASH
* Uncontrolled diabetes
* Any major surgery within 6 weeks of screening
* Unable to self-administer under the skin injections
* Any bone trauma, fracture or bone surgery within 8 weeks of screening
Prophylactic Mesh to Reduce The Incidence of Ventral Hernia

The incidence of ventral hernias has remained inappropriately high. Any innovation in order to reduce this incidence would be simply cost-effective. Although there is still some concern about the use of mesh in clean-contaminated or contaminated surgery, based in our experimental studies, we plan to use a mesh in the primary closure of abdominal incision to prevent incisional hernias.

The investigators propose a clinical trial to assess a model to prevent the incisional hernia after laparotomy to treat colorectal carcinoma is scheduled. A simple randomization is scheduled: in the intervention group a prefascial large-pore low-weight 5 cm wide polypropylene mesh is fixed covering the midline closure; in the control group a conventional closure with a running suture of long-term absorbable material with a suture/wound length ratio 4:1. The sample size was calculated with an estimated incidence of ventral hernia of 25% in the control group and 10% in the intervention group, 0,05 alfa and a 0,15 beta error. The main goal is the appearance of a ventral hernia after 24 months of follow-up. Other outcomes are wound complications and morbidity. Exclusion criteria are adult patients with a previous ventral hernia, estimated survival of less than 6 months or hemodynamic instability during surgery.

The diagnosis of ventral hernia will be assessed by clinical exploration on 3,6,12,18 and 24 months and abdominal CT controls at 6,12, and 24 months. The study will be statistically evaluated with SPSS 18.0.


Eligibility Criteria:
Inclusion Criteria:

* More than 18 years old.
* Patients operated with elective or emergency midline laparotomy with the diagnosis of colorectal cancer.
* Written informed consent or oral consent with the present of two witnesses who do not participate as investigators in the trial

Exclusion Criteria:

* Dissemination of oncologic disease: all stage IV tumors with estimated survival less than 3 months.
* Simultaneous participation in another trial with interference of intervention and outcome.
* Withdrawn or missing written consent.
* Mental condition rendering the subject incapable of understanding the nature, scope and consequences of the trial.
* Previous ventral hernia
The Impact of Perioperative Ketamine Infusion on Surgical Recovery

In order to effectively treat surgical pain with the least amount of opioids required, a multi-modal approach must include medications with different mechanisms of actions at alternative receptors. In light of the opioid epidemic, medical providers at Vanderbilt University Medical Center (VUMC) are strategically combining these medications in a bundled pain-regimen after surgery. These regimens have been shown to decrease opioid consumption, improve surgical outcomes, and reduce hospital stays, thus coining the term 'enhanced recovery pathway'. The combination of these medications has an indisputable synergistic effect. However, it is unknown how each medication contributes individually to the overall efficacy of the pathway. This study will examine the effects of ketamine, within the constructs of a multimodal pain regimen, on a) length of stay, b) opioid consumption, and c) surgical outcomes after major abdominal surgery.

Opioids are powerful analgesic medications that can reduce pain through action at the mu receptor. Unfortunately, activation of the mu receptor also results in undesirable side effects, such as respiratory depression, sedation, bowel ileus, nausea, itching, and tolerance. Therefore, in order to effectively treat pain with the least amount of opioids required, a multi-modal approach must include medications with different mechanisms of actions at alternative receptors. Some examples of non-narcotic pain medications include acetaminophen (Tylenol), anti-inflammatories (NSAIDS), muscle relaxants, local anesthetics, gabapentinoids (Lyrica), and ketamine, to name a few. In light of the opioid epidemic, medical providers at Vanderbilt University Medical Center (VUMC) are strategically combining these medications in a bundled pain-regimen after surgery. These regimens have been shown to decrease opioid consumption, improve surgical outcomes, and reduce hospital stays, thus coining the term 'enhanced recovery pathway' or enhanced recovery after surgery (ERAS). The combination of these medications has an indisputable synergistic effect. However, it is unknown how each medication contributes individually to the overall efficacy of the pathway. Ultimately, the investigators aim to perform a series of randomized controlled trials in which we isolate each component of the pathway to investigate its effects on length of stay, total opioid consumption, and surgical outcomes. The investigators will begin with studying ketamine.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or greater
* presenting at VUMC for abdominal surgery on the colorectal, ventral hernia or surgical oncology services on a weekday.

Exclusion Criteria:

* allergy or contraindication to ketamine
* unable or refuse to receive a neuraxial or regional nerve block
* patient refusal
* direct transfer from operating room to intensive care unit with endotracheal tube placed
* treating team elects to exclude the patient prior to study drug administration
* abortion of planned surgical procedure
A Study of Abemaciclib (LY2835219) in Healthy Participants With and Without Food

The purpose of this study is to evaluate the amount of abemaciclib that reaches the blood stream and how long the body takes to get rid of it when given with and without food. In addition, the safety and tolerability of the study drug will be evaluated. Information about any side effects that may occur will also be collected. The study will last about 43 days for each participant, not including screening.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy sterile males or surgically sterile or postmenopausal females
* Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m\^2), inclusive

Exclusion Criteria:

* Participated in a clinical trial involving investigational product within 30 days
* Have known allergies to abemaciclib, related compounds or any components of the formulation, or history of significant atopy
* Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
* Have an abnormal blood pressure
* Show evidence of human immunodeficiency virus (HIV), hepatitis B or hepatitis C
* Have donated blood of more than 500 milliliter (mL) within the last month
* Have an average weekly alcohol intake that exceeds 21 units per week (males up to age 65) and 14 units per week (males over 65 and females), or are unwilling to stop alcohol consumption 48 hours prior to each admission until collection of the last PK sample in each period
* Are unwilling to refrain from consuming xanthine-containing food and drink from 48 hours prior to admission until collection of the last pharmacokinetic (PK) sample in each period
* Are currently or have been smokers or users of tobacco or nicotine replacement products within the 6 months prior to admission or have a positive urine cotinine test
* Are unwilling to comply with the dietary requirements/restrictions during the study: Consume only the meals provided during the inpatient stays and refrain from eating any food or drinking any beverages containing grapefruit, grapefruit juice, grapefruit-containing products, Seville oranges, star fruit or star fruit juice, pomelo, or commercial apple juice or orange juice for at least 2 weeks prior to the first dose until the final PK sample is collected
Utilization of Genomic Signature as Decision-making for Adjuvant Treatment of Breast Cancer

Method: This multicentric prospective cohort is composed of patients with no metastatic breast cancer selected by tumor's genomic analysis and treated by chemotherapy with Anthracycline without Taxanes (6 cycles of FEC 100).

The patient can be included before or after the surgery and a written consent must be signed for the proteomic and genomic analysis of the tumor.

Patients who have a "good signature" for the genomic analysis will receive the standard chemotherapy.

Primary objective:

* To compare metastasis free survival at 5 years in a cohort of patients with no metastatic breast cancer, who are selected by their genomic profile of the tumor and received a standard chemotherapy containing Anthracycline, with result of retrospectives studies.

Secondary Objectives:

* Overall survival.
* Creation of a circuit (transport-extraction-genomic analysis-result) which allows the beginning of the chemotherapy within 6 weeks following the primary surgery.
* Histological and seric proteomic exploratory studies.


Eligibility Criteria:
Inclusion Criteria:

* Women aged between 18 and 70
* Patient with life condition \< 2 (WHO scale)
* One-sided breast adenocarcinoma with a histological evidence (all type)
* Clinical presentation which allowed a complete surgery with healthy limits
* Absence of metastasis detectable at clinical examination or radiology
* Histological evidence for homolateral axillary ganglionic invasion, whatever is the number of node invaded (N \> 1)
* The beginning of the chemotherapy within 6 weeks following the primary surgery

Exclusion Criteria:

* All metastatic affect
* Tumor classed \>= T4a: cutaneous invasion, deep adherence, inflammatory breast
* All chemotherapy, hormonotherapy or radiotherapy before surgery
* Tumoral residue not removed
* Any suspect clinic or radiologic lesion, in the contralateral breast, which is not controlled
* History of invasive neoplasm, mammary or other (except in situ carcinoma of cervix uteri and epithelioma)
Passive Microwave Radiometry (MWR) and AI for COVID-19 Complications Early Diagnostics of Lungs

World Health Organization (WHO) declared COVID-19 it as a global pandemic. It becomes clear that the virus spreading mostly deadly due to limited to access to diagnostics tests and equipment. Traditional radiography and CT remain the main methods of the initial examination of the chest organs. Now, most of the diagnostics has been focused on PCR, chest x-Ray/CT manifestations of COVID-19. However, there are problems with CT due to infection control issues, the inefficiencies introduced in CT room decontamination, and lack of CT availability in LMIC (Low Middle Income Countries). Passive microwave radiometry (MWR) is a cheap, non-radioactive and portable technology. It has already been used for diagnostics of cancer, and other diseases. The investigators have tested if MWR could be used for early diagnostics of pulmonary COVID-19 complications.

This was a randomized controlled trial (195 subjects) to evaluate the effectiveness of diagnostics using MWR in patients with pneumonia caused by COVID-19 while they are in hospitals of Kyrgyzstan, and healthy individuals.

The investigator have measured skin (IR) and internal (MWR) temperature by recording passive electromagnetic radiation through the chest wall in the projection of the lungs at 30 symmetrical points on both sides. Pneumonia and lung damage were diagnosed by X-RAY/CT scan and doctor's final diagnosis (pn+/pn-). COVID-19 was determined by PCR test (covid+/covid-).

Overall, the study suggests that the use of MWR is a convenient and safe method for screening diagnostics in COVID-19 patients with suspected pneumonia. Since MWR is an inexpensive, it will ease the financial burden for both patients and the countries, especially in LMIC


Eligibility Criteria:
Inclusion Criteria:

* Male and female gender, age 18-75 years
* Positive RT-PCR result of COVID-19
* Place of birth and residence (\<800m above sea level)
* Informed consent

Exclusion Criteria:

* - Lack of fever in a healthy group
* Exacerbation of COPD, very severe COPD with hypoxia (FEV1 \<40%, saturation \<92% at an altitude of 760 m).
* Co-morbidities, such as cardiovascular diseases, i.e. unstable systemic arterial hypertension, coronary heart disease; stroke; sleep apnea; pneumothorax last 2 months.
* Neurological, rheumatological or psychiatric illnesses, including excessive smoking (\> 20 cigarettes per day)
* Kidney failure
Effectiveness Between Nutritional Counseling Monthly Phone Call Versus Self Help Informative Booklet

The purpose of this study is to evaluate the most effectiveness between a personalized nutritional program with a counseling monthly phone call Versus personalized nutritional program with self help Informative Booklet in a group of obesity or overweight patients without counseling phone call.

Evaluate the best effectiveness between two methods applied in the Dietary Service of institute orthopedic Rizzoli for the achievement of the weight loss. Personalized nutritional program with counseling phone call versus personalized nutritional program with self help Informative Booklet in a controlled group.There will be compared two groups of patients: First group: patients subject to balanced personalized nutritional program associated to counseling monthly phone call ; compliance and loss of weight will be done monthly for one year. Second group: patients subject to balanced personalized nutritional program associated to self help informative Booklet; compliance and loss of weight will be done after six months and after one year from the first meeting.

Eligibility Criteria:
Inclusion Criteria:

* Female and male
* BMI \>25 and \<35
* Ages Eligible for Study: 18 years old to 75 years old
* Patients of the Institute Orthopedic Rizzoli subject to personalized nutritional program admitted to the wards and patients attending the clinic of Anaesthesiology, analgesic therapy, Rheumatology
* participants gave informed consent

Exclusion Criteria:

* Patients with psychiatric disorders (depression, bulimia, anorexia
* Concomitant use of medicines or food supplements that can alter the weight loss.
* Patients with inclusion criteria that have not signed the informative report and the declaration of consent.
Exercise Program to Improve Balance in Hemophilic Patients

This study evaluates the effectiveness of a program of physiotherapy exercises to train the balance and dual task in adults patients with hemophilia

The objective of the study is to create an exercise program to improve the static and dynamic balance in hemophilic patient. In addition, the effect of the exercise program on dual task, functionality, proprioception, QoL, risk of falls and the kinesiophobia will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of haemophilia A or B
* Willingness to exercise twice a week during the training program and to complete the pre- and post-program evaluations
* Approval by their hematologist to participate in the exercise program
* With hemostatic coverage supervised by your hematologist.
* Age between 18 and 60 years
* Informed consent signed.

Exclusion Criteria:

* Non adherence to instruction on proper exercise technique
* Surgical procedures performed 6 months prior to or during the exercise program
* A major bleeding episode that posed a risk or prevented exercise
* Need for major surgery
* Suffer from dizziness
* Withdrawal of informed consent
* Acquired hemophilia
Hepatopulmonary Syndrome and Postoperative Complications After Liver Transplantation : A Case-control Study

Hepatopulmonary Syndrome is a respiratory complication of liver cirrhosis defined as a triad: hypoxemia (PaO2 \< 80 mmHg in room air), chronic liver disease and intrapulmonary vasodilatations. Its prevalence varies between 4 and 32%. Numerous treatments have been tried but the only efficient therapy to cure the syndrome is liver transplantation. Without transplantation it is associated with a higher mortality which is the reason why hepatopulmonary syndrome patients have a higher priority to transplantation. However it appears in some restricted studies that hepatopulmonary syndrome is associated with more postoperative complications (infections, vascular and biliary complications, prolonged length of mechanical ventilation...).

The investigators hypothesised that hepatopulmonary syndrome patients have more postoperative complications after liver transplantation than non hepatopulmonary syndrome patients matched on age, MELD (Model for End-Stage Liver Disease) score, comorbidities, perioperative transfusion and noradrenaline doses.


Eligibility Criteria:
Inclusion Criteria:

* Liver transplanted patients

Exclusion Criteria:

* Living donor transplantation
* Bipartition transplantation
* Non-heat-beating donor transplantation
* Minor
* Double or multiple organ transplantation
* Non cirrhotic patients
* Retransplantation