cyrilzakka/clinical-trials huggingface dataset:
Randomised Controlled Trial of Structured Personal Care of Type 2 Diabetes Mellitus

The aims of a concluding 14-year follow-up study are:

* To investigate what long-term effect the project model for structured, personalized diabetes care has on 1) the patients' mortality and development of diabetic complications, 2) the patients' use of services from the primary and secondary sector, 3) the patients' self-rated health and motivation, and 4) the doctor-patient relationship.

Type 2 diabetes (T2DM) is an increasingly common illness that is linked to considerable excessive mortality. There are many indications that treatment of raised blood pressure and blood glucose as well as dyslipidaemia can postpone the development of diabetic complications. Treatment of T2DM is primarily done in general practice, where the results are not satisfactory. The purpose of the project is to create a basis so the existing research-based knowledge can be used to improve the quality of diabetes care in general practice.

The answer will be based on the information from 1,428 newly diagnosed diabetic patients aged 40 or over who were followed since 1989 in a randomised trial among more than 600 general practitioners. The intervention, which ended at the beginning of 1996, provided optimum conditions for follow-up, doctor-patient communication and treatment, among other ways by training the doctors, producing clinical guidelines and setting individual treatment goals. In the project, the general practitioner is seen as the coordinator of the whole health system's prophylactic efforts in relation to the individual diabetic patient.

The aims of a concluding 14-year follow-up are:

* To investigate what long-term effect the project model for structured, personalized diabetes care has on 1) the patients' mortality and development of diabetic complications, 2) the patients' use of services from the primary and secondary sector, 3) the patients' self-rated health and motivation, and 4) the doctor-patient relationship.

Eligibility Criteria:
Inclusion Criteria:

* all patients aged 40 or older with newly diagnosed diabetes between 1 March 1989 and 28 February 1991 based on hyperglycaemic symptoms or raised blood glucose values measured in general practice

Exclusion Criteria:

* threatening somatic disease, severe mental illness, or unwillingness to participate. For our analysis, we also excluded non-white patients and patients whose diagnosis was not established by a blood glucose measurement at a major laboratory within 500 days after diagnosis.
Bronchoscopy Anesthesia and Neuropsychological Assessment in Children (BANACH) Study

Fiberoptic bronchoscopy plays a very important role in the diagnosis and treatment of respiratory diseases in children.In China,this procedure is mainly performed under two different anesthesia methods：sedation and general anesthesia(GA) . Which is better ? there are still a lot of controversies . Several early retrospective studies suggest that, in addition to the possible increase in costs, general anesthesia in intraoperative complications, postoperative recovery and other aspects did not bring significant improvement. But clinically we observed that children under sedation often can not cooperate, they often shows anxiety,restless,crying,and so on, under these situation, some restraint measures may be used, which may have an impact on the child's neuropsychological development. Therefore ,we design this study ,aiming to compare the influence between sedation and general anesthesia (GA) on children 's neuropsychological development.


Eligibility Criteria:
Inclusion Criteria:

* Age 4-10 years
* American society of anesthesiologists(ASA) gradeⅠ～Ⅱ
* Plan to accept fiberoptic bronchoscopy treatment
* lives in the city where the research unit is located
* signed informed consent

Exclusion Criteria:

* preterm infants less than 28 weeks of gestational age or preoperative screening found that development, cognitive or behavioral abnormalities
* known congenital malformations may have a potential impact on the development of children's neuropsychological function
* known to have central nervous system disorders or meet the diagnostic criteria of Diagnostic and Statistical Manual(DSM) mental illness
* children with contraindications to intravenous general anesthesia
ReWalk Personal Device Postmarket Study

This study seeks to further evaluate the Multi-Tiered Training Program and to further explore the overall safety profile of the ReWalk Personal Device outside of the institutional setting under conditions of routine medical practice.

This study will monitor and further describe the long-term safety of the ReWalk Personal Device for Subjects and their Companions in institutional and non-institutional environments, such as the clinic, home, and community. The study will also evaluate the adequacy of the Multi-Tiered Training Program of the ReWalk Personal Device for Subjects, their Companions, and their Clinical Trainers, monitor and further describe all ReWalk Personal Device malfunctions and screen for potential Unexpected Adverse Events.

Eligibility Criteria:
Inclusion Criteria:

* For use in institutional and non-institutional environments: Subjects with spinal cord injury at levels T7 to L5.
* Age ≥ 18 years old;
* Hands and shoulders can support crutches or a walker;
* Healthy bone density;
* Skeleton does not suffer from any fractures;
* Able to stand using a device such as EasyStand;
* In general good health;
* Height is between 160 cm and 190 cm (5'3" - 6'2");
* Weight does not exceed 100 kg (220 lbs);
* Proficiency in spoken and written English language.

Exclusion Criteria:

* History of severe neurological injuries or disease other than SCI (MS, CP, ALS, TBI, etc.);
* Severe concurrent medical disease, including infections, circulatory, heart or lung, pressure sores;
* Severe spasticity (Ashworth 4)
* Uncontrolled clonus;
* Unstable spine or unhealed limbs or pelvic fractures;
* Heterotopic ossification;
* Significant contractures;
* Psychiatric or cognitive situations that may interfere with proper operation of the device or participation in this study;
* Pregnancy
Parent-to-parent Coaching While Awaiting Hospital Discharge With a Child With a Ventilator

The objective of the study is to pilot a parent-to-parent coaching model with experienced family members of children with Invasive Mechanical Ventilation (IMV) as parent coaches.

The objective of the study is to pilot a parent-to-parent coaching model with experienced family members of children with IMV as parent coaches. Parent coaches will advise parents of children with IMV awaiting hospital discharge on strategies for advocating for home nursing. Parents and parent coaches will meet as needed and engagement will be tailored to parent preference: text messaging, video or phone conferencing, or in-person visiting in the family home or hospital. Points of contact, issues addressed, and time required will be collected as needs assessment data to appropriately size and scale a future intervention. Enrollment and exit assessments will include completion of the Family Empowerment Scale (FES) and a brief structured interview about parents' perceived impact and acceptability, which will provide pilot data to inform a future intervention. The investigator hypothesizes that parents will gain self-advocacy skills specific to recruiting home health nurses and improve the size of their home nursing workforce through this coaching model.

Eligibility Criteria:
Inclusion Criteria:

* Parents of children with a tracheostomy and ventilator awaiting hospital discharge in Illinois.
* Parents must live or have their child hospitalized within approximately a 1 hour radius of the University of Chicago.
* The child must be enrolled in, or in the process of enrolling in the Division of Specialized Care for Children (DSCC) Home Care Program.
* The parent/legal guardian must have legal custody of the child and plan on living with the child in the home.

Exclusion Criteria:

* Wards of the state
Impact of Rheumatoid Arthritis on Body Composition, Bone Marrow Adiposity and Bone Mineral Density: a Case-control Study

During rheumatoid arthritis (RA) (in comparison with control subjects), body composition is altered with a loss of lean body mass, bone mass and an accumulation of fat mass.

Determination of total body fat and particularly its abdominal distribution (visceral adiposity) is important because of the cardiovascular (excess cardiovascular risk), metabolic (insulin resistance, diabetes and dyslipidemia) and bone (increased fracture risk) risks associated with this endocrine organ. Moreover, we do not have data concerning medullary adiposity in RA.

This pilot case-control study will be compare body composition, bone marrow adiposity and bone mineral density in patients with RA versus healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

Subjects:

Males and females of age (age ≥ 18 years). Patients with RA according to American College of Rheumatology/EULAR 2010 criteria, Patients who have signed the informed consent

Controls:

Males and females of age (age ≥ 18 years). subjects who have signed the informed consent

Exclusion Criteria:

* Patients who have received more than three anti-TNFinhibitors
* Patients who have previously received a Janus kinase (JAK) inhibitor
* Patients with concomitant therapies as described below :

A combination with methotrexate is allowed if methotrexate is started ≥3 months before the start of the study and at a stable dosage (≤25 mg/week) for ≥4 weeks.

A combination to conventional synthetic DMARDs (csDMARDs) other than methotrexate is not allowed within 4 weeks before and/or during the clinical trial

* Corticosteroid therapy \>10mg/d prednisolone equivalent is not allowed
* Intra-articular injections of corticosteroids are allowed if their number is less than or equal to 4
* Intravenous corticosteroid infusions are not allowed
* Immunosuppressants other than methotrexate are not allowed
* History or discovery of an osteoporotic fracture AND/OR T-score ≤-3 if ≥50 years old AND/OR Z-score ≤-3 if \<50 years old during the screening phase,
* Corticosteroid therapy ≥ 10mg/d prednisolone equivalent,
* Pathologies or treatments affecting bone metabolism (breast cancer with antiaromatase, digestive malabsorption, stomach cancer, primary hyperparathyroidism, uncontrolled hyperthyroidism...),
* History of radiotherapy on the lumbar spine or the hip studied,
* Patients undergoing hormone replacement therapy (HRT) or patients already under anti-osteoporotic treatment (bisphosphonates, strontium ranelate, teriparatide or denosumab) apart from calcium and/or vitamin D supplementation, Chronic renal failure with creatinine clearance (CKD-EPI formula) ≤ 30 ml/min,
Pharmacokinetics of Sildenafil in Premature Infants

The purpose of this study is to learn more about the safety and dosing of sildenafil in infants.

Pharmacokinetics and safety of sildenafil will be studied in preterm infants who are receiving sildenafil per standard of care or 1 dose prescribed for the study.

Eligibility Criteria:
Inclusion Criteria:

Cohort 1:

* Gestational age 28 weeks or less receiving sildenafil as standard of care \< 365 postnatal days

Cohort 2:

* Gestational age 28 weeks or less
* 7-28 postnatal days of age
* Mechanical ventilation or nasal continuous positive airway pressure (NCPAP) or high-flow nasal cannula
* Intravenous line in place

Exclusion Criteria:

Cohort 1:

* Any condition that would make the participant, in the opinion of the investigator, unsuitable for the study

Cohort 2:

* Previous exposure to sildenafil within 7 days prior to enrollment
* Any condition that would make the participant, in the opinion of the investigator, unsuitable for the study
* History of allergic reactions to sildenafil
* AST \> ULN or ALT \> 3x ULN
* Currently on a vasopressor for hypotension
* Known sickle cell disease
Financial Incentives for Increasing Exercise

Participants will be employees of Genzyme who volunteer to participate in a study on motivating healthy behaviors, involving giving them goals for taking a certain number of steps per day, and increasing that number over time. Participants will wear pedometers and upload their data to a website that allows them to monitor their progress, and have the opportunity to win money based on meeting their step goals.

Interested employees will schedule a day and time to complete a health screening at a "Health Fair" at their place of employment, to ensure that they are healthy enough to participate; at this time participants will also complete the investigators baseline dependent measures, and receive a pedometer. After a one-week baseline period during which they wear the pedometer and the investigators establish their typical number of steps per day, eligible participants will then be assigned to one of four treatments - a "no incentive" control condition, and three conditions in which they are entered into different kinds of monetary lotteries if they have met their step goals for that day. Participants' initial goal will be based on their steps during the baseline period, and the goal will increase by 250 steps each week, for a total of 12 weeks. After these 3 months, the incentives portion of the experiment ends, but participants continue to wear their pedometers and upload their data for an additional 6 months. At 3 months, 6 months, and then at the study end at 9 months, participants again complete the investigators dependent measures at follow-up Health Fairs at their place of employment.


Eligibility Criteria:
Inclusion Criteria:

* BMI of 28 or higher
* Pass the Par-Q
* answer "No" to all Par-Q questions
* at least 18 years of age
* has computer at home or work with compatible operating system (i.e. windows 2000, windows xp, windows vista, osX 10.3-10.5), internet access, and usb port

Exclusion Criteria:

* Anyone who does not meet all of the inclusion criteria
Tools for Reducing Inequity in Acute Leukemia (TRIAL): Beta Testing

This study aims to test the Tools for Reducing Inequity in Acute Leukemia (TRIAL) web-based application that is designed to support participants with acute leukemia by providing information and resources about leukemia and clinical trial participation.

The goal of this single-arm pilot study is to test the TRIAL web application which is designed to reduce inequity in clinical trial enrollment among participants with acute leukemia. The application aims to facilitate access to clinical trials and reduce barriers for underrepresented groups.

The research study procedures include screening for eligibility and questionnaires.

Participation in this research study is expected to last about 14 weeks.

It is expected about 75 people will participate in this study.

The National Cancer Institute (NCI) and American Society of Clinical Oncology (ASCO) are providing funding for this study.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* English speaking
* Ability to understand and willingness to sign written informed consent
* Clinical suspicion of acute leukemia
* Admitted to DFCI-affiliated inpatient unit

Exclusion Criteria:

* Cognitive impairment rendering the individual unable to participate in beta testing

  * This will be assessed by focused chart review and consultation with the patients' inpatient care team.
* The following populations will be excluded: adults unable to consent, individuals who are not yet adults (infants, children, teenagers \<18 years old), prisoners.
* Inability to participate in in-person application testing.
* Patients who participated in alpha-testing through protocol 23-404 (Appendix A)
(ACORD Study) - A Study of NeoRecormon (Epoetin Beta) in Patients With Early Diabetic Nephropathy

This study will assess the effect of anemia correction with NeoRecormon on cardiac structure and function in patients with early diabetic nephropathy. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients \>=18 years of age;
* type 1 or type 2 diabetes;
* stable glycemic control for \>=3 months;
* diabetic nephropathy.

Exclusion Criteria:

* women who are pregnant, breastfeeding, or unwilling to use a reliable contraceptive method;
* previous treatment with erythropoietin or other erythropoietic substance;
* nondiabetic renal disease, nephrotic syndrome;
* blood transfusion within the 3 months prior to enrollment;
* administration of any investigational drug within 30 days preceding the study start, and during the study.
Axillary Reverse Mapping (ARM) Technique

The purpose of this pilot study is to compare a new surgical technique (axillary reverse mapping) to standard axillary surgery in patients diagnosed with invasive or in situ breast cancer.

Lymphedema is a major chronic morbidity that occurs in patients undergoing treatment for breast cancer (BC). Surgery for BC includes axillary surgery with either sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND). Lymphedema occurs due to removal or disruption of lymphatic drainage of the arm that overlaps with drainage of the breast. The risk of lymphedema increases significantly with adjuvant radiation. Axillary reverse mapping (ARM) is a technique where blue dye is injected into the upper arm at surgery, allowing direct visualization of arm lymphatics and nodes during either SLNB or ALND. This allows preservation of arm lymphatics unless there is suspicion of metastatic disease in ARM lymphatics or if the ARM node is/are also the sentinel lymph node. Studies to date have largely been observational cohort studies, and mainly with low risk patients undergoing SLNB only. There is only one published randomized controlled trial, and this included only patients undergoing modified radical mastectomy.Our proposal is a prospective randomized pilot study. The study population includes patients undergoing axillary surgery (SLNB with mastectomy or ALND with either BCS or mastectomy or completion ALND after positive SLNB). The intervention group will undergo ARM; the control will undergo standard surgical treatment. Both groups will undergo standardized baseline and postoperative arm measurements and patients will complete symptom and quality of life questionnaires. The purpose is to determine the feasibility of the ARM technique, its accuracy in identifying and sparing arm lymphatics, and its ability to reduce the risk of lymphedema.

Eligibility Criteria:
Inclusion Criteria: women diagnosed with invasive breast cancer or ductal carcinoma in situ receiving the following treatment:

1. mastectomy and sentinel lymph node biopsy
2. breast conserving surgery or mastectomy and axillary lymph node dissection
3. completion axillary lymph node dissection after positive sentinel lymph node biopsy
4. cases receiving neo-adjuvant therapy (chemotherapy or hormonal therapy) who are having axillary lymph node dissection as part of their surgical treatment -

Exclusion Criteria:

1. males with breast cancer
2. women less than 18 years of age
3. known allergic reaction to patent blue dye
4. pregnant
5. previous radiation therapy to affected side
6. clinical N2/N3 disease -
Dose Dense Carboplatin, Taxotere and Herceptin As Primary Systemic Therapy in Breast Cancer

Dose dense therapy has been shown to increase survival in the adjuvant setting of breast cancer. It is unknown if dose dense therapy will improve survival in tumors that express her-2. This study evaluates a neoadjuvant regimen containing carboplatin, taxotere and herceptin when used in a dose dense manner in patients with large breast cancers. The endpoint of pathologic complete response is used as a surrogate marker for survival.

Dose dense therapy has been shown to increase survival in the adjuvant setting of breast cancer. It is unknown if dose dense therapy will improve survival in tumors that express her-2. This study evaluates a neoadjuvant regimen containing carboplatin, taxotere and herceptin when used in a dose dense manner in patients with large breast cancers. The endpoint of pathologic complete response is used as a surrogate marker for survival.Safety and tolerability assessed by number of grade 4 toxicities and hospitalizations

Eligibility Criteria:
Inclusion Criteria:

* HER-2 overexpressing breast cancer
* Clinical stage 2-3B
* Normal ejection fraction

Exclusion Criteria:

* Metastatic disease
* Low ejection fraction
Implementation of Work in Progress (WIP) Sequences in Magnetic Resonance Imaging (MRI)

Trial of new work in progress (WIP) sequences in MRI.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of ischemic or non ischemic cardiomyopathy

Exclusion Criteria:

* claustrophobia
* irregular heart rhythm
Sowing the Seeds of Confidence: Brief Online Group Parenting Programme for Anxious Parents of 1-3 Year Olds

To pilot a brief group early intervention aimed at reducing or preventing the intergenerational transmission of anxiety, with parents whose child is between 12 and 47 months. To explore feasibility and acceptability of such an intervention with this population.

All participants will attend two group sessions of 'psychoeducation' (psychologically informed information about the topic of transmitting anxiety) and cognitive-behavioural strategies aimed at reducing the transmission of anxiety from parent to young child. The two sessions will be delivered online via Microsoft Teams, last 2 hours each and will run one week apart. Outcome and acceptability measures will be collected before, immediately after, and 6 weeks after the intervention. Feasibility data (e.g. drop-out rate) will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* current or recent (within 2 years) primary diagnosis of anxiety disorder or self-report of clinically impairing anxiety problem within last 2 years,
* parent of child aged 12-47 months at time of intervention,
* access to an internet connection and smart phone/computer will be required to take part,
* male or female,
* resident in England,
* and over the age of 18

Exclusion Criteria:

* current severe co-morbid diagnoses, e.g. psychosis or acute suicidal risk (as the nature of the intervention is brief and in a group, the level of support needed to keep those with severe mental health disorders safe will not be available),
* current alcohol or drugs misuse
Impact of Early Versus Late Amniotomy on Labour Induction in Nulliparous Women After Vaginal Misoprostol

Investigation the effect of timing of amniotomy (early versus delayed) after vaginal misoprostol in induced labor.

Condition: induction of labour intervention: eary versus late amniotomy on labour induction after vaginal misoprostol Phase: Not applicable

study type: randomized clinical trial actual enrollment: 140 allocation: Random intervention model: two groups assignment masking: open lebal primary purpose: induction of labour actual study start: May 3, 2019 Primary Completion: January 10, 2020 actual study completion date: March 20, 2020

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women at 36 weeks gestation or more
2. Nullipara
3. singleton fetus
4. cephalic presentation with common medical causes for labour induction e.g. intrauterine fetal growth restriction, post term pregnancy and preeclampsia.

Exclusion Criteria:

1. Macrocosmic babies with estimated fetal weight of more than 4000 gram
2. Previous uterine scars
3. Pre labor premature rupture of fetal membranes
4. Polyhydramnios.