cyrilzakka/clinical-trials huggingface dataset:
Observation and Interactions Between Cardio-respiratory and Motor Transitions at the Limits of Moderate Exercise.

The goal of this observational study is to learn about physiological transitions around the limit of moderate exercise intensity on cardiac, respiratory and motor modalities, in healthy population.

The main questions it aims to answer is:

* is it possible to define criteria on cardiac, respiratory and motor modalities to identify transitions?
* are those transitions visible on embedded and non-intrusive monitoring equipment?
* are those identified transitions somehow connected to first ventilatory threshold (VT1)?

Participants will do a sub-maximal effort test on cycloergometer calibrated to make them cross their first ventilatory threshold.

Cycling is a commonly prescribed activity when it comes to physical activities for rehabilitation. Because it is soft and progressive effort, cycling suits well for patients with chronic conditions (diabete, cancer, fibromyalgia, ...) For safety and effectiveness of the activity, it is necessary to prescribe activity at a regular and moderate intensity. This can be achieved by personalizing intensities to match specifically the patient health condition in order to build an efficient and progressive rehabilitation program.

Physical activity prescription rely on four pillars: frequency, duration, volume and intensity. While first three pillars are quite easy to regulate,effort intensity is harder to handle on training planning. It is harder to measure, and defining personalized guideline for practice is more complex.

It is known that first ventilatory threshold (VT1) is a individualized marker representing the higher limit of moderate intensity effort zone. It makes it an interesting tool for the prescription of intensity for retraining purposes: it guaranties a safe practice, intense enough to make beneficial physiological adaptations for the patient.

In this retraining context and with this study, we aim to identify markers of this transition on cardiac, respiratory and motor modalities, with embedded and non intrusive equipment, during a sub-maximal effort test in laboratory.

Eligibility Criteria:
Inclusion Criteria:

* Capability to cycle during 20min
* No contraindication to cycling at a moderate pace
* No acute pathology (less than 2 years old)
* No cardiac or respiratory chronic pathology
* No locomotive problem on the spine or the lower limbs
* No recent injuries (less than 2 months)
* Stature compatible with the use of the plethysmography t-shirt

Exclusion Criteria:

* Pregnant (urine strip test) or breastfeeding women
* Persons referred to in articles L1121-5 to L1121-8 of the CSP (protected persons) person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure
* Subject being excluded from another study
* Subject who reached the ceiling of 4500 euros due to their participation in other studies involving human in the past 12 months
Microbiological Keratitis in a Countryside City of Brazil

The purpose of this study is to identify the predisposing factors, epidemiological features and clinical and microbiological diagnosis of infectious keratitis in two public referral centers of ophthalmology in a countryside city of Brazil.


Eligibility Criteria:
Inclusion Criteria:

* All patients admitted with clinical suspicious of keratitis from June 2008 to June 2009 (Keratitis group)
* 37 volunteers without any ophthalmologic claim, recruited in the two ophthalmology centers listed (Control study group)

Exclusion Criteria:

* In the Control Study Group, no infectious ocular disease was accepted
Skin-to-skin Contact to Promote Bacterial Decolonization in Preterm Infants

BACKGROUND Decolonization with topical antibiotics is necessary to prevent and / or control outbreaks of multidrug-resistant bacterial infection in the NICU (Neonatal Intensive Care Unit), but can trigger bacterial resistance. The objective of this study was to determine whether skin-to-skin contact of newborns colonized with MRSA (Methicillin-Oxacillin Resistant Staphylococcus Aureus) with their mothers could be an effective alternative for biological control of bacterial colonization.

METHODS: The investigators studied 102 newborns admitted to NICU in three public hospitals in São Luís, Brazil. Inclusion criteria were birth weight from 1300 to 1800g, length of stay \>4 days, newborns colonized by Staphylococcus aureus and/or Staphylococcus coagulase-negative methicillin-oxacillin resistant and mothers not colonized by these bacteria. Randomization was performed using a computer generated random numbers algorithm. Allocation to intervention and control groups was performed for each eligible newborn using a sealed opaque envelope. In the intervention group (n = 53) mother-infant skin-to-skin contact was held twice a day. The control group (n = 49) received routine care without skin-to-skin contact. There was no masking of newborn's mothers or researchers, but the individuals who carried out bacterial cultures and assessed results were kept blind to group allocation.

The primary outcome was decolonization of newborns' nostrils after 7 days of intervention. Safety was assessed by monitoring vital signs of newborns during the intervention. The secondary outcome was emergence of late onset presumed sepsis until the end of hospitalization period or 28 days of life, whatever happened first.

FUNDING: CNPq (Brazilian Research Council) and FAPEMA (Maranhão Research Foundation)


Eligibility Criteria:
Inclusion Criteria:

* singleton neonates,
* born in the three institutions of the study
* birth weight from 1300 to 1800g
* length of stay \>=4 days,
* newborns colonized by Staphylococcus aureus and/or Staphylococcus coagulase-negative methicillin-oxacillin resistant and mothers not colonized by these bacterias.

Exclusion Criteria:

* infants below 1300g and over 1800g,
Evaluation of Extended Infusion Set Wear Using Medtronic Extended Wear Sof-set Infusion Set

This is a blinded cross-over study to see if extended wear insulin infusion sets can prolong insulin infusion set wear up to 7 days in adults with Type 1 Diabetes.

This is a double blinded cross-over study. Subjects will be asked to wear infusion set either a standard infusion set or an extended wear infusion set. They will wear each infusion set twice, and the order of infusion set wear will be randomized with the first infusion set wear and then alternated over 4 weeks. By performing a cross over study using both experimental infusion sets and standard infusion sets, the investigators hope to see whether there is a benefit to using an extended wear infusion set.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of type 1 diabetes for at least one year and using an insulin pump for at least 12 months
2. The diagnosis of type 1 diabetes is based on the investigator's judgment; C-peptide level and antibody determinations are not needed.
3. Age 18 to 55 years
4. Hemoglobin A1c level less than or equal to 8.5%
5. Willing to use Novolog insulin while they are participating in the study
6. Total daily insulin dose is at least 0.3 units/kg/day
7. For females, not currently known to be pregnant
8. An understanding of and willingness to follow the protocol and sign the informed consent
9. Willingness to wear the experimental insulin infusion sets throughout the study
10. Must be able to understand spoken and written English

Exclusion Criteria:

1. Diabetic ketoacidosis in the past 3 months
2. blood urea nitrogen (BUN), Creatinine, or liver function test (ALT or AST) more than three times the upper limit of normal, or thrombocytopenia
3. Severe hypoglycemia resulting in seizure or loss of consciousness in the 3 months prior to enrollment
4. Pregnant or lactating females
5. Known tape allergies
6. Current treatment for a seizure disorder
7. Cystic fibrosis
8. Active infection
9. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:
10. Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian)
11. Presence of a known adrenal disorder
12. If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study
13. Abuse of alcohol
14. Dialysis for renal failure
Treatment of Anovulatory Infertility in PCOS Patients

Clomiphene citrate (CC) and metformin are two effective drugs used to induce ovulation in patients with polycystic ovary syndrome (PCOS), even if it is still unclear which compound between them should be initially administered. The aim of the study will be to compare in a clinical setting the efficacy of CC and metformin as first-line approaches for treating anovulation in infertile PCOS patients.

Eighty infertile anovulatory patients with PCOS will be allocated in two body mass index (BMI)- and age-matched groups (experimental and control groups).

Forty patients will receive the experimental treatment consisting of six months of 1700 mg/day metformin administration (experimental group), whereas other forty patients will receive CC administered using a traditional incremental-doses protocol (control group). In both groups, patients who will ovulate under treatment will continue the therapy for a total of six months.

During the study, the clinical and reproductive outcomes, and the adverse experience will be evaluated in each patient.

Eligibility Criteria:
Inclusion Criteria:

* Anovulatory infertility related to polycystic ovary syndrome

Exclusion Criteria:

* Neoplastic, metabolic, hepatic, and cardiovascular disorders or other concurrent medical illnesses
* Hypothyroidism, hyperprolactinemia, Cushing's syndrome, and non-classical congenital adrenal hyperplasia
* Current or previous (within the last six months) use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs.
* Organic pelvic diseases
* Previous pelvic surgery
* Suspected peritoneal factor infertility
* Tubal or male factor infertility or sub-fertility
Multicentric, Prospective, Randomized, Comparing Trial Between Bypass of the Femoropoplitea by PTFE and Heparin Bounded PTFE

Comparison of two kinds of protheses for bridging of the femoropoplitea and/or femorotibiale: PTFE with or without bounded heparin

Comparison of two kinds of protheses for bridging of the femoropoplitea and/or femorotibiale: PTFE with or without bounded heparin.

Evaluation of this comparison by clinical systems: ankle-arm index, duplex echo, follow-up of 2 years

Eligibility Criteria:
Inclusion Criteria:

* Patients with Peripheral Vascular Diseases with complaints of invalidating claudication, rest pain, ucera or gangrene
* Patients with damage of the arteria femoralis superficialis or poplitea, longer than 6 cm
* Reasonable outflow arteria
* Informed consent
* Patient able to take part in all follow-up examinations

Exclusion Criteria:

* Acute ischemia of the leg
* Patients with a ipsilateral inflow stenosis of more than 70% which can not be corrected before or during the surgery
* \< 18 years
* Pregnancy
* Recent heart attack (\< 1 month)
* Life expectancy less than 12 months
* Known allergy to heparin
* Known contrast allergy
* Known bleeding or coagulation disorder
Assessing the Potential for Reduced Toxicity Using Focal Brachytherapy in Early Stage, Low Volume Prostate Cancer

The purpose of this study is to see what side effects a type of radiation treatment called focal brachytherapy has in treating early stage prostate cancer. The study is also looking at how useful focal brachytherapy will be in treating prostate cancer. Additionally, the investigators would like to see how this type of treatment impacts quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Men ≥ 21 years of age with a life expectancy estimated to be \> 10-years.
* Diagnosis of adenocarcinoma of the prostate confirmed by MSKCC or participating site pathology review.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Prostate cancer clinical stage T1c-T2a
* PSA \< 10ng/mL (this will be the PSA level prompting the prostate biopsy)
* MRI evidence of one-sided disease performed within 3 months of registration
* Prostate size \<60 cc at time of treatment- if the prostate is larger, hormonal therapy is allowed to achieve the required size Screening biopsy parameters:
* Minimum of 10 biopsy cores
* Gleason grade 7 in two cores or less, with no primary Gleason grade 4 or 5 in any cores
* Unilateral cancer (only right-sided or left-sided, not bilateral)
* No more than 50 % cancer in any one biopsy core
* No more than 25 % of cores containing cancer
* Repeat transrectal or transperineal prostate biopsy that must meet the following parameters:
* Minimum of 12 biopsy cores
* Unilateral cancer (only right-sided or left-sided, not bilateral)
* Gleason grade 7 in two cores or less, with no primary Gleason grade 4 or 5 in any cores
* No more than 50 % cancer in any one biopsy core
* No more than 25 % of cores containing cancer

Subject Exclusion Criteria:

* Medically unfit for anesthesia
* Evidence or suspicion of extracapsular extension on MRI
* IPSS score \> 18
* Unable to receive MRI
* Prior radiotherapy for the current disease
The Effect of Care-oriented Practical Training on Nurses' Intensive and Critical Care Competency and HAIs Indicators

It was aimed to evaluate the effect of care-oriented practical training on the intensive and critical care competencies of nurses, the hand hygiene compliance rate of nurses and care support staff, and HAI indicators.

Does care-oriented practical training increase nurses\&#39;s intensive and critical care competencies? Does care-oriented practical training increase the hand hygiene compliance rate of nurses and care support staff? Does care-oriented practical training reduce HAI indicators in intensive care units?

Eligibility Criteria:
Inclusion Criteria:

* Working as a nurse in the Adult Intensive Care Unit
* Working as a care support staff in an adult intensive care unit
* Volunteering to participate in research

Exclusion Criteria:

* Wanting to withdraw from the research
* Not being able to attend the final test (due to illness, leave, report, etc.)
This Study Tests Whether Taking the Medicines Empagliflozin, Linagliptin, and Metformin Together in 1 Pill is the Same as Taking Them in Separate Pills. The Study is Done in Healthy Men and Women and Measures the Amount of Each Medicine in the Blood

To establish the bioequivalence of one fixed dose combination (FDC) tablet of empagliflozin/linagliptin/metformin extended release (XR) versus the free combination of empagliflozin tablet, linagliptin tablet, and metformin XR tablets administered as a single dose under fed conditions


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 55 years (incl.)
* BMI of 18.5 to 29.9 kg/m2 (incl.)
* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation
* Female subjects of childbearing potential willing to use adequate contraception.
* Further inclusion criteria apply

Exclusion Criteria:

* Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR), or Electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (BPM)
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease judged as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* Further exclusion criteria apply
Secondary Versus Tertiary Wound Closure in High Risk Gynecologic Abdominal Surgical Incisions

The purpose of this research study is to determine if closing a surgical wound differently is better than the procedure that is currently used. The wound will be closed with what is considered "tertiary intent." This means, rather than leaving the wound open, the wound will be partially closed after surgery, and then completely closed 4-7 days after surgery. The investigators also want to see how this new wound closure process affects your quality of life.

Primary Objective

To compare the percentage of patients whose wound remained closed on postoperative day #30 after tertiary closure compared to historical controls who underwent secondary would closure. We are primarily looking at time to wound closure. We will be able to abstract this information from the postoperative clinic visit notes from patients in the "historical control" cohort. We will identify 20 patients with characteristics described in the inclusion criteria of this study who underwent laparotomy with secondary would closure during the calendar year 2018.

Secondary Objectives

To compare the proportion of acute and chronic wound infection in wounds closed with a tertiary closure technique to historical controls receiving a secondary wound closure.

To compare the length of stay of patients receiving a tertiary wound closure to historical controls receiving a secondary wound closure.

To describe the number of patients receiving a tertiary wound closure that return within 30 days of surgery as compared to historical controls receiving a secondary wound closure.

To describe the quality of life in patients receiving a tertiary wound closure.

Eligibility Criteria:
Inclusion Criteria:

* Patients with high risk class II, class III, class IV abdominal wounds
* Undergoing laparotomy for gynecologic related disorders
* Patients undergoing laparotomy for both benign and malignant diagnoses will be included in this study

Exclusion Criteria:

* Pregnancy
* Allergy to triclosan
* Patients undergoing HIPEC
A Study on the Pharmacokinetics and Safety of Valcyte (Valganciclovir) in Pediatric Heart Transplant Recipients Less Than 4 Months of Age

This open label study will assess the pharmacokinetics and the safety and tolerability of Valcyte (valganciclovir) powder for oral solution in neonatal and infant heart transplant patients \< 4 months of age.


Eligibility Criteria:
Inclusion Criteria:

* Males and females, 0 to \< 4 months (\< 125 days) of age at the time of the last PK assessment in this study
* Parent or guardian of the patient is willing and able to give written informed consent
* Patient has received a first heart transplant
* Patient is at risk of developing cytomegalovirus (CMV) disease and is being treated with i.v. ganciclovir or oral valganciclovir for prevention of CMV
* Adequate hematological and renal function
* Able to tolerate oral medication (any appropriate form of tube feeding is acceptable)

Exclusion Criteria:

* Allergic or significant adverse reaction to acyclovir, valacyclovir or ganciclovir in the past
* Severe, uncontrolled, clinically abnormal diarrhea
* Liver enzyme elevation of more than five times the upper limit of normal for AST (SGOT) or ALT (SGPT)
* Patient requires use of any protocol prohibited concomitant medications
* Patient has previously participated in this clinical trial
Oxandrolone Rotator Cuff Trial

This study is about healing after a rotator cuff tear repair procedure. We hope to learn if a biologic medication: Oxandrolone, a synthetic derivative of the human hormone Testosterone (the principal male sex hormone and an anabolic steroid), given for 12 weeks following rotator cuff repair, is effective in aiding in the healing process and restoring muscle mass.


Eligibility Criteria:
Inclusion Criteria:

* scheduled for rotator cuff repair
* failed nonoperative management of chronic, full thickness rotator cuff tears
* full thickness rotator cuff tear confirmed on MRI

Exclusion Criteria:

* patients with prior shoulder surgery or prior rotator cuff repair
* tears larger than 5 cm
* significant glenohumeral arthritis (Hamada Grade 2 or higher)
* Untreated diabetes mellitus
* Pituitary tumor
* Rheumatoid arthritis
* Uncontrolled hypertension
* Congestive heart failure
* Myocardial infarction within the past 6 months
* End-stage renal disease
* Liver enzymes two times the normal value
* Deep Vein Thrombosis (DVT) within the past 6 months
* Disorder of the coagulation system
* Currently taking anticoagulation
* Claustrophobia
* Prior or current use of anabolic steroids
* Chromosomal disorders
* Prostate cancer
* Breast cancer
* Hypercalcemia
* Medications that interfere with testosterone production or function, including but not limited to 5 alpha-reductase inhibitors
* Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the Screening visit through 6 weeks after the last dose of study treatment
* Any other condition or treatment interfering with completion of the trial
Developing a Symptom List for Children With Cancer

Primary Objective

The aim of this research study is to develop a comprehensive inventory of symptoms that occur in children with advanced cancer who are receiving a specialist palliative care service.

Secondary Objectives

* To assess correlation between parent, child and nurse scores on the Memorial Symptom Assessment Scale (MSAS).
* To identify symptom prevalence in children with advanced cancer as identified by the child/young person (CYP), nurse and parent (to be analysed separately for parent, child and nurse).
* To identify whether there are any symptoms missing from the age appropriate MSAS as identified by the CYP, nurse and parent (to be analysed separately for parent, child and nurse).
* To identify whether any items on the age appropriate MSAS are not relevant to the population being studied (to be analysed separately for parent, child and nurse).
* To identify which symptoms cause the most distress as identified by the CYP, nurse and parent (to be analysed separately for parent, child and nurse).
* To identify degree of severity of each symptom as identified by the CYP, nurse and parent (to be analysed separately for parent, child and nurse).
* To identify which symptoms occur most frequently as identified by the CYP, nurse and parent (to be analysed separately for parent, child and nurse).
* To assess the trends between phase of illness and symptom profile, severity and distress.


Eligibility Criteria:
Inclusion Criteria:

* Any child/young person (CYP) aged 7 to 17 years and 364 days referred and accepted to the palliative care service (PATCH team) at the Royal Marsden (RM) will be eligible for inclusion. The PATCH team is responsible for co-ordinating palliative care services for children with both malignant and non-malignant conditions in the South Thames and South East Coast areas. The team can provide home visits, local hospital and hospice visits for symptom and palliative care advice. The team are also available by telephone 24 hours a day, 365 days a year to provide symptom advice to families and health care professionals from all settings who are caring for children known to the team. Acceptance to this service is via multidisciplinary team (MDT) discussion.

Exclusion Criteria:

* Severe cognitive impairment in the parent/carer
* Lack of fluent English
* Lack of ability to read and write English
* Psychological concerns about the CYP and/or parent/carer. All potential participants will be discussed with the psychosocial team before being invited to participate.