cyrilzakka/clinical-trials huggingface dataset:
Respiratory Stability and Vegetative Coupling During Neonatal Skin-to-skin Care

The main purpose of this study is to identify and to determine the involvement of cardio-respiratory coordination mechanisms during SSC between the preterm infant and his (her) parent.

The skin to skin care (SSC) is a technique that proceeds by laying the neonate ventrally on the parent's chest. Many positive effects are recognized as due to SSC i.e, maintaining the infant's body temperature, better sleep organization, neurocognitive development and cardio-respiratory stability, more strength in parent-infant affective relations, reduction in neonatal and parental stress, more success in feeding with breast milk. Nowadays, SSC is generalized in modern Neonatal Intensive Care Units as part of developmental care. However, the mechanisms involved in SSC are not totally understood. The hypothesis in this study is that the cardio-respiratory stability results partially from the intervention of the coordination between cardiac and respiratory activities. These suppose the involvement of complex mechanisms of cardio-respiratory coordination including neuro-autonomous loops with chemoreceptors and baroreceptors, bulbar vasomotor and respiratory regulatory centers, ortho-parasympathetic neuronal and chemical pathways and cardiac, vascular and lung effectors. In this study the identification of these characteristics will be performed by processing signals of ECG, SaO2 (arterial oxygen saturation), respiratory movements, perfusion index, cutaneous and ambient temperature extracted from the clinical monitoring systems. Each preterm infant included in the study will be explored twice, 5-10 days apart. The explorations will be carried out on 3 steps: before (at least 30 minutes), during (at least 60 minutes) and after (≥ 60 minutes) the SSC session. Each patient will participate in the study for 10 days at maximum. Inclusions in the study will last for a total period of 18 months and 10 days. The cardio-respiratory coordination will be assessed using coordigram technique, corresponding to the proportion of time with \> 0.7 amplitude on spectral density.

Eligibility Criteria:
Inclusion Criteria:

* Premature infant from 28weeks + 0 day to 36 weeks + 6 days gestational corrected age
* At least 72 hours postnatal age
* Benefiting skin-to-skin care

Exclusion Criteria:

* Severe congenital malformation and nervous system dysfunction (e.g., Ondine Sd)
* Septic shock
* Mechanical ventilation support
* Severe pulmonary arterial hypertension
* Analgesia morphinics at high dosage and curare
VR Executive Training of School-aged Children With ASD

Many studies support that children with autism spectrum disorder (ASD) show executive dysfunction. The applicant's NSC project report also indicated that in all areas in the behavior rating inventory of executive function, the second edition (BRIEF-2), including inhibit, self-monitor, shift, emotional control, initiate, working memory, plan/organize, task-monitor, and organization of materials, children in the typically developmental group showed better performance than children in the ASD group. The results also indicated that compared to the diagnosis of ASD, an executive function could be a better predictor of daily life adaptation. Similarly, more and more researchers put their efforts into executive training. However, the results are mixed. A meta-analysis showed that technology-based training can effectively improve the executive function of children with ASD. Children with ASD love game-like training as it provides friendly environments to children with ASD and induces less anxiety. The applicant, therefore, plans to develop a virtual reality executive function training program in the first year based on the applicant's previous experience with executive function training. The game will include the components of visual searching, reaction time, shift, planning, and working memory. At the end of the game, the game will provide visual feedback to the children to train in self-monitoring. In the second year, the applicant will conduct a randomized controlled trial to investigate the effectiveness of the training program. I plan to include 70 children with ASD and randomly assign them to either the executive training or control groups. Executive function and daily life adaptation will be the indexes of the effectiveness of the study.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with ASD by a qualified healthcare professional
* meeting the ASD criteria by using ADOS-2
* IQ higher than 80.

Exclusion Criteria:

* not meeting the ASD criteria by using ADOS-2.
* IQ lower than 80.
* comorbid physical and/or motor disabilities.
* comorbid mental disabilities except ADHD.
Lactobacillus Reuteri for Non-surgical Periodontal Treatment of Chronic Periodontitis With Type 2 Diabetes Patients

This study aims to investigate the clinical and microbiological efficacy of Lactobacillus reuteri as an adjunctive therapy to non-surgical periodontal treatment of chronic periodontitis with type 2 diabetes.

Periodontitis and diabetes affect the course and outcome of each other. Many studies have shown that for patients with periodontitis, concomitant diabetes can aggravate the destruction of periodontal tissue and accelerate the progression of periodontitis, which is an important risk factor for periodontitis. Affected by diabetes, patients with poor glycemic control have worse periodontal status, and the prognosis of periodontitis treatment is more suspicious. Conversely, periodontitis also affects diabetic status, and periodontitis is associated with dysglycemia, increased insulin resistance, and increased risk of diabetic complications. After periodontal therapy, it is expected to reduce the level of systemic inflammation and ultimately improve glycemic control and overall prognosis of diabetes. However, the treatment of periodontitis with diabetes is still a challenge, and how to improve the prognosis of patients with periodontitis with type 2 diabetes remains to be studied.

BioGaia Prodentis is a probiotic chewable tablet containing Lactobacillus reuteri (combination of L. reuteri DSM 17938 and L. reuteri ATCC 5289). Studies have shown that the use of the probiotics has an additional effect on periodontal therapy. However, in the periodontitis patients with type 2 diabetes, whether the use of this probiotic can improve the effect of periodontal therapy, few relevant research have published.

Eligibility Criteria:
Inclusion Criteria:

1. age between 35 to 70 years,
2. type 2 diabetes with treatment ≥ 6-month, with HbA1c≤7.5%,
3. generalized periodontitis (Stage III or IV),
4. no less than 15 teeth

Exclusion Criteria:

1. smoking, or quit smoking for less than 5 years;
2. Suffering from other known systemic diseases that can affect the progression of periodontitis (immune abnormalities, osteoporosis, history of head and neck radiotherapy, etc.);
3. Received periodontal treatment within 6 months;
4. Have taken antibiotics, non-steroidal anti-inflammatory drugs, immunosuppressants, hormones and other drugs that affect periodontal within 3 months;
5. Have taken probiotics within 6 months;
6. Prophylactic use of antibiotics is required;
7. Pregnant and lactating women;
Effect of Fimasartan on Extended RAS and Vascular Functions in Patients With Type 2 Diabetes and Hypertension

In this study, we will assess the change of extended renin-angiotensin system including serum ACE-2 and angiotensin(1-7) levels and subclinical atherosclerosis after using fimasartan (an ARB), compared to amlodipine in hypertensive patients with T2DM.

Several clinical trials aimed at studying the benefits of RAS blockade in the diabetic complications. HOPE, RENAAL, IRMA2, IDNT, ONTARGET studies proved that ACE inhibitors or ARBs reduced the risk of diabetic complications.

Recent studies proved that fimasartan, one of the ARBs, stabilizes the activity of renin-angiotensin system. However, understanding the change in concentration of serum ACE, ACE-2, angiotensin(1-7), and angiotensin-II should help clinicians select more appropriate drug between ACE inhibitors and ARBs with clear evidence. Moreover, since RAS antagonists are the first-line drugs for antihypertensive therapy in patients with T2DM, it is meaningful to understand the change of RAS-related factors in serum after using the drugs.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 30 years old
* Type 2 diabetes by American Diabetes Association criteria
* HbA1c: 6.5% ≤ - \< 10.0%
* Systolic blood pressure: 140 ≤ - \< 180 mmHg or Diastolic blood pressure: 85 ≤ - \< 110 mmHg
* Statin (-) or no change in low to moderate intensity statin \[14\] dose in recent 3 months

Exclusion Criteria:

* Contraindication of fimasartan or amlodipine
* History of RAS inhibitors (ACE inhibitors or ARBs) or calcium channel blockers in the previous 3 months
* Pregnant women, women with potential of pregnancy not using adequate contraception method as evaluated by the investigator, lactating women
* Type 1 diabetes or diabetes secondary to chronic pancreatitis or to pancreatectomy
* Confirmed cardiovascular disease (acute coronary syndrome, stroke, or transient ischemic attack) within 3 months of screening
* Chronic hepatitis B or C (except healthy carrier of HBV), liver disease (AST/ALT \> 3-fold the upper limit of normal)
* Chronic kidney disease (serum creatinine \> 2.0 mg/dL)
* Hyperkalemia serum potassium \>5.0 mEq/L
* Any previous cancer within 5 years (except squamous cell cancer, cervical cancer, thyroid cancer with appropriate treatment) except thyroid cancer or carcinoma in situ
Validation of Point of Care Liver Function Tests

This study is testing the accuracy of a point of care device that tests liver function within 20 minutes. The target population will be any adult who had liver function tests ordered and to be drawn on the same day as enrollment.

Outpatient diagnostics are slow and expensive due to turnaround times, complex workflows and high cost. Sometimes patients do not make it to laboratory testing if a lab is not available on site. Delays in testing can affect medical outcomes or patients can be lost to follow up.

Group K developed a paper microfluidic platform with an accompanying mobile application(app). The paper microfluidic device is a simple, inexpensive wax backed device with three testing areas. These areas have a mix of dried proprietary reagents that when combined with a patients drop of blood, or in the future, saliva or urine, will produce results in a color change. An app is then used to interpret the color change and output results to a doctor. The target population is adults who have an indication to collect a liver function panel that will be drawn on the same day as their clinic visit or during their inpatient hospital

Eligibility Criteria:
Inclusion Criteria:

* Have a liver function testing for the required 6 tests completed (Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), albumin, bilirubin, and total protein)
* 18 years or older

Exclusion Criteria:

* Inadequate blood sample obtained from finger stick
* Inconclusive liver function testing
* Not all 6 liver tests completed on the same sample
* Liver tests not drawn for normal method at same time as finger stick.
An Exercise Intervention Trial to Reduce Symptoms & Improve Clinical Outcomes of Platinum-Based Treatment in Ovarian Cancer Patients

This clinical trial studies how well an exercise intervention works in reducing symptoms and improving clinical outcomes in patients with ovarian cancer undergoing platinum-based chemotherapy. Exercise may "train" the body to repair deoxyribonucleic acid (DNA) damage more efficiently, which may reduce symptoms related to platinum-based chemotherapy, improve quality of life, increase survival, and decrease recurrence rates in patients with ovarian cancer.

PRIMARY OBJECTIVES:

I. To assess the feasibility of recruiting and enrolling newly diagnosed epithelial ovarian cancer patients who have undergone debulking surgery and will be starting platinum-based chemotherapy, to an exercise trial.

II. To evaluate adherence to the data collection and exercise trial protocol. It is necessary to determine the feasibility of collecting tablet-based questionnaire data and blood samples at multiple time points in one visit. It is also critical to determine whether the exercise intervention is feasible in this patient population.

SECONDARY OBJECTIVES:

I. To examine changes in DNA repair function before and after a single exercise session.

II. To examine changes in DNA repair function, body composition, quality of life, symptoms and patient satisfaction with care over the treatment time course.

III. To examine the effect of the exercise intervention on these measurements.

IV. To follow the patients an additional 12-months for clinical outcomes defined as death, cancer recurrence, or new primary cancer.

OUTLINE: Patients undergo supervised 1-on-1 exercise sessions for 60 minutes on day 1.Treatment repeats every 3 weeks for up to 18 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive a home-based exercise prescription including instructions for keeping patients' heart rate within 50-80% maximum.

After completion of study, patients are followed up for 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Women who have been newly diagnosed with a first primary, epithelial ovarian cancer, have undergone surgical debulking and who will be treatment according to the Armstrong method
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately.
* Newly diagnosed, primary, epithelial ovarian cancer
* Have undergone surgical debulking
* Will be treated according to the Armstrong method
* Read and understand English
* All subjects must have the ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Growth of Infants Fed With BabyNes System

The purpose of this study is to assess the growth of infants fed with BabyNes System, compared to the World Health Organization Reference, during the first four months of life.


Eligibility Criteria:
Inclusion Criteria:

* Healthy newborn
* Full term newborn (≥ 37 weeks gestation)
* Birth weight ≥ 2500 g and ≤ 4500 g
* Newborn from birth to 14 days of age at the time of enrollment
* The newborn's mother has voluntarily elected to exclusively formula feed her newborn
* Having obtained his/her signed legal representative's informed consentHealthy newborn infant

Exclusion Criteria:

* Congenital illness or malformation that may affect normal growth (especially immunodeficiency)
* Newborn whose mother's BMI was abnormal (\<18.5 or \>30kg/m2) at start of pregnancy
* Newborn whose mother has diabetes of type-1 or type-2
* Newborn whose mother has a chronic infectious disease
* Newborn whose parents / caregivers cannot be expected to comply with treatment
* Newborn currently participating in another nutritional interventional clinical trial (except for vaccination studies)
Maintenance Oral Vinorelbine or Observation After Vinorelbine-Docetaxel First Line Chemotherapy in Advanced Breast Ca

This 2 arms study will assess the efficacy and safety of the Vinorelbine-Docetaxel combination given as an initial upfront treatment (first line) to all metastatic breast cancer patients enrolled. Patients having a disease control following initial treatment, will be randomized to either oral Vinorelbine maintenance arm or Observation arm. The trial will also compare the efficacy and safety of maintenance oral Vinorelbine versus Observation.

To our knowledge, this is the first trial evaluating the role of oral Vinorelbine as a maintenance therapy versus observation following a first line treatment with iv/oral Vinorelbine+Docetaxel. Eligible patients will be enrolled in the trial to receive 6 cycles of iv(D1)/oral(D8) Vinorelbine + Docetaxel. For responding and SD patients, after the 6 cycles, they will be randomized either in observation arm or to receive a maintenance chemotherapy with oral Vinorelbine. The oral form of the drug was found to be most appropriate for a long term treatment allowing to preserve QoL of the patients. Oral Vinorelbine will be administered on D1, D8 every 3 weeks during maintenance treatment, until PD, unacceptable toxicity or patient refusal to continue. The trial will assess efficacy/safety of initial Vinorelbine-Docetaxel combination as well as the benefits of maintenance chemotherapy with oral Vinorelbine.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Patients \>=18 years of age
* Histologically or cytologically confirmed adenocarcinoma of the breast that is now metastatic or locally-recurrent and inoperable with curative intent
* Measurable and/or non-measurable disease
* The patient's primary and/or metastatic tumor is HER2 neu negative
* Documented metastatic disease previously untreated with palliative chemotherapy
* Adjuvant or neo-adjuvant chemotherapy (including treatment with docetaxel or any other chemotherapy) is allowed with a disease free survival of at least 6 months
* No symptom or sign of brain metastasis

Exclusion Criteria:

* Operable local recurrence
* Ascites or pericardial effusion as only site of metastasis
* Symptomatic peripheral neuropathy \> grade 1 according to the NCI Common Toxicity Criteria
* Radiotherapy to all areas of evaluable disease within the previous 4 weeks
* Disease significantly affecting absorption
* Severe hepatic insufficiency
* Patient previously treated with chemotherapy for their metastatic disease
Hysteroscopic Tissue Removal System Versus Bipolar Resectoscopy for Polypectomy: Long-term Results

In this study, a comparison is made between two types of polyp resection methods (hysteroscopic tissue removal and bipolar resectoscopy). More specifically, the effects of the resection on symptoms such as abnormal uterine bleeding, and on the recurrence of polyps. The aim of the study is to find a superior method in terms of symptom relieve and polyp recurrence so this method can be used in gynaecological practice.

* Rationale: Several techniques for hysteroscopic removal of intrauterine polyps exist today. Up until the first decade of this century, larger polyps were usually removed via bipolar resectoscopy. Later, the hysteroscopic tissue removal system (morcellation) was introduced in which the abnormal tissue is mechanically removed, which is then immediately aspirated. Previous studies comparing bipolar resection and morcellation show that this is an effective, fast, and safe method without major complications. However, the long-term results are still largely unknown.
* Research question/goal: To investigate the long-term results of the effectiveness of hysteroscopic removal of intrauterine polyps. Bipolar resection and morcellation are compared here.
* Study design: This is a prospective cohort study. The patients previously participated in a randomized study (2011-2014) and will now be contacted again for the completion of a one-time questionnaire. The study has an observational design.
* Study population: Women with a history of endometrial polyp that was previously removed via hysteroscopic morcellation in a previous study.
* Primary and secondary endpoints: The primary endpoint is the risk of recurrence of abnormal uterine bleeding at post-surgery follow-up. Secondary endpoints include recurrence of other symptoms, time to recurrence, symptom relief, onset of new symptoms, onset of new polyp, satisfaction with regards to symptoms, satisfaction with regards to the treatment in general, need for additional treatments for blood loss and occurrence of pregnancy (in subfertility group).

Eligibility Criteria:
Inclusion Criteria:

* participation in earlier study

Exclusion Criteria:

* N/A
Requests for Euthanasia and Assisted Suicide

The study epiDESA2 identifies all explicit requests for euthanasia or assisted suicide expressed by the person him/herself, regardless of which professional is asked and regardless of where the request is made (primary care, health institutions, medico-social institutions including nursing home care or at home) in the Burgundy-Franche-Comté region during six months.


Eligibility Criteria:
Inclusion Criteria:

Any adult :

* Living at home, or in medico-social institutions or hospitalized in primary care or health institutions of Burgundy-Franche-Comté,
* At the end of life due to advanced stage disease or a major change in the state of health of an elderly person,
* Who expressed an explicit request for euthanasia or assisted suicide,
* Who expressed their no objection to the collection of their datas,
* Who are covered by the French social security system.

Exclusion Criteria:

* They are underage
* The request was expressed by another person
* The request is not an explicit request
* The request appears in the context of a situation other than illness or a general change in state of health
* The patient is mentally confused
Comparison of Respiratory Functions and Physical Fitness Parameters of Professional Basketball Players With Sedentary Controls

The aim of the study was to compare the professional basketball players and sedentary controls in terms of respiratory function and physical fitness parameters and to investigate the relationship between respiratory function and physical fitness parameters in basketball players.

Basketball is one of the most common team sports in the world, where aerobic and anaerobic power is used together and taking into account the rising number of participants in non-professional leagues, it is especially popular among female athletes from various countries . Basketball players' muscular strength and endurance, power, speed, agility and physical properties such as reaction time are the main factors underlying the performance. In addition to this, respiratory functions are important as well as physical properties in basketball. Because during the maximal exercise, the blood flow to the inspiratory and expiratory muscles accounts for 15% of the total oxygen cost of the exercise. Assessment of the motor skills and physical characteristics of basketball players is very important for the positioning of the player, performance analysis and monitoring the effectiveness of the training. There are many studies examining the physical fitness characteristics of basketball players.However, no study evaluating respiratory muscle strength and endurance in female basketball players was found in the literature.therefore, this study was planned.

Eligibility Criteria:
Inclusion Criteria:

-

Inclusion criteria of basketball players:

* Female athletes with at least 3 years of professional basketball experience
* Volunteer to participate in the study
* 18-35 years
* Participating in training sessions regularly
* Non-smoking
* Do not use any supplements or medicines that affect physical performance

The inclusion criteria for healthy sedentaries were:

* 18-35 years old women
* Volunteering
* Have never done sports
* No smoking

Exclusion Criteria:

* • Doing any sport except basketball

  * Chronic respiratory or cardiovascular disease
  * Have had respiratory tract infection at least 4 weeks before the test (potential effect on respiratory muscle strength)
  * Have had an orthopedic injury in the last 3 months
  * Abandoned tests for any reason
  * Leaving the team or transferring to another team