cyrilzakka/clinical-trials huggingface dataset:
Intensive Lifestyle Interventions to Overweight and Obese Patients in Primary Care

The goal of this clinical trial is to compare in the effect of different lifestyle interventions in overweight and obese participants. The main questions it aims to answer are:

* effect on anthropometric measurements
* effect on lipid profile
* effect on weight-related quality of life
* observe the differences between interventions The study participants were stratified into three groups: intervention, control-1, and control-2.
* Intervention group: They were given a calorie-restricted diet and exercise plan by a dietician or physiotherapist at their first visit, and were followed up by telephone calls at weeks 2, 4, 6, 8 and 10 over 12 weeks.
* Control-1 group: During the initial medical interview, the participants were given a calorie-restricted diet programme by a dietician and an exercise programme by a physiotherapist; they were followed up over 12 weeks with telephone calls at week 4.
* Control-2 group: The participants were not provided with any programme, and the importance of weight loss was emphasised by the family physicians. Dietary and physical activity advice was given according to the recommendations in the Turkish Endocrine and Metabolism Association 2019 Obesity Diagnosis and Treatment Guide, and was followed up with phone calls at weeks 2, 4, 6, 8 and 10 over a 12-weeks.

With this study, it is aimed to evaluate the effect of intensive lifestyle intervention to be applied to patients and follow-ups made by telephone calls in order to protect overweight and obese patients who apply to primary health care services from obesity and complications of obesity in the pandemic process in which the number of applications to secondary and tertiary care decreased due to pandemic conditions and the number of applications to primary care increased, in addition to this, the susceptibility to obesity increased due to changing lifestyle behaviours with the effect of the pandemic; The aim of this study is to evaluate the effect of intensive lifestyle intervention and telephone follow-ups on body mass index, body composition, lipid profile, obesity-related quality of life and to evaluate different forms of intervention organised as intensive lifestyle intervention and increasing the frequency of follow-up.

Eligibility Criteria:
Inclusion Criteria:

Age 18-40 BMI ≥ 25 kg/m 2 Agreeing to participate in the study Not having a diagnosed chronic disease To be able to ambulate To be cooperative

Exclusion Criteria:

* Receiving medical treatment
* Secondary obesity (hypothyroidism, Cushing\&#39;s disease, etc.)
* Chronic disease (cardiovascular diseases, pulmonary diseases, presence of diabetes mellitus, liver diseases, renal diseases)
* Having hyperlipidaemia under treatment
* Cancer
* Pregnancy or breastfeeding
* Psychiatric disorder
* Orthopaedic or neurological disease that may prevent walking
* Are currently taking weight loss medication or enrolled in another weight loss program
* Having previously undergone obesity surgery or having surgery planned during the study period
Influence of Alfacalcidol on Falls in Osteopenic/Osteoporotic Postmenopausal Women (ALFA Study)

The purpose of this study is to evaluate the effect of alfacalcidol 1 µg daily on the number of fallers in postmenopausal, alendronate-treated, osteopenic or osteoporotic women.

primary outcome = number of fallers (patients with at least one locomotor fall incl.mixed falls)


Eligibility Criteria:
Inclusion Criteria:

* age \> 65 years
* postmenopausal women
* osteopenia/osteoporosis as defined by WHO criteria

Exclusion Criteria:

* Neoplasm or other severe diseases with life expectancy less than one year or expectation of rapid worsening within one year
* Chronic inflammatory rheumatoid disease
* Arthritis with continuous pain and influence on locomotion
* Inflammatory or metabolic bone disease, excluding osteoporosis.
* Subjects with antiosteoporotic medications who are not willing to switch over to alendronate treatment. Estrogen treatment can be continued
* 25-OH-Vitamin D3 \< 12 ng/ml (12 ng/ml = 30 mmol/L)
* Systemic corticosteroid treatments of more than one month within previous 12 months
* Intolerability for alfacalcidol
* Hypercalcaemia (\>2,7 mmol/l)
* Milk alkali syndrome
* Uncorrected, severe visual impairments
* Creatinin \> 2.5 mg/dl (\>220 µmol/L)
Procleix® Dengue Virus Assay Testing of Individual Donor Samples From Puerto Rican Blood Donors - American Red Cross

The objective of this study is to test individual donor samples (IDSs) with the investigational Dengue Assay on the TIGRIS System and to further characterize the Dengue Assay in the clinical setting.


Eligibility Criteria:
Inclusion Criteria:

* Donor must meet all the blood collection sites' standard eligibility requirements.
* Donor and/or legally authorized representative must be willing to undergo the site's routine informed consent process prior to study participation.
Effect of NAVA on Weaning Duration in Difficult to Wean Patients

It has been showed that over assist and patient ventilator asynchrony often occur in mechanical ventilated patients, especially in patients who failed weaning, which are associated with a prolonged duration of mechanical ventilation.Neurally adjusted ventilatory assist (NAVA) improves patient-ventilator synchrony, prevents excessive assist induced diaphragm inactivation. So the aim of this study was to detect that whether NAVA compared with PSV has the ability to reduce the duration of weaning in difficult to wean patients.

Intubated patients who were deemed ready for weaning by the clinical team but failed the first spontaneous breathing trials (SBT) or weaning were screened for eligibility. After enrollment, nasogastric tube eligible patient was replaced with a modified EAdi catheter. Then the patients were switched to a Servo-i ventilator. According to a random digits table, eligible patients were allocated randomly to ventilation with NAVA or pressure support ventilation (PSV). In PSV group, ventilator settings were determined by the physicians who in charge of the patients, and EAdi signals were not available for ventilator settings. In NAVA group, a daily NAVA level titration was performed to select the NAVA level which got approximate 50% unload, if the patients can't tolerate PSV or NAVA, PCV should be used to insure the ventilation safety. If the patients were under PCV mode, screening should be done by the researchers every 3 hours to make sure whether they will tolerate PSV or NAVA. In both group, daily measurement of diaphragmatic function was performed (only preformed in the first 10 patients of each group), followed by a 30 minutes SBT with PSV 5-7 cmH2O. Patients who were able to tolerate the SBT were extubated. Patients who completed the SBT and remained extubated \> 48 h were considered successfully extubated. Patients who failed SBT, or required noninvasive ventilation (NIV), or were re-intubated, or deceased within 48h post-extubation were considered extubation failure. Local sedation protocol including daily wakeup was performed during the research period. All continuous sedative infusions were discontinued at least 1 hour before the measurement of diaphragmatic function and SBT. Main end point was the duration of weaning, and second end point was extubation rate, diaphragmatic function and patient ventilator asynchrony.

Eligibility Criteria:
Inclusion Criteria:

Intubated patients who were deemed ready for weaning by the clinical team but failed the first spontaneous breathing trials (SBT) or weaning

Exclusion Criteria:

1. age \<18 or \>80 years,
2. tracheostomy
3. treatment abandonment
4. history of esophageal varices
5. gastro-esophageal surgery in the previous 12 months or gastro-esophageal bleeding in the previous 30 days
6. coagulation disorders (INR ratio\>1.5 and APTT\>44 s)
7. history of acute central or peripheral nervous system disorder or severe neuromuscular disease
8. history of leukemia, severe chronic liver or chronic cardiac disease
9. solid organ transplantation
10. malignant tumor.
eCoin for OAB Feasibility Follow-on Study

This trial is a prospective, multicenter, single-arm follow-on study will evaluate the safety and effectiveness of eCoinTM tibial nerve stimulation in subjects with urgency urinary incontinence (UUI) as defined by the American Urological Association (30). The follow-on study will evaluate changes from baseline in OAB symptoms as measured by voiding diaries and patient-reported outcomes through 24 weeks of eCoinTM therapy (which is the same as 28 weeks from study device reimplantation).


Eligibility Criteria:
Inclusion Criteria:

1. Individual participated in the eCoin Feasibility Study for Urgency Urinary Incontinence.
2. Individual was implanted with the study device during the eCoin Feasibility Study for Urgency Urinary Incontinence.

Exclusion Criteria:

1. In the opinion of the investigator, individual is not a good candidate for participation in the study.
The Effect of Baby Massage on Postpartum Depression and Maternal Attachment

This study was conducted to determine the effect of baby massage on postpartum depression and maternal attachment in the postpartum period.

The transition to motherhood is one of the life stages that brings about stress and change. Primiparous mothers, who will experience motherhood for the first time due to anxiety about the unknown, may experience more stress and their communication with their babies may deteriorate. In this process, the mother's seeing, touching and interacting with her baby positively affects her perception of her baby. The easiest and most natural way to do this is baby massage. Touching and massaging the baby maintains the baby's body contact, which strengthens the baby's sense of trust and supports the mother's development of attachment behavior. It also reduces mothers' levels of stress hormones such as cortisol and relieves depressive symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Primiparous,
* Cesarean section,
* Having a single baby,
* Between the ages of 19-35,
* Literate
* Effective communication.

Exclusion Criteria:

* Having a premature baby,
* Mother and baby have a disease that prevents massage,
* Loss of vision and hearing.
A Meal Test Study of LY900014 in Participants With Type 1 Diabetes Mellitus

Two forms of insulin lispro (LY900014 and Humalog®) and two forms of insulin aspart (NovoRapid® and Fiasp®) will be given to trial participants with diabetes mellitus type 1 by injection under the skin. The study will assess how fast the active ingredient (insulin lispro or insulin aspart) gets into the blood stream and how long it takes the body to remove it. A test meal will be given to trial participants to assess the course of the blood sugar lowering effect of the investigational products. The safety and tolerability of LY900014 will also be assessed. Screening is required within 14 days prior to the lead in. For each participant, the study will last up to 91 days.


Eligibility Criteria:
Inclusion Criteria:

* Are male or female participants with Type 1 Diabetes Mellitus (T1DM) for at least 1 year
* Have a body mass index (BMI) of 18.5 to 35.0 kilogram per meter square (kg/m²)
* Have a glycated hemoglobin (HbA1c) less than (\<)9.0 percent (%)
* Have had no episodes of severe hypoglycaemia in the last 6 months

Exclusion Criteria:

- Have a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from T1DM), hematological, or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
A Dose-finding and Confirmatory Trial of OPC-6535 in Patients With Active Crohn's Disease

The purpose of this study is to verify the safety and efficacy of OPC-6535 and determine the optimal dose by once-daily oral administration of OPC-6535 at 25 or 50 mg or placebo for 8 weeks in combination with base treatment (either a fixed oral dose of 5-aminosalicylic acid \[5-ASA\] or a fixed oral dose of 5-ASA plus enteral nutrition) in 180 patients with active Crohn's disease.


Eligibility Criteria:
Inclusion Criteria:

* Primary lesion in either small intestine or large intestine
* C-reactive protein (CRP) level above the upper limit of the normal range
* Patients who have been receiving a 5-ASA formulation (oral mesalazine) at a fixed dose of 2.25 g/day or higher (not exceeding the approved dose) and at a fixed dosing regimen
* Patients who have not received enteral nutrition or who have been receiving enteral nutrition at a fixed intake of 1200 kcal/day or less

Exclusion Criteria:

* Patients with an uncontrolled external fistula (including anal fistula)
* Patients with a history of total proctocolectomy or subtotal colectomy
* Patients with short bowel syndrome
* Patients with an artificial anus
* Patients with serious infectious disease (intra-abdominal abscess, etc)
* Patients with malignant tumor
* Female patients who are pregnant, lactating, or possibly pregnant, or who wish to become pregnant during the trial period
Novel Technique Lumber Spine Fusion: Unilateral Pedicular Screws Fixation Combined With Contralateral Interbody Cage

● Null hypothesis (H0): Unilateral pedicle screw with contralateral interbody cage has better outcomes than unilateral pedicle screw fixation with ipsilateral cage.

● Alternative hypothesis (H1):

Unilateral pedicle screw with contralateral interbody cage gives the same outcomes as unilateral pedicle screw fixation with ipsilateral cage.

Lumber interbody fusion is one of the commonest neurosurgical procedures. A lot of studies showed the value of unilateral approach which resulted in less cost, time and radiation exposure when use interbody cage with ipsilateral pedicular screws fixation in comparison to bilateral approach when use interbody cage with bilateral pedicular screws fixation.

Fusion rate, cage migration, and biomechanical stress were the main draw backs of unilateral approach by lumber interbody fusion with ipsilateral cage and screws. Cage size and location seemingly the main reasons with advice to use large cage and cage insertion in oblique fashion to cross the midline. This study was designed to solve these issues.

Sample size:

The Study will include 40 patients divided into two groups, each group containing 20 patients.

Eligibility Criteria:
Inclusion Criteria:

* Patient acceptance.
* Both sexes.
* Age (21-60) years old.
* Patients with monosegmental lumber degenerative spinal diseases including lumbar spondylosis, spondylolysis, spondylolisthesis grade one, or lumbar disc prolapse.

Exclusion Criteria:

* Patient refusal.
* Altered mental status.
* Patients with associated comorbidity interfere with surgery.
* Extremes of age.
* Multiple level lumbar degenerative disease
* Trauma
* Spinal tumour
* Active infection
* Previous lumbar operation
Breath-hold Cardiac Hybrid SPECT/CCTA

This study aims at combining inspiration breath-hold myocardial perfusion SPECT with coronary CT angiography.


Eligibility Criteria:
Inclusion Criteria:

* Referral for cardiac hybrid SPECT/CCTA
* Male and female subjects 18 years of age or older
* Written informed consent by the participant after information about the project

Exclusion Criteria:

* Contraindications for coronary CT angiography (including renal failure with a GFR \<30ml/min/1.73m2, allergies to iodinated contrast agents)
* Pregnancy or breast-feeding
* Previous coronary revascularisation
* Inability to follow the examination procedure (e.g. due to language barriers, severe mental disease etc
Activation Patterns of Respiratory Muscles to Loaded Inspiratory Muscle Tests in Healthy Adults Under Different Posture

Whether minimizing sternocleidomastoid (SCM) activation in supine position would increase diaphragm activation during loaded inspiratory muscle tests remains to be determined. Therefore, the purpose is to exam diaphragm and SCM activation during loaded inspiratory muscle tests in sitting and supine position in healthy adults.

Inspiratory muscle training usually performed in the upright sitting position. In healthy individuals, sternocleidomastoid (SCM) is rarely recruited during tidal breathing, but previous studies have demonstrated SCM activation during loaded inspiratory muscle tests in upright sitting position. Whether minimizing SCM activation in supine position would increase diaphragm activation during loaded inspiratory muscle tests remains to be determined. Therefore, the purpose is to exam diaphragm and SCM activation during loaded inspiratory muscle tests in sitting and supine position in healthy adults.

Eligibility Criteria:
Inclusion Criteria:

* age \> 20 years old
* without exercise habit (any exercise that less than 3 days/week)
* can cooperate with the measurements of this study

Exclusion Criteria:

* any clinical diagnosis that will influence the measurement, including any history of neuromyopathy
* angina, acute myocardial infarction in the previous one month
* pregnancy
* participated in inspiratory muscle training program in the previous three months
* any psychiatric or cognitive disorders, for example: Mini-Mental State Examination (MMSE) \< 24, that will disturb the communication and cooperation of the study
The Effect of Esketamine on Postoperative Pain Relief in Patients Undergoing Laparoscopic Surgery

The purpose of this study is to investigate whether continuous intraoperative infusion of esketamine combined with the addition of esketamine to postoperative PCIA can improve postoperative pain and sleep quality in patients undergoing laparoscopic uterine surgery under general anesthesia.

Esketamine is the right isomer of ketamine, which is better than the original ketamine and has fewer side effects. In addition, for some gynecological hysterectomy patients who have poor sleep quality and anxiety after surgery, Esketamine also has the effect of treating depression. Due to the side effects of postoperative nausea, vomiting and hyperalgesia caused by excessive dosage of some opioids, this study will continue to inject small doses of esketamine during the operation to reduce the intraoperative dosage of opioids, and add esketamine to the postoperative PCIA for analgesia. To explore whether this method can reduce the incidence of moderate and severe postoperative pain in patients with laparoscopic uterine surgery under general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

1. Patient Undergoing laparoscopic uterine surgery under general anesthesia (total hysterectomy, myomectomy);
2. Patients gave the informed consent and signed the informed consent form.
3. The ASA is Ⅰ-Ⅱ

Exclusion Criteria:

1. Patients allergic to anesthetics, ropivacaine, and esketamine or with contraindications to use;
2. Patients with cognitive dysfunction or an inability to communicate;
3. Transfer to the ICU after surgery;
4. Patients with hyperthyroidism, tachyarrhythmia, or severe hypertension;
5. Unwilling to use PCIA or refuse to participate in this trial;
6. Patients with liver and kidney dysfunction
Evaluation of Two Strategies for Debriefing in the Development of Skills for Neonatal Resuscitation

Introduction: Training of health professionals in neonatal resuscitation reduces risks and adverse events during this intervention. Simulation-based education with constructive immediate feedback (debriefing) is an effective teaching method for personnel in charge of neonatal resuscitation.

Objective: To evaluate two debriefing strategies for the development of neonatal resuscitation skills in professionals specialized in critical newborn care.

Materials and Methods: A simple blind randomized clinical trial was conducted. Twenty-four professionals (pediatricians, nurses, and respiratory therapists) were randomly assigned for two interventions; one group received oral debriefing and the other oral debriefing assisted by video. Three standardized clinical scenarios that were recorded on video were executed. A checklist was applied for the evaluation, administered by a reviewer blinded to the assignment of the type of debriefing.

Null hypothesis: The improved in the skills of neonatal resuscitation is the same for both strategies of debriefing.

Alternative hypothesis: The improved in the skills of neonatal resuscitation is different for both strategies of debriefing


Eligibility Criteria:
Inclusion Criteria:

* The specialized health professionals (Professional nurses, respiratory therapists, and pediatricians) in charge of newborn care that working in the Neonatal Unit areas, maternity wards, surgery rooms responsible for the care of caesarean sections, and those of pediatric emergencies of University Hospital of La Sabana

Exclusion Criteria:

* None
Laryngoscope-assisted Lightwand Intubation and Cervical Spine Motion

The aim of the study is to compare the effect of the laryngoscope-assisted lightwand intubation technique vs. the conventional lightwand intubation technique on the cervical spine motion during intubation in patients with the simulated cervical immobilization.

In clinical practice, the investigators have occasionally experienced some difficulties in the lightwand intubation in patients with cervical spine instability because manual in-line stabilization during intubation hinders free movements of the lightwand such as advancement, withdrawal, and scooping in the oral cavity. For this reason, jaw thrust is often used to secure enough space for free movements of the lightwand in the oral cavity in the traditional lightwand intubation technique. A recent study showed that laryngoscope-assisted lightwand intubation provided more successful intubation on the first attempt and less scooping movement than the traditional lightwand intubation by facilitating free movements of the lightwand in the oral cavity in patients with cervical immobilization during intubation for cervical spine surgery. In the laryngoscope-assisted lightwand intubation technique, the direct laryngoscope may provide sufficient space for free movements of the lightwand in the oral cavity without jaw thrust, which can result in cervical spine movement. However, the effect of the laryngoscope-assisted lightwand intubation technique on cervical spine motion is not investigated yet.

Eligibility Criteria:
Inclusion Criteria:

* Patients with American Society of Anesthesiologists physical status of 1-2 and age of 18-80 years undergoing elective endovascular coiling to secure cerebral aneurysm under general anesthesia in neuroangiographic rooms.

Exclusion Criteria:

* Patients with the upper airway abnormalities, such as inflammation, abscesses, tumours, polyps, or trauma.
* Patients with past medical history of gastro-oesophageal reflux disease and previous airway surgery, a high risk of aspiration, coagulation disorders, or Hunt Hess grade of 3-5.
* Body mass index \> 30