cyrilzakka/clinical-trials huggingface dataset:
Effects of a High Intensity Resistance Training in Muscular Strength, Agility, and Body Composition of Anorexia Nervosa Restricting Type Patients

The aim is to test the hypothesis that high-resistance training for 8 weeks, following the recommendations for healthy adolescents, is capable of eliciting increases in muscle strength, agility, skeletal muscle mass, and functional capacity without losing weight, body mass index (BMI) or fat mass in anorexia nervosa restricting type patients. Further, we hypothesize that the effects produced by the high-resistance training program will be maintained 4 weeks following the completion of the training program.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with anorexia nervosa restricting type
* age ≤16 years
* receiving psychological therapy 3 days/week, and daily life tracing (including diet)
* BMI \>14.0 kg/m2

Exclusion Criteria:

* being excessive exercisers (6 hours per week moderate to vigorous physical activity \[1952 counts/min\] upon admission)
* not being able to perform physical activity.
A Study on Switching From Daily DPP-4 Inhibitor to HSK7653 in Type 2 Diabetes Patients

To assess the effectiveness of HSK7653 tablets following the substitution of daily DPP-4 inhibitor (DPP-4i) over a 24-week treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 and Age ≤75 years
* T2DM patients,
* During the 12 weeks before screening, on the basis of diet control and exercise therapy, patients only regularly received daily DPP-4 inhibitors (such as sitagliptin, vildagliptin, saxagliptin, linagliptin, alogliptin and retagliptin , etc.) or combined with metformin (with a metformin dose of ≥ 1500 mg/day, or the maximum tolerated dose \< 1500 mg/day but ≥ 1000 mg/day);
* HbA1c ≥6.5% and HbA1c \<8.0%
* FPG \<10.0 mmol/L
* BMI ≥19 and BMI ≤ 35 kg/m2 (Body Mass Index)

Exclusion Criteria:

* Non-type 2 diabetes: Type 1 diabetes, gestational diabetes or other special types of diabetes.
* The presence of any of the following medical histories or conditions at the time of screening:
* History of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the recent 6 months;
* History of ≥2 episodes of severe hypoglycemia within the last 6 months;
* History of malignant tumors within the recent 5 years (except for cured basal cell carcinoma of the skin and cervical carcinoma in situ), or currently being evaluated for potential malignant tumors.
* Presence of severe mental disorders or language barriers, unwilling or unable to fully understand and cooperate.
* History of drug abuse within the past 5 years
* Previous history or clinical evidence of acute or chronic pancreatitis.
* Using other drugs that may affect blood glucose metabolism within 12 weeks prior to screening, including systemic glucocorticoids (except for inhaled or topical ones), growth hormones, etc.
* Any laboratory test index meeting the following criteria:
* Hemoglobin \< 110 g/L (for males) or \< 100 g/L (for females).
* Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \> 3 times the upper limit of the normal value.
* Total bilirubin (TBIL) \> 2 times the upper limit of the normal value.
* Fasting triglyceride (TG) \> 5.7 mmol/L.
* Estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI formula \< 45 mL/min/1.73m².
* Known to be allergic to the investigational products or related excipients.
From Innovation to Solutions: Childhood Influenza Vaccination Planning

The purpose of this study is to increase childhood influenza vaccination rates using the FDA licensed influenza vaccines according to national guidelines in a randomized cluster trial in which primary care offices are randomized to intervention or control with the control group receiving the intervention in the second year.

The investigators will conduct a stratified, randomized cluster trial of 20 diverse primary care practices to compare influenza vaccination rates in intervention and control sites. Intervention sites will use a package of newly developed and evidence-based techniques that will be tailored to their practice structure and culture, called the 4 Pillars Immunization Toolkit, in addition to receiving donated vaccine for early season vaccination. Control practices will not receive such assistance but will receive the intervention in the second year.

Eligibility Criteria:
Inclusion criteria:

For children: attendance at the selected health care center within the last year and age \>/=6 months thru 18 years.

Exclusion Criteria:

For children: Severe egg allergy or allergy to influenza vaccine
VAP Identification by AI

Ventilator-associated pneumonia (VAP) is the most frequent infection in the intensive care setting. For VAP there is currently no reliable diagnostic criteria. We aimed with the present study, using data from the mechanical ventilator to identify early this infection using artificial intelligence methods .

Ventilator-associated pneumonia (VAP) is defined as a hospital-acquired pneumonia occurring in patients submitted to invasive mechanical ventilation (MV) for at least 48 hours. VAP represents the most prevalent nosocomial infection in the intensive care setting. VAP is burdened by prolonged duration of MV and hospital length of stay and consequently increases hospital costs. Moreover, mortality and antibiotic use are also significantly affected. Unfortunately, there is currently no valid, accurate diagnostic criteria of VAP because even the most widely used ones are neither sensitive nor specific.. The insufficient sensitivity of these criteria to rule out VAP carries the risk of antibiotic overuse with the consequently emerging of antibiotic resistance and superinfections. On the other hand, the insufficient specificity to rule in VAP carries the risk of delayed administration of antimicrobial therapy leading to increased mortality. Ventilator-associated event surveillance failed to accurately identify VAP, too . The purpose of the present study is to develop different AI-algorithms using data continuously recorded form the mechanical ventilator in supporting clinicians for the early detection of VAP. An accurate AI-algorithm for early VAP identification has the potential to reduce morbidity, mortality, exposure to broad-spectrum and/or unnecessary antibiotics and finally to reduce costs.

Eligibility Criteria:
Inclusion Criteria:

* adult patients admitted to our ICU requiring invasive respiratory support for at least 48 hours

Exclusion Criteria:

* previuos pneumonia
Electrical Stimulation in Individuals With Chronic Neck Pain

The primary objective of the study was to evaluate the effects of diadynamic current and transcutaneous electrical nerve stimulation on pain and function in participants with chronic neck pain. The secondary objective of the research was to strengthen the neck muscles and enable participants with chronic neck pain to carry out everyday tasks on their own.

Chronic neck pain is a common problem in individuals of all ages. Approximately two-thirds of individuals experience neck pain at least once in their lifetime. The methods used to treat non-specific neck pain are conservative-oriented, with medical treatment and physiotherapy being the first-line modalities. Electrotherapy tools like transcutaneous electrical stimulation (TENS), interferential current, diadynamic current, laser, and ultrasound are used to treat chronic neck pain. So are thermal modalities like hot packs, cold packs, hydrotherapy, and infrared; exercise therapies like neuromuscular control, diversified therapeutic exercises, range of motion (ROM) exercises, and strengthening exercises; and interventions like massage, mobilization-manipulation, and traction.

Methods that reduce pain and improve function are essential in treatment. Electrotherapy is a commonly used treatment among physical therapy modalities. While the results of the use of TENS, an electrotherapy method, in chronic neck pain are included in some studies, the evidence regarding the effects of diadynamic currents is quite limited. The primary objective of the study was to evaluate the effects of diadynamic current and transcutaneous electrical nerve stimulation on pain and function in participants with chronic neck pain. The secondary objective of the research was to strengthen the neck muscles and enable participants with chronic neck pain to carry out everyday tasks on their own.

The study's hypotheses are as follows:

Hypothesis 1: There is a difference between the effects of diadynamic current and transcutaneous electrical nerve stimulation on pain in participants with chronic neck pain.

Hypothesis 2: There is a difference between the effects of diadynamic current and transcutaneous electrical nerve stimulation on functionality in participants with chronic neck pain.

Eligibility Criteria:
Inclusion Criteria:

Participants must be aged 18 to 60. Participants must report chronic neck pain for a minimum duration of three months.

Participants experiencing pain must have a Visual Analog Scale (VAS) score of at least 3.

Exclusion Criteria:

Participants with a history of neck or shoulder surgery Participants diagnosed with a rheumatic or neurological disorder
Safety Of ColoRectal Assessment and Tumor Evaluation by Colon Capsule Endoscopy

Following European guidelines patients undergoing colonoscopy in one of Odense University Hospitals units will now be offered a colon capsule endoscopy (CCE) in case of incomplete examinations. Patients formerly referred to colonoscopy in general anesthesia or patients who decline colonoscopy after having completed bowel preparation will also be offered a CCE. In our department we have conducted a comparison study documenting that the sensitivity of CCE is superior to CT colonography in both polyps \>9 mm and polyps \>5 mm, which is also supported by an Italian study. The safety and completion rate of CCE following incomplete colonoscopy is confirmed by several studies including one multicenter study and the completion rate is not significantly lower compared to other patient groups. In an incomplete colonoscopy it is always the most oral part of the colon which is not visualized, whereas in CCE, an incomplete investigation will most often have visualized the oral part. By combining incomplete colonoscopy results and incomplete CCE results we can identify patients who have had a complete colon investigation although both investigations were incomplete.

Aim: to investigate the quality of CCE and the completion rate in patients who have undergone an incomplete colonoscopy, have completed bowel preparation but declines colonoscopy or have been referred to colonoscopy in general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Incomplete colonoscopy, referral for colonoscopy under general anesthesia or declining colonoscopy after completion of bowel preparation.

Exclusion Criteria:

* Chrohn's disease with symptoms of stenosis and/or pacemaker
A Comparative Study of Sage-217 Plus an Antidepressant (ADT) Versus Placebo Plus an ADT in Adults With Major Depressive Disorder

The primary purpose of this study is to evaluate the efficacy of SAGE-217 plus an ADT in the treatment of major depressive disorder (MDD) compared to placebo plus an ADT.

This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MDD as diagnosed by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Clinical Trials Version (SCID-5-CT), with symptoms that have been present for at least a 4-week period
* 17-item Hamilton Rating Scale for Depression (HAM-D-17) total score of ≥24 at Screening and Day 1
* Participant in good physical health and has no clinically significant findings, as determined by the investigator, on physical examination, 12-lead electrocardiogram (ECG), or clinical laboratory tests
* Participant is willing, able, and eligible to take at least 1 of the 5 ADTs specified in the protocol (an eligible ADT is an ADT that has not been taken during the current depressive episode and for which the participant has no contraindications; further, a participant is not eligible for citalopram if escitalopram has been taken during the current depressive episode, and vice versa)

Exclusion Criteria:

* Has attempted suicide associated with the current episode of MDD
* Participant had onset of the current depressive episode during pregnancy or 4 weeks postpartum, or the participant has presented for screening during the 6-month postpartum period
* Participant has treatment-resistant depression
* History of bipolar disorder, schizophrenia, and/or schizoaffective disorder
* Known allergy to SAGE-217, allopregnanolone, or related compounds
* Has taken antidepressants within 30 days prior to Day 1, and/or has taken fluoxetine within 60 days prior to Day 1
Acupressure on Uremic Pruritus and Sleep Quality Among Patients Receiving Hemodialysis

The research is to explore the effect of acupressure on uremic pruritus and sleep quality among patients receiving hemodialysis. The research method adopts the experimental research method using randomization. The patients receiving the intervention of acupressure are in the experimental group, while those who do not receive it are in the control group.

There are about 60-90% of hemodialysis patients complain of itchy skin, which can cause the sleep quality decline. The important issue of non-invasive acupressure methods to relieve skin itching symptoms and to improve sleep quality are worth explored. Therefore, the research is to explore the effect of acupressure on uremic pruritus and sleep quality among patients receiving hemodialysis. The research method adopts the experimental research method using randomization. The patients receiving the intervention of acupressure are in the experimental group, while those who do not receive it are in the control group. The experimental group will receive the acupressure at the hemodialysis center for a total of 12 weeks, three times a week. The patients will receive 4 acupuncture points, including Quchi acupoint, Xuehai acupoint, Sanyinjiao acupoint, and Zusanli acupoint. Each acupoint will be pressed for 3 minutes, and totally 4 acupuncture points are 12 minutes. The effectiveness will be evaluated at the fourth week, eighth week and twelfth week. The effectiveness assessment in the study will use the "Visual Analog Scale (VAS)", "5D Pruritus Scale", and "Pittsburgh Sleep Quality Scale". This study uses the pre-test before the implementation of acupuncture, and uses the post-test at week 4, 8, and 12 end of acupuncture. Hopefully, this study may develop a beneficial non-drug care measures to improve the itching symptoms and sleep quality of hemodialysis patients, and to improve their quality of life. If this research result proves that the application of acupressure can be effective, it can not only improve the symptoms of itchy skin and sleep problems in hemodialysis patients, but also hope that can be extended to patients with end-stage renal disease.

Eligibility Criteria:
Inclusion Criteria:

1. At least 3 months hemodialysis
2. At least 1 month have itching
3. At least mild itching on the 5D tickling scale (9-11 points)
4. Can answer questions correctly

Exclusion Criteria:

1. Skin-related disease
2. Liver disease
3. Psychiatric disorder
4. Cancer undergoing chemotherapy or radiation therapy
5. Nerve or vascular or soft tissue diseases of the extremitie
6. Infections or surgeries on the extremitie
Exploring the Link Between Sleep and Brain Clearance

The purpose of this study is to assess the link between sleep and the clearance of waste products from the brain. This will be assessed in a group of healthy older adults.

First, the investigators want to assess the relationship between sleep parameters and markers for brain clearance, assessed with MRI and blood samples. Second, the investigators want to probe whether associations can be influenced by modulation of sleep parameters by means of auditory stimulation.

Eligibility Criteria:
Inclusion Criteria:

* Participation in previous longitudinal cohort studies at the study site
* Ability to provide written and verbal informed consent
* Fluency in the German language
* Stable home situation that allows for reliable application of the intervention for the duration of the study
* Ability to apply the intervention for the duration of the study, either alone or with support from a co-habitant
* For women: Hormonal contraception, if menstrual cycle is still present or has been present within a year
* Good general health status, normal cognitive function

Exclusion Criteria:

* Failure or inability to give informed consent
* Inability to follow the procedures of the investigation
* For women: pregnancy or breastfeeding
* Presence of sleep disorders (e.g. sleep apnoea, narcolepsy, restless leg syndrome, insomnia, rapid eye movement (REM) sleep disorder)
* Shift-work or a home situation that requires several awakenings during the night (e.g. newborn)
* History of serious illness likely to interfere with study outcomes
* Presence or history of a diagnosed neuropsychiatric illness
* Current diagnosis of uncontrolled or poorly controlled diabetes
* Current cancer of the brain or unstable cancer undergoing treatment
* Evidence of serious atherosclerotic cardiovascular disease
Change in Airway Peripheral Tone in COPD

Small airways disease is a pathological feature in mild to moderate COPD, which might be causally involved in disease progression. However, there are only limited studies available that prospectively identified patients at risk for small airway disease. Our intention is to investigate the early phase of the disease. In addition, we thereby want to build up a well-defined study population of patients in an early phase of the disease with a rapid decrease in lung function as measured by oscillometry and multiple breath washout (MBW)-testing. In addition, it is our goal to identify patients in an early stage of disease and patients at risk of fast progression and/or rapid decline in lung function.


Eligibility Criteria:
patients at risk for COPD

inclusion criteria:

* smoking history (at least 10 pack years)
* absence of airway obstruction (FEV1/FVC ≥ 70% after salbutamol 400µg)
* high symptom score (CAT ≥ 10) or long acting bronchodilator therapy
* age \> 35 years

exclusion criteria:

* respiratory infection within 4 weeks prior to inclusion
* other symptomatic pulmonary disease, except bronchial asthma

patients with early COPD

inclusion criteria:

* smoking history (at least 10 pack years)
* mild COPD (FEV1/FVC \< 70% and FEV1 ≥ 70% after salbutamol 400µg)
* age \> 35 years

exclusion criteria:

* respiratory infection within 4 weeks prior to inclusion
* other pulmonary disease, except bronchial asthma
Conservative Versus Liberal Red Cell Transfusion in Myocardial Infarction Trial: The CRIT Pilot

The purpose of this trial is to determine whether a conservative or a liberal blood transfusion strategy is better for patients with a heart attack and a low blood count.

The current standard of care for patients with heart attacks is to transfuse red blood cells when the hematocrit (red blood cell count) drops below 30 percent. However, there is little scientific basis for this current standard, and recent research has demonstrated that it is safe to allow the hematocrit (red blood cell count) to drop significantly lower in severely ill medical patients and in patients with heart disease undergoing major surgery. The investigators therefore propose this pilot trial to begin to determine whether or not it is safe to apply a more conservative blood transfusion strategy to patients with heart attacks.

In this study, patients who are within 72 hours of the onset of a heart attack and who are anemic (have a low red blood cell count) will be randomly assigned to one of two transfusion strategies while they are in the hospital: a liberal strategy of transfusing blood when the hematocrit falls below 30 percent (the current standard) or a conservative strategy of transfusing blood only when the hematocrit falls below 24 percent. It will then be determined which group fares better over the next 30 days.

The plan is to enroll 92 patients in this pilot trial in order to allow the researchers to plan for a much larger, definitive trial of this important question. It is anticipated that the conservative transfusion strategy will be similar to the standard (liberal) strategy in terms of patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

All of the following must be present:

* Acute myocardial infarction with presentation within 72 hours of randomization (acute myocardial infarction is defined as ischemic-type chest discomfort lasting at least 30 minutes associated with creatinine kinase MB (CKMB) or troponin \>upper limit of normal \[ULN\])
* Admission to CCU
* Hematocrit .30 or less
* Written, informed consent

Exclusion Criteria:

* Inability or unwillingness to receive red cell transfusions
* Active bleeding (overt blood loss accompanied by a decrease in hematocrit of at least 5% in the preceding 12 hours)
* Receipt of red cell transfusion within 7 days of randomization
* Prior severe transfusion reaction
* Pregnancy
* Imminent death
* Decision to provide limited care
* Age \<21
* Participation in another clinical trial in which blood transfusion is a requirement or a component of a primary or secondary endpoint
* Previous participation in the CRIT Pilot
Lumbar Drainage of Intraventricular Hemorrhage

Intracerebral hemorrhage (ICH) is a debilitating and fatal disease, especially when the hemorrhage is also entering the cerebral ventricles leading to acute hydrocephalus. In these cases, patients need a drainage through external ventricular drains (EVD). In the longer term, patients often need a permanent ventriculoperitoneal (VP) shunt to avoid hydrocephalus. Here we hypothesize that the early insertion of a lumbar drainage in addition to the EVD could lead to better functional outcome and avoidance of VP shunting by drainage of the blood which promotes inflammatory and adverse effects in the subarachnoid space. For that we propose a multi-center randomized clinical trial to investigate the hypothesis.


Eligibility Criteria:
Inclusion Criteria:

* ICH with IVH (with hemorrhage in the 3rd and/or 4rth ventricle) with the need for EVD placement due to acute hydrocephalus
* Age ≥ 18 y
* Lumbar drain can be inserted within 72 h after symptom onset or patient last seen well

Exclusion Criteria:

* Premorbid mRS score \> 2
* Pregnancy
* Life expectancy \<6 months
* Patient/family/caregiver unwilling or unlikely to opt for at least two weeks of aggressive therapy prior to consideration of transition to comfort measures/discontinuation of life support measures.
* Treating physicians deeming the prognosis as so grave that an aggressive therapy is not warranted.
* Other clear contraindication for treatment with a lumbar drain