cyrilzakka/clinical-trials huggingface dataset:
Electromyographic Activity of Preterm Newborns Submitted to Hammock Positioning

To compare and analyze the effects on the electromyographic activity of preterm newborns placed in the hammock position with the activity of newborns not placed in this position.

Randomized clinical trial, according to CONSORT standards, with newborn preterm gestational age \<34 weeks and birth weight \<1500 g, admitted to the intensive care unit. Newborns will be randomized. Those selected for the control group (CG) will be placed in the incubator following the service routine. Babies in the intervention group (IG), will be positioned supine in a hammock in the incubator, with the appropriate postural adjustments. The evaluation of muscle activity will be carried out through surface electromyography. Evaluations shall be performed immediately before the intervention; immediately after 24 hours of intervention; and within 24 hours without intervention, in order to compare the values before and after the intervention of the two groups, as well as if the effects of the intervention are maintained after its removal.

Eligibility Criteria:
Inclusion Criteria:

* Preterm Infants with gestational age \<34 weeks
* Free from mechanical ventilation in the last 48 hours prior to electromyographic evaluation
* Not in use of supplemental oxygen at the time of assessment

Exclusion Criteria:

* Apgar score of less than seven in the fifth minute
* Previous history of perintraventricular hemorrhage grade III and / or IV
* Congenital infection
* Congenital heart defects
* Neonatal Obstetric traumas
* Gastroesophageal Reflux Disease
* Genetic syndromes
* Congenital malformations
* Sepsis with meningitis
* Orthopedic and musculoskeletal alterations
The Utility of Peri-operative Arnica Montana for Reduction of Ecchymosis in Rhinoplasty Surgery

Arnica montana is a homeopathic drug that is made in accordance with the official methods of the Homeopathic Pharmacopoeia of the United States (HPUS) and is commonly used by cosmetic surgeons throughout the world, although there is no study proving its benefit after rhinoplasty surgery. The purpose of the research is to see if Arnica montana will reduce the amount of bruising and the intensity of the bruising after surgery. Photographs of the subject's face will be taken and used to analyze bruising after rhinoplasty surgery in subjects who receive Arnica montana and compare them to photographs of subjects who take a placebo (sugar pill).

Subjects will receive either oral arnica montana or placebo without any identifying labels or markers on the drugs.

During the post-operative period, the patients will be seen back in surgery clinic on post-operative days 3, 7 and 10. During the first two visits, the subject will receive routine post-operative care with no difference from patients not enrolled in the study. This includes routine sets of photographs. The participant will then return for a third post-operative visit lasting under ten minutes only for study photos using the left and right "three-quarters" view. Again, the subject will hold a measurement marker so length measurements can be made, and this marker will be held under the ear to not interfere with the routine cosmetic analysis of the photographs. The digital photographs will be used to analyze the bruising for the study. The ratio was calculated by dividing the number of pixels of bruised area over number of pixels of standard area.

Eligibility Criteria:
Inclusion Criteria: Adult patients who are deemed candidates for rhinoplasty surgery at UW Transformations will be eligible to participate in the study.

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Exclusion Criteria:

* Patients who are prisoners
* Patients who are pregnant and breast-feeding women
* Patients taking anti-coagulants (such as blood thinners), anti-platelet drugs (such as NSAIDS), or other homeopathic remedies during the peri-operative period
* Patients with a bruising or bleeding disorder
* Patients who take oral corticosteroid therapy
* Patients who suffer from severe liver or kidney disease
* Patients with malignancy, infection, immunodeficiency, metabolic syndrome, infectious or inflammatory gastrointestinal disease
* Patients with oral or contact allergies to Arnica montana or to any other member of the Asteraceae family of plants such as ragweed, chrysanthemums, marigolds, and daisies
Comparison of the Combination of Fenofibrate and 40 mg Simvastatin Versus 40 mg Simvastatin Monotherapy

Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary mechanisms and can be coadministered to patients with mixed hyperlipidemia. The overall objective of the study is to evaluate the efficacy and safety of combining fenofibrate and simvastatin in patients with mixed hyperlipidemia at risk of cardiovascular diseases.


Eligibility Criteria:
Inclusion Criteria:

* Mixed dyslipidemia

Exclusion Criteria:

* Diabetes,
* Known hypersensitivity to fenofibrate or simvastatin,
* Pregnant or lactating women,
* Contra-indication to fenofibrate or simvastatin,
* Unstable or severe cardiac disease.
After Induction Chemotherapy of DP Plus DDP Concurrent Radiotherapy With and Without Bevacizumab Study

This is a randomized, open controlled multicenter phase II clinical study. The SPSS statistical software estimation of sample size, selection of the initial treatment of locally advanced head and neck squamous cell carcinoma in 120 patients, such as to achieve the desired results, considering expanding the clinical, according to the proportion of 1:1 were randomly divided into two groups, all patients were taken, docetaxel + cisplatin 2 cycles of induction chemotherapy 、Concurrent chemoradiotherapy（tomotherapy+cisplatin）, The experimental group was added with AVASTIN.


Eligibility Criteria:
Inclusion Criteria:

Men and women are not limited, requirements of ECOG0-2, age 18-70 years old, pathological stage III (NCCN2012), had not received radiotherapy and chemotherapy, expected to survive more than 3 months, the routine testing, were in the normal range, signed the informed consent

Exclusion Criteria:

Do not meet the above criteria; allergic to docetaxel and AVASTIN, or metabolic disorders; associated with gastrointestinal bleeding, perforation and other serious diseases; severe liver disease, kidney disease, respiratory disease or unable to control diabetes, hypertension and other chronic disease; heart disease clinical symptoms; there is peripheral nervous system disorders or have obvious mental disorder and disorders of the central nervous system; active phase \>CTCAE2 clinical severe infection; a history of organ transplantation (including bone marrow transplantation of autologous peripheral stem cell transplantation); pregnant, lactating women, women of childbearing age and spouse refused to take effective means of contraception contraception; no legal capacity, continue to influence medical or ethical reasons for who
Point-of-care Monitoring of Antibiotic Concentration in Blood With UV-VIS Absorption Spectroscopy

This prospective clinical study will investigate if antibiotic concentrations in patients with severe infections can be monitored by the UV-VIS spectroscopy.

Early and correct antibiotic treatment has a fundamental effect on survival in severe infections, and to prevent resistance development. However, it is unclear if this is achieved in severely ill patients with severe infections. Underdosing of antibiotics leads to lack of effect against bacteria and selection of multi-resistant strains. Overdosing of antibiotics increases the risk of toxicity and poses a threat to the environment. Currently there is no method for rapid or bedside determination of antibiotic concentration in routine health care.

Pharmacolog AB, an Uppsala Med-tech company, has developed a technology and a product DrugLog® based on absorption spectroscopy in ultraviolet - visible (UV-VIS) frequencies that can measure the concentration of antibiotics.

The goal of this project is to investigate if antibiotic concentrations in patients could be monitored by the UV-VIS spectroscopy.

In a prospective observational study, blood samples from 100 patients with severe infections treated with cefotaxime, piperacillin/tazobactam or meropenem will be measured by UV-VIS spectroscopy as well as with the golden standard, High-performance liquid chromatography-mass spectrometry (HPLC-MS) at Klinisk farmakologi, Huddinge hospital, Stockholm.

After informed consent, samples will be taken prior to antibiotic treatment and three times thereafter. Demographic and clinical data will be registered.

Eligibility Criteria:
Inclusion Criteria:

* More than 18 years old
* Suspected infection where treatment with cefotaxime, piperacillin/tazobactam or meropenem is prescribed

Exclusion Criteria:

* Pregnancy
* Intermittent haemodialysis
* Patient with limited treatment decision
The Association Between Shock Index and Severity of Postpartum Blood Loss

The present study aims to determine the relationship between postpartum changes in the shock index and the severity of blood loss and other PPH results. Blood loss, heart rate and blood pressure will be systematically measured in the postpartum period in all participating women to explore new clinical indicators to identify those requiring clinical intervention for excessive bleeding.


Eligibility Criteria:
Inclusion Criteria:

* Receive care for vaginal delivery

Exclusion Criteria:

* Scheduled or transferred for cesarean section
* Cannot give informed consent
* Are not willing and/or cannot answer the questionnaire on their background
Exploring Unconventional Plant-Derived Metabolites for Glycemic Control: the Case of Pomegranate

The EXPLORER study will investigate whether supplementation with a pomegranate extract rich in ellagitannins is able to improve well-being and metabolic health in individuals without diabetes. The aim is to establish for the first time an association between the intake of ellagitanninsa and glycaemic control, the processing/aggregation of IAPP (a protein associated with diabetes), the state of the intestinal microbiota and circulating levels of urolithin B (a small bioavailable molecule resulting from the metabolism of ellagitannins).

This is a 12-week pilot study that is double-blind (neither participants nor researchers know who gets the treatment) and placebo-controlled (some people will receive a non-active substance). It will involve volunteers who do not have diabetes.

Phase 1 - Recruitment: Volunteers without diabetes, who are patients at a family health unit, will be recruited. Participants will provide informed consent and information such as sociodemographic and biochemical data.

Phase 2 - Intervention: The recruited individuals will be divided into two groups: one receiving the pomegranate extract supplement (intervention group) and the other receiving a placebo. In total, 60 participants will take part in the study.

A double-blinded, randomized, placebo-controlled pilot study was designed to assess the effect of Ellagitannins Pomegranate Supplements (EPS) in metabolic health of participants.

Participants will be recruited at the family health unit USF São Martinho de Alcabideche from the grouping of health centres ACES Cascais, and the study will be conducted according to universal bioethical principles.

At least 60 individuals with pre-diabetes will be included in the study. After the fulfilment of the inclusion criteria, they will be randomly assigned to the intervention group (IG) and the placebo group (PG). Equal distribution of gender, age and BMI will be ensured between the groups.

Eligibility Criteria:
Inclusion Criteria:

* Individuals without diabetes
* Both sexes
* Aged between 18 and 65
* Body Mass Index (BMI) less than 29.9 kg/m2
* Fasting plasma glucose levels below 126 mg/dL
* Haemoglobin A1C levels between 5.7 - 6.5%

Exclusion Criteria:

* Not agreeing to take part in the study
* BMI\>30 kg/m2
* Being diagnosed with diabetes
* Having any type of cognitive disorder
* Using anti-diabetic medication
* Alcohol or drug abuse
* Pomegranate allergy
* Regular use of food supplements
* Difficulty swallowing tablets
* Being on, or planning to be on during the study period, a different diet than usual
* Pregnancy, planning to become pregnant during the study, breastfeeding 1 year before or during the study
* Oncological, cardiac, hepatic, renal, thyroid or other endocrine diseases
* Medical or social conditions that may affect adherence
* Participating in another study at the same time.
Development of an Artificial Intelligence Algorithm

Mechanical obstruction of the small intestine is an interruption of intestinal transit due to an organic obstacle in the digestive tract that results in a shutdown of materials and gas. Without medical care, it can lead to perforation of the intestinal wall and acute peritonitis. It accounts for 4% of emergency department admissions and 20% of emergency surgeries

The abdominopelvic tomodensitometric examination is the gold standard for making a diagnosis and identifying the cause, the level of the lesion and looking for signs of severity related to the risk of ischemia of the intestinal tissue. Well characterized, these signs remain difficult to identify for a non-expert radiologist. The evaluation of the detection performance of these signs shows a sensitivity between 63 and 100% and a specificity between 61 and 96% with a great variation according to the signs studied.

Our research project aims to develop a tool for the detection of the three main signs of severity of mechanical intestinal obstruction to raise and standardize the level of detection of the risk of ischemia on abdominal CT images.

Eligibility Criteria:
Inclusion Criteria:

* Patient whose age is ≥ 18 years
* Patients with an abdominal scan performed at Saint-Joseph Hospital
* Patients diagnosed with mechanical obstruction of the small intestine on a flange or adhesion
* Patients having abdominal surgery within 48 hours of diagnosis or medical follow-up at Saint Joseph Hospital
* French-speaking patient

Exclusion Criteria:

* Patients with a history of abdominal surgery one month before diagnosis
* Patients objecting to the use of their data for this research
* Patient under guardianship or curatorship
* Patient under legal protection
* Patient deprived of liberty
The Role of L-arginine in Polycystic Ovary Syndrome

PCOS patients meeting the trial criteria were enrolled from the Shanghai 10th People's Hospital. The contents of this study were introduced to them, and they were invited to participate in the study. We further evaluated the efficacy and safety of arginine in treating PCOS by implementing the L-arginine clinical intervention protocol, and conducting post-intervention follow-up, efficacy evaluation, laboratory tests, and fecal sample 16S rRNA sequencing.

In this study, we will enroll PCOS patients who meet the trial criteria from the Shanghai 10th People's Hospital, introduce the content of this study to them, and invite them to participate in the study. Perform laboratory tests for PCOS and collect baseline stool and blood samples. The clinical intervention program of L-arginine was implemented, and post-intervention follow-up, efficacy evaluation and laboratory examination were carried out. Stool and blood samples were collected after the intervention, and 16S rRNA sequencing was performed on stool samples before and after the intervention. To analyze whether PCOS-related clinical and laboratory indicators improved after L-arginine treatment of PCOS, and to analyze the changes in patients' microbiome before and after L-arginine treatment, to clarify the effectiveness and safety of L-arginine treatment of PCOS.

Eligibility Criteria:
Inclusion Criteria:

* aged 18-45 years
* Diagnosis of PCOS with the Rotterdam diagnosis criteria (2003)

Exclusion Criteria:

* Pregnant women;
* Hyperthyroidism or hypothyroidism
* Severe liver and kidney function injury
* Cancer patients;
* Associated with severe infection, severe anemia, neutropenia and other blood system diseases;
* Have type 1 diabetes, single-gene mutated diabetes or other secondary diabetes;
* Patients with mental illness or intellectual disability;
* Have taken drugs for PCOS treatment in the last three months;
* Have a long history of taking hormone therapy;
* Currently or recently participating in another clinical trial.
The Role of Proper Insulin Injection Technique in the Treatment of Diabetes Mellitus

This is a prospective, post-marketing, single-arm clinical investigation on the effects of optimal insulin injection technique, in conjunction with the use of disposable Becton Dickinson (BD) Micro-Fine Plus 32G pen needles, by Type I and Type II Diabetes Mellitus patients, with or without lipohypertrophy, on clinical outcomes like HbA1c and hypoglycemic events, as well as changes in insulin Total Daily Dose (TDD) and patient's Quality of Life (QoL). During this study, each subject will be trained in the optimal insulin injection technique by personal training as well as by following online video training modules on a specific web-based platform.


Eligibility Criteria:
Inclusion Criteria:

1. Type 1 or type 2 diabetes mellitus;
2. At least 1 year of experience with insulin self-administration;
3. Use of insulin pen for insulin injections.
4. HbA1c \> 7.5 % measured at study entry or maximally 30 days prior to screening.
5. BMI below 40 kg/m2 at study entry.
6. Daily self-control of blood glucose level;
7. Access to the internet for watching video lessons.
8. Only outpatients are eligible for the study.
9. Availability of signed informed consent of the patient for inclusion in the study.

Exclusion Criteria:

1. Pregnant women or women planning to become pregnant during the time of study, breastfeeding women;
2. Subjects using an insulin pump;
3. Those using treatment with a Glucagon-Like Peptide (GLP)-1 receptor agonists alone;
4. Subjects not fluent in Russian (reading and writing).
5. Patients at high risk for ketoacidosis and/or hyperglycemia.
6. Psychic, physical or any other reasons hampering patient participation in the study (based on the reasonable opinion of the physician-investigator).
SPARK-ALL: Calaspargase Pegol in Adults with ALL

The purpose of this phase 2/3 study is to confirm the recommended doses and to evaluate the safety and pharmacodynamics of Calaspargase pegol for the treatment of adult patients with Philadelphia-negative Acute Lymphoblastic Leukemia.

The study will be conducted in 2 parts. Part 1 is a dose confirmation run-in period. Part 2 will enroll the remaining participants at the dose as confirmed or recommended in Part 1.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥22 and \<55 years with newly-diagnosed and cytologically confirmed and documented Philadelphia-negative B-cell or T-cell ALL by World Health Organization (WHO) classification (2016).
* Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 2.
* No prior therapy for ALL such as chemotherapy and radiation therapy before signing the informed consent except for limited treatment (≤7 days) with corticosteroids or hydroxyurea and a single dose of intrathecal cytarabine.

Exclusion Criteria:

* Patients with Philadelphia chromosome positive ALL, Burkitt's leukemia, mixed lineage/mixed phenotype acute leukemia, and acute undifferentiated leukemia per WHO classification (2016).
* Patients with Down syndrome.
* Patients with Hepatitis B (positive for HBs antigen), and Hepatitis C (HCV antibody) at inclusion
* Participants known to be HIV-positive.
* Known history of non-gallstone-related pancreatitis.
* Known severe hepatic impairment (bilirubin \>3 x upper limit of normal \[ULN\]; transaminases \>10 times ULN.
* Pre-existing history of hepatic veno-occlusive disease (VOD).
* Age ≥ 55 years.
* BMI \> 35 kg/m2.
Acupuncture in Herpes Zoster Neuralgia (ACUZoster)

Symptoms that herald herpes zoster include pruritus, dysesthesia and pain along the distribution of the involved dermatome. The most distressing symptom is typically pain and the most feared complication is postherpetic neuralgia (PHN), the persistence of pain long after rash healing. PHN is defined as pain persisting more than 3 months after the rash has healed. Both, the acute pain associated with herpes zoster and the chronic pain of PHN, have multiple adverse effects on health-related quality of life.

The primary objective of the trial presented is to investigate whether a 4 week semi-standardised acupuncture is non-inferior (first step) or superior (second step) to (a) the anticonvulsive drug gabapentin and (b) sham laser acupuncture in the treatment of pain associated with herpes zoster in addition to standardised analgesics. Secondary objectives include an assessment of the change of sensoric function, of long-term effectiveness, the occurrence of PHN and an evaluation of several pain specific questionnaires


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of acute HZ
* Pain intensity \> 30 mm visual analog scale

Exclusion Criteria:

* Patients with insulin-dependent diabetes mellitus or other diseases influencing the peripheral sensibility (e.g., polyneuropathia, chronic pain syndromes, cutaneous irritations i.e. burns)
* Patients under age
* Uncompliance
* Pregnancy or lactation
* Surgery within the last 3 month
* Severe heart/lung/kidney disease
* Diseases influencing the quality of life
* Psychiatric diseases (e.g., depression, schizophrenia, dementia)
* Chronic intake of analgesics, neuroleptics, antidepressants, corticoids, alpha-agonists
* Acupuncture, transdermal electric neurostimulation or other Complementary and Alternative Medicine treatment within the last 4 weeks
* Contraindications according to the summary of product informations against analgesic treatment (i.e., metamizol, paracetamol, tramadol, morphine) or the investigational medicinal products (gabapentine, acupuncture needles)
Accuracy of the New Barrett TAL Formula With the Argos Measurements: A Multicenter Prospective Study

This study is a prospective, multi-site, multi-surgeon, observational study of refractive accuracy with the Argos using BTAL after successful cataract surgery. Subjects will be assessed pre-operatively, operatively and at 5-8 weeks postoperatively. Clinical evaluations will include measurement of visual acuity, manifest refraction, and preoperative biometry.


Eligibility Criteria:
Inclusion Criteria:

Subjects are eligible for the study if they meet the following criteria:

* Cataract surgery that was completed without complications with biometry measured using the Argos biometer.
* Subjects that elect Clareon SY60WF aspheric lens (Alcon, Fort Worth, TX).
* Potential post-operative visual acuity of better than logMAR 0.30 (20/40).
* BTAL was used to determine the IOL power implanted.

Exclusion Criteria:

If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

* Patients with pre-existing ocular pathology that in the opinion of the principial investigator would influence the postoperative refraction.
* Any disease or pathology, including but not limited to irregular corneal astigmatism and keratoconus, that is expected to reduce the potential postoperative BCDVA to a level worse than 20/40.
* Patients with history of previous ocular surgery.
* Patients with signs of inability to understand consent for study and procedure planned.
* Eyes with intraoperative or postoperative complications.
* Suboptimal surgical outcomes that are not related to the treatment plan, e.g. capsular tear, cystoid macular edema.
* Astigmatism \>±0.75D.

Each investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.