cyrilzakka/clinical-trials huggingface dataset:
40% Orally Administered Dextrose Gel is More Effective Than 25% Dextrose

The aim of this study was to evaluate the safe of 40% Dextrose oral administration on blood glucose concentration and to reducing of pain before painful procedures on healthy term neonate 72 hours aged.

During the study period around 2000 term neonates were born in the university affiliated hospital. Five to 7 term neonates were assessed weekly by the principal investigator (PI) for study eligibility. The parents of neonates who met the inclusion criteria received information about the study after which they were invited to participate. Written informed consent from parent was obtained. The PI entered data into the online Research Randomizer which provided a randomization number corresponding to a numbered treatment pack containing two syringes, each containing 2ml of an identical and therefore blinded liquid. Study investigators, clinical staff, parents and monitors remained blinded to treatment allocation until data analysis was completed. To ensure standardization the included term infants were not breastfeed 30' prior to the heel stick and a standardized heel lance was used.Each infant was taken to a separate room with the mother by the assigned nurse to provide a quite environment. All infants were awake at the time of the procedure. Their clothes were removed and wet diapers were changed. In both groups, the infants were placed in a supine position on a changing table. Dextrose administration and the heel stick were undertaken by an experienced staff neonatal nurse. The heel was warmed with a warm wet towel up 2' minutes before the procedure. The heel was disinfected shortly before the procedure started.

Eligibility Criteria:
Inclusion Criteria:

* were born at ≥ 37 weeks of gestation were
* APGAR score of ≥ 7 five minutes after birth
* had a postnatal age of ≥ 72 hours
* were breastfed (but not 30' prior to the testing HS)
* were undergoing a routine heel stick for metabolic screening between the third and fifth postnatal day

Exclusion Criteria:

* any kind of medical instabilities needing a transfer to the neonatal intensive care unit (NICU)
* severe intrapartum asphyxia defined as a 5' Apgar score less than 3
* parenteral nutrition and the presence of neurological symptoms
* congenital anomalies
* other conditions requiring treatment for hypo- or hyperglycemia
* those in which the heel lance procedure failed
Evaluation of Soft Tissue Profile Changes Following Autogenous Fat or Onlay Polyetheretherketone (PEEK) Augmentation Versus Sliding Genioplasty for Correction of Deficient Chin

Fat is a filler with ideal properties as it naturally integrates into tissues with 100 % biocompatibility. Moreover, fat contains different cell types, including adipocytes, fibroblasts, smooth muscle cells, endothelial cells, and adipogenic progenitor cells called"preadipocytes"2, adipose-derived stem cells (ASCs) which have a differentiation potential similar to that of other mesenchymal stem cells and it could be harvested in great amounts with minimal donor-site morbidity, ASCs have proved to be particularly promising for regenerative therapies. In addition, it's relatively inexpensive and readily available, which makes it an attractive alternative for facial augmentation.

On the other hand PEEK is considered a highly biocompatible material with mechanical properties almost similar to cortical bone. It is widely used in cranioplasties and facial reconstruction.

The chin is the most noticeable facial structure which plays an important role in perception of facial esthetics; therefore deficient chin is considered an annoying defect for the patient. Traditional techniques used for correction, which are osseous genioplasty and alloplastic augmentation, have some reported complications. These complications include hematoma in the floor of the mouth; though a rare complication is considered to be a life threatening condition. Also, wound dehiscence, infection, Chin hypoesthesia/dysesthesia due to mental nerve injury which occurs in 3.4% to 12% of cases , chin ptosis, lip ptosis, drooling, and an increase in lower teeth show due to failure to reattach the mentalis muscle to its natural origin on the anterior face of the mandibular body and tooth root damage which may occur during the osteotomy. Also bone resorption, implant displacement, infection and foreign body reaction were reported as a complication with some alloplastic implants .

This study aims to avoid the complications of surgical correction of deficient chin by using less invasive approach.

Trial design:

3 Groups of patients will be assigned to this trial: Study group1: Will use autogenous fat augmentation in deficient chin. Study group2: Will use onlay PEEK augmentation in deficient chin. Control group: Surgical correction of deficient chin with sliding genioplasty. Trial design: Randomized Controlled clinical Trial

Eligibility Criteria:
Inclusion Criteria:

•.Medically free patients.

* Patients with deficient chin..
* Age range is between 18 and 45 years
* No sex predilection.

Exclusion Criteria:

* Patients with systemic condition contraindicating with the surgical procedure.
* Previously corrected chin.
* Patients indicated for other skeletal mandibular procedure during the same surgical session.
Comparison of Combination of Beclomethasone Dipropionate and Formoterol Fumarate Versus Single Components Assessed by Knemometry and Urinary Cortisol Measurements in Asthmatic Children

This is a single centre, double-blind, double-dummy, randomised, single-centre, 2-way cross-over study in asthmatic children already treated with inhaled corticosteroids.


Eligibility Criteria:
Inclusion Criteria:

* Prepuberal male and female outpatients, ≥ 5 and ≤ 11 years old in Tanner stadium I according to Investigator's assessment
* Clinical diagnosis of mild asthma during at least two months prior to screening visit
* Forced Expiratory Volume during the first second (FEV1) \> 80% of predicted normal values at screening visit

Exclusion Criteria:

* Endocrinological diseases including growth impairment or other chronic diseases
* Any concomitant disease requiring additional treatment with topic or systemic glucocorticosteroids
Interferon Alfa, Isotretinoin, and Paclitaxel in Treating Patients With Recurrent Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Some tumors become resistant to chemotherapy drugs. Giving interferon alfa and isotretinoin together with paclitaxel may reduce resistance to the drug and allow the tumor cells to be killed.

PURPOSE: This phase II trial is studying how well giving interferon alfa and isotretinoin together with paclitaxel works in treating patients with recurrent small cell lung cancer.

OBJECTIVES:

* Determine the frequency and duration of response in patients with recurrent small cell lung cancer treated with interferon alfa, isotretinoin, and paclitaxel.
* Determine the toxic effects of this regimen in these patients.
* Determine the duration of survival in patients treated with this regimen.
* Correlate the levels of bcl-2 in peripheral blood monocytes with response and survival in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive interferon alfa subcutaneously and oral isotretinoin on days 1 and 2 and paclitaxel IV over 1 hour on day 2 of weeks 1-6. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 37-83 patients will be accrued for this study.

Eligibility Criteria:
Inclusion Criteria

* Histologically or cytologically confirmed recurrent small cell lung cancer (SCLC) with clinically confirmed measurable disease
* Age 18 and over
* ECOG Performance status 0-3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Bilirubin no greater than 1.5 mg/dL
* AST no greater than 2 times upper limit of normal (ULN)
* Creatinine no greater than 1.5 mg/dL
* Triglycerides no greater than 1.5 times ULN
* Patients must have had prior chemotherapy treatment for SCLC, and toxicities must have resolved to less than or equal to grade 1
* Women of childbearing potential and sexually active males are strongly encouraged to use an accepted and effective method of contraception.

Exclusion Criteria

* History of another neoplasm other than SCLC except for non-metastatic, non-melanoma skin cancers, carcinoma in situ of the cervix, or cancer cured by surgery or small field radiotherapy at least 5 years before registration
* Pregnant or nursing, with a negative pregnancy test within 2 weeks prior to registration
* Severe depression requiring medication
* Use of the following drugs within 4 weeks prior to registration: carbamazepine, ethanol, tetracycline, doxycycline, minocycline, topical acne products containing Retin-A, vitamin A, cisplatin, ketoconazole, phenytoin or other antiepileptic drugs
* Use of GM-CSF or G-CSF within 4 weeks prior to registration
* Prior paclitaxel or interferon therapy
* Radiation therapy within 60 days prior to registration
* Chemotherapy within 60 days prior to registration
Clinical Trial Study About Human Adipose-Derived Stem Cells in the Stroke

The objective of the study is to confirm the safety and possible efficacy of Adipose-Tissue Derived Stem Cells treatment of chronic stroke. Specifically, the study will transplant autologous ADSCs into brain surrounding ischemic infarct in adult (65-80 years old) subjects who have chronic non-hemorrhagic stroke (\>6 months).

This open-label clinical trial will compare outcomes of subjects with chronic stroke. Six subjects will be to treatment (n=3) groups. The treatment group will receive brain transplants of autologous ADSCs. Treatment group will receive rehabilitation after the transplantation. Subjects will be assessed by magnetic resonance imaging (MRI) and eight standardized stroke indices: National Institutes of Health Stroke Scale (NIHSS), ( Barthel Index )、 ( Berg balance scale )、 (Fugl - Meyer test )、(Action research arm test )、 (Purdue pegboard )、 ( grip strength measurement ) 、(somatosensory evoked potential, SSEP) at 1 month, 3 months, and 6 months after treatment.

Eligibility Criteria:
Inclusion Criteria:

* stroke investigators with age 65 to 80 years
* history of stroke between six months and 10 years
* Systolic pressure and Diastolic pressure were maintained under 160 mmHg and 110 mmHg
* INR \< 2.5, platelets counts 1-5 x 10\^5/μl
* Damaged area range between 0.5 cm to 6 cm by brain MRI

Exclusion Criteria:

* Pregnant women
* Investigators with AIDS, cancer, liver dysfunction
* Others can't fit into the trial evaluate by investigator
A Clinical Trial to Evaluate the Effectiveness of Lactobacillus Reuteri for Periodontitis in a Chinese Population

The aim of this study is to determine the efficacy of application of Lactobacillus Reuteri probiotics therapy on clinical improvement and on microbial shift in Chinese periodontitis patients.

Periodontitis is a chronic inflammatory disease with a prevalence of 80% in Chinese adults, which is the main cause of tooth loss in adults. Periodontitis has also been demonstrated to be a risk factor for cardiovascular diseases, diabetes, and many other systemic diseases due to the host immune response elicited by periodontal pathogenic bacteria. In the last decade, probiotics therapy using Lactobacillus Reuteri has been applied for periodontitis patients in European countries. But no evidence has been provided for its effectiveness in a Chinese population. The aim of this study is to determine the efficacy of application of Lactobacillus Reuteri probiotics therapy on clinical improvement and on microbial shift in Chinese periodontitis patients. The influence of probiotics therapy on the host inflammatory cytokines levels in periodontitis patients with systemic diseases is also evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. 18-65 years of age
2. Patients diagnosed with periodontitis clinically evident according to International Classification of Periodontal Diseases (2017) with periodontal probing depth ≥4mm, attachment loss of the most severe site in the adjacent area ≥3mm, and imaging bone loss more than 1/3 of the root length
3. Natural teeth remaining in the mouth≥ 14

Exclusion Criteria:

1. Patients with any other systemic diseases which likely to alter the progression and course of periodontitis, except coronary disease, diabetes or hypertension.
2. Patients with aggressive periodontitis.
3. Patients who received any periodontal treatment in the past 6 months
4. Pregnant or lactating women
5. Patients who smoke
6. Patients in the acute phase of an infectious disease
7. Patients taking bisphosphonate mediation
8. Patients who are on any probiotic, anticoagulants or antibiotic supplements for the past 3 months
9. Patients allergic to lactate products
10. Patients who are deemed uncooperative
Development of Pneumonia Due to Alveolar Glucose Levels in Systemic Hyperglycemia

Incidence of Pneumonia in Patients with high systemic glucose levels.

Clinical and mechanistic studies have shown that a hyperglycaemic metabolic condition is associated with a higher incidence of infection and consecutive increased morbidity and mortality. The underlying mechanisms in detail are not completely understood. So far it is not clear whether systemic increased glucose levels are caused by a stress reaction of the body through a catabolic metabolism situation as well as a "stress-induced insulin resistance", or infections are promoted by hyperglycemia. From in vivo and in vitro studies, a glucose threshold for the lung is known (147 mg / dL), similar to that in the kidney. It can be hypothesized, that an intra-alveolar glucose in turn promotes bacterial growth as a nutrient substrate. The aim of the study is to determine the concentration of glucose in the alveolar space in connection with hyperglycemic conditions, and to demonstrate a higher incidence of pneumonia in this patient group. The study will enroll cardiac surgery patients receiving surgical treatment and expected postoperative ventilation. Systemic blood glucose monitoring is recorded throughout hospitalization, as well as the removal of bronchial aspirates intraoperatively and during ventilation to measure glucose levels and bacterial levels. The incidence of pneumonia is recorded during the postoperative period by means of radiological examinations and / or microbiological examinations.

Eligibility Criteria:
Inclusion Criteria:

* women and men over the age of 18 years
* voluntary consent to study participation of the patient
* Planned cardiac surgery with expected endotracheal ventilation of ≥ 1 day postoperatively

Exclusion Criteria:

* age \<18 years
* pregnancy
* Non-able-bodied patients (disempowerment / loss of consciousness, limitation of the ability to express one's own will, for example through disability)
* subsequently withdrawn consent
* accommodation in an institution on the basis of official or court orders
* lack of or insufficient knowledge of German language, whereby the understanding of the written patient education is not guaranteed.
* Immunosuppressed patients
* Patients with a malignant disease
Impact of Physiotherapy Session in Cardiac Surgery Patients

This work consists, first of all, in making an inventory of the physiotherapy of the patient undergoing cardiac surgery under high flow oxygenation at the CHRU NANCY.

Then, in a second step, the impact of the physiotherapy on the lung ultrasound score associated or not with the NIV of the patient under OHD after cardiac surgery will be studied.

The objective is therefore to answer the following research question: what is the impact of a physiotherapy session with or without non-invasive ventilation in patients receiving high flow oxygenation after cardiac surgery on the lung ultrasound score measured by ultrasound?

Main hypothesis: Physiotherapy is associated with NIV when it is prescribed in patients undergoing high flow oxygenation after cardiac surgery.

Secondary hypothesis: Physiotherapy + NIV further improves pulmonary aeration versus physiotherapy + high flow oxygenation.


Eligibility Criteria:
Inclusion Criteria:

* Person who has received full information on the organization of the research and has not objected to the use of the data.
* Person benefiting from cardiac surgery programmed on Cardiothoracic Bypass
* Patient under high flow oxygenation
* Age ≥ 18 years old
* 18.5 ≤ BMI ≤ 35 kg/m2
* Conscious and oriented patients: Glasgow 15

Exclusion Criteria:

* Surgical emergencies: grafting, dissections...
* Lumbar drainage in progress
* Beating heart surgery
* Refusal to participate in the study
* Persons referred to in Articles L.1121-8 and L.1122-1-2 of the Public Health Code (minors, person under guardianship, under curatorship)
Study to Evaluate ctDNA of mCSPC Patients Receiving Apalutamide in Japan

To evaluate changes in genomic alterations for 73 PC driver genes during apalutamide treatment

This clinical study is an open-label, multicenter, interventional, Phase 4 study to evaluate changes in genomic alterations for 73 PC driver genes during apalutamide treatment in patients with mCSPC. A total of 100 participants to be treated by apalutamide will be registered in this study. All participants will undergo blood collection for ctDNA, single-nucleotide polymorphisms (SNPs), and human-leukocyte antigen (HLA) typing at pre- and posttreatment of apalutamide.

Eligibility Criteria:
Inclusion Criteria:

* Men aged ≥20 years.
* Participant has documented diagnosis of metastatic PC with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology.
* Participant has metastatic PC that is castration naïve or castration sensitive and is permitted to receive less than 6-months ADT or CAB before registration and less than 36-months neoadjuvant or adjuvant hormonal therapy.
* If a participant is treated with ADT or CAB, he has maintained a response to hormonal therapy of stable disease or better, by investigator assessment of imaging and PSA.
* Participant is willing to receive apalutamide for mCSPC in the participating site of this study.
* Participant is of Japanese nationality.
* Participant must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.

Exclusion Criteria:

* Participant does not agree to assess ctDNA including 73 PC driver genes, SNPs, and HLA typing.
* Participant has received any prior therapy of abiraterone, docetaxel, enzalutamide, apalutamide or darolutamide.
* Participant has known allergies, hypersensitivity, or intolerance to apalutamide or its excipients (refer to the package insert).
* Participant has contraindications to the use of ADT based on routine treatment.
* Participant has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the evaluation of active double cancer, etc.
Pharmacist Assisted Medication Program Enhancing the Regulation of Diabetes

The purpose of this study is to demonstrate that pharmacists working collaboratively with physicians and other providers in an ambulatory care setting can improve glucose, blood pressure, and lipid control, as well as improve quality of life, adherence to screening and general preventative measures.

It is evident that a multi-disciplinary approach is key to the success in controlling the disease of diabetes and its complications. The value of pharmacists' involvement in disease state management in producing positive outcomes for patients has been well documented in the literature. There have been several studies that have shown that pharmacists' involvement in diabetes care improves glycemic control. There are also studies that look at pharmacists' management of glycemic control and adherence to the ADA guidelines. Many of these studies are retrospective, lack a randomized control group, had a small study sample, or were short term. We undertook a prospective, randomized study to demonstrate that pharmacists working collaboratively with physicians and other providers in an ambulatory care setting can improve glucose, blood pressure, and lipid control, as well as improve quality of life, adherence to screening and general preventative measures.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18
* A1c \> 8% within the 6 months prior to the data acquisition date
* Primary Care physician at Lahey Clinic Burlington site
* Diagnosis of T2 DM for minimum of 6 months

Exclusion Criteria:

* Concurrently enrolled in any other pharmacist-run or diabetes study
* Receiving diabetes management by an outside provider
* A medical condition that may adversely affect compliance with the treatment protocol
A Randomized-Controlled Trial to Examine the Effects of a Daily Probiotic Supplement on Common Symptoms of Menopause

Symptoms of menopause can significantly affect overall quality of life. It is hypothesized that probiotic supplements can reduce the severity of these symptoms. This 90-day randomized controlled trial will examine the effects of the Provitalize Natural Menopause Probiotic on weight loss, waist circumference, sleep, and symptoms of menopause including hot flashes, night sweats, mood swings, anxiety, fatigue and brain fog. Participants will take either the test product or a placebo daily. All participants will complete study-specific questionnaires and provide sleep data from their Fitbit at Baseline, Day 30, Day 60 and Day 90. At Baseline, Day 30, Day 60 and and Day 90, participants will also provide a bodyweight measurement and a waist circumference measurement.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 45-65 years old
* Must experience hot flashes and/or night sweats at least once per day
* Must also be experiencing at least two symptoms of menopause, such as sleep disturbances, mood changes, fatigue and lack of energy, changes in sexual function, urinary changes, weight gain, or vaginal changes
* Can be either natural or surgical menopause
* Has not had a period in the last 12 consecutive months
* Willing to adhere to the study protocol for the duration of the study
* Willing to stop taking any other herbal remedies or supplements for the duration of the study
* Self-reports as "generally healthy"
* Has never taken Provitalize before
* No planned invasive medical procedures for the duration of the study or in the three weeks leading up to the study start

Exclusion Criteria:

* Not experiencing hot flashes and/or night sweats at least once per day and two other symptoms of menopause such as sleep disturbances, mood changes, fatigue and lack of energy, changes in sexual function, urinary changes, irregular or absent periods, or vaginal changes
* Unwilling to stop taking any other herbal remedies or supplements for the duration of the study
* Current use of conventional hormone replacement therapies, or plan to start during the study duration
* Current use of hormonal birth control, or plan to start during the study duration
* Known allergies or hypersensitivities to any product ingredients
* Current or history of uterine fibroids, endometriosis, polycystic ovarian syndrome, or history of abnormal pap smear
* Anyone with any known severe allergies requiring the use of an epi-pen
* Unwilling to adhere to the study protocol
* Anyone living with uncontrolled or chronic health disorders, including oncological or psychiatric disorders
* Pregnant, breastfeeding or trying to conceive
* Currently taking a prescription sleep aid