cyrilzakka/clinical-trials huggingface dataset:
FLEX - Long-term Extension of FIT (Fracture Intervention Trial)(0217-051)

This study was conducted among women who had previously received alendronate for 3 to 6 years during the Fracture Intervention Trial (FIT). Participants in the FLEX study were randomly assigned to receive alendronate (either 5 or 10 mg/day) or matching placebo during the next 5 years, in order to evaluate the effects of continuing or discontinuing alendronate treatment on bone mineral density and biochemical markers of bone turnover.


Eligibility Criteria:
Inclusion Criteria:

* To be eligible to participate in this study, women needed to have previously participated in the Fracture Intervention Trial (FIT) and to have been part of the group treated with alendronate in FIT
* They needed to have received at least 3 years of treatment with alendronate in the FIT trial
* In addition, their bone mineral density (BMD) at the hip needed to be better than it was at the start of FIT

Exclusion Criteria:

* Patients were excluded if they had conditions that contraindicated alendronate therapy and if they might have used other medications for the treatment of osteoporosis
* Women were also excluded if BMD at the hip was below a certain level (T-score \<=-3.5); that is, if it were 3.5 standard deviations or more lower than the average for young adult women
Smoking Increases the Risk of Postoperative Wound Complications: a Propensity Score-matched Cohort Study

Cigarette smoking is associated with surgical complications, including wound healing and surgical site infection. However, the association between smoking status and postoperative wound complications is not completely understood. Our objective is to investigate the effect of smoking on postoperative wound complications for major surgeries.

Smoking at the time of surgery is recognized as a risk factor for cardiovascular, respiratory, and wound-related perioperative complications. Wound-related complications can prolong hospital stays, increase hospital resource utilization, and pose an obvious threat to patient recovery. A brief statement on perioperative smoking cessation about smoking impacting wound healing was published by the American Society of Anesthesiologists' Task Force on Smoking Cessation. Recently, a consensus statement on perioperative smoking cessation by Society for Perioperative Assessment and Quality Improvement (SPAQI) mentioned that smoking cessation should be done as soon as practicable with surgical scheduling. More extended abstinence is associated with lower rates of wound healing complications.

Several studies have described smoking harms wound healing in specific operations, such as plastic surgery, breast surgery, gastrointestinal surgery, and hip surgery. They found surgical site infection and wound delayed healing more frequently in smokers. But in a few small studies and some surgery, conflicting results were found. Besides, risk factors associated with wound complications include infection, smoking, aging, malnutrition, immobilization, diabetes, vascular disease, and immunosuppressive therapy.

This study aims to determine the impact of smoking on wound complications for all kinds of major surgeries. To clarify the risks, our study uses the updated National Surgical Quality Improvement Program (NSQIP) database to find if patients who were active smokers are more likely to have wound-related complications postoperatively. We hypothesized that the active smoking population will have increased infectious complications and wound dehiscence compared with the nonsmoking population.

Eligibility Criteria:
Inclusion Criteria:

* From NSQIP dataset, patients with complete information for baseline parameters and without preoperative open wound infections

Exclusion Criteria:

* Incomplete information of baseline parameters, and with preoperative wound infection
Prevena™ Incision Management System vs Conventional Management for Wound Healing

Comparison in abdominal wound healing after contaminated or dirty surgery with incisional negative pressure wound therapy versus standard dressing.

All patients submitted to contaminated or dirty abdominal surgery have more risk of surgical site infections. The investigators intend to randomize this kind of patients and comparison wound healing after dressed with incisional negative pressure wound therapy or standard dressing.

In the study group INPWT (Prevena) is positioned immediately next surgery and dressed for six days. Every patients will be medicate in sixth, ninth, fifteenth and thirtieth day after surgery and will be valued wound healing with a scale score.

Moreover for each patient it will be assessed risk developing wound complications through possum score and comorbidities.

Eligibility Criteria:
Inclusion Criteria:

* abdominal surgery
* open surgery
* contaminated or dirty surgery

Exclusion Criteria:

* not abdominal surgery
* mininvasive surgery
* clean surgery
Ketone Supplementation, Glycogen Replenishment and Time Trial Performance Following Glycogen Lowering Exercise

20 healthy trained males will volunteer to participate in this study. there will be 2 treatments: Carbohydrate- ketone supplementation and carbohydrate alone. The purpose of this study is to evaluate the effect of glucose-ketone supplementation on a 20 km cycling time trial with a 2-hour feeding during a 4-hour recovery period following glycogen depleting exercise.

Carbohydrates (starches \& sugars) are important muscle fuel for exercise at moderate to high intensities. Low glycogen content (stored form of carbohydrates in the body) is associated with fatigue. Thus, greater initial glycogen content has been associated with better performance not only in high intensity intermittent sports, but also in prolonged endurance sports. Dose-response studies have determined that ingestion of 1.2 g·kg-1·h-1 of CHO is the appropriate acute recovery dose to optimize glycogen repletion, with no apparent benefit at higher doses. Protein in combination with CHO has also been proposed to enhance glycogen resynthesis when 1 part protein is provided with \~4 parts CHO. Both strategies, optimal CHO intake and CHO in combination with protein for glycogen resynthesis, have resulted in better exercise performance a few hours after a depleting exercise bout. A recent study provided athletes with ketone esters in a drink after glycogen depleting exercise and found that in the presence of high glucose availability, ketone esters increased glycogen stores by 50% compared to a no ketone, high carbohydrate treatment. However, the authors of this study provided a large quantity of carbohydrates intravenously to maintain blood glucose at 10Mm/L. Consequently, it is unknown whether or not ingesting glucose at the optimal dosage would have the same effect. Furthermore, it is unclear whether or not this difference would translate into improved performance in efforts of more moderate duration. Therefore, the purpose of this study is to assess the effect of glucose-ketone supplementation on a 20 km cycling time trial with a 2-hour feeding during a 4-hour recovery period following glycogen depleting exercise.

Eligibility Criteria:
Inclusion Criteria:

* In order to be eligible to participate in this study you must be a healthy male or female exercise trained individual (at least 1y training experience - at least 3x week), aged 18-40 years.

Exclusion Criteria:

* have not involved been involved in regular exercise (at least 3x week for at least the past year)
* Have symptoms or take medication for respiratory, cardiovascular, metabolic, neuromuscular disease
* Use any medications with side effects of dizziness, lack of motor control, or slowed reaction time
* Are taking part in another research study
* For women, if you are pregnant or become pregnant during the study.
* Have a history of concussion/head injuries.
* Have an excessive alcohol intake (\>2 drinks/day)
* Are a smoker
Evaluation of the Interest of Ultra-high Frequency Doppler Ultrasound (UFDU) in the Surgical Management of Patients Operated in an Awake Condition for a Cerebral Tumor

In brain tumor surgery we are confronted mainly with two types of difficulties: (i) the identification of the tumor and its limitations in relation to the healthy brain; (ii) the identification of functional cerebral regions, ie implicated in neurological function (motor skills, sensitivity, language, vision, cognition, etc.). The reference method currently used to improve the quality of resection of brain tumors while minimizing neurological risk for patients is so called "wakeful" surgery with direct electrical stimulation (DES) of the brain. The investigators routinely use ultrasound to localize the tumor within the brain, but to date there is no pre- or intra-operative imaging tool to reliably identify tumors and functional brain regions. There is therefore a need for innovative imaging in this field.

For this reason, the investigators propose to evaluate the interest of a new High Frequence Ultrasound Doppler (HFUD) (VEVO ®, Visualsonics, Toronto, Canada) in the surgical management of patients operated in an awake condition for a brain tumor. The ultra high frequency allows to reach a spatial resolution of 30 μm, 5 to 10 times better than MRI and conventional ultrasound. The Doppler mode allows the detection of microvascular flows of speeds less than 1 mm / second. The safety of this device is demonstrated and validated by CE marking (December 2015).


Eligibility Criteria:
Inclusion Criteria:

* operated patient of a cerebral tumor in an awake condition
* age\> 18 years
* neurological condition allowing the realization of the tests in the operating room

Exclusion Criteria:

* not indicated for "awake" surgery
* refusal of participation of the patient
* pregnant or nursing women
A Phase 2 Study of LY2495655 in Participants With Pancreatic Cancer

This phase 2 study is a multicenter, randomized, double-blind, placebo-controlled trial in participants with locally advanced/inoperable or metastatic pancreatic cancer, and will investigate 2 different doses of LY2495655 in combination with standard of care chemotherapy.


Eligibility Criteria:
Inclusion:

* Unresectable or metastatic pancreas cancer; participants with previous radical surgery for pancreas cancer are eligible after progression is documented
* Participants may have received previous adjuvant treatment with gemcitabine with or without radiotherapy for pancreas cancer
* ECOG (Eastern Cooperative Oncology Group) Performance status ≤ 2
* Adequate organ function
* Have an estimated life expectancy of at least 12 weeks and in the judgment of the investigator, will be able to complete at least 2 cycles of treatment
* Ability to perform the indicated functional performance measures at baseline

Exclusion:

* Prior systemic therapy for unresectable/metastatic pancreas cancer
* Any medical or psychiatric condition, orthopedic or neuromuscular conditions that could limit participation or confound study results
* Currently taking medications that are considered both muscle building and performance enhancing (for example, androgen therapies, or anabolic steroids)
Degludec Insulin Use in Critically Ill Patients

Background:

Dysglycemia in critically ill patients is common, where 40% to 54% of patients were found to be hyperglycemic on intensive care unit admission. Several randomized controlled trials (RCT) were conducted to address the importance of glycemic control during critical illness on patient's outcomes.

The American association of diabetes recommends initiation of insulin infusion for critically ill patients aiming to target glucose levels 140-180 mg/dl. However, several limitations prevent the use of insulin infusion in critically ill such as the requirements of frequent blood glucose measurement and nursing staff workload, which in turn led to the use of the subcutaneous rapid acting and basal insulin during critical illness. The evidence on the use of subcutaneous insulin therapy compared to insulin infusion is mainly derived from observational studies that showed conflicting results.

Multiple RCTs demonstrated the comparable efficacy of degludec versus glargine in blood glycemic control and better safety profile in terms of nocturnal hypoglycemia and severe hypoglycemia in the outpatient/inpatient diabetic population. Studies addressing the role, safety, and efficacy of degludec in critically ill patients are lacking.

Study aim:

To assess the effectiveness of using insulin degludec as basal insulin in conjunction with subcutaneous regular insulin sliding scale (ISS) in the glycemic control in critically ill patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and above
* Newly admitted critically ill patients with diabetes and expected ICU stay ≥ 48 hours
* Medical or surgical ICU patients

Exclusion Criteria:

* Patients who were already started on insulin infusion based on physician discretion.
* Postoperative patients with expected ICU stay less than 48 hours
* Diabetic ketoacidosis or hyperosmolar hyperglycemic state.
* Patients with Do-Not-Attempt-Resuscitation (DNAR) status or imminent plan to palliation due to terminal disease.
* Refusal of the treating physician to enroll the patient into the study.
* Patients with diabetes mellitus Type 1.
* Patients who already eating prior to study enrollment
Study to Assess Management Strategies for the Use of Esomeprazole (Nexium) in Helicobacter Pylori Infected Patients

The primary objective of this study is to investigate whether eradication treatment of Helicobacter pylori followed by therapy with esomeprazole for a total of 8 weeks extends the time to relapse in patients with gastroesophageal reflux disease (GERD).

A relapse is defined by two consecutive symptom scores of the Eraflux questionnaire within 14 days that are equal or above the critical value of 25.

The secondary objectives are

1. To compare the time to relapse in the two H. pylori positive study groups with the H. pylori negative control group
2. To compare the pattern of inflammation and atrophy in the two H. pylori positive treatment groups with the naturally H. pylori negative control group at relapse.
3. All the above objectives analyzed for the efficacy subset that is the per-protocol patients broken down by effective H. pylori-eradication.

Secondary endpoints will be analyzed by the following parameters and their interactions:

1. Treatment : Eradicated, Non-eradicated, Hp-negative control
2. Esophagitis at study start: grades 0, A/B and C/D
3. Gender
4. Alcohol intake
5. NSAID/ASA intake (for histological results)

   * Trial with medicinal product


Eligibility Criteria:
Inclusion criteria:

For inclusion in the study the subject must fulfill all of the following criteria:

1. Patients aged between 18 and 70 years.
2. Chronic symptoms (\>8 weeks) suggestive for GERD, as defined in Table 2 with or without reflux esophagitis grade A-D (Los Angeles classification)
3. Indication for endoscopy due to GERD symptoms is given
4. Written informed consent

Table 2: Lead GERD criteria

For inclusion in the study, all of the following lead GERD criteria should hold:

* At least one of the symptoms heartburn or regurgitation.
* At least 8 weeks ongoing symptoms.
* At least 3 times a week.
* At least moderate intensity, corresponding to light impairment in daily life and occasional need for drugs.

Exclusion criteria:

Any of the following is regarded as a criterion for exclusion from the study:

1. Severe organic esophageal disease other than reflux esophagitis (e.g. carcinoma, esophageal stenosis).
2. Gastric or duodenal ulcers
3. Patients with visible Barrett's mucosa; no histological confirmation is required for exclusion
4. History of previous esophageal or gastric surgery
5. Alcohol or drug abuse
6. Severe organic or psychiatric disease
7. Pregnancy or lactation
8. Women with child-bearing potential if no medically accepted contraceptive measures are used
9. Contra-indication to amoxicillin, clarithromycin or esomeprazole (Nexium)
10. Need for concomitant medication which could interfere with the investigational products (substrates of CYP3A4)
11. Suspected or confirmed poor compliance
12. Participation in a clinical study within 8 weeks prior to enrollment.
Retrospective Study of Pediatric Patients With Covid-19 in Alsace in 2020-2021

Covid-19 is an illness that appeared in China between the end of December 2019 and the beginning of 2020 after several cases of pneumonia of undetermined etiology were reported in the Hubei province in central China. These are caused by a previously unknown coronavirus, initially named 2019-nCoV then SARS-CoV-2, which was identified on January 7, 2020 in the Bronchoalveolar Lavage (BAL) of patients hospitalized in China. As for the first European cases, they were diagnosed in France on January 24, 2020.

A Chinese study published in April 2020 (4) concerning adult patients showed that 14% of these cases could be defined as severe and that 5% of cases could be defined as critical.

Another Chinese study showed that all children, regardless of age, could be infected and that asymptomatic, mild and moderate cases accounted for more than 90% of cases.

In France, the Covid-19 epidemic hit Alsace hard from March 2020, mainly due to the cluster formed by the evangelical assembly of the Christian Open Door Church taking place from February 17 to 21 in Mulhouse in the Haut-Rhin.

Thus, it is interesting to study pediatric patients hospitalized for Covid-19 in Alsace during 2020 in order to discover the clinical characteristics of these patients.

The main objective of this study is to retrospectively describe the clinical, biological and radiological characteristics of pediatric patients hospitalized for Covid-19 in Alsace in 2020-2021, both in conventional service and in continuing care or intensive care.

Eligibility Criteria:
Inclusion Criteria:

* Subject aged from 1 month to 18 years
* Hospitalized for Covid-19 in conventional service, continuing care or intensive care for Covid-19 or in whom SARS-CoV-2 infection was strongly suspected during the allat period from January 1, 2020 to December 31, 2021
* Subject who has not expressed, after information, his opposition to the reuse of his data for the purposes of this research
* Parental authority having not expressed, after information, their opposition to the reuse of their data for the purposes of this research.

Exclusion Criteria:

* Subject or their parental authority having expressed their opposition to participating in the study
Influence of Deep Versus Moderate Neuromuscular Blockade During General Anesthesia on 30-day Readmission Rates

Deep neuromuscular block (NMB) has shown to produce superior surgical conditions during various abdominal and non abdominal surgeries. It is however unknown if the application of deep NMB leads to favourable outcome, such as lower rate of postoperative complications in general and surgical infections in specific and ultimately lower readmission rates. In the leiden university medical center, deep NMB is routinely applied for a variety of procedures, most notably laparoscopic abdominal and retroperitoneal surgery, eye surgery and neuro radiologic intervention surgery, since 2014. This retrospective study intends to investigate whether the application of deep NMB for these procedures affects patient outcome and readmission rates.


Eligibility Criteria:
Inclusion Criteria:

* deep neuromuscular block
* moderate neuromuscular block
* general anesthesia
* complete anesthesia chart

Exclusion Criteria:

* incomplete anesthesia chart
* missing data regarding postoperative complications or readmission
The Turkish Version of the Smartphone Impact Scale

Smartphone Impact Scale (SIS) was originally developed in English to determine the cognitive, affective, social, and behavioral impacts of smartphones in everyday life. The purpose of this study was to translate and cross-culturally adapt the SIS instrument into Turkish and investigate its psychometric properties.

Smartphone Impact Scale (SIS) was originally developed in English to determine the cognitive, affective, social, and behavioral impacts of smartphones in everyday life. The purpose of this study was to translate and cross-culturally adapt the SIS instrument into Turkish and investigate its psychometric properties. Two hundred healthy young adults will include. For cross-cultural adaptation, two bi-lingual translators used the back-translation procedure. Within a 5-to-7-day period after the first assessment, the participants completed the Turkish version of SIS (SIS-T) to evaluate test-retest reliability. Cronbach's alpha (α) was used to assess internal consistency. The correlations with the Turkish version of the Smartphone Addiction Scale (SAS-T) and Turkish version of the Nottingham Health Profile (NHP-T) will determine to check the validity.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 35 years
* Having a smartphone that was connected to the Internet for at least 6 months
* Being a volunteer to participate

Exclusion Criteria:

* Having cognitive impairment
* Having disabilities in understanding, speaking and reading Turkish
To Study the Absorption, Distribution, Metabolism and Excretion of AZD1305

The purpose of this study is to learn more about how AZD1305 is handled by the body, i.e the absorption, distribution, metabolism and excretion of AZD1305.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* A body mass index (BMI=weight/height2) of 19 to 30 kg/m2

Exclusion Criteria:

* Potassium outside normal reference values
* ECG findings outside normal range
Clinical Utility of a New Silver Gel for Use on Chronic Wounds

This investigation will be conducted in the US as a single-center study to evaluate in total 10 subjects, to explore the clinical utility of a new silver gel for use on chronic wounds.

Both inpatients and outpatients will be included in this study. The patients will present with chronic wounds in need of initial treatment prior to initiating standard of care (i.e. wound bed with eschar or slough), in need of treatment after debridement or with presenting inflammation along with need for treatment.Only one wound will be chosen for treatment in the study and the area should not exceed 10x10 cm and not be deeper than 6 cm. Photos of the wound will be taken at each visit.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. Both genders with an age \>18 years
3. Subjects with chronic wounds \< 1 year chronicity that are assessed as having localized infection or inflammation (i.e. not felt to have systemic involvement) as indicated by the presence of at least 2 of the following clinical signs of infection:

   * Erythema
   * Edema
   * Warmth
   * Increased drainage
   * Foul odor
4. Subject's wounds may also present with:

   * presence of eschar or slough that needs to be treated prior to normal standard of care OR
   * A need for topical care after debridement
5. Study site to include only ONE wound to be treated

Exclusion Criteria:

1. Presence of fever with 2 or more clinical signs of infection that in the opinion of the investigator is indicative of a more systemic type infection.
2. Use of anti-microbial dressings or topical agents such as antiseptics, local antibiotics and steroids within 7 days
3. Wound \> 1 year old
4. Wound \> 10 cm x 10 cm (l x w)
5. Wound \> 6 cm deep
6. Use of chemical/enzymatic and biological debridement within 7 days of investigation start
7. Necrotizing wounds
8. Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer and severe anaemia) judged by the investigator to be a potential interference in the treatment.
9. Subjects with poorly controlled diabetes mellitus (as judged by the investigator).
10. Subjects treated with systemic glucocorticosteroids, except subjects taking occasional doses or doses less than 10mg prednisone/day or equivalent.
11. Known allergy/hypersensitivity to any of the components of the investigation products.
12. Subjects with physical and/or mental conditions that are not expected to comply with the investigation, including subjects totally confined to bed.
13. Participation in other clinical investigation(s) within 1 month prior to Previously randomized to this investigation