cyrilzakka/clinical-trials huggingface dataset:
Postoperative Belladonna and Morphine Suppositories in Vaginal Surgery

Our primary aim is to determine whether the routine use of belladonna and morphine suppositories will improve pain control following vaginal surgery. Treatment will begin immediately following surgery and every 8 hours for 16 hours.

Minimizing postoperative pain is vital to a successful surgical recovery. Inadequate pain control may result in nausea, vomiting, an extended hospital stay, and reduced patient satisfaction. Oral and parenteral narcotics are commonly used for pain relief and their use may exacerbate the incidence of sedation, nausea, and vomiting; ultimately delaying convalescence. Previous studies have demonstrated that rectal analgesia following surgery results in lower pain scores and less intravenous morphine consumption. Belladonna and opium suppositories are routinely prescribed at our institution and their efficacy has not been confirmed.

A prospective, randomized, double-blind, placebo-controlled trial will be undertaken using belladonna and opium rectal suppositories following vaginal surgery. Treatment will begin immediately following surgery and continue every 8 hours for a total of 3 doses.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for elective vaginal surgery requiring general anesthesia at the Mayo Clinic Hospital. This would include a vaginal hysterectomy with culdoplasty or post-hysterectomy prolapse repair, including culdoplasty with or without anterior/posterior repair.

Exclusion Criteria:

* Participation in another trial using an investigational product.
* Pregnancy.
* Scheduled for a non-vaginal surgical procedure.
* Scheduled for a robotic hysterectomy.
* Scheduled to have combined surgeries (vaginal surgery plus another non-vaginal surgery).
* There is a known hypersensitivity to belladonna and/or opium.
* Contraindication to narcotic use.
* Chronic pain with preoperative pain score greater than 4 out of 10 points.
* Clinically significant substance abuse.
* Mental condition that may impair the ability to provide study assessments.
Acute Effects of Meteorological Factors and Air Pollution on Cardiovascular Health

The goal of this observational study is to analyze the acute effects of meteorological factors and air pollution on cardiovascular system. The main question it aims to answer is:

1. How do meteorological factors and air pollution affect cardiovascular system?
2. What is the interaction between meteorological factors and air pollution on cardiovascular system?

Participants will:

1. Provide their health data obtained in physical examination, including but not limited to blood pressure, blood routine, urine routine and B-ultrasound.
2. agree that the research team will use their personal identification number, gender, age, education level and other information for statistical analysis of the data.

The collected data include: ID number (or unique identification code similar to ID number), physical examination date, work unit, occupation, gender, age, systolic blood pressure, diastolic blood pressure, height, weight, blood routine, urine routine and blood biochemical examination results,Color Doppler (or B-ultrasound) examination results (thyroid color Doppler, abdominal color Doppler, urinary color Doppler, cardiac color Doppler, cervical vascular color Doppler, etc.), electrocardiogram, cardiac CTA, carbon 13 breath test, and written diagnosis results of liver fibrosis.

Eligibility Criteria:
Inclusion Criteria:

·Relevant records in the physical examination database shall be ≥3 times

·≥18 years old

Exclusion Criteria:

* Relevant records in the physical examination database shall be ≥３times
* Serious heart and lung diseases
* Malignant tumors
* Serious mental illness in the past
Bifeprunox Extension to Extension Study in Patients With Schizophrenia

The purpose of this study is to provide access to bifeprunox for patients, who have completed previous studies with bifeprunox, and require continued treatment with bifeprunox, other treatment not being adequate. A further purpose is to investigate the safety and side-effects of bifeprunox during long-term treatment.

This is a non-controlled, open-label, flexible-dose, international multi-centre extension study. The patient population consists of male and female patients with schizophrenia, who have completed open-label bifeprunox studies 10206 or 10265, and require continued treatment with bifeprunox, other treatments not being feasible as judged by the investigator.

Eligibility Criteria:
Inclusion Criteria:

* Patients, suffering from schizophrenia, having completed studies 10206 or 10265
* Otherwise healthy
* Female patients of non-childbearing potential, or non-pregnant, not breast-feeding women using adequate contraception
* The patient must be in need of treatment with bifeprunox (that is, the switch to another compound is not feasible)

Exclusion Criteria:

* Current Axis I primary psychiatric diagnosis other than schizophrenia
* Significant risk of suicide and/or violent behaviour
* Other psychiatric, neurological or behavioural disorders that may interfere with study conduct
* Substance or alcohol abuse, current cannabis dependence
* Clinically significant physical illness
Stimulus Phase Duration on Discomfort and Electrically Induced Torque of Quadriceps Femoris

This study aims to examine the variation in muscle torque and discomfort produced when electrically stimulating quadriceps femoris using pulsed current with three different phase durations in order to establish whether there are any advantages or disadvantages in varying the phase duration over the range examined.


Eligibility Criteria:
Inclusion Criteria:

* sedentary healthy university students.

Exclusion Criteria:

* history of knee surgery or injury,
* musculoskeletal, cardiovascular or neurological disease including impaired sensation.
Contrast Enhanced Spectral Mammography (CESM) Study

The aim of this study is to determine if the addition of Contrast Enhanced Spectral Mammography (CESM) to standard diagnostic imaging, results in a decision regarding patient management - discharge, follow-up, surgery or treatment - being made sooner than it would if the patient had followed the standard course of investigations and review.

Women with suspicious breast lesions following mammography and ultrasound will be eligible for the study. Those who consent to participate will be randomised either to receive Contrast Enhanced Spectral Mammography (CESM) in addition to standard care or to receive standard care alone.

Women randomised to receive CESM will undergo the procedure either during the same visit or if necessary on another date within a week. Any additional suspicious lesions detected by CESM will be biopsied along with the original lesion either under ultrasound or x-ray guidance. Biopsy of suspicious lesions is standard care and not part of the research protocol. Those randomised to receive standard care will undergo ultrasound or x-ray guided biopsy of any suspicious lesion identified by ultrasound or mammography.

Results of all biopsies will be discussed at the next multidisciplinary (MDT) meeting where a treatment decision (conservation surgery, mastectomy or neoadjuvent therapy) will be made for those with confirmed disease. MRI will be performed on appropriate women in line with standard practice. Additional disease detected by MRI will be biopsied, either under ultrasound or MRI guidance, if this will influence patient management. The results from these cases will be discussed at the next MDT meeting.

For those women in either arm of the study with benign biopsy results standard care will be followed.

A proforma will be used to record patient pathway, biopsy results and MDT patient management decisions for each case.

For women who received both CESM and MRI, a retrospective review of these images will be made in order to compare diagnostic accuracy. Images from each imaging modality will be read by a different reader for each case. CESM images will be read without the knowledge of MRI results and vice versa. A proforma will be completed by readers to record findings.

Eligibility Criteria:
Inclusion Criteria:

* Be willing and able to give written informed consent for participation in the study.
* Have a lesion of suspicion 3, 4 or 5 following mammography and ultrasound.

Exclusion Criteria:

* Known or suspected pregnancyBreast implant
* Previous breast cancer
* Known renal impairment
* History of anaphylactoid or anaphylactic reaction to any contrast media
* Contrast media within 24 hours prior to CESM
* Commencement of neo-adjuvant chemotherapy, hormone treatment, radiotherapy or surgery for this episode
Inflammatory Response Secondary Using Intravenous Anesthesia Versus Inhalation Anesthesia With Halogenated Agents

Lung ventilation required for lung resection surgery induces a proinflammatory response including cytokine production and recruitment of leukocytes and macrophages in the lung associated with postoperative complications, mainly acute lung injury (ALI). The lung-protective ventilation has been shown reduce this inflammatory response and play a protective role against ALI, even though it is unclear the role of intravenous and inhalational anesthetic agents in immunomodulation of the inflammatory response during lung ventilation and its possible protective role against ALI. This study aims to determine the effect of anesthetic agents on markers of lung inflammation, the mechanisms of oxidative stress and ischemia-reperfusion, and assess the relationship between these mediators and postoperative morbidity defined as percentage of postoperative lung complications (ALI / ARDS, pneumonia and atelectasis), length of stay in ICU, hospital stay and mortality at 30 days. The investigators hypothesis, based on results of our group in animal research, is that inhalants cause a lower proinflammatory response to intravenous agents for lung resection surgery.

A clinical trial is design with two groups (propofol, sevoflurane) managed all with lung protective ventilation, in which the markers will be measured before and after one-lung ventilation in both lungs and in plasma before, during and after one-lung ventilation. postoperative lung complications, ICU and hospital stay and 30 days mortality.


Eligibility Criteria:
Inclusion Criteria:

* candidates to Lung resection surgery at Hospital General Universitario Gregorio Marañón (males and females)
* willing to participate and sign informed consent
* age \> 18 años and legal capable
* no urgent surgery.
* FEV1 \>50% or CVF \> 50%
* no previous steroids or immunosuppressors chronic treatment (three months before the surgery)

Exclusion Criteria:

* pregnancy and breast feeding
* propofol or sevoflurane hypersensibility.
* have received blood derivate product within 10 days before surgery.
* when protective pulmonary ventilation is not possible during one Lung ventilation.
* Heart failure \> II NYHA within one week before surgery
Misoprostol for Cervical Ripening Before Copper Intrauterine Device Removal

Intrauterine devices are the most common used method of contraception in the world, mostly in developing countries, because they offer long-term, reversible and relatively safe contraception. At present, 50% of intrauterine devices users are women of reproductive age and most of them are requesting Intrauterine device removal to regain their fertility. In general, an intrauterine device should be removed during menses or preferably immediate after menses because intrauterine device removal is usually easy because the cervix is still soft.

The intrauterine device is usually removed by firmly grasping the threads at the external os; traction should be applied away from the cervix. If resistance is present, the removal should be stopped until it is determined why the intrauterine device is not moving. Some deeply embedded intrauterine device may need to be removed by hysteroscope \[4\].

In practice, many women, however, have an intolerable pain during intrauterine device removal and some of them requesting painkiller or even anesthesia to allow the physician to remove it. Cervical hardening and adhesions are the major factors making IUD removal difficult especially in post-menopausal women.

Insertion and removal of IUD in nulliparous women is possible but it may carry more pain, more difficulty than in parous women. We think that this problem is also present in women has no vagina delivery before. So, the intrauterine device removal actually has some difficulty or pain in the nulliparous women, women delivered by elective caesarian section or postmenopausal women.

Many medical agents for cervical ripening prior to the removal have been emerged like misoprostol. Misoprostol is commonly used for cervical ripening in the first and second trimester miscarriage and prior intrauterine devices insertion. The use of vaginal misoprostol before intrauterine device insertion in women who had never delivered vaginally before may increase the ease and success of insertion with pain felt during the procedure .

However and up to our knowledge; no studies had been reported the effect of misoprostol on removal pain in women delivered only by elective cesarean section.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-45 years
2. Menstruating women
3. Nonpregnant women
4. Delivered before only by elective cesarean section
5. Women who did not receive any analgesics in the 24 h prior to Intrauterine device removal.
6. Using copper 380 A Intrauterine device for contraception only
7. Requesting Intrauterine device removal for returning of fertility

Exclusion Criteria:

1. Women with allergy to misoprostol or any medical disease that contraindicates its use
2. Ultrasonographic evidence of displaced Intrauterine device.
3. Women who will refuse to participate in the study.
4. Women who had any other type of Intrauterine device.
Effects of GLP1-RA on Ectopic Fat Deposition in Chronic Kidney Disease

Chronic kidney disease (CKD) is a burden of morbidity and mortality. Increased protein breakdown in skeletal muscle (wasting) and ectopic fat deposition are important determinants of poor clinical outcome in patient with CKD. Insulin resistance plays a critical role in skeletal muscle wasting and ectopic fat deposition. Glucagon-like peptide-1 receptor agonists (GLP-1RA) decrease ectopic fat deposition in patients with type 2 diabetes, prediabetes, obese and overweight subjects.

The influence of GLP-1RA on ectopic fat deposition in CKD patients in unknown. The investigators' will test the hypothesis that GLP-1RA decreases intermuscular (ectopic) fat deposition in patients with stage 3-4 CKD. The investigators' will do so by addressing the following specific aims:

Specific Aim 1: To test the hypothesis that GLP-1RA decreases intermuscular fat deposition in patients with stage 3-4 CKD.

Specific Aim 2: To test the hypothesis that GLP-1RA improves skeletal muscle mitochondrial function in patients with stage 3-4 CKD.

Specific Aim 3: To test the hypothesis that GLP-1RA improves physical performance in patients with stage 3-4 CKD.

Specific Aim 4: To test the safety and feasibility of 12 weeks of dulaglutide 1.5 mg/wk administration as an adjunct therapy to the standard care of patients with stage 3-4 CKD.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with stage 3-4 CKD (eGFR 15-59 ml/min/1/73 m2)
2. Age ≥ 18 years and ≤75 years

Exclusion Criteria:

1. Patients with type 1 diabetes mellitus
2. Patients with T2D who are on insulin therapy or who started a new antidiabetic medication within 1 month prior to study or who received incretin-based therapy within 3 months prior to study
3. BMI \<25 kg/m2, BMI \>40 kg/m2
4. HbA1c\>8% measured within 1 month prior to study, or a history of hypoglycemic episode within 1 year prior to study, or a history of diabetic ketoacidosis
5. Uncontrolled hypertension (\>200/100 mmHg) despite optimal antihypertensive therapy
6. Arrythmia, heart failure (NYHA class III-IV), valve disease or heart diseases other than coronary artery disease
7. History of major gastrointestinal surgery, inflammatory bowel disease, pancreatitis or cholelithiasis
8. Personal or family history of medullary thyroid cancer, or personal history of Multiple Endocrine Neoplasia (MEN)-2
9. Pregnancy, breast feeding or intention to become pregnant
10. Previous renal transplantation
11. Acute or chronic infectious diseases
12. Cancer or chemotherapy within 3 years prior to study
13. Treatment with systemic corticosteroids within 3 months prior to study
14. Known or suspected allergy to dulaglutide
15. Claustrophobia or other contraindications for magnetic resonance imaging
Review of Human Herpes Viruses in Burns

Herpes simplex virus, cytomegalovirus and varicella zoster virus infection are purported to play a pivotal role in morbidity and mortality in burns. Thus far, there is no existing systematic review (Level of Evidence III or higher) describing the unique role as well as concurrent infections of these viruses in burns. The aim of this review is to point out the clinical differences between these human herpes virus subtypes, to outline established therapy approaches, and to provide evidence for virus related morbidity and mortality in burns.

This systematic review was created according the PRIMSA (preferred reporting items for systematic reviews and meta-analyses) guidelines and checklist.

We performed an review of the medical literature to identify all studies that contain HSV, CMV and VZV infections in burns.Therefore, systematic review of the Medline database by using PubMed and Ovid interface was conducted. Also the Web of Science interface was used for systematic literature search.

On the PubMed interface, we used the following search terms: ("HSV"\[All Fields\] OR "herpes"\[All Fields\] OR "CMV"\[All Fields\] OR "cytomegalovirus"\[All Fields\] OR "VZV"\[All Fields\] OR "varicella-zoster"\[All Fields\]) AND ("burns"\[MeSH Terms\] OR "burns"\[All Fields\] OR "burn"\[All Fields\] OR "thermal trauma"\[All Fields\]). For Ovid we used: exp Burns/ AND (exp Herpes Zoster/ or exp Encephalitis, Herpes Simplex/ or exp Herpes Simplex/ or exp Herpes Simples Virus Vaccines/), exp Burns/ AND (exp Cytomegalovirus/ or exp Cytomegalovirus Infections/), exp Burns/ AND (exp Chickenpox/ or Herpesvirus 3. Human/ or exp Herpes Zoster/). And for Web of Science we used: (TS=(HSV OR herpes OR CMV OR cytomegalovirus OR VZV OR varicella-zoster) AND TS=(burn OR burns OR thermal trauma)) AND LANGUAGE: (English) AND DOCUMENT TYPES: (Article); Timespan: All years; Indexes: SCI-EXPANDED, SSCI, A\&HCI, CPCI-S.

Eligibility Criteria:
Inclusion Criteria:

* Patients who presented with at least 1% TBSA burned
* Patients who presented with a viral infections during their hospitalization

Exclusion Criteria:

* Patients who had no burns
* Patients who had no viral infections during their hospitalization
Factor IX Inhibition in Thrombosis Prevention (The FIXIT Trial)

The purpose of this study is to determine whether TTP889 prevents venous thromboembolism following surgery to repair hip fracture.

FIXIT is the first Phase 2 study of TTP889. The trial is a proof-of-concept study to determine the safety and antithrombotic efficacy of TTP889 in patients at risk for venous thromboembolism (VTE). The study is a multi-center, randomized, double-blind, parallel-group evaluation of 300 mg TTP889 or placebo, administered orally once daily for three weeks, in patients who have undergone surgery to repair unilateral fracture of the upper third of either femur and who have completed 5 to 9 days of postoperative prophylactic treatment for VTE.

Eligibility Criteria:
Inclusion Criteria:

* Must have undergone reparative surgery within 72 hours after unilateral hip fracture, defined as fracture of the upper third of either femur
* Must have started standard prophylactic treatment for VTE with low molecular weight heparin (LMWH) or heparin before surgery or within 24 hours after hip fracture surgery, and continued treatment with LMWH or heparin for at least five days, but not more than nine days, after surgery
* Last dose of LMWH or heparin must have been administered at least 12 hours, but not more than 48 hours, before dosing with study drug
* Females must have a negative serum pregnancy test
* Must weigh at least 45 kg
* Must demonstrate the mental and physical ability and willingness to follow all study-specific instructions
* Must be able to read, comprehend and sign the Ethics Committee-approved informed consent form

Exclusion Criteria:

* Evidence of active bleeding
* Clinical signs of VTE
* Any medical requirement for (or intention to use) continued anticoagulation after randomization through the end of study
* History of intracranial bleeding, hemorrhagic stroke, or gastrointestinal bleeding within 3 months of study start
* Presence of active malignant disease
* Hip fracture associated with multiple trauma, that places patient at excessive risk for hemorrhage or organ system failure, or that may make it difficult or impossible to perform bilateral lower limb venography
* Intention to take aspirin at doses greater than 325 mg/day
* Hemoglobin \< 5.45 mmol/L (9 g/dL), hematocrit \< 29%, or a platelet count \< 100,000/mL at the screening visit
* Elevated ALT or AST level \> 3.0 times the ULN, or an elevated total bilirubin \> 1.5 the ULN at the screening visit
* Creatinine \> 180 mmol/L (2.0 mg/dL) at the screening visit
* Any other laboratory value at screening that the Investigator considers to be clinically significant and warrants exclusion from the study
* Patient is currently breast feeding a child and wishes to continue breast feeding
* Previous allergy to contrast material or any other contraindications to perform bilateral lower limb venography
* The use of another investigational drug within 28 days of study entry
Feasibility of a 8-week Telerehabilitation Program for Patients With Thoracic Neoplasia Receiving Chemotherapy

Exercise-based rehabilitation improves physical function, fatigue and quality of life in patients with thoracic neoplasia. Consequently, the need for rehabilitation across the continuum of care in oncology is growing rapidly. However, the implementation of this type of intervention is limited because of many barriers such as patients' symptoms and poor accessibility to programs. In this context, healthcare systems should develop and implement new approaches to dispense these services. Consequently, telerehabilitation is a promising strategy to improve access and adherence to rehabilitation.

OBJECTIVES To investigate the feasibility, adherence and satisfaction of a home-based telerehabilitation program (TELERP) with real-time physiological parameters acquisition in patients with unresectable thoracic neoplasia receiving chemotherapy and to explore its effects on patients' functional capacity.

METHODS Five patients receiving chemotherapy followed an 8-week TELERP using real-time monitoring combined with interactive exercises. The TELERP included supervised (15) and unsupervised (9) strengthening and cardiovascular exercise sessions at a rate of 3 sessions/week. The feasibility of the TELERP, adverse outcomes, technical issues, program adherence and satisfaction were analysed. Prior to and after the program, a six-minute walking test (6MWT), a timed up and go (TUG) and a timed stair test (TST) were done to assess functional capacity


Eligibility Criteria:
Inclusion Criteria:

* Patients had to have an ECOG functional status of 0 (Asymptomatic) or 1 (Symptomatic but completely ambulatory);
* Have a sufficient understanding of verbal and written French instructions
* Live in a geographic region served by a high speed Internet connection.

Exclusion Criteria:

* oxygen pulsed saturation (SpO2) \<80% during the cardiopulmonary exercise test
* contraindications to exercise testing according to the American Thoracic Society and American College of Chest Physicians Exercise Testing Guidelines
* cerebral or bone metastasis
* a history of significant cardiovascular disease, hypertension, diabetes or musculoskeletal concerns that might limit their ability to perform active exercises
* severe psychiatric illness compromising adherence to the rehabilitation training routine.