cyrilzakka/clinical-trials huggingface dataset:
Duloxetine for Acute Post-mastectomy Pain

The objective of this study is to evaluate the analgesic effect of oral dulexitine tablet (administered 2 h before surgery) as well as the ideal dose for acute postmastectomy pain.

patients undergoing mastectomy with axillary evacuation will be divided to four groups, Placebo group: received placebo capsule Duloxetine 30: received duloxetine 30 mg capsule Duloxetine 60: received duloxetine 60 mg capsule Duloxetine 90: received duloxetine 90 mg capsule the study medication is administered orall 2 h before surgery. Primary outcome variable: the first postoperative 24 h morphine consumption Secondary outcome: the VAS pain score measured every 4 h in the first 24 h postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Adult females scheduled for unilateral MRM with axillary evacuation for breast cancer,
* American Society of Anesthesiologists physical status (ASA) class I and II

Exclusion Criteria:

* Patients with a known allergy to Duloxetine or morphine,
* A history of drug or alcohol abuse,
* Patients with impaired kidney or liver functions,
* Patients with chronic pain or regularly receiving analgesics,
* Any psychiatric illness that would interfere with the perception and the assessment of pain.
* Any reason that resulted in the protocol violation.
A Research Study of a New Medicine NNC0519-0130 in Japanese and Non-Japanese Men

NNC0519-0130 is a new medicine which may possibly help participants with type 2 diabetes. This study, will look into how safe the new medicine NNC0519-0130 is, and we will measure its concentrations in the blood and look at its effects. This study will last for a maximum of 22 weeks and Japanese and Non-Japanese male participants will be included.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 23.0 kilogram per meter square (kg/m\^2) and 39.9 kg/m\^2 (both inclusive) at screening with a minimum weight of 50 kilogram (kg). Overweight should be due to excess adipose tissue, as judged by the investigator.
* Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator.
* For Japanese participants: Both parents of Japanese descent.
* For non-Japanese participants: Both parents of Caucasian descent.

Exclusion Criteria:

* Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
* Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
* Glycosylated haemglobin (HbA1c) greater than or equal to 6.5 percent (48 millimoles per mole \[mmol/mol\]) at screening.
* Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of paracetamol, ibuprofen, acetylsalicylic acid (ASA), and domperidon, or topical medication not reaching systemic circulation, within 14 days before screening.
RCT of Olanzapine for Control of CIV in Children Receiving Highly Emetogenic Chemotherapy

Chemotherapy-induced nausea and vomiting (CINV) are among the most bothersome symptoms during cancer treatment according to children and their parents. Most children receiving highly emetogenic chemotherapy (HEC), including those receiving hematopoietic stem cell transplant (HSCT) conditioning, experience CIV despite receiving antiemetic prophylaxis. Olanzapine improves CINV control in adult cancer patients, has a track record of safe use in children with psychiatric illness, does not interact with chemotherapy and is inexpensive. We hypothesize that the addition of olanzapine to standard antiemetics will improve chemotherapy-induced vomiting (CIV) control in children receiving highly emetogenic chemotherapy


Eligibility Criteria:
Planned receipt of HEC or cyclophosphamide ≥ 1 g/m2/day (≥ 33 mg/kg/day) for cancer treatment or autologous or allogeneic HSCT conditioning.81,82 Examples of HEC are: busulfan IV (myeloablative dosing), carboplatin ≥175mg/m²/dose, cisplatin ≥12mg/m²/dose, cytarabine ≥3g/m²/day, melphalan \>140mg/m², methotrexate ≥12g/m²/dose and thiotepa ≥300mg/m²/dose.

Plan for inpatient admission from administration of first study drug dose until 24 hours following administration of last study drug dose.

Body weight of at least 12.5 kg

2.5 to \< 18 years of age. Note that the minimum age requirement corresponds to an approximate body weight of 12.5 kg.

Samples for all laboratory tests will be obtained within one week prior to administration of the first chemotherapy dose of the study chemotherapy block or the first HSCT conditioning dose:

* Plasma creatinine within 1.5 times the upper limit of normal for age.
* Amylase within age-appropriate limits
* Plasma conjugated bilirubin within ≤ 3x upper limit of normal for age unless attributable to Gilbert's Syndrome
* ALT ≤ 5x upper limit of normal for age

Baseline ECG within the month prior to study drug administration without known clinically significant abnormalities including pathologic prolongation of QTc

A plan for scheduled, round-the-clock receipt of ondansetron, granisetron or palonosetron for antiemetic prophylaxis during administration of chemotherapy or HSCT conditioning.

Negative pregnancy test if female of childbearing potential

Patients of childbearing potential must consent to use adequate contraception (males and females) or agree to practice abstinence

Parent or child able to speak a language in which the (modified Pediatric Adverse Event Rating Scale (PAERS) is available.

Optional: Child participants in the optional assessment of nausea severity must be 4 to 18 years of age. Child and a parent/guardian must be English, Spanish or French-speaking. The Pediatric Nausea Assessment Tool58 (PeNAT) is validated in English-speaking children 4 to 18 years old with an English-speaking parent/guardian and has been translated into Spanish and French. The MAT is available in English, Spanish and French.
Influence of Knee Alignment and Pelvis Rotation on Accuracy of Radiograph Measurements Before Total Knee Arthroplasty

The aim of this study is to determine the accuracy of long leg standing X-rays with respect to coronal alignment of the knee.

Long leg standing x-ray is a routine examination to measure the femoral valgus angle before a total knee arthroplasty. Newer studies have shown that coronal leg alignment influences the rotation of the distal femoral part. This rotation might influence the measurements obtained with a long leg standing x-ray.

The primary purpose of this study is to determine whether there is a significant difference between 2D measurements taken on the x-ray and 3D measurements obtained with a CT scan.

Eligibility Criteria:
Inclusion Criteria:

Knee osteoarthritis scheduled for knee arthroplasty

Exclusion Criteria:

* previous leg deformities or surgery that changes alignment
Closure of Skin in ChorioAmnionitis Research Pilot Study

The purpose of the CSCAR pilot study is to improve the design of a full-scale trial by determining the patient recruitment rate and participation rate. The objective of the full-scale trial is to determine the optimal method of skin closure after Caesarean delivery in women with chorioamnionitis, which is an acute inflammation of the membranes and chorion of the placenta, seen typically after rupture of membranes with ascending polymicrobial bacterial infection. Women in labour with chorioamnionitis will be randomized at the time of Caesarean delivery to skin closure with either staples or sutures. The women will be followed at 6 weeks and 6 months post-partum in order to establish the occurrence of surgical site infection and wound disruption, as well as evaluation of the scar and other secondary questions.

The investigators hypothesis is that closure of skin with sutures will have a rate of wound infection that is no higher than the rate of wound infection when closing skin with staples. The investigators also hypothesize that closure with sutures will have a decreased rate of wound disruption, increased patient satisfaction and decreased length of hospital stay compared to skin closure with staples.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of chorioamnionitis (Fever ≥ 38.0°C AND at least TWO of: Maternal tachycardia: Heart rate \> 100bpm, Fetal tachycardia: Baseline heart rate \> 160bpm, Uterine tenderness, Foul smelling / purulent vaginal discharge, White Blood Cell count \> 15,000 cells/mm3)
* Caesarean delivery with Pfannenstiel incision
* Pregnancies \>24 weeks
* Scheduled or non-elective procedures
* Primary or repeat Caesarean delivery
* No restrictions based on BMI
* No exclusions due to DM (GDM or non GDM)
* No exclusions due to multiple gestation pregnancy

Exclusion Criteria:

* Non-Pfannenstiel incision
* Immune compromising disease
* History of keloid formation
* Chronic steroid use
* Allergy to staples
* Planned postpartum care at another facility
A Study Of Mircera In Patients With Kidney Disease Who Are Not On Dialysis

This open-label, non-randomized, retrospective-prospective, non-interventional study will evaluate the efficacy and safety of Mircera in patients with stage III-IV chronic kidney disease (CKD) not on dialysis. Patients will receive open-label treatment with Mircera for 12 months at a dose to be determined by the investigator.


Eligibility Criteria:
Inclusion Criteria:

* Patients with stage II-IV CKD not on dialysis, including renal transplant patients, who are receiving erythropoiesis-stimulating agent (ESA) treatment or are ESA-naive
* Patients who will not require dialysis within 12 months after the start of Mircera therapy
* Patients whose life expectancy is greater than 12 months after Mircera initiation
* Patients \>/= 18 years and \</= 75 years of age
* Patients who are female and of childbearing potential must be using effective contraception methods
* Patients with no contra-indications to ESA treatment (for example, hypersensitivity, non-controlled hypertension and others according to the local SmPC)
* Patients who have given written informed consent where local regulations allow or require it

Exclusion Criteria:

* Patients with stage I-II or stage V CKD
* Poorly controlled hypertension
* Active malignant disease
Hydroxychloroquine in Prevention of Preeclampsia

Pre-eclampsia complicates up to 8% of pregnancies and is a major contributor to maternal mortality and morbidity The only effective treatment is delivery, which leads to significant neonatal morbidity and mortality if carried out preterm, especially when the disease occurs early in pregnancy. Vascular endothelial dysfunction and immunological impairment are associated with preeclampsia. To date, there is no effective or optimal therapeutic approach for these conditions. Hydroxychloroquine has endothelial protective action via ant diabetic, lipid lowering, antioxidant effects or direct endothelial protection. Hydroxychloroquine is an antimalarial and immunomodulatory agent. In pregnancy, hydroxychloroquine is prescribed for inflammatory conditions associated with adverse perinatal outcomes such as systemic lupus erythematosus, antiphospholipid syndrome and placental inflammatory lesions such as chronic histiocytic intervillositis, hydroxychloroquine has therapeutic potential to improve placental function in pregnancies associated with heightened inflammation.


Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women in 1st 6 weeks gestation.
2. History of preeclampsia in previous pregnancies.
3. Women who accepted to participate

Exclusion Criteria:

1. Risk factors (multiple gestation, chronic hypertension, chronic renal disease).
2. Known contraindication to a treatment by HCQ (retinopathy, hypersensitivity to chloroquine or HCQ, G6PD deficiency, chronic liver or kidney insufficiency, heart block, significant chronic digestive, hematologic disease epilepsy or psychotic disorders.) or disorder of lactose metabolism
3. Patient already using HCQ (rheumatoid arthritis, Lupus, solar eczema). 4.impossible for follow up
Detection of Coronary Vulnerable Plaque With Contrast-enhanced Magnetic Resonance Imaging

MRI has the ability to visualize the arterial vessel wall. Wall thickening and atherosclerotic plaque components can be visualized in the carotid arteries and the aorta. Previous studies also demonstrated the ability of MRI to visualize the coronary vessel wall. The ultimate goal of coronary vessel wall imaging is to detect vulnerable atherosclerotic plaque thereby. This might prevent complications, e.g., chest pain (angina) or myocardial infarction.

The goal of this study was to validate MRI of the coronary vessel wall by comparing it to intravascular ultrasound (IVUS), to detect atherosclerotic plaque in the coronary vessel wall and to look at the uptake of the albumin-binding contrast agent gadofosveset in atherosclerotic plaques. The main hypothesis is that due to the albumin binding characteristics, uptake of the contrast agent will take place in the more vulnerable plaques compared to less vulnerable plaques. MRI will be compared to X-ray coronary angiography and intravascular ultrasound, two techniques currently considered as the standard of reference for imaging of the coronary arteries and vessel wall.


Eligibility Criteria:
Inclusion Criteria:

* scheduled X-ray angiography for known coronary artery disease, valvular disease or chest pain with unknown origin
* age \> 18 yrs and \< 90 yrs
* Informed consent

Exclusion Criteria:

* arrhythmia
* hemodynamic unstable patients
* contra-indications for (contrast-enhanced) MRI
* age \< 18 yrs or \> 90 yrs
Smoking Cessation in Cancer Treatment

The intervention to be studied is a smoking cessation program offered to newly diagnosed cancer patients at their first consultation for treatment at an oncological hospital department.

The theoretical basis for the smoking cessation program is motivational interviewing (MI), an established counselling method previously used in smoking cessation programs as well as in other behaviour change programs. MI is defined as "a directive, client-centred counseling style for eliciting behaviour change by helping clients to explore and resolve ambivalence" (Miller 1983, cited in a Cochrane report by Lindson-Hawley, N et al., 2015). The 2015 Cochrane review concluded that MI may help people to quit smoking, but underlined at the same time that there were huge variations in study quality and intervention implementations. To our knowledge, a MI-based smoking cessation program has to a very limited extent been tried in a hospital setting before.

The program includes a cessation kit with a few samples of different smoking cessation drugs (nicotine replacement therapy) and consists of at least four individual counselling sessions (30-60 min) and follow up as needed during six months with a trained smoking cessation counsellor. Counselling will take place at the hospital premises, in conjunction with scheduled cancer treatment sessions for the patients.

In the current study, two nurses or radiation therapists at each of the included hospitals will receive training in using MI in smoking cessation counselling. The Norwegian Directorate of Health's standard smoking cessation program based on MI will be modified to be appropriate for cancer patients in treatment. The Norwegian Cancer Society (NCS) will be responsible for the training and the adaptation of the program. NCS will cover on average a 50 percent position designated smoking cessation counselling at each cancer ward. Counselling (one to one counselling) will take place in connection with cancer treatment appointments, before or after (preferably before as patients might feel unwell or nauseas after treatment), except for the first appointment that will happen before cancer treatment starts. Each counselling session will last for approximately 30-60 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed cancer patients
* Offered radiation, chemo or immuno therapy in a designated hospitals
* Current smokers or recent quitters (within the last six weeks)
* 18 years or older

Exclusion Criteria:

* Survival prognosis less than 12 months
* Suffering dementia or other mental illnesses
A Multicenter Assessment of LBR-101 in High Frequency Episodic Migraine

The purpose of this study is to determine whether monthly subcutaneous administration of LBR-101 (fremanezumab) is safe and provides migraine prevention in subjects with high frequency episodic migraine.


Eligibility Criteria:
Inclusion Criteria:

* Males or females aged 18 to 65 years of age.
* A signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study including any known and potential risks and available alternative treatments.
* Subjects fulfilling criteria for episodic migraine as per the Second Edition of The International Headache Society (Olesen and Steiner 2004), who experience migraine at high frequency as follows:

  i. History of headaches on more than 8 days per month for at least 3 months prior to screening

ii. Verification of headache frequency through prospectively collected baseline information during the 28-day run-in phase demonstrating headaches (of any type) on at least 8 days with at total of 8 to 14 days\* fulfilling criteria for migraine.

\*Operational definition for migraine and probable migraine days are presented in the statistical section of this protocol.

* Body Mass Index (BMI) of 17.5 to 37.5 kg/m2, and a total body weight between 50 kg and 120 kg, inclusive.
* Demonstrated compliance with the electronic headache diary during the run-in period by entry of headache data on a minimum of 22/28 days (80% compliance).

Exclusion Criteria:

* Subject has received onabotulinum toxin A for migraine or for any medical or cosmetic reasons requiring injections in the head, face, or neck during the six months prior to screening.
* Subject uses medications containing opioids (including codeine) or barbiturates (including Fiorinal®, Fioricet®, or any other combination containing butalbital) on more than 4 days per month for the treatment of migraine or for any other reason.
* Failed \> 2 medication categories or \> 3 preventive medications (within two medication categories) due to lack of efficacy for prophylactic treatment of episodic or chronic migraine after an adequate therapeutic trial
* Treatment with an investigational drug or device within 30 days of study entry or any prior exposure to a monoclonal antibody targeting the CGRP pathway.
The Impact of "Natural" Cesarean Delivery on Peripartum Maternal Blood Loss.

Throughout the history, the neonate was dependent on maternal touch and care for survival. In modern obstetrics, with hospital care the neonates are seldom separated from their mothers after delivery. Early skin to skin (ESTS) contact after delivery was found to increase milk production, lactation and improve maternal and neonatal outcome.

Oxytocin is the primary hormone responsible for uterine contraction and prevention of postpartum hemorrhage (PPH). ESTS contact increases oxytocin secretion.

The rate of cesarean deliveries (CDs) increased dramatically over the past decades. CD was found to decrease postpartum milk production, postpones early lactation and decreases exclusive breastfeeding.

During the typical CD, the neonate is usually presented for a short while to the mother and breastfeeding is usually delayed at least a number of hours until after the surgery and the recovery period.

Natural CD, enable ESTS contact during the surgery and give the mother the opportunity to start breastfeeding immediately after delivery of the neonate in the surgery suit. Oxytocin secretion increases with ESTS and during breastfeeding.

The aim of this study is to examine blood loss that occurs after Natural CD compared to standard CD without an ESTS contact.


Eligibility Criteria:
Inclusion Criteria:

* Estimated to be appropriate for gestational age fetus.
* Sonographic dating before 20 weeks of gestation.

Exclusion Criteria:

* Non-scheduled CD.
* Major fetal malformations.
* Multiple gestations.
* Non-controlled diabetes.
* Severe pre-eclampsia.
* General anesthesia.
* HIV carrier
* Neonatal need for early resuscitation.
LLLT of Trophic Ulcers of Lower Extremities and Chronic Venous Insufficiency

The aim of this study was to evaluate comparatively the efficiency of traditional treatment methods in patients with chronic venous diseases of C6 class, and a new combined low level laser therapy (LLLT) by LASMIK device.

The results of outpatient examination and treatment of patients with venous trophic ulcers, observed in the City Polyclinic of "Tula Municipal Clinical Hospital №2" were analyzed.

During a longitudinal study, a group of patients was followed up in the period of complete or partial recovery. International classification of lower extremity chronic venous disorders СЕАР was used as a clinical classification of chronic venous insufficiency (CVI).

Depending on the applied treatment method, patients were divided into 2 groups:

1. (n=34) Conventional treatment
2. (n=34) Conventional treatment + combined LLLT, including external exposure with 635nm wavelength + intravenous laser blood illumination (ILBI) with 365-405nm (UV-spectrum) and 520-525nm (green spectrum) wavelength alternately, according to the special scheme

Eligibility Criteria:
Inclusion Criteria:

* over 18 years of age,
* CVI Stage 6 (S6) in compliance with СЕАР

Exclusion Criteria:

* hemorrhagic syndrome,
* neoplastic syndrome,
* hyperthermic syndrome (fever, patient body temperature over 38°C),
* syndrome of systemic (cardiac, vascular, respiratory, renal and hepatic) and multiple organ failure (general severe illness),
* cachexic syndrome (severe general exhaustion),
* epileptic syndrome,
* hysterical syndrome,
* convulsive syndrome
Evaluation of Dipyridamole in Preventing Post-Transplant Hypophosphatemia in Kidney Transplant Recipients

The primary goal is to determine if Dipyridamole can improve serum phosphate levels and reduce the need for phosphate supplementation.


Eligibility Criteria:
Inclusion Criteria:

* Adult kidney transplant patients.
* No known contraindications to Dipyridamole

Exclusion Criteria:

* Contraindications to Dipyridamole.
* Patients with delayed graft function (defined as the need for dialysis within seven days post-transplantation).
* Patients requiring Plavix, direct oral anticoagulants (DOACs), or Coumadin.