cyrilzakka/clinical-trials huggingface dataset:
Carbetocin in the Prevention of Primary Postpartum Haemorrhage

Postpartum haemorrhage (PPH) ranks as the first cause of maternal mortality in developing countries and it is the cause of 25% of maternal deaths worldwide.

Carbetocin is a long-acting synthetic octapeptide analogue of oxytocin with agonist properties. Like oxytocin, carbetocin binds to oxytocin receptors present on the smooth musculature of the uterus, resulting in rhythmic contractions of the uterus, increased frequency of existing contractions and increased uterine tone.

Postpartum hemorrhage is defined as a blood loss more than 500 ml, and serious PPH as a blood loss more than 1,000 ml.

It is a common maternal morbidity in high-resource countries and is trending upward and prevention of postpartum haemorrhage is, therefore, of great importance for improved maternal health care.

Although two-thirds of the PPH cases occur in women without predisposing factors, there are several risk factors for PPH. The most frequent cause of PPH is uterine atony, contributing up to 80 % of the PPH cases .

Studies investigating effect of increased BMI on birth outcomes in a general obstetric population revealed an association between obesity and PPH. The overall increased risk of postpartum hemorrhage among obese women was 8-13%, depending on obesity class.

The risk of postpartum haemorrhage is much higher for women undergoing Cesarean section, particularly in developing countries, where the majority of operations are carried out as an emergency procedure.

Maternal obesity is associated with an elevated risk of intrapartum cesarean section, mainly due to reduced uterine contractility culminating in failure to progress in labor .

Up to date, which uterotonic agent suitable for prophylactic use is being debated and literature lacks of clear endpoints on this item .

The most routinely and widely used uterotonic agent for preventing postpartum haemorrhage is oxytocin, but it only has a half-life of 4-10 min. So, it must be administered as a continuous intravenous infusion to achieve sustained uterotonic activity, which is inconvenient and makes dosing errors a possibility.

Eligibility Criteria:
Inclusion Criteria:

* Age: 20-40years.
* Body mass index (BMI): Obese ≥30 kg/m2 and non-obese women \<30 kg/m2 calculated using maternal height and weight measured to the nearest centimeter and kilogram, respectively, at time of admission to labor word.
* Gestational age: Gestational age ≥37 weeks (gestational age will be recorded according to the last menstrual period and confirmed by ultrasound). In case of discrepancy, a 1st trimesteric ultrasound will be taken as the actual gestational age.
* Singleton pregnancy.

Exclusion Criteria:

Patients who have any factors that might increase the risk of postpartum haemorrhage will be excluded as anemic patients (Hb\<10.5g%), antepartum haemorrhage ( placenta previa, placental abruption ), uterine myomata, multiple gestation, polyhydramnios.

* Patients with pre-existing bleeding or thromboembolic disorder.
* Patients with chronic medical diseases (cardiac, hepatic, renal)
Varied Practice on LAPSIM

To investigate whether training using a random selection of exercises on a laparoscopic virtual reality simulator results in a stronger retention of skills when using a proficiency-based training program compared to conventional self-directed training.


Eligibility Criteria:
Inclusion Criteria:

* Medical Students enrolled at a Danish University

Exclusion Criteria:

* Not being enrolled at a medical program at a Danish University, having participated in other virtual reality studies regarding laparoscopy, have had training or practice in laparoscopy on either pigs or in the clinic, have any medical conditions that may hinder a standard learning process when it comes to skills acquisition (eg. parkinson's disease, limited eye-sight etc).
Prospective Study to Evaluate Safety of Deb-TACE With 100µ Beads in Patients With Non Resectable HCC

This is an observational, multicenter, single arm, prospective study to evaluate safety and tolerability of selective and ultraselective drug eluting beads transcatheter intraarterial chemoembolization (DEB-TACE) with up to 3 ml of well calibrated 100 µ microspheres and up to 150 mg of doxorubicin, for the treatment of non resectable hepatocellular carcinoma (HCC).

The hypothesis is that 100 µ beads penetrate deeper into the tumor than those eluting beads with larger volumes without increasing the risk and complications of DEB-TACE.

In this observational, prospective study patients will undergo DEB-TACE and subsequent follow up procedures according to standard clinical practice. The primary aim of the study is to describe treatment safety and tolerability of 100 µ beads in DEB-TACE. As a secondary end-point a description of efficacy parameters will be obtained.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with a diagnosis of HCC according to European Association for the Study of the Liver (EASL) and American Association for the Study of Liver Diseases (AASLD) criteria and staged by BCLC criteria
2. Indication for receiving transarterial chemoembolization DEB-TACE with 100 µ microspheres according to usual clinical practice.
3. Able and willing to participate and give their written informed consent.
4. Both genders and ≥ 18 years old.
5. Eastern Cooperative Oncology Group (ECOG) 0
6. Preserved hepatic function (Child-Pugh ≤ B7).
7. No evidence of tumoral invasion in portal vein or main biliary ducts.
8. Able to go through image diagnostic techniques such as CT or MRI.
9. Preserved cardiac and renal function.
10. No concomitant active infections that require antibiotic treatment.
11. Measurable disease according to mRECIST criteria.
12. Life expectancy over 6 months.

Exclusion Criteria:

1. ECOG ≥ 1
2. Child-Pugh ≥B8.
3. Presence of ascitis or encephalopathy
4. Extrahepatic tumoral disease.
5. Tumoral vascular invasion
6. Serum bilirubin\>3 mg/dl.
7. Cr Clearance ≤ 60 ml/min
8. If any of the following is contraindicated:

   1. Administration of doxorubicin
   2. Iodated contrasts
   3. CT or MRI procedures
   4. Transarterial embolization procedures
   5. White blood cells (WBC) \< 2000 /mm3
   6. Neutrophil count \< 1500 /mm3
   7. Ejection fraction \< 50 %
   8. Platelet count \< 5 x 104/mm3, international normalized ratio (INR) \> 2,0)
   9. Transaminases (AST and/or ALT) \> 5x upper limit of normal or \>250 u/l
   10. Known hepatofugal portal vein flow
   11. A-V intrahepatic macroscopic fistula
9. Pregnant or breast feeding women.
10. Tumor burden involving more than 50% of the liver.
11. Active bacterial or fungal infection.
12. Other concomitant tumors.
13. Any other condition that according to investigator criteria, contraindicates DEB-TACE.
14. Patients not willing to participate and/or give their written informed consent.
Tacrolimus Ointment Long Term Safety in Young Children With Atopic Dermatitis

The objective of this study is to assess the safety and efficacy of 0.03% tacrolimus ointment as long-term treatment in paediatric patients with atopic dermatitis.

This is a long-term, multi-centre, non-comparative phase II study. All centres participating in the FG-506-06-32 pharmacokinetics study will be offered the protocol as a follow-up. Only patients enrolled by those centres for the above mentioned study, who applied at least one dose of study medication and benefited from treatment with 0.03% tacrolimus ointment, can be enrolled.

During episodes of active disease, a thin coat of ointment is applied on each lesion. In the first three weeks, frequency of application is twice a day; after three weeks treatment is continued once a day. All atopic dermatitis lesions are treated until clearance (i.e. itch has gone). In case of a flare-up or worsening treatment twice daily treatment is re-started for three weeks and thereafter reduced to once daily.

Safety is assessed from adverse events reported by the patient and/or his parents or observed by the investigator at the site of application and elsewhere. The safety evaluation includes monitoring of routine haematology and serum chemistry parameters. Blood samples are analysed by local laboratories. Blood samples are taken to determine concentrations of tacrolimus.

Height, weight and pulse of the patient are recorded at each visit.

Efficacy is assessed by physician's global evaluation of clinical response, patient's parent/guardian's assessment of global response, physician's assessment of individual signs and the affected area assessment.

Eligibility Criteria:
Inclusion Criteria:

* Patient has participated in the study FG-506-06-32, has applied at least one dose of study medication and has benefited from treatment in the opinion of the investigator.
* Patient is likely to benefit from further treatment with tacrolimus ointment in the opinion of the investigator.

Exclusion Criteria:

* Patient has a skin disorder on the affected (and to be treated) area, other than atopic dermatitis, requiring treatment.
* Patient has clinically infected atopic dermatitis.
Safety of Everolimus and Pemetrexed in Lung Cancer Patients

This study will evaluate the safety of everolimus in combination with pemetrexed when used as treatment in patients with non small cell lung cancer.


Eligibility Criteria:
Inclusion criteria:

* Lung cancer
* Only one prior regimen of chemotherapy for the treatment of non small cell lung cancer
* Adequate bone marrow function
* Adequate liver function
* Adequate renal function
* Negative serum pregnancy test

Exclusion criteria:

* History of another primary malignancy in the last 5 years
* Having recently received an investigational drug
* Having recently received major surgery of wide field radiotherapy
* Chronic treatment with immunosuppressive therapy, steroids or liver enzyme modulators
* Severe or uncontrolled medical conditions

Other protocol-defined inclusion/exclusion criteria may apply
Prediction of Methotrexate Response - A Pilot Study

The objective of this study is to identify genetic predictors of individual methotrexate (MTX) response in patients with rheumatic diseases by determining genetic and metabolomic factors related to nutrient metabolism and drug transport.

The development of better genetic predictors of individual MTX treatment response would provide invaluable prognostic information prior to initiating treatment, which would allow more appropriate choice of therapy, decreased adverse events, and more efficient dose-escalation of the drug, with ultimate benefits of improved effectiveness and tolerability rates in patients being treated with MTX for autoimmune diseases.

Despite being the gold-standard therapy for rheumatoid arthritis and other types of chronic autoimmune diseases since 1951, MTX's efficacy and safety profile limit its use: MTX is discontinued in greater than 50% of patients secondary to inefficacy or poor tolerability. Upon initial treatment, discontinuation rates approach 12% because of drug toxicity, despite prophylactic measures such as the co-administration of folic acid. The causes of primary failure, secondary failure, and adverse events of MTX may be related to genetic variation of dihydrofolate reductase (DHFR) and other genes involved in folate metabolism, one-carbon transfer, and drug transport. The purpose of this study is to identify genetic variations involved in methotrexate response so that we may better understand the pharmacodynamics of MTX metabolism in patients with rheumatic diseases.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients (i.e. \>18 years of age) who are enrolled at NorthEast Rheumatology at the Carolinas Medical Center - NorthEast who will be initiating MTX as standard treatment for their particular rheumatic disease, which may include (but not be limited to) conditions such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, inflammatory-bowel disease related arthropathies, lupus (systemic lupus erythematosus, cutaneous lupus erythematosus), Sjogren's syndrome, Behcet's disease, systemic sclerosis, and vasculitides.
* No prior enrollment into this study
* Enrollment and initial blood sample collection prior to first MTX administration
* Written informed consent

Exclusion Criteria:

* NONE
A Comparison of Totally Intravenous and Inhalation Anesthesia for Intraocular Pressure During Robot-Assisted Laparoscopic Radical Prostatectomy

Robot-assisted laparoscopic radical prostatectomy (RALRP) has gained popularity during the past decade and has widely replaced conventional open prostatectomy in many institutions due to reduced blood loss, nerve sparing, less postoperative pain and shorter hospital stay. However, laparoscopic surgery is performed with intraperitoneal carbon dioxide insufflation, which leads to increased intraocular pressure (IOP). In particular, robot-assisted laparoscopic radical prostatectomy (RALRP) usually requires a steep Trendelenburg position and often prolonged insufflation times, which is known to effect the increase in IOP during surgery and may result in ophthalmic complications such as postoperative vision loss (POVL). The majority of patients undergoing RALRP is old aged and often present with comorbidities. Advanced age, underlying diabetes mellitus (DM) or hypertension renders the patient vulnerable to damage due to increased IOP. Moreover, the possibility of the patient having undiagnosed glaucoma is also increased, and therefore methods to prevent such complications are needed. As of now, intravenous hypnotic agents, inhalation anesthetics and opioids have been reported to decrease IOP by relaxing extraocular muscle tone and increasing aqueous humour outflow to some extent. Among these agents, propofol has been reported to be more effective than other inhalational anesthetics in decreasing IOP. The goal of this prospective, randomized controlled trial is to compare the effect of propofol and sevoflurane on IOP in patients undergoing RALRP in the steep Trendelenburg position with carbon dioxide pneumoperitoneum.


Eligibility Criteria:
Inclusion Criteria:

1. ASA class 1 or 2
2. Adults over the age of 20 and under 70
3. Patients undergoing robot-assisted laparoscopic radical prostatectomy
4. Patients that have given informed consent

Exclusion Criteria:

1. Patients with known ophthalmic diseases (glaucoma, diabetic retinopathy, cataract, retinal detachment)
2. Patients with history of ophthalmic surgery
3. Patients with high baseline intraocular pressure (over 30 mmHg)
4. Patients with active cardiac conditions (unstable angina, congestive heart failure)
5. Patients with uncontrolled hypertension (diastolic blood pressure \> 110 mmHg)
6. Patients with history of allergic reactions to propofol
7. Illiterate patients
Ultrasonography Biofeedback for Diaphragm Training in Athletes With Non-specific Lumbo-pelvic Pain

Objective: To determine the effectiveness of diaphragm visual biofeedback reeducation by ultrasonography in conjunction with high-intensity inspiratory muscle training versus isolated high-intensity inspiratory muscle training in athletes with lumbo-pelvic pain. Methods: A single blinded randomized clinical trial will be carried out. A total sample of 80 athletes with lumbo-pelvic pain will be recruited and randomized into 2 groups: one group will be treated by isolated high-intensity inspiratory muscle training during 8 weeks, and another group will be treated with diaphragm visual biofeedback reeducation by ultrasonography during 6 weeks in conjunction with high-intensity inspiratory muscle training during 8 weeks. Outcome measurements will be diaphragm muscle thickness evaluated by ultrasonography (main outcome measurement), pain intensity, pressure pain threshold, disability, quality of life and respiratory parameters by spirometry, which will be assessed before and after intervention.


Eligibility Criteria:
Inclusion Criteria:

* Athletes with non-specific lumbopelvic pain during 6 weeks

Exclusion Criteria:

* Neural disorders
* Systemic disorders
* Cognitive disorders
A Supportive Care Programme for People With Heart Failure

Efficient health care systems for the management of chronic diseases in the community may improve clinical outcomes and simultaneously encourage patients to remain healthy. Supportive care, may contribute to empower heart failure (HF) patients for self- management and providing them with the follow-up and care based on their needs and values through the HF trajectory. To develop the current program an assessment of the support needs of HF patients' will be undertaken and the investigators will take into consideration of their personal preferences, for instance means of communication and way of exercise as part of the intervention. The present study aspires to evaluate the effectiveness of an individualized supportive care management program in terms of the four different components that comprise supportive care in HF. The objectives of this study are to:

1. Determine supportive care needs of HF patients as reported in the literature.
2. Explore Cypriot patients' identified supportive care needs.
3. To develop and test a self-management supportive care programme for HF patients.


Eligibility Criteria:
Inclusion Criteria

* clinical diagnoses with HF (HFpEF or HFrEF), established by a cardiologist
* New York Heart Association classification stages I-IV
* Diagnosis established for at least 6 months before the start of the intervention period
* Ability to understand, write and read in Greek language

Exclusion Criteria:

* Refuse to take part in the research
* Dementia or other severe mental illness
* Transfer to nursing homes after discharge
* Difficulty in contacting them by a phone call
* Patients with chronic degenerative diseases (Alzheimer, cancer, etc)
A Clinical Study to Assess the Effect of Vildagliptin on Postprandial Lipid Parameters in Patients With Type 2 Diabetes

This study was not conducted in the United States. Many people with type 2 diabetes also have high cholesterol levels. The purpose of this study was to evaluate the effects of vildagliptin, an unapproved drug, on blood lipid measures such as triglycerides and cholesterol in people with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Blood glucose criteria must be met
* Genetic markers associated with increased risk of cardiovascular disease
* Not currently on drug therapy for type 2 diabetes
* Body mass index (BMI) in the range 25-40

Exclusion Criteria:

* Pregnancy or lactation
* Type 1 diabetes
* High cholesterol as defined by the protocol
* Evidence of serious diabetic complications
* Other protocol-defined exclusion criteria may apply
Dynamic Changes in Some Facial Muscles After Hyaluronic Acid Filler Injection

assess electrophysiological changes in some facial muscle dynamics following hyaluronic acid filler injection in superficial versus deep level of injection.

Participants will be subjected to injection of cross-linked hyaluronic acid fillers on both sides of the face in 3 different regions: temples, cheeks and chins.

Each female will undergo:

1. Before injection:

   1. Aesthetic facial clinical analysis.
   2. Baseline quantitative surface electromyography.
   3. Baseline digital photography.
2. Injection:

   Each female will receive the injection in the particular facial region at superficial level to the muscle (subcutaneous) on one side and the same amount at deep level to the muscle (supraperiosteal) on the other side.
3. One week after injection:

   1. Follow up quantitative surface electromyography.
   2. Follow up digital photography.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 20-60 years.
2. Sex: females.
3. Areas eligible for injection: temples, cheeks and chin.

Exclusion Criteria:

1. Active infection near the site of injection.
2. Pregnant or lactating women.
3. Patients suffering from any neuromuscular disorders.
4. Known allergy/hypersensitivity to hyaluronic acid fillers.
5. History of botulinum toxin injection in the last 4 months.
6. History of injection of fillers in the last 2 years.
7. Patients receiving any muscle relaxants.
8. Coagulation disorder or anticoagulants therapy.
Oral Nifedipine Versus IV Labetalol in Severe Pre Eclampsia

OBJECTIVE: To determine the efficacy of nifedipine and labetalol in terms of control of BP in pre eclamptic pregnant patients

Design: Randomised control trial

SETTING: Department Obstetrics \& gynaecology, Services Hospital, Services Institute of Medical Sciences. Lahore

POPULATION: Pregnant patients with BP 160/110 or symptoms of severe preeclampsia

METHODS: Patients are randomised to receive nifedipine (10 mg tablet, orally, up to five doses) and intravenous placebo saline injection or intravenous labetalol injection (in an escalating dose regimen of 20, 40, 80, 80 and 80 mg) and a placebo tablet every 15 minutes until the target blood pressure of ≤140/90mmHg is achieved. Crossover treatment is given if the initial treatment regimen is unsuccessful

Gestational hypertension is associated with increased risk of maternal morbidity and mortality. Parenteral therapy needs more resources, more monitoring and supervision. Oral therapy is cheap, easily available, easy to administer especially in resource constrained settings

OBJECTIVE: To determine the efficacy of nifedipine and labetalol in terms of control of BP in pre eclamptic pregnant patients

Design: Randomised control trial SETTING: Department Obstetrics \& gynaecology, Services Hospital, Services Institute of Medical Sciences.Lahore POPULATION: Pregnant patients with BP 160/110 mm Hg or symptoms of severe preeclampsia

METHODS: Patients are randomised to receive nifedipine (10 mg tablet, orally, up to five doses) and intravenous placebo saline injection or intravenous labetalol injection (in an escalating dose regimen of 20, 40, 80, 80 and 80 mg) and a placebo tablet every 15 minutes until the target blood pressure of ≤140/90mmHg is achieved. Crossover treatment is given if the initial treatment regimen is unsuccessful

Eligibility Criteria:
Inclusion Criteria:

* Gestational age 24 to 41 weeks
* BP \> 160/110 mm Hg with proteinuria
* Patients with S/S of imminent eclampsia as headache, visual disturbance.

Exclusion Criteria:

* Gestational age \< 24 wks
* Non proteinuric chronic hypertension
* Eclampsia
* Cardiac patients, asthma, severe renal disease, allergy to Nifedipine or Labetalol
A Phase Ib Study of JMKX001899 in Combination With Other Therapies in Advanced NSCLC Harboring KRAS G12C Mutation

This is a phase 1b, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and efficacy of JMKX001899 in combination with IN10018 or in combination with chemotherapy or in combination with IN10018 and chemotherapy in subjects with locally advanced or metastatic NSCLC with KRAS G12C mutation.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically documented Stage IIIB or IIIC NSCLC disease not amenable for surgical resection or definitive chemoradiation or Stage IV NSCLC disease.
2. Known KRAS G12C mutation, and negative results for other driver genes with approved targeted therapies.
3. Measurable disease according to RECIST 1.1.
4. An Eastern Cooperative Group (ECOG) performance status of 0 or 1.
5. Adequate organ function.

Exclusion Criteria:

1. Subjects with carcinomatous meningitis or spinal cord compression; or with other evidence indicating that central nervous system (CNS) metastases or leptomeningeal metastases are not yet controlled.
2. Prior chemotherapy, radiotherapy, immunotherapy or treatment with an investigational agent within 4 weeks of receipt of study drug (within 6 weeks for nitrosoureas, mitomycin C; within 2 weeks of small molecule targeted therapies, traditional medicine with anticancer indication).
3. History of prior malignancy in the past 3 years, with the exception of curatively treated malignancies.
4. Gastrointestinal (GI) tract disease causing the inability to take oral medication or affect drug absorption.