cyrilzakka/clinical-trials huggingface dataset:
Impact of Pasireotide on Postoperative Pancreatic Fistulas Following Distal Resections

Between 2000 and 2016 258 distal pancreatectomies were performed at our University Hospital which were included in our analysis. Pasireotide was used in between July 2014 and April 2016. Patients received 900-ug pasireotide administered twice daily perioperatively. We analyzed patients who received octreotide treatment separately. Complications such as fistulas (POPF), delayed gas-tric emptying (DGE), postoperative hemorrhage (PPH), reoperations and mortality were recorded and analyzed 90 days postoperatively

In total, between 2000 and 2016 in our University Hospital there were 276 elective distal pancreatectomies performed. In this retrospective cohort study, we included 258 of those distal pancreatectomy patients in the database in to our analysis. Pasireotide was administered preoperatively to all patients undergoing distal pancreatic resection between July 2014 to April 2016, as a part of a new practice in our clinic. One patient received both pasireotide and octreotide, for whom drug delivery was stopped after one day, and who was ex-cluded from analysis. We also excluded nine patients because insufficient data were found. Seven patients were excluded because they were recruited to another clinical study.

In total, 47 patients (18%) received 900-ug pasireotide administered subcutaneously twice daily for a week or until discharged from the hospital. We analyzed separately 31 (12%) patients who re-ceived octreotide peri-operatively. All other 180 (70%) distal resection patients operated on beween 2000 and 2016 constituted the control group.

The drug used in this study, pasireotide (Signifor), was supplied by Novartis Europharm Ltd. (Novartis, Basel, Switzerland). The drug manufacturer did not take part in the study nor did it cover any costs.

We collected information about the patient age, gender, the American Society of Anesthesiologists (ASA) Physical Status Classification, tumor histology and grade and type of resection. In addition, we recorded postoperative information, the length of the hospital stay, fever following surgery (\>38 °C), complications and surgical and other re-operations.

Eligibility Criteria:
Inclusion Criteria:

All distal pancreatic resection patients in our time frame

Exclusion Criteria:

Included in another clinical trial, received both medications, inadequite patient records
Steroid-Antiviral Treatment in Rehabilitation of Facial Palsy

The purpose of this study is to assess the efficacy of antiviral medicine (acyclovir) in recovery of complete facial Palsy. Fifty patients (Males and females) with acute Facial Palsy within the first 3 days of onset with age ranged from 15-60 years old. Each patient was submitted to the following clinical evaluation using House and Brackmann 6 facial function scoring system and Synnybrook grading system. Neurophysiological assessment of facial nerve and muscles was done before and after the end of treatment, then after the end of first and second month of treatment. EMG was done for facial muscles of both sides beside measuring facial nerve excitability to determine the excitation threshold by recording the minimum electrical stimulus required to produce visible muscle contraction. A difference greater than 3.5 mA between the affected and unaffected side is considered significant in terms of poor prognosis. Nerve conduction study of facial nerves of both sides using concentric needle electrode. Trigeminal Blink reflex for both sides of the face. Facial functional recovery was defined as "good" or "complete" using the same criteria used in the 2001 practice guideline. An outcome of grade I or II was considered a good recovery using the House and Brackmann 6 facial function scoring system

The purpose of this study is to assess the efficacy of antiviral medicine (acyclovir) in recovery of complete facial Palsy. Fifty patients (Males and females) with acute Facial Palsy within the first 3 days of onset with age ranged from 15-60 years old. Each patient was submitted to the following clinical evaluation using House and Brackmann 6 facial function scoring system and Synnybrook grading system. Neurophysiological assessment of facial nerve and muscle was done before and after the end of treatment, then after the end of first and second month of treatment. EMG was done for facial muscles of both sides beside measuring facial nerve excitability to determine the excitation threshold by recording the minimum electrical stimulus required to produce visible muscle contraction. A difference greater than 3.5 mA between the affected and unaffected side is considered significant in terms of poor prognosis. Nerve conduction study of facial nerves of both sides using concentric needle electrode. Trigeminal Blink reflex for both sides of the face. Facial functional recovery was defined as "good" or "complete" using the same criteria used in the 2001 practice guideline. An outcome of grade I or II was considered a good recovery using the House and Brackmann 6 facial function scoring system

Eligibility Criteria:
Inclusion Criteria:

* Acute onset facial palsy within the first three days of onset. Age ranged from 15-60 years old

Exclusion Criteria:

* Patients with brittle diabetes mellitus, Morbid obesity, renal or liver impairment, osteopenia, prior history of steroid intolerance.
Online Childbirth Preparation Education in Covid-19 Pandemic

Today, pregnancy and childbirth are important life events that involve many difficulties and changes that must be overcome for both men and women. During this process, changes occur in the pregnant woman's body, emotional state and family life. These changes often cause pregnant women to experience anxiety about the baby's health and their own health, and to create new stressful situations. Adding the pandemic conditions to this situation further complicates the process and it is seen that the fears of women towards the birth and postpartum period will increase even more. Childbirth preparation classes reduce the fear and anxiety of women and create a positive perception of birth. For this reason, it is more important to give birth preparation education to women during in pregnancy during the pandemic period. However, it is not possible to give face-to-face birth preparation education to women in this process. For this reason, the aim of this study is to examine the effect of online childbirth preparation education in pregnancy on worries and fear of birth, preparation for birth, and well-being of self and baby in the Covid 19 pandemic.

The research is a pre-post test randomized controlled experimental study. The block randomization method will be used. The universe of the research will consist of women who applied to Pamukkale University Research and Application Hospital pregnant outpatient clinic, and have a healthy pregnancy at 24-34 weeks of gestation. The education will be done online. The sample size was calculated in the G\*power statistics program using the data of a study in which the childbirth preparation education intervention was previously performed (α =0.05, d=1.05). Accordingly, it was found that 16 people should be taken for each group to sampling for 80% power. Considering that there might be losses, the number of samples was increased by 10% and it was planned to include a total of 36 people in the study. Intention-to-treat analysis will be performed to manage bias and losses.


Eligibility Criteria:
Inclusion Criteria:

* Be over 18 years old
* Volunteering to participate in research
* Be at 24-34 weeks of gestation
* Be nulliparous
* Not having a high risk pregnancy
* Be able to read and write Turkish
* Be able to fill out an online survey form
* Planning to have a normal spontaneous vaginal delivery

Exclusion Criteria:

* Be under the age of 18
* Not completing eight hours of childbirth preparation education
* Having a mental disorder that prevents answering survey questions
* Having a psychiatric illness
* Be able not use Microsoft Teams app
Observational Peripheral IV Insertion Study

IV placement is a common and necessary for surgical procedures. Unfortunately, pain associated with needle catheterization experienced during peripheral IV placement is a source anxiety and discomfort in many patients. The intensity of pain and distress caused by procedures can vary from mild to moderate, but also may be severe in certain patients resulting in numerous physiological, psychological, and emotional consequences. As such, the investigators ultimately aim to evaluate the techniques that could make the placement of the IV more comfortable.

As a preliminary study, the investigators are interested in conducting a prospective observational study to collect baseline data to characterize and collect baseline data on pain associated with needle catheterization in the hospital.

Many factors including size of needle, experience of the individual placing IV, previous history of depression may vary the IV placement experience of a patient; however, only some of these factors may directly affect the magnitude of pain experienced by a patient. Currently, there is limited literature available on what factors affect the pain/satisfaction patients experience with IV insertion. Soysal et al. have previously reported that depressed patients reported higher severity of pain during IV catheter placement than non-depressed patients in a cross-sectional, observational study (n= 925). The authors have also demonstrated that age, sex, site of IV catheter insertion, use of antidepressant drugs, and whether the individual placing the IV catheter is a nurse or physician do not affect the magnitude of pain. Similarly, Van Loon et al have demonstrated that insertion of a smaller sized peripheral intravenous catheter did not result in lower pain sensation. However, Galvin et al. conducted a randomized clinical trial that demonstrated that the site of IV catheter insertion makes a difference in the pain patients feel during IV catheter insertion. Furthermore, no study exists that has investigated whether patients experience a different magnitude of pain when different levels of physician trainees place the IV catheter. Also, no study exists that compares whether peripheral IV cannulation with no pain relief method versus intradermal lidocaine 1% injection versus intradermal lidocaine 2% injection versus Buzzy® device affect the pain/satisfaction that patients experience with IV catheter insertion.

Through the conduction of this study, the investigators hope to further evaluate which factors and techniques affect the experience patients have with peripheral IV cannulation; this knowledge could help the investigators figure out ways to make IV cannulation as comfortable as possible for patients in the future.

Eligibility Criteria:
Inclusion Criteria:

* Adults ages 18 to 99
* Patients requiring intravenous catheter insertion for their operation/procedure.

Exclusion Criteria:

-
Study to Evaluate the Safety and Efficacy of KITE-439 in HLA-A*02:01+ Adults With Relapsed/Refractory HPV16+ Cancers

This study has 2 parts: Phase 1A and Phase 1B. The primary objectives of Phase 1A are to evaluate the safety of KITE-439 and to determine a recommended Phase 1B dose. The primary objective of Phase 1B is to estimate the efficacy of KITE-439 in adults who are human leukocyte antigen (HLA)-A\*02:01+ and have relapsed/refractory human papillomavirus (HPV)16+ cancers.


Eligibility Criteria:
Key Inclusion Criteria:

* Advanced cancer defined as relapsed or refractory disease after at least 1 line of therapy that included systemic chemotherapy and that is not amenable to definitive locoregional therapy
* HPV16+ tumor as confirmed by the central laboratory
* HLA type is HLA-A\*02:01+ per local assessment
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Key Exclusion Criteria:

* Presence of fungal, bacterial, viral, or other infection requiring anti-microbials for management

  * Note: Simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the Kite medical monitor
* Primary immunodeficiency
* History of autoimmune disease (eg, Crohns, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years prior to enrollment
* Known history of infection with human immunodeficiency virus (HIV), hepatitis B (HBsAg positive), or hepatitis C (anti-HCV positive). A history of treated hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative polymerase chain reaction (qPCR) and/or nucleic acid testing

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Outpatient Clinic for Late Outcome for Breast Carcinoma in MAASTRO Clinic.

In order to evaluate the late outcome in patients curatively treated for breast cancer, a special outpatient clinic will be developed.

There are two main purposes of the outpatient clinic. The first purpose is evaluating the results of the radiation treatment by mapping A) late toxicity and B) tumour control and survival.

The second purpose is that this outpatient clinic for late outcome will also function as a pilot for a new CAT (Computer Assisted Theragnostics, abbreviated CAT project) in which multiple late outcome variables will be recorded. In this pilot we want to investigate whether physical presence of the patient on the outpatient clinic, allowing physical examination, has any added value to the questionnaires filled in by the patient at home.

The ultimate aim of this new CAT project is to use these multicentric data to develop models for predicting both oncological outcome and late side effects. Insight in the beneficial and adverse effects of a certain treatment using these predictive models, will be required choose the optimal treatment for the individual patient using a shared decision making process.


Eligibility Criteria:
Inclusion Criteria:

* All patients treated for breast cancer with curative intent in MAASTRO clinic in 2002-2003 who are still alive.
* Consent to invitation letter and willing to participate.

Exclusion Criteria:

* Treatment without curative intent.
* No consent to invitation letter
Bolus Versus Continuous Infusion of Meropenem

This study arises from the need to optimize antibacterial drug usage to face increasing drug resistance among gram-negative pathogens in intensive care units. Gram-negative organisms are responsible for 70% of drug-resistant infections acquired in the intensive care unit. Meropenem is a β-lactam, carbapenem, antibacterial agent usually administered by intermittent infusion. As β-lactam efficacy is determined by the time in which the drug concentration exceeds the minimum inhibiting concentration of the target pathogen, intermittent infusion of this short half-lived drug can lead to precipitous drops in serum drug levels, an occurrence linked to emergence of resistant pathogens. The investigators hypothesize a beneficial effect of a continuous meropenem infusion on mortality and emergence of drug resistant pathogens. All patients enrolled will receive 1 g of meropenem bolus. After that, subjects will be randomized to receive a continuous infusion of study drug 3g/day or a bolus administration of the same amount of drugs. The investigators expect a reduction of mortality and emergence of extensive or pan drug resistant pathogens from 52 to 40% in the continuous infusion group.


Eligibility Criteria:
Inclusion Criteria:

Will be enrolled patients who:

* Are able to express informed consent or the latter can be given by his/her next of kin or as requested by Ethical Committee.
* Need a new antibiotic treatment, by clinical judgment, with meropenem
* Are admitted to ICU
* Have Sepsis or septic shock. Sepsis defined as having all the following 1. SIRS (Systemic Inflammatory Response Syndrome); 2. suspected or documented infection; 3. a SOFA score ≥ 2. Septic shock defined as having all the following 1.Sepsis; 2. Persisting hypotension requiring vasopressors to maintain MAP ≥65mmHg and having a serum lactate level \>2 mmol/L (18mg/dL) despite adequate volume resuscitation.

Exclusion Criteria:

Will be excluded patients who:

* Are able to express informed consent and deny it
* Are already receiving study drug or other carbapenem both as a bolus or continuous infusion
* Have a known allergy or intolerance to study drug, to other carbapenem antibacterial agents or severe allergic reaction to β-lactam antibacterial agents or to anhydrous sodium carbonate (study drug excipient)
* Have a little chance of survival, as defined by a SAPS II score greater than 65
* Have concomitant acquired immunodeficiency syndrome (stage 3 according to CDC)
* Received immunosuppressant or long-term corticosteroid therapy (more than 0.5 mg/kg/day for over 30 days)
A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of TAK-954 in Healthy Adult Participants

The purpose of this study is to evaluate the safety, tolerability, and PK of single ascending intravenous doses of TAK-954.

The drug being tested in this study is called TAK-954. This study will assess the safety, tolerability, PK and PD of single ascending TAK-954 higher intravenous doses than those previously studied.

The study will enroll approximately 6 participants. Participants will be randomly assigned (By chance, like flipping a coin) to one of the three treatment sequences-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need).

In each treatment sequence, each participant will receive 2 doses of active drug out of 3 dose levels (TAK-954 0.5 mg, TAK-954 1 mg, or TAK-954 2 mg) and 1 dose of Placebo. Dose escalation will be based on the available safety/tolerability data from the previous period.

This single center trial will be conducted in the United States. The overall time to participate in this study is approximately 73 days. Participants will make a final visit on Day 16 after receiving their last dose of study drug for a follow-up assessment.

Eligibility Criteria:
Inclusion Criteria:

1. Body mass index (BMI) greater than or equal to (\>=) 18 and less than or equal to (\<=) 32 kilogram per square meter (kg/m\^2), weighing \>=50 kilogram (kg) at screening.
2. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, orthostatic vital signs, or ECGs, as deemed by the Investigator or designee.
3. Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dose and throughout the study, based on participant self-reporting.

Exclusion Criteria:

1. History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
2. Has infrequent bowel movements (less than approximately once per day) within 30 days prior to first dosing.
3. Recent history of abnormal bowel movements, such as diarrhea, loose stools, or constipation, within 2 weeks of first dosing.
Anlotinib Therapy in Patients With Advanced Lung Cancer.

Purpose of the study: To observe the efficacy and safety of Anlotinib Hydrochloric Therapy in Patients with advanced Lung cancer in real world.

Subjects of the study: advanced Lung cancer.

Methods of the study:

This is a real world, prospective, Non-Interventional, Follow-up registration study.

Patients will get Anlotinib according to their condition and willingness. Anlotinib will give orally, once daily on days 1-14 of a 21-day cycle. After the procedure, regular follow up after every cycle.

End point:

Primary end point: progression-free survival (PFS). Secondary end points: overall survival (OS), disease control rate (DCR), overall response rate (ORR).


Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥18 years of age, man or woman, who had to provide written informed consent prior to enrollment.
2. Patients who had to have histologically and/or cytologically confirmed NSCLC that failed at least 2 kinds of systemic chemotherapy (third line or beyond), or who will obtain benefit from antiangiogenic therapy after investigator's assessment.
3. Eastern Cooperative Oncology Group performance status of 0-2.

Exclusion Criteria:

1. Contraindication of anlotinib.
2. Pregnant or lactating women.
3. Other patients who can't enroll after investigator's assessment.
Digital Support for Parents of Children in Child Health Care

Becoming a parent is a life-changing event that can be both gratifying and stressful. As a parent, one is responsible for another person, where there sometimes is a need for new information, knowledge, and advice to live up to the new requirements that a changing family situation requires. The objective of this study is to develop and evaluate a new digital channel in child health care for support of parents in child health care issues with particular focus on eHealth literacy and satisfaction with care. An intervention is planned to run over eight months and will be evaluated in an intervention- and control group (from another health care centre) at baseline, 4 months and at 8 months follow-up. Data includes interviews and questionnaires about parental stress and eHealth literacy as well as satisfaction with care. Data will be analysed with qualitative and statistical methods. Expected outcomes is reduced parental stress and increased satisfaction with child health care.


Eligibility Criteria:
Inclusion Criteria:

\* Swedish speaking parents with children (0-6 years) in Swedish child health care

Exclusion Criteria:

* Parents who are registered at an address other than their child
* Parents younger than 16 years