cyrilzakka/clinical-trials huggingface dataset:
The Safety of S53P4 Bioactive Glass for Mastoid Obliteration

In recent years, mastoid obliteration (MO) after mastoidectomy has gained popularity. However, the choice for obliteration material has been a point of discussion. Autologous materials have the advantage of being freely available without cost.Synthetic materials on the other hand have unlimited supply, hold volume over time and have no risk of donor site morbidity. Comparative studies between materials are rare and the few available were unable to ascertain superiority.

Our hospital has been utilizing the same material for obliteration since 2011: S53P4 bioactive glass (BAG). It since has become our main operating procedure to obliterate the mastoid cavity with BAG granules following both canal wall up (CWU) and canal wall down (CWD) mastoidectomy. This bioactive glass has several important characteristics, such as the retaining of volume over time and antibacterial properties.

An important factor when selecting obliteration material is safety. Data on this was reported in several studies, but unfortunately these studies only investigated short-term safety in small and selected cohorts of patients, often without comparison. Additionally, large studies with extensive follow-up are necessary to detect rare complications and long-term pitfalls. Therefore, the aim of this study is to determine the safety of BAG in a cohort that encompasses all cases that underwent CWU+MO and CWD+MO in our institute and compare these results to a non-obliteration cohort. The main outcomes are short- and long-term safety, as indicated by surgical complications in the first year following surgery and revision surgeries during follow-up, respectively. We compare the obliteration cohort to the non-obliteration cohort, hypothesizing that obliteration results in a comparable or lower rate of complications and revision surgeries


Eligibility Criteria:
Inclusion Criteria:

* Canal wall up or canal wall down mastoidectomy
* Operated between 2010 and 2022
* All indications are included

Exclusion Criteria:

* Other surgical techniques, such as subtotal petrosectomy
Tumour Registry Breast Cancer

The registry aims to collect and analyse information on the antineoplastic treatment of breast cancer in daily routine practice of office-based and clinic-based medical oncologists in Germany.

The TMK is a prospective, longitudinal, nation wide cohort study with the purpose to record information on the antineoplastic treatment of breast cancer in Germany. The registry will follow patients for up to five years. It will identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics, biomarker testing and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented.

The impact of nutrition (MaNut) and physical activity (MaNut) on the course of the adjuvant disease will be examined, as well as long-term effects of adjuvant treatment (MaTox) and the multiple patient-reported outcomes (MaLife).

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer
* 18 years and older
* Antineoplastic or antihormonal treatment

Exclusion Criteria:

* No breast cancer
* Below 18 years
* No antineoplastic or antihormonal treatment
Effects of Nasal High Flow Therapy on Ventilation and Gas Exchange in Healthy Newborns

Nasal High Flow (NHF) and CPAP are established forms of respiratory support in neonates and often produce similar clinical outcomes. It has been shown in adults that NHF produce different effects on ventilation during wakefulness and sleep. There is no physiological data on effects of NHF in neonates. The physiological effects may be impacted by sleep/awake status.

The aim of the study to investigate the effects of NHF therapy on ventilation and gas exchange during wakefulness and sleep in healthy term newborns.

Interventions:

NHF will be applied at 8 L/min (AIRVO 2) via (OPT 316) Optiflow nasal cannula interface without supplemental oxygen. Participants will act as their own control (no intervention) in a randomized crossover study design.

Physiological measurements:

1. Ventilation will be assessed using Respiratory Inductance Plethysmography (RIP) (Respitrace QDC, Viasys, USA).
2. Blood carbon dioxide (CO2) and oxygen levels will be measured by a non-invasive transcutaneous monitor (Tosca, Radiometer, Demnark).
3. All experiment will be recorded using Analogue-to-Digital converter (Powerlab, ADInstruments, New Zealand) and LabChart software with video recording of the patient.
4. Sleep/awake statuss will be determined by videorecording of the patient and Electroencephalogram (EEG) (Alice Polysomnography System Philips, USA)
5. The total study time will be \<3 hours in total for each participant. Routine measurement of heart rate, respiratory rate and oxygen saturation will be performed as per standard neonatal clinical practice.
6. Intervention can be terminated if at any time SpO2 drops below 80%, TcCO2 increases above 60 mm Hg, Respiratory Rate increases above 80 breaths per min for more than one minute).

The researcher is an experienced neonatal consultant will be conducting the research and observing the baby throughout the study.

Protocol:

Both control and NHF intervention periods will last a maximum of 40 min each. The maximum duration of the study including set-up, calibration, intervention, washout ans control will be \<3 hours. At the beginning of the study when all probes are attached a self-calibration period of RIP will be followed by a calibration of breathing volume with a pneumotachometer attached to a nasal mask. After all calibrations are completed a baseline measurement will be followed by either NHF 8 L/min or a control period without NHF. At the end of this period the interventions will be changes either to control or NHF, which will follow by a washout period (no NHF) and an additional calibration of RIP with a pneumotachometer.

Eligibility Criteria:
Inclusion Criteria:

* Healthy full or near full-term newborns of 1-2 days of age.
* A parent has given written informed consent to their baby's participation.

Exclusion Criteria:

* Infants who are clinically unstable and unsuitable for non-invasive respiratory support as judged by consultant clinician or required supplemental oxygen.
* Known upper airway, lower respiratory tract, cardiac or gastrointestinal tract anomaly.
* A parent has not given written informed consent.
A Study to Efficacy and Safety of CWP-0403 in Type 2 Diabetes Mellitus Patients

This trial is to evaluate the efficacy and safety of CWP-0403 at 100 mg or 200 mg twice daily compared with placebo in type 2 diabetic patients with inadequate glycemic control by diet therapy or combination of diet and exercise therapy.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 DM patients
* Subjects who couldn't control the blood glucose despite of a dietary and exercise therapy more than 6 weeks at screening visit
* FPG ≤ 270mg/dL at screening visit
* Patients who consent to participate in this trial by written Informed Consent Form

Exclusion Criteria:

* Type 1 DM or secondary diabetes
* Subjects who are administrating insulin or need to insulin therapy
* History of oral anti-hyperglycemic drugs within 6 weeks before screening visit
* Body mass index \< 20 kg/m2 or \> 40.0kg/m2
* Subjects who are assessed to be inappropriate for this trial by investigator
Treatment Decisions for Multi-vessel CAD

This study is a multi-center randomized trial to evaluate the Multi-vessel Coronary Artery Disease Option Grid patient decision aid compared to usual care in patient reported decisional conflict, knowledge, and shared decision making.

Multi-vessel coronary artery disease can be treated through percutaneous coronary intervention, coronary artery bypass grafting, or medical therapy. Treatments have risk benefit tradeoffs, making patient preference integral to the treatment decision. The Multi-vessel Coronary Artery Disease Option Grid patient decision aid was developed to improve the decision making process for patients and clinicians.

Objectives:

1. Evaluate The Multi-vessel Coronary Artery Disease Option Grid impact on patient treatment decisional conflict, knowledge, and shared decision making.

   The randomized controlled trial will compare validated and standardized measures of patient decisional conflict, shared decision making, and condition specific treatment knowledge between Option Grid and usual care patients. The investigators hypothesize Option Grid patients will have improvements in patient decisional conflict, shared decision making, and knowledge compared to usual care patients. Baseline feasibility enrollment at each site prior to randomization will be used to identify current treatment patterns, and prepare intervention delivery and fidelity. Registry data will be used to identify patient treatment received and compared between Option Grid and usual care arms.
2. Examine the physician and patient process of and factors influencing Multi-vessel Coronary Artery Disease Option Grid use.

Semi-structured interviews and process evaluations will be used to describe Option Grid use and experience and identify factors that are associated with beneficial Option Grid use.

Eligibility Criteria:
Inclusion Criteria:

* Stable multi-vessel coronary artery disease diagnosed by coronary angiography defined as left main disease (\>50% stenosis) or multi-vessel coronary artery disease (\>70% stenosis in two or more coronary arteries)
* At relative equipoise for at least two potential treatment options, in which the treating cardiologist or surgeon has determined the treatments are anatomically feasible and safe.

Exclusion Criteria:

* Prior coronary artery bypass grafting
* Unable to read or write English
* Not cognitively able to participate in the Option Grid as determined by clinician
Alpha-gal Pork Challenge

This study is investigating the hypothesis that alpha-gal is responsible for the gastrointestinal symptoms that occur in some alpha-gal syndrome subjects following the consumption of mammalian meat. This will be tested by comparing symptoms and immune responses in subjects with alpha-gal syndrome following consumption of "wild-type" pork (which contains alpha-gal) versus consumption of a novel pork product which has been genetically modified to lack alpha-gal (GalSafe pork from Revivicor Inc.).


Eligibility Criteria:
Inclusion Criteria:

Alpha-gal cases:

* Age 18-70
* Patient report of episodic GI symptoms within past 6 months that correlated with ingestion of mammalian meat and/or dairy and which improved on a mammalian avoidance diet.
* IgE to α-Gal \>0.1 IU/mL at screening visit.
* Willingness and ability to comply with scheduled visits and study procedures.

Control subjects:

* Age 18-70
* Regularly consume/tolerate mammalian meat without obvious associated gastrointestinal or skin symptoms.
* Have eaten mammalian meat within the past 2 weeks
* Willingness and ability to comply with scheduled visits and study procedures.

Exclusion Criteria:

Alpha-gal cases:

* History of anaphylaxis that was or could have been attributed to mammalian meat in the estimation of the PI.
* IgE to pork which exceeds the value of IgE to α-Gal on screening test
* Unexplained, persistent urticaria or pruritis.
* Pregnancy, breastfeeding or lack of birth control in women of child-bearing age.
* At the discretion of the principal investigator, patients may be excluded due to poorly controlled chronic gastrointestinal conditions including but not limited inflammatory bowel disease (i.e., Crohn's disease, ulcerative colitis, microscopic colitis), acid reflux/heartburn, history of bariatric surgery or gastric banding, active peptic ulcer disease or any abdominal surgery within the past 2 months.
* Patient is unable to swallow food or has poor peripheral access.
* Patient has any medical or physiological disorder or condition that, in the opinion of the Investigator, would compromise the well-being of the patient or study or prevent the patient from meeting or performing study requirements.

Control subjects:

* History of anaphylaxis that was or could have been attributed to mammalian meat in the estimation of the PI
* Unexplained, persistent urticaria or pruritis.
* Poorly controlled chronic gastrointestinal problem
* Patient is unable to swallow food or has poor peripheral access
* Patient has any medical or physiological disorder or condition that, in the opinion of the Investigator, would compromise the well-being of the patient or study or prevent the patient from meeting or performing study requirements.
Hydrocortisone Replacement in Patients With Secondary Adrenal Insufficiency (SUPREME CORT)

The aim of this study is to investigate whether a physiologically low hydrocortisone (HC) dose is better for cognition as compared to a physiologically high HC dose. In addition, quality of life, metabolic profile and somatosensation will be described in relation to HC dose.

* Rationale: A wide variety in hydrocortisone (HC) substitution dose-regimens are considered physiological for patients with adrenal insufficiency. However, it is likely that cognition is negatively influenced by higher cortisol exposure to the brain. No studies have been performed to assess the effects of treatment regimens with a low physiological HC substitution dose on cognition in comparison to a high physiological HC substitution dose. These treatment regimens should take body weight and multiple dosing into account. In addition, substitution doses should be monitored by clinical evaluation and biochemical analysis for adverse effects associated with over- or under-replacement.
* Intervention: Patients with secondary adrenal insufficiency will be randomized in two groups to receive either a low dose HC (0.2-0.3 mg/kg body weight) for 10 weeks followed by 10 weeks of high dose HC (0.4-0.6 mg/kg body weight) or vice versa. At baseline and after both treatment periods, patients will be tested.

Eligibility Criteria:
Inclusion Criteria:

* Patients with secondary adrenal insufficiency.
* Age ≥ 18 - 75 years
* ≥ One year after tumor treatment with surgery and/or radiotherapy
* On stable concomitant medications for at least six months prior to entry of study
* Body weight 50-100 kg

Exclusion Criteria:

* Inability of legal consent
* Documented cognitive impairment
* Drug abuse/dependence
* History of / current psychiatric disorders
* Use of anti-epileptics (e.g. carbamezapine)
* Cushing Disease
* Type 1 diabetes or Type 2 diabetes with medication known to induce hypoglycemia (f.e. Sulfonylurea derivatives
* Current treatment for second malignancy
* Have a significant medical condition (e.g. hepatic, respiratory, or cardiovascular) which, in the opinion of the investigator, may interfere with the interpretation of results and safety or efficacy evaluations.
* A history of frequent hypocortisolism
* Hospitalization during study
* Work in shifts
SYMPTOM MANAGEMENT EDUCATION GIVEN WITH MICRO TEACHING METHOD ENRICHED WITH STANDARD PATIENT IN PALLIATIVE CARE

The study was planned as a randomized controlled pre-test, post-test intervention study to determine the effect of symptom management training in palliative care given with micro-teaching method enriched with standard patient on nursing students' knowledge levels, reflective thinking levels and therapeutic communication skills related to palliative care.

Sample of study was calculated as 36 using G\*Power Software (ver. 3.1.9.2) for 80% power and medium effect size (f=0.40) at 95% confidence level in line with the data of Lin et al. The experimental and control groups were planned as 20 students each with a 10 percent loss. Participants were assigned to the experimental and control groups by the stratified randomization method. The locks were assigned to layers using Microsoft Excel. A pre-test will be applied to both groups. The control group will receive palliative care brochure for patients and their relatives.The practice group will be shared the 4 most common symptoms in palliative care nursing: pain, fatigue, respiratory distress and loss of appetite. The practice group will be 5 groups and there will be 4 students in each group. During the practice, each student will provide patient education about only one symptom. The standard patient will participate in the intervention in the application laboratory and the students will participate in the intervention in the computer environment. Video recordings will be taken while the students are giving education. After watching the experts, peers and their own video with the micro-teaching group evaluation form, the student himself/herself will make an evaluation. At the same time, a lecturer from outside the research will fill in the Standard Patient Check-List Evaluation Form. The application will be repeated one week later. After all the applications, the students will watch the video of their own 2 more times and the post-test will be applied to both groups. After one month, a retention test will be applied to the students in both groups.

Eligibility Criteria:
Inclusion Criteria:

* Students taking palliative care course for the first time,
* Students who agreed to participate in the study,

Exclusion Criteria:

* Students who have already taken the palliative care course,
* Students who answered the data collection forms incompletely,
* Students who do not want to continue the research,
* Students who missed even one of the theoretical or practical sessions of the study.
* Students with experience of caring for a palliative care patient
BMS-790052 (Daclatasvir) Plus Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Black/African-Americans, Latinos and White/Caucasians With Hepatitis C

The purpose of this study is to compare the rates of sustained virologic response in each cohort (Black-African Americans, Latinos) in this study to historical rate.


Eligibility Criteria:
Inclusion Criteria:

* Participants chronically infected with Hepatitis C virus (HCV) genotype 1
* HCV RNA viral load of ≥10,000 IU/mL at screening
* No previous exposure to interferon formulation, ribavirin or HCV direct antiviral agent
* Self-described as Black-African American, Latino or White-Caucasian
* Results of a liver biopsy obtained ≤36 months prior to first treatment compensated cirrhotics with HCV liver biopsy from any time prior to first treatment.

Compensated cirrhotics were capped at approximately 25%

Exclusion Criteria:

* Evidence of decompensated liver disease
* Documented or suspected Hepatocellular carcinoma (HCC)
* Positive for Hepatitis B or HIV 1/HIV 2 antibody at screening
Valsartan and Amlodipine Compared to Losartan and Amlodipine in Hypertensive Patients

Hypertensive patients with moderate hypertension have a risk to develop cardiovascular events of 15-20% over a period of 10 years. It is important to reach quickly the advised target, but often this result can be obtained with a combination therapy. Some evidences demonstrate sartans and calcium channels blockers can be very useful and safe, but it is also important to verify which association can give side effects or give some pharmacokinetic interactions that can negatively influence the clinical combination efficacy.


Eligibility Criteria:
Inclusion Criteria:

* diastolic blood pressure in sitting position 100 to 109 mmHg and systolic blood pressure \> 140 mmHg at the end of the selection period

Exclusion Criteria:

* type 2 diabetes mellitus
* heart failure
* AMI in the previous 6 months
* angina pectoris
* secondary hypertension
* malignant hypertension
* women child-bearing potential
* women who are pregnant and lactating
* suspected history of allergy to the sartans or calcium channels blockers
Comparison Between McGrath and Macintosh Laryngoscopes for DLT Intubation in Thoracic Surgery Patients.

The goal of this RCT is to compare outcome with McGrath vs Macintosh laryngoscopes among patients undergoing thoracic surgery. The main questions it aims to answer are,

1. Rate of successful intubation at first attempt and
2. Time for intubation required with each device. Participants are required to sign the informed consent for, they will be placed in two groups, Group A: Macintosh (DL) Group B: McGrath (VL) Researchers will compare in Group A: Macintosh (DL) and Group B: McGrath (VL) the differences in rate of successful intubation at first attempt and time for intubation required with each device.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* American Society of Anaesthesiologists physical status (ASA) I, II, III
* Elective thoracic surgery patients, requiring one lung ventilation.

Exclusion Criteria:

* Patients requiring rapid sequence induction
* Patients with a structural problem in the airway on chest radiography
* History of difficult intubation
* Planned tracheostomy \\ the presence of a tracheostomy

  * Patients with a BMI \>35 kg\\m2. Who at risk of regurgitation\\ Aspiration
  * Anticipated Difficult Airway (Mallampati IV)
  * Pre-existing sore throat or hoarseness, or recent respiratory infection (\<15 days)
PTK787 in Patients With Advanced Metastatic Pancreatic Adenocarcinoma

The purpose of this research study is to find out if an experimental drug called PTK787/ZK222584 might be effective against advanced or metastatic pancreatic cancer.

In order for tumors to grow and spread to other parts of the body, they need to have a growing blood supply. Tumor cells have been shown to produce substances that stimulate the abnormal growth of new blood vessels that allow the tumor to grow. In adults, blood vessel cells normally divide very rapidly. It is thought that PTK787/ZK222584 may interfere with the growth of new blood vessels. A drug that interferes with the growth of new blood vessels might stop tumor growth, and possibly shrink the tumor by keeping it from receiving nutrients and oxygen supplied by the blood vessels. Since normal blood vessel cells divide very rarely, it might be possible to stop tumor growth without harming normal tissues.

This is an open-label, phase II multi-center therapeutic trial investigating the efficacy and tolerability of PTK787/ZK222584 in patients with metastatic or advanced pancreatic cancer who failed first line gemcitabine-based therapy. The primary objective of this study is to evaluate the 6-month survival rate, time to progression, and tolerability of the regimen in pancreatic cancer patients treated with PTK787/ZK222584 as second-line therapy.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Zubrod performance status of 0 - 2
* Histological or cytological diagnosis of pancreatic adenocarcinoma
* Measurable or evaluable disease determined as per RECIST criteria
* Life expectancy \> 12 weeks
* Written informed consent
* Patients must have failed or progressed on prior gemcitabine-based therapy for advanced or metastatic disease.

Exclusion Criteria:

* Islet cell or neuroendocrine carcinomas of the pancreas.
* History or presence of central nervous system disease.
* Patients with a history of another primary malignancy \< 5 years
* Prior chemo therapy \< 21 days prior to registration.
* Prior biologic or immunotherapy \< 14 days prior to registration
* Prior full field radiotherapy \< 28 days or limited field radiotherapy \< 14 days prior to registration.
* Major surgery \< 28 days prior to registration.
* Patients who have received investigational drugs \< 28 days prior to registration.
* Prior therapy with anti-VEGF agents.
* Pleural effusion or ascites that causes respiratory compromise.
* Female patients who are pregnant or breast feeding.