cyrilzakka/clinical-trials huggingface dataset:
Amniotic Membrane in Decompressive Craniectomy to Reduce Scarring

The purpose of this study is to evaluate the effectiveness of dHACM in reducing scar tissue formation in craniectomy patients as well as facilitating reoperation and repair. Specifically this study compares craniectomy without dHACM application to craniectomy with placement of dHACM between the galea and dura over dural suture line and/or exposed parenchyma.


Eligibility Criteria:
Inclusion Criteria:

* Adults ages 18 or older.
* Diagnosed with closed head trauma or cerebral infarction where decompressive craniectomy with durotomy is performed.
* Willingness to comply with study procedures.
* The patient's or legally authorized representative's (LAR's) ability to give full written consent.

Exclusion Criteria:

* Prior surgery at the site
* Participation in another ongoing trial
* Open cranial wounds
* Site exhibits clinical signs and symptoms of local infection.
* Current diagnosis of cancer at the site
* Prior radiation therapy treatment at the site.
* Patients on any investigational drug(s) or therapeutic device(s) within 30 days preceding screening.
* Known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.
* Presence of any condition(s) which seriously compromises the subject's ability to complete this study, or has a known history of poor adherence with medical treatment.
* Currently taking medications which could affect graft incorporation (supervising physician's discretion).
* Allergy to gentamicin sulfate and/or streptomycin sulfate
Safety and Aesthetic Outcomes of Breast Conserving Surgery With Peri-areolar Incision Approach

Cosmetic result after breast-conserving surgery (BCS) would impose great effect upon patient's quality of life. Although peri-areolar incision has been widely used in benign breast tumor excision, mastopexy procedures and skin-sparing mastectomy with primary reconstruction, the actual safety and aesthetic outcome of the peri-areolar incision approach in BCS for cancer patients has not been established by randomized, controlled trials.

This trial was design to compare the Safety and aesthetic outcomes of breast conserving surgery between peri-areolar incision approach and traditional methods.

The Trial aims to determine whether BCS with the peri-areolar approach: 1) is safe in terms of the rates of recurrence and metastasis; 2) can improve the post-operative aesthetic score and QOL score.

Eligibility Criteria:
Inclusion Criteria:

* patients desire for breast conserving surgery;
* fulfills criteria for breast conserving surgery;
* the maximum diameter of the tumor should be less than the semi-perimeter of the areola and that the proximal margin of tumor should be at least 1 cm away from the areola;
* patients suitable to receive BCS with either the peri-areolar incision or the traditional incision were included;

Exclusion Criteria:

* patients not suitable for breast conserving surgery;
* skin or sub-cutaneous tumor invasion as definite contra-indication of skin-sparing;
* male or bilateral breast cancers who might bring up bias in deciding aesthetic outcomes and expenditure;
* Patients who were supposed to benefit from a certain kind of incision were also excluded at the researcher's discretion.
Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion (Part A)

This will be a descriptive study designed to evaluate the propensity for hospitalized pediatric patients treated adequately with Clinolipid or standard of care (Intralipid) from 7 up to 90 days to develop Essential Fatty Acid Deficiency (EFAD). Additionally, this study design will evaluate the safety and efficacy of using Clinolipid or Intralipid in a pediatric population.


Eligibility Criteria:
Inclusion Criteria:

1. Patients and/or their legal representative must be able to understand the study and voluntarily sign the informed consent form (ICF) per 21 CFR Part 50.55(e)
2. Patients and/or their legal representative accept adherence to protocol requirements
3. Patients who are expected to require parenteral nutrition (PN)for at least 7 days
4. Premature infants (born at 24 to \<37 weeks of gestation with a birth weight ≥750g) require at least 80% of targeted energy requirements by PN at study entry (up to 1 month CA); full term infants and children require at least 70% of targeted energy requirements by PN at study entry

Exclusion Criteria:

1. Patients who are not expected to survive hospitalization or with a severe critical unresponsive illness at time of initiation with foreseeable intercurrent events that could jeopardize the patient's participation in the study, as judged by the Investigator (e.g., unresponsive shock, sepsis, renal failure requiring dialysis, severe unresponsive metabolic acidosis, and/or severe unresponsive metabolic disorders);
2. Patients with a known hypersensitivity to lipid emulsion, egg or soybean proteins, or any of the active substances, excipients, or components of the container or who have a history of an adverse event due to ILE;
3. Patients with liver disease including cholestasis;
4. Patients with severe hyperlipidemia or severe disorders of lipid metabolism characterized by hypertriglyceridemia (triglyceride \>400 mg/dL);
5. Patients who are unable to tolerate the necessary laboratory monitoring;
6. Patients who are enrolled in another clinical trial involving an investigational agent;
7. Patients with a known history of either severe hemorrhagic or severe hemolytic disease as judged by the investigator;
8. Premature infants born \<24 weeks of gestation and patients ≥18 years;
9. Premature infants with a birth weight \<750 g;
10. Patient requires or is expected to require propofol for sedation;
11. Patient has received a diagnosis of Coronavirus Disease of 2019 (COVID-19) (diagnosis \<2 months prior and/or symptoms have not resolved.
12. Newborn patient born to a mother who was diagnosed as COVID-19 positive at delivery or within 2 months prior to delivery
13. Female patients who are pregnant. Note: All female patients ≥12 years of age must have a negative urine human chorionic gonadotropin (hCG) pregnancy test at screening. For female patients \<12 years of age, a urine hCG test at screening will be performed at the discretion of the investigator based on childbearing potential.
Motivational Interviewing for Adult Kidney Transplant Recipients

Purpose: This study aimed to determine the effect of motivational interviewing on self-management of treatment regimen, medication adherence, and patient outcomes in adult kidney transplant recipients between 3 months and 6 months after kidney transplant in the transplant outpatient clinic.

Design: The research is a single-centered, single-blind, parallel and 1:1 randomized active comparative experimental study.

Method: A total of 80 individuals, of the 40 in the control group and 40 in the intervention group, will be included in the study. Motivational interview sessions for the intervention group will be held 3 times between 15-30 minutes with an interval of 10 days. The control group will be given routine care (approximately 1 hour of face-to-face standard training) by the nurse educator. Within the research pattern, intervention and control groups will be applied pre-test at the first interview and post test after one month. In addition, follow-up test will be performed 3th month. The data will be obtained using the Self-Management Scale in Kidney Transplant Recipients, Visual Analog Scale (VAS) for self-care and VAS for medication adherence. In the study, Standard Protocol Items: Recommendations for Interventional Trials- SPIRIT(2013) and CONSORT 2010 (Consolidated Standards of Reporting Trials) were used.


Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study,
* aged ≥18 years old
* 3-6 months after kidney transplant
* Speaking, reading and writing in Turkish
* Having a mobile phone

Exclusion Criteria:

* Request to leave work

Removing Criteria:

* Development of rejection
Treatment of Good Prognosis, BCL-6 Negative Diffuse Large Cell Lymphoma With CHOP-R in Patients < 61 Years Old.

The purpose of this study is to determine whether a specific subtype of lymphoma responds optimally to treatment with rituximab and chemotherapy.

Treatment with rituximab and chemotherapy (R-CHOP)is the accepted treatment for young patients with diffuse large B cell Non-Hodgkin's Lymphoma. However not every patient benefits with this expensive therapy. Recent data suggest that patients with BCL-6 negative lymphoma are more sensitive to Rituximab therapy. It is also known that patients with high-intermediate and high IPI risk does not benefit form standard three weekly CHOP chemotherapy.

In this study we intend to define a subgroup of patients in whom this therapy will be of maximum benefit.

We will prospectively treat a group of patients with the following characteristics:

\< 60 years old low and low intermediate IPI risk BCL-6 negative B-cell NHL Treatment regimen: R-CHOP (standard dosis) for 8 cycles

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Large B cell Non-Hodgkin Lymphoma CD20+
* BCL-6 negative
* Age \< 61 years old
* ECOG 2 or less
* IPI low, low intermediate
* Stage II, III or IV
* Signed Informed Consent

Exclusion Criteria:

* Stage I
* Previous treatment
* Lymphomatous central nervous system involvement
* Heart disease
* Kidney failure (serum creatinine \> 2 mg/dl)
* HIV +
* Viral Hepatitis
* Pregnancy
A Randomized Controlled Trial About Teaching Parents How to Manage Childhood Immunization Pain

There is no effect of a parent-directed fact sheet about pain management during childhood immunization and pre-test on parent learning about evidence-based pain relieving methods.

Over 90% of young children demonstrate severe distress during vaccination. Pain relieving strategies are uncommonly used, despite a plethora of evidence for physical, pharmacological and psychological techniques. Parents commonly report pain as a harm-related concern for childhood immunizations and are dissatisfied with current practices. Unmitigated pain causes long-term adverse sequelae, including; anticipatory fear and hypersensitivity to pain at future procedures in children, and parental non-compliance with immunization schedules. Health providers and parents report the major barrier to routine use of pain management is parental lack of knowledge about effective strategies. Lack of time is reported as a secondary barrier. An educational tool about immunization pain management targeted to parents that can be practically implemented in the clinical setting within usual time constraints is needed.

Eligibility Criteria:
Inclusion Criteria:

* new mothers with health full-term infants
* 5 minute Apgar 7 or more

Exclusion Criteria:

* non-english speaking mothers
* mothers with psychiatric conditions
* infants admitted to intensive care unit
Efficacy of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 CKD

The purpose of this clinical trial is to evaluate the long-term efficacy and safety of low-dose oral corticosteroids combined with cyclophosphamide therapy and low-dose corticosteroids monotherapy, on a background of maximal RAS inhibitor therapy, for IgA nephropathy with stage 3 or 4 chronic kidney disease.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven IgA nephropathy;
* Proteinuria ≥1.0g/day while receiving maximum tolerated dose of RAS blockade;
* Estimated glomerular filtration rate 15-60 ml/min/1.73/m2.

Exclusion Criteria:

* Indication or contraindication for immunosuppressive therapy with corticosteroids
* Use of corticosteroids and other immunosuppressive drugs within the last 1 year
* Current unstable kidney function for other reasons
* Under 18 years old
* Patients with secondary IgAN
* Patients who are unlikely to comply with the study protocol in the view of the treating physician
Observational Study to Evaluate Safety of Levemir® in Type 1 and Type 2 Diabetes

This study is conducted in Asia. The aim of this observational study is to evaluate the incidence of adverse events while using Levemir® under normal clinical practice conditions.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 or type 2 diabetes mellitus

Exclusion Criteria:

* Subjects who are unlikely to comply with the protocol
* Subjects who are currently being treated with Levemir®
* Subjects who previously were enrolled into the study
* Subjects with hypersensitivity to Levemir® or any of its excipients
Effect of Copanlisib on Metformin Pharmacokinetics and Pharmacodynamics

The purpose of this study is to learn about a drug-drug interaction. When two medications are taken together at the same time, one medication may change the activity of the other medication in the body - this is called a drug-drug interaction. This study is looking at the effect the Bayer study drug, copanlisib, has on metformin, a commonly used medication to treat diabetes. During the study, blood and urine samples will be collected and analyzed to learn about pharmacokinetics (how copanlisib changes metformin levels in the body) and pharmacodynamics (the effect metformin has on the body when taken together with copanlisib) when someone takes both copanlisib and metformin together.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects - as determined by the investigator or medically qualified designee based on medical evaluations, including medical history, physical examination, laboratory tests and cardiac monitoring
* Aged 18 to 45 years at the first screening visit
* Body Mass Index (BMI) of 18.0 - 34 kg / m\*2 , with body weight ≥ 50 kg
* Creatinine clearance ≥ 90 mL/min using the Modification of Diet in Renal Disease
* Adequate end organ and bone marrow function

Exclusion Criteria:

* Existing relevant diseases of vital organs (e.g. liver diseases, heart diseases), central nervous system (for example seizures) or other organs (e.g. diabetes mellitus)
* Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
* Relevant respiratory insufficiency / disorder
* Administration of strong CYP3A4 inhibitors or inducers within 2 weeks prior to dosing
* Known history of hypersensitivity (or known allergic reaction) to copanlisib, metformin, related compounds, or any components of the formulation
Patient Reported Experiences and Outcomes Associated with Standard C-Section Wound Closure Versus STRATAFIX/DERMABOND PRINEO Wound Closure (CS-PREO)

The aim of the study is to compare outcomes between patients receiving standard C-section wound closure compared to a wound closure bundle that includes Stratafix sutures and Dermabond PRINEO.

The purpose of this study is to evaluate patient experience and patient reported outcomes following cesarean delivery in women receiving either standard wound closure or a wound closure bundle which includes both Stratfix sutures and Dermabond Prineo.

Patients in both study arms will complete established questionnaires capturing patient-reported experience measures (PREMS) and patient-reported outcome measures (PROMS).

Eligibility Criteria:
Inclusion Criteria:

1. Patient must be 18 years of age or older at time of recruitment
2. Patients opting for a planned (elective) C-Section (13-36 weeks gestation) will be eligible to consent.
3. Patients must have internet access and/or a smartphone in order to access the digital platform to complete the study questionnaires
4. Patients must speak and write in English as study questionnaires will only be provided in English
5. Patients must have coverage from the Ontario Health Insurance Plan (OHIP)

Exclusion Criteria:

1. Patients assessed by the participating surgeon with any conditions that may compromise their:

   * Ability to consent or use the virtual care platform (e.g., patients with intellectual disabilities)
   * Expectation of significant maternal complications that may affect the surgery
2. Patients who enroll in the study but have an unplanned emergency C-section
High Resolution Colonic Manometry in Relation to 3D-Transit Times in Healthy Controls.

Background: Within recent years, new methods for detailed assessment of gastrointestinal (GI) motility have been developed. Hence, the electromagnetic 3D-Transit system is a safe, non-invasive method for detailed description of GI motility. The system tracks the exact position of an ingested electromagnetic capsule through the entire GI tract and provides detailed information on both regional transit- and contraction patterns. High Resolution Colonic Manometry (HRCM) allows extremely detailed description of contraction patterns in the colon. The HRCM is however an invasive method, as the catheter is placed during colonoscopy. Before widespread use of capsule-based techniques (3D-Transit or others), the system needs to be validated by another method.

Study Objectives: The purpose of this study is to investigate weather pressure changes measured by HRCM correlate with passage patterns recorded by 3D-Transit. This has been assumed so far, but has never been further investigated.

Hypothesis: Movement of the electromagnetic 3D-Transit capsule within the colon correspond well with pressure changes determined with HRCM.

Materials and methods: HRCM and 3D-transit will be performed simultaneously in 20 healthy participants. A colonoscopy is performed to install the HRCM catheter and place two 3D-Transit capsules within the colon. For 24 hours, the participants lie in a bed in the research lab while pressure changes from the HRCM catheter are recorded and the 3D-Transit capsules are followed through the gastrointestinal system.

Perspectives: If data from the 3D-Transit technique correlate well with HRCM, the method provide a non-invasive alternative allowing detailed assessment of colonic motility.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 70
* Normal gastrointestinal function
* Psychologically able to give an informed content.

Exclusion Criteria:

* Known gastrointestinal disease
* Intake of medication with known effects on the movement patterns in the gastrointestinal system.
* Pregnancy and lactation
* Unable to follow the scheduled program in the trial due to mental illness or instability.
Can You Breathe Your Way To Better Health?

The purpose of this clinical trial is to explore the effects of either a 2-week high-intensity interval training (HIIT) or breath training intervention on measures of overall health, circulating biomarkers of stress, and immune function.

Specific aims include: - Does a 2-week HIIT or breath training intervention improve measurements of overall health, including heart rate variability, physical activity, sleep quality, and severity of depression, anxiety, and stress? -Does a 2-week HIIT or breath training intervention improve circulating concentrations of stress-related biomarkers? Does a 2-week HIIT or breath training intervention improve immune function? Researchers will compare HIIT and breath training to see if equivalent immune improvements are observed.

Participants will: -Undergo 2 weeks of HIIT or breath training interventions at a frequency of 3 times per week for 30 minutes or 5 times per week for 5 minutes if placed into an intervention group. -Undergo testing measures at the two pre- and post-intervention time points, if placed in the intervention groups or the healthy control group.


Eligibility Criteria:
Inclusion Criteria:

* Age, 18-50 years
* Sex, Male and Female
* Informed Consent, The capability and willingness to give written informed consent to understand the exclusion criteria and to accept the randomized group assignment is required.
* PAR-Q+, The capability and willingness to complete the physical activity readiness questionnaire, with no medical clearance needed.
* Physical Activity: Participants must refrain from regular HIIT and structured breathing practices for a month before participation
* Depression, Anxiety, and Stress Scale, Subcategory Scoring (DASS-21) Participants must score in the mild or greater category for Depression, Anxiety, and Stress. Depression ≥ 10, Anxiety ≥ 8, and Stress ≥ 14.

Exclusion Criteria:

* Age: Individuals under 18 years and over 50 years
* Significant Respiratory Conditions, including but not limited to asthma, chronic obstructive pulmonary disease,
* Significant Cardiovascular Disease: Participants with a known cardiovascular condition such as a previous myocardial infarction, congestive heart failure, stroke, or transient ischemic attack, cardiomyopathy, serious arrhythmia, peripheral vascular disease, untreated atherosclerosis, or hypertension.
* Significant Musculoskeletal Disease, including but not limited to osteopenia, osteoporosis, rheumatoid arthritis, and sarcopenia
* Cognitive and Mental Health, including but not limited to untreated anxiety, untreated depression, post-traumatic stress disorder, and thoughts of suicide.
The Effect of Flow-controlled Ventilation on Hemodynamic and Respiratory Parameters in Laparoscopic Surgeries

It is aimed to investigate the effect of flow controlled ventilation on intraoperative respiratory parameters and hemodynamic parameters in laparoscopic operations.

Study will begin after ethics committee approval and the patient's written and verbal consent .

Prospective observational studies will be conducted on patients over the age of 18 who will undergo laparoscopic surgery in the operating rooms. Patients who did not give verbal and written consent, emergency interventions, patients at risk of aspiration, patients with an ASA physical status above 3 and a diagnosis of COPD will be excluded.

Patients will be randomized and divided into two groups. Patients intraoperatively ventilated with a conventional ventilator (GE™ Avance™ CS2, VCV mode) Group 1, intraoperative ventilation Ventinova ( Evone®, Ventinova Medical, Eindhoven, the Netherlands, FCV mode) will be referred to as Group 2. Standard monitoring (ECG; SpO2, end tidal CO2,arterial blood pressure) will be applied to all patients. Anesthesia induction will be performed with propofol, fentanyl, rocuronium bromide as standard; In addition, anesthesia maintenance of the patients will be provided with propofol and remifentanil.

Respiratory parameters such as peripheral SpO2, PaCO2 value, peak airway pressure of each group will be recorded, and intraoperative hemodynamic parameters (systolic, diastolic, mean blood pressure, heart rate) of each group will be monitored and recorded.

Postoperative respiratory functions and length of hospital stay of all patients will be monitored and recorded.

Eligibility Criteria:
Inclusion Criteria: patients who will undergo laparoscopic surgeries, ASA 1,2,3 physical status

-

Exclusion Criteria:

* patients who do not give verbal and written consent, emergency interventions, patients at risk of aspiration, patients with an ASA physical status above 3 and a diagnosis of COPD