cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Satisfaction With Remifentanil Analgesia in Parturients During the Childbirth

Retrospective observational study to determine the efficacy of remifentanil during the delivery. Authors will search the data in period between 2010 and 2014 in cohort of 100 parturients and obtain data of analgesic efficacy (VAS score after remifentanil analgesia induction) and parturients satisfaction with the method.

In retrospective observational study will authors search the documentation of parturients. The cohort size is estimated to 100 subjects, in period between 2010-2014. Excluded will be all patients who did not signed the informed consent for processing with their medical data.The main aim is to evaluate the efficacy of the remifentanil analgesia in parturients in the first phase of delivery.

The analgesic efficacy will be evaluated by the change in VAS (visual analogue scale) score after induction of remifentanil analgesia Satisfaction will be evaluated by the questionary.

Eligibility Criteria:
Inclusion Criteria:

* parturients during the delivery
* administered remifentanil analgesia
* signed informed consent

Exclusion Criteria:

* informed consent not signed
* missing data about the analgetic method a analgetic efficacy
Radiation Therapy in Treating Patients With Aggressive Fibromatoses

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.

PURPOSE: Phase II trial to study the effectiveness of radiation therapy in treating patients who have aggressive fibromatoses.

OBJECTIVES:

* Determine the efficacy of moderate-dose radiotherapy, in terms of local control, in patients with aggressive fibromatoses.
* Determine the acute and late side-effects of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive radiotherapy 5 days a week for 5.5 weeks for a total of 56 Gy in 28 fractions.

Patients are followed every 3 months for 2 years and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed aggressive fibromatoses arising in any site

  * Primary, recurrent, or progressive disease that is inoperable or requires a major operation resulting in a large functional or cosmetic deficit or mutilation

    * Progressive disease defined as at least 20% increase in tumor size on 2 MRI scans within 1 year after any prior therapy except radiotherapy OR
  * Incompletely resected tumor with gross residual disease not suitable for further surgery

    * Resected within the past 3 months
* Lesions must be suitable for radiotherapy

  * No bulky intra-abdominal disease in close relation to small bowel
* Measurable disease

PATIENT CHARACTERISTICS:

Age:

* 16 and over

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* No conditions that would preclude study follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Prior chemotherapy allowed
* No concurrent chemotherapy

Endocrine therapy:

* Prior endocrine therapy allowed
* No concurrent endocrine therapy

Radiotherapy:

* See Disease Characteristics
* No prior radiotherapy to indicator lesion

Surgery:

* See Disease Characteristics
* Prior surgery allowed

Other:

* No prior isolated limb perfusion with tumor necrosis factor
* No concurrent isolated limb perfusion with tumor necrosis factor
Sino-nasal Inhalation of Colistin in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization

The purpose of this study is to determine whether the nasal inhalation of Colistin is effective to decrease the Pseudomonas aeruginosa bacterial count in the nasal lavage fluid.


Eligibility Criteria:
Inclusion Criteria:

* subject has a confirmed diagnosis of cystic fibrosis
* detection of P. aeruginosa in nasal lavage (culture) with chronic P.a. colonization of the lung (from day -28)
* informed consent of the patients or parents
* subject \>= 6 years
* subject is able to comply with the inhalation procedures and nasal lavage procedures scheduled in the protocol
* women of childbearing potential are only included into the study, if they are using an effective method of birth control during the protocol

Exclusion Criteria:

* subject has a critical condition defined as: forced expiratory volume at one second \< 30% and / or arterial oxygen saturation \< 93% without O2-substitution; need of O2-substitution
* subject had an ear, nose, and throat surgery within 3 months prior to study
* subject shows signs of nasal bleeding
* subject has an ear drum perforation
* subject had an acute rhinosinusitis or a pulmonary exacerbation at study entry with need of additional systemic antibiotic therapy against pseudomonas aeruginosa
* subject is unlikely to comply with the procedures scheduled in the protocol
* subject has a known allergic reaction to the medication
* subject is pregnant or breastfeeding
* subject participates in another clinical trial within 30 days prior to study entry or 30 days after end of the study.
* systemic (oral or intravenous) antibiotic treatment against P.a. 14 days prior to the inclusion and during the study
Perioperative Mechanism of Acute Kidney Injury in Cardiovascular Surgery

Continuous observation of acute renal injury after cardiac surgery, at the same time retention of blood samples, to test indicators，and to select the research route from the clinical actual test results .


Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergoing selective cardiac surgery, aged between 18 and 80.

Exclusion Criteria:

* Normal range of creatinine before operation
Prevention of Critical Incidents Related to the Nursing With Patients in Intensive Care Units

The purpose of this study is to assess the effectiveness of a best practices nursing protocol in intensive care units on the occurrence of critical incidents compared to the common practices.

To develop the best practices nursing protocol in intensive care units, three steps were necessary:

1. An incidence study of occurrence of critical incidents linked to nursing was conducted during a month in nine intensive care units to identify high risk clinical situations
2. A qualitative study (individual interviews and focus groups) with nurses was led to elicit nurse's risk anticipatory strategies during nursing
3. Based on the results of the two previous step, a working group proposed a best nursing practices protocol to limit critical incidents

Methodology to assess the effectiveness of the protocol of best nursing practices:

The statistical unit is the nursing act for one patient meeting the inclusion criteria (a patient is nursed two times or more per day) Nine intensive care units are included in the study Intensive care units includes 127 beds, their average occupancy rate is approximately 80 % which means about 330 nursing a day and about 9900 nursing a month.

An occurrence of critical incidents (primary outcome measure) of 25% is expected (approximately 2475 critical incidents per month). To show a reduction of 50% of critical incidents in the interventional group, 6 month inclusion will be necessary, whatever the value of the inflation coefficient.

The patient will be under observation during 60 min if a critical incident occurs. And only during nursing if no critical incident occurs.

Data will be collected at bedside.

Patients will be included for the entire duration of the hospitalization in intensive care unit, if inclusion criteria are still met.

Data collection:

* Characteristics of the intensive care unit
* Characteristics of the patient
* Characteristics of the nurse
* Characteristics of the medical equipment of the patient
* Physiological parameters before, during and after nursing (see primary outcome measures)

The best nursing practices protocol will be consider as efficient if a reduction of 50% of critical incident can be established.

Statistical analysis will be in the intent-to-treat.

Hospitals as part of qualitative policy request a declaration of each critical incident. This circus of declaration will not be changed.

Eligibility Criteria:
Inclusion Criteria:

* Patient in intensive care units
* Patient who has received complete information on the organization of the research and who has not objected to his participation and the exploitation of his data

Exclusion Criteria:

* Moribund patients
* Nursing made in the chair or in the shower stretcher
* Patient able to wash and dress alone (or just with the assistance of a nurse)
* Person under legal protection
* Person deprived of liberty by a judicial or administrative decision
* Person being the object of psychiatric care by virtue of articles L. 3212-1 and L. 3213-1 of the french Code of Public Health
Effect of LIA on Postoperative Pain Following ACL Reconstruction

An anterior cruciate ligament (ACL) rupture is one of the most common sport injuries, which typically develops after a sudden knee torsion. Arthroscopic repair of the ACL is often required as a complete ACL tear can cause instability of the knee joint.

During arthroscopic reconstruction the lower leg is reattached to the upper leg using part of the hamstring tendon (mm. gracilis and mm. semitendinosus). Optimal postoperative analgesia is necessary to allow a quick recovery. Intravenous analgesia during surgery is often associated with a number of side effects such as nausea, vomiting and muscle weakness and does not anesthetize the donor site of the hamstring tendon graft. Local infiltration of ropivacaine and lidocaine in the knee joint and at the donor site can be a valuable asset to control the postoperative pain.

This study evaluates the effect of local infiltration analgesia (LIA) on the postoperative pain in the first month after an ACL reconstruction. Half of participants will only receive intravenous analgesia during surgery, the other half will receive intravenous analgesia and a LIA.

2 x 20 patients which are planned for arthroscopic ACL reconstruction are randomised: standard-group and LIA-group.

All patients receive standardised multimodal intravenous analgesia. After standardised induction of anesthesia, patient positioning and administration of basic analgetics (paracetamol, diclofenac, clonidine and morfine), patients in the LIA-group receive a local infiltration in the knee of 10 mL ropivacaine and 10 mL lidocaine.

Visual Analogue Scores are assessed 15 minutes after awakening from surgery and on Day 1, 2, 3, 7, 14, 21 and 28 after surgery. Postoperative analgesic consumption are registered in the first month after the surgery. The quality of recovery after anesthesia is assessed on Day 1 by the postoperative quality of recovery score (QoR-15).

Eligibility Criteria:
Inclusion Criteria:

* elective arthroscopic anterior cruciate ligament reconstruction
* adult

Exclusion Criteria:

* unwilling or unable to grant written informed consent
* revisions
* contra-indication for ropivacaine
Evaluation of Medical Device

A preliminary study was conducted from 01/26/2015 to 10/26/2015 on 605 patients admitted to MIA with an intravenous and/or a urinary catheter.

the investigators analyzed:

* the demographic characteristics of the patient
* the final diagnosis
* the patient's severity and the patient outcome after discharge from MIA
* the justification of the venous and or a urinary catheter
* the duration of the prescription of the device Evaluation on admission of the need to maintain an intravenous or urinary catheter. Adjusting the prescription in terms of duration or withdrawal of the device in order to limit their complications (lymphangitis, superficial thrombophlebitis, bacteremia related to health care, urinary tract infection).

Hypothesis:

Limit the length of stay and reduce the cost of hospitalization.


Eligibility Criteria:
Inclusion Criteria:

* Patient with an intravenous catheter and/or a urinary catheter.
* Patient is more than 18 years old.
* Patient who accepts to have his medical records reviewed for research.
* Patient with health insurance

Exclusion Criteria:

* Refusal of participation in the study
Substance Use Disorders and Tobacco Habits

In the department for substance use disorders at Uppsala University Hospital there are two wards. One that is locked, where the patients that are emitted can not go out to smoke and another ward where there is a possibility to go out and smoke during the day.

The smoking habits on those two floors will be compared and how they feel about smoking will be evaluated when they are admitted to the ward, at discharge, after 1 mont and after 6 months.

In the department for substance use disorders at Uppsala University Hospital there are two wards. One that is locked, where the patients that are emitted can not go out to smoke and another ward where there is a possibility to go out and smoke during the day.

The smoking habits on those two wards will be compared and how they feel about smoking will be evaluated when they are admitted to the ward, at discharge, after 1 mont and after 6 months.

The questionnaires that will be used for evaluation are:

Fagerstöms test for nicotine dependence, Alcohol Use Disorders Identification Test and Drug Use Disorders Identification Test and the symptoms of Tobacco withdrawal mentioned in DSM-V.

Parameters that will be measured are: pulse, bloodpressure, peak expiratory flow, wight and height.

There will also be some questions about their smoking and snuff habits, if they have tried to quite smoking Before and how they were affected by the stop.

Eligibility Criteria:
Inclusion Criteria: Substance use disorder -

Exclusion Criteria: Disorganization, psychosis and if you can not speak Swedish.

-
Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease (US202)

The primary objective is to evaluate the efficacy of T-817MA as measured by ADAS-cog and ADCS-CGIC.

The secondary objectives are:

* To evaluate the safety and tolerability of T-817MA measured by clinical safety laboratories, physical examinations, ECGs and solicitation of adverse events.
* To evaluate the efficacy of T-817MA as measured by ADCS-ADL, FAQ, Neuropsychiatric Inventory (NPI) and Mini-mental State Examination (MMSE).


Eligibility Criteria:
Inclusion Criteria:

* Male or female (post-menopausal or surgically sterile)
* Patients with Mild to moderate Alzheimer's disease who are receiving donepezil (Aricept®) or rivastigmine transdermal system (Exelon® Patch), . Memantine (Namenda®) is allowed only when prescribed in combination with donepezil or rivastigmine transdermal system.
* Age 55 to 85 inclusive
* Patients must be living in the community
* Patients must have an eligible informant or study partner (caregiver)
* Patients and eligible informant or study partner (caregiver) must be able to read and understand English.
* Informed consent obtained from both the patient and the caregiver

Exclusion Criteria:

* Patients with clinically significant cardiac, hepatic or renal impairment
* Patient have a dementia not of the Alzheimer's type etc (According to the protocol)
* Patients who are taking any drug other than donepezil or rivastigmine transdermal system for Alzheimer's disease, including olal rivastigmine (Exelon®), galantamine (Razadyne®)
Evaluation of the LightSheer HS Hand Piece as Compared to the LightSheer ET Hand Piece for the Intended Use of Hair Removal and Permanent Hair Reduction

To observe the qualitative comparison of follicular damage between treatment with the LightSheer Duet hand pieces (ET and HS) as assessed by horizontal biopsy.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male adult, 18 years of age or older with skin type I-V;
2. Having a suitable treatment area for hair removal with brown or black hair (no gray);
3. Able and willing to comply with the treatment/follow-up schedule and requirements;
4. Able to read, understand and provide written Informed Consent.

Exclusion Criteria:

1. Showing symptoms of hormonal disorders, as per the Investigator's discretion;
2. Use of oral isotretinoin (Accutane®) within 6 months, or off label use of topical isotretinoin in immediate treated area or in its proximity within 3 months, of study enrollment or during the course of the study;
3. Prior skin treatment with laser or other devices on the same treated areas prior to study enrollment or during the course of the study;
4. Adverse reaction to the treatment gel to be used in the evaluation;
5. History of keloid formation or poor wound healing in a previously injured skin area;
6. Significant skin conditions affecting treated area or inflammatory skin conditions;
7. Open laceration, abrasion, active cold sores or herpes sores on area to be treated;
8. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications;
9. Having a bleeding disorder or taking anticoagulation medications within the preceding 6 months;
10. Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the area to be treated;
11. Significant concurrent illness, such as diabetes, lupus, epilepsy or cardiac disorders, which might be aggravated as a result of treatment;
12. Unable or unlikely to refrain from tanning, including the use of tanning booths, tanning spray or cream, during the course of the evaluation;
13. Photosensitivity disorder that can be exacerbated by infrared light;
14. Tattoos in the treatment areas;
15. Dysplastic nevi in the treatment areas;
16. Allergy or history of an allergy to the topical anesthetic used.
17. Participation in a study of another device or drug within 3 months prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria;
18. Mentally incompetent, prisoner or evidence of active substance or alcohol abuse;
19. Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study.
Increasing Communication About Live Donor Kidney Transplant

This study will test the efficacy of a communication intervention intended to increase and improve kidney transplant candidates' communication about live donor kidney transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Wait listed for kidney transplantation in active status (i.e., status 1 or 2)
* Adult (at least 18 years of age)
* English speaking
* Capable of making medical decisions (i.e., not cognitively impaired)
* Non-institutionalized

Exclusion Criteria:

* Not listed for kidney transplantation or wait listed, but not in active status
* Under 18 years of age
* Non-English speaking
* Cognitively impaired
* Institutionalized
Viral Specific T-cells for Treatment of COVID-19

The purpose of this research study is to learn more about the use of viral specific T-lymphocytes (VSTs) when given in the presence of COVID-19 signs and symptoms, caused by the virus SARS-CoV-2. VSTs are cells specially designed to fight viral infections. These cells are created from a blood sample collected from a donor who has recovered from COVID-19 infection. VSTs are investigational meaning that they are not approved by the Food and Drug Administration (FDA).

COVID-19 is a new virus and treatment options are evolving rapidly. VSTs have been successfully used to treat many different viral infections and may be beneficial in treating COVID-19 in the absence of other treatments.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who have evidence of infection with SARS-CoV-2
2. Patients with symptomatic COVID-19 disease, as defined by at least one of the following

   1. Imaging (CXR, CT scan, etc.) with pulmonary infiltrates consistent with COVID-19 infection
   2. Requirement for supplemental oxygenation
   3. Need for additional respiratory support, including, but not limited to High flow 02, CPAP, BiPAP, Mechanical ventilation
3. Age \>1 day
4. Clinical status must allow tapering of steroids to \< 0.5mg/kg prednisone or other steroid equivalent
5. Have failed at least one FDA-approved treatment for COVID-19 disease
6. Must be able to receive VST infusion in Ohio (informed consent obtained by CCHMC PI or sub-investigator either in person or by phone)

Exclusion Criteria:

1. Uncontrolled bacterial or fungal infection
2. Uncontrolled relapse of malignancy
3. Unlikely to survive within 48 hours of VST infusion
3D Analysis of Cemento-Osseous Lesions

COD lesions effect a wide range of different anatomical areas, show different volume and morphometric characteristics.

Fibro-osseous lesions of the jaws are one of the important lesion groups for which identification and diagnosis create clinical difficulties. In previous studies, the features of the lesions and the effects of COD on anatomical structures were analysed via CBCT images by measuring the lesion's dimensions linearly for the first time in the Brazilian population. However, 3D measurements of the volume need to be taken to assess the actual spread over adjacent anatomical structures. The purpose of this retrospective study is to measure the volume of the lesions that have been diagnosed as COD in the Turkish population by using 3D images. This will contribute to an advanced study conducted on the global population to observe a change in these morphologies with respect to different geographical and ethnic origins.

Eligibility Criteria:
Inclusion Criteria:

* They were diagnosed with fibro-osseous lesions with the help of cone beam computed tomography between 2017 and 2020 were included in the study.
* The lesions diagnosed radiologically and followed up for at least one year were included in this study.

Exclusion Criteria:

-Radiographs with insufficient diagnostic images were not included.
Assessing Perceived Versus Actual Knowledge and Quality of Life in Pre-Dialysis Chronic Kidney Disease (CKD) Patients

Aims: The investigators' primary objective is to assess both perceived and actual disease knowledge in local pre-dialysis Chronic Kidney Disease (CKD) patients. The investigators hypothesize that actual disease knowledge is poorer than perceived. As the secondary objectives, the investigators will also assess the HRQoL and examine the association between level of knowledge and HRQoL in pre-dialysis CKD patients. The investigators hypothesize that HRQoL of pre-dialysis CKD patients is poorer than that of the general population while pre-dialysis CKD patients with greater disease knowledge have a better HRQoL than those with poorer knowledge.

Methodology: A survey was developed to assess both perceived and actual knowledge on five aspects - general knowledge, nephrotoxic medications, diet restrictions, symptoms of CKD and its complications and renal replacement therapy (RRT) options. For the assessment of HRQoL, the following questionnaires will be used - Kidney Disease Quality of Life-Short Form (KDQOL-SF) version 1.3, EuroQoL 5 Dimensions (EQ-5D), Family Functioning Measure (FFM), and Oslo-3 Social Support Scale (OSS-3). All study questionnaires will be provided in 3 main languages - English, Chinese and Malay. A standardized data collection form was developed to retrospectively collect demographic and clinical information from the patients' electronic medical records and patient charts. Descriptive statistics will be used to report all results.


Eligibility Criteria:
Inclusion Criteria:

* patients at least 21 years of age,
* able to read English, Chinese or Malay,
* have stage 3 to 5 CKD as identified from their medical records, but are not receiving dialysis.

Exclusion Criteria:

* patients who do not consent,
* have already been started on dialysis,
* are cognitively impaired as assessed by the recruiter or unable to fill up questionnaires on their own.