cyrilzakka/clinical-trials huggingface dataset:
Non-Pharmacological Interventions on Patient Experience and Healthcare Utilization in Adult Cardiac Surgery Patients

This study will assess whether non-pharmacological interventions by a comfort coach affect the amount of opioid pain medication used, as well as perceived physical pain and emotional anxiety and healthcare utilization for adult cardiac surgery patients. Participants that are eligible for the study will be randomized to the comfort coach arm or standard of care. Both groups will complete surveys at the specific time frames in order to compare their outcomes. The study hypothesis is that there will be a decrease in opioid use in the intervention group compared to the standard of care arm during the 90-day perioperative course, as well as a decrease in pain and anxiety along with a lower composite outcome of healthcare utilization.


Eligibility Criteria:
Inclusion Criteria:

* Receiving a first-time elective status open heart cardiac surgery procedure in the Frankel Cardiovascular Center at Michigan Medicine during the recruitment period through a full or miniature sternotomy incision
* Opioid-naïve, defined as not taking a home opioid medication at time of preoperative H\&P

Exclusion Criteria:

* Patients undergoing cardiac transplantation, implantation of ventricular assist device, reoperation, and any planned use of circulatory arrest
* Chronic opioid users defined as taking an opioid at time of preoperative clinic visit
* Non-English speaking
* Inability to understand or complete surveys
* Pregnancy
* Unable to sign legal consent form (legal guardian signature not acceptable)
Patient Satisfaction and Crestal Bone Loss of Polymer Infiltrated Ceramic Network Versus Lithium Disilicate Implant Hybrid Abutment Crowns in Esthetic Zone

P: Population: Patients requiring single unit implant restoration in esthetic zone I: Intervention: Polymer-infiltrated-ceramic-network abutment crown (VITA Enamic-VITA Zahnfabrik) C: Comparison: Lithium disilicate ceramic abutment crown (IPS e. max-Ivoclar Vivadent) O: Outcome: patient satisfaction , crestal bone loss and periodontal parameters T: Time: 12 months S :Randomized controlled trial research question:For patients receiving implants in esthetic zone, Does the use of polymer-infiltrated-ceramic-network hybrid abutment crown offer better patient satisfaction , less bone loss and better peri-implant clinical parameters when compared to lithium disilicate hybrid abutment crowns?


Eligibility Criteria:
Inclusion Criteria:

1. Patients above 18 years old.
2. Patients able to read and sign the informed consent document.
3. Medically free patients or with controlled systemic disease.
4. Patients with good bone quality and quantity evaluated using C.B.C.T.
5. Patients willing to return for follow-up examinations and evaluation.
6. Patients having single missing recently extracted premolar tooth.

Exclusion Criteria:

1. Young patients in growth stage.
2. Patients with unsuitable implantation sites (patients with major boney defects or sever bone resorption)
3. Pregnant women to avoid any complication that may occur in dental office.
4. Patients with uncontrolled systemic disease (hypertensive patient or uncontrolled diabetic patient)
5. Psychiatric problems or unrealistic expectations.
6. Multiple adjacent missing teeth.
7. Patients with bad oral hygiene. -
Effect of Kinesiotaping Augmented By Resistive Exercise on Fatigue, Physical Strength, Quality of Life in Breast Cancer Survivors

The purpose of the study will be to investigate the effect of kinesotaping augmented by resistive exercise on fatigue, muscle strength, and QoL in breast cancer survivors.

The present study will provide an evidence base to women's health care providers about the effect of strength training augmented by kinesotaping on fatigue, QoL and muscle strength in breast cancer women compared to strength training alone

Eligibility Criteria:
Inclusion Criteria:

* Patient's age will range from 40- 55 years.
* Their body mass index (BMI) will be from 25 to 29,9 Kg/m2.
* They suffer from breast cancer.
* They will receive chemotherapy within previous 3 months.
* They complain from fatigue, deterioration in their daily living activity (ADL) and feeling of weakness in their muscles.

Exclusion Criteria:

* Respiratory or heart problems affecting mobility
* Marked skeletal deformity.
* Visual system affection.
* Cognition problems.
* Previous surgeries at their back and/or lower limbs.
Tool for Inappropriate Prescription Evaluation: The TaIPE Study

A mono-center, randomized controlled trial will be conducted at the University Hospital of Lausanne. Hospitalized patients will be randomly assigned from the emergency department to two sub-units composing the acute care for elders (ACE) unit. In one subunit, potentially inappropriate prescriptions will be detected and treatment optimized according PIM-Check. In the other, STOPP/START criteria will be independently applied.


Eligibility Criteria:
Inclusion Criteria:

* All patients meeting the admission criteria of the acute care for elders (ACE) unit will be eligible.

Exclusion Criteria:

* none
IVC Ultrasonography Versus Plethysmographic Variability Index for Prediction of General Anesthesia Induction Hypotension

This thesis aims to evaluate the ability of preoperative plethysmographic variability index to predict post-induction hypotension in comparison with ultrasound measurements of inferior vena cava (IVC) diameter.

Prospective cohort study. Upon arrival to the operating room, routine monitors (ECG, pulse oximetry, and non-invasive blood pressure monitor) will be applied, intravenous line will be secured and routine premedications (ranitidine 50 mg and ondansteron 4mg) will be administrated.

Then inferior vena cava ultrasonography will be performed. Maximum and minimum IVC diameters over a single respiratory cycle will be measured using built-in software. The CI will be calculated as: CI = (dIVCmax - dIVCmin)/dIVCmax , it will be expressed as a percentage.

Plethysmographic variability index and a perfusion index readings will be taken preinduction in the form of three readings on one-minute interval.

Induction of anaesthesia will be achieved using propofol (2 mg/Kg) and atracurium (0.5 mg/Kg). Endotracheal tube will be inserted after 3 minutes of mask ventilation.

Anaesthesia will be maintained by isoflurane (1-1.5%) and atracurium 10 mg increments every 20 minutes. Ringer lactate solution will be infused at a rate of 2 mL/Kg/hour.

Any episode of hypotension (defined as mean arterial pressure \< 80% of the baseline reading) will be managed by 5mcg norepinephrine.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18years)
* ASA I-II-III
* Patients scheduled for elective surgeries under general anaesthesia.

Exclusion Criteria:

* Operations which will last for less than 15 minutes.
* Patients with cardiac morbidities (impaired contractility with ejection fraction \< 40% and tight valvular lesions, unstable angina).
* Patients with heart block and arrhythmia (atrial fibrillation and frequent ventricular or supraventricular premature beat).
* Patient with decompansted respiratory disease (poor functional capacity, generalized wheezes, peripheral O2 saturation \< 90% on room air).
* Patients with increased intraabdominal pressure (intrabdominal mass compressing IVC).
* Patients with peripheral vascular disease or long standing DM affecting PVI readings.
* Pregnancy
The Effects of General Anesthesia on Microcirculation of Central and Peripheral Soft Tissue: a Comparison of Inhalational and Intravenous Anesthetics

Effects of different general anesthetics on peripheral microcirculation.

Human keep body temperature in a narrow range by a variety of regulatory mechanism. Peripheral thermal receptors send signals to central nervous system which regulate body temperature via peripheral effectors, such as vasoconstriction, vasodilatation, shivering, sweating and etc. In patients undergoing general anesthesia, the regulatory mechanism is altered. General anesthesia changes blood distribution in the body, the metabolic rate of muscle, threshold of thermal regulation in the brain and etc, so that heat distribution and microcirculation condition will also change. In this study, near-infrared spectroscopy (NIRS) is used to measure the microcirculatory condition. NIRS is a non-invasive continuous measurement to detect tissue saturation with the method of different wavelength of near-infrared. General anesthesia with inhalational sevoflurane and intravenous propofol is separated into 2 groups. Because of different mechanism of general anesthesia of these 2 anesthetics, different physiologic response may occur. Body temperature and somatic saturation are compared in each group.

Eligibility Criteria:
Inclusion Criteria:

1. Breast surgeries under general anesthesia
2. BMI 18.5\~30

Exclusion Criteria:

1. Cardiac disease
2. Lung disease
3. Renal disease
4. Neurological disease
5. Autonomic nervous system dysfunction
Early Diagnosis of Therapy-associated Cardiotoxicity Basing on PET/CT in Lymphoma

To explore the value of 18F-fluorodeoxyglucose (FDG) PET/CT imaging in early diagnosis of treatment-related cardiotoxicity (TACT) of lymphoma using visual method and semi-quantitative method.

First of all, the cardiac 18F-FDG uptake in patients with lymphoma will be observed by visual method: according to the uptake site, it will be divided into left ventricular uptake and biventricular uptake, and according to the degree of uptake, it will be divided into equal uptake (myocardial uptake is lower than cardiac blood pool uptake), moderate uptake (myocardial uptake is between cardiac blood pool uptake and liver uptake) and high uptake (myocardial uptake is higher than liver uptake). According to the uptake pattern, it can be divided into diffuse and segmental uptake.Then,using the region of interest method to mesure the value of myocardial uptake of 18F-FDG.The difference value of heart's SUVmax (Δ SUVmax- heart) and% Δ SUVmax- heart before and after chemotherapy or immunotherapy will be calculated. And SUVmax- heart / SUVmax- mediastinum ratio, SUVmax- heart / SUVmax- liver ratio and SUVmax- heart / SUVmax- background ratio (left gluteal muscle) after treatment. Taking the abnormality of ECG (early TACT) as the end point.

Eligibility Criteria:
Inclusion Criteria:

1. No previous history of heart disease.
2. normal echocardiography, ECG and laboratory tests (creatine kinase, myoglobin, troponin, brain natriuretic peptide) before treatment.

3.18F-FDG PET/CT examination before and after treatment

-

Exclusion Criteria:

1.receiving radiotherapy and chemotherapy at the same time. 2.previous chest radiotherapy. 3. with severe hepatic or renal dysfunction.

-
A Clinical Trial Testing the Efficacy of PDT in Preventing Amputation in Diabetic Patients

The feet of diabetic patients continue to be an important problem in medicine. In general, patients with diabetic foot have some sort of amputation, especially in underserved populations. It is clearly necessary to develop novel treatment strategies for this worldwide health problem. Photodynamic therapy (PDT) , is a low cost and highly effective alternative treatment concerning infections avoiding amputations in the diabetic foot.

Patients with infected diabetic foot were grouped according to the Wagner system for classifying foot lesions. All patients presented Wagner Grade 3 classification, with osteomyelitis in one or more toes. The study included only patients who had circulatory viability.

For PDT treatment the fistula and/or ulcer was used as a gateway to the bone. The treated area (bones and fingers) was irrigated with a solution of phenothiazinium salts. After that, light irradiation was performed with optical fibers or led device above the wound. PDT treatment always in outpatients, once or twice a week.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years old
* diabetes
* diabetic foot
* Wagner grade III

Exclusion Criteria:

* age \< 18 years old
* non-diabetic
* Wagner IV and V
* ischemia
A Phase III Study of Insulin Aspart Injection to Evaluate the Efficacy and Safety

This is a multicenter, randomized, open, parallel group, active-controlled study. The study period is 25 to 26 weeks, including screening period of 1-2 weeks and treatment period of 24 weeks.

After the screening visit, all patients who met all inclusion criteria and do not meet any of the exclusion criteria were randomized into the experimental group or the controlled group. The subjects in the experimental arm will receive insulin aspart injection combined with basal insulin (Lantus ®), and the subjects in the controlled arm will receive NovoRapid ® (active control) combined with basal insulin (Lantus ®). The experimental drug or the controlled drug will be administered subcutaneously prior to three meals (or can be administered immediately after meal if necessary), and the basal insulin (Lantus ®) will be administered at bedtime. The treatment period is 24 weeks, during which the subjects will be followed up at the clincic cetres at 1, 2, 4, 8, 12, 18, 24 weeks of treatment. At the end of 24-week treatment, if the adverse events continue, the subjects will be followed until recovery or stabilization of the AEs.

Eligibility Criteria:
Inclusion Criteria:

* Patients were diagnosed with diabetes；
* BMI≤35.0 kg/m2；
* Insulin therapy for at least 3 months before recruitment；
* HbA1c7\~13%

Exclusion Criteria:

* Patients to study drug allergy；
* to Liver and kidney impairment；
* Liver and kidney impairment；
* used systemic steroid treatment in past 2 months .
Patisiran in Patients With Hereditary Transthyretin-mediated Amyloidosis (hATTR Amyloidosis) Disease Progression Post-Liver Transplant

The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of patisiran in participants with hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) with disease progression after liver transplant.


Eligibility Criteria:
Inclusion Criteria:

* Received liver transplant for treatment of hATTR amyloidosis ≥12 months before study start
* Has increase in polyneuropathy disability (PND) score after liver transplant
* Has received stable immunosuppressive regimen with ≤10 mg/day of prednisone for at least 3 months before study start
* Has Karnofsky Performance Status (KPS) of ≥70%
* Has vitamin A level greater than or equal to lower limit of normal

Exclusion Criteria:

* Has previously received inotersen or patisiran
* Has clinically significant liver function test abnormalities
* Has known portal hypertension with ascites
* Has estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73 m\^2
* Has known leptomeningeal amyloidosis
* Has infection with hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
* Has New York Heart Association heart failure classification of \>2
* Is wheelchair bound or bedridden
* Has received organ transplants other than liver transplant
* Will be using another tetramer stabilizer during the study
The Belgian Diabetes in Pregnancy Follow-up Study

Gestational diabetes (GDM) is a form of diabetes that develops during pregnancy. GDM is associated with increased risks for pregnancy complications such as macrosomia s and preterm delivery. Women with a history of GDM have a high risk to develop a type 2 diabetes (T2DM) within the next ten years after delivery. The children are also at increased risk of developing obesity and T2DM later in life. Studies are needed to find more accurate predictors for the metabolic risk later in life. This will help to individualize the follow-up and to develop tailored prevention strategies in women and offspring with a history of GDM. In this research project we will therefore investigate how the long-term metabolic risk can more accurately be predicted in a follow-up cohort of the 'Belgian Diabetes in Pregnancy study' (BEDIP-N). We will study the relationship between maternal weight, degree of body fat and degree of hyperglycaemia in pregnancy on the long-term metabolic risk of 375 women and offspring pairs 3-7 years after the delivery across different gestational glucose tolerance groups based on the 2013 WHO criteria in pregnancy. In addition, we will study whether a promising new biomarker, glycated CD59, is a good predictor for the long-term metabolic risk.


Eligibility Criteria:
Inclusion Criteria:

* Mothers who participated in the completed BEDIP-N study and received both the GCT as the OGTT during pregnancy
* Offspring born at the time of participation in the BEDIP-N study

Exclusion Criteria:

* Mothers:

  * Current pregnancy
  * Treatment that influences glycaemic status such as high dose corticoids.
  * History of bariatric surgery
  * gastro-intestinal surgery changing the absorption of glucose (Billroth II)
  * A normal study visit will not be possible (incompliance, psychiatric problems...)
  * Diagnosed with type 1 diabetes or the presence of auto-immune antibodies for type 1 diabetes

Offspring:

* Treatment that influences glycaemic status such as high dose corticoids.
* A normal study visit will not be possible (incompliance, psychiatric problems...)
* Diagnosed with type 1 diabetes or the presence of auto-immune antibodies for type 1 diabetes
Stroke Team Remote Evaluation Using a Digital Observation Camera- Long Term Outcomes(STRokE DOC-LTO)

SPECIFIC AIM: The specific aims of this study are to evaluate the long term outcomes of patients previously enrolled in the STRokE DOC ("STRokE DOC Trial (NCT00283868)") telemedicine clinical trial.

AIM 1: Aim 1 is a non- randomized, retrospective, data collection study assessing long term patient outcomes of patients previously enrolled in a telemedicine vs. telephone clinical trial (STRokE DOC Trial ("STRokE DOC Trial (NCT00283868)"); now completed). STRokE DOC-LTO will evaluate, (only for those patients previously enrolled in the original telemedicine vs. telephone clinical research trial), the long term patient outcomes; comparing telemedicine versus telephone-only consultations.

SPECIFIC AIM: The specific aims of this study are to evaluate the long term outcomes of patients previously enrolled in the STRokE DOC ("STRokE DOC Trial (NCT00283868)") telemedicine clinical trial.

AIM 1: Aim 1 is a non- randomized, retrospective, data collection study assessing long term patient outcomes of patients previously enrolled in a telemedicine vs. telephone clinical trial (STRokE DOC Trial ("STRokE DOC Trial (NCT00283868)"); now completed). STRokE DOC-LTO will evaluate, (only for those patients previously enrolled in the original telemedicine vs. telephone clinical research trial), the long term patient outcomes; comparing telemedicine versus telephone-only consultations.

Specific Protocol Information: The protocol will contact these patients by telephone. One of 5 Stroke Center team members will contact the patient, using strict telephone scripted language (approved by the IRB) and ask questions regarding

1. current functional status
2. death
3. Hemorrhage
4. Recurrent Stroke
5. Disposition for 3 time periods (6 months after index event, 12 months after index event, and "current" time of contact.

Eligibility Criteria:
Inclusion Criteria are:

1. Male or female subjects, age \> 18 years.
2. Prior enrollment into the STRokE DOC ("STRokE DOC Trial (NCT00283868)") clinical research trial.

Exclusion criteria are:

1. Male or female subjects, age \< 18 years.
2. Patients not previously enrolled into the STRokE DOC ("STRokE DOC Trial (NCT00283868)") clinical research trial.
Gait Classification in Children With Cerebral Palsy, a Reliability Study

The goal of this observational study is to assess whether gait classification patterns can be reliably obtained from video recordings in comparison with three-dimensional kinematic data.

The main questions it aims to answer are:

Are gait classifications from video recordings reliable between raters? Are gait classifications from video recordings valid in comparison with three-dimensional kinematic data?

Gait analysis data from participants who visited the gait lab in the Karolinska Hospital will be used for this purpose.

Current retrospective observational study aims to assess the reliability and validity of gait pattern classification systems in ambulatory children with CP. Gait classification is often performed using kinematic gait data obtained via a three dimensional (3D) data captured in a specialized gait lab using infra-red cameras. However, not all hospitals and clinical centers have access to such a specialized gait lab, and therefore often use video recordings as an alternative for gait classification. It is currently not known whether such a classification based on solely video recordings is equally reliable in comparison with kinematic gait data. For this purpose, current study aims to assess the reliability and validity of video recordings to classify children with CP according to predefined gait classifications. Sagittal plane video recordings during barefoot walking in children with CP will be used to classify the study participants into seven different gait classification patterns. For reliability, inter-rater reliability between raters scoring the video recordings will be assessed. To evaluate whether video recordings could serve as a valid alternative for kinematic gait data, the agreement between the classifications from the video recordings and the kinematic data additionally will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Main diagnosis of spastic cerebral palsy
* Age 3 to 18 at the time of gait analysis
* Availability of barefoot walking data collected at the Karolinska Hospital gait lab
* Written informed consent of both parents to use the clinically collected data as research data

Exclusion Criteria:

* Main diagnosis of dyskinetic or ataxic cerebral palsy
* No barefoot walking trials available
* No kinematic data available
* BTX-A injections 6 months prior to gait analysis
* Orthopaedic surgery one year prior to gait analysis
A Prospective Cohort Study:Forecast Fracture Risk With a Serum Marker of Type 2 Diabetes in Guangzhou Community

The objective of this study is to find out the biochemical markers which have independent predictive value of fragility fractures risk with Type 2 diabetes in Guangzhou community and evaluate bone strength better and increase the ability of recognizing fracture risk through following-up visits the bone metabolism index like esRAGE-to-pentosidine ratio of the petients with type 2 diabetes and osteoporosis,compared with the classical fracture risk assessment instrument.


Eligibility Criteria:
Inclusion Criteria:

* (1) aged 18-65 years; (2) patients were diagnosed with type 2 diabetes based on the definition of diabetes of WHO in 1999.

Exclusion Criteria:

* 1. type 1 diabetes and other specific types of diabetes; 2. diabetes related acute complications like diabetic ketoacidosis and hyperglycemic hyperosmolar status. 3. had used drugs that is known to have effect on bone(like active vitamin D, bisphosphonate, calcitonin, estrogen receptor modulators, estrogen, thiazolidinediones); 4. suffer from diseases that is known to have effect on bone (hyperthyroidism, hypothyroidism, hyperparathyroidism, hypoparathyroidism,cushing syndrome,chronic renal failure,renal tubular acidosis,osteoporosis after gastrectomy,osteoporosis caused by liver disease,rheumatoid disease,osteoporosis induced by gastrointestinal absorption dysfunction); 5. disuse osteoporosis; 6. cannot be exposure to sunlight due to skin diseases; 7. use glucocorticoids for over 3 months.