cyrilzakka/clinical-trials huggingface dataset:
PVB vs PECS Block in Breast Surgery

Purpose to compare paravertebral thoracic block (PVB) and pectorals nerves block as analgesic option for major breast surgery.

102 patients undergoing reconstruction breast surgery will be randomized into two groups: Group PVB (n=51) will receive US guided paravertebral thoracic block (between T2-T6) performed with 30ml of 0.25% levobupivacaine before general anesthesia (TCI-TIVA) induction.

Morphine patient control analgesia (PCA) with loading dose i.v. titrated by the PACU nurse if pain \> 5/10 at rest Group PECS (n=51) will receive US guided pectorals nerves block performed with 30ml of 0.25% levobupivacaine before general anesthesia (TCI-TIVA) induction.

Morphine PCA with loading dose i.v. titrated by the post-anesthesia care unit (PACU) nurse if pain \> 5/10 at rest

Primary Outcome Measures:

Morphine consumption (mg) (Time Frame: 24 hours) in two Groups

Secondary Outcome Measures:

Pain at rest and during movement quantified as Numerical Rating Scores (0-10) during the first 24 hours postoperatively.

Eventual side effects such as nausea/vomiting. Time necessary to perform the procedure. Pain during procedure execution quantified as Numerical Rating Scores (0-10) Hypnotic and opioids intraoperative consumption to ensure general anesthesia with Bispectral Index between 40 and 60.


Eligibility Criteria:
Inclusion Criteria:

* age\> 18 years
* ASA score I - II - III
* undergoing elective reconstruction breast surgery
* signed informed consent

Exclusion Criteria:

* chronic therapy with opioids/ antidepressants
* urgent/emergent surgery
* postoperative transfer to the intensive care unit
* known allergy to any drug medication
* local skin infection
* epilepsy
* alcohol or drug abuse
Outcome of Rehabilitation of Older People in Primary Health Care

The Outcome of Multi-Disciplinary, Structured Rehabilitation of Older People in a District Inpatient Rehabilitation Centre is better than in a Standard Primary Health Care Rehabilitation Programme in Short Term Beds in Nursing Homes.


Eligibility Criteria:
Inclusion Criteria:

* Both Genders
* Age=\>65 Years
* Diagnoses: Stroke, Hip Fractures, Osteoarthritis, Chronic, slowly progressing Diseases, Functional Decline due to Old Age, Functional Decline due to Long Hospital Stay
* Assessed to have a Rehabilitation Potential

Exclusion Criteria:

* Age\<65 Years
* Patietns with Highly Progressive Diseases
* Sunnaas ADL Index\<10
* MMSE\<18
* Deeply Depressed Patients with no Initiative
* Patients with Speech Dyspnoea
* Patients with unstable Angina Pectoris
* Patients with not diagnosed Cardiac Arrythmias
Educational Video Versus In-person Genetic Counseling for Hereditary Cancer

The identification of mutations in cancer susceptibility genes is important as it makes it possible to recommend specific cancer treatments, implement risk reduction strategies or early detection of cancer, and identify family members at risk. The guidelines for evaluating patients who are candidates for genetic testing recommend pre-test genetic counseling. However, the limited number of specialists trained to provide genetic counseling worldwide, and particularly in developing countries such as Mexico, makes it difficult to implement such recommendations. The present proposal aims to compare, through a randomized non-inferiority study, a pre-test education strategy using a pre-recorded video against in-person counseling. This strategy could potentially increase access in places with limited resources.

The general hypothesis of the research is that patients who are candidates for cancer genetic susceptibility testing who receive pre-test education via video will consent to genetic testing in the same proportion as those who receive it during an in-person visit.

The specific objectives of the study include: 1) to compare the proportion of patients who are tested in both groups; 2) to assess knowledge about hereditary cancer in both groups after the intervention; 3) assess anxiety symptoms in both groups after the intervention; and 4) assess satisfaction with the information received during the intervention.Patients \>18 years of age who meet the criteria for genetic testing to evaluate genetic cancer susceptibility genes and who have not previously undergone genetic testing or genetic counseling will be invited. The intervention group will receive education via pre-recorded video and the control group will receive genetic counseling during an in-person consultation.


Eligibility Criteria:
Inclusion Criteria:

* Meet cancer genetic testing criteria

Exclusion Criteria:

* Had a genetic testing before
* Had genetic counseling before
Safety Study of a Single Dose of REGN88(SAR153191)in Patients With Rheumatoid Arthritis

This study will test the safety and tolerability (how the body reacts to the drug) of REGN88 and placebo (an inactive substance that contains no medicine) in patients with Rheumatoid Arthritis.

This is a multi-center, randomized, double blind, placebo-controlled, single dose escalation study of the safety and tolerability of subcutaneously administered REGN88 in rheumatoid arthritis patients who are receiving concomitant methotrexate.

Three (3) sequential dose cohorts of 5 subjects (4:1 active: placebo) will be dosed SC with REGN88 or placebo. Subjects who complete the study will participate in 14 study visits over 16 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥ 18 years of age
2. Subjects must weigh \> 50 kg and \< 100 kg
3. Diagnosis of Rheumatoid Arthritis (RA) as defined by the 1987 revised American College of Rheumatology (ACR) criteria with disease duration of no less than 6 months and ACR class I-III
4. For women of childbearing potential, a negative serum pregnancy test at the Screening Visit (Visit 1) and a negative urine pregnancy test at Day -1
5. For men and women of childbearing potential, willingness to utilize adequate contraception and not become pregnant (or have their partner\[s\] become pregnant) during the full course of the study.

Exclusion Criteria:

1. A history of Listeriosis or active tuberculosis (TB)
2. Persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the Screening Visit
3. History of prior articular or prosthetic joint infection
4. History of a hypersensitivity reaction, other than localized injection site reaction (ISR), to any biological molecule
5. Significant concomitant illness such as, but not limited to cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease that would adversely affect the subject's participation in this study
6. Received administration of any live (attenuated) vaccine within 3 months prior to the Screening Visit
Single Incision Laparoscopic Colorectal Surgery

Single incision laparoscopic surgery (SILS) is the further development of the concept of minimally invasive surgery for colorectal cancer,which rapidly developed in the field of colorectal surgery. Through the development of single hole laparoscopic colorectal cancer radical surgery and clinical study and follow up accordingly, evaluating the feasibility, surgical effectiveness and economy help to promote the popularization and application of single hole laparoscopic techniques in the field.

The patients with colorectal cancer will randomly divided into single incision laparoscopic surgery group and conditional laparoscopic surgery group. The operation time, blood loss, the incidence of lymph node , the number of postoperative complications, the gastrointestinal function recovery time, postoperative hospital stay，the number of local recurrence and distant metastasis, survival rate and the total cost of hospitalization will be evaluated to confirm the feasibility of single incision laparoscopic surgery is effective and economical. It is worthy of clinical application.

Eligibility Criteria:
Inclusion Criteria:

* 18 years \< age \< 80 years
* Tumor located in colon and high rectum ( the lower border of the tumor is above the peritoneal reflection)
* Pathological colorectal carcinoma
* Clinically diagnosed cT1-4aN0-2 M0 lesions according to the 7th Edition of AJCC Cancer Staging Manual
* Tumor size of 5 cm or less
* ECOG score is 0-1
* ASA score is Ⅰ-Ⅲ
* Informed consent

Exclusion Criteria:

* Body mass index (BMI) \>30 kg/m2
* The lower border of the tumor is located distal to the peritoneal reflection
* Pregnant woman or lactating woman
* Severe mental disease
* Previous abdominal surgery（except appendectomy and cholecystotomy）
* Emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer
* Requirement of simultaneous surgery for other disease
Nurse AMIE for Echo Show: Randomized Control Trial

The Nurse AMIE platform has been modified for use as an Amazon Alexa skill for use on the Echo Show device. The investigators will recruit women receiving treatment for metastatic breast cancer and randomize patients to receive standard treatment (control) or the Nurse AMIE for Echo Show program. Nurse AMIE is a supportive care program for women undergoing chemotherapy and helps manage symptoms. The investigators will test the feasibility of using the Nurse AMIE program as well as its effectiveness at managing symptoms.

The investigators will recruit 42 MBC patients and randomize them into a partial crossover trial in which immediate treatment group participants receive the Nurse AMIE intervention in full for 3 months, then continue Nurse AMIE (without navigation) for 3 months, while the delayed intervention group will not receive an intervention for 3 months, followed by receiving the Nurse AMIE full intervention with navigation for 3 months. The primary comparisons will be between the immediate treatment and delayed treatment groups over the first 3 months.

Intervention. Participants will all receive an Amazon Echo Show device, WiFi connection (if patients do not already have one), pedometer, and resistance bands. Each day, the participant will open the Nurse AMIE for Echo Show, which will result in the daily greeting. After the greeting, participants will be asked to provide a verbal rating of their symptoms (e.g., pain, sleep, fatigue, and distress).

After completing the symptom survey, Nurse AMIE will use an algorithm to discern which of the intervention modules to offer as assistance for the reported symptoms. These interventions include exercise, guided relaxation, cognitive behavioral therapy, and soothing music. These guideline-based interventions are provided as audio files or YouTube-style videos. In addition, Nurse AMIE provides a daily educational nutrition tip as well as recipes designed to be of interest to people undergoing chemotherapy.

Each week, the participant will receive a phone call from the study navigator. This navigator will monitor symptom ratings daily and will discuss symptoms, interventions, and step goals with the participant each week.

Eligibility Criteria:
Inclusion Criteria:

1. Female patient with metastatic breast cancer receiving care at PSCI
2. Age: ≥18years of age
3. Personal in-home Wi-Fi access
4. Personal device capable of receiving telephone calls for weekly study facilitator check-ins
5. Fluent in written and spoken English
6. Sufficient vision/hearing to use the Alexa Echo Show.

Exclusion Criteria:

1. ECOG Performance Status score of \>2
2. Patients with significant medical or psychiatric conditions (beyond breast cancer, its treatment, and its symptoms) that in the opinion of the research team exclude the subject from participation.
3. Receiving any behavioral intervention.
4. Pregnant
5. Cognitive impairment
6. Life expectancy of less than 6 months as determined by the treating physician
Dog Assisted Therapy: Comparing Duration Treatments for Patients with Fetal Alcohol Spectrum Disorder

The objective of the present study was to assess the efficacy of a shorter version program of Dog Assisted Therapy (DAT) (8 sessions) compared to a longer version (16 sessions) for children and adolescents with Fetal Alcohol Syndrome (FASD). We evaluated the impact of DAT on social skills, internalizing and externalizing problems, quality of life, severity of the disorder and emotional well-being of parents. We conducted a randomized controlled trial in a cohort of 55 patients with FASD.

FASD can be classified into three subtypes. FAS is identified by (1) facial abnormalities, (2) growth deficits, abnormal brain development, or irregularities in neurophysiology, and (3) neurobehavioral issues. Partial Fetal Alcohol Spectrum Disorder (FASD) shares similarities but presents with fewer physical characteristics, while Alcohol-Related Neurobehavioral Disorder (ARND) solely exhibits neurobehavioral symptoms without facial anomalies.

Previous research has highlighted the effectiveness of psychological intervention programs focused on emotional regulation for individuals with FASD. Similarly, studies have emphasized the benefits of interventions targeting social skills. These interventions have been shown to result in reductions in externalizing behaviors, with social skills training specifically correlating with improvements in social competence and a decrease in problematic behaviors Recently a new form of behavioral therapy has been gaining popularity in improving the physical and mental health of young adults, known as Animal Assisted Therapy (AAT). Animal Assisted Therapy lays its foundation in human attachment theory and social cognitive theory where it is argued that animals can be potentially viewed as a transitional attachment object and thus aid to improve psychosocial functioning.

Eligibility Criteria:
Inclusion Criteria:all participants needed to have stable doses of medication for at least two months before the study and agree not to seek out any other psychiatric or psychological treatment during the study.

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Exclusion Criteria:Patients who were not behaviorally stable, presented agressive behavior or required more intensive treatment (hospitalization or day hospital) were excluded.

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Study of the Inflammatory Reaction in Standard vs Single Port Cholecystectomy for Uncomplicated Cholelithiasis

This is a study of the inflammatory reaction in standard 4 port laparoscopic cholecystectomy vs Single Port Laparoscopic (SIL) cholecystectomy. It is assumed that the reduced trauma in SIL Cholecystectomy causes reduced inflammatory reaction compared to the 4 port laparoscopic cholecystectomy.

Two groups of 20 patients each are included in this study. Pre operatively, 6 and 24 hours postoperatively, blood is taken from these patients, it is centrifuged and the plasma is taken. IL-6, a-defensins and CRP are measured for each sample.

Eligibility Criteria:
Inclusion Criteria:

* Uncomplicated cholelithiasis
* American Society of Anesthesiologists (ASA) I or II
* No previous operations in upper abdomen
* Body mass index (BMI) \<30

Exclusion Criteria:

* Cholecystitis
* ASA \> II
* BMI\>30
* Previous operations in upper abdomen
* Previous operations in intestine
Evolution of Corporeal Composition in the PeriOperative Period

Denutrition and Obesity are risk factors for perioperative surgical complications.

In patient with cancer, incidence of denutrition is markedly increased. Surgical resection of cancer induces a high intensity cellular stress response and catabolism reinforcing the risk for perioperative denutrition.

In this study, we thought to investigate the change in body composition during the perioperative period using anthropometric measurements and Bioelectrical Impedance Analysis (BIA).

Body composition measurements will be performed before surgical procedure (7 days) and at day 1, day 5, 1 month, 3 months and 6 months after surgery.

Others data will be recorded including anthropometric measurements, nutritional intake, occurence of surgical complication, type of surgical procedure, type and stage of cancer, and CT-scan measurements of subcutaneous abdominal fat, visceral fat and peri-renal fat before surgery and at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Gastrointestinal cancer (esophagus, gastric, pancreatic, hepatic, colorectal and anal)
* Or Lung cancer
* And planned surgical resection
* Age \> 18 years

Exclusion Criteria:

* Surgical procedure planned \< 48 h
* Pregnancy
* Presence of a cardiac stimulator
Isoflurane During Cardiopulmonary Bypass

There is no clinical way of assessing the depth of anaesthesia while patients are on the heart-lung machine. A new method of measuring the depth of anaesthesia using brainwaves called the Bispectral index (BIS) has been developed and its use in cardiac surgery is now widespread. However BIS is also altered by patients body temperature. As cooling is common during heart surgery the use of BIS to measure the depth of anaesthesia during heart-lung bypass remains controversial. This study aims to find out what depth of anaesthesia is produced according to BIS during heart lung bypass using a standard anaesthetic technique that utilises the anaesthetic isoflurane.

There is no clinical way of assessing patients' depth of anaesthesia on the heart-lung machine. For this reason, the amount of volatile anaesthetic agent like isoflurane, that is administered has traditionally been determined by anaesthetists' clinical experience. Recently, a device that assesses depth of anaesthesia by analysing the electrical brain waves called the Bispectral index (BIS) has been introduced. The study aims to determine whether the level of anaesthesia produced by isoflurane using the traditional approach is more than required simply to maintain unconsciousness according to BIS. In addition, the study will determine whether the concentration of isoflurane in exhaust gases from the heart-lung machine can be used as an estimate arterial blood concentration and so, depth of anaesthesia.

The study will recruit patients who are scheduled for heart surgery using a heart-lung machine. Patients will be anaesthetised using a long established balanced technique including the administration of isoflurane 2.5% whilst supported on the heart-lung machine. Measurements of exhaust gas concentration of isoflurane from the heart-lung machine and level of BIS will be recorded at three time points. Simultaneously, three arterial blood samples will be taken and the isoflurane concentration measured in these samples. The BIS levels will be averaged and the proportion of patients with a BIS below 40 (lower limit of normal) will be calculated. Concentrations of isoflurane in the exhaust gas of the heart-lung machine will be compared with blood concentrations of isoflurane and the both concentrations will be compared with the level of BIS to establish whether they can be used to assess depth of anaesthesia.

If this study finds that a large proportion of patients have more than adequate levels of anaesthesia, then future studies could explore whether administering lower concentrations of isoflurane improves outcome whilst maintaining anaesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Participants over the age of 18
* Scheduled for elective cardiac surgery under the care of trial anaesthetists
* Patient has provided informed consent to participate

Exclusion Criteria:

* Patients presenting for emergency cardiac surgery
* Patients who will have cardiac surgery that does not require cardiopulmonary bypass
* Unwilling/unable to provide informed consent
* Patients under the age of 18
* Anaesthesia undertaken by anaesthetists not involved in trial
Breathe: Slow Paced Breathing to Lower Blood Pressure

The purpose of this study is to investigate the nature of the physiological reasons for the decreases in resting blood pressure that can result from systematic practice of computer-guided breathing exercises or meditative relaxation.

In this randomized clinical trial, persons with moderately elevated blood pressure were trained in either computer-guided breathing exercises or meditative relaxation to breathing. The computer-guided breathing exercise involves listening to tones of ascending and descending pitch to which breathing is entrained to low frequencies over a 15 minute interval. The meditative relaxation involves passive attention to natural breathing for the same duration. Participants will perform these breathing exercises daily at home for four weeks. Before and after the intervention, respiratory, cardiovascular, and urinary endogenous digitalis-like factors will be systematically recorded to determine the extent to which chronic neuroendocrine changes underlie the reductions in blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* Over 21 years
* Systolic blood pressure 130-160 or diastolic blood pressure 85-100

Exclusion Criteria:

* More than one antihypertensive medication
* Beta blockers, angiotensin converting enzyme inhibitors or angiotensin receptor blockers
* History of coronary artery disease, heart failure, stroke, angina or coronary revascularization
* Kidney disease, defined as plasma creatinine \> 1.5mg/dL
* Diabetes, defined by insulin or oral hypoglycemic medication or blood sugar \> 126mg/dL
* Pulmonary disease, defined as chronic obstructive pulmonary disease, bronchitis, asthma, or use of inhaler
* Upper respiratory infection during past 30 days
* Medication that affects central nervous system function
* Steroid use
* Current pregnancy or lactation within past six months
* Current birth control medication or hormone replacement therapy
* Condition that in the judgment of the Principal Investigator is incompatible with the research study
Vildagliptin 50 mg Twice Daily in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin

The study is designed to demonstrate the short term efficacy and safety of vildagliptin 50 mg bid in patients with Type 2 Diabetes Mellitus inadequately controlled with Metformin.


Eligibility Criteria:
Inclusion Criteria:

* Patients who sign the informed consent
* HbA1c in the range of \> 7 to ≤10.5% at Visit 1
* Ability to comply with all study requirements

Exclusion Criteria:

* Pregnant or lactating women
* Serious cardiovascular disorders
* Liver/renal disease or dysfunction
* Anti-diabetic other than metformin, thiazolidine, or α-GI or insulin
* Laboratories values abnormalities as defined by the protocol