cyrilzakka/clinical-trials huggingface dataset:
Effect of Pneumoperitoneum on Remifentanil Requirements in the Surgical Pleth Index-guided Analgesia

The primary purpose of this study is to investigate the effect of pneumoperitoneum on remifentanil requirements in the surgical pleth index-guided analgesia for laparoscopic gastrectomy.


Eligibility Criteria:
Inclusion Criteria:

* laparoscopic gastrectomy under general anesthesia

Exclusion Criteria:

* atypical hemoglobin disease, infective state, cardiovascular disease, peripheral vascular disease
Objective Results of Anterior Cruciate Ligament Reconstruction With and Without Internal Suture Augmentation Technique

The purpose of this study is (1) To report, compare and corelate the patient reported outcomes (PRO) (IKDC score, Lysholm Score) and range of motion (ROM) among patients following hamstring autograft ACLR with and without independent suture tape reinforcement against objective laxity test using Lachmeter. (2) Rate of complications and reoperation.

Investigators performed a randomized control trial in two groups utilizing All- inside ACLR. Group I was augmented by suture tape and Group 2 without suture tape augmentation. From October 2018 to June 2020, 20 patients underwent all-inside ACL reconstruction with internal suture augmentation technique (Group I, Brace group) and the other 18 patients underwent all- inside ACL reconstruction without internal suture augmentation technique (Group II, non-brace group). Demographic data (age, sex, side of injury, time since injury), manual assessment (Lachman test, pivot shift test, ROM), PROs (IKDC score, Lysholm score) and Lachmeter examination were collected and analyzed at fixed time points during follow-up period as mean duration of follow up in our series was 18 months ± 3.4 (range, 12-24 months).

Eligibility Criteria:
Inclusion Criteria:

* Age 20-35 years old.
* Patients will be diagnosed as ACL tear by the following:

I. History of knee traumatic event. II. Clinical examination (ant. Drawer test, Lachman test and pivot shift test). III. Radiological evidence of ACL tear by MRI.

Exclusion Criteria:

* Other intra or extra articular knee injuries.
* Previous ACL surgery on the affected knee.
* Bilateral ACL injuries.
* Significant Articular surface injury.
* Medical comorbidities
* Patients with malalignment (genu varum. Genu valgum and Genu recurvatum)
* Neuromuscular disorders
Managing Inflammatory Bowel Disease

Inflammatory Bowel Disease (Crohn's disease and ulcerative colitis) often results in significant life disruption, hospitalization and surgery. While psychosocial factors are not believed to cause IBD, such factors can contribute to the ability of individuals with IBD to cope with the disease, and ineffective coping may lead to the exacerbation of IBD symptoms. The goal of this study is to evaluate the efficacy of a social learning and cognitive behavior therapy approach for treating children with IBD. The primary outcomes of interest are IBD symptoms, medical visits, quality of life, and overall disability.

Inflammatory Bowel Disease (Crohn's and ulcerative colitis; IBD), a serious medical condition that affects children and adolescents, is often associated with high rates of health care utilization and disability, including school absences. While psychosocial factors are not believed to cause IBD, research suggests that they may increase illness-related dysfunction. Prior studies suggest that response to chronic illness is, in part, acquired during childhood through social learning processes and may be modified with psychosocial interventions. This randomized controlled trial will compare a social learning and cognitive behavior therapy (SLCBT) treatment to an education and support condition (ES). 180 children with IBD will be recruited and followed for 12 months. It is hypothesized that SLCBT participants, compared to those in the ES condition, will, at one-year follow-up: 1) exhibit greater decreases in IBD symptoms, medical visits for IBD, and functional disability, and greater increases in quality of life; 2) demonstrate greater use of cognitive coping, relaxation and stress management skills, and their parents will demonstrate greater reductions in maladaptive responses to illness behavior; and 3) exhibit greater reductions in anxiety, depression, and somatization. Results will lead to innovative interventions for IBD and other chronic childhood medical conditions.

Eligibility Criteria:
Inclusion Criteria:

* Child has been diagnosed for at least 3 months
* Child age is 8-17
* Child has lived with primary caregiver full-time for at least the past 5 years and for at least half of his/ her lifetime
* Child is medically approved to engage in normal daily activities

Exclusion Criteria:

* Chronic disease other than IBD (e.g., pancreatitis, diabetes, epilepsy)
* Major surgery in past year unrelated to IBD
* Developmental disabilities that require full-time special education or that impair ability to respond to treatment
Use of Various Configurations of Different Arterial Grafts in Total Arterial Revascularization

CABG is a difficult and very critical surgery , it is done to revascularize the myocardium in cases of cardiac ischemia . If the myocardium is still viable in selected patients then it is the treatment of choice with outstanding results . Indications of this operation are more than 50% diameter stenosis of the left main coronary artery, more than 70% diameter stenosis in proximal left anterior descending artery (LAD), more than 70% diameter stenosis in three major coronary vessels, ventricular septal defect related to myocardial infarction , papillary muscle rupture , free wall rupture , ventricular pseudoaneurysm , life-threatening ventricular arrhythmias, and cardiogenic shock. Multiple methods have evolved to achieve the best outcome .The revascularization process depend on two main graft either artery or venous , each has its advantage and disadvantage according to their elasticity , ability to deliver an adequate flow and sustain high blood pressure. Our focus is on the different configuration used for the revascularization by using the artery grafts only due to the superiority of the artery graft in comparison to the venous according to the outcomes and not the feasibility of the technique .It is recommended to begin with internal thoracic artery then saphenous vein if both failed then multiple conduits will be used . Bilateral internal thoracic artery grafting can be an optimal option for coronary artery bypass grafting ,but it's the long-term outcome is still under study.There is no accepted configuration of the anastomosis to be used in the multiple conduits .


Eligibility Criteria:
Inclusion Criteria:

* All patients with multi-coronary vessel disease eligible for CABG surgery .

Exclusion Criteria:

* 1. age more than 70 years 2. diabetic patient 3. single vessel disease 4. associated valvular disease 5. previous open heart surgery 6. hemodynamic unstability 7. Ejection fraction less than (40%)
Analgesic Efficacy of Dexamethasone in Different Routes of Administration in Transverse Abdominis Plane Block

Transverse abdominis plane (TAP) block is a regional anaesthesia technique that provides analgesia to the parietal peritoneum as well as skin and muscles of the anterior abdominal wall. In the past, a number of adjuvants have been added to the local anaesthetics in peripheral and neuraxial blocks resulting in an effective and long lasting analgesia.In recent times, dexamethasone has been increasingly used as an adjuvant to local anaesthetics in peripheral nerve blocks. Dexamethasone has a long and efficient glucocorticoid structure and also has anti-inflammatory property. It also blocks the C- fibers of pain pathway. When added to local anaesthetics as an adjuvant in peripheral nerve blocks, it has shown to prolong the analgesia time. A number of previous studies have also shown an opioid sparing effect of steroids, when used intravenously perioperatively. Though previous studies have shown that addition of dexamethasone to local anaesthetics in transverse abdominis plane block prolongs the duration of block, however it is not known whether this effect of dexamethasone is due to its peripheral action or because of its systemic absorption. Thus, in this study planned to compare the effectiveness of dexamethasone on quality and duration of analgesia when used as an adjuvant with local anaesthetics in transverse abdominis plane block versus when given systemically by intravenous route along with transverse abdominis plane block using local anaesthetics only, in patients undergoing gynaecological laparoscopic procedures under general anaesthesia.


Eligibility Criteria:
Inclusion Criteria:

1. Women aged between 18 to 70 years undergoing gynaecological laparoscopic surgeries under general anaesthesia
2. ASA physical status1 or 2

Exclusion Criteria:

1. Local infection
2. Morbid obesity (body mass index \>35kg/m2)
3. Allergy to local anaesthetics
4. Patient refusal
5. Severe respiratory or cardiac disorders
6. Pre-existing neurological deficits
7. Liver or renal insufficiency
8. Preexisting diabetics
9. Patient on steroid treatment for any reason.
10. Peri Operative use of steroids
Efficacy and Safety Study of MSRD-100 in Subjects With Atopic Dermatitis >=3 Months of Age and Older

This is a double-blind, randomized, vehicle-controlled, multi-center, parallel group Phase 3 study of MSRD-100 in the treatment of atopic dermatitis in subjects aged 3 months and up

This is a 4-week efficacy, safety and tolerability study of MSRD-100 applied twice daily for 4 weeks compared to its vehicle among subjects ≥3 months of age in the treatment of atopic dermatitis covering ≥5% body surface area.

The study will consist of up to 4 visits which includes Screening - Visit 1 (Screening), Baseline - Visit 2 , Visit 3 (Day 14), and an End of Treatment/Final Study Visit - Visit 4 (Day 28).

Study IDs M169981001 and M169981002 are two identical studies being run in parallel with different study sites.

Eligibility Criteria:
Key Inclusion Criteria:

1. Subjects who are male or female, ≥3 months of age on the date of Baseline Visit.
2. Subjects with a diagnosis of atopic dermatitis, active inflammation and meeting the Hanifin and Rajka Diagnosis Criteria for atopic dermatitis.
3. Subjects must have an Investigator Global Assessment (IGA) score of ≥2 at baseline.
4. Subjects who have atopic dermatitis covering ≥5% Body Surface Area (BSA) excluding the eyelids, perioral area, around the nostrils, and in the diaper area (for subjects who wear diapers or plastic pants).
5. Subjects who have atopic dermatitis with a sign and symptom score ≥ 2 on the following three signs and symptoms: erythema, infiltration/papulation, and erosion/oozing/crusting present in at least one body surface area affected.

Key Exclusion Criteria:

1. Unstable course of atopic dermatitis (spontaneously improving or rapidly deteriorating) as determined by the investigator over the previous 4 weeks prior to baseline.
2. Concurrent conditions and history of other diseases.
3. Used any of the following treatments within the indicated washout period before the baseline visit or those who would require the following during the study.
4. Subjects who require treatment with any other topical or systemic therapy for the study disease other than bland emollients in untreated areas of disease.
Immunogenicity and Safety Study of 2 Doses of Live Attenuated Varicella Vaccine

The purpose of this study is to observe the occurrence of adverse events, seroconversion rate and geometric mean titres(GMTs) of 2 doses of live attenuated varicella vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent
* Participant is aged ≥ 1 year to ≤ 3 years
* Participant without preventive inoculation of varicella vaccine and previous history of chickenpox and zoster
* Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures
* Body temperature ≤ 37.5℃

Exclusion Criteria:

* Known allergy to any constituent of the vaccine
* Known acute illness, severe chronic disease, acute exacerbation of chronic disease and fever
* Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth
* Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction
* Failed to the Expanded Programme on Immunization(EPI)
* Receipt of any vaccine in the 4 weeks preceding the trial vaccination
* Plan to receive any vaccine in the 4 weeks following the trial vaccination
* Known bleeding disorder
* Receipt of whole blood, blood plasma or immunoglobulin in the 5 months preceding the trial vaccination
* Reported the history of acute illness had need systemic antibiotics or anti-viral treatment of infections in the 7 days preceding the trial vaccination
* An acute illness with or without fever (temperature ≥ 38.0℃) in the 3 days preceding enrollment in the trial
* Participation in any other interventional clinical trial
* Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine
The Use of a Morcellator in Operative Hysteroscopy for Benign Intracavitary Lesions: a Feasibility Study

Polyps, intracavitary myomas and retained products of conception (RPOC) are common benign intracavitary lesions of the uterus and frequently cause abnormal uterine bleeding or pain. In general, intracavitary lesions are treated by operative hysteroscopy with bipolar resectoscopic removal under general anaesthesia, performed in the theatre (OR). Potential problems with this approach are thermal damage and impairment of visibility due to loose tissue fragments necessitating multiple entries for tissue removal.

Recently, lesion morcellation by hysteroscopy has been introduced as an alternative technique. Compared to the resectoscopic approach, morcellation is reportedly associated with a shorter total procedure time, smaller fluid deficit and number of insertions. A few trials also registered a higher success rate in completeness of resection.

No significant differences in odds of surgical complications have been reported.

Most hysteroscopic morcellators have diameters up to 8 mm, for which cervical dilation under general anaesthesia is usually needed.

Recently, companies have developed hysteroscopic morcellators with smaller diameters, e.g. 6.3 mm for the 19 Fr. intrauterine BIGATTI Shaver (IBS®). This means less need for cervical dilation, and potential use without anesthesia.

At this moment, there are no prospective studies available on feasibility of the 19 Fr. intrauterine BIGATTI Shaver (IBS®). Before implementing hysteroscopic morcellation in our department, we need a feasibility study assessing the method in standard conditions in the operation room or in ambulatory setting under sedation.

Trial objectives:

Assessment of the feasibility of hysteroscopic morcellation of benign uterine intracavitary lesions. The primary objective is to assess the completeness of hysteroscopic resection in patients undergoing the procedure under general anesthesia or sedation.

Secondary objectives are to assess perioperative parameters as operation time, need for cervical dilation, adverse events, pain, operator satisfaction; to assess quality of tissue for histological examination; to assess postoperative complications and pain.


Eligibility Criteria:
Inclusion Criteria:

* Patients:

  * Female

Ultrasonographic diagnosis of an intracavitary lesion, according the IETA terms and definitions

* endometrial polyp
* FIGO 0-1 myoma (maximum diameter 2 cm)
* RPOC (maximum diameter 2 cm, no enhanced myometrial vascularity)

Exclusion Criteria:

* • Active vaginal bleeding

  * (possible) malignancy
  * \< 18y
  * Patient refusal
  * Pregnancy
  * Impossibility to access the uterine cavity (e.g. severe cervical stenosis)
  * Absence of intracavitary lesion (endometrial polyp, FIGO 0-1 myoma or RPOC) at hysteroscopy
Nicotine Lozenge Bioequivalence Study

To compare the bio equivalence of new nicotine lozenge formulation with the reference nicotine lozenge so as to deliver the same nicotine blood profile.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be healthy smokers who usually smoked their first cigarette within 30 minutes of waking.
* Body Mass Index within the range 19-27 kilograms/meters\^2

Exclusion Criteria:

* Participants who used chewing tobacco or tobacco products other than cigarettes within 21 days of screening visit
Preventing Loss of Weight, Fat Free Mass and Activities of Daily Living

Malnutrition of elder orthopaedic patients leads to weight loss and loss of fat free mass. Changes in the individual's nutritional status and body composition may adversely affect the patient's postoperative level of activity.

Aim. Thus, the purpose of the present study is to report changes in postoperative weight, FFM and functions vital to daily living in a group of elder orthopaedic patients that were actively involved in their nutritional care during the hospital stay.

Malnutrition of elder orthopaedic patients leads to weight loss and loss of fat free mass. Changes in the individual's nutritional status and body composition may adversely affect the patient's postoperative level of activity.

Aim. Thus, the purpose of the present study is to report changes in postoperative weight, FFM and functions vital to daily living in a group of elder orthopaedic patients that were actively involved in their nutritional care during the hospital stay.

Method. The study comprises 253 patients aged 65+ and admitted either for hip- or knee replacement or with a fractured hip. Following a quasi-experimental design, 142 patients were allocated to the control group and 109 patients to the intervention group. The intervention programme focused on patients' involvement in their nutritional care. Body composition by bio impedance and functional status by a standard chart were assessed at admission and four months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Aged 65 and above admitted either for elective hip- or knee replacement or acute with a fractured hip were allocated to the study. Patients included in the study were to stay in hospital for more than 7 days and agree on coming to the outpatient clinic for a follow-up four months after surgery.

Exclusion Criteria:

* Patients who refused to participate, patients were not able to understand the instructions,or received dietary treatment due to DM. Patients who suffered from cancer, gastrointestinal disorders or were undergoing steroid treatment. In addition, patients who were unable to participate due to serious heart disorders; or were transferred to intensive or cardiac units after surgery and did not return to the ward.
Investigating Trends in Quality of Life in Patients With Idiopathic Pulmonary Fibrosis (IPF) Under Treatment With Nintedanib

Multi-center, non-interventional, prospective cohort study aiming to enroll 240 Idiopathic Pulmonary Fibrosis patients receiving treatment with nintedanib in a consecutive manner from 10-12 reference centers across Greece.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥40 years of age.
* Patients that have signed Informed Consent Form.
* Treatment naive patients with an initial IPF diagnosis no more than 3 months prior to enrolment according to 2011 American Thoracic Society (ATS)/ European Respiratory Society (ERS)/ Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) guidelines who are initiating treatment with nintedanib (as monotherapy for IPF) the latest on the enrollement day or have initiated treatment with nintedanib (as monotherapy for IPF) within the past 7 days prior to enrolment.
* Patients for whom the decision to prescribe therapy with nintedanib according to the locally approved product's Summary of Product Characteristics (SmPC) has already been taken prior to their enrolment in the study and is clearly separated from the physician's decision to include the patient in the current study.
* Patients that are able to read, understand and complete the study specific questionnaires.

Exclusion Criteria:

* Treatment with nintedanib for more than 7 days prior to study enrolment.
* Patients receiving a combination therapy of nintedanib \& pirfenidone for IPF.
* Patients that meet any of the contraindications to the administration of the study drug nintedanib according to the approved SmPC.
* Prior treatment with pirfenidone or other treatment for IPF.
* Participation in an interventional study.
* Patients currently receive treatment with any investigational drug/device/intervention or have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) before the initiation of therapy with nintedanib.
BAY58-2667 Dose Finding Trial Investigating Fixed Doses in Patients With Acute Decompensated Chronic Congestive Heart Failure (ADHF)

A placebo controlled, double-blind and randomized study to assess different doses of a new drug (BAY58-2667) given intravenously, to evaluate if it is safe and can help to improve the well-being of patients with acute decompensated heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Male and non-pregnant, non-lactating female subjects, age \>/= 18 years of age; or women without childbearing potential defined as postmenopausal women aged 55 years or older, women with bilateral tubal ligation, women with bilateral ovariectomy, and women with a hysterectomy
* Subjects must have the clinical diagnosis of CHF made at least three months prior to enrollment
* Subjects must experience worsening of both of the symptoms below leading to hospitalization at the time of entry into the study:

  * dyspnea and
  * clinical evidence of volume overload

Exclusion Criteria:

* Acute de-novo heart failure
* Acute myocardial infarction and/or myocardial infarction within 30 days
* Valvular heart disease requiring surgical intervention during the course of the study
* Heart failure due to or associated with uncorrected primary valvular disease, malfunctioning artificial heart valve, or uncorrected congenital heart disease
* Primary hypertrophic cardiomyopathy
* Acute inflammatory heart disease, eg, acute myocarditis
* Unstable angina requiring angiography
Assessment of Efficacy and Tolerance of a Follow-On Milk Containing a Mixture of Prebiotics Fed to Young Children in Salvador, Bahia, Brazil

This clinical study will evaluate the effect on incidence of diarrhea, respiratory illness, stool patterns and growth of two cow's milk-based beverages for children.


Eligibility Criteria:
Inclusion Criteria:

* Child 9 - 48 months of age
* Child has consumed a cow follow-on milk during the 48 hours prior to enrollment
* Child's weight for age is within the 10th -90th percentiles
* Child's length for age is within 10th - 90th percentiles
* Signed informed consent obtained

Exclusion Criteria:

* Children who are receiving predominantly breast-milk
* Serious concurrent illness
* Children with diarrhea or acute respiratory infection during the 48 hours prior to randomization
* Children with a history of underlying metabolic or chronic disease or congenital malformation which, in the opinion of the Investigator, is likely to interfere with the normal growth and development or the evaluation of the participant.