cyrilzakka/clinical-trials huggingface dataset:
Terminal Weaning of Mechanical Ventilation or Extubation in Anticipation of Death in the Intensive Care Unit

The purpose of the study is to assess the dying process in critically ill patients with decision to withdraw invasive mechanical ventilation in anticipation of death and to compare effects of extubation and those of terminal weaning of mechanical ventilation on relatives and care givers. The investigators primary hypothesis is that extubation is associated with less symptoms of post-traumatic stress disorders in relatives, as compared to terminal weaning.


Eligibility Criteria:
Inclusion Criteria:

* End of life decision to withdraw invasive mechanical ventilation after at least 48 hours of ICU stay

Exclusion Criteria:

* Age under 18 years
* Non invasive mechanical ventilation
* Brain death
* Death before withdrawal of mechanical ventilation
* No French-speaking relative
* Refusal of relative to participate the study
Dimenydrinate vs Ondansetron for PONV (DONV)

This study will investigate the impact of dimenydrinate (H1-receptor antagonist) versus ondansetron (HT3-receptor antagonist) in postoperative nausea and vomiting, in surgery-related preoperative stress and in the incidence of postoperative complications that could lengthen the LOS in PACU and/or the overall LOS.

Dimenydrinate has been extensively used for motion sickness. However, as far as postoperative nausea and vomiting is concerned the results are still conflicting.

This study will investigate the impact of dimenydrinate (H1-receptor antagonist) versus ondansetron (HT3-receptor antagonist) in postoperative nausea and vomiting, in surgery-related preoperative stress and in the incidence of postoperative complications that could lengthen the LOS in PACU and/or the overall LOS.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years old
* ASA PS I-III
* Undergoing laparoscopic general surgery operations or laparoscopic gynecological operations

Exclusion Criteria:

* Refused to participate
* Age other than 18-75 years old
* Pregnant patients
* Non-elective operations
* Patients that are not able to receive p.os agents
* Medical history of Brugada Sdr or Brugada-like/related ECG abnormalities
* Long-Qt Sdr or concurrent use of medications that may cause long-QT ECG abnormalities
* Medical or family history of psychosis
* Allergy in dimenydrinate or in dimenydrinate drug versions
* Perioperative use of dexamethasone
Evaluation of Outcomes of Minimally Invasive Non- Surgical Versus Surgical Therapy in Furcation Involvement.

The reduced rate of success experienced in the treatment of Furcation involvement (FI) seems to result from the incomplete removal of subgingival plaque and calculus in the interradicular area owing to the peculiar anatomy of the furcation space.

Regarding the therapeutic approach, although FI treated with a conservative approach may not yield the same satisfactory results as single rooted teeth; it has been shown that teeth with FI have a remarkable survival rate following conservative treatment in patients demonstrating a satisfactory plaque control. Minimally invasive techniques aim to retain the preoperative gingival architecture, create a minimal wound and gently handle soft and hard tissues. It becomes imperative to see the differences in clinical, and patient centered outcomes of minimally invasive non- surgical versus surgical technique in the management of furcation involvement in mandibulae molar.

Patients will be recruited from outpatient clinic of Department of Periodontics, PGIDS, Rohtak after screening based on given inclusion and exclusion criteria. after initial session of scaling and root planing patient will be re -elevated at the and of 6 to 8 weeks those having grade 2 furcation involvement in any mandibular molar and meeting other eligibility criteria will be randomly allocated to test group and control group Test group -Experimental sites designated to receive non-surgical treatment will be submitted to careful subgingival debridement using curettes and ultrasonic device using 3.5 x magnification.

control group-Surgical technique will be followed with minimally flap reflection and incisions will be performed with papilla preservation techniques. vertical- releasing incisions will not be made, and the full-thickness flap will be minimally elevated. The granulation soft tissue will be dissected with a blade and carefully removed with curettes. The visible calculus will be carefully removed with curettes and an ultrasonic device. The flaps will be re-positioned and sutured and patient follow up 3 to 6 months .

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy patients with diagnosis of generalized stage 3 periodontitis (Grade A or B) with at least one mandibular molar with FI (Degree 1 or 2-according to Hamp, 1975 and Subclass A or B- according to Tarnow and Fletcher, 1984), interproximal bone coronal to the furcation fornix and root trunk length ≤ cervical two thirds of the root length as measured on a periapical radiograph.
* Full mouth plaque score \< 30% after initial therapy
* Full mouth bleeding score \< 30% after initial therapy
* Having undergone a course of subgingival instrumentation in the past three months

Exclusion Criteria:

* Pregnant or lactating females
* Requiring antibiotic premedication
* Received antibiotic treatment in the previous 3 months
* Previous periodontal surgery in the last 1 year
* Smokers
* Pulpal or periapical pathology
* Third molar
* Non restorable tooth
* Trauma from occlusion
Impact of Adapted Physical Activity on Patient's Recovery Following Allogeneic Stem Cell Transplantation for Hematological Malignancy

It is a study about adaptated physical activity for patients receiving a stem cell transplantation. They will benefit of 6 adaptated individuals lessons at home between 1 month and 3 months after stem cell transplantation. The study's goal is to observe if adaptated activity has an positive impact on weight loss and on life quality.


Eligibility Criteria:
Inclusion criteria :

* Patient aged 18 or more
* Patient with social security
* Patient who accept the study and sign the consent form
* Patient programmed for an allogenic stem cell transplantation

Non inclusion criteria :

* Patients with a guardianship
* Patients with a significant additional physic or mental disease

Exclusion criteria

* Patients who did not receive an allogeniac stem cell transplantation
* Patients still hospitalized between day 30 and day 100 after stem cell transplantation
* Patients who finally refuses the study
* Patients who develop a physical or mental incapacity to practice physical activity
Association of Perioperative Daily Steps and Postoperative Recovery Among Surgical Patients

Walking is the most common, simple and convenient way of exercise with the lowest cost. Studies have shown that daily steps are related to important health outcomes such as cardiovascular events and all-cause mortality. Catrine et al. believe that daily steps can be used as a basic index to evaluate physical fitness. Many observational studies have found that postoperative daily steps collected by wearable devices or smart phones are related to length of hospital stay or even postoperative depression, which is suggested that the average daily steps may be an important index to predict the prognosis of patients.

So the investigators aim to explore the association between peri-operative average daily steps and postoperative recovery of patients scheduled for elective surgery.

Patients scheduled to undergoing elective surgery including thoracic surgery ,abdominal surgery, primary hip replacement and radical mastectomy will be recruited.The exclusion criteria are as follows: With preoperative unconsciousness; Day surgery (planned length of stay \< 1 day); Wheelchair, walking aid or crutch were used before operation; Unable to walk due to physical limitations; The collection time of preoperative steps was less than 1 week; The patient refused to participate.

After recruitment and screening , the investigators will ask the participants to wear a smart band to record data of their daily steps , in addition the investigators will collect the peri-operative data of these participants which includes their rehabilitations and clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

Patients scheduled to undergo elective surgery including thoracic surgery abdominal surgery, primary hip replacement and radical mastectomy ; Age≥18 ASA Ⅰ～Ⅲ Able to wear smart band

Exclusion Criteria:

With preoperative unconsciousness Day surgery (planned LOS \< 1 day) Wheelchair, walking aid or crutch were used before operation Unable to walk due to physical limitations The collection time of preoperative steps was less than 1 week The patient refused to participate
Stroke Ready: A Stroke Preparedness Brief Intervention

This is a randomized controlled behavioral intervention trial to assess the efficacy of a brief intervention to increase stroke preparedness.

This is a randomized controlled behavioral intervention trial to assess the efficacy of a brief intervention to increase stroke preparedness. Subjects will be randomized to a brief face-to-face stroke preparedness intervention compared to a healthy lifestyle stroke risk reduction intervention. The primary outcome is behavioral intent to call 911 using a self-administered survey

Eligibility Criteria:
Inclusion Criteria:

* over 18 years of age

Exclusion Criteria:

* none
Treatment of Type 2 Diabetes With Long Acting Basal Insulin in Jordan

Primary Objective:

-To assess the change in glycosylated hemoglobin (HbA1c) in uncontrolled Type 2 diabetes patients on OAD agent in Jordan after 6 months of treatment with basal insulin (Insulin glargine).

Secondary Objectives:

* To evaluate the percentage of patients achieving target of HbA1c ˂7%.
* To evaluate the change in fasting plasma glucose (FPG).
* To assess the following safety criteria: hypoglycemic events, body weight changes, and overall safety.
* Describe the titration process: changes in glargine insulin dose at 3 months and 6 months, changes in the titration doses used (if any), and time to reach control.

The total duration of study period per patient is up to 6 months.

Eligibility Criteria:
Inclusion criteria :

* Patient ≥ 18 years old.
* Male or Female.
* Type 2 diabetes patients.
* Uncontrolled with previous therapy (HbA1c \>7%), evident in HbA1c test within the last 1 month before study entry.
* Insulin naïve patients: any patient uncontrolled after one or a maximum of two lines of therapy including: monotherapy (Metformin alone or any other Oral Anti-Diabetic agent (OAD) if contraindicated or intolerance) and/or dual therapy (any OAD combination), at maximum tolerated dose in the last 3 months.
* Signed informed consent.
* Signed informed consent.

Exclusion criteria:

* Patient not willing or not able to perform self-monitoring blood glucose.
* Patient not willing or not able to self-titrate insulin glargine under physician's guidance.
* Patient not suitable for participation according to what is specified in the approved Summary of Product's Characteristics or according to medical or clinical conditions, as judged by the Investigator.
* History of impaired hepatic function defined as alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than three times the upper limit of normal, evident in testing done in the last 3 months.
* History of impaired renal function defined as serum creatinine \>135 μmol/L (\>1.525 mg/dL)in men and \>110 μmol/L (\>1.243 mg/dL) in women, evident in testing done in the last 3 months.
* Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method at physician's discretion).
* Treatment with systemic corticosteroid within 3 months prior to study entry.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Concomitant Use of Buccal Fat Pad Derived Cells and Autogenous Bone in Alveolar Cleft Osteoplasty

Our aim was to combine regenerative techniques with bone grafting in human models to increase predictability and survival of reconstructed tissue. The MSCs in this study were derived from an intra oral fat source (BFP) and were cultured over natural bovine bone mineral granules and delivered within the lateral ramus cortical bone plate (LRCP)to treat human alveolar cleft defects.

Patients enrolled in the present study were suffering from alveolar cleft and had previously received orthodontic treatment and only required secondary alveolar grafting. The buccal fat pad derived stem cells (BFPSCs) were harvested from buccal fat pad tissues of the patients. Patients were divided into 3 groups. Group A , the control group, was treated with anterior iliac crest (AIC) spongy bone to fill defects, followed by coverage with collagen membrane. Group B was treated with lateral ramus cortical bone cage (LRCP), used to create a protected healing space by fixing it to adjacent walls of the cleft defect. Group C was treated with (AIC) as in Group 1, but BFP-derived MSCs cultured over NBBM were put over the spongy bone and covered with a collagen membrane.Passage 3 BFPSCs were loaded on the implants ( Cerabone (Botiss, Berlin, Germany) a natural bovine bone mineral (NBBM); a granular biomaterial with a 200- to 850-µm particle size) 3 days prior to transplantation.Cone beam computed tomography (CBCT) was obtained after 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral congenital cleft lip and palate
* Previous presurgical orthodontic treatment

Exclusion Criteria:

* History of malignancy
* History of radiation
* History of chemotherapy
* Pregnancy
* Systemic diseases contradicting dental and surgical treatments
* Conditions or drugs affecting bone remodeling or bone metabolism and connective tissue
* Allergy to collagen
Hypoxic Exercise in Lower Extremity Artery Disease

The aim of this randomized controlled trial is to:

Phase I: To explore, in a first pilot phase, the adequate combination of hypoxia severity and exercise intensity in patients with symptomatic lower extremity artery disease (LEAD). Acute walking performances and physiological responses (vascular and muscular) to a normobaric hypoxic exercise performed will be assessed at two different altitudes (1500 m and 2500 m).

The results of this first phase will then be used to determine the optimal hypoxic level for the exercise training program which will be assessed during the Phase II.

Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic LEAD (Fontaine stage ≥ IIa)
* ABI ≤ 0.9
* TBI ≤ 0.6 if incompressible arteries (diabetes and renal insufficiency)
* Signed written informed consent form

Exclusion Criteria:

* Neurological and neuromuscular disorders which can limit balance and walking
* Any history of altitude-related sickness
* Any health risks (assessed during clinical history) linked to hypoxia exposure
* Acclimatization or exposure to hypoxia of more than 2000 m for more than 48 h during a period of 6 months before the study
* Medication required for the treatment of migraines, claustrophobia that may interfere with the interpretation of the results
* Obstructive sleep apnea (\> 25 Apnea-Hypopnea Index)
* Prior leg/foot amputation
* Pregnant women
* Cardiac contraindication to exercise
Clinical Impact of Pharmaceutical Consultations in Patients Treated for Chronic Obstructive Pulmonary Disease at Home

The implementation of pharmaceutical consultations in the city or at the hospital could modify the occurrence of exacerbations related to chronic obstructive pulmonary disease after return of the patient to his home.


Eligibility Criteria:
Inclusion Criteria:

* The patient has signed the consent form.
* The patient is affiliated to a health insurance programme
* The patient is at least 18 years old (≥).
* The patient is admitted to complete hospitalization (for patients in the "Hospital and Control" groups).
* The patient is diagnosed with stage 2 to 4 Chronic Obstructive Pulmonary Disease. The diagnosis as well as the stage of the disease are validated by a pulmonologist at the facility.
* The patient has one or more inhaler devices to treat Chronic Obstructive Pulmonary Disease.
* The patient returns to his / her home when discharged from hospital (for patients in the "Hospital and Control" groups).
* The patient is available for a follow-up of 12 months.

Exclusion Criteria:

* The subject participates in another interventional study.
* The subject is in an exclusion period determined by a previous study.
* The patient is under safeguard of justice.
* The subject refuses to sign the consent.
* It is not possible to give the patient (or his/her trusted-person) informed information.
Intelligent Needle Tip Tracking Using Ultrasound Imaging for Infraclavicular Brachial Plexus Blocks

In a randomized controlled crossover study design, ultrasound guided infraclavicular brachial plexus blocks will be performed with and without the aid of a needle tip tracking (NTT) system. Specialists in anaesthesiology with average experience in ultrasound guided PNB techniques will perform the blocks. 26 volunteers will be included. The primary objective is to investigate the effect of the NTT system on performance time, as a measure for improved block performance. Secondary objectives are the effects of the NTT system on dexterity, peripheral nerve block characteristics, subjective experience, and peripheral block performance.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status 1 or 2
* Volunteers that have given informed written consent

Exclusion Criteria:

* BMI \< 18 kg/m2
* BMI \> 35 kg/m2
* Body weight \> 95 kg
* Volunteers that cannot cooperate during the examination
* Volunteers that do not speak or understand Norwegian language
* Volunteers with neurologic disease, nerve- or vascular impairment
* Volunteers with known coagulopathy
* Volunteers that are allergic to Lidocaine or other local anaesthetic agents
* Medications at the investigators discretion
* Volunteers with concomitant medical treatments interfering with PNB treatment
* Skin disease or infection affecting the whole-body surface or within the area of examination
* Any reason why, in the opinion of the investigators, the volunteer should not participate
* Subject participates in a potentially confounding drug or device trial during the course of the study
* Pregnancy and lactation period
* Women of childbearing potential who do not use an effective and secure method for birth control
Contrast Enhanced Ultrasound Medical Imaging for Identifying Breast Masses

This clinical trial investigates the role of contrast enhanced ultrasound (CEUS) in identifying cystic breast masses as benign or malignant. Ultrasound is a diagnostic imaging test that uses sound waves to make pictures of the body without using radiation (x-rays). Ultrasounds are widely used to diagnose many diseases in the body. This trial may help researchers learn if using CEUS will help in determining whether or not an ultrasound guided biopsy is necessary.

PRIMARY OBJECTIVES:

I. To examine and compare the distribution of CEUS parameters in breast masses that were evaluated as Breast Imaging Reporting and Data System (BI-RADS) 4a, 4b, 4c or 5 by conventional ultrasound (US) and were recommended for ultrasound guided biopsy, and to evaluate whether these parameters can be used to classify suspicious cystic-appearing breast masses as benign or malignant.

Ia. To develop a CEUS-based radiomics workflow to extract radiomic metrics (\> 1600 features) in classifying breast mass malignancy (Radiomics).

Ib. To develop a systematic and rigorous machine learning (ML)-based framework comprised of classification, cross-validation and statistical analyses to identify the best performing classifier for breast malignancy stratification based on CEUS-derived radiomic metrics (time-intensity curve \[TIC\] analysis and Radiomics).

Ic. To assess the independent contribution of radiomics classifier and time-intensity curve classifier to the model accuracy in discriminating benign from malignant cases (TIC analysis versus \[vs.\] Radiomics).

Id. To assess the potential benefit of machine learning classifier in preventing unnecessary biopsy (TIC analysis and Radiomics).

OUTLINE:

Patients receive a contrast agent (Lumason or DEFINITY) intravenously (IV) and then undergo CEUS scan over 60-90 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed breast masses assigned as BIRADS 4a, 4b, 4c or 5 by conventional US and recommended for ultrasound guided biopsy
* Age \>= 18 years
* Female

Exclusion Criteria:

* Contraindications to microbubble contrast: Patients who have a known pulmonary hypertension and any known hypersensitivity to US contrast agent
* Women who are pregnant, possibly pregnant, or lactating
* Women currently undergoing neoadjuvant chemotherapy
* Women \< 18 years of age
* Masses in the same breast that had prior lumpectomy for cancer
* Women with cancer in the same breast will be excluded however, women with cancer in the contralateral breast will be eligible to participate in the study
* Women with an allergy to perflutren
* Prior history of biopsy for that specific lesion
The Relationship Between Thicknesses and Isokinetic Strength of Hip Flexor and Extensor Muscles

The aim of this study is to investigate the relationship of hip muscle thicknesses measured by ultrasonography with hip flexion and extension strength and clinical parameters in prosthesis users with unilateral traumatic transfemoral amputation.

The aim of this study is to investigate the relationship of hip muscle thicknesses measured by ultrasonography with hip flexion and extension strength and clinical parameters in prosthesis users with unilateral traumatic transfemoral amputation.

This study will be useful in understanding whether ultrasonography is an appropriate imaging method in the follow-up of changes in functional strength in the hip girdle in patients with unilateral traumatic transfemoral amputation.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18-65
* The time elapsed after amputation \> 6 months
* Using prosthesis for at least 3 months
* Being able to walk without an assistive device

Exclusion Criteria:

* Bilateral lower extremity amputation
* Presence of neurological, cardiovascular, and pulmonary disease that may affect walking performance
A Study of Omalizumab in the Prevention of Allergen Induced Airway Obstruction in Adults With Mild Allergic Asthma

This was a multicenter, randomized, double-blind, parallel-group, three-arm, placebo-controlled study designed to demonstrate the efficacy of two different formulations of omalizumab compared with placebo in reducing the airway reaction to an inhaled aeroallergen solution in adult subjects with mild allergic asthma.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form
* Meet criteria for the diagnosis of allergic asthma
* Be between the ages of 18 to 65 years
* Have a normal chest X-ray within 2 years of screening

Exclusion Criteria:

* Need daily controller medication for asthma
* History of hypersensitivity to the study drug or to drugs with similar chemical structures or to any ingredients, including excipients of the study medication or drugs related to omalizumab (e.g., monoclonal antibodies, polyclonal gamma globulin)
* Have a documented medical history of anaphylaxis
* Have lung disease other than mild allergic asthma
* Have taken other investigational drugs within 30 days or 5 half-lives prior to the screening visit, whichever is longer
* Are unable or unwilling to comply with study procedures and visits
* Are pregnant or lactating
* Have significant medical illness other than asthma, including malignancies, parasitic infections, immune system disorders, and thrombocytopenia
* Have been treated with omalizumab within 12 months prior to screening
* Currently smoke or have a history of smoking more than 10 pack-years
* Have a history of drug or alcohol abuse, which, in the judgment of the investigator, may put the subject at risk for being unable to participate fully in the study for the duration of the study