cyrilzakka/clinical-trials huggingface dataset:
Accuracy Study of Robot-assisted Screw Insertion in Spinal Surgery

The investigators present the design of a randomized trial to compare the accuracy and safety of screw insertion using the robot-assisted technique versus the conventional fluoroscopy-assisted technique in spine surgery at multicenter. The accuracy and safety of screw insertion are measured by deviation of guide pin placement position, deviation of screw placement position, and intraoperative or postoperative complications. Secondary outcome parameters such as radiation exposure, postoperative recovery, duration of surgery, length of hospital stay and economic appraisal were also evaluated and compared between treatment groups.

In spinal surgery, the accurate placement of implants is the key to ensure the success of the surgery, to achieve the safety and clinical requirements of internal fixation. Robot-assisted technology has become an effective means to improve the accuracy of implants with higher accuracy, free from fatigue and equivalent repetitive operation. The investigators present the design of a randomized trial to compare the accuracy and safety of screw insertion using the robot-assisted technique versus the conventional fluoroscopy-assisted technique in spine surgery at multicenter.

500 participants per group (1000 participants in total) are being recruited after diagnosis and before treatment through multi-hospital system and randomised to 1) robot-assisted technique or 2) conventional fluoroscopy-assisted technique in spine surgery. Outcomes are being measured pre-operatively, during- surgery and at 3, 6, 12 months post-surgery. The accuracy and safety of screw insertion are measured by deviation of guide pin placement position, deviation of screw placement position, and intraoperative or postoperative complications. Secondary outcome parameters such as radiation exposure, postoperative recovery, duration of surgery, length of hospital stay and economic appraisal were also evaluated and compared between treatment groups.

The study is addressing key questions of importance by evaluating the TiRobot-assisted technique versus the conventional fluoroscopy-assisted technique in spine surgery at multicenter. Outputs include evidence to facilitate more effective and safe decision making about surgical treatment for spine.

Eligibility Criteria:
Inclusion Criteria:

* age 18 or above, gender not limited;
* patients eligible for surgery;
* the patient signed the informed consent and agreed to participate in this study.

Exclusion Criteria:

* patients with severe osteoporosis;
* patients with old fractures;
* patients with developmental deformity of the vertebral body with screw placement;
* patients complicated with severe systemic diseases;
* patients with coagulation dysfunction;
* patients deemed unsuitable for the test by the clinical institution.
Larsen & Toubro (L&T) Noninvasive Blood Pressure Module Performance Validation

To validate accuracy of the readings of noninvasive blood pressure (NIBP) module with sphygmomanometer as per the requirements of AAMI SP10:2002. This study is for adult and pediatric population.


Eligibility Criteria:
Subjects: Healthy volunteers

Inclusion Criteria:

* Healthy subjects
* Age between 1 - 60 yrs
* Both genders
* Consenting for the study

Exclusion Criteria:

* Subjects suffering from cardiorespiratory, neurological or endocrinal disorders
* Subjects with alcohol abuse/dependance
* Female subjects who are pregnant or lactating
* Subjects with pace maker implantations

Subjects: Diseased subjects

Inclusion Criteria:

* Patients of hypertensive, ICU and in patients of different diseases
* Age between 1 - 80 yrs
* Both genders
* Consenting for the study

Exclusion Criteria:

* Healthy volunteers
MBI for Psychological Distress, SI and NSSI Among Young Adults

Designed to measure the impact of Mindfulness Based Intervention on depression, anxiety, stress, psychological distress, Suicidal Ideation, Non-Suicidal Self Injury urge and Mindfulness in young adults. Those individuals who agree to participate in the trial and identified with high levels of psychological distress and Suicidal Ideation, randomly divided into interventional (n=30) and control (n=30) groups. The Mindfulness Based Stress Reduction intervention then administered to the interventional group for eight weeks and pre and post intervention assessment done for both the groups.

Study assessment measures:

* Informed consent form
* Demographic questionnaire
* Screener questions form
* Assessment instruments:
* Depression Anxiety and Stress Scale (DASS-21)
* Suicide Ideation Scale (SIS)
* Alexian Brothers Urge to Self Injure Scale (ABUSI)
* Mindfulness Attention Awareness Scale

Eligibility Criteria:
Inclusion Criteria:

* Participants aged 18-24, of any gender, who consented to participate and could comprehend English (the language of the questionnaires).
* Selected respondents from the initial survey were included based on specific criteria:
* Willingness to continue participation.
* Unmarried status.
* Pursuing education (Bachelors, Masters, or Ph.D.) , Pakistan.
* Non-hosteller and unemployed.
* Residing with both parents.
* Affirmative response to screener questions about suicidal ideation (SI) and non-suicidal self-injury (NSSI).
* High scores on psychological distress and SI scales.

Exclusion Criteria:

* Participants failing to meet inclusion criteria or falling under the following categories were excluded:
* Non-students.
* History of present or past psychiatric illness, with recent medication or treatment within the past year.
* Presence of debilitating physical diseases or disabilities. Involvement in or history of substance use.
* Long-term medication for any condition, as these factors could impact study results.
Standard of Care Lifestyle Support for Stage III NSCLC Patients

Offering an early-initiated supportive care program to stage III NSCLC patients to prevent deterioration of performance status and increase compliance of patients that complete chemoradiation as well as the patients receiving 12 months of durvalumab.

In inoperable Stage III Non-Small Cell Lung Cancer (NSCLC), consolidation immune checkpoint inhibition with the PD-L1 inhibitor durvalumab, given within 6 weeks after completion of concurrent platinum-based chemoradiotherapy (CCRT) for 12 months results in remarkable improvement of 3-year overall survival rates (57% vs 43.5%). This tri-modal therapy has become the new standard of care. Unfortunately, the tri-modal therapy frequently causes adverse events such as fatigue and, to a much lesser degree, cough, dyspnea and pneumonitis, resulting in treatment cessation in 15% - 53% of the patients (15%) (53%). For the most optimal overall survival (OS) and disease-free survival (DFS), compliance to the full treatment regimen, i.e. in the ideal situation 100% of patients completing their full course of CCRT and receiving durvalumab for one year, is expected to have significant and relevant beneficial effects. Optimizing patients' fitness is essential in order to handle the tough full treatment regimen.

Eligibility Criteria:
Inclusion Criteria:

* Pathological diagnosis of adequately staged (according to standard practice using chest-CT, FDG-PET, brain imaging MRI/CT) NSCLC
* Participant is willing and able to give informed consent for participation in the trial
* Aged 18 years or above
* Scheduled to receive one of the following two therapeutic strategies:

  * Concurrent chemotherapy and radiotherapy with photons (60 Gy in 30 fractions of 2 Gy) followed by durvalumab in patients with stage III NSCLC
  * Concurrent chemotherapy and radiotherapy with protons (60 Gy in 30 fractions of 2 Gy) followed by durvalumab in patients with stage III NSCLC
* Able and willing to comply with all trial requirements

Exclusion Criteria:

* Mixed non-small cell lung cancer with other histology such as small cell lung cancer
* Not able to comply with the study protocol
* Less than 18 years old
* Pregnancy or not able to comply with adequate contraception in women with child baring potential
* Previous radiotherapy to the chest for benign or malignant conditions, including radiation for breast cancer
* Previous malignancy treated with chemotherapy, immune therapy or radiotherapy (irrespective of when this happened)
* Previous malignancies treated with surgery only are allowed if 2 years or more before inclusion in the present study
Omalizumab Treatment in Venom Immunotherapy With Systemic Reactions

The purpose of this study is to evaluate if omalizumab co-treatment may allow reintroduction of honey bee venom immunotherapy in patients with immunotherapy treatment failure due to systemic reactions.

Some honey bee venom allergic patients cannot be treated with venom immunotherapy due to systemic reactions during immunotherapy - immunotherapy failure due to systemic reactions. High basophil allergen sensitivity is a risk factor for venom immunotherapy failure due to systemic reactions. Omalizumab decreases basophil sensitivity. Venom immunotherapy failure patients will be co-treated with omalizumab during another attempt of immunotherapy introduction. Patients will be clinically and immunologically followed up after the introduction.

Eligibility Criteria:
Inclusion Criteria:

* severe anaphylactic reaction after honey-bee sting (Mueller grade III or IV) confirmed sensitization to honey-bee venom,
* honey-bee venom immunotherapy treatment failure due to systemic reactions.

Exclusion Criteria:

* systemic mastocytosis,
* pregnancy,
* use of beta-adrenergic blocking agents.
Death Rate in Anesthesia, a Study in a Tertiary Hospital

Death rate in anesthesia is one of the most valuable methods to assess the safety of anesthesia practice among different types of patients.

In this study, the investigators will follow the death among patients who underwent surgery under anesthesia whether regional or general over the next two years from 2016 to 2018.

Death rate in anesthesia is one of the most valuable methods to assess the safety of anesthesia practice among different types of patients. Most of the studies of death rate in anesthesia are retrospective with many drawbacks and pitfalls like absence of information in the records of the patients.

In this study, the investigators will follow the death among patients who underwent surgery under anesthesia whether regional or general over the next two years from 2016 to 2018, by examining the patients records from the hospital database and recording the events that occur to the dead patients.

The end point of this study will be anesthesia death rate inside the hospital.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent anesthesia and surgery.
* Patients who died inside the hospital.

Exclusion Criteria:

* Patient who underwent anesthesia and surgery and do not died and discharged home.
* Patients who died outside the hospital.
Evaluation of Galectin-3 Levels in GCF And Saliva of Patients With Different Periodontal Diseases

The aim of this study is to assess the levels of galectin-3 in the GCF and saliva in patient with gingivitis and patient with stage III periodontitis.

The aim of this study is to assess the levels of galectin-3 in the GCF and saliva in patient with gingivitis and patient with stage III periodontitis.

This study will be conducted in the Oral Medicine and Periodontology department, Faculty of Dentistry- Cairo University, Egypt.

Patients will be selected from the outpatient clinic of the department of Oral Medicine and Periodontology, Faculty of Dentistry-Cairo University.

Eligibility Criteria:
Inclusion Criteria:

1. For healthy group: individuals with less than 10% bleeding on probing area, having a probing depth less than 4mm and no loss of attachment were included in the study.
2. For the gingivitis group: individuals with 10% or more bleeding on probing area, having a probing depth of less than 4mm and no attachment loss.
3. For the periodontitis group that has not received periodontal treatment in the last 6 months
4. For the periodontitis group: individuals with 30% or more bleeding on probing area, at least 2 teeth not adjacent to each quarter jaw with a depth of 5 mm or more and 4 mm or more attachment loss, coronal 1/3 and more on radiography (horizontal and / or vertical) bone loss.
5. Presence of a minimum of 15 natural teeth.

Exclusion Criteria:

1. Individuals with any known systemic disease.
2. Pregnant and lactating women.
3. Individuals that received periodontal treatment within the last 6 months.
4. Individuals with a history of systemic antibiotics and anti-inflammatory drugs within the last 3 months.
5. Former or current smokers.
Observational Examination of Thermoregulation in Total Joint Arthroplasty

Total joint patients have poor outcomes with infection since they are having permanent hardware implanted. Infection prevention in this group is therefore critical and a major source of discussion in both the orthopedic and anesthesia literature.

Hypothermia has been shown to increase the risk of infection and blood loss. However, studies have not examined when in the operation or how fast patients temperatures drop. This study will observe how patients' temperatures change during total joint arthroplasty. By identifying when body temperature changes occur, prevention strategies may be developed and implemented.

Peri-operative hypothermia can have deleterious effects. While there is no standard consistent definition within the literature mild hypothermia is commonly defined as a core temperature between 34 and 36 °C. Mild hypothermia has been shown to increase the occurrence of surgical site infections, cardiac morbidity, coagulopathy leading to increased blood loss and transfusion requirements, impaired drug metabolism, and prolonged emergence from anesthesia. In addition, there is evidence that maintaining intra-operative normothermia can shorten hospital length of stay. Despite the fact that intra-operative temperature monitoring and warming are considered standard of care, peri-operative hypothermia in total joint arthroplasty patients remains an issue for several reasons. A large proportion of patient undergoing joint replacement are elderly, making them susceptible to peri-operative hypothermia. In addition, regional anesthesia causes vasodilation and promotes heat flow from the core to the periphery and impairs central and autonomic thermoregulation such that patients receiving neuraxial anesthesia can be particularly susceptible to perioperative hypothermia. Finally, core temperature monitoring is typically not used during regional anesthesia and hypothermia may go undetected for long periods of time.

The primary goal of this study was to examine the incidence of hypothermia during lower extremity arthroplasty. A secondary aim was to identify patient and operative factors associated with hypothermia in order to improve future preventative strategies. Our hypothesis was that peri-operative hypothermia occurs in the majority of patients undergoing lower extremity arthroplasty. In addition, we hypothesized that certain patient and anesthetic factors (such as low body mass index and receiving general anesthesia) would increase the incidence of hypothermia.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years of age and over that are scheduled to undergo total hip or total knee joint arthroplasty.

Exclusion Criteria:

* Patients unable to give informed consent will be excluded.
A Study of BBI503 in Asymptomatic Recurrent Ovarian Cancer Patients With CA-125 Elevation

This was an open-label, single-arm, Phase II study in which amcasertib (BBI503) was administered to adult, asymptomatic patients with recurrent ovarian cancer who had elevated CA-125.


Eligibility Criteria:
Key inclusion criteria:

1. Histological or cytological confirmation of epithelial ovarian, primary peritoneal, or fallopian cancer from any previous time point.
2. Recurrent or relapsed after completion of initial therapy of epithelial ovarian, primary peritoneal, or fallopian cancer from any previous time point (includes completion of surgery with or without postoperative chemotherapy, including maintenance chemotherapy)
3. Elevation of CA-125 according to the following definitions:

   * Patients with an elevated CA-125 before chemotherapy and normalization of CA-125 with/after chemotherapy must show evidence of CA-125 greater than or equal to 2 times the upper limit of normal (ULN) on 2 occasions at least 1 week apart
   * Patients with an elevated CA-125 before cancer chemotherapy, which never normalizes, must show evidence of CA-125 greater than or equal to 2 times the nadir value on 2 occasions at least 1 week apart
   * Patients with CA-125 in the normal range before cancer chemotherapy must show evidence of CA-125 greater than or equal to 2 times the ULN on 2 occasions at least 1 week apart

     * For patients who have received subsequent treatment for recurrent cancer, "chemotherapy" in the above criteria refers to the most recent round of chemotherapy.
4. Patients with a history of ovarian cancer who are asymptomatic and who do not have documented previous CA-125 levels may enroll if the CA-125 is greater than three times the ULN on two occasions, at least one week apart
5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0

Key exclusion criteria:

1. Symptoms (other than ≤ grade 1 fatigue, anxiety, depression, or other psychological symptoms) that, in the opinion of the treating oncologist, are a direct result of cancer recurrence. (Examples of symptoms that would preclude enrollment include unintentional weight loss, ≥ grade 2 fatigue, and new abdominal pain unrelated to operative procedures for the ovarian malignancy.)
2. Receiving any other investigational agent that would be considered a treatment for the primary neoplasm. Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents ≤14 days of first dose of study drug
3. Major surgery ≤28 days before start of treatment
4. History of another primary malignancy with an associated disease-free interval of less than 5 years, except for curatively treated basal cell or squamous cell carcinoma of the skin or in situ cancer of the cervix.
Comparison of Dual Task Gait Characteristics in Individuals With Amputation and Healty Individuals

In amputee, dual task has been found to cause a decrease in walking speed. However, there is no study of how gait characteristics are affected when the speed does not change. The aim of this study is to compare the time-distance characteristics of walking with single task, cognitive dual task, motor dual task in transtibial, transfemoral amputee and healthy people.

Walking is a complex task in which sensory and cognitive systems must be involved. The lower extremity amputee may need to use cognitive resources to focus on walking, monitor and control the prosthetic movements. The need to use cognitive resources may be higher in those with more proximal level amputation, such as above-knee level. The role of cognition and concentration is revealed by a cognitive task performed with posture and gait control using the dual task method. The dual task paradigm provides information about the automation of the default processes that underpin good performance disclosure. This approach involves performing two tasks at the same time. Dual task is divided into primary task and secondary task. The performance of the primary task while performing a single task is recorded. If there is a drop in performance when the secondary task is added, this indicates that the primary task needs high attention.

In proximal amputations, with the lost of movement system structures, functional impairment increases. Amputation from the proximal level affects daily life activities and walking ability more. Above-knee amputees reported more functional difficulties in ambulatory ambulation than transtibial amputee.

The aim of this study is to compare the time-distance characteristics of walking with single task, cognitive dual task, motor dual task in transtibial, transfemoral amputee and healthy people.

Eligibility Criteria:
Inclusion Criteria:

* Using a transtibial or transfemoral prosthesis for at least 1 year,
* Between the ages of 18-65,

Exclusion Criteria:

* To be diagnosed as a neurological, orthopedic, cognitive disorder,
* Having a condition other than amputation that may affect gait.
* Having different permanent disabilities other than amputation,
* Using walking aid,
Exposure Chamber Trial With Cat Immunotherapy

The main purpose of this trial is to investigate if any of three different doses of cat hair immunotherapy is safe for treatment of cat allergic patients.


Eligibility Criteria:
Inclusion Criteria:

* A history of rhinoconjunctivitis on exposure to cats
* Positive Skin Prick Test response (wheal diameter at least 3 mm larger than the negative control
* Positive specific IgE against Fel d1 (at least IgE Class 2)
* Minimum qualifying rhinoconjunctivitis symptom score during EEC exposure at Visit 2

Exclusion Criteria:

* Uncontrolled asthma within the past 12 months, or asthma requiring regular use of inhaled corticosteroids
* FEV1 less than 80% of predicted
* Subjects who suffer from significant seasonal allergic rhinoconjunctivitis, and cannot complete the clinical trial outside the local pollen season, or who have significant allergy to other allergens (e.g. other animals or house dust mites) that cannot be avoided during the trial period
* Subjects who cannot tolerate baseline challenge in the Environmental Exposure Chamber
* History of anaphylaxis with cardio/respiratory symptoms
* A medical history of severe drug or food allergy with symptoms such as difficulty breathing, swelling of the face or a feeling of severe dizziness or increased heart rate
* Chronic urticaria
* History of severe cardiac disease
* Treatment with immunosuppressives, anti-IgE monoclonal antibodies, tricyclic antidepressants or MAOIs
Choroidal Response to Novel Spectacle Lens to Control Myopia Progression

Diurnal variations in the thickness of the choroid have been reported in the literature, and, more recently, the role of the choroid has been studied with respect to its role in myopia (near-sightedness) progression.

Diurnal variations in the thickness of the choroid have been reported in the literature , and, more recently, the role of the choroid has been studied with respect to its role in myopia (near-sightedness) progression. SightGlass Vision, Inc is conducting a multi-site, randomized, controlled, interventional study to confirm the efficacy and safety of spectacle lenses designed to inhibit the progression of myopia by reducing image contrast in peripheral vision. CORE is participating as a clinical site in this three year study which aims to compare changes in ocular length and cycloplegic auto-refraction in children randomised to wear one of either two test or one control spectacle lens designs; the CPRO-1802-001 (Cypress_SG) study. The sponsor is interested in conducting choroidal thickness measurements only at CORE's site by inviting those participants who have already been found eligible for the CPRO-1802-001 study to participate in this parallel study.

Eligibility Criteria:
Inclusion Criteria:

* Participating in the CPRO-1802-001 (Cypress_SG) study at CORE
* Read and signed an Assent and their parent/guardian has signed an information consent letter

Exclusion Criteria:

* Transient health condition which may affect the eye(s) (e.g. a common cold, active allergies, fatigue, etc;)