cyrilzakka/clinical-trials huggingface dataset:
Allogeneic Cellular Vaccine 1650-G for Non-Small Cell Lung Cancer

Rationale: Vaccines made from allogeneic tumor cells may help the body build an effective immune response to kill tumor cells.

The Purpose of this study is to evaluate the effects of a lung cancer vaccine in patients with Stage I or Stage II Non-Small Cell Lung Cancer (NSCLC) after completion of initial definitive therapies.

The study is an open label investigation of the cellular vaccine called 1650-G. Patients receive 2 vaccine injections intradermally in the thigh given 4 weeks apart. Patients will be followed weekly after each vaccine injection and then monthly for 4 months. Patient follow-up continues with evaluations at 6 months and 1 year after receiving the first vaccine injection. Immunologic responses to the vaccine will be assessed from blood samples obtained at each visit following immunizations.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed Stage I or Stage II Non-Small Cell Lung Cancer
* Surgically resected at least 4 weeks ago but not more than 6 months ago
* Bronchoalveolar carcinomas allowed
* Completion of any chemotherapy or radiation given in conjunction with Surgery (neoadjuvant or adjuvant)
* No evidence of disease following initial therapy evidenced by a CXR, CT or PET scan within 6 weeks of enrollment
* ECOG performance status of 0 to 2
* Adequate organ and marrow function defined as follows:

  * Hemoglobin ≥9.0 gm/dL
  * Bilirubin \< 2.5 x upper limit of normal
  * AST \<2.5 x upper limit of normal
  * ALT \<2.5 x upper limit of normal
  * Creatinine \<3 mg/dL
* Women of childbearing potential must have a negative pregnancy test and be willing to use acceptable methods of contraception through week 16.

Exclusion Criteria:

* Cardiovascular disease defined as:

  * New York Heart Association Class III or IV (Section 19.2) congestive heart failure
  * hemodynamically significant valvular heart disease
  * myocardial infarction within the last six months
  * active angina pectoris
  * uncontrolled ventricular arrhythmias
  * stroke within one year
  * known cerebrovascular disease
* History of HIV, infectious hepatitis, or chronic immunosuppressive disease
* concurrent shorter courses of immunosuppressive medications during and for 16 weeks after study treatment
* History of an allergic reactions to any colony stimulating factor (GCSF, GMCSF)
* Female patients must not be pregnant or breastfeeding.
* History of participation in any investigational drug study within 4 weeks preceding initiation of study treatment.
Effect Of Stretching Programme On Shoulder Performance In Volleyball Players With Posterior Shoulder Tightness

When the dominant arm is compared with the non-dominant arm in overhead athletes there is a serious internal rotation limitation in the dominant arm. Due to overhead activity, adaptive changes in shoulder joint mobility and flexibility are indicated. Internal rotation limitation is often associated with increased external rotation. One of the reason of this adaptive change is posterior shoulder tightness which is common in overhead athletes as well as in volleyball players. The aim of this study is to determine the effect of stretching program on the range of motion, flexibility of posterior shoulder muscles and functional performance.


Eligibility Criteria:
Inclusion Criteria:

* Posterior shoulder tightness ( 15 degree internal rotation limitation compared with non dominant side)
* Being a professional volleyball player ( at least 3 years experience in the professional league)
* At least having 4 training days in a week
* negative impingement tests ( Hawkins, Neer or Jobe)
* No shoulder pain

Exclusion Criteria:

* Having any shoulder surgery
* Having a shoulder injury in last 6 months
* Having any neck problem or neck pain
* Having a systemic illness
* Sublocated shoulder
Biomechanical Reconstruction of Three Different Hip Stem Designs in Hip Dysplasia Using a 3D CT-based Planning Software

A random population of 200 CT scans of pelvis and thigh in an adult population affected by hip dysplasia will be selected. The aim of this study is to evaluate the biomechanical reconstruction of the hip anatomy provided by three different hip stem designs in dysplastic cases, using a 3D CT based software for pre-operative planning.

Pre-operative planning in hip arthroplasty with dedicated software is a useful guide to provide a better reconstruction of the biomechanical parameters of the replaced hip and to optimize the choice of component, improving the geometric understanding of the hip anatomy and the interaction between the native morphological structure and the prosthetic component.

The use of a 3D CT-based software for pre-operative planning may provide a better knowledge of the hip anatomy, simulating the biomechanical parameters more closely than a 2D X-ray-based software. In addition, it is the only way to anticipate the correct interaction between the prosthetic components, or the combined anteversion, a key factor in preventing implant instability.

Severe hip deformities, like developmental hip dysplasia, may not be adequately reconstructed by every implant and 3D pre-operative CT may increase the three-dimensional anatomical knowledge of the hip, improving the choice of the correct implant and possibly reducing the possible consequences of intra and post-operative complications.

Therefore, the purpose of this study is to pre-operatively plan, in a random series of 200 native pelvis and thigh CT scans performed in patients with hip dysplasia, 3 different types of hip stem designs using the 3D Hip-Op software, with the aim of analyzing, on the CT simulations, the percentage of adequate reconstruction of the optimal biomechanical parameters (combined anteversion between 25°-50°, global offset not inferior to 12% of the native offset, leg lengthening not superior to 3 cm, sagittal and coronal tilt not superior to +/-5°, canal filling not inferior to 80%). The percentage of every stem design providing the optimal reconstruction in dysplastic hips (all the 5 parameters matched) will be assessed. The single parameters, especially the combined anteversion, the offset restoration and the leg lengthening, will be assessed for every simulation.

Eligibility Criteria:
Inclusion Criteria:

* definition of developmental hip dysplasia according to Wiberg (center edge angle \<20°)
* pre-operative CT scan extended from the fourth lumbar vertebra to the tibial plateaus

Exclusion Criteria:

* other types of hip pathologies
* inadequate Ct scans
The Effect of Using Walking Aid On TUG Test

The Timed Up and Go Test is a measurement tool that allows the participant to use assistive devices and walking aids during the test that evaluates functional mobility. This study was conducted to determine the effect of using walking aids on the Timed Up and Go test and it's correlation with balance in stroke patients.

Cross-sectional, observational study

Eligibility Criteria:
Inclusion Criteria:

* Mini Mental State Test \>24
* Stroke patients who can walk 10 meters with or without walking aid

Exclusion Criteria:

* Individuals dependent on bed or wheelchair
* Individuals with musculoskeletal disease that may adversely affect mobility and balance.
* Individuals who have had any operation in the last 6 months
Fluorescent Approach for Refined Endoscopic Marking With Clip Localization and Identification Procedure

* Title of the Study Testing a Fluorescent Surgical Marker Clip for Tumor Localization in Minimally Invasive Colorectal Surgery
* Purpose of the Study This study aims to determine if a fluorescent surgical marker clip can accurately and safely localize tumor locations in the colon during minimally invasive colorectal surgery. The study will compare the effectiveness of this clip to the current method using a dye called Indocyanine Green (ICG).

The main questions the investigators aim to address are:

Can the clip safely and effectively localize tumor sites compared to ICG dye? What side effects or medical issues might arise with the use of the clip?

-Study Design Assignment

Participants will be randomly assigned to one of two groups:

The clip group: A fluorescent clip will be placed near the tumor. The dye group: ICG dye will be injected near the tumor.

Procedures Participants will undergo a colonoscopy to mark the tumor location before surgery using either the fluorescent clip or ICG dye.

* Follow-Up Participants will attend follow-up visits after surgery to monitor for any side effects or complications.
* Eligibility Inclusion Criteria

Participants may qualify if:

They are 19 years or older. They are scheduled for minimally invasive colorectal surgery for a tumor or suspected tumor.

Exclusion Criteria

Participants cannot enroll if:

They have certain medical conditions, such as blood clotting disorders or allergies to metals or iodine.

They are pregnant or breastfeeding.

-Participant Role By participating, individuals will contribute to advancing research aimed at improving methods for tumor localization during surgery, potentially leading to enhanced surgical outcomes in the future.

For questions or concerns, participants are encouraged to contact the investigators or the research team.


Eligibility Criteria:
Inclusion Criteria:

* Aged 19years or more
* With colonic neoplasm planning minimally invasive surgery
* Need localization of lesion before surgery

Exclusion Criteria:

* Planned total proctocolectomy
* Contraindication of colonoscopy
* On pregnancy or breast-feeding
Comparisons of Two Types of Armeo Robot for Upper Extremities

Comparison of two types of robot (Armeo power vs Armeo spring) for upper extremity rehabilitation on upper extremity function

The purpose of this study is to compare two types of robot. The robot used in this experiment was Armeo power and Armeo spring. Armeo power could provide assistive force via motor, on the other hand, Armeo spring could not provide any assist.

Thus the results from this study might suggest usefulness of motorized robot.

Eligibility Criteria:
Inclusion Criteria:

* Hemiplegic patients secondary to first cerebrovascular accidents
* Onset ≥ 3 months
* 26 ≤ Fugl-Meyer Assessment score ≤ 50
* 3 ≤ Shoulder or elbow MRC scale ≤ 4
* Shoulder or elbow flexor spasticity modified ashworth scale ≤ 1+
* Cognitively intact enough to understand and follow the instructions from the investigator

Exclusion Criteria:

* History of surgery of affected upper limb
* Fracture of affected upper limb
Ultrasound Guided Erector Spinae Plane Block vs External Oblique Intercostal Plane Block for Nephrectomy

The patients will be randomly allocated into two equal groups using a computer program.

Group A: will receive U S guided external oblique intercostal block after induction.

Group B:

Patients will receive US guided erector spine block after induction.

Patients will be premedicated with IV midazolam (0.05 mg/kg). Under standard monitoring including Electrocardiography, Non-Invasive Blood Pressure, and Pulse Oximetry. General Anesthesia will be induced with Fentanyl (1-2 μg/kg), Propofol (2-3 mg/kg), and Atracurium (0.5-0.8 mg/kg). Pressure controlled Volume guarantee Ventilation mode will be used to maintain O2 Saturation Above 98%. Anesthesia will be maintained with Isoflurane 1.2 Minimum Alveolar Concentration inhalation

Eligibility Criteria:
Inclusion Criteria:

* Eligible patients will be older than 21 years old with American society of anesthesiology ASA physical status I\& II\&III scheduled for elective (Subcostal) Nephrectomy

Exclusion Criteria:

* Patients who are:
* Uncooperative.
* Having allergy to any of the study drugs.
* Known abuse of alcohol or medication.
* Having Local infection at the site of injection or systemic infection.
* Pregnancy.
* With coagulation disorders or on anticoagulation therapy.
Clinical Trial to Evaluate the PK Interactions of YHR2402 Monotherapy and YHR2402 and YHR2403 Co-Administration in Healthy Volunteers

An open-label, randomized, single-dose, crossover study to evaluate the pharmacokinetic interactions and safety after co-administration of YHR2402 and YHR2403 compared to the administration of YHR2402 independently in healthy subjects

26 healthy subjects will be randomized to one of the 2 groups in the same ratio.

"YHR2402" and "YHR2402"+"YHR2403" will be administered to Subjects in group 1 by crossover design on day 1, 15

"YHR2402"+"YHR2403" and "YHR2402" will be administered to Subjects in group 2 by crossover design on day 1, 15.

Eligibility Criteria:
Inclusion Criteria:

* Those who are 19 years old and under 55 years old at the screening visit
* Those whose weight is over 50kg(male), over 45kg(female) and their body mass index (BMI) shall be between 18.0 kg/m2 and 30.0 kg/m2
* Those who express their voluntary consent to participate in the trial by signing a written consent
* Those who are judged eligible to participate in the trial by the principal investigator(or delegated investigators) after screening test

Exclusion Criteria:

* Those who have participated in a bioequivalence study or other clinical trials and have been administered with investigational products in 6 months prior to the first administration
* Others who are judged ineligible to participate in the trial by the principal investigator
PET/CT in the Management of Patients With Early Stage Endometrial Cancer

Endometrial cancer (EC) is the most common gynecologic malignancy in the developed countries and is the fifth most common cancer among women worldwide. Typically present well or moderately differentiated, early stage endometrioid histotype with a prognosis usually favorable. Pelvic lymph nodes (LNs) represent the most common site of extra-uterine disease in patients with clinical early stage disease and the role of lymphadenectomy in early stage EC has been one of the major controversies in gynecology oncology. Lymphadenectomy doesn't improve survival or reduce disease recurrence although supported to provide prognostic information and allowing tailoring of adjuvant therapy. Nevertheless, lymphadenectomy is not performed without serious short-term and long-term morbidity. Although surgical staging is the most accurate and standard method to determine LNs involvement, the introduction in clinical practice of a non-invasive modality that allows an accurate staging of EC would be essential. Available evidence report the accuracy of Positron Emission Tomography and Computed Tomography (PET/CT) for the detection of LN metastasis in EC with a sensitivity of 63% and specificity of 94.7%. This prospective comparative analysis between PET/CT, histological findings, and follow up data will be performed to investigate the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of integrated PET/CT for nodal staging of EC per patient and per LN chain analyses, in women affected by intermediate (grade 1 and 2 endometrioid lesions with deep myometrial invasion \> 50% or grade 3 endometrioid lesion with \< 50% myometrial invasion) or high risk (grade 3 endometrioid lesion with deep myometrial invasion \> 50% or non-endometrioid histotype) early-stage EC. Furthermore, the preoperative classification of EC in intermediate and high-risk class will allow to investigate its prognostic value.


Eligibility Criteria:
Inclusion Criteria:

* Women with diagnosis of early stage intermediate and high-risk endometrial cancer.

Exclusion Criteria:

* Not eligible for standard surgical treatment; Not eligible for preoperative staging with PET/CT
Hospital Admissions in Children Aged 3 Months to 5 Years Presenting With Fever to the Emergency Department

This study primarily aims to describe factors associated with hospitalisation of children aged 3 months to 5 years presenting with fever to an urban paediatric A\&E departments by describing and analysing characteristics both of those patients admitted to hospital and those managed in the community. To complement this, information on the short-term healthcare utilization by families attending the emergency department because of feverish illness will be collected. The study will be carried out in one participating centre in Switzerland and the United Kingdom, respectively, to enable a head to head comparison of the assessment and admission practices in two European countries. The resulting data will be used as the basis for further research in this area and will provide information on how to optimally structure service provision in acute febrile childhood illness.

A significant number of children 0 to 5 years of age are seen in paediatric Accident \& Emergency departments (A\&E) with feverish illness. Most of these patients could safely be managed in a primary care setting, particularly with guidelines in place on how to optimally assess these children. Some patients, however, will require admission, either because of a potentially serious underlying disease or because of other factors, for example parental concern or difficulties in communication because of language barriers. An increase in the number of children attending A\&E departments with feverish illness as well as a rise in the volume of admissions has been noted over time. To enable an appropriate adaptation of acute medical services for children an in depth understanding of the assessment and admission processes is crucial.

Eligibility Criteria:
Inclusion Criteria:

* Child aged 3months to 5years
* Temperature above or equal to 38°C measured by any method or reported hot by parents

Exclusion Criteria:

* none
Effectiveness of Beclomethasone Dipropionate Nasal Aerosol for Perennial Allergic Rhinitis

This study will be a prospective observational study of "real world" BDP nasal aerosol users with PAR, with or without seasonal allergic rhinitis (SAR). Subjects will respond to monthly online surveys regarding rhinitis control, concomitant medical conditions, concomitant (non-AR) medications, current AR therapy, and adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age 12 years or greater at time of enrollment
* Diagnosis of PAR for at least one year; and 2)a positive skin prick (ie, epicutaneous) or serum-specific IgE test within the past 2 years to a perennial allergen as appropriate for the location; and 3)PAR symptoms that are consistent with exposure to this allergen for at least one year
* Uncontrolled rhinitis symptoms at the time of assessment as confirmed by a score of 21 or less on the RCAT
* Newly prescribed BDP Nasal Aerosol (within the past 7 days but have not yet used)
* Willing and able to complete surveys in English on a computer with internet access
* Willing and able to provide informed consent prior to entering the study (or parent/caregiver/legal guardian if applicable)

Exclusion Criteria:

* Current acute or chronic sinusitis or chronic purulent nasal discharge
* Rhinitis medicamentosa or nasal structural abnormalities (including nasal polyps and clinically significant septal deviation) that significantly interfere with nasal airflow
* Acute upper respiratory infection within the past 14 days
* Used any pressurized metered-dose inhaler INS product (including BDP Nasal Aerosol and Ciclesonide Nasal Aerosol) within the past 90 days
* Used any experimental therapy for AR within the past 30 days
* Any condition which the investigator feels may interfere with the study
Nursing Led Interdisciplinary Intervention in Prevention of Girl Child Mortality and Maltreatment

In Northern India, skewed sex ratios, female feticide and higher child mortality rates for girls have become serious concern. The female child mortality as a result of son preference have increased during the last several decades. Since families cannot know the sex of the fetus due to Indian government policies, they now 'neglect' girl child to ensure there are few survivors. Survival chances of second and third daughters are plunging neglecting healthcare and nutrition has become tool for death as 'good riddance'.


Eligibility Criteria:
Inclusion Criteria:

* Families having girl child before
* High risk families with high expectation of having son

Exclusion Criteria:

* Families having son before
* Relocation and moving out of town during study period
* Not ready to consent for intervention
Enhancing Attention and Wellbeing Using Digital Therapeutics

The goals of the proposed research are to first determine the minimal and/or optimal dose of a digital intervention required for cognitive enhancement, and then to examine the impact of several potential moderators of treatment effects (i.e., cognitive decline, AD polygenic hazard score, cardiovascular risk, and race/ethnicity). This knowledge gained from his high-impact study with transform the field of cognitive interventions, paving the way for a precision medicine model for cognitive enhancing interventions that improve quality of life for older adults and individuals with cognitive deficits at risk of developing dementia.


Eligibility Criteria:
Inclusion Criteria:

* 60+ years old (adult)
* English language fluency
* owning a smartphone or tablet

Exclusion Criteria:

* Under 60 years old (minor)
Study of Colchicine to Treat and Prevent Recurrent Pericarditis (First Episode)

The purpose of the study is to determine whether colchicine is safe and effective in the treatment and prevention of recurrent pericarditis (first episode).

Colchicine is safe and effective in the management of recurrent pericarditis after failure of conventional treatment. Preliminary data have shown that it may be effective also in treatment of the first attack of recurrent pericarditis and the prevention of further recurrences.

Comparisons: The study will compare the safety and efficacy of colchicine in the treatment of the first attack of recurrent pericarditis and the secondary prevention of recurrences. Colchicine will be used in addition to conventional treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with the first attack of recurrent pericarditis
* Age≥ 18 years
* Informed consent

Exclusion Criteria:

* Suspected neoplastic, tuberculous, or purulent etiology
* Known severe liver disease and/or elevated transaminases \>1.5 times the upper limit of normality
* Serum creatinine \>2.5 mg/dl
* Serum creatine kinase (CK) over the upper limit of normality or known myopathy
* Known gastrointestinal or blood disease
* Pregnant or lactating women or women not protected by a contraception method
* Known hypersensibility to colchicine
* Treatment with colchicine at enrolment