cyrilzakka/clinical-trials huggingface dataset:
Real-time Activity Monitoring to Prevent Admissions During RadioTherapy

This study will aim to demonstrate that implementation of a rapid, multidisciplinary supportive care program for patients receiving chemoradiotherapy who are deemed to be at high risk for hospitalization based on real-time pedometer data will reduce the rate of hospitalization during chemoradiotherapy or within four weeks of radiotherapy completion.

Primary Objective

* To demonstrate that implementation of a rapid, multidisciplinary supportive care program for patients receiving chemoradiotherapy who are deemed to be at high risk for hospitalization based on real-time pedometer data will reduce the rate of hospitalization during chemoradiotherapy or within four weeks of radiotherapy completion.

Secondary Objectives

* To demonstrate the feasibility of a program of rapid, multidisciplinary supportive care triggered by real-time pedometer data.
* To characterize the interventions enacted by our multidisciplinary supportive care team.
* To explore if interventions enacted by our multidisciplinary team for patients with low recent step counts lead to increased step counts in subsequent weeks compared to historical controls.
* To collect biospecimens for future correlative studies examining associations between blood/urine biomarkers and patient activity levels.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* ECOG performance status 0-2
* Able to ambulate independently (without the assistance of a cane or walker)
* Diagnosis of invasive malignancy of the head and neck region, lung, esophagus, or stomach
* Planned treatment with fractionated (≥15 treatments) external beam radiotherapy with concurrent chemotherapy (or cetuximab) with curative intent (including preoperative or postoperative treatment)
* Women of childbearing potential must:

  * Have a negative serum or urine pregnancy test within 72 hours prior to the start of study therapy
  * Agree to utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study therapy is completed
  * Be advised of the importance of avoiding pregnancy during trial participation and the potential risks of an unintentional pregnancy
* All patients must sign study specific informed consent prior to study entry.
Posterior Pole Asymmetry Analysis (PPAA) for Early Glaucoma

Spectrailis optical coherence tomography has come with a new posterior pole asymmetry analysis for glaucoma diagnosis. The aim of the investigators study was to assess its applicability in diagnosing early glaucoma patients.


Eligibility Criteria:
Inclusion Criteria:

* Age more than 18 years
* Best corrected visual acuity 20/40 or better
* Refractive error within ±5D sphere and ±3D cylinder
* Willingness to participate in the study

Exclusion Criteria:

* Media opacities preventing imaging
* Intraocular surgery within the last 6 months
* Any retinal or neurological disease other than glaucoma that could confound the results of visual field examination and OCT.
Predictors of Reactive Thrombocytosis in Critically Ill Septic Patients

Reactive or secondary thrombocytosis is defined as abnormally high platelet count (≥4,50,000 platelets per micro-liter) in the absence of chronic myeloproliferative disease. In critically ill patients reactive thrombocytosis is not uncommon during recovery phase and an association has been seen with poor outcome and increased risk of subsequent VTE. However, not all patients with infection respond with thrombocytosis. No study has enumerated the risk factors or predictors of reactive thrombocytosis in critically ill septic patients.

All patients admitted to intensive care unit of the department of Critical Care Medicine during one year period will be screened for possible inclusion in this study. In this prospective observational study, demographic and clinical characteristics of all ICU patients who fulfill inclusion criteria will be collected along with relevant laboratory tests done for patient management routinely. ICU prognostication scores, i.e., Acute Physiologic and Chronic Health Evaluation (APACHE) II score and Sequential Organ Failure Assessment (SOFA) score will also be recorded. ICU survivors will be followed up in their routine ICU follow up clinic visits.

Sample size was estimated at 10% incidence rate of reactive thrombocytes, two sided 95% confidence interval and 4.5% margin of error of the incidence rate, sample size came out to be 171. Finally in this study investigators have targeted to include at least 180 participants. Sample size was estimated using software power analysis and sample size, 2008 (PASS-8).

Eligibility Criteria:
Inclusion Criteria:

* All adult (≥18 years) ICU patients with the diagnosis of sepsis will be considered.

Exclusion Criteria:

* Age \<18 years
* Pregnancy
* H/O Malignancy
* Thrombocytosis at admission
* Primary thrombocytosis
* Post-splenectomy
* Chronic inflammatory disease (e.g. Connective tissue disorders, IBD, temporal arteritis)
* Known immunosupressive condition
* Chronic infectious diseases (e.g. tuberculosis, chronic pneumonitis)
Lidocaine and Ketamine Versus Standard Care on Acute and Chronic Pain

The investigators are conducting this study to find out if intravenous (injected through the vein) infusion of lidocaine and ketamine administered with general anesthesia is as effective as a paravertebral block in lessening pain after surgery and that both of these techniques are superior to general anesthesia alone in reducing pain immediately after surgery and in the long-term.

Participants will be randomized into one of three study groups; Group 1 - Paravertebral Group - ropivacaine is injected near the spine before surgery. Midazolam and fentanyl are administered intravenously for sedation. Group 2 - Lidocaine/Ketamine - General anesthesia with lidocaine and ketamine administered intravenously throughout your surgery and for 60 minutes after surgery. Group 3 - General Anesthesia Alone. General anesthesia with placebo administered intravenously throughout surgery and for 60 minutes after surgery. All participants will rate their pain on a scale from 0 to 10 after surgery and on days 1 and 2 after surgery. Participants are called 3 and 6 months after surgery for pain and quality of life assessments

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 and less than 75 years
* Male
* Unilateral inguinal hernia scheduled for elective open repair

Exclusion Criteria:

* Incarcerated hernia or urgent procedure
* Reoperation (recurrent hernia)
* Contraindication to regional anesthesia such as:
* Coagulopathy
* Infection at the site of needle insertion
* Pre-existing chronic pain (at any site) requiring treatment
* Contraindication to any study medication (local anesthetic or ketamine)
* History of significant Axis I psychiatric disease (major depressive disorder,bipolar disorder, schizophrenia, etc.)
* Significant hepatic (ALT or AST \> 2 times normal) or renal (serum creatinine \> 2 mg/dl) impairment
Individualized Pneumoperitoneum Pressure in Colorectal Laparoscopic Surgery

Optimizing all factors that increase the intra-abdominal volume and performing an individualized strategy should allow us to reduce the pneumoperitoneum insufflation pressure while maintaining optimal surgery conditions for a laparoscopic colorectal surgery, compared to the standard strategy of maintaining fixed intra-abdominal insufflation pressures (12-15 mmHg).

In the context of multimodal rehabilitation in colorectal laparoscopic surgery (Fast Track or ERAS (Enhance Recovery After Surgery)) multiple strategies have been introduced that have managed to improve patient recovery, decrease postoperative complications, decrease hospital days and decrease the overall costs per process.

The possibility of performing individualized colorectal laparoscopic surgery with the minimum insufflation pressure guaranteeing optimal surgical conditions has not been evaluated and this would allow us to reduce the impact of surgery on the patient, decrease perioperative morbidity and improve patient recovery.

In our study, abdominal compliance, Pv0 and maximal Pv were determined during the initial performance of the pneumoperitoneum, and then a stepwise protocol for the reduction of intra-abdominal pressure (IAP) insufflation was stablished with evaluation by the surgeons, until reaching the minimal insufflation IAP in which optimal surgical conditions are maintained.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* ASA I-III (American Society of Anesthesiologists physical status classification)
* Signed informed consent
* Absence of cognitive deficit

Exclusion Criteria:

* Urgent surgery
* Pregnancy or breastfeeding
* Immune Disorder
* Advanced renal, hepatic or cardiopulmonary disease
* Negative to participate in the study
* Under 18 years
* Inability to give consent
* Associated neuromuscular disorders
* Allergy to rocuronium/sugammadex
* Contraindication for use of rocuronium/sugammadex
TNFalfa Blocking Treatment of Spondylarthropathies

The purpose of the study is to establish a Danish cohort of spondylarthropathy (SpA) patients who are being treated with TNFalfa blockers. By following the TNFalfa blocking treated patients the researchers want to identify better biomarkers for disease activity and disease progression. In addition, the researchers want to identify predictors for disease progression.


Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years old
* Spondylarthropathies according to the European Spondylarthropathy Study Group (ESSG) criteria
* Sacroiliitis by X-ray or magnetic resonance imaging (MRI)
* Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)\>3
* No signs of tuberculosis (TB)
* Sufficient contraception

Exclusion Criteria:

* Wish of pregnancy or nursing
* Previous treatment with TNFalfa blocker
* Disease-modifying anti-rheumatic drugs (DMARDs) other than methotrexate (MTX) later than 4 weeks before inclusion
* Steroid treatment later than 4 weeks before inclusion
* Immunosuppressing agents later than 4 weeks before inclusion
* Severe infections within 3 months
* HIV-infection
* Active hepatitis B and C
* Active or latent TB
* Severe chronic diseases
* Heart insufficiency (New York Heart Association \[NYHA\] 3 and 4)
* Malignancy
* Systemic lupus erythematosus (SLE) or SLE-like disease
* Abuse of narcotics or alcohol
* Major psychiatric disorders
Evaluation of Case Management for First Episode Psychosis Using the PEPsy-CM Checklist

Psychotic disorders are often chronic conditions that lead to impaired functioning, quality of life and social integration. Current research and recommendations for good practice are moving towards early detection and intervention. It is recognized that this leads to better adherence, alliance to care and knowledge of pathology for the patient, especially in young patients. For more than a decade, early intervention services (EIS) are opened in France over an increasingly large territory. Still too few studies assess the impact of these structures in France. These EIS offer a multimodal intervention (social, professional, psychotherapeutic). The intervention of case managers (or care coordinators in french) seems to be the core of EIS. The case manager has a fundamental role in the process of recovery in coordinating each individual's treatment and ensuring continuity of care.

The PEPsy-CM study aims to evaluate the effectiveness on the relapse rate of a 3 year Program for Early Psychosis based on Case Management (PEPsy-CM) compared to TAU in a population of young people with a FEP.

A qualitative evaluation of case management practice in EIS seems essential to assess the impact of case managers under real conditions.

Based on the Australian Good Practice Recommendations (EPICC integrity tools) and the case management practice manuals, the PEPsy-CM check-list questionnaire was developed to evaluate the practice of case management in the EIS in France. This check-list contains different 35 items. The final score between 1(poor) to 5 (good) is established to determine the quality of the case management. Qualitative data are also collected during the interview with the participants.


Eligibility Criteria:
Inclusion Criteria:

* Professional working in an early intervention center treating first episodes of psychosis
* Professional involved in the organization/management of the center or practicing case management.

Exclusion Criteria:

* Professional not working in the early intervention center
* Professional working in the early intervention center but not having a role in the organization or management of the center or as case manager
* Professional who does not take charge of people who have had a first psychotic episode
A Study to Assess Retention Rate, Persistence and Adherence in Population of Spondylarthritis (Ankylosing Spondylitis and Psoriatic Arthritis) Patients Treated With Adalimumab in Routine Clinical Settings in Russian Federation

The objective of this study is to access retention rate, persistence and adherence in population of spondylarthritis (SpA) (ankylosing spondylitis (AS) and psoriatic arthritis (PsA)) participants treated with adalimumab in routine clinical settings in the Russian Federation.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of AS or PsA.
* Planned prescription or prescribed no more than 1 month before to enrolment therapy with adalimumab. Treatment has to be prescribed according to the local product label and prescription guidelines.
* At the moment of start of treatment with adalimumab moderate/severe AS or PsA (BASDAI \> 4 for AS; DAS28 \>3,2 for PsA).
* Negative result of tuberculosis (TB) screening test and TB specialist permission to start biologic therapy.
* Authorization (Consent) for Use/Disclosure of Data signed by the participant.

Exclusion Criteria:

* Has contraindications for the treatment with adalimumab (please see the latest version of the locally approved label).
* Participants who are unable to walk and perform basic self-care activities either due to SpA or a comorbid condition.
* Any biologic drugs taken over before 3 months of enrolment to the study.
* Previous participation in this program.
Pulmonary Surfactant(PS) Therapy at High Altitude Area

The traditional concept believes that the etiology of neonatal respiratory distress syndrome (RDS) is immature development of lung,especially the surfactant synthesis system,and RDS is still one of the major causes of mortality and morbidity in newborns, especially premature infants\[1\].In recent years, using pulmonary surfactant replacement therapy (PS treatment) in the treatment of respiratory distress syndrome (RDS) is a major breakthrough in neonatal medicine \[2\].Combined with clinical practice and experience,and through Meta analysis of related randomized controlled trials (RCTs),it confirms that natural surfactant treatment can reduce mortality,the incidence of pulmonary air leaks (pneumothorax and interstitial lung emphysema),and the incidence of bronchopulmonary dysplasia (BPD) or 28-day-old mortality.For RDS in preterm infants whose gestation is \<35 weeks ,surfactant replacement therapy is also more effective than in nearly term and full term infants.Therefore, in the analysis of cases of different gestational age groups,the investigators should focus on the study of premature infants cases.Due to less relevant research for using PS treatment to cure newborn RDS in high altitude area,this retrospective study conducts statistics and analysis of recently three-year cases in some hospital of high altitude area,to explore the treatment effect of the high altitude region and the impact of altitude on the treatment.

in order to explore feasibility and efficacy for PS treatment of newborn RDS in high-altitude area ,and its efficacy at different altitudes, the investigators conduct a multi-center retrospective study of RDS cases in Qinghai and Tibet these two high-altitude area,and use RDS cases under the unique conditions to do statistics and analysis.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with respiratory distress syndrome(RDS)

Exclusion Criteria:

* major congenital abnormalities
Artificial Intelligence (AI) - Assisted Visual Impairment Screening Model: Community-based Implementation and Evaluation of Performance, Feasibility and Costs.

The goal of this observational study is to evaluate the performance, operational efficiency, acceptability, feasibility, and cost-effectiveness of an AI-assisted screening model for visual impairment in a community setting. The main questions it aims to answer are:

* Can the AI-assisted screening model improve screening and referral accuracy compared to the current traditional screening approach?
* Does the AI-assisted model enhance operational efficiency and reduce healthcare costs in a community setting?

Researchers will compare the AI-assisted model with the current traditional screening approach to assess its impact on screening accuracy, operational efficiency, and cost-effectiveness.

Participants will:

* Undergo vision screening using either the AI-assisted model or the traditional model.
* Provide feedback on the acceptability of the screening approach.
* Contribute to evaluating the feasibility and costs associated with each screening method.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 50 years old and above.

Exclusion Criteria:

* Individuals aged below 50 years old.
5HT3 Antagonism and Auditory Gating in Schizophrenia

The target groups in this study are brain waves and neurotransmitters (chemical messengers) in the brain. Subjects with diagnosed with schizophrenia will be studied. The study will help understand more about normal brain functioning and how that functioning differs in people with schizophrenia. Another purpose of this study is to determine how the altered brain functioning in schizophrenia contributes the symptoms found in the illness.


Eligibility Criteria:
Subjects with diagnosed with schizophrenia will be studied.
The Comparison of HYAJOINT Plus and Hyalgan Hyaluronan Supplement for Knee Osteoarthritis Pain

The aim of this study was to compare single injection HYAJOINT Plus Synovial Fluid Supplement used on the single and repeat treatment of knee osteoarthritis that has the same safety and effectiveness as three-injection hyaluronan, Hyalgan.

The study was a random, evaluator-blinded, controlled, single center clinical trial. Recruiting patients who have been suffered from the osteoarthritis pain under conventional nonpharmacologic therapy or analgesics for a long time and randomly divided into two groups, HYAJOINT Plus or Hyalgan group, when the inclusion criteria was met and the inform consent was obtained. They were followed for 56 weeks including visits at 4, 12, 26, 39, and 52 weeks post-treatment for the safety and effectiveness evaluation. After complete 52-week visit, subjects would received HYAJOINT Plus on the target knee. These subjects were followed for 4 weeks to assess the safety of repeat treatment or cross reactions of the use from three-injections to single-injection hyaluronan treatment. The primary endpoints were the incidence of any adverse events during the study, as well as the objective assessment of pain visual analog scale at baseline and every visit.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic knee osteoarthritis for at least 6 months despite nonoperative treatment and/or physical therapy
* Average knee pain score ≧ 30 mm on a 100-mm VAS
* Kellgren-Lawrence grade 2 or 3 knee osteoarthritis based on radiographs taken within previous 6 months 18
* If the VAS pain score of the contralateral knee with radiographic evidence of bilateral knee osteoarthritis was \< 30 mm

Exclusion Criteria:

* Hip OA
* Kellgren-Lawrence grade 4 on target knee
* Clinical apparent active symptoms like infections
* Intra-articular injections of hyaluronan within the past 6 months
* Previous orthopaedic surgery on spine or lower limb
* Intra-articular injections of steroid type drugs within the past 3 months
* Diagnosed as Lupus erythematosus, Rheumatoid arthritis, Hemiparesis, Neoplasm or received hemodialysis
* Known allergy to avian proteins or hyaluronic acid products
* Women ascertained or suspected pregnancy or lactating
Hospital Based Registry of Childhood Cancer in Pediatric Oncology Units in French Speaking Africa

The ultimate aim of this registry is to collect precise information concerning the children coming to oncology units working with the French African Oncology Group. This data will help to plan and provide correct pediatric oncology treatment and care for this population.

Collecting the data will give much needed information on numbers, stage, treatment and outcome. The register will give data for local and national health authorities in planning pediatric cancer programs.

This register is a registration of all children entering hospital based pediatric oncology units, working in selected hospitals in French speaking Africa. The data collected includes: demographic and socioeconomic status as well as clinical status and outcome.

The register also collects information on vital status, treatment abandonment and loss to follow-up.

Data, collected locally is entered on line using the Research Electronic Data Capture (REDCap) program. Data are stored under the responsibility of the IT department at Gustave ROUSSY in Paris- Villejuif.

Eligibility Criteria:
Inclusion Criteria:

1. Any child presenting at any one of the participating units for treatment
2. Any child with any type of cancer
3. Any child or adolescent less than 18 years of age.

Exclusion Criteria:

1. No cancer found
2. Age greater than 18 years -
Molecular Imaging of Breast Cancer With Breast PET/CT

This study is a feasibility study to determine if a combined breast PET/CT scanner can image malignant functional activity while determining anatomical structure in the same clinical setting for patients with breast cancer. End-points of this study are whether women will accept the imaging position and timing, and whether functional properties of breast cancer can be imaged with this device. The secondary purpose of this study is to explore protocol parameters with a view to optimizing imaging performance whilst minimizing patient discomfort. Imaging results will be compared to histological samples to determine ground truth.

PET is literally a molecular imaging modality. In monitoring the patient's response to a specific chemotherapeutic regime, baseline and subsequent PET/CT scans can be used to quantitatively determine the therapeutic effect of the regime, using the standard uptake value (SUV), a common metric in PET imaging. The breast PET/CT system will facilitate molecular imaging of breast cancer using a number of radiolabeled molecules, available both commercially (18-FDG) and from the research environment.

Eligibility Criteria:
Inclusion Criteria:

- Normal Adult Volunteers

* Female, at least 18 years of age
* Ability to lie motionless for up to 20 minutes

Patient Volunteers

* Female, at least 18 years of age
* Diagnostic findings from prior mammography highly suggestive of invasive breast carcinoma (BI-RADS category 5)
* Not pregnant or breast-feeding
* Ability to lie motionless for up to 20 minutes

Exclusion Criteria:

* Normal Adult Volunteers

  * Inability to understand the risks and benefits of the study

Patient Volunteers

* Recent breast biopsy
* Diagnostic findings from prior mammography highly suggestive of noninvasive ductal or lobular carcinoma
* Uncontrolled diabetes
* Diabetic and blood sugar level \> 200 mg/dL
* Positive urine pregnancy test or currently breast-feeding
* Inability to understand the risks and benefits of the study