cyrilzakka/clinical-trials huggingface dataset:
Virtual Reality Software for Patients With Stroke

The goal os this clinical trial is to develop and validate a gamified, fully immersive, and stroke-specific virtual reality software to improve physical disability and quality of life in patients with stroke.

The main questions it aims to answer are:

* To assess the effects of a gamified, fully immersive and stroke-specific virtual reality 10-week intervention combined with usual care rehabilitation, compared to usual care rehabilitation alone and in combination with a commercially available VR system, on disability in patients with stroke.
* To assess the effects of a gamified, fully immersive and stroke-specific virtual reality intervention combined with usual care rehabilitation, compared to usual care rehabilitation alone and in combination with a commercially available virtual reality system, on quality of life, upper-body motor function, gross manual dexterity, handgrip strength, static and dynamic balance, and cognitive function in patients with stroke

Stroke is the leading cause of long-term disability and ranks as the second most prevalent cause of mortality worldwide. According to data from the World Health Organization, since 2005, the global probability of a person experiencing a stroke has increased by 50 percent. It is expected that 1 in 4 individuals will face the risk of having a stroke in their lifetime. A stroke can result in significant loss of motor functions, communications abilities, weakness, or hemiparesis, leading to a diminished quality of life. Therefore, improving the rehabilitation process is evidently of paramount significance. Virtual reality has emerged as a novel strategy to improve neurological diseases; however, there is an absence of an immersive software designed specifically for stroke patients within a gamified environment. Therefore, the aim of RESET randomized controlled trial is to evaluate the effect of a gamified, fully immersive, and stroke-specific virtual reality software on disability in stroke patients.

Eligibility Criteria:
Inclusion Criteria:

* Women and men with either an ischemic or hemorrhagic stroke
* Stroke between the last 7 to 14 days
* Functional independence before stroke (modified Rankin scale \<3)
* Paresis of the lower extremity, upper extremity, or both, with a score ≤3 on the "motor arm" item of the National Institutes of Health Stroke Scale (NIHSS) scale
* Trunk control in seated and standing position
* Ability to understand basic instructions and to decide whether to sign informed consent

Exclusion Criteria:

* Moderate-severe aphasia that precludes understanding the required tasks
* Cognitive impairment that precludes cooperation with tasks
* Serious behavioral problems or mental disorders
* Lower extremity deep vein thrombosis, quadriplegia, neurodegenerative diseases, lower limb fractures, or recent myocardial infarction
* Vital organ (heart, lung, liver, kidney, etc.) failure, malignant tumor, or other unstable condition
* A history of cerebrovascular disease (if not fully resolved)
* Photosensitive epilepsy
The Effect of Oral Care Protocol on Prevention of Oral Mucositis in Pediatric Cancer Patients

This study conducted to determine the effects of two oral care protocols containing sodium bicarbonate or saline solution in the prevention of oral mucositis (OM), mucositis degree, and recovery time in children with cancer.

The study conducted as a randomized controlled trial with a parallel design with two groups; Study group/ Oral care protocol with saline solution Control group/ Oral care protocol with sodium bicarbonate solution

Study Hypothesis; There is a difference in oral mucositis (OM) between groups. There is a difference in the degree of OM between groups. There is a difference in the OM recovery time between groups. There is a difference in demographic variables in patients with and without mucositis.

The study sample was comprised of 43 children with cancer aged 1-17 years, received chemotherapy for ≥3 days at inpatient clinics, and whose families agreed to their participation in the study. Patients excluded who have oral ulceration or mucositis, taking any antiviral or antifungal therapy for OM before enrollment in the study. This trial was a triple blinded which the patients/parents, nurses, and the investigators have no idea about the groups.

In the study, patients were allocated by the blocked randomization. After naturally separating the gender variable into 2 layers, the age was divided into 5 layers as "\<1 year, 1-3 years,\>3-6 years, 6-12 years,\>12 years", and the diagnosis variable was divided into 3 layers as "ALL, AML and oncological tumors."

Socio-Demographic Data Collection Form, International Child Mucositis Rating Scale (CHIMES), and Mucositis Follow-up Form used.

The child who do not have mucositis and who will be hospitalized for more than 3 days for chemotherapy will be distributed to the groups by stratified randomization method, the information of the patients will be obtained with the sociodemographic data collection form, oral care training will be given to the patient and the family, oral care protocol will be applied and it will be evaluated daily with the CHIMES and Mucositis Follow-up Form, and the severity of mucositis according to the World Health Organization Mucositis Assessment Index, the mean score of the CHIMES, recovery time will be monitored through the Mucositis Follow-up Form.

Eligibility Criteria:
Inclusion Criteria:

* have cancer, aged 1-17 years, received chemotherapy for ≥3 days at inpatient clinics and whose families agreed to their participation in the study.

Exclusion Criteria:

* who have oral ulceration or mucositis, in terminal period, taking any antiviral or antifungal therapy for OM before enrollment in the study.
Evaluation of the Use of Cefoxitin in Combination in Continuous Parenteral Administration in the Treatment of Bone and Joint Infections

Cephamycin related to 2nd generation cephalosporins, the use of cefoxitin has long been limited to antibiotic prophylaxis. Because of its spectrum (sensitive staphylococci, enterobacteria including ESBL, streptococci, anaerobes), its stability and its low cost, it could be useful in curative bone and joint infections, especially in case of infection polymicrobial disease in patients for whom antibiotic alternative per os is limited.


Eligibility Criteria:
Inclusion Criteria:

* patients havind had a bon and joint infeciton treated with cefoxitin in combination in continuous parenteral administration

Exclusion Criteria:

-
The Effect of Head and Shoulder Positioning on the Cross-sectional Area of the Subclavian Vein in Obese Adults

In the present study, the cross-sectional area of subclavian vein, and the depth of the SCV from the skin are assessed in different head positions (neutral, rotation to ipsilateral or contralateral sides) and different shoulder positions (neutral or lowered) in spontaneous breathing obese adults.


Eligibility Criteria:
Inclusion Criteria:

* Healthy obese adults (BMI ≥ 30)

Exclusion Criteria:

* Medication affecting vascular elasticity History of central venous catheterization or clavicle fracture History of lung surgery, operation of chest cage
A Big Data-based Cohort Study for Cataract Patients

Cataract is an important cause of blindness and visual impairment worldwide. At present, the only effective treatment method is surgery. The visual function of most patients can be significantly improved after surgery, but there are still 5-20% of patients whose visual function cannot be improved after surgery. Previous studies have found that the surgical complications and postoperative visual function of cataract patients are closely related to the condition of the fundus, but the current fundus camera cannot perform clear fundus imaging of cataract patients, and the existing potential visual inspections, such as retinal visual inspection, are also inaccurate. Predict postoperative visual acuity. Therefore, there is an urgent need for a reliable postoperative effect prediction system for cataract patients to provide reference for both ophthalmologists and patients.

This study intends to collect patient medical record information and traditional/ultra-wide fundus photos and other multi-modal data. Firstly, this study will use artificial intelligence technology to enhance fundus photos of cataract patients to obtain clearer fundus photos. Then this study will use both medical record information and traditional/ultra-wide fundus photographs to predict postoperative vision and visual function of cataract patients.


Eligibility Criteria:
Inclusion Criteria:

* Candidates for cataract surgery (phacoemulsification and intraocular lens implantation) within a week.

Exclusion Criteria:

* Unwilling or unable to receive fundus photography
A Randomized Controlled Trial to Compare the Glycemic Control, With or Without the Connected Solution, of Adult Type 2 Diabetic Participants on Basal Insulin in Taiwan

The Connected Solution investigated in this study is the combination of the titration module "Insultrate" and a cell phone application (app) named Health2Sync (H2S) that synchronizes participants' self-monitoring blood glucose data and electronic health records to a platform overseen by their treating physicians. This study investigates if this Connected Solution helps to improve glycemic control more effectively than physician-recommended routine management (i.e., usual care) in participants with Type 2 Diabetes Mellitus (T2DM).

Study duration per participant will be up to 9 months, including a screening period of up to 3 months and a study intervention period of 24 weeks (± 14 days).

Eligibility Criteria:
Inclusion Criteria:

* Participants must be ≥ 20 years of age at the time of signing the informed consent
* Participants were diagnosed with T2DM prior to the screening visit
* Participants who are insulin naïve, or already treated with basal insulin but uncontrolled with the same insulin regimen for at least 3 months (90 days) prior to Day 1
* Participants with HbA1c between 7.5% and 11% (inclusive) at the screening visit and Day 1
* Participants with fasting self-measured blood glucose (fSMBG) or fasting plasma glucose (FPG) \>130 mg/dL at the screening visit and Day 1
* Capable of giving signed informed consent
* Willing and able to use the H2S app and glucometer

Exclusion Criteria:

* Participants with diabetes other than T2DM
* H2S app/ BGM is not appropriate for the participant or use of device is otherwise contraindicated (in the opinion of the investigators)
* Participants with hypoglycemia unawareness or with severe hypoglycemia within the past 90 days prior to the screening visit and until Day 1
* Hospitalization (for any reason) in the past 30 days prior to the screening visit and until Day 1
* Participants with severe conditions/concomitant diseases precluding their safety or ability to participate in this study, as judged by the investigators - Participants are not on stable dose of glucose lowering therapy including OADs, glucagon-like peptide-1 (GLP-1) receptor agonists, or basal insulin therapy within the past 12 weeks prior to the screening visit and until Day 1 per investigator's discretion
* Participants using mealtime insulin for more than 10 days in the last 90 days before the screening visit and until Day 1
* Participants who used H2S app within 1 month prior to the screening visit and until Day 1 randomization
* Participants who have taken other investigational drugs within 90 days or 5 half-lives prior to screening or randomization, whichever is longer

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Effect of Diabetes Mellitus on Success of Spinal Anesthesia

Some of the authors says that diabetes mellitus is a risk factor for spinal anesthesia failure. However, that opinion was not determined in a trial. Thus the investigators aimed to investigate the effect of diabetes mellitus on spinal anesthesia.

The investigators will include all of the patients who will undergo surgery with spinal anesthesia. The investigators will observe the patients with or without diabetes mellitus. And the investigators will examine the effect of diabetes mellitus on failure of spinal anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* surgery with spinal anesthesia

Exclusion Criteria:

* heart failure
* coronary artery disease
Study Evaluating Ovasave, an Autologous Cell Therapy, in Patients With Active Crohn's Disease

The investigational product, named Ovasave (Ova-Treg), is a cell-based therapy, consisting of an autologous antigen-specific regulatory type 1 T lymphocyte expanded population administered via the intravenous route as an infusion.

The study is a multicenter, randomised, double-blinded, placebo-controlled, multi-dose and multi-injection study; followed with a 16-week phase with either the possibility for an open-label treatment part or a safety follow-up part with no injection.

Then, the patients will be followed in an additional long-term safety follow-up, of maximum duration of 3 years from the first administration.

During double-blinded phase, the treatment consists of 2 intravenous (i.v.) administrations of antigen-specific autologous T regulatory cells or placebo:

* Group A: 1.10e4 cells and 1.10e4 cells
* Group B: 1.10e6 cells and 1.10e6 cells
* Group C: 1.10e7 cells and 1.10e7 cells
* Group D: Placebo and Placebo

During double-blinded phase, two i.v. administrations of study drug (Ova-Treg) will be administered, one at week 0 and another one at week 8 for the group A, B and C. Two injections of Placebo will be administered, one at week 0 (V4) and another one at week 8 for the group D. During double-blinded phase, all the patients will be followed during 16 weeks. This will be followed by an additional period of 16 weeks when the patient is expected to receive two additional administrations of Ovasave at 10e6 cells dose (Open-label phase), except if refused by the patient or not recommended by the Investigator, representing the follow-up phase. These third and fourth administrations will be performed for all groups (A, B, C and D) with an injection of Ovasave at 1.10e6 cells administered at week 16 and week 24. A patient who didn't receive the 2 first administrations during the double-blinded phase cannot receive the third and the fourth administration during Open-label phase.

Eligibility Criteria:
Main Inclusion Criteria:

1. Active Crohn's Disease diagnosis defined as patients with medical history of signs, symptoms and biological evidence of active bowel inflammation:

   * Documented endoscopic evidence of inflammatory bowel disease (IBD), compatible with Crohn's diagnosis at least 1 year prior to screening and
   * High sensitive C-reactive protein (hs-CRP) \> 10 mg/L at V1.
2. Failure or intolerance to conventional treatments including corticosteroid, immunosuppressant and at least one biologics; and had not responded (primarily failure) or responded and then lost response completely (no response or need to increase the dose / secondary failure) or were intolerant to this therapy at a dose indicated for CD
3. Documented CDAI (Crohn's Disease Activity Index) above 250 points (CDAI ≥ 250) at screening or within the past 3 months;
A Phase Ib Study of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion

A Phase Ib Study to Evaluate the Safety, Tolerance, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion


Eligibility Criteria:
Inclusion Criteria:

1. The participant voluntarily joined the study, signed an informed consent form, and had good compliance.
2. Age ≥ 18 years and ≤ 75 years old, regardless of gender.
3. Participants with advanced solid tumors diagnosed by histopathology or cytopathology.
4. Malignant pleural effusion confirmed by histopathology or cytopathology or clinically diagnosed as moderate or above and requiring drainage.
5. Eastern Cooperative Oncology Group (ECOG) performance status: 0 to 2.
6. Life expectancy of at least 3 months.
7. Adequate organ function.
8. Female participants of childbearing potential should agree to use contraception to prevent pregnancy until 6 months after discontinuation of JMKX000197. The serum pregnancy test result should be negative 7 days before enrollment and must be a non-lactating participant. Male participants must agree to use effective contraception during the study and for 6 months after discontinuation of JMKX000197.

Exclusion Criteria:

1. Bilateral pleural effusion or concurrent peritoneal effusion, or concurrent pericardial effusion.
2. Pleural effusion is either encapsulated or severely separated; Or merge with chylothorax; Or combined with infectious pleural effusion.
3. Have used interferon gene stimulating factor (STING) agonists for pleural perfusion。
4. Known allergies to the study drug or its excipient components.
5. Have participated in other clinical trials within 28 days prior to randomization.
6. Major surgery within 28 days prior to randomization.
7. Central nervous system metastatic disease, leptomeningeal disease, or cord compression.
8. Clinical unstable or uncontrolled concomitant cardiovascular, pulmonary, hepatic, renal or seizures diseases.
9. Uncontrollable systemic infections (viruses, bacteria, fungi), including but not limited to positive HBsAg and HBV DNA, positive HCV RNA, positive HIV antibody test or combined infections within the first 28 days of randomization and require systemic anti-infective treatment.
10. Have a history of organ transplantation.
11. Any further condition which, in the opinion of the Investigator, the participant is not suitable in the present study.
Effect of Keratinized Mucosa on Peri-implant Health

The aim of this clinical study is to evaluate the significance of keratinized mucosa and to investigate the influence of free gingival graft procedure on peri-implant health status in patients after prothesis delivery.

The study will be conducted in Faculty of Dentistry, Kutahya Health Sciences University . The patients who applied to the Department of Periodontology, received dental implant treatment, and required routine follow-up for the maintenance of peri-implant health will be included. Clinical and radiographic examinations will be performed at baseline (prothesis delivery) and at the end of the 3rd, 6th month, 1st year following the prosthetic loading. During clinical examination probing depth (PD), modified plaque index (mPI) and modified bleeding index (mBI) measurements will be evaluated with the Williams periodontal probe. These measurements will be taken at four points of the implant (mid-buccal, mesio-buccal, disto-buccal and mid-lingual) and these four measurements will be averaged for each implant. In addition, the amount of keratinized mucosa (KM) in the implant sites will be evaluated by measuring the mucosal margin and mucogingival junction on the vestibular surface with the same probe. After clinical examination, a periapical radiograph will be taken using a parallel technique to determine marginal bone loss surrounding the implant. The distance between the implant neck and the most coronal part of the alveolar crest will be measured on the mesial and distal surfaces for each implant on the obtained radiographs and the average of the two measurements will be taken. The parameters checked during clinical and radiographic examination will be compared between patients with or without keratinized mucosa and whose keratinized mucosa has been increased by free gingival graft.

Eligibility Criteria:
Inclusion Criteria:

* Being over the age of 18
* Having dental implant treatment and prosthetic restoration
* Not having received bone augmentation treatment at the implant site
* To comply with maintenance controls after dental implant treatment

Exclusion Criteria:

* Pregnancy
* Having used systemic antibiotics within 6 weeks prior to the start of the study
* Having a disease that affects bone and soft tissue metabolism, such as hyperthyroidism, hyperparathyroidism, and uncontrolled diabetes mellitus
* Using drugs that cause immunosuppression
* Using a medicine that affects bone metabolism, such as a bisphosphonate
Trial to Evaluate the Safety and Immunogenicity of a 20-Valent Pneumococcal Vaccine in Adults 65 Years of Age or Older With Prior Pneumococcal Vaccination

This Phase 3 will describe the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine formulation in adults 65 years of age or older with prior pneumococcal vaccination


Eligibility Criteria:
Inclusion Criteria

1. Male or female adults 65 years of age or greater.
2. Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy in the previous 6 weeks or hospitalization for worsening disease within 12 weeks before receipt of investigational product.
3. Female subject of nonchildbearing potential; male subject not able to father children or who is able to father children and willing to use a highly effective method of contraception.
4. Male or female adults who meet 1 of the following:

   1. Vaccination with PPSV23 greater than or equal to 1 year and less than or equal to 5 years prior to vaccination in the study, and no prior 13vPnC vaccination (Cohort A).
   2. Vaccination with 13vPnC greater than or equal to 6 months prior to vaccination in the study, and no prior PPSV23 vaccination (Cohort B).
   3. Vaccination with 13vPnC followed by PPSV23 (PPSV23 vaccination greater than or equal to 1 year prior to vaccination in the study) (Cohort C).

Exclusion Criteria

1. Serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the subject from participating in the study.
2. History of microbiologically proven invasive disease caused by S pneumoniae.
Real-world Clinical Effectiveness and Patient Insight Associated With Adding Sodium Glucose Co-transporter 2 Inhibitor to Gliclazide Modified Release

The study objectives are to assess over the gliclazide MR-SGLT2i combined treatment course in patients with T2DM adding SGLT2i to gliclazide MR-based therapy.

The primary objective is to determine the effectiveness of adding SGLT2i to gliclazide MR-based therapy in patients with T2DM, as measured by HbA1c changes.


Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed with T2DM for at least two years prior to index date
* Patient aged ≥18 years at the index date
* Patient naïve to SGLT2i prior to index date
* Patient treated with gliclazide MR at a minimum daily dose of 60 mg at the index date
* Starting treatment with SGLT2i added to gliclazide MR based therapy, during the eligibility period, with a minimum of 60 days of combined gliclazide MR-SGLT2i treatment
* Presence of at least two assessments of HbA1c laboratory test results from the medical records

Exclusion Criteria:

* Diagnosis of diabetes other than T2DM (e.g., type 1, gestational) at index date
* Use of antidiabetic drugs other than those permitted by the inclusion criteria, at index date