cyrilzakka/clinical-trials huggingface dataset:
Influenza Vaccination Digital Interventions for People Living With Diabetes

The overall objective of this prospective randomized controlled study is to assess and quantify the impact of digital interventions to increase vaccination rates and vaccination-related outcomes in a connected population with self-reported diabetes. The digital intervention will be delivered via a campaign sent to participants, with interventions varying with each study arm. Participants will be blinded to study participation status.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Lives in the U.S.

Exclusion Criteria:

* \< 18 years old
* Does not live in the U.S.
Study of CM313 (SC) Injection in Subjects With Primary Immune Thrombocytopenia (ITP)

This is a randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and initial efficacy of CM313 (SC) injection in patients with primary immune thrombocytopenia.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old ≤ 75 years old, male or female.
* Fully understand and are able to comply with the requirements of the protocol and voluntarily sign the informed consent form.

Exclusion Criteria:

* Previously received allogeneic stem cell transplantation or organ transplantation.
* Laboratory abnormalities with clinical significance at screening visit.
* Pregnant or breastfeeding women, or women planning to become pregnant or breastfeeding during the study period; Male partners who plan to become pregnant during the study period.
* With any other situations that are not suitable for participation in this study by the investigator.
A Study to Evaluate the Efficacy of Tolterodine on Specific Symptoms in Adult Patients With Overactive Bladder.

The purpose of this study is to evaluate the efficacy and safety of tolterodine in impacting the primary symptom or complaint of patients with OAB.


Eligibility Criteria:
Inclusion Criteria:

* self-reported symptoms of OAB for ≥ 3 months prior to screening
* OAB as defined by urinary frequency (a minimum of 8 micturitions per 24 hours)
* urgency (defined as a strong and sudden desire to urinate) or urge incontinence a minimum of 2 episodes in 3 days, as confirmed by the micturition diary between screening and baseline
* patients who describe the degree of bothersomeness of their most bothersome OAB symptom as "moderately ", "a great deal ", or "a very great deal" per the OAB Bother Rating Scale

Exclusion Criteria:

* any condition that would contraindicate their usage of tolterodine once daily, including: narrow angle glaucoma, urinary retention, gastric retention
* any clinically significant local urinary tract pathology which could mimic the symptoms of OAB, such as infection or hematuria
* stress incontinence, functional, or overflow incontinence as determined by the investigator
* symptomatic acute urinary tract infection (UTI) during the run-in period, or recurrent UTIs defined by treatment for symptomatic UTI \>3 times in the 12 months prior to participation in this clinical trial
* clinically significant urinary tract obstruction
* history of lower urinary tract surgery (e.g. prostate removal or destruction, incontinence surgery) within the past 3 months
* clinically significant interstitial cystitis or significant bladder pain syndrome
Clinical Study on Third-line Treatment of Advanced Duodenal Adenocarcinoma by Fuquinitinib Combined With Sindillimab

This research project is a single-center, retrospective clinical exploration study. It aims to retrospectively analyze data from 20 patients with advanced duodenal adenocarcinoma who received third-line treatment with furquinelone combined with sintilimab, in order to determine the clinical efficacy and safety of this combination therapy in advanced duodenal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients must meet all of the following criteria to be eligible for inclusion:

Age between 18 and 80 years (inclusive); Imaging findings consistent with unresectable local advanced, recurrent or metastatic duodenal adenocarcinoma; Histologically confirmed unresectable local advanced, recurrent or metastatic duodenal adenocarcinoma; ECOG performance status 0-2; At least one measurable or evaluable lesion according to RECIST v1.1; Third-line or above treatment with the combination of sintilimab and furquimatinib.

Exclusion Criteria:

-

Patients meeting any of the following criteria will be excluded:

Patients with incomplete clinical data or laboratory examination that affects statistical analysis; Patients who have had other malignant tumors in the past 5 years; Patients who have had arterial thrombotic diseases such as angina, myocardial infarction, and transient ischemic attack in the past 6 months; Patients who have received other types of anti-tumor or experimental treatment; Pregnant or lactating women; Patients with other diseases or abnormal mental status that may affect the patient's treatment; Patients who have received other types of immune therapy, anti-angiogenic drugs, or small-molecule tyrosine kinase inhibitors.
Economic Evaluation of an Exercise Program After Multidisciplinary Rehabilitation in Patients With Chronic Low Back Pain

The purpose of the study is to compare, after functional multidisciplinary rehabilitation for chronic low back pain, an exercise program to the routine follow-up which is simply to advice patients to exercise regularly at home. The exercise program should help patients stay active, which should translate into a better long term quality of life and decreased days off work.


Eligibility Criteria:
Inclusion Criteria:

* subacute or chronic low back pain
* phases 2 to 6 of the Krause classification
* without irritative neurological deficit
* age between 18 and 60
* having completed functional multidisciplinary rehabilitation

Exclusion Criteria:

* phases 7 and 8 of the Krause classification
* entitled to a total disability pension
* acute neurological deficit in progress
* sciatica
* pregnancy
* acute inflammatory rheumatic disease
* non-osteoarticular thoracic pain
* spinal fracture within the last 3 months
* osteoporosis
* tumor
* severe heart failure or respiratory failure
* active drug addiction
* current involvement in litigation related to low back pain
* active psychiatric pathology
Effectiveness of Specific Strength Training Combined With Static Stretching of the Posterior Neck in Office Workers With Chronic Neck Pain: A Clinical Trial

Objective: To determine the effectiveness of strength training combined with stretching compared to specific strength training in office workers with chronic neck pain.

Methods: A single blind randomized clinical trial will be conducted. Participants will be adult of both sexes with sedentary office work and chronic neck pain.

The intervention will consist of a strength training program for the neck and shoulder muscles combined with static stretching of the neck, while the comparison group will only perform strength training. In addition, both groups will receive ergonomics guidelines.

Short-term, medium-term, and long-term evaluations will be performed using the Northwick Park Neck Pain Questionnaire (NPQ), Neck Disability Index (NDI), and Tampa Scale of Kinesiophobia (TSK).


Eligibility Criteria:
Inclusion Criteria:

* Adults aged between 18 and 70 years.
* Workers from companies in the Community of Madrid.
* Sedentary employees who work at least 20 hours in the office.
* Subjects with nonspecific chronic neck pain.
* All individuals who have decided to participate voluntarily after having read and signed the patient information sheet and the informed consent form.

Exclusion Criteria:

* Arterial hypertension (systolic BP \>160, diastolic BP \>100) or cardiovascular diseases.
* Diagnosed metabolic disorders.
* Symptomatic disc herniation or severe cervical spine disorders.
* Postoperative conditions.
* History of severe trauma to the neck and shoulder region.
* Pregnancy.
* Subjects with a body mass index (BMI) greater than 29.9 kilograms per square meter (kg/m2).
* Presence of physical or mental impairments that prevent the correct execution of the interventions and/or their corresponding evaluation.
* Having undergone surgery in the previous six months.
* Participating in parallel research studies.
* Not having a permanent job position.
* Using two monitors.
* Using a laptop.
Anaesthesia With Propofol Versus Midazolam : Effect on Oxidative Stress in the Brain of Head Trauma Patients

Severe traumatic brain injury is associated with an increased production of free radicals causing brain damage. First line treatment of these patients aims to maintain cerebral perfusion and includes deep anaesthesia. Propofol has recently shown anti oxidant properties that need to be confirmed when used in these patients. The main objective of this study is to evaluate the effect of propofol compared to midazolam on intra cerebral oxidative stress following severe traumatic brain injury.

Severe traumatic brain injury is associated with an increased production of free radicals causing brain damage. First line treatment of these patients aims to maintain cerebral perfusion and includes deep anaesthesia. Propofol has recently shown anti oxidant properties that need to be confirmed when used in these patients. The main objective of this study is to evaluate the effect of propofol compared to midazolam on intra cerebral oxidative stress following severe traumatic brain injury. Measurements will be performed by use of intracerebral microdialysis.

Eligibility Criteria:
Inclusion Criteria:

Age≥18 years, Severe traumatic brain injury with a Glasgow coma scale ≤8 related to the trauma, Stage II, III or IV of the US Trauma Data Bank on the CT scan, Need for intracranial pressure monitoring, Written informed consent from the patient's next-of-kin. If no relative is present as the time of inclusion, the patients will be included according to the emergency procedure.

Non-inclusion Criteria:

Traumatic brain injury requiring urgent neurosurgical intervention due to blood collection, Contraindication to propofol or midazolam, History of head trauma \> 12 hours before intra cranial pressure monitoring, Patient receiving propofol by continuous infusion since head trauma.
Intraoperative Neuromonitoring of the Recurrent Laryngeal Nerve Versus Neurostimulation

The purpose of this study is to evaluate if intraoperative neuromonitoring associated to neurostimulation of recurrent laryngeal nerve reduce the rate of recurrent laryngeal palsy respect to neurostimulation alone.

Anatomic and functional preservation of the recurrent laryngeal nerve is a key element of thyroid surgery. Surgical exposure and visual identification of the nerve during thyroid surgery has been shown to provide the best rates of normal postoperative vocal fold function. Nevertheless, identification of the nerve sometimes can be difficult in patients who are heavily scarred or who have undergone previous surgery. Moreover, an anatomical intact nerve does not always correlate with normal vocal fold function. So it is mandatory to identify the nerve and to establish its function. Two techniques are described to facilitate identification of the nerve and to test its function. One is the neurostimulation with laryngeal palpation which is an intermittent monitoring techniques that permits to evaluate the contraction of cricoarytenoid muscle (laryngeal twitch ) after stimulation of RLN or vagal nerve with an electric stimulator probe. More recently some authors have suggested a continuous intraoperative neuromonitoring which provide audio and visual feed back when the nerve is electrically or mechanically stimulated during thyroidectomy. However controversy remains as to whether intraoperative neuromonitoring confers any significant benefit in injury prevention of recurrent laryngeal nerve.

Eligibility Criteria:
Inclusion Criteria:

* Mono or bilateral thyroid surgery

Exclusion Criteria:

* Previous thyroid and parathyroid surgery
* Thyroidectomy with mono or bilateral neck dissection
* Extended thyroidectomy for locally advanced thyroid carcinoma
* Retrosternal goitre
* Minimally invasive thyroid surgery
* Preoperative palsy
The Influence of Preoperative Warfarin Medication on Thromboelastography and Blood Transfusion

Warfarin therapy is usually monitored using the international normalized ratio (INR), and prolonged INR means coagulation impairment that can leads elevating transfusion requirement after operation. This study was designed to assess the relationships with warfarin and TEG values related to transfusion amount, to set up blood transfusion strategy in patients on atrial fibrillation undergoing cardiac surgery.

This study was a retrospective evaluation of patients who have received cardiac surgery with Maze-operation from March 2008 to November 2013.

Patients who have atrial fibrillation undergoing cardiac surgery with Maze-operation were included.

The following exclusion criteria are applied:

1. Patients who have taken medicine related to coagulation (such as antiplatelets like aspirin and clopidogrel) except warfarin or bridged heparin
2. Patients whose laboratory values could not be confirmed by medical records review.

Patients were categorized by two groups.

1. W group: patients on atrial fibrillation who have taken warfarin for p.o medication.
2. C group: patients on atrial fibrillation who have not taken warfarin for p.o medication.

Using blood sample, authors examined as follows:

1. Preoperative (maximum 5days before operation) and postoperative (30min after ICU admission) coagulation values with haematologic values: PT/aPTT, INR, Hb, Hct, platelet levels.
2. ROTEM values at 30min after anaesthetic induction and 30min after ICU admission: Clotting time (CT), clot formation time (CFT), maximum clot firmness (MCF), maximum lysis (ML)
3. Intraoperative (during operation) and postoperative (during admission, an expected average of 5 weeks) total transfusion amount: RBC, FFP, PC, cryoprecipitate.
4. Post operative 24 hr bleeding amount in the chest tube drain bottle.
5. The duration (maximum 2 weeks) of warfarin discontinuation. (in W group)

Statistical analysis was performed using unpaired t-test and chi-square test to compare patients demographic data and other parameters. To determine the relationship of INR and ROTEM parameters with bleeding amount and transfusion amount, multiple linear regression model that accounted for all confounder variables was used. For each factor in the multiple regression model, variables with a p value of less than 0.10 were kept in the final model. The data was analyzed using the program Statistical Package for the Social Sciences ver. 18.0 (SPSS Inc, Chicago, USA). A value of p \< 0.05 was considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who have atrial fibrillation undergoing cardiac surgery with Maze-operation.

* W group : Patients who have had warfarin therapy before operation due to treat Atrial fibrillation
* C group : Patients who have not had warfarin therapy before operation

Exclusion Criteria:

* 1. Patients who have taken medicine related to coagulation (such as antiplatelets like aspirin and clopidogrel) except warfarin or bridged heparin.
* 2. Patients whose laboratory values could not be confirmed by medical records review.
Effects of Stochastic Whole-body Vibration Training on Balance and Executive Functions

Falls represent a significant financial burden, costing millions of dollars annually in Switzerland (SUVA, 2022). Good cognitive abilities and good balance represent modifiable protective factors against falls (Kurz, 2008). The present study investigates the impact of stochastic whole-body vibration training (SR-WBV) on executive functions and balance. To this end, participants were randomized into an intervention group or a control group. Participants in the intervention group underwent SR-WBV at a frequency of 5 Hertz (Hz), while participants in the control group underwent SR-WBV at 2 Hz. The training on an SRT Zeptor® Medical plus noise device consisted of three one-minute intervals of vibration, interspersed with one-minute rest periods. Data on executive functions (Updating, Shifting, Inhibition) and balance were collected before and after the intervention , complemented by subjective assessments of concentration and balance through questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Healthy

Exclusion Criteria:

* Pregnancy
* The presence of osteosynthetic materials (e.g., screws, plates, wires)
* Joint problems (particularly in the knees, hips, and back)
* Musculoskeletal issues
* Disc herniation
* Rheumatism
* Cardiovascular problems
* Balance disorders
* Red-green color blindness
* Intensive training within 24 hours prior to the assessment.
* Use of central nervous system medications
Extracorporeal Cytokine Adsorption as Additive Treatment of CAR-T Associated Cytokine Release Syndrome (CRS)

Patients with severe CAR-T cell associated cytokine release syndrome (CRS) (defined as vasopressor dependent) will be treated with standard of care (SOC) + cytokine adsorption (6hourly for 24 hrs).

Primary endpoint is the change in plasma IL-6 between 0 and 24 hrs.


Eligibility Criteria:
Inclusion Criteria:

* severe CRS (\> 3) and / or severe CRES (\>3)

AND

- CRS/CRES onset \< 6 hrs

Exclusion Criteria:

* Heparine allergy
* contraindication for anticoagulation
Association Between Body Composition and Digestive System Cancer Survival

Investigators intend to utilize clinical data from the Department of Oncology at Jiangsu Provincial People's Hospital to analyze changes in body composition in digestive system tumor patients before and after receiving anti-tumor drug treatment. Investigators aim to uncover the association between baseline body composition and overall/progression-free survival in patients with digestive system tumors. Additionally, Investigators plan to investigate the relationship between changes in body composition during anti-tumor drug treatment (chemotherapy and immunotherapy) and the prognosis of tumor patients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged between 18 and 85 years old.
* Patients with histologically confirmed digestive tract cancers, such as esophageal cancer, gastric cancer, small intestinal cancer, colorectal cancer, as well as pancreatic cancer, liver cancer, gallbladder cancer, etc.
* Patients admitted for anti-tumor-related drug treatment.
* Expected survival period of more than three months.
* ECOG PS score: \< 4.
* No severe psychological disorders, physical disabilities, dementia, Alzheimer's disease, pulmonary tuberculosis, HIV/AIDS, or other infectious diseases.
* Patients must have sufficient organ and bone marrow function, meeting the following criteria:

  1. Hematological criteria:

     Hemoglobin (Hb) ≥ 90 g/L (without blood transfusion in the past 28 days). Absolute neutrophil count (ANC) ≥ 1.5×109/L. Peripheral blood monocytes \> 1500mm3. Platelet count (PLT) ≥ 100×109/L.
  2. Biochemical criteria:

     Total bilirubin (TBIL) ≤ 1.5 × the upper limit of normal (ULN). ALT and AST ≤ 2.5×ULN; if there is liver metastasis, ALT and AST ≤ 5×ULN. Creatinine (Cr) ≤ 1.5×ULN or creatinine clearance rate (CCr) ≥ 60 ml/min (Cockcroft-Gault formula).
  3. Coagulation function is sufficient, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN.
* Women of childbearing potential must have a negative pregnancy test (serum or urine) within seven days before enrollment and must voluntarily use appropriate contraception methods during the observation period and within six months after the last dose.
* Signed informed consent.

Exclusion Criteria:

* Female patients who are pregnant or breastfeeding.
* Patients with accompanying diseases, as judged by the investigator, pose a serious risk to patient safety or may affect the patient's ability to complete the study.
* Patients with poor compliance who refuse to undergo body composition measurements.
* Patients who experience a severe adverse event judged by the investigator as no longer suitable for continued participation in the study or those who become unexpectedly pregnant.
* Patients who are unwilling to continue in the clinical trial and insist on withdrawal.
* The investigator deems it necessary to terminate the study.
* Patients who were mistakenly included but did not meet the criteria.
Efficacy and Safety of Anthrax Vaccine, GC1109

1. BACKGROUND The newly developed anthrax vaccine GC1109 has been proven safe and effective in preclinical studies.
2. OBJECTIVE

   - To evaluate the immunogenicity and safety of the anthrax vaccine GC1109 in healthy male volunteers.
3. STUDY DESIGN

   * single-blinded
   * randomized
   * placebo controlled
   * phase 1 study


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male subjects between 18 and 45 years of age at the time of screening visit
2. 18.5kg/m2 ≤BMI \< 30kg/m2 at the time of screening visit
3. Subjects without congenital or chronic disorder

Exclusion Criteria:

-
Focus on Analysis of Recovery in Oximetry

Analysis of localizations for symptoms and ischemia on treadmill and of the recovery profiles of patients that have had an exercise oximetry

Patients referred for exercise oximetry have buttocks thighs and calves recording during exercise and in the recovery period for a minimum of 10 minutes.

For each limb probe the decrease from rest of oxygen pressure (DROP) index is calculated as a subtraction of chest changes from limb changes throughout rest, exercise and recovery. DROP was measured as a routine on buttocks, thighs and calves and a minimal DROP lower than minus 15 mmHg considered indicative of the presence of regional blood flow impairment (ischemia) in the considered area.

Recordings and patients characteristics are recorded on a institutionally validated database.

A comparison will be performed of symptoms by history to symptoms reported on treadmill and hemodynamic results attained through DROP values.

Re-analysis of the recordings after ethical approval will be performed in an aim at estimating the duration of 50% and 90% recovery of DROP at the different levels (buttocks tigh and calves) to account for hemodynamic impairmenty not only at the calf (calves) level.

Eligibility Criteria:
Inclusion Criteria:

* Available exercise oximetry recording

Exclusion Criteria:

* Deny of the use of the medical file from the patient