cyrilzakka/clinical-trials huggingface dataset:
Vaccination Practices for Inflammatory Bowel Disease Patients in China With Gastroenterologists

The aim of the current study was to evaluate the knowledge of Chinese gastroenterologists on vaccinating patients with IBD under the assistance of Chinese Crohn's \& Colitis Foundation. The Chinese Crohn's \& Colitis Foundation (CCCF) is the first nonprofit,volunteer-driven foundation specifically for patients with IBD in China.It has been joined by IBD specialists at various hospitals in China.

The questionnaire contained questions regarding the respondents'information, including their gender, years in practice, clinical specialty,and source of knowledge on immunization practices. The questionnaire mainly contained three sections: knowledge of vaccinations for hepatitis A virus (HAV), HBV, and varicella; current vaccination practices for the IBD group; and reasons for not recommending these vaccinations to patients with IBD. The questionnaire composed of 13 items specifically on the three vaccinations mentioned above for immunosuppressed patients with IBD. All questions were conducted based on recognized guidelines and were reviewed by 18 IBD experts. The questionnaire captured the frequency with which the respondents assessed patients with IBD for anti-HAV/hepatitis B surface antigen (HBsAg), hepatitis B core antibody, and hepatitis B surface antibody/ anti-HAV levels, and acquired infection and immunization histories. Whether the respondents recommended these three vaccines to the IBD group before treatment was also elicited.

Eligibility Criteria:
Inclusion Criteria:

* gastroenterologists were members of tertiary hospitals

Exclusion Criteria:

* pediatricians were excluded, as were retired gastroenterologists and those currently in training
Balance Trainning for Sarcopenic Inpatients Aged 80+ Years

Resistance training and aerobic exercise have been recommended for sarcopenic patients. However, whether balance training would further benefit for sarcopenic patients on the basis of resistance training and aerobic exercise remains unclear. The purpose of this study is to explore the effect of balance training on improving the mobility of elderly patients with sarcopenia. Balance training involves doing exercises that strengthen the muscles that help keep the aged upright, including the legs and core. These kinds of exercises can improve stability and help prevent falls.


Eligibility Criteria:
Inclusion Criteria：

* Sarcopenia defined by the Asia Working Group of Sarcopenia (AWGS)
* Agree to participant this study and sign the informed consent
* Aged 80 years or over

Exclusion Criteria:

* Patients who could not follow the training plan due to cognitive impairment, emotional problems or any other reasons;
* Severe heart and lung diseases;
* Renal insufficiency;
* Any type of tumor;
* Bedridden patients
Effect of Colour Temperature of Reading Lamp on Refractive Error Development

This is a 12-month longitudinal randomized controlled trial aiming to evaluate the effect of colour temperature of reading lamp on refractive error development.

Myopia has reached epidemic in the world, especially in East Asia. The proportion of myopic population increases drastically during schoolage. Lack of light exposure has been suggested to be a risk for myopia development, in which additional reading lamp may alleviate this condition. However, the effect of colour temperature of the reading lamp is unknown on childhood refractive error development. In this study, investigators will randomly allocate school-aged children into groups, who will receive reading lamps of different colour temperatures for their daily use. The participants' refractive error and axial length will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* aged between 4 and 18 years

Exclusion Criteria:

* have received myopia control intervention
Multiple Ascending Dose Study for AZD 7268 in Japanese Healthy Male Volunteers

This is a multiple ascending dose study (MAD) in the Japanese population with AZD7268. This MAD study will evaluate the safety, tolerability and pharmacokinetics of orally administered AZD7268 after multiple ascending doses.


Eligibility Criteria:
Inclusion Criteria:

* Provision of Informed Consent
* Healthy male subjects, with suitable veins for cannulation or repeated venipuncture

Exclusion Criteria:

* Inability to understand or cooperate with given information
* Any positive result on screening for human immune deficiency virus (HIV), Hepatitis B, Hepatitis C and syphilis test
* History of seizure (including infant febrile seizures) or family history of seizure
Anxiety and Depression in Patients Hospitalizes for an Acute Exacerbation of COPD

This study will try to elucidate wheter the impact of a psychiatric intervention in patients hospitalized because an acute exacerbation of COPD and anxiety/depression and reconsulting at 1 and 6 month after discharge.


Eligibility Criteria:
Inclusion Criteria:

* Men and women of any ethnic group
* Above 40 years old
* Diagnose with Chronic Obstructive Pulmonary disease (COPD) according to the ATS/ERS guidelines
* Acute exacerbation of COPD according to the following criteria:

  a) Cyanosis b) Obnubilations or mental confusion d) Respiratory Rate above 25 per minute e) Failure of ambulatory treatment f) Co-morbidities that worsens respiratory condition g) Dyspnea

Exclusion Criteria:

* Less than 6 months expectancy of life
* Needing of mechanical ventilation
* Severe cardiovascular disease
* Pregnancy
* Previous diagnosis of depression/anxiety
Exploration of Treatment Effect of Novel Hormone Therapy Combined with Local Treatment Based on PSMA PET/CT Evaluation in MHSCP Patients

At present, there is still controversy over the treatment of metastatic hormone sensitive prostate cancer (mHSPC). Major guidelines and consensus suggest that novel hormone therapy (NHT) should be used as the basic treatment for mHSPC, and metastasis directed therapy can be combined depending on the clinical situation. However, it is still unclear how to develop more specific and individualized treatment plans for mHSPC patients. On the other hand, prostate-specific membrane antigen (PSMA) which is highly specifically expressed in prostate epithelial cells has been widely used as a PET/CT target for the diagnosis and staging of prostate cancer. However, there is still a lack of clinical evidence on how to use it to guide the treatment of prostate cancer. Therefore, this study intends to include patients diagnosed with mHSPC by PSMA PET/CT. After 6 months of NHT, PSMA PET/CT will be re-evaluated and patients with remaining active lesions on PSMA PET/CT will be included for randomization. The aim of this study is to explore the effect of NHT combined with local treatment on delaying disease progression and prolonging survival in patients with active lesions on PSMA PET/CT after NHT, providing new insights into the treatment of mHSCP patients.


Eligibility Criteria:
Inclusion Criteria:

1. Male patients over the age of 18;
2. The physical condition (PS) score of the Eastern Cooperative Oncology Group (ECOG) is 0, 1, or 2 points;
3. Expected lifespan \>2 years;
4. All newly diagnosed patients with metastatic prostate cancer (mHSPC, metastatic hormone sensitive prostate cancer) diagnosed by PSMA PET/CT, and still present active lesions on PSMA PET/CT after receiving new endocrine therapy;
5. Has not received any other treatment for prostate cancer before;
6. No significant organ dysfunction upon evaluation;
7. Agreed to sign the written consent form for this study, indicating a comprehensive understanding of the purpose and process of this study, and willingness to participate in this study.

Exclusion Criteria:

1. A medical history of any other active malignant tumor within 2 years (excluding fully treated basal cell or squamous cell skin cancer, superficial bladder cancer or any other cancer in situ that is currently in complete remission);
2. Prostate biopsy shows sarcomatoid cells, ductal carcinoma, or neuroendocrine cell components;
3. Severe complications, immune suppression, severe mental illness, severe activity restriction, or inability to comply with this study;
4. Currently participating in other clinical trials for prostate cancer;
5. According to the researcher's judgment, there are conditions that are not in line with the best interests of the subjects participating in the study, or may hinder, limit, or interfere with the study protocol.
Memory and MRI Changes With Hippocampus Avoidance Prophylactic Cranial Irradiation(HA-PCI) for Small Cell Lung Cancer(SCLC)

This is a prospective, randomized phase-II study observing the memory preservation and functional brain MRI changes with conformal avoidance of the hippocampal neural stem-cell compartment during prophylactic cranial irradiation for small cell lung cancer patients.

Brain metastasis is rather high in small cell lung cancer patients. Prophylactic cranial irradiation(PCI) is the standardized treatment. However, cognitive dysfunction like memory damage is observed in quite a number of patients after brain irradiation, which may due to the hippocampus being irradiated. Thus, the investigators conduct the study by reducing the dose to the hippocampal neural stem-cell compartment (HAZ) during PCI.

Patient Population: Age: 18-65y; small cell lung cancer undergoing PCI; Eastern Cooperative Oncology Group (ECOG) score: 0-1.

The patients are randomized to 2 arms:

Arm Routine PCI: PTV(planning target volume) 25Gy/10F. Arm Hippocampus avoidance PCI(HA-PCI): PTV 25Gray(Gy)/10Fraction(F), HAZ Dmin\<9Gy Dmax\<16Gy).

Measurements: Hopkins verbal learning test(HVLT) and functional brain magnetic resonance imaging.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically conformed small cell lung cancer;
2. Complete response (CR)/partial response (PR) after chemo-radiotherapy;
3. ECOG (Eastern Cooperative Oncology Group) : 0-1;
4. No imaging evidence of brain metastasis before PCI;
5. Normal hemodynamic indices before the recruitment (including white blood cell count\>4.0×109/L, neutrophil count\>1.5×109/L, platelet count \>100×109/L, hemoglobin≥90g/l, normal liver/kidney function);
6. Able to understand this study and have signed informed consent.

Exclusion Criteria:

1. Unable to receive MRI;
2. Medical history of central nervous system, cognitive or psychological diseases;
3. The expectation of life is less than 6 months;
4. Female in pregnancy or lactating;
5. The researchers consider the patient not appropriate to be enrolled.
Relationship Between Upper Extremity' Viscoelastic Properties and Functionality in Subacute Stroke

In stroke patients, the shoulder-upper extremity complex is affected and reduces independence and quality in activities of daily living. Investigating the relationship between the functions of the upper extremity muscles and viscoelastic properties is important in understanding the rehabilitation of individuals with stroke.

Upper extremity functions of individuals will be measured and correlated with viscoelastic properties of upper extremity muscles. The box and block test will be used for the function test. The viscoelastic properties of the muscles will be measured with the myotonPRO device. Deltoideus, Triceps, Biceps, Brachioradialis and Extansor digitorum longus were evaluated with myotonPRO. The tonus, stiffness and elasticity of muscles were recorded. Assessments will applied bilaterally and average recorded.

Eligibility Criteria:
Inclusion Criteria:

Patients who had ischemic SVO 3-9 months ago Individuals who have had a stroke for the first time MAS ≤ 2 of spasticity in paretic upper extremity

Exclusion Criteria:

TIA survivors Presence of cognitive deficits ( Mini-Mental State Examination score ≥ 24) Presence of another neurological, neuromuscular or orthopedic disease Presence of diseases that cause pain, such as fibromyalgia or arthritis Comorbidity with depression or psychiatric illness
Natural History of Cerebral Palsy Prospective Study

The study will describe the natural history of cerebral palsy (CP) as children develop over the first 2 years of life.

This study aims to describe the early natural history of cerebral palsy (CP) by mapping the development of infants with, or at-risk of CP, over the first two years of life. Infants will be assessed at regular intervals up to 24 months of age, across a variety of childhood development to provide the first comprehensive developmental trajectories of this group. In doing so, it will contribute to the existing knowledge of CP development to assist clinicians and therapists with accurate information on prognosis and provide targeted interventions early and at the 'just-right' challenge. Where indicated, individual participants' results from this study will be used to inform their therapy. This study is intended to form part of a larger multi-site international study.

Eligibility Criteria:
Inclusion Criteria:

* Infants will be included if they have a diagnosis of CP or "at high risk of CP" and under the age of 12 months.
* Infants at high risk of CP as defined by any two (any combination) of the following:

  1. Neuroimaging predictive of a motor disability including the involvement of 1 or more of the following structures: sensori-motor cortex, Basal Ganglia, Posterior Limb of the Internal Capsule, pyramids.
  2. Trajectory of cramped synchronized general movements (GMs) on General Movement Assessment (GMA) OR absent fidgety GMs at fidgety age
  3. Hammersmith Infant Neurological Exam (HINE) scores \<57 @ 3months or \<60 @ 6months or \<63 @9 months

     Infants will also be included if they meet BOTH of the following criteria (even if infants have a HINE score greater than the cut off scores stated above:

     i. Unilateral brain injury on neuroimaging (magnetic resonance imaging (MRI) or cranial ultrasound (CUS)) predictive of CP ii. Clinical signs of asymmetry

     Exclusion Criteria:
* Infants with progressive or neurodegenerative disorders or genetic disorders not associated with CP
* Infants with other disability diagnoses e.g. Down Syndrome
Safety and Efficacy of Therapeutic INduced HYPERTENSION in Acute Non-cardioembolic Ischemic Stroke (SETIN-HYPERTENSION)

The purpose of this study is to evaluate the safety and efficacy of the induced hypertension using phenylephrine in patients with noncardioembolic ischemic stroke.

The investigators hypothesized that phenylephrine induced-hypertension can result in good clinical response without serious complications in patients with noncardioembolic ischemic stroke.

See below

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute ischemic stroke confirmed by diffusion-weighted imaging (DWI) performed within 24 hours of symptom onset or symptom worsening(defined by a 2-point or more increase in NIH stroke scale (NIHSS)score including one or more increase in the motor score of affected upper and lower limbs in NIHSS during hospitalization or clear history of symptom worsening judged by investigator before hospitalization) confirmed by DWI performed within 24 hours of aggravation.
* Baseline NIHSS score 4-18 points
* Alert mental status
* Newly developed paresis, aphasia, or neglect

Exclusion Criteria:

* Patients underwent recanalization therapy
* Systolic blood pressure \>170 mmHg at baseline
* Patients with history or at risk of hemorrhagic stroke
* History of significant arrhythmia (e.g. atrial fibrillation)
* Unable to perform MRI scans or undergo MRI scans \> 24 hours of symptom onset or progression
* Large cortical infarction on DWI (more than 1/2 of middle cerebral artery territory)
* 3 or more cortical microbleeds on gradient-echo MRI
* Coronary artery disease, congestive heart failure, or hypertrophic cardiomyopathy
* Anticoagulation therapy (phenylephrine group only)
* Patients with high-risk cardioembolic sources
* Cervical or cerebral artery dissection or unruptured aortic/cerebral arterial aneurysm
* Decreased consciousness
* Pregnant or Lactating patient
* Seizure at stroke onset
* Life expectancy \< 6 months
* Pre-stroke modified Rankin scale (mRS) \>= 2
* Patients without informed consent
Omeprazole Delayed Release (DR) Capsules Bioequivalence Study of Dr. Reddys Under Fasting Conditions

This study examines the bioequivalence of Dr. Reddy's Omeprazole delayed release capsules under fasting condition.

This is a randomized, two-treatment, two-period, two-sequence, single dose, crossover bioequivalence study to compare Omeprazole 40 mg Delayed Release Capsules (Dr.Reddy's Laboratories Ltd.,) with Prilosec® 40 mg (Omeprazole Delayed Release Capsules (manufactured by Merck \& Co., Inc., USA) in 44 healthy, adult, human subjects under fasting conditions.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who provided written informed consent.
* Subjects who were healthy within 18-45 years of age, weighing at least 50 kg.
* Body mass index of ≥ 18 kglm2 and ≤ 25 kg/m2, with body weight not less than 50 kg.
* Subjects with normal health as determined by medical history and physical examination performed within 15 days prior to the commencement of the study (dosing in period-I).
* Subjects with normal ECG, chest X-ray (PA view) and vital signs.
* Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.

Test product, dose, mode of administration and batch number
Safety Surveillance of MenACWY-CRM Vaccine in Children

The purpose of this study is to summarize the occurrence of incident serious medically attended events and events of interest up to 1 year following MenACWY-CRM vaccination administered as part of routine clinical care. This US FDA post-marketing commitment study is an open-label, descriptive, epidemiological safety surveillance study of MenACWY-CRM vaccine in subjects 2 to 10 years of age within a large US Healthcare Maintenance Organization. The 26 events of interest are events commonly evaluated in vaccine safety studies and include certain neurological, immunological, vascular, musculoskeletal and hematologic disorders. All events are collected retrospectively.

This is an observational study, vaccines administration and data that is collected is only as part of routine clinical care. Vaccinated subjects are not actively recruited.

Events of Interest: Diabetes Mellitus, Rheumatoid arthritis, Idiopathic Thrombocytopenic Purpura, Iridocyclitis, Acute glomerulonephritis, Nephrotic syndrome, Grave's disease, Autoimmune hemolytic anemia, Myasthenia Gravis, New onset asthma, Allergic urticaria, Anaphylaxis, Meningococcal Disease, Intentional Injury

Eligibility Criteria:
Inclusion Criteria:

* Registered with the HMO for at least 6 months prior to vaccination.
* Between the ages of 2 and 10 years (inclusive - i.e. has not reached their 11th birthday) at the time of the vaccination.
* Received any MenACWY-CRM vaccination during the vaccination period at the participating centers.

Exclusion Criteria:

* None
Novapak Prospective Observational Clinical Trial

The Novapak study is a prospective, observational, multi-site, non-controlled, non-randomized, case-series, with a 2 week and 1-month follow-up in adults undergoing nasal/sinus surgery with Novapak Nasal Sinus Packing and Stent device used as indicated post-operatively and is being conducted to obtain clinical data on the safety and effectiveness of the Novapak device under use as intended in the device indications.

The primary objective is to assess the safety of the Novapak Nasal Sinus Packing and Stent device used as indicated post-operatively in patients undergoing nasal/sinus surgery by:

* Collecting all AEs directly attributed to the device and/or those that cannot be determined; and calculating a point estimate and confidence interval
* Collecting all AEs and calculating an overall rate and safety profile for the device

The secondary objectives are to confirm device effectiveness through assessing adhesions, bleeding, healing and health during the procedure, 2 weeks and 1-month post treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is at least 18 years of age.
2. Subject undergoing nasal/sinus surgery with the intended need for nasal sinus packing (i.e., Novapak).
3. After being informed of the nature of the study; the subject understands, agrees to its provisions, is willing to participate and provide written consent.
4. Mentally stable and able to follow the instructions for self-assessment/questionnaire completion.

Exclusion Criteria:

1. Subject has a shellfish allergy.
2. Subject has known bleeding disorder or prescribed anticoagulants.
3. Subject has craniofacial abnormalities that may interfere with access to the sinuses.
4. Subject is immunocompromised (e.g., taking immunosuppressive medication).
5. Subject is participating in another investigational device, biologic, or drug study and has not completed the primary endpoint(s) or if there is a potential for clinical interference beyond the primary endpoint.
Evaluation of Mineralized Plasmatic Matrix With and Without Collagen Membrane in Peri-implant Bone Regeneration

This study focuses on comparing the effect of MPM with or without collagen membrane on delayed implant placement in anterior maxillary aesthetic zone.


Eligibility Criteria:
Inclusion Criteria:

* Patients with missing anterior maxillary teeth and having deficient alveolar thickness.
* Good oral hygiene
* Alveolar ridge width less than 4 mm.

Exclusion Criteria:

* Medically compromised patients.
* Heavy smokers.
* Current chemotherapy or radiotherapy
Computerized Facial Recognition for Automated Diagnosis of the Facio-Scapulo-Humeral Muscular Dystrophy (FSMHD)

The clinical diagnosis of Facio-Scapulo-Humeral Muscular Dystrophy (FSHMD) requires the movement of patients to a medical centre and a lengthy examination involving medical personnel, and may be underestimated in the most moderate cases. Thus, it requires costly and burdensome logistics both for patients living in remote areas and having to undertake long and expensive travel, and for clinical staff. This is an obstacle to large-scale diagnosis. The investigators plan to alleviate these limitations through the use of digital facial analysis technology that would enable large-scale diagnosis of patients through telemedicine.

Motivated by the reasons described above and by preliminary results, the goal of this project is to develop methods to automatically detect and monitor the progression of this disease using computer vision algorithms. In order to do this, the investigators will first build up a bank of images and videos of patients with moderate to severe FSHMD, patients with other muscular dystrophies causing facial muscle asymmetry, as well as control subjects without facial involvement. Each of these subjects will be characterized clinically and genetically.

The investigators will then develop computer tools using video and audio sensors capable of detecting facial muscle damage in patients with FSHMD and differentiating them from control subjects on the one hand and patients with other muscular dystrophies on the other hand. The investigators wish to use the most recent advances in terms of "deep-learning" and improve their architecture in order to achieve our objectives.

In addition to this holistic approach, the investigators will study facial recognition approaches capable of accurately identifying different facial areas on images, as well as the relevance of different statistical properties of facial dynamics (duration and intensity). These algorithms will also be useful for monitoring the evolution of facial damage in order to develop a specific measurement tool that could be used in patient follow-up and in clinical trials on early stages of the disease.


Eligibility Criteria:
- Patient belonging to one of these four groups:

* Group 1 FSMHD confirmed or to be confirmed with moderate facial involvement
* Group 2 FSMHD confirmed or to be confirmed with severe facial involvement.
* Group 3 Other disease NM confirmed or to be confirmed.
* Group 4 control subjects.

Exclusion Criteria:

* Patient presenting all pathologies judged by the investigator to interfere with the smooth running of the study (facial trauma, ...).
* Pregnant or breastfeeding women of childbearing age.