cyrilzakka/clinical-trials huggingface dataset:
Study to Assess the Clinical Efficacy of the Specialized Enteral Tube Nutrition Composition Nutrison Advanced Cubison as a Part of Complex Pressure Ulcers (PU) Therapy

A large number of studies are devoted to studying the effect of patient nutrition on the occurrence and treatment of pressure ulcers. Several studies, including the US National Long-term Treatment of Pressure Ulcers Study, have shown that weight loss and malnutrition were associated with a higher risk of pressure ulcers.

One of the successful products specially created for the treatment of pressure ulcers and taking into account the results of research is the high-protein, energy-rich, ready-to-use enteral tube feeding food product Nutrison Advanced Cubison. It is a complete enteral nutritional supplement with an innovative nutrient composition for patients with chronic wounds, including pressure ulcers, or at increased risk of developing them.

Taking into account the available data, it seems expedient to continue studying the unique combination of nutrients that make up the study food product Nutrison Advanced Cubison in order to develop the most effective nutritional protocols for patients at risk for the treatment and prevention of pressure ulcers.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with stroke / TBI and who are on tube feeding
* Presence of pressure ulcers of 2-3 stages
* Informed voluntary consent to medical intervention is formalized in accordance with the requirements of the Federal Law of 21.11.2011 N 323-FZ "On the basics of protecting the health of citizens in the Russian Federation."

Exclusion Criteria:

* Hemodynamically unstable patients
* Severe renal impairment (GFR \<30 ml / min)
* Moderate or severe liver failure (Child-Pugh Class B or C)
* Oncological diseases (lasting more than 5 years)
* Hypersensitivity to any component of the test food mixture
* Inclusion in clinical interventional research
* Uncertainty of the investigator about the willingness or ability of the subject to comply with the protocol requirements
* Any other medical or non-medical reasons that, in the opinion of the physician, may prevent the patient from participating in the study
ORCA Study: Osteoarthritis and Risks Associated With the Consumption of NSAIDs

Cross-sectional epidemiological study in patients with diagnosis of osteoarthritis (OA) in order to evaluate risk factors associated with the use / prescription of non-steroidal anti-inflammatory drugs (NSAID).

OBJECTIVE: To evaluate the presence of risk factors associated with the use / prescription of non-steroidal anti-inflammatory drugs (NSAID) in patients diagnosed with osteoarthritis (OA).

MATERIALS AND METHODS: A multicentric, cross-sectional epidemiological study, will be carried out in patients ≥ 38 years of age, with a previous diagnosis of primary or secondary OA, according to criteria of the American College of Rheumatology (ACR). The presence of at least one risk factor for the use / prescription of NSAIDs is the main variable. The secondary variables to be evaluated include: Demographical characterization of the patients, current disease status (level of pain and functional limitation), treatment (s) used (related or not to OA) and events side effects associated with the treatment (s). The analysis will be carried out from two perspectives: A first descriptive approach and a second analytical approach.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 38 years
* Previous diagnosis of OSTEOARTRITIS (primary or secondary) at least 30 days before or more, in at least one or more of the following locations: Knee and / or Hip and / or Hand, according to criteria of the American College of Rheumatology (ACR)

Exclusion Criteria:

* Refusal to participate in the study by the patient.
* Patients who, in the judgment of the Investigator, do not understand or are not willing to adequately answer to the questions.
* Mental or psychiatric illness that, in the judgment of the investigator, does not allow adequate information to be obtained.
A Study of JNJ-54767414 (Daratumumab) in Combination With Lenalidomide and Dexamethasone in Japanese Participants With Previously Untreated Multiple Myeloma Who Are Ineligible for High-dose Therapy and Autologous Stem Cell Transplantation

The purpose of this study is to evaluate the safety of daratumumab when combined with lenalidomide and dexamethasone in Japanese participants with newly diagnosed multiple myeloma who are not candidates for high-dose chemotherapy and autologous stem cell transplantation (ASCT).


Eligibility Criteria:
Inclusion Criteria:

* Participants with documented multiple myeloma (MM) satisfying the CRAB (calcium elevation, renal insufficiency, anemia, and bone abnormalities) criteria , monoclonal plasma cells in the bone marrow more than equal to (\>=) 10 percent (%) or presence of a biopsy proven plasmacytoma, and measurable disease Measurable disease as defined by any of the following: (a) immunoglobulin (Ig) G MM: serum monoclonal paraprotein (M protein) level \>=1.0 gram/deciliter (dL) or urine M protein level \>= 200 milligram(mg)/24 hours; or (b) IgA, IgM, IgD, or IgE MM: serum M protein level \>=0.5 g/dL or urine M protein level \>=200 mg/24 hours; or (c) Light chain MM without measurable disease in serum or urine: serum Ig free light chain (FLC) \>=10 mg/dL and abnormal serum Ig kappa lambda FLC ratio
* Participants newly diagnosed and not considered a candidate for high-dose chemotherapy with autologous stem cell transplantation (ASCT) due to being \>=65 years old, or in subjects less than (\<) 65 years old presence of important comorbid condition(s) likely to have a negative effect on the tolerability of high-dose chemotherapy with ASCT
* Pretreatment clinical laboratory values meeting the following criteria during the Screening Phase
* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
* A woman of childbearing potential must have 2 negative serum or urine pregnancy tests at Screening, first within 4 weeks prior to dosing and the second within 3 days prior to dosing

Exclusion Criteria:

* Participants with diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, or smoldering MM
* Participant with plasma cell leukemia or other conditions in which Ig (immunoglobulin) M protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions
* Participants who have prior or current systemic therapy or ASCT for MM, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 mg/day for a maximum 4 days) of corticosteroids before treatment
* Participants with history of malignancy (other than MM) within 5 years before the date of the first daratumumab administration
* Participants who have radiation therapy within 14 days of the first dose
Safety and Efficacy of Oral Febuxostat in Subjects With Gout

The purpose of this study is to compare febuxostat allopurinol in subjects with gout.

A randomized, double-blind, multicenter, allopurinol-controlled and parallel-assigned study comparing 40 mg, 80 mg of febuxostat, and allopurinol 300 mg in subjects with gout. Subjects will receive treatment for 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Hyperuricemia (serum urate ≥8.0 mg/dL) and gout by Chinese Rheumatism Association Criteria;
* Renal function defined as a serum creatinine level of \< 2.0 mg/dL and creatinine clearance of \> 20 milliliters per minute (mL/min) by Cockcroft and Gault formula;
* No gout flare 2 weeks beforehand during 2-week screening period.

Exclusion Criteria:

* Pregnancy or lactation;
* Concurrent therapy with urate lowering agents, azathioprine, 6-mercaptopurine, thiazide diuretics, or medications containing aspirin (\>325 mg) or other salicylates;
* Body Mass Index (BMI) \>50 kilogram per meter²(kg/m²);
* A history of active liver disease, or hepatic dysfunction;
* A history of bronchial asthma;
* A history of renal calculi or thyroid disease;
* Secondary gout Joint diseases induced by rheumatoid arthritis, psoriatic arthritis and bone tumor;
* Intolerance to allopurinol and Ibuprofen;
* Alcohol intake of ≥ 14 drinks/week;
* Clinically significant medical condition.
Effect of Cemented Implantation in Shoulder Replacement on Blood Pressure

To clarify the downward trend of blood pressure affected by bone cement implantation during shoulder replacement operations.

A total of 350 cases of proximal humeral fracture are planned to be recruited and receive semi-shoulder replacement in Department of Orthopedics and Trauma，Peking University People's Hospital．The blood pressure data are collected from patients' anesthesia records. Both the systolic and diastolic blood pressure are recorded at four time spots during operation: the time before using of bone cement (time period A), 0-5 min after using cement (time period B), 5-10 min after using cement (time period C) and 10-15min after using cement (time period D). The data of blood pressure are collected according to anesthesia records．

Eligibility Criteria:
Inclusion Criteria:

•patients with three or four part of proximal humeral fracture receiving cemented shoulder replacement

Exclusion Criteria:

* pathologic fracture
* severe hypertension or hypotension
Development of Anaesthesia Electronic Medical Record

Normally, anaesthesia personnel make a record patients' information during the surgical procedure. Pre and post-operatively, they visit patients to make sure that their customers are well informed regarding the whole process and satisfied with the service as well as any complications that might be existed.

The investigators would like to develop an anaesthesia electronic medical record at the point of care. The objectives are to record peri-operative patients' information in a real-time fashion, manage all administrative tasks as annual reports, and operate data as search engine for research and educational purpose.

Department of Anaesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University provides services to patients undergoing operative procedures in many fields; such as Traumatic surgery, Orthopaedics surgery, Eye surgery, Ear, Nose and Throat surgery, Plastics surgery, Cardio-thoracic surgery, Neurosurgery, General surgery, Urological surgery, Head and Neck surgery, Paediatric surgery, Obstetrics surgery, Gynaecological surgery, Electro-convulsive therapy, Radiological services, Endoscopic centre, Intensive Care Unit, Acute Pain service, Pain Clinic and Pre Anaesthesia Assessment Centre.

Normally, anaesthesia personnel make a patient information record during the surgical procedure. Pre and post-operatively, they visit patients to make sure that their customers are well informed regarding the whole process and satisfied with the service as well as any complications that might be existed.

The patient data, a crucial document for both medical and official terms, has been developed and improved continuously by the department. Daily, about 250 informations are transferred from paper-pencil to electronic, computerised format for statistical purpose and further reference. Still, the department has to face the data problem in many aspects.

1. Daily, an abundant of information needs to be transferred to computer by non-medical personnel. This results in time consuming, data loss and piles of document.
2. Unclear peri-operative handwriting of medical or technical terms, particularly on copied files results in untrustworthy and disgraceful of patients' evidence.
3. Scanned files results in difficulties of data retrieval for assignments in research, education, administrative policy and finance. Consequently, a hospital becomes an unfaithful and treacherous organisation.

The investigators would like to develop an anaesthesia electronic medical record at the point of care. The objectives are to record peri-operative patients' information in a real-time fashion, manage all administrative tasks as annual reports, and operate data as search engine for research and educational purpose.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing anaesthesia

Exclusion Criteria:

* N/A
Shanghai Infants Gut Microbiome Associated Study

The purpose of this study is to evaluate the effect of probiotics on the gut microbiome of infants treated with antibiotics.

This study aims to examin the impact of probiotics under 2 separate conditions, probiotics concurrent administration with antibiotic and probiotics administration during the recovery phase.Birth,7 days,14 days(or 21 days) and 42 days data will be collected and put into analysis to provide somes suggestions on the probiotics use in the clinical for the infants treated with antibiotics.

Eligibility Criteria:
Inclusion Criteria:

* Newborns with infectious diseases treated with antibiotic

Exclusion Criteria:

* Gestational weeks \<37
* Birth weight \<2500g or ≥4000g
* History of asphyxia anoxia at birth
* With congenital metabolic diseases or hereditary diseases
* With gastrointestinal diseases
Impact of Acute Computed Tomography on Treatment Decisions and Time to Intervention in Renal Colic

This study intend to evaluate the use of acute computed tomography (CT) when acute renal colic, regarding treatment decisions, time to intervention and additional visits to the Emergency Department

All patients with a diagnosis of urolithiasis at the Emergency Department in Helsingborg was included during one year, 1 July 2019 to 30 June 2020. Data regarding size and location of stone, treatment, follow up was extracted from the medical records.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of urolithiasis at the Emergency Department in Helsingborg

Exclusion Criteria:

* Patients with a locked medical record
Neural Progenitor Cell and Paracrine Factors to Treat Hypoxic Ischemic Encephalopathy

The purpose of this study is to investigate the efficacy and safety of allogenic neural progenitor cell and paracrine factors of human mesenchymal stem cells for patients with moderate/severe Hypoxic-Ischemic Encephalopathy

Neonates diagnosed moderate/severe Hypoxic-Ischemic Encephalopathy after birth will receive routine therapy and be randomized to four arms for allogenic neural progenitor cells transplantation，paracrine factors of human mesenchymal stem cells intrathecal injection，combination of cell and factor or only routine therapy. Patients will be followed for neurodevelopmental outcome at 12 and 18 months in Pediatrics of Navy General Hospital. Magnetic Resonance Imaging, electroencephalogram, Bailey scores, Peabody development measure scale and Gross motor function measure assessment will be obtained in the following research.Results will be analyzed and described in study reports.

Eligibility Criteria:
Inclusion Criteria:

1. gestational age ≥ 34weeks, body weight ≥ 2kg.
2. 1 minute apgar score ≤3, and 5 minutes apgar score ≤5, OR umbilical arterial blood gas potential of hydrogen\<7.0, OR 30 minutes base excess≤-12 mmol/L, OR need for ventilation 5 minutes after birth.
3. All infants must have signs of encephalopathy (such as convulsion, coma, dystonia, abnormal primitive reflex and irregular respiration) within 6 hours of age or continued abnormal EEG for more than 24h.

Exclusion Criteria:

1. Does not meet the inclusion criteria
2. Suffer from other serious organic disease or congenital, hereditary metabolic diseases
3. Intracranial active infection, or neuromuscular damage outside central nervous system
4. potential of hydrogen / electrolyte disorders without improvement or stability
5. Coagulation disorders associated with bleeding tendency
6. Immune function is not perfect
7. Patients or his guardian refuse consent.
8. Patients or his guardian don't accept the follow-up schedule.
Evaluation of Efficacy and Safety of Long-acting Risperidone Microspheres in Patients With Schizophrenia or Other Psychotic Disorders When Switching From Typical Antipsychotic (Oral/Depot) or Atypical Oral Other Than Risperidone

The purpose of this study is to evaluate the efficacy, tolerability and safety of patients on long-acting Risperidone microshpheres injection. The major advantage of long-acting injection over oral medication is facilitation of compliance in medication taking. Non-compliance is very common among schizophrenic and is a frequent cause of relapse.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with schizophrenia or another psychotic disorder according to DSM IV criteria who requires long term antipsychotic therapy
* Currently treated with either an atypical antipsychotic, other than risperidone, a conventional depot antipsychotic or oral conventional antipsychotic
* Subject has been symptomatically stable on a stable dose of an antipsychotic the last month
* Subject and/or patient's relative, guardian or legal representative has signed the informed consent form

Exclusion Criteria:

* First antipsychotic treatment ever
* On clozapine during the last 3 month
* Serious unstable medical condition
* History or current symptoms of tardive dyskinesia
* History of neuroleptic malignant syndrome
* Pregnant or breast-feeding female
* Female patient of childbearing potential without adequate contraception.
* Participation in an investigational drug trial in the 30 days prior to selection
* Known intolerance/non-responder to risperidone
Perceived Impact of the COVID-19 Pandemic on Medical Management and Symptoms in a High Risk Group

The Swiss population underwent a period of confinement related to the COVID-19 pandemic (March 16 to May 11, 2020) decided by the Swiss Federal Government. Among the Swiss population, certain groups were identified as vulnerable subjects by the Federal Office of Public Health. This study focuses on the perceived impact of this period on health care and health status in a specific vulnerable group: patients under long term noninvasive ventilation (respiratory support) at home for chronic respiratory failure.

The Swiss population underwent a period of confinement related to the COVID-19 pandemic (March 16 to May 11, 2020) decided by the Swiss Federal Government. Among the Swiss population, certain groups were identified as vulnerable subjects by the Federal Office of Public Health. This study focuses on the perceived impact of this period on health care and health status in a specific vulnerable group: patients under long term noninvasive ventilation (respiratory support) at home for chronic respiratory failure.

The objective is to determine, in a specific vulnerable group, how the confinement related to the COVID-19 pandemic affected health care and health status, as perceived by the patients.

The primary outcome is a questionnaire focusing on practical health care issues regarding respiratory support, health status and perception of the COVID-19 issue:

* Symptom score (related to noninvasive ventilation: NIV)
* Thymic disturbances (score of anxiety and depression)
* Compliance to treatment (assessed via tele-monitoring: routine procedure)

It is a non-interventional questionnaire-based observational study of patients followed by the Division of Pulmonology of Geneva University Hospitals with home NIV, aged above 18 years of age and in a stable clinical condition.

Eligibility Criteria:
Inclusion Criteria:

* Patients followed by the Division of Pulmonology of Geneva University Hospitals with home NIV
* Aged above 18 years of age
* Stable clinical condition

Exclusion Criteria:

* Age below 18 years of age
* Unwillingness to participate
* Unstable clinical condition
Exercise Effects in Multiple Sclerosis

A growing body of work suggests that regular exercise can support symptom management and improve physical function for people living with multiple sclerosis (MS). Although exercise is known to be beneficial for managing many symptoms related to MS, its effects on the central nervous system, and whether these effects change with different types of exercise, are not well understood. Here, the investigators have designed a clinical trial that compares the effects of distinct exercise protocols on aspects of physical function, physical fitness, and central nervous system function. This research will be the first to compare the effects of different types of exercise on central nervous system changes in people with MS.

A total of 69 participants with multiple sclerosis (MS) and moderate motor disability in the province of Saskatchewan, Canada will be randomly assigned to receive one of three distinct exercise programs. All exercise programs will be delivered three times per week in 60-minute group sessions over the course of 12 weeks under the supervision of Clinical Exercise Physiologists. Exercise programming will include activities focused on mobility, fitness, and flexibility. Assessments of physical function, physical fitness, and central nervous system function will be conducted immediately before, after, and six weeks following completion of the exercise programs.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of progressive MS by a neurologist
* physician clearance for exercise
* a Patient-Determined Disease Steps (PDSS) score between 3 and 7 (i.e., moderate motor disability)
* a Timed 25-Foot Walk (T25-FW) test time \> 6.0 s.

Exclusion Criteria:

* a baseline score \>24 on the Godin-Shephard Leisure Time Physical Activity Questionnaire (i.e., high physical activity levels)
* absolute contraindications to TMS (e.g. history of seizure)
* a history of any neurological conditions other than MS
* relapse in the past three months (self-reported, neurologist confirmed)
* psychiatric diagnosis
* substance abuse
Sagittal Balance Through Ages

The parameters of the sagittal balance of the cervical, thoracic and lumbar spine vary according to the types of spino-pelvic organization (types 1-4 according to Roussouly). These parameters have been described as a function of age in previous scientific work without taking into account the pelvic anatomy (pelvic incidence and spino-pelvic organization). This work, carried out within the framework of a round table of the French Society of Spinal Surgery (SFCR), would make it possible to provide a more detailed repository of existing radiographic parameters.


Eligibility Criteria:
Inclusion criteria:

* Minor or major subject aged 5 to 100
* Subject having carried out a telecolonne or EOS type X-ray for spinal balance (low back pain, sciatica, cervico-brachial neuralgia, inequality of length of the lower limbs) in spinal surgery consultation
* Subject not having expressed its opposition, after information, to the re-use of its data for the purposes of this research.

Exclusion criteria:

* Subject with surgical history, fractures, osteoporotic packing, vertebral deformation (scoliosis, kyphosis, spondylolisthesis grades 2-5), vertebral osteolysis (spondylodiscitis, tumor or metastasis).
* Subject who expressed his opposition to participate in the study
* Subject under guardianship or curatorship
* Subject under judicial protection