cyrilzakka/clinical-trials huggingface dataset:
A Study on the Bone-health Effectiveness of Applying Recombinant Factor VIII Fc (rFVIIIFc) to Patients With Hemophilia A (Prototype A)

Study Objectives\*

1. Provide a systematic evaluation of the treatment outcomes in patients with hemophilia A
2. Emphasize the importance and clinical benefits of rFVIII-Fc in joint and bone health.
3. Compare the clinical outcomes from 1 year before and after switching to EHL.
4. Exploratory: Identify biomarkers that could provide more useful and convenient evaluations of joint and bone health. (Time-saving and easy to monitor)

In this study, we would like to focus on the evaluation of joint and bone health in persons with severe hemophilia A (PwHA) treated with rFVIIIFc prophylaxis. We also aim to identify potential biomarkers for assessing the joint and bone health of PwHA. Since the joint and bone health examinations are time-consuming, expensive, and require special equipment, the patients could only receive the examinations annually to realize the status of their joint health. The biomarkers testing will provide a more convenient and time-saving option on the joint and bone health evaluation for PwHA. Therefore, surrogate of biochemical marker(s) to represent the joint and BMD progression is an unmet need for clinical practice. Investigating different biomarkers and combining them with the joint and BMD results to provide a systematic approach for elucidating the treatment outcomes of PwHA treated with rFVIIIFc is major goal of this study.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with severe hemophilia A (all ages).
2. Patients with moderate type hemophilia A with hemophilic arthropathy.
3. Currently on rFVIIIFc regular prophylaxis and have previous medical record with regular prophylaxis with standard half-life product for one year
4. Able and willing to undergo joint and bone examinations

Exclusion Criteria:

1. Participants of other interventional studies.
2. Patients with current inhibitors.
3. History of major neurological disease (eg. Stroke, Parkinson's disease, neuropathy, etc.)
4. History of major psychiatric disease (eg. Schizophrenia, bipolar disorder)
5. Significantly impaired vision/hearing
Intracranial Pressure Monitoring in Sever Traumatic Brain Injury Single Center Experience

Intracranial pressure (ICP) is defined as the pressure inside the skull, and therefore, the pressure inside the brain tissue and the cerebrospinal fluid (CSF). The relationship between CSF and intracranial blood volumes is described by the Monroe Kellie doctrine; because the brain is incompressible, when the skull is intact, the sum of the volumes of brain, CSF, and intracranial blood is constant.

ICP \>15 mmHg is considered to be elevated, and this is considered an important cause of secondary injury leading to irreversible brain injury and death. ICP monitoring is used in a number of conditions; traumatic brain injury, intracerebral haemorrhage, subarachnoid haemorrhage, hydrocephalus, malignant infarction, cerebral oedema, CNS infections, hepatic encephalopathy, to name a few, and in all of these conditions ICP monitoring in the light of other parameters can influence management for better outcomes.

There are 4 ways to monitor intracranial pressure:

1. An intra-parenchymal method, the catheter is placed into the brain parenchyma through a burr hole; it has a lower complication rate, lower infection rate, and no chance of catheter occlusion or leakage. Neurological injury is minimized because of the small diameter of the probe. In addition, malposition of the transducer has less impact on errors of measurement.
2. An intra-ventricular method, the catheter is placed into one of the ventricles (lat. Ventricle). The catheter can also be used for therapeutic CSF drainage and for administration of drugs.
3. Subdural method, this method is used if monitoring needs to be done right away. A hollow screw is inserted through a burr hole and placed through the Dura mater.
4. An epidural sensor is inserted between the skull and dural tissue. This procedure is less invasive than other methods.

ICP monitoring methods is associated with a number of complications. These include risk of infection, haemorrhage, obstruction, difficulty in placement, malposition, etc.

The use of an ICP monitor is associated with significantly lower mortality when compared with patients treated without an ICP monitor

Eligibility Criteria:
Inclusion Criteria:

1. Age \>18
2. GCS \< 8
3. patient with severe brain insult ( Marshall class II to IV)
4. patients admitted within 24 hours from the trauma time

Exclusion Criteria:

1. Patients admitted for surgery (ex; surgical EDH) .
2. patient diagnosed as brain death
Arm Use With Soft-robotic Glove

This study, aimed at investigating the impact of using a supportive soft-robotic glove on actual arm and hand use in daily life, is designed as a single-case experimental design study. 3-5 patients with limitations in hand function due to trauma-related or neurological conditions are asked to participate. Participants will be asked to use a soft-robotic glove at home for six weeks during daily activities relevant to them, while that glove supports the grip of their most affected hand. For several weeks before, during and after the use of the soft-robotic glove, participants will be asked to do some short tests (wearing an activity meter on both wrists during the day, performing a hand squeeze test under the supervision of the researcher via video call) and to answer some questions related to perceived hand function and well-being (a total of at least 15 times during 12-14 weeks). The present study is a follow-up to previous studies that investigated the effect of (previous versions of) the same robotic glove (Carbonhand; Bioservo Technolo-gies AB, Kista, Sweden) on hand function, in order to better understand and explain the observed therapeutic effect.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 90 years
* Experience difficulties in performing ADL due to hand function limitations as a result of trauma-related injury or neurologic disorder
* Being in a chronic/stable phase of disease as judged by their physician
* Able to activate the soft-robotic glove by generating pressure on finger/palm sensors when grasping an object
* Ability to relax an active grip
* Sufficient cognitive status to understand two-step instructions
* Having (corrected to) normal vision
* Able to provide written informed consent
* Living independently

Exclusion Criteria:

* Severe sensory problems of the most-affected hand
* Severe acute pain of the most-affected hand
* Wounds on the hands that can provide a problem when using the glove
* Severe contractures limiting passive range of motion to the extent that the glove can't be donned/activated comfortably
* Co-morbidities limiting functional use/performance of the arms and/or hands
* Severe spasticity of the hand (≥2 points on Ashworth Scale)
* Severe proximal weakness (MRC shoulder elevation\<4)
* Used the Carbonhand system in the past 3 months
* Participation in other studies that can affect functional performance of the arm/hand
* Receiving arm-/hand function therapy during the course of the study
* Insufficient digital literacy to conduct video calls
* Insufficient knowledge of the Dutch or English language to understand the purpose or methods of the study
Combined Malonic and Methylmalonic Aciduria (CMAMMA): Gene Identification and Outcome Study

The investigators are interested in learning more about the changes found in the condition called "Combined elevation of Malonic and MethylMalonic Acid, or CMAMMA. " Malonic, or MA and MethylMalonic, or MMA, are acids formed from the breakdown of protein under normal conditions. However, in the condition called CMAMMA there is an increase of these acids in the blood and urine, which is not normal.

Some people with high MA and MMA in their blood and urine have a serious disease, starting as a baby or young child that includes heart disease and problems in learning. These people have changes in a special enzyme called Malonyl CoA Decarboxylase (MCD). Other people who have a high level of MA and MMA do not have any obvious illness. The investigators are not sure why they have high levels of MA and MMA and why they are not sick.

The goal of this study is to learn more about why some people have a high level of MA and MMA and to make sure there are no medical problems as a result of these high levels. The investigators also want to find out which gene and enzyme cause the high levels of MA and MMA.


Eligibility Criteria:
Inclusion Criteria:

1. Elevated Malonic and Methylmalonic Acid in blood and urine
2. Any age
3. Any sex
4. Asymptomatic

Exclusion Criteria:

1. Defect in malonyl-coenzyme A decarboxylase (MCD) enzyme
2. History of metabolic acidosis, developmental delay and seizures
A Clinical Study of TQB3912 Tablets in Patients With Advanced Malignant Tumor

This is a study to evaluate the maximum tolerated dose (MTD), occurrence of all adverse events (AEs) and serious adverse events (SAEs), pharmacokinetic parameters and antitumor effect of TQB3912 tablets in Chinese adult patients with advanced malignant neoplasm. The study was divided into phase Ia and phase Ib, Phase Ia: Dose escalation period, to evaluate the safety and tolerability of TQB3912 tablets, determine MTD; Phase Ib: Effectiveness exploration period, to expand the safe and effective dose group, and to recommend appropriate dosage and method for subsequent clinical research.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who voluntarily join the study, sign the informed consent form, and have good compliance.
* Aged from 18 to 75 years; Eastern Cooperative Oncology Group performance status score: 0-2; at least 3 months of expected survival period.
* Subjects with relapse advanced malignant solid tumors clearly diagnosed by pathology and/or cytology.
* The function of main organs is normal.
* Subjects need to adopt effective methods of contraception.

Exclusion Criteria:

* Subjects with other malignancies currently or suffered within 3 years.
* Subjects with Grade 1 or above unhealed toxicity reaction of Common Terminology Criteria for Adverse Events Version 5.0 due to previous antitumor treatment.
* Subjects who have received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before first administration.
* Subjects with long lasting wounds or fractures.
* Subjects with a history of psychotropic drug abuse unable to quit or with mental disorders.
* Subjects with any severe and/or uncontrolled disease.
* Subjects who have received surgery, chemotherapy, radiotherapy or other anticancer therapies 4 weeks before the first administration.
* Subjects who have taken Chinese patent medicines with anti-tumor indications in the drug instructions that National Medical Products Administration approved within 2 weeks before the first administration.
* Subjects with pleural effusion, pericardial effusion or ascites that cannot be controlled and need repeated drainage.
* Subjects who have participated in other clinical studies within 4 weeks before the first administration.
* According to the judgment of the investigators, there are accompanying diseases that seriously endanger the safety of patients or affect the completion of the study.
Study to Compare Oxymorphone Extended-Release (Opana ER) Versus Oxycodone Controlled-Release (Oxycontin)

The purpose of this study is to compare the subjective and objective effects of Oxymorphone ER (Opana ER) versus Oxycodone CR (Oxycontin).


Eligibility Criteria:
Inclusion Criteria:

* Recreational opioid use.
* At least 3 lifetime occasions of recreational use of an oral intact modified-release opioid product.
* BMI within range of 19.0 to 29.9 kg/m2, inclusive, minimum weight of 50.0 kg at screening and Day 0 of treatment period 1

Exclusion Criteria:

* Self-reported history of drug or alcohol dependence in the past 2 years or presence of drug or alcohol dependence in the past 12 months as defined by the DSM-IV, including subjects who have ever been in a drug rehabilitation program.
* Unwillingness or inability to abstain from recreational drug use as required for the study.
* History of acute asthma or other obstructive airway disease or any condition that may increase the risk for respiratory depression, judged as clinically significant by the investigator or designee.
* History of neurologic conditions such as convulsive disorders or severe head injury, judged as clinically significant by the investigator or qualified designee.
* History of Addison's disease, hypothyroidism, pancreatitis, prostatic hypertrophy, or urethral stricture.
* Use of non-prescription or prescription medications or natural health products within 7 days prior to first drug administration in the qualification phase and throughout the study, unless in the opinion of the investigator or designee, the product will not interfere with the study procedures or data integrity or compromise the safety of the subject.
* Uses of Monoamine oxidize inhibitors (MAOIs) within 14 days of first drug administration in the qualification phase and throughout the study.
* Current consumption of greater than 20 cigarettes (or 2 cigars) per day or inability to abstain from smoking (or use of any nicotine-containing sub stance) for at least 14 hours.
Annual Study to Investigate Influenza Vaccine Due to New Virus Strains for the 2007/2008 Influenza Season in Europe

Influenza (flu) viruses change continuously, therefore also the parts of viruses used in influenza vaccines can vary from year to year. In Europe, manufacturers/marketing holders of these vaccines are required to be involved in ongoing clinical trials and to present the results to the competent authorities each year. The current study is a phase IIIa clinical trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. It is part of the ongoing clinical trial program for Influvac® and will be done to assess the immunogenicity and safety and tolerability of next season's trivalent influenza subunit vaccine in two groups of healthy subjects: subjects aged \>= 18 and \<= 60 years and subjects \>= 61 years of age (elderly).


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent.
* Healthy and aged \>= 18 and \<= 60 years or \>= 61 years of age.
* Mental health good enough to understand the study and the informed consent form and to fill in the questionnaire.

Exclusion Criteria:

* Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine.
* Having fever and/or presenting with an acute infectious episode of the upper and/or lower respiratory airways.
* Having experienced a serious systemic and/or local reaction after previous influenza vaccination.
* Having an auto-immune disorder (e.g. RA, SLE, auto-immune thyroid disorders) or other disorders affecting the immune system, taking immunosuppressive medication (such as systemic corticosteroids) including the four weeks preceding the start of the study (date of informed consent), or having a disease in a terminal stage.
* Having received vaccination against influenza within the previous six months before Visit 1.
Effects of Essential and Non-Essential Amino Acids on Post-Exercise Muscle Collagen Synthesis in Young Men

The purpose of this study is to assess which amino acids are affecting acute muscle collagen synthesis in response to supplementation and exercise.

This is a double-blinded, randomized controlled, parallel design study, with 3 treatment groups (placebo, collagen peptide, and essential amino acid). The study will involve 3 visits: a baseline testing/familiarization session, and 2 exercise trials which will include muscle biopsies, blood draws, and the infusion of a tracer isotope in order to measure muscle protein synthesis.

Eligibility Criteria:
Inclusion Criteria:

* Can fluently read and write in English
* Male
* 18 - 35 years

Exclusion Criteria:

* Diabetes, cardiovascular disease, or current pharmaceutical therapy
* Medical conditions impacting ability to undertake strenuous physical activity
* Lower body resistance training in the previous 6 months
* BMI \> 30
* Currently smoking with cigarettes
* Allergy to any study supplements
* Currently taking any protein, amino acid, or collagen supplement
* Participate in greater than 2 hours of weekly vigorous exercise
Effect of Suboccipital Release in Patients With Fibromyalgia Syndrome

This study was designed to examine the efficacy of suboccipital release in Patients With FMS and to provide preliminary evidence regarding its effects on pain and QOL by objectively measuring Cortisol level in FMS patien

Forty female patients with FM ( age : 20- 45 Years ) participated in the study after suing the consent form . Participants were randomly allocated assigned into 2 equal groups ( control group \[ G1 \] and study \[G2 \] ) . Group

1 received selected physical therapy programme. Group 2 recieved suboccipital release. All participants were assessed for cortisol and pain level by using visual analogues scale and neck disability scale. Also participants were assessed by pressure algometer for pain intensity. Participants were assessed for QOL by FIBROMYALGIA IMPACT QUESTIONNAIRE (FIQR) . treatment was done 3 sessions per weeks for successive 6 weeks pre and post assessment for all valuable were Done

Eligibility Criteria:
Inclusion Criteria:

* women between 20-45 years old, (ii) diagnoses according to the 2016

American College of Rheumatology criteria for fibromyalgia \[1\]

* Symptoms have been present at a similar level for at least three months (iii) Absence of other disorders that causes similar symptoms: systemic lupus erethromatosis (SLE), rheumatoid arthritis (RA) and Lyme disease based on laboratory investigations (erythrocyte sedimentation rate (ESR), Anti anti-cyclic citrullinated peptide (Anti CCP), antinuclear antibody (ANA) and Rheumatoid factor(RF)).
* Exclusion Criteria:

  * any medical, neurological, or psychiatric illness, use of strong opioids or other painkillers except paracetamol and/or ibuprofen, benzodiazepine, illicit drug or alcohol use, recent use of cannabis, pregnancy, breast feeding, and the presence of pain syndromes other than FM. Presence of other autoimmune disorders e.g.: rheumatoid arthritis and systemic lupus erethromatosus
Liraglutide Improve Cognitive Function in Patients With Type 2 Diabetes Mellitus

Patients with diabetes are susceptible to dementia, but regular therapy fails to reduce the risk of dementia. In previous observational study, the investigators found that liraglutide can improve cognitive function in patients with T2DM through a metabolism-independent pathway. Here the investigators aim to further verify such effects through a randomized, controlled study.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Type 2 Diabetes Mellitus

Exclusion Criteria:

* T2DM with acute diabetic complications;
* type 1 diabetes;
* other diseases affecting cognitive function (e.g., congenital dementia, brain trauma, epilepsy, severe hypoglycemic coma, cerebrovascular disease, ischemic heart disease, renal dysfunction);
* alcohol abuse, mental illness, and psychoactive substance abuse;
* history of thyroid disease;
* any surgical or medical conditions that could significantly influence the absorption, distribution, metabolism, or excretion of interventional drugs;
* unwillingness to provide informed consent.
Phase I Clinical Trial of a Candidate Herpes Zoster Vaccine

This is a phase I, randomized, observer-blinded study to evaluate the safety, tolerability, and immunogenicity of BV211(a herpes zoster vaccine) in Adult Volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy resident aged 30-70 years with body weight ≥ 50 kg for males and ≥ 45 kg for females, BMI within the range of 19.0-32.0 (including the boundary value), who can provide legal identification.
* Willing to participate in the study and sign ICF.
* Women of childbearing age shall take effective contraception measures 30 days before vaccination up to 6 months post full vaccination and not in lactation period. The pregnancy test on the day of vaccination shall be negative.
* Will attend all scheduled follow-up visits and follow the requirements of the clinical study.

Exclusion Criteria:

* Smoking, and/or excessive alcohol use.
* Failed the screening test of illicit drugs, including THC.
* Axillary temperature above 37.3℃.
* History of herpes zoster.
* Received any herpes zoster vaccine.
* Received any vaccine within 14 days or live vaccine within 28 days before vaccination.
* Received gamma immunoglobulin or intravenous immunoglobulin within 3 months before vaccination.
* Have acute illness or are in the acute exacerbation phase of a chronic disease within 3 days before vaccination.
* Allergic history to any vaccine-related component; history of severe allergies to any vaccine.
* History of convulsions, epilepsy or encephalopathy (such as congenital brain hypoplasia, brain trauma, brain tumor, cerebral hemorrhage, cerebral infarction, brain infection, damage to nerve tissue in brain caused by chemical drug poisoning, etc.) and psychiatric history or family history of mental illness.
* Asplenia or functional asplenia, and asplenia or splenectomy caused by any reason.
* Primary or secondary immunocompromised or diagnosed with congenital or acquired immunodeficiency, infection of HIV, lymphoma, leukemia, SLE, JRA, inflammatory bowel disease or other autoimmune diseases.
* Received immunosuppressive therapy (such as long-term application of systemic glucocorticoids ≥ 14 days, dose ≥ 2 mg/kg/day or prednisone ≥ 20mg/day or equivalent to that dose of prednisone, excluding inhaled, intra-articular and topical steroid) within 3 months before vaccination.
* Serious cardiovascular diseases (pulmonary heart disease, pulmonary edema), liver and renal diseases and diabetes with complications.
* History of thrombocytopenia or other coagulation disorders, which may cause contraindications to intramuscular injection.
* Abnormal blood pressure (systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg) before vaccination; abnormal ECG
* Laboratory indicators out of the specified ranges (i.e., out of 1.5x of ULN or LLN), or with clinical significance as judged by the physician.
* Current/long-term history of alcohol abuse and/or history of drug abuse.
* Any other factors judged by investigator that may affect the safety of the subject or evaluation of the study.