cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetic Model of Fibrinogen Plasma Levels After Fibrinogen Administration

characterize the fibrinogen PK in patients with acquired -chronic (cirrhotic patients) or acute- hypofibrinogenemia (severe trauma or critical haermorrhage), showing endogenous production.

Fibrinogen, a plasma-soluble protein synthesized by the liver, is the key substrate for the plasmatic blood coagulation, reaching a critically low plasma concentration earlier than other coagulation factors in case of bleeding. Fibrinogen Pharmacokinetics (PK) after single doses of fibrinogen concentrate (FC), using modeling approaches, has only been evaluated in congenital afibrinogenaemic patients. The aims of this study are to extend the modeling process to characterize the fibrinogen PK in patients with acquired -chronic (cirrhotic patients) or acute- hypofibrinogenemia (severe trauma or critical haermorrhage), showing endogenous production. Influencing factors of differences on the fibrinogen PK between sub-populations will be identified.

Eligibility Criteria:
Inclusion Criteria: AFIBRINOGENEMIC, TRAUMATIC AND CIRRHOTIC AFTER FIBRINOGEN ADMINISTRATION -

Exclusion Criteria: NA

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Targeting Osteosarcopaenia and Multimorbidity for Frailty Prevention

The aging population and its accompanying burden from non-communicable chronic diseases predicts an increasing impact imposed by frailty on healthcare systems. This is due to a lack of normative data for older adults and reliable risk stratification methods to develop effective approaches to the prevention of frailty.

In this study, the investigators plan to form a common dataset for phenotype identification, risk stratification of frailty and its targeted treatment plans in the at-risk and mildly frail population.

Osteosarcopaenia and multimorbidity have emerged as two key antecedent factors driving the cycle of frailty, leading to adverse outcomes. However, it remains unclear how multimorbidity and/or osteosarcopaenia act singly or in concert to influence the expression and trajectory of the frailty continuum.

OPTIMA-C will develop unifying administrative and data platforms, exploring the feasibility of inclusive screening for sarcopaenia early during rehabilitation hospital stay. Early muscle ultrasound will also be utilised to determine key muscles possibly predictive of rehabilitation functional or global outcomes in the studied populations and their correlation with acute disease outcomes. Digital markers are quantified and correlations are investigated with physical, muscle and bone imaging findings.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 50y
2. Asian ethnicity
3. First diagnosis (stroke, Traumatic Brain Injury (TBI), knee osteoarthritis, breast cancer)
4. Living in community
5. Able to understand 1 step simple commands
6. For inpatients: (i) within 12 weeks of disease (stroke/TBI) onset, and (ii) within 2 weeks of rehabilitation ward admission
7. For outpatients: (i) \>6 months from initial diagnosis of first stroke, TBI, knee osteoarthritis or breast cancer, and (ii) at least standby assistance, modified independent or independent in ambulation with /without walking.

Exclusion Criteria:

1. Nursing home or dormitory resident
2. Non-resident status in Singapore (e.g. foreign worker, tourist, temporary visit pass)
3. Impairments affecting understanding of questionnaires and tasks: e.g. severe deafness, severe visual impairment and severe /global aphasia,
4. Presence of active fractures, dislocations, non-weight bearing status, burns, unhealed wounds, active skin infections/eczema and agitated behaviour or delirium
5. Anticipated life expectancy \< 1 year
6. Presence of tracheostomy, ventilator, renal dialysis, end-organ failure
7. Patients with disorders of consciousness.
8. Pregnant or lactating participants

   For Knee Osteoarthritis patients only:
9. Alternative diagnosis to knee OA e.g. Referred pain from hip or spine.
10. Other forms of knee arthritis eg. Inflammatory, post traumatic
11. Previous knee arthroplasty
Sitagliptin and Endothelial Dysfunction

Over the years, numbers of cardioprotective drugs have been evaluated to attenuate lethal ischemia-reperfusion (IR) injuries. There is little study whether sitagliptin protects against endothelial dysfunction induced by IR injury in humans.

Glucagon-like peptide-1 (GLP-1) is a novel insulinotropic peptide which is rapidly degraded by the enzyme dipeptidyl peptidase-4 (DPP-4). In addition to its attractive merit in type 2 diabetes, interest in the cardioprotective effects of GLP-1 has been increased with various reports and evidence. Previously, the investigators could show exenatide, GLP-1 receptor agonist protects ischemic/reperfusion injury-induced endothelial dysfunction through opening of KATP (ATP-sensitive potassium) channels in human ischemic/reperfusion injury model. But, recent clinical studies showed 2 different DPP-4 inhibitors, alogliptin and saxagliptin, did not decrease major adverse cardiovascular events even though improving glycemic control. The investigators will investigate the role of sitagliptin in human ischemic/reperfusion (IR) injury model of forearm conductance vessels as previous described method.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteer age 20 to 40 years
* non-smoker

Exclusion Criteria:

* High blood pressure (\>140/90 mmHg) or any antihypertensive medications
* diabetes
* any cardiovascular disease
* kidney disease
* thyroid disease
* cerebrovascular disease
* liver disease (bilirubin level \>2 mg/dl)
* pregnancy
* body mass index \>25 kg/m2
The Hemostatic Effectiveness of "HANBIO" Gauze During Non-emergent Gynecology Surgery.

The objective of this study is to collect the hemostatic effectiveness and device safety data of "HANBIO" Gauze in subjects have acute wound result from gynecology surgery.


Eligibility Criteria:
Inclusion Criteria:

* Female between 20 and 70 years of age.
* Subject scheduled for a non-emergent, gynecological surgery.
* Subject has an identified bleeding site/area intraoperatively.
* Subject is willing to comply with all aspects of the study and have signed informed consent form.

Exclusion Criteria:

* Pregnant or lactating female.
* The wound is chronic wound that not healed within 8 weeks, e.g. ulcers.
* The wound is caused by radiation or burns.
* Subject is sensitive or allergic to collagen.
* Subject is sensitive or allergic to polyester (PET).
* Subject has medical history of coagulation disorder or disease (e.g., hemophilia, thrombocytopenia).
* Subject receives anticoagulants or antiplatelets.
* Subject plans to receive other hemostatic gauze/dressing/agent/medical device as primary hemostasis.
* Subject has participated in another clinical trial within the past 30 days.
* Subjects with any pre-operative or intra-operative findings that may preclude conduct of the study procedure or unable to evaluate the outcomes.
Effect of Combination Therapy on Knee Osteoarthritis Pain in Postmenopausal Women

the aim of this study is to investigate the efficacy of Combination Therapy on Knee Osteoarthritis Pain in Postmenopausal Women

Osteoarthritis (OA) is the most common musculoskeletal condition affecting the quality of life of older adults. The prevalence of OA is very high 45% in females in comparison to males, especially after menopause due to the hormonal changes. In the physical therapy practice, therapeutic ultrasound (US) is one of the most frequently applied electrotherapeutic modalities in orthopedics physiotherapy. Simultaneous application of two therapeutic modalities at the same site is described as combination therapy (CT). The most commonly used CT is US \& Transcutaneous neuromuscular electrical stimulation (TENS )where this approach was effective in pain modulation .The use of combination therapy is highly preferable because of the advantageous effect both electro-therapy and ultrasound provide simultaneously. There are no current studies on using combination therapy in the treatment of pain in mild to moderate knee osteoarthritis in post-menopausal women and we don't know the proper treatment dose.The study is designed as a prospective, randomized, pre-posttest, controlled trial.where we have two groups Intervention group and control. the intervention group will recieve strengthening exercises in addition to combination therapy 10 minutes for each session, 3 times per week, for 3 weeks.The Control group will recieve the same strengthening exercises as intervention group and sham combination therapy 10 minutes for each session, 3 times per week, for 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Forty women who suffer pain out of mild to moderate knee osteoarthritis
* Their age will range from 55 to 65
* At least one year after last menstruation.
* Their BMI will be ranged from 25 to 35 kg/m2

Exclusion Criteria:

* Neurological disorders.
* Cardiovascular disorders.
* Severe knee osteoarthritis
* Areas of the body where cancerous lesions exist.
* Any skin impairment at site of application as inflammation, lesion, wounds, infection and swelling.
* Pacemaker and any metallic implants.
Effects of OMT on ANS: a Thermography Study

the study will investigate the effect of a specific type of touch intervention on the activity of autonomic nervous system measured using thermography


Eligibility Criteria:
Inclusion Criteria:

* adults above 18y and below 35y
* without any congenital, genetical and chronic disease
* without any symptomatology

Exclusion Criteria:

* congenital, genetical and chronic disease
* neurological, cardiovascular, psychiatric disease
* acute pain
* paediatric patients
* adults over 35 years old
Intravenous Beta-blockade for Improvement of Autonomic Activity

Chronic beta-adrenoceptor blockade is known to improve outcome of high risk patients whereas amelioration of autonomic activity was demonstrated to be a major cause of outcome improvement. Therefore, perioperative beta-adrenoceptor blockade is recommended in patients with Revised Cardiac Risk Index score of three or greater. The investigators hypothesise that preoperative intravenous beta-adrenoceptor blockade for treatment of hypertension and/or tachycardia improves autonomic activity reflected by increase of Total Power of Heart Rate Variability.

Material and Methods: After IRB approval 20 patients scheduled for elective cardiac surgery were included into the study. Routine medication was continued throughout the study as recommended by the guidelines. HRV (TP and Low to High Frequency ratio (LF/HF) reflecting sympathetic to parasympathetic balance) was analysed prior to induction of general anesthesia and beta-adrenoceptor blockade in all patients (Baseline). Patients were assigned by their baseline hemodynamics. Patients with hypertension (systolic blood pressure \> 140mmHg or diastolic blood pressure \> 90mmHg) or tachycardia (heart rate \> 80bpm) were assigned to group BETA-BLOCK. In this group metoprolol-boli (2mg) were administered intravenously in stepwise manner until hemodynamic values decreased to normal. Total dosage was recorded. After normalisation of hemodynamics, second HRV analysis was performed (Intervention). Normotensive and normocardic patients were assigned to group CONTROL. No intervention was performed. Statistics: Mann Whitney U test for comparison between groups and between events Baseline and Intervention within group BETA-BLOCK, p\<0.05.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for coronary artery bypass surgery
* Ejection fraction \> 30 %
* Informed consent

Exclusion Criteria:

* Emergency cases
* Myocardiac infraction within 4 weeks
Unicompartmental Knee Arthroplasty vs High Tibial Osteotomy.

Valgus high tibial osteotomy (HTO) and unicompartmental knee arthroplasty (UKA) are established treatment options for patients with medial compartmental osteoarthritis (OA) of the knee.However, the clinical outcomes of these treatment modalities for unicompartmental OA have become subjects of debate.

Although HTO for the correction of malalignment in the medial osteoarthritic knee has been shown to provide successful outcomes in some studies, it is technically difficult to achieve the ideal valgus position postoperatively, and the likelihood of postoperative complications after HTO is greater than that after UKA . As compared with HTO, UKA has been reported to provide better long-term results, to have a shorter time to full weight bearing, to allow easier rehabilitation, and to have fewer perioperative complications. Furthermore, indications for UKA are broadening, including younger and more active patients, since encouraging midterm and long-term results were published.

Eligibility Criteria:
Inclusion Criteria:

1. - Medial compartment osteoarthritis with exposed bone on both femur and tibia.
2. -Functionally intact Anterior Cruciate Ligament (superficial damage or splitting is acceptable)
3. -Full thickness and good quality lateral cartilage present
4. -Correctable intra-articular varus deformity (suggestive of functionally intact medical cruciate ligament) 5-Medically fit showing an American Society of Anesthesiologists (ASA) of 1 or 2

Exclusion Criteria:

1. Require revision knee replacement surgery.
2. Have rheumatoid arthritis or other inflammatory disorders.
3. Are unlikely to be able to perform required clinical assessment tasks.
4. Have symptomatic foot, hip or spinal pathology.
5. Previous knee surgery other than diagnostic arthroscopy and medial menisectomy.
6. Previously had septic arthritis.
7. Have significant damage to the patella-Femoral Joint especially on the lateral facet.
Multicenter Prospective Evaluation of Radiofrequency for Anal Fistulas

Anal fistula treatment is associated with increasing risk of anal incontinence until 40% of cases. New and alternative treatments (glue, advancement flap, plug...) decrease this risk, but with fistula efficacy treatment in 40 to 60% of cases. Radiofrequency might destroy fistula tract without lesion of anal sphincter.

Objective : Fistula healing rate and anal continence, 6 and 12 months after radiofrequency procedure.

Methods : Clinical and MRI evaluation before, 6 and 12 months after treatment. Patients : 50 patients with low, high, complex and Crohn disease fistula. An intermediate analysis is expected after the first 20 patients, to verify morbidity.

Evaluations :

* Fistula clinical healing 6 and 12 months after procedure
* Fistula MRI healing 12 months after procedure
* Anal continence before and after procedure
* Feasibility og radiofrequency procedure
* Morbidity
* Success and failure prognostics factors of this procedure

: Anal fistula treatment is associated with increasing risk of anal incontinence until 40% of cases. New and alternative treatments (glue, advancement flap, plug...) decrease this risk, but with fistula efficacy treatment in 40 to 60% of cases. Radiofrequency might destroy fistula tract without lesion of anal sphincter.

Objective : Fistula healing rate and anal continence, 6 and 12 months after radiofrequency procedure.

Methods : Clinical and MRI evaluation before, 6 and 12 months after treatment. Patients : 50 patients with low, high, complex and Crohn disease fistula. An intermediate analysis is expected after the first 20 patients, to verify morbidity.

Evaluations :

* Fistula clinical healing 6 and 12 months after procedure
* Fistula MRI healing 12 months after procedure
* Anal continence before and after procedure
* Feasibility og radiofrequency procedure
* Morbidity
* Success and failure prognostics factors of this procedure

Schedule :

* First inclusion march 2017
* Last inclusion march 2018
* Evaluations until march 2019.

Eligibility Criteria:
Inclusion Criteria:

* Adult Patient agreeing to participate in the study and signing the consent to participate
* Patients with an anal fistula previously drained, without diverticulum\> 10 mm in MRI after drainage.
* For women of childbearing age, they must have a negative urine pregnancy test

Exclusion Criteria:

* Patient minor,
* Patients who are linguistically or psychologically unable to understand the information given and to give informed consent,
* Patient incapable, in the opinion of the investigator, to complete the self-questionnaires,
* Against-indication to radiofrequency treatment (infectious anal pathologies, anal fissures, residual staples of previous treatment Longo,
* Pregnant woman,
* Patient carrying a pacemaker,
* Patients participating in another clinical study,
* Against indication to the realization of an MRI,
* Patient with a fistula with insufficient drainage, against indicating the removal of the stem (congestive fistula, oozing, with internal and / or external congestive orifices).
Buccal Evaluation of Mobile Beach Workers

Tumors in the oral region occur more frequently in men over 40, but can affect people of both gender and all ages, even children. The prevention of oral cancer acquires relevance in public health, particularly if the investigators consider that the preventive approach is compatible with the nature of this disease, as the mouth favors easy visual access. The objective of this study is evaluation the prevalence of oral and perioral injuries in workers who were exposed to the sun on the beaches, investigating possible associations of a sociodemographic, occupational and general health nature.

Tumors in the oral region occur more frequently in men over 40, but can affect people of both sexes and all ages, even children. The prevention of oral cancer acquires relevance in public health, particularly if the investigators consider that the preventive approach is compatible with the nature of this disease, as the mouth favors easy visual access. The objective of this study is evaluation the prevalence of oral and perioral injuries in workers who were exposed to the sun on the beaches, investigating possible associations of a sociodemographic, occupational and general health nature. Firstly, information about the care, symptoms and forms of prevention will be explained for each worker approached, if the individual agrees to an oral examination, it can be performed by evaluating lips and peri-oral mucosa and within the needs of oral treatment, it can be referred for treatment at the clinic of the Dentistry Especialist Center of Santos/SP The street vendors who underwent the first assessment will be visited 2 more times according to the schedule, after the carnival of 2020 being the last assessment and thus being able to have data on the effectiveness of the information and past care during the visits made. As expected results, a greater awareness of the dangers of sun exposure, greater protection care and the ability to carry out self-examination at home being an information disseminator.

Eligibility Criteria:
Inclusion Criteria:

* be walking beach worker

Exclusion Criteria:

* not wanting to participate in the evaluation
Home-based Proprioceptive Neuromuscular Facilitation for Subjects With Type 2 Diabetes Mellitus

In this research work, the concept of strengthening technique of proprioceptive neuromuscular facilitation (PNF) incorporated with tendon gliding exercise (TGE) will be used to improve neuromuscular function of upper extremity of patients with diabetes mellitus. The first specific aim of the study is to examine the effects of home-based PNF exercise on the motor, sensation and functional performance parameters of upper extremity of the patients with diabetes mellitus. In addition, whether adding a tendon gliding exercise (TGE) to the home-based PNF exercises can provide better treatment effects for the patients with diabetes mellitus will also been investigated in this study. One of the hypothesis of this study is the prescribing home-based PNF exercise program has a positive treatment effect on neuromuscular function of the upper extremity of patients with diabetes mellitus. And,the other is home-based PNF in conjunction with TGE provides better benefits for neuromuscular function of the upper extremity of patients with diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Study participants will include clinically defined diabetic patients who are diagnosed based on the 1997 criteria of the American Diabetes Association. The inclusion criteria of the enrolled subjects are who suffered from neuropathy as diagnosed by abnormalities in either a nerve conduction study and / or quantitative sensory testing.

Exclusion Criteria:

* DM patients with (1) traumatic nerve injuries of the upper limbs, (2) trauma to the hand or congenital anomalies of the wrist and hand, (3) skin infections or disease, (4) known vascular complications of diabetes, such as stroke may have compromised the physical integrity of the patient, (5) grade 2 or higher arterial hypertension (\>160/100 mmHg) or (6) cognitive deficits
Flortaucipir PET Imaging in Subjects With FTD

This study is designed to assess the usefulness of flortaucipir in Positron Emission Tomography (PET) imaging for subjects diagnosed with Frontotemporal Dementia (FTD).


Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed by a dementia specialist with symptomatic clinical syndromes with expected Frontotemporal Dementia (FTD) pathology will be enrolled. Clinical syndromes associated with FTD pathology include: behavioral-variant FTD, FTD with motor-neuron disease, non-fluent/agrammatic and semantic variants of primary progressive aphasia, progressive supranuclear palsy syndrome and corticobasal syndrome.
* Have provided informed consent or have a legally authorized (LAR) provide consent for study procedures
* Have had volumetric brain MRI obtained in site's companion protocol within one year of enrollment
* Can tolerate PET scan procedures

Exclusion Criteria:

* Have clinically significant cardiac, hepatic, renal, pulmonary, metabolic, or endocrine disturbances that pose potential safety risk
* Have history of risk factors for Torsades de Pointes (TdP) or taking medication known to cause QT prolongation
* Have history of drug or alcohol dependence within the last year
* Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity, or not using reliable contraception
* Have history of relevant severe drug allergy or hypersensitivity
* Have received an investigational medication under FDA IND protocol within 30 days of planned imaging session
* Have received a radiopharmaceutical for imaging/therapy within 24 hours of imaging session
* Possess PET scan evidence of amyloid deposition
* Determined by the investigator to be unsuitable for this type of study