cyrilzakka/clinical-trials huggingface dataset:
Analytical Performance Evaluation of Blood Glucose Monitoring Systems- Investigator Sponsored Contour® XT Comparator Study - Ulm Germany

In this clinical trial, accuracy evaluation of Bayer Contour XT blood glucose monitoring system and blood glucose monitoring systems from other companies across the overall tested glucose range will be performed.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Male or female subjects with type 1 or type 2 diabetes or healthy subjects
* For BG adjustment people with type 1 diabetes

Exclusion Criteria:

* Severe acute illness that, in the opinion of the Investigator, might pose additional risk to the patient
* Chronic illness that, in the opinion of the Investigator, might pose additional risk to the patient
* Current condition that, in the opinion of the Investigator, doesn't enable subject to participate in the study
* For BG adjustment people with type 1 diabetes without CHD, condition after myocardial infarction, PAOD, cerebral events or hypoglycaemia unawareness
* Legal incompetence or limited legal competence
* Age \< 18 years
* Dependency from the sponsor or the clinical investigator
* Mental incapacity or language barriers precluding adequate compliance with the study procedures
The Prevention of Contrast Induced Nephropathy by Sarpogrelate in Patients With Chronic Kidney Disease

Background:

Contrast-induced nephropathy (CIN) is a serious clinical problem associated with increased morbidity and mortality, particularly in patients with chronic renal insufficiency. Although some agents including hydration with saline are being prescribed to prevent renal deterioration in these high risk patients, their efficacy is not clear defined and debatable. Therefore additional prophylactic pretreatments are needed.

Methods/Design:

Present study aims to investigate differences in occurrence of CIN after sarpogrelate premedication in patients with chronic kidney disease (CKD). 268 participants, aged 20-85 years with a clinical diagnosis of CKD will be recruited. They will be randomly allocated to one of two conditions: (i) a routine treatment without sarpogrelate group (ii) routine treatment with sarpogrelate (a fixed-flexible dose of 300 mg/day). The primary outcome is the occurrence of CIN during 4 weeks after receiving contrast agent.

Discussion:

As of May 2010, there were no registered trials evaluating the therapeutic potentials of sarpogrelate in preventing for CIN. If sarpogrelate decreases the worsening of renal function and occurrence of CIN, it will provide a safe, easy and inexpensive treatment option.

All patients with CKD scheduled for CAG will be eligible, assuming their ability to understand the character and individual consequences of participation as well as giving written informed consent. CKD is defined as estimated glomerular filtration rate (eGFR) \<60 mL/min per 1.73 m2 using modification of diet in renal disease (MDRD) formula or serum creatinine (Cr) \> 1.5 mg/dL.

The MDRD formula was defined in the following way. Where the Cr concentration is in mg/dL:

eGFR = 186 × serum Cr-1.154 × Age-0.203 × (0.742 if female) Exclusion criteria are age less than 20 years or more than 85 years, liver cirrhosis greater than or equal to Child class B, decreased serum platelet level (\< 100,000/uL), patients who received or are schedule to receive percutaneous renal intervention, currently are taking anticoagulation drugs, unable to give informed consent. Patients in shock, maintaining hemodialysis, hemofiltration, peritoneal dialysis will be excluded.

Eligibility Criteria:
Inclusion Criteria:

* patient with chronic kidney disease scheduled for coronary angiogram

Exclusion Criteria:

* age less than 20 years or more than 85 years
* liver cirrhosis greater than or equal to Child class B
* decreased serum platelet level (\< 100,000/uL)
* patients who received or are schedule to receive percutaneous renal intervention
* currently are taking anticoagulation drugs
* unable to give informed consent
Post Market Clinical Follow-Up Study Protocol for CONSERVE® Press-Fit Femoral Components

MicroPort Orthopedics (MPO) is conducting this PMCF study to evaluate the safety and efficacy of its THA and resurfacing components marketed in the EU. These types of studies are required by regulatory authorities for all THA and resurfacing devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with MEDDEV 2.12/2 rev 2.

MicroPort Orthopedics Inc. (MPO) currently markets several total hip arthroplasty (THA) and resurfacing components throughout the world, including the European Union (EU). As part of the process for gaining approval to market in the EU, MPO is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of these components. The objectives of this study are to evaluate component survivorship, total functional outcome scores, and radiographic outcomes of implanted subjects at out to 10 years follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Has undergone primary hip resurfacing for any of the following:
* Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, or painful hip dysplasia;
* Inflammatory degenerative joint disease such as rheumatoid arthritis; or
* Correction of functional deformity
* Subject is implanted with the specified combination of components
* Subject is willing and able to complete required study visits or assessments

Exclusion Criteria:

* Subjects skeletally immature (less than 21 years of age) at time of primary resurfacing surgery
* Subjects currently enrolled in another clinical study which could affect the endpoints of this protocol
* Subjects unwilling to sign the Informed Consent document
* Subjects with substance abuse issues
* Subjects who are incarcerated or have pending incarceration
Clinical Efficiency of Natural Herbal Based Gel.

This clinical trial was conducted in School of Dentistry, Islamabad from 15th June 2023 to 16th January 2024. A total 202 participants took part in study and were divided equally into two groups i.e Control group and Experimental group where Control group was not given any treatment for oral ulcer whereas Experimental group was given herbal based Denpro oral gel 2-4 times a day for at least 4 weeks topically on ulcer area. Mouth ulcer size in patients was measured on first day " Visit=0", second day " Visit=1", third day " Visit=2", fourth day " Visit=3", seventh day " Visit=4" and fourteenth day " Visit=5" for reduction and complete recovery. Data was analyzed by One way ANOVA and POST HOC Tukey test.

This clinical trial was conducted in School of Dentistry, Shaheed Zulfiqar Ali Bhutto medical university for the period of six months from 15th June 2023 to 16th January 2024. Ethical approval was taken from the Ethical Review Board committee of the hospital with the Letter # SOD/ERB/2023/43-01. The participants volunteered in the study after the brief explanation about the aims and objectives study. These participants were enrolled in the study after receiving their informed written consents. Total 202 participants took part in the study and did show up during the entire follow up period of the study. 54 males and 148 females participated in this clinical trial after their confirmation of not having allergy to any type of medication. These patients were divided into two groups i.e Control group and Experimental group. Control group was not given anything but Experimental group was given Denpro oral gel (Gennec Health Sciences PVT, LTD, Karachi, Pakistan) for treating the ulcer 2-4 times a day for at least 2 weeks. They were instructed to apply the gel topically on the ulcer area with the help of finger or applicator after the meals or before sleeping. Moreover, they were forbidden to use any other medication for the treatment of the oral mouth ulcer to avoid the bias. Mouth ulcer size in both the control group and Experimental group was measured on the first day " Visit=0" which was taken as the baseline, again measured on second day " Visit=1" , third day " Visit=2" , fourth day " Visit=3" , seventh day " Visit=4" and finally, fourteenth day " Visit=5". These multiple visits were carried out for checking the reduction in its size and complete recovery of the oral mucosa without using anything in Control group and after the application of the gel in the Experimental group.

Eligibility Criteria:
Inclusion Criteria:

* Mouth ulcer size greater than 2mm that appeared within 48 hours.

Exclusion Criteria:

* Mouth ulcer size lesser than 2mm that did not appear within 48 hours.
Extrapleural Intercostal Catheter vs. Thoracic Epidural for Thoracotomy Pain

We will compare thoracic epidural anesthesia which is presently used for management of pain after thoracotomy to an intra-operatively placed extrapleural intercostal catheter. The study wil be double blinded and prospective.

The aim of this study is to evaluate the efficacy of thoracic epidural vs. continuous extra-pleural intercostal local anesthesia for the treatment of post thoracotomy pain in adult patients. Study patients will be randomized between the thoracic epidural and continuous extrapleural catheter groups\[Figure 1\]. Because thoracic epidural anesthesia is the gold standard but continuous extrapleural intercostal local anesthesia is potentially easier and less prone to complications, the study will be structured as an "equivalence study". The null hypothesis (Ho) is that continuous intercostal nerve blockade is worse than epidural for post-thoracotomy pain management. Therefore, the alternative hypothesis (Ha) is then that continuous intercostal nerve blockade is equal to or better than epidural for post-thoracotomy pain management.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral thoracotomy
* Video Assisted thoracotomy with high likely hood of converting to open thoracotmoy

Exclusion Criteria:

* Bilateral thoracotomy
* Planned bilateral thoracotomy
* Planned chest wall resection
* Planned combined thoracotomy and laparotomy procedure
* VATS procedure without conversion to unilateral thoracotomy
* Emergency operation
* Critically ill patients
* Patients who require an assistive device (i.e. cane, walker, or wheel chair) for mobility
* Patients who are unable to give informed consent
* Patients with preoperative chronic back or chest wall pain
* Empyema or other infective condition increasing the risk of epidural infection
* Coagulopathy
* Decision of the surgeon or anesthesiologist, or choice of the patient
* Infection at site of epidural placement
* Patients with other co morbidities which exclude thoracic epidural placement
* Patients under the age of 18 years
Spiral Strapping for Improving Upper Limb Functions

Upper limb recovery after stroke is unacceptably poor with almost half of stroke survivors likely to regain some functional use. The rehabilitation process for upper extremity for individuals with stroke is of long duration and clinicians face the challenge of identifying a variety of assistive appliances that may be adapted and graded to facilitate this process. One of these appliances that is widely used in rehabilitation is splint and strapping. Therefore, this study aims to investigate the effectiveness of this modality in rehabilitation of the upper limb in stroke survivors.

Stroke often results in spasticity and associated motor impairments in the upper limb Spasticity in the upper limb commonly interferes with its motor activities, and results in impairments in the upper limb muscles. Persistent upper limb impairments can lead to limitations in activities of daily living, and quality of life. Assistive devices to facilitate the use of the hemiplegic upper extremity are considered to be the most important modalities in improving the functions of the upper limb. The splint is one of the most assistive tools in the rehabilitation of such individuals. The supportive and corrective functions provided by upper limb and hand splints have been shown to inhibit spasticity and promote the capabilities of the upper limb in individuals with stroke This study aims to evaluate the effectiveness of spiral strapping on inhibition of spasticity and improving upper limb functions in individuals with chronic stroke.

Eligibility Criteria:
Inclusion Criteria:

The inclusion criteria were as follow:

* Participants were diagnosed as chronic stroke patients.
* Participants were selected to be in the spastic phase.
* The degree of spasticity in the affected upper limbs, was ranged between grades (1, 1+\&2) according to Modified Ashworth Scale.
* Participants were all between 50 and 60 years old, of both sexes.
* Participants were cognitively able to understand and follow instructions.
* Participants had the ability to extend their wrist joints at least 20° and ﬁngers 10° from full ﬂexion. This range allowed participants to engage easily in performing a designed functional program.

Exclusion Criteria:

The exclusion criteria were as follow:

* Participants who were with any orthopedic condition or fixed deformity that interfere with the upper limb functions.
* Participants who were with spasticity of more than score 2 according to the Modified Ashworth Scale.
* Participants who had cognitive or perceptual problems.
* Participants with seizures, visual impairments, or auditory problems.
* Participants who had shoulder pain on a visual analogue scale of \> 6/10.
* Participants who had Botulinum Toxin in the upper extremity musculature six months before baseline assessment.
Observational Study of MIRCERA in Users of Self-Application and Multidose Systems

This non-interventional, observational study investigates the efficiency, safety and acceptance of MIRCERA in participants, who received erythropoiesis stimulating agent (ESA) using a self-application system. For each participant, the investigator documents 9 months of treatment with Mircera with respect to efficacy, safety and acceptance.


Eligibility Criteria:
Inclusion Criteria:

* Anemia caused by CKD only
* Life expectancy of more than (\>) 9 months in the judgment of the attending physician
* Ferritin \>200 micrograms per liter (mcg/L) in accordance with the relevant guidelines
* The time point of changing to Mircera was only 3 months ago at the longest

Exclusion Criteria:

N/A
Effect of Iron/Zinc-Biofortified Pearl Millet on Growth and Immunity in Children Aged 12-18 Months in India

In this study, iron- and zinc-biofortified pearl millet will be fed to young children in Mumbai, Maharashtra, India over a period of nine months to measure growth and immune function in comparison to children receiving non-biofortified pearl millet.

Iron and zinc deficiency remain a major worldwide public health problem, especially in developing countries such as India. In this randomized study, 700 children aged 12-18 months from Mumbai, Maharashtra, India will be fed either iron and zinc biofortified pearl millet or control pearl millet three times per day, six days per week, for nine months. The goal of this study is to examine the effects of iron and zinc biofortified millet on immune function, growth, and cognitive function in this age group. The key outcome measures are biomarkers of iron and zinc status, growth, and immune function. Serum concentrations of hemoglobin, ferritin, serum transferrin receptor, and zinc will be assessed at enrollment (baseline), at an intermediate time point (midline; random serial sampling) and after 9 months of follow-up (endline). Additionally, we will measure concentrations of C-reactive protein (CRP) and alpha 1-acid glycoprotein (AGP), as iron and zinc biomarkers can be influenced by inflammation. To assess cognitive function in a subset, multiple specific aspects of memory, attention, and processing speed will be assessed. Higher-level, integrative cognitive abilities that require the coordination of multiple specific functions, such as problem-solving and exploratory behavior and global aspects of attention during free play with toys, will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Age 12 months, 0 days to 18 months, 30 days (at time of screening/baseline visit)
* Hemoglobin ≥9 g/dL

Exclusion Criteria:

* Age less than 12 months, 0 days or older than 18 months, 30 days (at time of screening/baseline visit)
* Hemoglobin \< 9 g/dL and/or hemoglobinopathy
* Presence of severe malnutrition according to Wellcome Classification (marasmus, marasmic kwashiorkor, kwashiorkor, weight-for-height z-score \< -3)
* Prior diagnoses of HIV/AIDS or Tuberculosis, or Current diagnosis of HIV/AIDS, malaria, Dengue fever, Tuberculosis requiring \>1 day hospitalization
* Children who do not have a caretaker to bring him/her to feeding center
* Possibility of migrating out of the slum dwelling for longer than 4 weeks
* Prior or current consumption of iron or zinc supplements in the past 1 year
* Any known dietary allergies
Impact of a One-month Long Detoxification Diazepam Treatment on Early Alcohol Relapse

Alcohol-dependence is a medical condition that can lead to the occurrence of an alcohol withdrawal syndrome (AWS) in case of alcohol drinking cessation. Diazepam is the reference medication for preventing or treating AWS. The recommended average diazepam treatment duration is usually around one week, and this duration is generally not considered to impact the subsequent relapse rate in alcohol drinking.

However, several previous studies have found that patients experienced frequent anxious symptoms during the weeks following detoxification. Such symptoms may foster early relapse in alcohol drinking. Furthermore, it has been suggested that this anxiety could pertain to late withdrawal symptoms.

The DIAMA study hypothesizes that extending the diazepam detoxification treatment to one month can significantly reduce the cumulated relapse rate in alcohol drinking over the three following months.

* inclusion at Day 5 of the outpatient alcohol detoxification procedure
* randomization in two arms: 1) "10 day - diazepam"; and 2) "30 day - diazepam"
* tapering of diazepam over the 10 days following the beginning of the detoxification procedure in the first arm; tapering of diazepam over the 30 days following the beginning of the detoxification procedure in the second arm.
* 3-month-long follow-up after detoxification. Objective of maintaining abstinence from alcohol. No use of additional anticraving drug. Standardised psychotherapeutic support based on the BRENDA model.
* Longitudinal recording of alcohol consumption using the Alcohol Timeline Follow-Back method.
* Assessment of craving (Obsessive-Compulsive Drinking Scale) and anxiety (State-Trait Anxiety Inventory; Hamilton Anxiety Rating Scale) at Days 5 (baseline), 15, 30, 60 and 90 (final assessment).

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV-Tr criteria for alcohol dependence
* Diazepam-based outpatient detoxification procedure started 5 days prior to inclusion

Exclusion Criteria:

* contraindication for outpatient detoxification
* occurrence of delirium tremens or seizures during the pre-inclusion period
* contraindication for using diazepam
* any other DSM-IV-TR criteria for substance abuse or dependence in the preceding year (except from tobacco)
* concurrent axis-I psychiatric disorder
* concurrent neurological pathology or cognitive impairment
* concurrent social risk, i.e., homelessness or social isolation
* liver failure, cancer, or significant breathing disorder
Clinical Performance Evaluation of AI-Enabled Automated Gram Staining Device

The investigators have developed an analysis AI for Gram staining. In this study, the investigators will compare the testing accuracy of automated Gram staining equipment with AI with the testing accuracy of laboratory technicians. Based on the results, the investigators will examine the possibility of clinical application of the automated Gram staining device.

Gram staining,whitch provides crucial information for selecting antibiotics in the diagnosis and treatment of infectious diseases, is often manually performed in many laboratories, and the microscopic findings are subjectively interpreted and reported based on the experience of laboratory technicians. Automating the entire process from staining to microscopic examination, as achieved by the AI-equipped automatic Gram staining device, can reduce the labor required for Gram staining. This automation enables even less experienced technicians to quickly report Gram staining results.

The aim of this study is to evaluate the accuracy of the Auto microscopic examination of Gram-stained samples using anonymized processed slides created from clinical specimens. This evaluation will be compared with the accuracy of microscopic examinations performed by hospital laboratory technicians.

If the accuracy of the machine is demonstrated, it can be registered as a medical device and proceed to the implementation stage in actual clinical settings. The implementation of this device in clinical laboratories is expected to reduce workload, expedite processes, and contribute to the optimization of antibiotic use based on Gram staining results.

Eligibility Criteria:
Inclusion Criteria:

1. Patients in whom a Gram stain test was ordered

Exclusion Criteria:

No exclusion criteria
Comparing the Assessment Accuracy Between Submental Ultrasound and Speech Therapists for Nasogastric Tube Removal

The goal of this randomized controlled trial is to compare the assessment accuracy between submental ultrasound and speech-language pathologists on nasogastric tube removal in post-acute dysphagia adult patients.

The main question it aims to answer is: whether the assessment accuracy of submental ultrasound is the same or better than the assessment speech therapist. Participants will undergo submental ultrasound and speech-language pathologists' assessments, and randomly distribute to submental ultrasound (SUS) and speech-language pathologist (SLP) group for evaluation.

SUS group will enter oral feeding diet and tube removal training protocol based on the submental ultrasound criteria for swallowing function (Maximum hyoid bone displacement≧ 1.38 cm); while the SLP group will enter the above training protocols based on the speech-language pathologist's assessment.

Researchers will compare the nasogastric tube removal rate, vital signs, basic laboratory data, hyoid bone displacement on submental images, chocking and aspiration rate, the success rate of training protocols, Functional Oral Intake Scale (FOIS), etc. to see if the swallowing function and nasogastric tube removal assessment of submental ultrasound is consistent with speech-language pathologists' assessments.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 and above
* Patients using a nasogastric tube
* Patients with a nasogastric tube placed due to acute conditions, such as increased oxygen demand, temporary loss of consciousness, or other illnesses causing weakness and a risk of aspiration. After treatment, there is no longer any indication for continued nasogastric tube placement.

Exclusion Criteria:

* Patients with impaired consciousness
* Patients with long-term nasogastric tube placement
* Patients requiring a high-concentration oxygen mask or mechanical ventilation with intubation
* Patients with significant drooling or frequent aspiration of saliva
* Patients who have undergone oral or head and neck surgery
* Patients who have received radiation therapy for the head and neck