cyrilzakka/clinical-trials huggingface dataset:
Prospective Randomized Trial Between Needle Fasciotomy and Xiapex for Dupuytrens Contracture

The purpose of this study is to investigate whether percutaneous needle fasciotomy is as effective for treating Dupuytrens contracture as Xiapex. Immidiate treatment effect is to be investigated, as iskontracture size after 5 years. Contracture size after one and three years, and subjective hand function is also to be investigated.

Prospective randomized study between Percutanous Needle Fasciotomy and Xiapex for Dupuytrens contracture.

A total of 50 patiens are to be randomized to eighter percutaneous needle fasciotomy or Xiapex treatment.

The patients randomized to xiapex treatment are treated as described in the product manual. Extentin treatment after one day.

The patients randomized to percutaneous needle fasciotomy are treated with the cutting teqnique: A littel quaddle local anestesia (xylocaine with adrenaline) is to be injected subcutant over the cord. After thet we use a 19G needle to cut the cord sufficient number sites to extend the finger.

The patients will be follwed up at 3 weeks, 3 months, 1 year, 3 years and 5 years. Investigators record contracture size, quicq-DASH, pain (VAS) and hand disability (VAS) pretreatment and at all controlls. At 3 weeks investigators register procedure complain. Side effects and complications, and advere effects are also to be investigated.

Our hypothesis is that it is no difference between the two methods in regard of contracture size after five years.

Inclution criteria: Symptomatic primary Dupuytrens contracture with palpable cord in one to three fingers, involving MCP, and total contracture size is over 30 degrees. Patient age over 18 years.

Exclution criteria:

Previously treated Dupuytrens contracture in the same hand more than tree affected fingers we will not include thumbs Other symptomatic injury or disease influencingf hand function ASA\>3 Expected lifetime less than five years tetracycline treatment within two weeks pregnancy nursing allergy to clostridium histolyticum concmittent other clinical trial

Eligibility Criteria:
Inclusion Criteria:

* symptomatic Dupuytrens contracture with palpable cord, involving MCP, total contracture size over 30 degrees

Exclusion Criteria:

* previous treated dupuytrens contracture same hand
* more than tree fingers involvement
* we will not include thumbs
* other things affecting hand function
* ASA\>3
* expected to live under five years
* Tetracycline treatment within two weeks
* pregnancy
* nursing
* allergy to clostridium histolyticum
* participant in other trial
Managing Aftercare for Stroke (MAS): MAS-I - a Cross Sectional Study of Post-rehabilitation Stroke Burden and Patients' Needs

In this first step of the study the investigators will assess the needs, disease burden and current treatments of long-term stroke patients (phase MAS-I).

The ultimate aim of the complete MAS project (MAS I, II \& III) is the development of a model of stroke aftercare delivery that can be evaluated to estimate effects in both our local and the wider stroke population.

After discharge from hospital the current healthcare system in Germany allows considerable flexibility (therefore complexity) of patient access and mobility between multiple care providers in the community setting. The investigators believe this aftercare could be better coordinated by a specialized coordinated stroke aftercare service. Comprehensive coordinated multidisciplinary care is a proven concept with proven benefits in both acute and rehabilitation care provided in stroke units and neurorehabilitation centres. In this study the investigators postulate that a similar coordinated approach to care can be extended to the phase after in-patient rehabilitation has ended (i.e. "long-term management" as opposed to "early supported discharge") for disabled patients with stroke living in the community.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Participation in one of the previously conducted stroke cohort studies: STRAWINSKI or PREDICT
* Modified Rankin Score (mRS) recorded as = 1 - 5 (at last follow up during cohort study)
* Informed consent signed by patient or legal representative

Exclusion Criteria:

* Unwilling to have pseudonymised data stored, analyzed \& anonymously published.
* Patients participating in the previous studies recruited in centres outside Berlin
System Accuracy and User Performance of Blood Glucose Monitoring Systems for Self-Testing in Managing Diabetes Mellitus

The aim of this test is to determine the system accuracy and user performance evaluation of three Blood Glucose Monitoring systems. For system accuracy evaluation the measurement data should cover the whole range of glucose concentration which could usually be expected in patients with diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with type 1 or type 2 diabetes and healthy subjects
* Signed and dated informed consent form
* For small modifications of the insulin doses to achieve certain blood glucose values (system accuracy evaluation): Male or female subjects with diabetes mellitus type 1 with intensified insulin therapy (intensified conventional therapy) or insulin pump therapy (continuous subcutaneous insulin infusion)

Exclusion Criteria:

* Pregnancy or lactation period
* Severe acute illness that in the opinion of the investigating physician might confound the results of the test or which could result in a risk to the patient caused by the test
* Mental incapacity or language barriers precluding adequate compliance with the test procedures
* Severe chronic illness besides diabetes mellitus as assessed by the investigating physician that might confound the results of the test or which could result in a risk to the patient caused by the test
* Legal incompetence or limited legal competence
* Dependency from the sponsor or the clinical investigator (e.g. coworkers of the sponsor or the clinical research center)
* For user performance evaluation: Subjects having used the test systems before themselves or having participated in a study with these Blood Glucose Monitoring Systems
* For system accuracy evaluation: subjects intended to provide blood samples with glucose concentrations between 50 and 80 mg/dl must not have coronary heart disease, myocardial infarction in history, cerebral events in history, peripheral artery occlusive disease- or impaired hypoglycaemia awareness
Automated Fetal Weight Estimation: A Multicenter Validation Using Fractional Limb Volume

This trial is a collaborative study between 4 sites worldwide. A total of 600 research subjects will be enrolled. We will investigate the validity of using 5D Limb Volume software to improve on estimated fetal weight predictions over a broad range of gestational ages. The purpose is to compare the accuracy and precision of birth weight predictions based on this new technology as compared to the current 2D birth weight prediction models.

Ultrasound has been used for over 20 years to estimate fetal weight prior to birth. Sometimes this estimation is not always similar to what the baby actually weighs. In addition to the regular measurements taken at routine ultrasound exams, 3D ultrasound of the baby's arm and leg soft tissue may give us more precise information on how much the baby weighs. This measurement is called fractional limb volume. Fractional limb volume (FLV) is a soft tissue measurement of the arm or thigh that can be used to evaluate body composition. This measurement mostly reflects the fat and muscle development with a small amount of bone.

The recent introduction of 5D Limb Volume software (Samsung, Seoul, Korea) now makes it possible to efficiently and reproducibly measure semi-automated FLV using a computer guided technique.

Subjects will receive one ultrasound scan 4-7 days before their delivery. Both 2D and 3D measurements will be taken. These measurements will then be used to estimate fetal weight. We will compare estimated weight to actual birth weight in order to determine the accuracy and precision of the 5D Limb Volume technology. This data may also be used to develop new weight estimation models that could provide better accuracy and/or precision than what is currently provided using published methods.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women (28-42 weeks) within 4-7 days of delivery
2. Planned delivery at the collaborating hospital where the fetal US scan was performed
3. Body mass index at first official prenatal appointment below 35.0 kg/M2
4. Firm US dating criteria (early crown-rump length \< 14 weeks gestational age)

Exclusion Criteria:

1. Presence of technical factors (e.g. obesity) that make it difficult to visualize fetal structures
2. Oligohydramnios determined by amniotic fluid index less than 5cm
3. Fetal distress or unstable maternal condition
4. Structural or chromosomal fetal anomalies
Pregnancy Outcome and Vitamin D Level Among Vitamin D Supplementation During Pregnancy

To compared pregnancy outcome (Serum vitamin D level in mother and infant , preeclampsia rate, preterm birth rate, Infant birth weight, Infant length , APGAR score) between pregnant women who were given vitamin D supplementation and pregnant women who were given placebo


Eligibility Criteria:
Inclusion Criteria:

* Thai female
* Singleton pregnancy
* Age at 18 years old or more
* Gestational age at 18-22 weeks
* Accept to enroll

Exclusion Criteria:

* Pregnant women who not planned to delivery at Rajavithi hospital
* Abnormal kidney function
* Use antiepileptic drugs , or vitamin D supplementation
* Allergy to vitamin D
* Who were diagnosed as vitamin D deficiency
A Study to Determine Number of Patients Who Develop High Ammonia Levels After Receiving Recombinant Erwinia Asparaginase

This study evaluates the incidence of symptomatic hyperammonemia (high ammonia levels) in patients being treated with recombinant Erwinia asparaginase.

PRIMARY OBJECTIVE:

I. To determine incidence of patients who develop hyperammonemia secondary to recombinant Erwinia asparaginase.

II. To characterize patients at risk for hyperammonemia secondary to recombinant Erwinia asparaginase.

OUTLINE: This is an observational study.

Patients undergo blood sample collection, complete surveys, and have their medical records reviewed on study.

Eligibility Criteria:
Inclusion Criteria:

* Followed by pediatric hematology/oncology
* Receiving recombinant Erwinia asparaginase for treatment of malignancy

Exclusion Criteria:

* Patients \< 1 year of age
* Patients who have previously received recombinant Erwinia asparaginase within the past two weeks
Social Functions to Promote Home-based Cognitive Training

This study will examine whether among older adults social interaction functions in a home-based cognitive training program can better support adherence to training and reduce social isolation.

The goal of this project is to conduct a pilot study to test the feasibility of two new features, a chat function and a leaderboard function, to encourage social interactions and support adherence to cognitive training protocols (mental exercises delivered via a tablet) over a period of time (2 months), and uncover individual difference factors that can predict poor adherence in the future and social interactions in the game. Even effective cognitive interventions may fail if individuals do not adhere to them for an extended period. This project will compare cognitive training games with chat function and leaderboard in reducing social isolation and improving adherence to the training, compared to an external control group using a generic reminder system delivered via smartphone text messages to promote adherence. The ultimate goal, as effective technology-based interventions to improve cognition become available, is to help support their benefit for older adults by maximizing long-term adherence.

Eligibility Criteria:
Inclusion Criteria:

* 65 years of age or older
* Normal or corrected to normal visual acuity
* Must pass a dementia screening.

Exclusion Criteria:

* Parkinson's, Alzheimer's disease, or any other neurodegenerative disease
* Terminal illness
* Severe motor impairment
* Not living in the Tallahassee area for the entire 6 month study period
Evaluating the Effect of an Evidence-Based One Page With Supplemental Visual Aids on the Knowledge and Perceptions of Blood Pressure Management Among Adults With Hypertension

The purpose of this study is to evaluate changes in patient knowledge of blood pressure management and perceptions of making lifestyle changes to manage their blood pressure after implementation of an evidence-based one-page teaching protocol with supplemental handouts and optional use of suggested apps and web sites.


Eligibility Criteria:
Inclusion Criteria:

* Adults from 18 to 75 years old
* Ability to self-consent
* English-speaking
* Able to read/write English
* Currently prescribed at least one medication for treatment of essential primary hypertension

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
Local Lidocaine Infiltration for Pain Management Post Cesarean Delivery.

The objective of this prospective, double-blinded, placebo-controlled, randomized study is to evaluate the impact of preemptive analgesia using incisional site infiltration of lidocaine as compared to saline solution on post operative pain control in women undergoing cesarean deliveries.

The studied population would be based on women who are scheduled for an elective cesarean delivery under general/spinal analgesia using a transverse lower abdominal incision.

Prior to each operation, the surgeon will be provided with a syringe containing a 20 mL solution of 1% lidocaine or 0.9% sodium chloride, which will be injected subcutaneously to the incisional site region after anesthesia and before the beginning of the surgery.

After the operation the conventional post cesarean analgesic regime will be used and recorded for all women.

The self-report of pain will be assessed by the patient using a validated visual analog scale, as instructed by the nursing staff.

The patient's mark will be used as a numerical index of pain intensity. The reports will be taken by the patients in intervals of 4 hours for 48 hours after the operation. In addition, analgesic requirements of the patient will be monitored and recorded by the nursing staff and used for comparison between the two study group

Eligibility Criteria:
Inclusion Criteria:

* Women who are scheduled for an elective cesarean delivery under general/spinal analgesia using a transverse lower abdominal incision.

Exclusion Criteria:

* More than two previous cesarean deliveries
* Other abdominal operations in the past
* Morbid obesity
* Diabetes mellitus, neurological diseases, systemic vascular disease.
* Mental disability
* Lidocaine sensitivity
Application of Trans Cranial Direct Current Stimulation for Executive Dysfunction After Traumatic Brain Injury

Traumatic brain injury (TBI) particularly affects the frontal lobes and patients often suffer from executive dysfunction and behavioral disturbances. These types of injuries often involve axonal damage to pre frontal brain areas, which mediate various cognitive and behavioral functions. Dorsolateral prefrontal circuit lesions cause executive dysfunction, orbitofrontal circuit lesions lead to personality changes characterized by disinhibition and anterior cingulate circuit lesions present with apathy. Patients who suffered traumatic frontal lobe damage often demonstrate a lasting, profound disturbance of emotional regulation and social cognition.

Weak transcranial direct current stimulation (tDCS) induces persisting excitability changes in the human motor cortex. this effect depends on the stimulation polarity and is specific to the site of stimulation. Interacting with cortical activity, by means of cortical stimulation, can positively affect the short-term cognitive performance and improve the rehabilitation potential of neurologic patients. In this respect, preliminary evidence suggests that cortical stimulation may play a role in treating aphasia, unilateral neglect, and other cognitive disorders.

Several possible mechanisms can account for the effects of tDCS and other methods on cognitive performance. They all reflect the potential of these methods to improve the subject's ability to relearn or to acquire new strategies for carrying out behavioral tasks. It was also found that Activation of prefrontal cortex by tDCS reduces appetite for risk during ambiguous decision making.

In this tDCS study the investigator uses one anode and one cathode electrode placed over the scalp to modulate a particular area of the central nervous system (CNS). The stimulation is administered via the neuroConn DC.Stimulator Serial number 0096. The DC-STIMULATOR is a micro-processor-controlled constant current source. The DC-STIMULATOR is a CE-certified medical device for conducting non-invasive transcranial direct current stimulation (tDCS) on people.Electrode positioning is determined according to the International EEG 10-20 System.


Eligibility Criteria:
Inclusion Criteria

* Ages 18-70 years.
* Traumatic Brain injured patients who were diagnosed with executive function difficulties.
* Patients who are able to cooperate and comprehend simple instructions.
* Patients who can provide informed consent after both oral and written information was given and discussed.

Exclusion Criteria:

* Pregnancy.
* Patients who sufferred a penetrating head trauma.
* Patients who underwent a frontal craniotomy
* Patients with a history of Psychiatric problems
* In cases of Severe Porencephaly at stimulation site
* Active Epilepsy or a history of seizure.
Study to Evaluate the Safety and PK of LODIENT Tablet 80/2.5mg in Healthy Adult Volunteers

A randomized, open label, single dose, 2-sequence, 4-period, cross-over phase I clinical trial to compare and evaluate the safety and pharmacokinetics after oral administration of "LodienT tablet 80/2.5mg(telmisartan/s-amlodipine)" and "TWINSTA tablet 80/5mg(telmisartan/amlodipine)" in healthy adult volunteers.

Amlodipine is a drug which belongs to calcium channel blockers (CCBs) and is used to treat hypertension. The molecule contains one chiral carbon atom and exists as a racemic mixture. As only the S-enantiomer of amlodipine \[S-amlodipine\] shows the CCB effect and R-amlodipine is responsible for the development of peripheral edema, purifying S-amlodipine can reduce the incidences of peripheral edema and other side effects.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy volunteers aged more than 19 years old
2. Subject does not have congenital or chronic disease and is without pathologic symptom or finding on medical exam.
3. Subject was determined eligible according to the results of clinical laboratory tests like serum test, hematologic test, blood chemistry test, urine test etc. and vital signs, electrocardiography, physical exam etc. performed during the screening exam.
4. 90mmHg≤SBP≤139mmHg and 60mmHg≤DBP≤89mmHg)
5. Body mass index (BMI) of 18-30kg/m2
6. Willing and able to provide written informed consent

Exclusion Criteria:

1. Administration of other drug than can modulate metabolic enzyme within 1 months prior to the scrrening day.
2. Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs
3. Continued excessive use of alcohol(alcohol\>21 cups/day) and severe heavy smoker (cigarette \> 20 cigarettes per day)
4. Administration of other investigational products within 6 months prior to the first dosing
5. Subject with the following conditions in laboratory test : AST(sGOT) or ALT(sGPT) \> Upper normal limit × 1.5
6. Subject with whole blood donation within 60 days, component blood donation within 14 days, blood donation within 30 days
7. Subject who take a medication that affect to the pharmacokinetics of drug within 10 days
8. Subject with decision of non-participation through investigator's review
An Assessment of the Prevalence of Spatial Neglect in Stroke Survivors With Aphasia

The purpose of this study is to determine if stroke survivors with aphasia have spatial neglect (Phase 1). If they are determined to have the condition Phase 2 will be offered: which is prism adaptation treatment. This is a pilot study that will be performed with 4-5 subjects.

Spatial neglect is a disorder that may occur after a brain injury such as stroke. Spatial neglect may affect stroke recovery. One example of this heterogeneous condition: Individuals with spatial neglect often pay more attention to one side of what they are looking at, even though they have no difficulty seeing. The study investigators would like to screen stroke survivors with aphasia because they may also have spatial neglect (right neglect after left hemisphere stroke), which is said by the literature to occur in 25% of cases. If it is identified, a treatment approach will be offered, to attempt to remediate the condition using prism goggles, following a prism treatment protocol based on previous studies.

Eligibility Criteria:
Inclusion Criteria:

* A stroke survivor with aphasia who is a member at the Adler Aphasia Center

Exclusion Criteria:

* Has a history of brain tumor, head injury with loss of consciousness, dementia, alzheimers