cyrilzakka/clinical-trials huggingface dataset:
Botulinum Toxin for Chronic Neuropathic Pain

Treatment of peripheral neuropathic pain with Botulinum Toxin (BoNT) has showed promising results since the first study was released in 2001. Further research, however, is needed in order to strengthen the treatment, and a number of questions are unanswered. This includes which indication is the treatment the most effective, how should the treatment be administered, what is the duration of the effect? This study is a prospective interventional open label study, designed to assess the efficacy and safety of Botolinum toxin in the treatment of chronic neuropathic pain.

Background:

There are eight randomized controlled trials investigating the effectiveness of BoNT for peripheral neuropathic pain. The indications in the studies include diabetic neuropathy, post-herpetic neuropathy, and peripheral nerve injury. Overall, the studies indicate a treatment effect that is significantly better than placebo. However, the studies are relatively small, their outcome measures vary, making comparison difficult, and there is considerable variation in the degree of pain reduction. The duration of the effect of BoNT treatment varies greatly and has not been systematically studied. The current evidence provides a promising background in the treatment of BoNT og neuropathic pain, but further research and documentation are needed.

At the Interdisciplinary Pain Center, Zealand University Hospital, BoNT treatment is already used for patients with neuropathic pain, who do not respond to 1. and 2. line treatments. This study will evaluate the efficacy of the treatment.

Method:

The objective of this study is to prospectively follow a one-year cohort and subsequently conduct a follow-up of 7 months (three treatments) for patients initiating BoNT treatment. The follow-up includes monitoring the treatment's effectiveness, duration, and recording adverse reactions.

Eligibility Criteria:
Inclusion Criteria:

* Condition of neuropathic pain verified by paraclinical examination or supported by underlying diseases (e.g., diabetes or herpes zoster).
* The condition is characterized by allodynia, hyperalgesia, and/or neuralgiform symptoms such as burning and stabbing pain.
* The affected area can be identified through objective examination with detection of disturbances in touch using cotton swabs, pin-prick, and/or vibration

Exclusion Criteria:

* Mixed etiology of pain not solely attributable to neuropathy (e.g., fibromyalgia and neuropathy or nociceptive pain and neuropathy).
* Contraindication to BoNT treatment (allergy to the toxin).
* Pregnancy.
* Diseases where BoNT treatment is contraindicated, such as motor neuron diseases and muscular dystrophy.
* Severe psychiatric disorder.
Personalised Modeling and Simulation Procedures for the Differential Diagnosis of Dynapenia: a Study on Healthy Volunteers

The ForceLoss study aims to develop personalised modeling and simulation procedures to enable the differential diagnosis for the loss of muscle force, namely dynapenia. Dynapenia can be caused by diffuse or selective sarcopenia, lack of activation, or improper motor control. Each of these causes requires different interventions, but a reliable differential diagnosis is currently impossible. While instrumental methods can provide information on each of these possible causes, it is left to the experience of the single clinician to integrate such information into a complete diagnostic picture. But an accurate diagnosis for dynapenia is important in a number of pathologies, including neurological diseases, age-related frailty, diabetes, and orthopaedic conditions. The hypothesis is that the use of a mechanistic, subject-specific model of maximum isometric knee extension, informed by a number of instrumental information can provide a robust differential diagnosis of dynapenia.

In this preliminary study, on healthy volunteers, the investigators will develop and optimize (i) the experimental protocol and (ii) the modeling and simulation framework, assessing both feasibility and reliability of the proposed procedures. Medical imaging, electromyography (EMG) and dynamometry data will be collected and combined to inform a personalised musculoskeletal model of each participant. Biomechanical computer simulations of a Maximal Voluntary Isometric Contraction (MVIC) task will then be performed. To validate the proposed approach, the models' estimates will be compared to in vivo dynamometry measurements and experimental EMG data.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 15 and 30 kg / m²

Exclusion Criteria:

* Neurological, rheumatic or tumoral diseases;
* Pathologies or physical conditions incompatible with the use of magnetic resonance imaging and electrostimulation (i.e., active and passive implanted biomedical devices, epilepsy, severe venous insufficiency in the lower limbs, pregnancy);
* Previous interventions or traumas to the joints of the lower limb.
Pilot Study Person-centred Tablet Intervention

First evaluation of FindMyApps, a tablet intervention consisting of a selection tool for usable apps for self-management and meaningful activities and a training that supports informal carers to help people with dementia to learn how to use the tablet and the tool.

Testing the feasibility and mechanism of impact of FindMyApps, a tablet intervention consisting of a selection tool to help persons with dementia find usable apps for self-management and meaningful activities and a training that supports informal carers to employ errorless learning principles to help people with dementia to learn how to use the tablet and the tool.

An exploratory pilot randomized controlled trial was carried out with a mixed-methods design. Twenty persons with mild dementia and carer dyads were randomly assigned to the FindMyApps group (n = 10) that used the FindMyApps training and selection tool, or a control condition that just got a tablet (n = 10). After informal carers had received the training, the dyads in the experimental group started with the three-month intervention. Pre and post-test measurements consisted of questionnaires and post-test semi-structured interviews.

Eligibility Criteria:
Inclusion Criteria:

* Eligible dyads had to be community dwelling.
* Persons with dementia had Mild Cognitive Impairment or mild dementia with a score of 3 to 4 on the Global Deterioration Scale (GDS; 45), with or without a confirmed diagnosis.
* Availability of an informal carer or volunteer to provide support.

Exclusion Criteria:

* Participation in another intervention trial
* Severe visual and/or physical impairment.
Phase 2 Study of Nimotuzumab in Pediatric Recurrent Diffuse Intrinsic Pontine Glioma

This is a phase 2, single-arm, multi-center study, with a safety review component, designed to evaluate the efficacy and safety of nimotuzumab in approximately 44 patients with recurrent diffuse intrinsic pontine glioma (DIPG) following one previous regimen for their disease. Patients must be diagnosed with radiologically verified recurrent diffuse intrinsic pontine glioma that is measurable in at least two dimensions. Patients are eligible without histologic confirmation. Treatment regimen will consist of two phases-induction and consolidation.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Patients with recurrent, diffuse intrinsic pontine gliomas
* Patients should have had 2 of the following 3 neurological symptoms: cranial nerve deficit, long tract signs, ataxia and a onset prior to initial diagnosis \< 6 months.
* Evidence of disease progression
* Have a Lansky or Karnofsky Performance Status of \> 40
* Be between the age \>3 years to \< 18 years of age
* Have a tumor that is measurable radiologically
* For female patients of childbearing age: presence of a negative pregnancy test within 7 days prior to day 0.
* Use of effective contraception
* Adequate hematological, renal, and hepatic function

Exclusion Criteria:

* A history of prior use of EGFR-targeting agents (monoclonal antibodies, tyrosine kinase inhibitors)
* More than one line of treatment
* Patients with disseminated disease are not eligible
* Had radiation therapy completed within 12 weeks of enrollment
* Previous chemotherapy completed \< 2 weeks prior to enrollment
* If female, is pregnant or lactating
* Has other existing serious medical conditions
* Has any condition, therapy, or medical condition, which, in the opinion of the attending physician could represent a risk for the patient or adversely affect the study objectives
* Is currently taking or planning to take other investigational drugs during the study
* Known contraindications against antibodies
Genetic Variation in CLTCL1 and Whole-body Glucose Control

Maintaining stable blood glucose concentrations after eating has important implications for health. Individuals who are better able to maintain stable blood glucose concentrations after consuming carbohydrate have a lower risk of mortality from cardiovascular disease. Muscle is the primary tissue for glucose disposal following a meal, and responsiveness of this tissue to insulin is dictated by GLUT4 translocation to the muscle cell membrane. Clathrin heavy chain isoform 22 (CHC22) is a protein that plays a key role in intracellular GLUT4 action, and it may play an important role in whole-body glucose control. Genetic variation in the gene which codes for CHC22 may be able to explain differences in glucose control at the whole-body level.

The ability to maintain relatively stable blood glucose concentrations after eating has important implications for health. Individuals who are better able to maintain stable blood glucose concentrations after consuming carbohydrate have a lower risk of mortality and morbidity from cardiovascular disease. Muscle is the primary tissue for glucose disposal after a meal and the ability to tolerate a glucose load is largely dependent on the ability of muscle to respond to insulin by translocating the glucose transporter, GLUT4, to the muscle cell membrane, facilitating glucose import into muscle from the circulation. Therefore, by understanding the mechanisms that explain why some people are better able to maintain glucose control can give insight into how to target physiological pathways (such as muscle glucose uptake) to reduce disease risk and improve health.

Clathrins are cytoplasmic proteins that play essential roles in cell membrane trafficking pathways. Pilot data indicate that the clathrin heavy chain isoform 22 (CHC22) plays a key role in intracellular targeting of GLUT4 and may therefore play an important role in whole-body glucose control. Cell-based studies suggest that genetic variation in the CLTCL1 gene (which encodes for CHC22) at SNP rs1061325, influences GLUT4 retention. It is currently unknown whether genetic variation in CHC22 has consequences for whole-body glucose control in humans.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index between 18.5-29.9 kg/m\^2
* Aged 18-65 years
* Able and willing to provide informed consent and safely comply with study procedures

Exclusion Criteria:

* Any reported condition or behaviour deemed either to pose undue personal risk to the participant or introduce bias
* Any diagnosed metabolic disease (e.g. type 1 or type 2 diabetes)
* Any reported use of substances which may pose undue personal risk to the participants or introduce bias into the experiment
* Lifestyle not conforming to standard sleep-wake cycle (e.g. shift worker)
Effectiveness of Adding Interleukin-2 to Anti-HIV Drugs in Patients Recently Infected With HIV

The purpose of this study is to see whether taking interleukin-2 (IL-2) and other anti-HIV drugs affects the course of HIV disease in patients with primary HIV infection (the time period that immediately follows infection with HIV).

After primary HIV infection, the actual infection is spread through an increasing amount of HIV virus in the body. Studies have shown that, by taking a combination of anti-HIV drugs, it is possible to reduce the amount of HIV in the body to almost undetectable levels. This study will find out if starting anti-HIV drugs during primary infection will interrupt or reduce the spread of HIV in patients' bodies.

Following initial exposure to HIV, infection is established through the rapid replication of a homogeneous strain of the virus. Preliminary studies of combination antiretroviral therapy show that it is possible to reduce circulating HIV RNA to below detectable levels at this phase. Sustained suppression of viral replication or viral eradication may be possible only before HIV has become integrated in the immune system and undergone a number of quasi species mutations. This study will assess the feasibility of interrupting the natural course of HIV infection by using antiretroviral therapy soon after initial infection.

Nelfinavir (NFV) and zidovudine/lamivudine (Combivir) treatment starts as soon as possible and at most, 7 days from the diagnosis of HIV infection, and continues for 104 weeks. After 4 weeks of therapy patients are randomized to begin receiving IL-2 therapy or to delay starting it until Week 48. Patients may choose not to receive IL-2 treatment and remain in the study. Patients have clinic visits to measure viral load every 4 weeks. At a final clinic visit, physical examinations and collection of semen, cervical fluid, blood, and saliva specimens are done. Eligible consenting patients have a tonsil biopsy. Patients are reimbursed for participation in this study.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Have recent HIV infection.
* Are available for follow-up for at least 96 weeks.
* Are at least 18 years old.
* Use a barrier method of birth control.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have a condition such as Epstein-Barr virus, CMV mononucleosis syndrome, or acute streptococcal pharyngitis.
* Have taken anti-HIV therapy for over 4 weeks.
* Have or have had cancer requiring chemotherapy or radiation therapy within 1 month of study entry and have not yet recovered from the effects.
* Abuse alcohol and other drugs.
* Are pregnant.
* Have a condition which interferes with intestinal absorption, such as severe diarrhea.
tDCS and Bimanual Therapy for Children With Hemiplegic Cerebral Palsy

The goal of this study is to test the efficacy of transcranial direct current stimulation combined with bimanual training on hand function in children with unilateral spastic cerebral palsy (USCP). Children who enroll in the protocol will be randomized to receive either sham (not stimulating) tDCS plus bimanual training, or active (stimulating) tDCS plus bimanual training.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of congenital hemiplegic cerebral palsy
* Ability to lift and grasp light objects with affected hand
* Ability to extend wrist of affected hand 15 degrees
* Ability to follow instructions and provide informed assent
* Parent(s) able to provide informed consent

Exclusion Criteria:

* Seizures after age 2 years
* Spasticity medication within 6 months before study
* Selective dorsal rhizotomy
* Surgery in affected upper extremity within year before study
Conditioning Electrical Stimulation to Improve Outcomes in Cubital Tunnel Syndrome

Cubital tunnel syndrome is the second most common compression neuropathy. In severe cases, functional recovery, even with surgery, is often poor. Therefore, alternative adjunct treatments capable of increasing the speed of nerve regeneration are much needed.

The effect of brief conditioning electrical stimulation on nerve regeneration has been showed to be efficacy in animal studies. In this double-blind, randomized, controlled study, the investigators will compare the physiological and functional improvements post surgery compared with the controls who received surgery alone. Because electrical stimulation is reasonably well-tolerated and the treatment only takes an hour, it is a potentially feasible clinical tool for patients with severe nerve injury.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged \>18 yr,
2. If signs and symptoms of severe CuTS (ie, McGowan-Goldberg grade 3) were observed,
3. If needle EMG examination showed evidence of chronic motor axonal loss and reduced recruitment in the ulnar-innervated intrinsic hand muscles, and
4. If electrophysiologic evidence of severe motor axonal loss with motor unit number estimation (MUNE) greater than 2 standard deviations below the normative mean.

Exclusion Criteria:

1) Patients were excluded if they had concurrent nerve injury, prior surgery for CuTS or coexisting neurologic conditions
Keloid Radiation Registry

Radiation therapy has been, and is being used in treatment of patients with keloid. Radiation is typically used as an adjunct to surgery in order to reduce the recurrence rate of keloid.

Radiation therapy is not free of long term side effects. Radiation Therapy is known to cause secondary cancers. The investigators also do not have a good understanding as to how effective radiation therapy is in preventing recurrence of keloid.

Purposes of this study are to determine the long term safety as well as efficacy of radiation therapy when used for treatment of keloid.

The Keloid-Radiation project is a clinical registry of patients with keloid who have been treated with Radiation Therapy. This registry aims to monitor the at least 1,000 keloid patients who received radiation therapy to their keloid and to collect epidemiological and clinical data about these patients in order to assess the long term safety and effectiveness of radiation therapy.

Radiation is currently being used in the treatment of keloid, thus enabling the epidemiological characteristics of patients, analysis of treatment response, modeling the influence of risk factors on patients´ risk of developing long term complications such as a cancer, as well as the detailed analysis of the dose delivered, equipment used and radiation planning. This study intends to gather data about the long term efficacy and safety of radiation therapy and rate of developing secondary cancers in patients who have received radiation therapy for treatment of their keloid.

Eligibility Criteria:
Inclusion Criteria:

1. Clinically confirmed diagnosis of keloid
2. History of radiation therapy for treatment of keloid
3. All Ages
4. Signed informed consent form ( by parent or legal guardian if patient is under the age of 18)

Exclusion Criteria:

* None
The Effectiveness of a Chatbot-facilitated High Alert Medication Education for 2-year Post Graduate Nurses

This study involves three stages. In the first stage, qualitative research design is used to understand clinical nurses' learning needs on high alert medication. In the second stage, " high alert medication knowledge inventory " and " high alert medication safety inventory " will be developed based on the literature and results from qualitative study in the stage one. In the third stage, randomized control trail study design will be used. The nursing staffs in the experimental group receive " online simulation of high alert medication safety training ", the staffs from the control group receive classroom teaching regarding high alert medication". A total of 124 nurses will be invited to participate in this study, 62 subjects will be assigned in each group . After the intervention, we will examine the learning effectiveness.


Eligibility Criteria:
Inclusion Criteria:

1. Nursing staff who are licensed and have passed the Medication Safety Course for Newcomers to independently perform drug delivery techniques.
2. Nursing staff who are willing to participate in this research and complete the research consent form.

Exclusion Criteria:

1. Not fully involved in the study
2. Nursing staff not involved in dispensing medicine
Comparison of Prevention and Appropiate Obstetric Interventions for Prolonged Second Stage Labor at Term Pregnancies During Vaginal Delivery

Randomized Control Trial for Comparison of Prevention and Appropiate Obstetric Interventions for Prolonged Second Stage Labor at Term Pregnancies During Vaginal Delivery.

This study includes prolonged second stage phase and not prolonged second phase in pregnant women to singletons at the weeks between 37-42. Fetal head level will be at or below the ischial spines in all patients.Patients with fully dilated cervix will be included in the study and the bladder will be emptied completely on the labor table. Patients diagnosed with fetal distress will not be included in the study.Indicated patients will be randomly divided into three groups; one group will be only subjected to a Fundal Pressure (Kristaller Maneuver), second group will only be subjected to Vacuum Extraction and the third group will be subjected to both Fundal Pressure (Kristaller Maneuver) and Vacuum Extraction. Maternal episiotomy needs presence of second and third degree perineal tears, presence of postpartum hemorrhage and need for blood transfusion , cesarean rates and fetal first and fifth minute Apgar score , fetal blood gas parameters, presence of fetal trauma, need for neonatal intensive care will be evaluated among three randomized groups.

Eligibility Criteria:
Inclusion Criteria:

* term pregnancy weeks between 37-42, singleton, vertex presentations
* prolonged second stage of labor
* Fetal head is minimum at the level of ischial spin
* maternal incompatibility during/after second stage of labor
* complete cervical dilatation

Exclusion Criteria:

* Fetal distress
* Uncomplete cervical dilatation
* twin pregnancies or polycyesia
* Pregnancy weeks lower than 37weeks
* other than vertex presentations
* Fetal Anomalies
Effects of DHA on Post-operative Fibrosis of Trabulectomy Blebs in Glaucoma Surgery

Post-operative fibrosis of trabulectomy blebs is a major cause of surgical failure leading to a renewed increase in intraocular pressure. The use of anti-metabolites over many years has made it possible to improve success rates for this surgery but these drugs have numerous adverse effects as they are toxic. Alternative therapies are thus necessary, and we believe that DHA could have antifibrotic effects on fibroblasts and could thus improve success rates in this surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing trabulectomy or deep sclerectomy
* Patients informed about the study

Exclusion Criteria:

- Patients who refuse to take part in the study
Effect of Selenium Supplementation on Trace Mineral Antioxidant Enzyme and Amino Acid Metabolism in Infants

The objectives of the study were to assess the serum selenium, zinc, and copper status and plasma and white blood cell antioxidant enzyme activities of low birth weight infants receiving selenium supplemented and non-selenium supplemented parenteral nutrition from initiation of parenteral nutrition until discontinuation of preterm formula or hospital discharge.


Eligibility Criteria:
Inclusion Criteria:

* Weight less than 1500 g at birth
* Not capable of receiving enteral feedings prior to 7 days postnatally

Exclusion Criteria:

* Metabolic abnormalities such as inborn errors of metabolism
* Current viral infections
* Enterocolitis confirmed by diagnosis
* Presence of congenital anomalies, severe cardiac disease, liver disease, severe renal and neurological diseases, cholestasis, hemolytic disease and severe gastrointestinal disease
* Evidence of chronic white blood cell disease