cyrilzakka/clinical-trials huggingface dataset:
Transcutaneous Spinal Cord Stimulation and Robotic Therapy

Lumbosacral spinal stimulation activates the neural network involved in the control of locomotion at the spinal level. However, its effects are limited to the production of robust rhythmic patterns of alternating movement, being currently in the absence of therapeutic value. On the other hand, the use of robotic technology for gait rehabilitation has experienced significant growth during the last years and its clinical efficacy is similar to others traditional interventions.

Spinal cord injury (SCI) often results in complete or partial paralysis below the level of lesion, having a profound physical, psychological and socioeconomic impact on the affected person's life. Between the different approaches for the rehabilitation of SCI, we can find robot therapy. Robot-assisted gait training has emerged as a promising therapy for improving walking ability, balance and motor function in neurological patients. The underlying principle of this therapy is based on the execution of repetitive and task-specific training able to generate appropriate afferent inputs, activating the central pattern generators in the lumbosacral spinal cord. Another novel therapy is the use of transcutaneous spinal cord stimulation (tSCS), applied through self-adhesive electrodes in the skin. tSCS activates similar mechanisms than epidural stimulation and is able to stimulate the spinal locomotor circuits in SCI patients. It allows the activation of rhythmic, flexo-extension movements in the paralyzed lower limbs.

The aim of this study is to analyze the feasibility, safety and efectiveness of a program of 20 sessions of 30 Hz-tSCS applied over T11-12 intervertebral space combined with Lokomat training in patients with incomplete SCI.

Eligibility Criteria:
Inclusion Criteria:

* AIS C or D.
* 2-6 months after injury.
* Neurological level of injury between C4-T11.
* Ashworth less or equal 2.
* Penn less or equal 2.
* To understand and to sign the informed consent.

Exclusion Criteria:

* Metal implants over T11-T12
* Electronic device implants.
* Epilepsy
* Allergy to the electrode material
* Pregnancy
* Concomitant pathologies
* Pathology or fracture of the lower limbs
* Musculoskeletal injury in the lower limbs
* Lower limbs dysmetria
The Effect of tDCS on Motor Learning and Neural Network in Stroke Patients

This study is to investigate the effect of transcranial direct current stimulation (tDCS) simulation on motor learning to stroke patients compared to sham stimulation


Eligibility Criteria:
Inclusion Criteria:

* Unilateral stroke including basal ganglia lesion patients
* Chronic patients over 6 months after onset
* Patients with the movement of fingers

Exclusion Criteria:

* History of psychiatric disease
* Significant other neurological diseases except for stroke
* Difficult to perform this experiment
* Patients who are deemed difficult to participate in this research by the investigator
* Patients with metal implants and medical devices
* History of epilepsy
* Pregnancy
* Skin defect at the site of electrode attachment
Safety and Efficacy of the WaisFix100i for Intracapsular Femoral Fracture Fixation

The purpose of this study is to determine the safety and efficacy of using WaisFix100i device for Intracapsular Femoral Fracture Fixation.

Fractures of the neck of the femur represent an estimated cost to society that exceeds ten billion dollars annually in the USA only.

Fractures have been treated with immobilization, traction, amputation, and internal fixation throughout history. Immobilization by casting, bracing, or splinting a joint above and below the fracture was used for most long bone fractures.

Several studies have suggested that reduction and fixation of an Intracapsular fracture of the hip with multiple pins or screws is associated with a lower rate of morbidity and mortality than treatment with prosthetic replacement. With improved methods of fixation and a tendency toward earlier weight-bearing, internal fixation is believed to be a better mode of treatment for younger, more active patients.

On the other hand, the internal fixation procedure may result with number of possibilities for serious complications and biomechanical disadvantages, leading to the device failure. This led to a growing tendency to prefer total or partial hip replacement as the common treatment for intracapsular fracture, although the internal fixation is the favorable procedure in the professional literature.

OrthoMediTec has developed the WaisFix100i device, a new concept for Intracapsular Femoral Fracture Fixation and bone grafting using minimally invasive procedures. The WaisFix100i combines a new and unique Internal Triangular Cage nail fixator and three lag screws.

The Internal Triangular Cage is inserted into the femoral neck as a strong, solid beam structure to guide and hold the screws in place. The cage supplies the structure to hold the bone graft and screws at the fracture site.

The objectives of this single arm, multi-center, prospective study, are to evaluate the safety and efficacy of using the WaisFix100i device in intracapsular femoral fracture fixation surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Male/Female with Intracapsular femoral fracture type Garden I-II and several III.
2. Age 50 to 75.
3. Subject able to comprehend and give informed consent for participation in this study.

Exclusion Criteria:

1. Known active infectious disease.
2. Terminal diseases
3. Patients in high risk and/or acute cardio-vascular disease.
4. Known cognitive disorder, psychiatric and/or neurological disease
5. Physician objection.
6. Age under 50 or above 75.
7. Concurrent participation in any other clinical study
8. Patients cannot understand or not willing to sign the informed consent.
Cat-PAD Follow on Study

Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with allergic rhinoconjunctivitis and/or asthma.

The purpose of this optional observational follow-on study is to further evaluate rhinoconjunctivitis symptoms on exposure to cat dander in the EEC among subjects who completed all dosing visits in study CP005 approximately one year after the start of treatment.

Subjects who completed all dosing visits and the post treatment challenge (PTC) in study CP005 will be invited to attend the Screening Visit for CP005A. Subjects will attend for 4 visits to the EEC on successive days. Following the last EEC visit a follow-up visit will be performed 3-10 days later.

Eligibility Criteria:
Inclusion Criteria

* Previously randomised in study CP005, completed all treatment visits and the Post Treatment Challenge (PTC).

Exclusion Criteria

* "Partly controlled" and "uncontrolled" asthma
* History of anaphylaxis to cat allergen
* FEV1 of less than 70% of predicted
* Subjects who cannot tolerate baseline challenge in the EEC
* Treatment with beta-blockers,Alpha-adrenoceptor blockers, Tranquillizers or psychoactive drugs
* A history of any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment)
A Pilot Study of Diffusion MRI in the Assessment of Pancreatic Tumor Response

Patients with pancreatic cancer are treated with combinations of surgery, radiation therapy and chemotherapy, depending on the location of the cancer and other individual patient health factors. The goals of therapy are to reduce or eliminate the cancer cells, but without serious damage to normal cells. Investigators at The University of Michigan are conducting a research project, to see if treatment effects on an individual patient's cancer cells can be detected early by new imaging tests in patients with resectable pancreatic cancer undergoing neoadjuvant chemoradiotherapy.

Patients with pancreatic cancer are treated with combinations of surgery, radiation therapy and chemotherapy, depending on the location of the cancer and other individual patient health factors. The goals of therapy are to reduce or eliminate the cancer cells, but without serious damage to normal cells.Each patient is unique in terms of the cancer type and location and its sensitivity to treatments. Investigators at The University of Michigan are conducting a research project to see if treatment effects on an individual patient's cancer cells can be detected early by new imaging tests in patients with resectable pancreatic cancer undergoing neoadjuvant chemoradiotherapy. Each patient is unique in terms of the cancer type and location and its sensitivity to treatments.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologic or cytologic proof of pancreatic cancer, for whom the treatment plan, at the time of enrollment, is neoadjuvant chemoradiotherapy followed by surgical resection.
* Patients must be \>18 years old.
* Patients cannot weight over 300 pounds, the weight limit of the MRI table.
* Patients must have adequate renal function (estimated glomerular filtration rate \> 60 mL/min/m2), to minimize the small risk of nephrogenic systemic sclerosis associated with gadolinium injection.
* Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of UM hospital.

Exclusion Criteria:

* Patients must have no previous radiation to the abdomen.
* Patients who are pregnant or lactating are excluded.
Online Self-Help Intervention for Insomnia: With or Without Feedback

The object of this study is to determine whether feedback added to a self-help protocol for insomnia enhances the treatment effect. In this study all participants receive an online self-help cognitive behavioral therapy (CBT) intervention consisting of information (psycho-education) about sleep and cognitive-behavioural exercises. Adult persons with insomnia will be invited via a popular scientific website to fill out online questionnaires. Half of the participants will received by e-mail from a therapist, the other half of the participants will do the intervention without feedback. Participants will be measured 4, 16, and 40 weeks after intervention with the same questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Insomnia
* Access to internet
* Dutch citizen

Exclusion Criteria:

* Alcohol or substance abuse
* Being suicidal
* Sleep apnea
* Schizophrenic or having a psychosis disorder
Diagnostic Imaging Aid for Management of Cervical Lesions

A handheld digital colposcope which utilizes flurorescent light is being tested for the rapid detection and management of cervical lesions. The handheld research device captures cervical images which with the fluorescent light show the regions of cervical tissue that autofluoresce. The investigators will study the relationship between the level of fluorescence and the samples of tissue (biopsies) obtained from the patient as part of her routine care. The investigators will also compare the efficacy of the hand held device with the data being collected from the other research devices being tested by the team, i.e. the multispectral digital colposcopes.


Eligibility Criteria:
Inclusion Criteria:

* Women who are at least 18 years old
* Women who are not pregnant as confirmed by a urine test
* Women who are not breastfeeding
* Women who understand the study procedures and can provide written informed consent

Exclusion Criteria:

* Women who do not meet the inclusion criteria
* Women who have had a hysterectomy
Safety of Formalin-free Fixatives for In-Vivo Fixation of Skin Lesions.

Existing methods of diagnosing and treating skin lesions are either surgical, which enables an histological diagnosis or destructive (electrodesiccation, liquid nitrogen, laser, caustics) with no possibility of obtaining histology. The ingredients of current formulations for in-vivo skin fixation (Mohs, Solcoderm) are unstable, inconvenient for application and painful - therefore their use was abandoned. The investigators will examine the safety of stable formalin-free formulations for in-vivo fixation of human skin lesions .These formulations were safe and had a rapid onset of fixation effect in in-vivo animal studies.

The formulations are comprised of standard non-toxic laboratory chemicals that are used in various dermatological preparations.

Transition metal salts - Zinc chloride, zinc bromide, zinc iodide,zinc nitrate, zinc sulphate. copper chloride ,copper bromide, copper iodide, copper nitrate, copper sulphate.

Keratolytics - salicylic acid , lactic acid, nitric acid, pyruvic acid,oxalic acid, trichloro acetic acid, phenol, resorcinol,urea .

The solvents and penetration enhancers of the ingredients - Water, ethanol, dimethyl sulfoxide, propylene glycol, glycerol.

Patients with skin lesions that after clinical diagnosis are usually treated by dermatologists with destructive modalities without an histological evaluation will be included in the study. The clinical diagnoses include viral warts, seborrheic warts, skin tags, solar keratoses, fibromata and hemangiomata.

The treated lesions will be located on the trunk and limbs. Lesions on the face will not be included in the study.

The formulations will be infiltrated intra-dermally into the lesions in a maximal volume not exceeding 0.05 ml.

After the achievement of the desired local fixation effect, the lesions will be examined by a pathologist.

The patients will be closely followed-up during the procedure and the degree of possible associated pain will be evaluated. Possible local infection and the degree of scarring will be evaluated until complete healing of the treated area will occur.

The histological result will be informed to the patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with skin lesions that are not treated with histology

Exclusion Criteria:

* Seriously ill patients
Evaluation of the Discriminative Abilities of Biomarkers for the Diagnosis of Acute Mesenteric Ischemia Compared with Another Similar Clinical Presentation: a Pilot Study

Acute mesenteric ischemia (AMI) is associated with high mortality (50-80%). The prognosis depends on the time it takes to diagnose the condition, and the possibility of revascularization in eligible patients. Delayed diagnosis is due in particular to the aspecific clinical presentation and the absence of biomarkers to guide early diagnosis, lactates often being elevated at an already irreversible stage. Adenosine deaminase is produced in the presence of ischemia (known from myocardial ischemia), and is present on the surface of intestinal villi. The investigator's hypothesis is that, in the event of digestive ischemia resulting in abnormalities of mesenteric permeability, adenosine deaminase will enter the bloodstream and increase its soluble plasma activity, along with an increase in lymphocyte-bound adenosine deaminase.

The main objective is to evaluate the discriminatory capacities of soluble adenosine deaminase, collected via blood sampling, for the diagnosis of IMA in comparison with the reference method (injected abdominopelvic CT scan), performed for abdominal pain suggestive of IMA.

The study will be based on a prospective monocentric cohort. Currently, there is no specific biological marker for IMA, and the gold standard for diagnosis is the injected abdominopelvic CT scan, performed for hyperintense abdominal pain.

Two groups will be identified on the basis of the gold-standard abdominopelvic scan:

* the "IMA patients" group: patients with hyperintense abdominal pain, and IMA confirmed by CT scan
* the "non-IMA patients" group: patients with hyperintense abdominal pain, but with a diagnosis other than IMA on the CT scan.

  130 subjects will be included in this study Inclusion period: 18 months Follow-up period: 1 month Analysis period: 5 months Total duration: 24 months


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 years of age or older
* with an indication (hyperintense abdominal pain with no obvious diagnosis other than acute mesenteric ischemia) for an injected abdominopelvic scan for hyperintense abdominal pain suspected of acute mesenteric ischemia
* Including pregnant or breast-feeding women, as this is a risk factor for AMI in young subjects
* Affiliated with the French social security system
* Able to express non-opposition in writing

Exclusion Criteria:

* Presenting acute myocardial ischemia, to avoid biasing the levels of the biomarkers studied (increased in this clinical situation)
* Patient in a period of exclusion from another research protocol at the time the non-opposition is signed,
* Person protected by articles L1121-6 and L1121-8 of the French Public Health Code (deprived of liberty by court order, socially vulnerable, adult incapable or unable to express non-opposition).
* Persons who are unable to read and understand the French language sufficiently to give their consent to participate in research.
The Effect of Genetic Polymorphism on Interactions of Clopidogrel and Cilostazol in Healthy Volunteers

The aim of this study is to investigate the effects of genetic polymorphisms on pharmacokinetic and pharmacodynamic interactions of clopidogrel and cilostazol in Korean healthy adult volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subject whose CYP2C19 genotype was determined

Exclusion Criteria:

* Subject who has abnormal laboratory test results
Lifestyle-Related Health Outcomes in Prediabetes and Diabetes

This study looks as how a health education intervention strategy effects health outcomes in overweight and obese adolescents.

This study aims to do the following:

1. To evaluate whether a health education and coaching strategy in overweight and obese adolescents (≥85th percentile) with high risk for type 2 diabetes is superior to usual care (single nutrition consultation) for weight management, clinical health outcomes (measures of glucose tolerance), lifestyle behavior outcomes (diet and physical activity) and outcomes of importance to patients such as satisfaction with the health care team, treatment goals, and psychosocial functioning.
2. To evaluate whether a health education and coaching strategy in obese adolescents with diabetes (type 1 or type 2) is superior to usual care (single nutrition consultation) for weight management, clinical health outcomes (measures of diabetes control), lifestyle behavior outcomes (diet and physical activity) and outcomes of importance to patients such as satisfaction with the health care team, treatment goals, and psychosocial functioning.
3. At baseline, before the interventions described in Aims 1 and 2, to identify key diet and physical activity factors, patient characteristics, or biomarkers which are predictive of diabetes risk.
4. At baseline, before the interventions described in Aims 1 and 2, can associations between glycemia, cardiometabolic risk factors, and diet and physical activity behaviors in overweight and obese adolescents who are at risk for type 2 diabetes be identified using the Bright Futures questionnaire, a survey for lifestyle behavior which is normally used in the clinic setting.

Eligibility Criteria:
Inclusion Criteria:

1. male and female adolescents/young adults,
2. age 10-21,
3. Tanner stage II-V,
4. overweight or obese (body mass index ≥85th percentile for age and sex).

Exclusion Criteria:

1. pregnancy,
2. use of medications that adversely affect glucose metabolism (such as glucocorticoid-containing medications or atypical antipsychotics), and
3. syndromic obesity (such as Prader Willi, hypothalamic obesity, or Laurence- Moon-Biedl).
Otolith Function in Patients With Primary Ciliary Dyskinesia

The purpose of this study is to determine whether patients with primary ciliary dyskinesia (PCD) have reduced or absent otolith function.The otolith system is a specific part of the inner ear vestibular (balance) system that detects linear movement.

Primary ciliary dyskinesia (PCD) is a genetically inherited condition. It is due to structural abnormalities of cilia, which are microscopic hairs found in organs and cells throughout the body. Patients with this condition typically develop upper respiratory tract symptoms such as sinusitis and glue ear, lower respiratory tract problems such as recurrent chest infections, and fertility problems. There is currently no evidence that patients with PCD have a higher incidence of balance problems. However, recent animal studies have shown that cilia may also be important in the development of part of the inner ear balance (vestibular) system, specifically the part that detects linear movement known as the otolith system.

The investigators hope to determine whether patients with PCD have absent or reduced otolith function compared to the normal population. Balance problems are not currently screened for in PCD patients, and could be unrecognized and therefore untreated. It is also possible that PCD patients have compensated for absent otolith function and so are unaffected under normal circumstances; any additional insult to their balance system would cause more pronounced difficulties than expected and treatment might need to reflect this.

Eligibility Criteria:
Inclusion Criteria:

* aged 16-30 years
* Confirmed diagnosis of PCD under the care of the PCD team at the Royal Brompton Hospital

Exclusion Criteria:

* Aged under 16 years
* Unconfirmed or "suspected" PCD
* Previous history of balance disorders or diagnoses
* Previous history of sensorineural hearing loss
* Previous middle or inner ear surgery (other than grommet insertion)