cyrilzakka/clinical-trials huggingface dataset:
VNS-induced Corticospinal Plasticity

The goal of this study is to learn more about the connections between the brain, spinal cord, and muscles and how these connections can be strengthened after neurological injury.

Non-invasive stimulation techniques can be used to appropriately time converging inputs to induce changes in cortical output circuits of human primary motor cortex, a neuromodulatory protocol known as paired-associative stimulation (PAS). Experiments seek to examine interactions between cortical PAS and non-invasive vagus nerve stimulation (VNS) to understand the extent to which VNS amplifies cortical plasticity in humans.

Eligibility Criteria:
Inclusion Criteria:

INDIVIDUALS WHO HAVE HAD A STROKE:

1. Diagnosis of first ever stroke
2. At least 6 months after stroke onset
3. Motor-evoked potentials in hand/arm muscles
4. Subjects must show an understanding of the study goals and have the ability to follow simple directions as judged by the investigators.

   ALL INDIVIDUALS:
5. Between the ages of 18 and 75 years old

Exclusion Criteria:

INDIVIDUALS WHO HAVE HAD A STROKE:

1. Hemispatial neglect, aphasia, or cognitive impairment that would impact testing and would interfere with the ability to follow simple instructions, as judged by the investigators

   ALL INDIVIDUALS:
2. Neurological disorder(s) influencing movement (besides stroke)
3. History of seizure or epilepsy
4. Metallic brain implants
5. Bodily implants such as cardioverter defibrillators, insulin pumps, ventriculoperitoneal shunts, cochlear implants, or pacemakers
6. Pregnant or expecting to become pregnant
7. Difficulty maintaining alertness and/or remaining still
8. Silicone or plastic allergy
9. History of vestibular disorders (eg, Vertigo, Meniere's Disease, etc.)
Effect of Intensive Motor Rehabilitation in Subacute Stroke Patient

Early stroke rehabilitation is known to be an effective and essential therapy in gaining functional independence and preventing complications. However, there was no consensus of proper amount of motor rehabilitation in stroke patients. In this study, the investigators investigated the effects of the intensive motor rehabilitation during subacute phase to improve motor function at 6 months after onset in patients with first-ever strokes.

Intensive cognitive rehabilitation group

- physical and occupational therapy for 3 hours on every working day for 2 weeks

Eligibility Criteria:
Inclusion Criteria:

* Acute first-ever stroke
* Upper limb score of Fugl-Meyer assessment at 7 days after onset : 25\~84

Exclusion Criteria:

* Transient ischemic stroke
* Joint contracture of affected upper extremity
Effects of Chromium Picolinate on Food Intake

The purpose of this study is to test the effects of chromium picolinate on food intake, food cravings, eating attitudes, and appetite. If chromium picolinate is found to have a beneficial impact on satiety and food intake, then this supplement may be an alternative or adjunctive treatment for overweight people desiring to modify their food intake. The primary hypothesis of this study is that among individuals who report being carbohydrate cravers, chromium picolinate supplementation will reduce food intake during a test lunch meal and produce greater satiety in comparison to a placebo.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria are:

1. Healthy female who has not been diagnosed with diabetes, cardiovascular illness, or other chronic diseases,
2. Food craver, determined by self-reported craving for carbohydrates on two out of three validated measures of food cravings,
3. \> 18 years of age and \< 50 years of age, and
4. Body mass index between 25 and 39.9 kg/m2. Participants will be scheduled for testing during the luteal phase of their menstrual cycle to limit the confounding effect of the menstrual cycle on energy intake. We will include women who are taking monophasic oral contraceptives but will exclude other oral contraceptive regimens. Participants with very irregular menstrual cycles will also be excluded because this irregularity will make it very difficult to schedule testing during the luteal phase of the menstrual cycle.

Exclusion Criteria:

Potential participants will be excluded for the following reasons:

1. Participants who report smoking cigarettes will be excluded because of the effects of nicotine upon taste and appetite,
2. Participants who have a diagnosable eating disorder (i.e., anorexia or bulimia nervosa) will also be excluded since intentional restriction of eating and binge eating/overeating could increase the variability of the data,
3. Participants who report using diet pills will be excluded since diet pills may potentially influence appetite, hunger, and/or satiety,
4. Participants will be excluded if they are taking anti-depressant medications, anti-psychotic medications, or any medications that may potentially influence appetite, hunger, and/or satiety,
5. Participants who are not determined to be carbohydrate cravers will be excluded,
6. Participants will also be excluded if they report any allergies to the foods that will be used in the study.
Antimicrobial Peptides in Periodontitis

Periodontal diseases are complex chronic pathologies presenting a high prevalence worldwide. Etiopathological process involved in initiation and progression of these multifactorial diseases are not well understood, explaining the huge clinical forms variability and the complexity of the currently used classification of periodontal diseases. Recently, the implication of antimicrobial peptides (AMPs) have been suggested as potential track of explanation for periodontal diseases pathogeny. The here presented study explore the level of expression of genes coding those peptides by studying periodontal smears obtained from healthy and periodontitis patients.

This study explore the level of expression of genes coding those peptides by studying Messenger RNA (mRNA) purified from periodontal smears obtained from healthy and periodontitis patients by "Masterpure©" protocol.After reverse transcription (RT-PCR), in-silico design of primers and specificity and efficiency calculation, Complementary DNA (cDNA) are quantified by a semi-quantitative method (delta-delta CT) vs a Housekeeping gene. Wilcoxon-Mann \& Whitney tests and Chi² tests are performed to check the significativity of the results between groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering of moderate to severe chronic periodontitis as described by the classification Armitage-1999, aged 35-65yo

Exclusion Criteria:

* Pregnant females, patients suffered from any other systemic diseases (cardiovascular, pulmonary, liver, cerebral, diseases or diabetes, cancer)
* patients that had received antibiotic treatment in the previous 3 months or who were taking long-term anti-inflammatory drugs; who had received a course of periodontal treatment or orthodontics treatment within the last 6 months; who were heavy smokers (\>5 cig/day)
The Effect of Rebamipide for Non-steroidal Anti-inflammatory Drugs (NSAID) - Induced Small-intestinal Injuries

The purpose of this study is to evaluate the efficacy of rebamipide for NSAID-induced small-intestinal injuries.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* 20 to 85 years of age
* RA, OA, or low back pain
* No change of drugs before 3 months
* Under 5 mg of corticosteroid use
* CRP \< 1mg/dl
* Small-intestinal mucosal injuries more than one
* Hemoglobin level is below normal range

Exclusion Criteria:

* Known or suspected small-bowel disease, including Crohn's disease and seronegative arthritis
* Prostaglandins, metronidazole or salazosulfapyridine
* Can not swallow
* Eith pacemaker
* After gastrointestinal operation
* Serious concomitant cardiovascular, endocrine, gastrointestinal(including symptoms of ileus), neurologic, psychiatric, renal, or respiratory disease.
* Taking rebamipide before one week
* Any other conditions that the investigator feels would interfere with data interpretation or create under risk.
Automated Oxygen Titration with O2matic Home Oxygen Therapy (O2matic HOT) Phase 1

O2matic HOT is a further development of O2matic and is intended for home oxygen use with patients in need of long-term oxygen treatment (LTOT). O2matic HOT is a closed-loop system which on basis of signals from pulse oximetry titrates the oxygen flow to the patient. In this crossover trial patients are admitted for 24 hours twice. Once with usual fixed dose oxygen and once with oxygen titration by O2matic HOT.

The purpose of this study is to examine if automated oxygen control based on pulse oximetry to patients with domiciliary long-term oxygen treatment (LTOT) is better than manually controlled oxygen treatment in keeping SpO2 within intended target interval. In manually controlled oxygen treatment flow is usually kept constant for months between visits from specialist nurse, whereas in automated control the patient can titrate oxygen flow several times a day based on pulse oximetry in a closed-loop system.

Eligibility Criteria:
Inclusion Criteria:

* Verified COPD with FEV1/FVC \< 0.70
* Need of LTOT (PaO2 \<= 7.3 kPa or SpO2 \< 88 % on ambient air)
* Cognitively able to participate
* Willing to provide informed consent

Exclusion Criteria:

* Moderate or severe exacerbation in COPD within 4 weeks from study start
* Major comorbidities (cancer, uncontrolled chronic disease)
* Asthma or other disease with need of higher SpO2
* Pregnancy
* Fall in pH below 7.35 or increase in PaCO2 \> 1 kPa on 5 liters of oxygen
* Active smoking
* LTOT use less than 1 hours/day
Transcranial Magnetic Stimulation for Evaluation and Treatment of Repetetive Behaviors in Autism

This study is a trial of low frequency Repetitive Transcranial magnetic stimulation( rTMS) for subjects with autism spectrum disorders, specially targeting repetitive behaviors.

This project is a 3-week double blind cross-over trial for adolescents and adults who meet criteria for autism and have clinically prominent repetitive behaviors. The investigator will apply low frequency rTMS for 20 minutes 5 times a week for 3 weeks targeting the area of brain which was involved in repetitive behaviors. The investigator will obtain clinical measures of repetitive behaviors as well as social functioning pre and post treatment. As a control and a cross-over condition , we will stimulate other area of brain which has nothing to do with repetitive behaviors but may improve social functioning in autism spectrum disorders. In addition to r TMS we will perform a pre and post treatment perfusion functional MRI and obtain TMS measure of excitability of brain.

Eligibility Criteria:
Inclusion Criteria:

1. English Speaking
2. Capacity to give consent and sign HIPAA Authorization
3. Patients currently taking psychotropic medications must be at the same stable dose and likely to be able to continue at the same dose throughout the study
4. ASD diagnosis according to the DSM-IV TR Symptom and Criterion checklist for ASD
5. Significant level of repetitive behaviors to distinguish from movement disorders to be in at least 3 out of 6 sub-scales (stereotyped behavior, self-injurious behavior, compulsive behavior, ritualistic behavior, sameness behavior, restricted behavior) -

Exclusion Criteria:

1. Women of child-bearing potential not using birth control, pregnant or breast feeding
2. H/o Bipolar Disorder (lifetime), any Psychotic Disorder (lifetime) history of Major Depressive Disorder or of substance abuse or dependence within the past year
3. Significant sub-average intellectual function (IQ\<70)
4. Intracranial implants
5. Increased risk of seizure for any reason, including prior diagnosis of epilepsy, seizure disorder, febrile seizure, increased intracranial pressure or history of significant head trauma with loss of consciousness for \> 5 minutes.
6. Current significant laboratory abnormality
7. Neurological disorder including but not limited to space occupying brain lesion, any history of seizures, history of cerebrovascular accident, fainting, cerebral aneurysm, dementia, Huntington chorea, Multiple Sclerosis -
Procalcitonin Reveals Early Dehiscence in Gastric Surgery: the PREDIGS Study

Background. Gastric cancer surgery is associated with high risk for postoperative morbidity and mortality. Anastomotic leak (AL) is one of the worst complications associated with relevant short and long-term sequelae. Procalcitonin (PCT) is a biomarker used to monitor bacterial infections and guide antibiotic therapy and has been shown to have better predictive value of AL after colorectal surgery than C-reactive protein (CRP) and white blood cell count (WBC).

Purpose. Investigators designed a monocentric pilot study to test if PCT might be a sensitive and reliable marker of AL after gastric surgery


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing all different kinds of gastric surgery (from partial to total gastrectomy) for cancer, WITH an anastomosis performed
* elective setting

Exclusion Criteria:

* age \< 18 years
* pregnant women
* patients undergoing gastric surgery for benign disease or other kinds of gastric surgery without an anastomosis being performed
EFFECTS OF RESISTANCE TRAINING IN ELDERLY

This comes from a non-randomized clinical trial, which aims to check on elderly women the effects of a program of resistance training (TR) in physical performance, in respiratory functional capacity, on health and quality of life.

Will be measured the strength of the respiratory muscles (Mip and Mep), peak expiratory flow (Peak-Flow), thoracic movements and abdominal movements, distance traveled in Incremental Shuttle Walk Test, grip strength manual, pulmonary leukocytes, biochemical parameters and indicators of quality of life and physical activity through the WHOQOL-old and IPAQ-short. The data will be tested against the distribution of the Gauss curve, by the shapiro-wilk test and, if they have a normal distribution (parametric) are expressed as mean and standard deviation, if not submit normal (non parametric) distribution will be expressed as median or range interquartílico. The first chance to compare the evolution of the group studied, will be applied to two-way ANOVA. If the distribution is abnormal, it will apply Mann-Whitney test. The multiple regression test will be used to compare the Mip and Mep with variables with the Peak-Flow, Thoracoabdominal mobility, distance traveled, immune competence, physical fitness and quality of life in the groups studied.

Eligibility Criteria:
Inclusion Criteria:

* 60 year old or more
* Do not have cardiac or respiratory diseases
* neurological, Musculoskeletal and other diseases preventing the practice of exercises
* not being a smoker; agree to participate in the study and signed an informed consent (IC); in the last six months preceding the evaluation did not have participated in physical activity program with the aim of improving physical performance.

Exclusion Criteria:

* Difficult to complete the tasks
* Acute diseases
* Refuse to continue the program
Expanded Access Protocol for STOMP-II Patients Who Were Unable to Receive Treatment Subsequent to Adipose Tissue Collection

The goal of this Expanded Access Protocol is to provide expanded access of AVB-114 to patients who had their fat tissue collected as part of a clinical trial (STOMP-II), but who were subsequently not treated with AVB-114 because they did not meet all eligibility criteria or the investigational product was not successfully manufactured.

AVB-114 is an autologous investigational product under evaluation in Seeded Cells on Matrix Plug Treating Crohn's Perianal Fistulas (STOMP-II; a prospective, multicenter, randomized, blinded outcome assessment, controlled, add-on therapy phase II study) for the treatment of complex perianal fistulas in subjects with Crohn's disease. EAP-STOMP2 is an expanded access protocol for patients who had adipose tissue collected per the STOMP-II protocol, but who were subsequently unable to receive AVB-114 treatment due to screen failure or product manufacturing issues and thus withdrew from the study. Patients will receive AVB-114 as deemed appropriate by investigator and Avobis Bio.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated ICF.
2. Adipose tissue previously collected per the STOMP-II protocol, but were subsequently unable to receive AVB-114 treatment due to screen failure or product manufacturing issues and thus withdrew.
3. Diagnosed with Crohn's disease and a target perianal fistula with one internal opening and at least one external opening.

Exclusion Criteria:

1. Suffer from any condition or illness that, in the opinion of the Investigator, would compromise patient safety.
2. Pregnant, trying to become pregnant, or are breast feeding. Women of childbearing potential (WCBP) and males who have sexual partners that are WCBP must agree to use an adequate method of contraception while participating in this EAP.
3. Known allergies or hypersensitivity to aminoglycosides.
4. History of clinically significant fat-directed autoimmunity.
5. Active, unresolved infection requiring parenteral antibiotics.
6. Unresolved abscess at time of treatment (if screening Pelvic MRI identifies an abscess, it must be resolved before treatment).
7. Target fistula with any of the following characteristics (note that presence of a second fistula tract that is distinctly separate from the target fistula, or a target fistula with a single internal opening and multiple external openings is not exclusionary):

   1. Target fistula has a branching blind ending sinus tract (no external opening) that investigator assesses to be at elevated risk of abscess formation if treated with AVB-114.
   2. Target fistula is a genito-urinary fistula, including rectovaginal (i.e., fistulae that transverse the vaginal canal).
   3. Any anatomical limitation to successfully securing the fistula plug disk.
Viscoelastic Properties of Respiratory and Peripheral Muscles of COPD Patients

The aim of this study was to compare the viscoelastic properties of auxiliary respiratory muscles and peripheral muscles of chronic obstructive pulmonary disease patients with healthy subjects. Myotonometry was used to evaluate the viscoelastic properties of the muscles. The viscoelastic properties of the sternoclaidus mastoid, pectoralis major, upper trapezius, deltoid, biceps brachii, rectus femoris, gastrocinemius, and tibialis anterior muscles were evaluated.

muscle viscoelastic properties; muscle tone, stiffness and elasticity. These features may vary due to muscle overuse, lack of relaxation and recovery. The aim is to investigate these differences in COPD patients and healthy individuals.

Eligibility Criteria:
Inclusion Criteria:

* male gender,
* body mass index (BMI) between 18.5-29.9 kg/m2,
* stable COPD patients

Exclusion Criteria:

* being in the acute exacerbation period for COPD patients,
* having undergone any neurological, orthopaedic or thoracic surgery,
* presence of malignancy in any organ,
* presence of comorbidities affecting muscle atrophy (myasthenia gravis, muscular dystrophy, etc.).
Effect of PTH(1-34) Treatment on Fracture Healing in Vivo

The purpose of the study is to investigate, whether PTH(1-34) is able to promote fracture healing in postmenopausal women with fractures of the hip or shoulder.


Eligibility Criteria:
Inclusion Criteria:

* Acute new osteoporotic trochanteric or collum chirurgicum fracture
* Postmenopause

Exclusion Criteria:

* Calcium metabolic disease other than osteoporosis
* Diseases known to affect calcium homeostasis
* Dementia
* Hypersensitivity to drug or other components of medication
* pre-existing hypercalcemia
* Decreased kidney function
* Increased alkaline phosphatase
* Prior external radiation therapy or brachytherapy of the skeleton
* Skeletal malignancies or bone metastases
* Alcohol and/or drug abuse
* Systemic treatment with corticosteroids within the last four weeks
* Non-cooperating patients
* Patients who do not speak and understand the danish language
Outcomes in Patients With Myeloproliferative Neoplasm and Splanchnic Vein Thrombosis

Patients with Myeloproliferative neoplasms are at particular risk for developing arterial and venous thrombosis, especially thrombosis in the splanchnic venous system. The patho-physiology and natural history of MPN related SVT is poorly understood and treatment algorithms vary greatly. This is of considerable importance since the morbidity and mortality in this group of patients is high. This study aims to observe patients with MPN related SVT over a period of five years to document their clinical progress. Methods of observation include clinical assessment, standard investigations and laboratory based research investigations

Study Title Morbidity and portal circulation in patients with Myeloproliferative neoplasms and splanchnic vein thrombosis: Mascot Protocol No. MPN-SVT v11; 02/Dec/2013 Study Design Prospective observational longitudinal study of patients with MPN related splanchnic vein thrombosis(study group) and patients with MPN without SVT (control group) Study Participants Patients with myeloproliferative neoplasms (MPN) and splanchnic vein thrombosis (SVT), patients with MPN and splenomegaly.

Number of subjects 40 patients Follow-up duration 5 years Study duration January 2014- January 2019. Primary Objectives 1. To describe morbidity/portal circulation in the patient group over the 18m from baseline 2. To examine if there are changes in endpoints from baseline to 18m 3. To compare patients with MPN related SVT and MPN without SVT Secondary Objectives 1. To describe morbidity/portal circulation in the patient group over 5 years from baseline 2. To examine if there are changes in endpoints from baseline to 5 years 3. To assess the impact of treatment including cytoreductive therapy, Janus kinase (JAK) inhibition and antithrombotic treatment on end points.

4. To assess adequacy of anti-thrombotic agents with reference to recurrence, recanalisation and extension of splanchnic thrombosis, non-splanchnic thrombotic events and bleeding frequency.

Exploratory objectives 1. Assess the utility of endothelial colony assay as marker of disease 2. Assess the utility of adhesion molecules as markers of disease

Primary Endpoint Composite end point comprising occurrence or change in morbidity or portal circulation over 18 months Secondary Endpoint Occurence or change in morbidity or portal circulation over 3-5 years

Eligibility Criteria:
Inclusion Criteria:

1. MPN with SVT between 3 weeks to 5 years of diagnosis of SVT: study arm
2. MPN with palpable splenomegaly or enlarged by Ultrasound: control arm

Exclusion Criteria:

Age \<18 years Patients with SVT without MPN
Association Study Between Periodontal Disease and Male Infertility

The aim of the present study is to examine the association between fertility parameters and the periodontal status of men attending fertility and in vitro fertilization clinic.

An association has been found between periodontal diseases and preterm low birth weight, coronary heart disease, and cerebral infarction. Anaerobic gram negative bacterial plaque that forms subgingivally is the direct causative factor for the development of Gingivitis and Periodontitis.

However, its possible association with male infertility have not yet been investigated.

Eligibility Criteria:
Inclusion Criteria:

* Consent to participate in study

Exclusion Criteria:

* Systemic uncontrolled disease