cyrilzakka/clinical-trials huggingface dataset:
The Effects of Treadmill Training With Visual and Auditory Cues on Gait Parameters in Parkinsonian Patients in Advanced Stages of Disease.

The first aim of this study was to evaluate the effect of a gait training using treadmill with visual and auditory cues in patients in stages IV Hoehn \& Yahr (H\&Y). The second aim was to compare the obtained data of these patients in advanced stages with those in mild to moderate stages.

Gait is altered in Parkinson's disease (PD) patients. It has been shown that treadmill training with visual and auditory cues is useful in improving the gait's parameters in patients in early-moderate stages of disease. No data are available about the effectiveness of this training in those subjects in advanced stages of PD. The first aim of this study was to evaluate the effect of a gait training using treadmill with visual and auditory cues in patients in stages IV Hoehn \& Yahr (H\&Y). The second aim was to compare the obtained data of these patients in advanced stages with those in mild to moderate stages.

150 patients with PD in early-moderate and advanced stages of disease (50 in H\&Y stage 2, group 1, 50 in H\&Y stage 3, group 2 and 50 in H\&Y stage 4, group 3) were enrolled. All patients underwent an intensive treatment: 20-minutes treadmill training per day, 6 times a week, for 4 weeks. Treadmill speed was previously set at 2.0 km/h and progressively increased until a maximum of 3.5 km/h, taking always into account the patients' physical abilities. All patients were evaluated at the enrolment and at the end of the 4-weeks treatment. The first evaluation consisted in one-minute walking on treadmill without the use of cues at 1.5 km/h speed, for all patients. The outcome measurements were: the average length of the right step, the average length of the left step, the coefficient of variance of both steps, and the gait cycle.

Eligibility Criteria:
Inclusion Criteria:

Parkinson Disease

Exclusion Criteria:

comorbidity with other neurological condition
A Pilot Study on Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment of Bipolar Depression

This is a pilot project to study if repetitive Transcranial Magnetic Stimulation (rTMS) will benefit patients with bipolar depression safely. Based on published studies, this study hypothesizes that rTMS on the left dorsal prefrontal lobe will improve symptoms in some patients who have failed at least two medications.

Candidate with bipolar depression will be screened after signing informed consent. Those who meet the selection criteria will be treated with daily rTMS for 3 weeks and be followed-up at 2 weeks. Participants will keep their ongoing medication unless a medication significantly increases the possibility of seizure. They must be on the same dose of antidepressant medication for least 4 weeks without improvement of symptoms before being recruited into the study. Mood and other observed mental status will be measured by standard psychological scales.

Eligibility Criteria:
Inclusion Criteria:

* bipolar I or II patients, currently in a depression episode
* Patient must have failed at least 2 medication
* Score of 21-item Hamilton Rating Scale for Depression (HAM-D)

Exclusion Criteria:

* Rapid cycling bipolar or mixed episode of mood disorder by definition of current DSM criteria
* Substantial risk of suicide during the screening period that requires inpatient care
* Presence of psychosis
* Dual diagnosis of other primary, currently clinically significant severe mental disorders
* History of other significant neurological diseases, such as seizure disorder, stroke, brain tumors, abnormalities in the blood vessels in brain, dementia, Parkinson's disease, Huntington's chorea or multiple sclerosis
* History of any medical event that may increase the risk of having seizure, such as head trauma with unconsciousness for more than 5 minutes or a family history of seizure
* Significant medical complications that may deteriorate during the trial or have increased likelihood of danger consequences
* Patients who are pregnant or intend to become pregnant during the study period
* Any metallic prosthesis in head, neck or upper body (including cardiac pace maker) that cannot be safely removed during treatment
* Current Vagus Nerve Stimulation (VNS) treatment or Electroconvulsive Therapy (ECT) treatment, or with history of failed ECT treatment
* Patient's Motor Threshold for TMS cannot be detected
* Significant side effects which are intolerable during the screening or any later stage of the trial
* Started psychotherapy within the previous 8 weeks or foreseeable psychotherapy will be started or changed in 6 weeks
Flu Vaccine Response in Patients on Biologic Therapies

This proposed study will assess the immunogenicity, safety, and clinical efficacy of an influenza vaccine booster dose strategy in patients with autoimmune diseases who are receiving immunosuppressive therapies. Investigators will compare serologic responses to single versus a booster dose of influenza vaccine in patients with inflammatory bowel disease (IBD- Crohn's Disease or Ulcerative Colitis) or rheumatologic diseases who are receiving immunosuppressive therapies. Subjects will be randomized to receive either one or two doses of influenza vaccination in year #1. In year# 2, all participants will be given two doses of influenza vaccine. Serologic responses will be measured pre and 4-6 weeks post vaccination. This study will also assess the immunogenicity and safety of a booster vaccine strategy in the prevention of influenza-like illness (ILI). Investigators anticipate that booster dose strategy will improve both clinical and serologic responses in this vulnerable population.


Eligibility Criteria:
Inclusion Criteria:

* Children ages 3-22 years
* Rheumatologic condition (JIA, Uveitis, SLE and other rheumatologic disorders) or inflammatory bowel disease (Crohn's disease or ulcerative colitis) and who are receiving immunosuppressive therapies as follows:

  * TNF inhibitors \[etanercept (Enbrel), adalimumab (Humira®), infliximab (Remicade®)\]
  * anti IL -1 \[anakinra (Kineret®) or canakinumab (Ilaris®)\]
  * IL-6 tocilizumab (Actemra®)
  * anti IL-12/23 ustekinumab (Stelara®)
  * anti CTLA-4 \[abatacept (Orencia®)\]
  * vedolizumab (Entyvio®)
  * azathioprine (Imuran®)
  * 6 mercaptopurine (Purinethol®)
  * Cyclosporine
  * Leflunomide
  * Mycophenolate
  * methotrexate (Otrexup® or Rasuvo®)

Exclusion Criteria:

* Prior allergic reaction to any vaccine components
* Other contraindication to influenza vaccination
* Severe egg allergy
* Pregnancy
* Prior Guillain-Barre syndrome
* Therapy with oral corticosteroids ≥2 mg/mg/day within 4 weeks of study entry
* Prior rituximab
* Prior cyclophosphamide
* Prior IVIG within 8 weeks
* Acute febrile illness at time of study evaluation
* No prior history of two doses of influenza in the past for ages 3-8 years
The Impact of Intraoperative Systemic Lidocaine Infusion on Chronic Postoperative Pain After Video-assisted Thoracic Surgery (VATS)

Systemic lidocaine infusion may improve the patients' chronic post surgical pain after video-assisted thoracic surgery


Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 65 years
* ASA class 1 and 2
* Patients who are scheduled for video-assisted thoracic surgery

Exclusion Criteria:

* Allergy to local anesthetics or contraindication to use of lidocaine
* Pregnancy
* Severe cardiovascular disease
* Renal failure
* Liver failure
* Neurologic and psychologic disease
* Chronic treatment with analgesics or chronic pain patients
* Previous history of thoracic surgery (open or video-assisted)
* Patients' refusal
System Accuracy of the Blood Glucose Monitor for Personal Use JT100

This study assesses the system accuracy a blood glucose monitoring systems pursuant to ISO 15197

This study assesses the system accuracy the blood glucose monitoring systems for personal use TJ100 pursuant to ISO 15197:2015 guidelines

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients with clinical indication for blood glucose testing
* Signed form of consent
* Minimum age of 18 years
* Subjects are legally competent and capable to understand character, meaning and consequences of the study

Exclusion Criteria:

* Pregnancy or lactation
* Severe acute disease (at study physician's discretion)
* Acute or chronic diseases with inherent risk of aggravation by the procedure (at study physician's discretion)
* Current constitution that does not allow participating in the study (e.g. hematocrit out of
* the devices's specifications, medication known to influence blood glucose measurements; Appendix A of ISO 15197)
* Being unable to give informed consent
* Age younger than 18 years
* Legally incompetent
Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea Pedis

To demonstrate comparable safety and efficacy of Taro Pharmaceuticals Inc. butenafine hydrochloride cream 1% (test product) and Lotrimin Ultra® cream (reference listed drug) in the treatment of interdigital tinea pedis, and to show the superiority of the active treatments over that of the placebo (vehicle).


Eligibility Criteria:
Inclusion Criteria:

* Microbiologically confirmed clinical diagnosis of interdigital tinea pedis
* If female and of child bearing potential, prepare to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., condom, intra-uterine device (IUD), oral, transdermal, injected or implanted hormonal contraceptives).
* A confirmed clinical diagnosis of interdigital tinea pedis. Lesions are to be predominately interdigital but may extend to other areas of the foot (the non-interdigital lesions must not be hyperkeratotic).
* The presence of tinea pedis infection, confirmed by the observation of segmented fungal hyphae during a microscopic potassium hydroxide (KOH) wet mount examination (potassium hydroxide mount preparation).
* Identification of an appropriate dermatophyte by culture sent to the central laboratory. The appropriate dermatophytes are Trichophyton rubrum, Trichophyton mentagrophyte or Epidermophyton floccosum.

Exclusion Criteria:

* Use of any of the following within the indicated timeline:
* Oral or injectable steroids
* Any oral anti-fungals within 4 weeks of the study start
* Use of topical corticosteroids or any other topical antipruritics on the feet within 72 hours of the study start.
* Any prescription or over-the-counter (OTC) topical antifungals on the feet within two weeks prior to study entry
* Use of any antihistamines within 72 hours of the study start.
* Any known hypersensitivity to butenafine or other antifungal agents.
* Evidence of any concurrent dermatophytic infection of toe nails (onychomycosis) or other dermatological condition of the foot that may interfere with the Investigator's evaluation of tinea pedis.
* Patients with recurrent tinea pedis (more than 3 infections in the past 12 months) who have been unresponsive to previous antifungal therapy.
A Controlled, Blinded Study to Validate the Diagnostic Accuracy and Assess the Clinical Utility of a Host-response Based Diagnostic Tool for Distinguishing Between Bacterial and Viral Etiologies in Pediatric Patients Presenting to the ED With Suspicion of Acute Infection

To externally validate the diagnostic accuracy and assess the clinical utility of a host-response based diagnostic tool called ImmunoXpert™, for differentiating between bacterial and viral etiologies in pediatric patients \>3 months old with suspicion of Respiratory tract infection (RTI) or Fever without Source (FWS)


Eligibility Criteria:
Inclusion Criteria:

* Documented peak temperature ≥ 38°C (100.4°F) (AND)
* Symptom duration ≤ 7 days (AND)
* Clinical suspicion of RTI (OR)
* Fever without a clear source (OR)
* Acute gastroenteritis (OR)
* Urinary tract infection

Exclusion Criteria:

* Antibiotic treatment of over 48 hours' duration at time of presentation
* Another episode of febrile infection within the past 2 weeks
* A proven or suspected HIV1, HBV, or HCV infection
* Congenital immune deficiency (CID)
* Active malignancy
* Current treatment with immune-suppressive or immune-modulating therapies, including without limitations:

  * Use of high dose steroids \>1 mg/kg/day prednisone or equivalent in the past two weeks Monoclonal antibodies, anti-TNF agents
  * Intravenous immunoglobulin (IVIG)
  * Cyclosporine, Cyclophosphamide, Tacrolimus
  * G/GM-CSF, Interferons
* Other severe illnesses that affect life expectancy and quality of life such as:

  * Moderate to severe psychomotor retardation
  * Post-transplant patients
  * Moderate to severe congenital metabolic disorder
Diagnostic Challenges in IC (and Male CPPS)

The etiology and pathogenesis of interstitial cystitis (IC) and its related condition in men, chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) has remained elusive. This has hampered development of mechanistic treatment strategies for these common, chronic and distressing medical conditions. We believe that IC and perhaps CP/CPPS are a spectrum of complex but inter-related genetic and acquired diseases resulting from the interaction of several genes regulating immune/inflammatory and neurogenic parameters and environmental factors/circumstances or exposure, culminating in the combination of pain, frequency, urgency and sexual specific symptoms. New research has delineated the dynamic and powerful association of the immune and neurogenic system in pain activation. An immune-modulated neurogenic model of IC illuminating the action of immune derived substances and pain related substances might be important in discovering the determinants of pain, voiding dysfunction and gender specific sexual problems. This inter-related dynamic model of IC disease pathogenesis could be explored for potential avenues leading to novel diagnostic and treatment strategies. We plan to identify and evaluate the sensitivity and specificity of several novel nerve and inflammation related markers in the diagnosis and follow up of IC (and CP/CPPS). By correlating the levels of urine immune and pain related substances to disease mechanisms, severity and progression, we may be able to create a human disease specific model for diagnosis and treatment.


Eligibility Criteria:
Inclusion Criteria:

* Participant has signed and dated the appropriate Informed Consent document.
* Participant must have had symptoms of discomfort or pain in the pelvic region for at least a three (3) month period within the last six (6) months.

Exclusion Criteria:

* Major structural/anatomical urinary tract abnormalities
* Underlying inborn conditions
Comparison of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP and IPV Separately Administered Vaccines in Terms of Immune Response and Safety

The aims of this study are to compare the immunogenicity and safety of the GSK Biologicals' combined DTaP-IPV vaccine with separate administration of DTaP and IPV vaccines, when administered as a fifth dose of acellular pertussis vaccine to children aged 4 to 6 years when co-administered with MMR vaccine in subjects who had previously received four doses of Infanrix, three doses of poliovirus-containing vaccine and MMR vaccination.


Eligibility Criteria:
Inclusion Criteria:

* Healthy children between and including 4 and 6 years of age.
* Previously received 4 doses of GSK Biologicals' DTaP, 3 doses of IPV vaccine and 1 dose of measles, mumps, and rubella vaccine.

Exclusion Criteria:

* Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the administration of study vaccines, or planned use during the study period.
* Chronic administration or planned administration of immunosuppressants or other immune modifying drugs within six months prior to study vaccination or planned administration during the study period
* Administration of immunoglobulins and/or blood products within 3 months prior to vaccination.
Natural History Study for Patients With Nemaline Myopathy in the UK

The goal of this study is to to learn more about what assessments would be useful to measure for NM and what normally happens during the lives of people with NM to support future clinical trial development.

Current treatments for people living with nemaline myopathy are supportive only. Several potential therapies are in development which may be available in the next 5-10 years. The barrier to these becoming available is that there is little data available on the natural progression (natural history) of nemaline myopathy. This means that it would be difficult to do a clinical trial of a treatment because it is not known which assessments would be useful to measure or what normally happens during the lives of people with NM.This study aims to better define the natural history and disease specific outcome measures and biomarkers.

This study will comprehensively evaluate the natural clinical progression of the disease using medical data and examination findings, scales and questionnaires for the assessment of motor function, breathing, swallow function and Quality of life and fatigue. In addition it will collect data on continuous movement and gait analysis using real world data and wearable sensors (Syde and Maiju), blood samples for future genetic and proteomic analysis and respiratory analysis using ventilatory and thoraco-abdominal pattern for paediatric participants.

Eligibility Criteria:
Inclusion Criteria:

* Patient and/or parent or legal guardian must be willing and have the ability to provide written informed consent for participation in the study.
* Male or Female
* Any age
* Diagnosis of NM which in most cases includes having a disease-causing variant/s in one of the known NM causative genes and a consistent clinical phenotype.

Exclusion Criteria:

* Any confirmed chronic or acute condition or disease affecting any system(s), which could interfere with the results of the study and/or the compliance with the study procedures. This will be subject to the clinical judgement of the Chief Investigator (CI) and/or the Principal Investigator (PI).
* Clinically significant medical finding on the physical examination other than NM that, in the judgment of the Investigator, will make the patient unsuitable for participation in, and/or completion of the study procedures.
* Participants of ongoing (interventional) clinical trials that assess the efficacy of potential treatments will be excluded as assessments need to be done on the basis that represent the natural progression of NM.
* Safety concerns. This includes anything that might put the participant and/or their Parent(s) or Guardian(s) at risk through participating in the study potentially including but not limited to: Safeguarding concerns, Social Issues and Health issues.
Strength Training as Prevention and Treatment of Late Effects in Long-term Survivors of Pediatric HSCT.

Today the overall survival of childhood cancers has increased to above 85%. This increase is partially caused by treatment with bone marrow transplantation. A bone marrow transplantation is an efficient treatment against high-risk leukemia, as well as other life-threatening immunological and hematological diseases. However, it is unfortunately also related to the risk of developing a long series of late effects during early adulthood, such as low muscle mass, cardiovascular disease and diabetes. Conditions known from the older generations of the general population and also conditions highly related to lifestyle factors in the general population.

In the group of survivors after bone marrow transplantation, the cause for these late effects is not fully understood, as the same close association to lifestyle factors as seen in the general population, is not present in this group. Multiple studies have examined the possible causes, and it have been shown that certain elements of a bone marrow transplantation, ie. total body irradiation, are associated with the risk of developing late effects. As the cause is not fully understood, it is not known whether the treatment and preventive strategies, that would be applied in the general population for these conditions, are effective in this group.

Therefore, in this study the investigators aim at examining the effect of a strength training intervention on the development of the aforementioned late effects to treatment with bone marrow transplantation during childhood.

The investigators will invite a group of persons, transplanted during childhood, as well as an age- and sex-matched control group to participate in the study. Both groups will go through a 16-week strength training intervention, and a thorough health examination before and after the intervention, to assess metabolic status and body composition.

If the investigators find a positive effect of strength training on muscle mass and risk factors for developing cardiovascular disease and diabetes in persons, treated with bone marrow transplantation during childhood, it will support the implementation of structured training programs in the follow-up of these patients. Thereby hopefully contributing to an increased quality of life, as well as an increased life expectancy in the group of survivors after bone marrow transplantation during childhood.


Eligibility Criteria:
Inclusion Criteria:

* Living in Copenhagen, Denmark or surrounding area - making it possible to engage in strength training 3 times a week at Bispebjerg Hospital, Copenhagen, Denmark.
* ≥ 18 years old

Exclusion Criteria:

* Illness or physical handicap making it impossible to participate in the training intervention
* Pregnancy
* Not Danish or English speaking
* Anemia
* Already performing regular structured physical training
* Strict vegan or vegetarian diet
* Illness or ongoing treatment that hinders study examinations
Home Administration of FluMist by Parents/Caregivers

This study will examine the feasibility of having parents and caregivers administer FluMist live intranasal vaccine to their children at home outside the traditional medical environment and without the involvement of medical personnel.

The study will recruit patients and families that are already eligible to receive the FluMist vaccine. After consent is obtained and vaccine is given to the family, they will go home to administer vaccine to other members within 24 hours. Telephone follow up within 48 hours will confirm that vaccine was given successfully and within 9-12 days to assess patient preferences for giving vaccine at home and if there were any adverse events.


Eligibility Criteria:
Inclusion Criteria:

1. The primary caregiver must be 18 years of age or older and willing to give written informed consent for study participation
2. The primary caregiver must be the parent or legal guardian of all the children in living in the household
3. All the children in the household who are 2 through 17 years of age must receive their primary care in the clinic
4. All the children in the household who are 2 through 17 years of age must have private insurance that will provide for the cost of influenza vaccination
5. There must be at least one member of the household who is 2 through 17 years of age, presenting for care in the clinic, eligible to receive Live Attenuated Influenza Vaccine (LAIV) and whose primary care giver is willing to administer LAIV to them in the clinic with supervision
6. There must be at least one family member of the household who is 2 through 17 years of age, not presenting for care in the clinic, eligible to receive LAIV and whose primary care giver is willing to administer LAIV to them in the in-home setting
7. There must be a working refrigerator in the household
8. The primary caregiver must have a working telephone number and be willing to be contacted for study follow-up by telephone or e-mail
9. The primary caregiver is available for the entire study period - 12 days following the last dose of LAIV to be administered to a child
10. The primary caregiver must agree to complete a 30 minute post vaccination assessment and an 8 day diary following vaccination for each child receiving LAIV.

Exclusion Criteria:

1. Children in the family receive vaccine through Vaccines for Children program