cyrilzakka/clinical-trials huggingface dataset:
Classical Guitar for Parkinson's Disease

The purpose of this study is to understand if training Parkinson's disease patients in classical guitar will improve motor function, mood, and quality of life. While medication has been found to be effective for many Parkinson's disease patients, many patients still have symptoms. Previous studies have found that music and rhythm-based activities can help Parkinson's disease symptoms. A previous study looked at the effect of playing classical guitar on Parkinson's disease symptoms. They found positive changes in Parkinson's disease symptoms that lasted for 6 weeks after the study ended. Further, there were positive changes in depression, anxiety, and quality of life.

Subjects will be asked to take part in classical guitar lessons once a week for six weeks and physical therapy once a week for six weeks. There will be 40 people enrolled in the study. Twenty people will have classical guitar lessons first and physical therapy second. The other twenty people will have physical therapy first and classical guitar lessons second. The study will last a total of 12 weeks. Each session will last 1-2 hours. Sessions will be held at the Northwest Chapter headquarters of the American Parkinson's Disease Association.

Examples of the types of activities subjects will do during the physical therapy sessions include finger exercises, tasks with both hands, tasks while standing, and tasks while walking.

Examples of the types of activities you will do during the classical guitar lessons include playing chords and songs on the guitar.

Subjects will have physical exams and complete questionnaires at the beginning of the study, at six weeks, and at the end of the study.

If subjects have Apple watches, they will be asked to download an application called StrivePD on their watch and iPhone. StrivePD is an application that allows subjects to keep track of their Parkinson's disease symptoms or set medication reminders, for example. When used with an Apple watch, it can automatically record symptoms like tremors. During this study, the StrivePD application will only be used to collect data about what percentage of the day they have tremors and how much they sleep.

Eligibility Criteria:
Inclusion Criteria:

* 50-90 years old
* Diagnosis with Parkinson's disease by a Movement Disorder specialist

Exclusion Criteria:

* Professional musician or formal music training
* Inability to play a classical guitar physically
* Inability to follow instruction
* Receiving physical therapy at the time of the study
* Unable to attend all sessions of study
Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease

Chronic obstructive pulmonary disease is a leading cause of mortality worldwide.

It is a systemic disease which includes pulmonary, cardiac, muscular, digestive and cognitive impairments.

Pulmonary rehabilitation is a symptomatic treatment to reduce dyspnea and functional incapacity. However, it effects on cognitive dysfunction are not well known.

The aim of this study is to assess the effects of a comprehensive pulmonary rehabilitation program on cognitive dysfunction in patients with severe to very severe chronic obstructive pulmonary disease using the Montreal Cognitive Assessment tool.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18years;
* Chronic obstructive pulmonary disease stade III to IV;
* Referred for pulmonary rehabilitation.

Non Inclusion Criteria:

* Pregnancy or likely to be;
* History of psychiatric, neuro-vascular, cognitive disease or cranial trauma;
* Active alcoholism;
* Guardianship;
* Hospitalisation for acute exacerbation of chronic obstructive pulmonary disease in the previous 4 weeks;

Exclusion Criteria:

* Interruption of the pulmonary rehabilitation program \> 15 days;
* Disruption of the training before the 18th session;
* Less than 18 sessions in four month.
Impact of Canine Mediation Practice in Psychomotor Therapy on Improving the Quality of Life in Adult Epileptic Patients.

In addition to the search for new pharmaceutical or surgical solutions that could improve the therapeutic management of epileptic individuals, it is interesting to ask whether other complementary approaches, such as canine mediation in psychomotor therapy, could enhance the quality of life in this population.

However, there is currently no evidence indicating that exposure to animals through mediation sessions would be beneficial for epileptic individuals, particularly regarding their quality of life, anxiety, emotional management, or cognition (such as social cognition). In the absence of current data in this population, it seems pertinent to study the impact of this practice on people with epilepsy. Furthermore, beyond quality of life, it would be valuable to examine whether it also influences anxiety or the frequency of seizures in individuals with epilepsy (a phenomenon reported for epileptic individuals living with a pet dog or a service dog). Canine mediation could help better manage and regulate the emotions of epileptic individuals, as well as improve their self-esteem.


Eligibility Criteria:
Inclusion Criteria:

* Person aged ≥ 18 years
* Presenting pharmacoresistant epilepsy according to the criteria of the International League Against Epilepsy
* Requiring psychomotor therapy sessions for one of the following indications:

Difficult emotional and relational management And/or global motor difficulties And/or body schema organization disorder And/or temporo-spatial disorder

* Explicit consent or no opposition to participation in the study by the patient and/or their legal representative or guardian
* Image rights consented by the patient and their legal representative or guardian, if applicable
* Hospitalization or residence at the Teppe Institute or at the FAM (Foyer d'Accueil Médicalisé) des 4 Jardins planned for at least 3 months
* Affiliated with or a beneficiary of a social security scheme

Exclusion Criteria:

* Fear or phobia of dogs
* Epileptic person benefiting from a legal protection measure other than guardianship or curatorship
* Person with insufficient cognitive abilities to respond to the questionnaires
* Pregnant or breastfeeding woman
Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome

The study is a multicentre randomized controlled trial with the objective to compare the effect of transanal irrigation with glycerol suppositories in patients suffering from major Low Anterior Resection Syndrome (LARS).

Transanal irrigation (TAI) is used as a second-line treatment following unsuccessful personalised conservative treatment (PCT) of LARS. However, it is unknown if scheduled, initiated defecation with the aid of a glycerol suppository will have the same clinical effect as TAI. Thus, the aim of this study is to compare the effect of TAI with a glycerol suppository in patients suffering from major LARS.

The study is a multi-centre, randomised, controlled, 12 weeks, parallel-group trial comparing treatment with TAI to treatment with glycerol suppositories. Patients will be randomised - stratified by centre and neoadjuvant radiotherapy - in a 1:1 ratio to receive treatment with TAI or glycerol suppositories. Primary endpoint will be assessed by the end of week twelve.

Eligibility Criteria:
Inclusion Criteria:

* Patients electively treated for rectal cancer with a low anterior resection.
* Unsuccessful PCT after at least 4 weeks of treatment for LARS (LARS score \>29 at evaluation).
* At least 3 months after surgery (including reversal of a temporary loop-ileostomy).
* Age \>= 18 years
* Ability to understand written and spoken language actual for the including site (due to questionnaire validity).

Exclusion Criteria:

* Former use of TAI
* Prior systematic use of rectal emptying aids
* Anastomotic stenosis
* History of anastomotic leakage
* Current metastatic disease or local recurrence
* Ongoing oncological treatment
* Postoperative radiotherapy for rectal cancer
* Previous or current cancer in other pelvic organs than the rectum
* Underlying diarrhoeal disease
* Inflammatory bowel disease
* Dementia
* Spinal cord injury, multiple sclerosis, Parkinson's disease or other significant neurologic disease assessed to be a contributory cause to LARS symptoms.
* Inability of patient to use TAI
* Inability and unwillingness to give informed consent
* Pregnancy or intention to become pregnant during the trial period
An Observational Study to Investigate the Effects of Rapid Transmeridian Travel

Observational study to investigate circadian rhythm patterns


Eligibility Criteria:
Inclusion Criteria:

* Ability and acceptance to provide written consent
* Men or women between 18-75 years
* Body Mass Index of ≥ 18 and ≤ 30 kg/m2

Exclusion Criteria:

* History (within the 12 months prior to screening) of psychiatric disorders
* Major surgery, trauma, illness or immobile for 3 or more days within the past month
* Pregnancy or recent pregnancy (within 6 weeks)
* A positive test for drugs of abuse at the screening visit
* Any other sound medical reason as determined by the clinical investigator
12- Week Open Label Treatment of Refractory Bipolar Depression

1. Determine the change in symptomatology and function in refractory bipolar depression, when treated with combination of DEP+AZP for a period of 12 weeks
2. Determine the tolerability and safety of AZP added to DEP in the treatment of refractory bipolar depression

)Determine the change in symptomatology and function in refractory bipolar depression, when treated with combination of DEP+AZP for a period of 12 weeks

2) Determine the tolerability and safety of AZP added to DEP in the treatment of refractory bipolar depression

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of bipolar disorder I or II according to M.I.N.I.
* patient has signed informed consent
* male, or female who is using effective birth control if of child bearing age
* age 18 and above
* currently in a depressed phase, with or without psychotic features, of the illness based on DSM-IV/MINI criteria
* score of more than 19 on the MADRS
* history of treatment refractory bipolar depression as defined by failure of the depressive episode to respond to a mood stabilizer alone or a combination of 2 or more mood stabilizers or a combination of a mood stabilizer and an antidepressant

Exclusion Criteria:

* current liver disease,
* illness precluding the use of depakote er
* patients who have been treated with a DEP and AZP combination in the past
* Alcohol/drug dependence in the past one month
* CNS neoplasms, demyelinating diseases, degenerative neurological condition or active CNS infection
* history of seizure, known EEG with frank paroxysmal activity, known CT of brain showing gross structural abnormalities, cerebral vascular disease by history or structural brain damage from trauma
* thyroid dysfunction
* unstable general medical condition
* require antipsychotic other than abilify
Regular Physical Exercise in Duchenne Muscular Dystrophy

This study examine whether an evidence-based individual user-preferred exercise program will increase the physical activity level in boys with Duchenne muscular Dystrophy (DMD).

Regular physical activity is recommended in DMD. However, due to progression of muscle weakness and loss of function, a sedentary lifestyle is normal, and disuse of still functioning muscles leads to a secondary deterioration. Use of steroids have proven to decrease the rate of progression, and also leads to adverse advents like obesity and osteoporosis.

Use of muscle strength training and aerobe exercise in DMD, may optimize muscle function, cardio-respiratory fitness and overall physical activity level, in addition to decrease possible adverse advents.

In this study, children with DMD attending Haukeland University Hospital will be invited to participate (N≈14). The participant's physical activity level is registered during a four week baseline period and follow up. At start, 6 months and 12 months, a five day hospital stay will be conducted, both for testing and to prescribe an individual user preferred physical exercise program. The exercise program will be performed at home between the hospital visits. Benefits, safety and feasibility of regular physical exercise will be examined during follow-up and end of study. For comparison of the physical activity level and motor function, DMD children attending standards of care follow-up at others Norwegian regional pediatric rehabilitation clinics will be invited to participate in a control group.

Eligibility Criteria:
Inclusion Criteria:

* Patients with conclusive DMD diagnosis
* Written consent
* Able to perform physical exercise and answer questions

Exclusion Criteria:

* Lack of consent
* Cognitive disabled unable to answer questionnaire, understand instructions, and able to know what they participate in.
* Language difficulties
Painful Diabetic Peripheral Neuropathy Study of Chinese OutPatiEnt

Painful Diabetic peripheral Neuropathy Study of Chinese OutPatiEnt (PDN-SCOPE): a multi-center cross-sectional registry study of clinical characteristics and treatment survey of PDN in China

Painful diabetic peripheral neuropathy (PDN) presents a serious health problem in China. SCOPE is a cross-sectional, multi-centers registry study with a target sample size of 1500 patients who are experiencing PDN. The patients are treated following guideline and local practice. Real-world data including demographics, medical histories, VAS, PHQ, GAD -7 and therapies are collected. The primary objective is to analyze the clinical characteristics of PDN. The secondary objectives include anxiety depression distribution and current treatment status.The SCOPE study will help to find actual clinical manifestation and treatment and improve the overall treatment outcome of Chinese patients with PDN.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older patients
2. definite diagnosis of type I and type II diabetes
3. evidence of symptoms, signs and/or electrophysiology of diabetic peripheral neuropathy
4. complains of spontaneous pain (continuous or intermittent needle pricking, electric pain, burning pain etc.) or induced pain (hypersensitivity, sensory inversion).
5. the pain lasts for at least 3 months
6. signed informed consent

Exclusion Criteria:

1. other causes of neuropathic pain, non-neuropathic pain or mixed pain, such as neck / lumbar degenerative disease, arthritis, nerve root compression, para-neoplastic syndrome, cerebrovascular disease, spinal cord diseases and other peripheral neuropathy (immunity, toxic and nutritional neuropathy etc.)
2. dementia, substance abuse etc. and other conditions seriously affecting cognitive and communication skills
Methadone Associated With Morphine for Cancer Pain

The study was prospective, randomized. Patients with cancer pain were evaluated, one group receiving methadone with morphine and another group receiving morphine as the only opioid. Pain intensity, total morphine dose and adverse effects were evaluated.

Opioids are the most important analgesics for the relief of cancer pain. In addition tolerance and hyperalgesia may ocurr as a consequence of treatment with these drugs. Medications for pain relief may also cause increased pain. NMDA receptor blockers may prevent or reduce the development of hyperalgesia. Methadone is a weak NMDA receptor antagonist and therefore its association could prevent hyperalgesia. The primary endpoint of the study was whether the administration of low dose methadone associated with morphine promotes better analgesic effect in patients with cancer pain, And secondarily to assess whether there is a reduction in the total dose of opioid needed for pain relief, and whether reduction of the opioid-related adverse effects occurs.

Eligibility Criteria:
Inclusion Criteria:

* Approved by the Ethics Committee
* signed the informed consent
* cancer pain
* starting the WHO thirth analgesic ladder,

Exclusion Criteria:

* cognitive impairment
* psychiatric disease
* illicit drug user
* hypersensitivity to the study drugs
* pregnant
COX Inhibition and Biomarkers During Neoadjuvant Chemoendocrine Therapy for ER+, HER2- Stage I-III Breast Cancer

This study is designed to assess the safety and clinical activity of tamoxifen and the COX inhibitor, aspirin, given in combination with standard AC-T chemotherapy (doxorubicin, cyclophosphamide, and paclitaxel) for the treatment of high-risk estrogen receptor (ER)+, human epidermal growth factor receptor 2 (HER2)- breast cancer. If successful, the study could improve long-term outcomes for a subpopulation of women with aggressive stage I-III ER+/HER2- breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 18 or older
4. Newly diagnosed with ER+/HER2- stage I-III breast cancer according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines and the 8th edition of the American Joint Committee on Cancer (AJCC); ER positive is defined as ≥ 1% positive nuclear staining
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
6. Life expectancy ≥ 6 months
7. Women of childbearing potential and men must agree to use adequate contraception (see section 5.4) prior to study entry and for at least 3 months following the last dose of tamoxifen
8. If genomic profiling has been performed (OncotypeDx, Mammaprint or other), then the score must be in a medium- or high-risk range.
9. Adequate Organ Function as described below. There are no requirements regarding recent transfusions Absolute Neutrophil Count ≥1000/mm3 Platelets ≥100,000/mm3 Hemoglobin ≥9 g/dL Serum Creatinine or Glomerular Filtration Rate (GFR) ≤ 1.5 x upper limit of normal (ULN) Bilirubin ≤ 1.5 x ULN (except in patients with Gilbert's disease, where bilirubin to 4x ULN or direct bilirubin ≤ ULN is allowed) Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x ULN Alkaline phosphatase ≤ 2.5 x ULN
10. Ability to take oral medication

Exclusion Criteria:

1. Receipt of any systemic treatment for the current diagnosis of breast cancer (breast biopsy, excisional biopsy, or other local therapy is acceptable as long as residual disease is present and is appropriate for systemic chemotherapy and additional curative intent resection)
2. Current use of anticoagulant (e.g. warfarin (Coumadin), heparin, direct oral anticoagulants (DOAC)) within 72 hours of registration
3. Pregnancy or lactation
4. Currently in prison
5. Requirement for supplemental oxygen therapy
6. Current active cancer other than breast cancer
7. History of severe bleeding that, in the treating investigator's opinion, would put the patient at increased risk with daily 325 mg aspirin use
8. Known allergic reactions to aspirin, tamoxifen, doxorubicin, cyclophosphamide, or paclitaxel
9. Participants classified according to the New York Heart Association classification as having Class II - IV heart disease (section 12.2)
10. History of thrombosis or cerebrovascular accident
Radiation Exposure in Spine Intervention Under Angiography

Evaluate radiation exposure and procedure times for continuous fluoroscopic monitoring during lumbar ESI

The purpose of this prospective study was to evaluate radiation exposure and procedure times for fluoroscopic monitoring during lumbar ESI with analyzing the differences among operators (experienced staff and trainee) and among different method for ESI.

Eligibility Criteria:
Inclusion Criteria:

* Suspected of having radiculopathic low back pain

Exclusion Criteria:

* Angiography is contraindicated
E-health Intervention in Women With Pregnancy Distress

The study aims to reduce the levels of distress (depression and anxiety) during pregnancy. The study investigates the effectiveness of an eHealth pregnancy distress-reducing mindfulness training in women with pregnancy distress.

During pregnancy, women are at risk for mental health problems: up to 20% present with distress symptoms (depression and/or anxiety). Apart from the adverse effects on the woman herself, pregnancy distress negatively affects pregnancy outcome, infant health, postpartum mother-child interaction and child development.

Mindfulness-based interventions are a type of intervention that is increasingly being used to treat symptoms of stress, anxiety and depression. They are cheap and accessible to the whole population.

Current study aims to examine the effectiveness of a mindfulness training to reduce distress during pregnancy. Women who score above cut off on the Edinburgh Depression Scale (EDS) and Tilburg Pregnancy Distress Scale (TPDS) at 12 weeks of gestation, will be randomly allocated to the intervention or control group. Women in the intervention group will be contacted and invited to participate in the mindfulness-based intervention, which consists of 8 weeks of internet mindfulness training. The control group will receive care as usual.

The primary outcome of the study is: Does the mindfulness internet training "Ontspannen zwanger", offered during pregnancy, reduce pregnancy distress, compared to care as usual? The secondary outcome is: Does the mindfulness internet training result in better mindfulness skills?

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women (18+y) who have their first antenatal visit \< 12 weeks;
* Score above cut off on the Edinburgh Depression Scale (EDS) and Tilburg Pregnancy Distress Scale (TPDS) at 12 weeks of gestation;
* Dutch-speaking or understanding Dutch.

Exclusion Criteria:

* Gemelli pregnancy (or higher order pregnancy);
* Known endocrine disorder before pregnancy (diabetes-I, Rheumatoid arthritis);
* Severe psychiatric disease (schizophrenia, borderline or bipolar disorder);
* HIV;
* Drug or alcohol addiction problems;
* Any other disease resulting in treatment with drugs that are potentially adverse for the fetus and need careful follow-up during pregnancy;
* No access to the internet.
Competency Training, Staff Performance, & Family Outcomes

This proposal examines the impact of an augmented competency based approach to training of home visitors and supervisors for delivery of the Nurse Family Partnership (NFP) on staff performance, fidelity to the program model, and family outcomes relative to child maltreatment and early behaviors associated with youth violence. The central premise underlying the proposed study is that the augmented competency based curriculum and clinical consultation to supervisors will improve nurses' knowledge and skills in working with families, which in turn, will lead to greater fidelity to the home visit guidelines (i.e., quality implementation), which in turn, will result in better maternal and child health outcomes.

A two group experimental design will be used to examine the impact of an augmented competency-based curriculum for NFP home visitors and supervisors coupled with structured clinical consultation by NFP National Office professional development staff, as compared against the standard curriculum currently used, on quality of program implementation and family outcomes.

Eligibility Criteria:
Inclusion Criteria:

* First time mothers (enrolled during pregnancy) and their children

Exclusion Criteria:

* See above. No other exclusion criteria will be used.